Adcetris (brentuximab vedotin)

What is Adcetris?

Adcetris is a brand-name prescription medication that’s used to treat certain forms of lymphoma in adults. Lymphoma is a form of cancer that affects your lymphatic system and certain white blood cells called lymphocytes.

Specifically, Adcetris is FDA-approved to treat:

• Classical Hodgkin lymphoma (cHL). Adcetris treats cHL that either:
  • Is stage 3 or stage 4 and has not been treated yet.*
  • Has a high risk of relapse (coming back) or progression (getting worse) after a stem cell transplant.
  • Has relapsed after having a stem cell transplant. Or, if a stem cell transplant isn’t possible, has relapsed after at least two courses of chemotherapy with multiple drugs.
• Certain types of T-cell lymphoma. Adcetris treats the following forms of T-cell lymphoma, which are also types of non-Hodgkin lymphoma:
  • Certain types of peripheral T-cell lymphoma, including systemic anaplastic large cell lymphoma (sALCL), that haven’t been treated yet.*
  • sALCL that’s relapsed after at least one course of chemotherapy with multiple drugs.
  • Primary cutaneous anaplastic large cell lymphoma and a type of mycosis fungoides, either of which have relapsed after systemic treatment†.

For more information about the types of cancer that Adcetris is used to treat, see the “Adcetris uses” section below.

* Adcetris is taken with certain chemotherapy drugs to treat these forms of lymphoma.
† Systemic treatment is treatment that affects the entire body.

Drug details

Adcetris contains the active drug brentuximab vedotin. Adcetris contains both a monoclonal antibody and a chemotherapy drug.*

Adcetris works to lower the amount of lymphoma cancer cells in the body. It’s a targeted therapy for lymphoma. This means the drug targets (works precisely on) cancer cells and destroys them. The goal of targeted therapy is to cause less of an effect on healthy cells, compared with traditional chemotherapy.

Adcetris is available in one strength: 50 milligrams (mg). It comes as a powder in a single-dose vial. The powder is mixed into a liquid solution, which is then given by your healthcare provider as an intravenous (IV) infusion. (An IV infusion means the drug is injected into your vein over time.) You’ll likely have Adcetris infusions every 2 or 3 weeks.

* For details about these two drug types, see the “How Adcetris works” section below.

Effectiveness

Clinical studies have shown Adcetris to be effective in treating all of the forms of lymphoma for which it’s approved. For information about the effectiveness of Adcetris, see the “Adcetris uses” section below.

Adcetris generic or biosimilar

Adcetris is available only as a brand-name, biologic drug. It’s not currently available in a biosimilar form. A biosimilar medication is a drug that’s similar to a brand-name biologic drug.

Biologic drugs are made from living cells. It’s not possible to copy these drugs exactly. A generic, on the other hand, refers to drugs made from chemicals. A generic is an exact copy of the active drug in a brand-name medication.

Biosimilars are considered to be just as safe and effective as their parent drug. And like generics, biosimilars tend to cost less than brand-name medications.

Adcetris cost

As with all medications, the cost of Adcetris can vary.

The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

It’s important to note that you’ll have to get Adcetris at a specialty pharmacy. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or may require help from healthcare professionals to be used safely and effectively.

Before approving coverage for Adcetris, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Adcetris, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Adcetris, or if you need help understanding your insurance coverage, help is available.

Seattle Genetics, Inc., the manufacturer of Adcetris, offers a program called SeaGen Secure. For more information and to find out if you’re eligible for financial support, call 855-473-2873 or visit the program website.

Generic or biosimilar version

Adcetris is available only as a brand-name, biologic drug. It’s not currently available in a biosimilar form.

A biosimilar medication is a drug that’s similar to a brand-name biologic drug. Biosimilars tend to cost less than brand-name medications. For more information, see the “Adcetris generic or biosimilar” section above.

Adcetris side effects

Adcetris can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Adcetris. These lists do not include all possible side effects.

For more information about the possible side effects of Adcetris, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs they have approved. If you would like to notify the FDA about a side effect you’ve had with Adcetris, you can do so through MedWatch.

Mild side effects

Mild side effects of Adcetris can include*:

• infusion-related reactions†
• fatigue (lack of energy)
• nausea and vomiting†
• diarrhea†
• constipation
• abdominal (belly) pain†
• upper respiratory tract infections, such as the common cold
• fever
• hair loss
• weight loss
• stomatitis (soreness or inflammation inside your mouth)
• mucositis (inflammation or ulcers on the lining of your digestive tract)

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Adcetris. To learn about other mild side effects, talk with your doctor or pharmacist, or see Adcetris’s prescribing information.
† For more information about these side effects, see “Side effect details” below.

Serious side effects

Serious side effects from Adcetris aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• Lung problems, such as lung inflammation or respiratory distress syndrome. Symptoms can include:
  • new or worsening cough
  • new or worsening trouble breathing
• Liver damage. Symptoms can include:
  • fatigue
  • loss of appetite
  • pain in your upper right abdomen (belly)
  • dark urine
  • yellowing of your skin or the whites of your eyes
• Serious skin reactions. Symptoms can include:
  • flu-like symptoms, such as fever, shivering, and body aches
  • skin pain
  • widespread rash that’s red or purple
  • blistering or peeling of the skin
• Pancreatitis (inflammation of your pancreas). Symptoms can include:
  • severe abdominal pain
• Serious digestive problems, such as ulcers, bleeding, inflammation, tears, or blockages in your stomach or intestines.* Symptoms can include:
  • severe abdominal pain
  • passing black or tarry stools
  • vomiting blood, or vomit that looks similar to coffee grounds
  • chills
  • fever
  • severe nausea and vomiting
  • severe diarrhea
• Serious allergic reaction, such as anaphylaxis.*
• Peripheral neuropathy (nerve damage in your hands and feet).*
• Blood disorders, such as low levels of red blood cells or white blood cells.*
• High blood sugar level.*
• Progressive multifocal leukoencephalopathy (PML), a serious condition that’s caused by a viral infection in your brain.*†

* For more information about these side effects, see the “Side effect details” section below.
† Adcetris has a boxed warning for progressive multifocal leukoencephalopathy (PML). This is the most serious warning from the Food and Drug Administration (FDA). For more information, see the “Side effect details” section below.

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail about certain side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Adcetris. It’s not known how often allergic reaction may have occurred in clinical trials of the drug, however.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (warmth, swelling, and redness in your skin)

A more severe allergic reaction, such as anaphylaxis, is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing
• dizziness
• loss of consciousness

Call your doctor right away if you have an allergic reaction to Adcetris, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

If you have an anaphylactic reaction to Adcetris, your doctor will stop your Adcetris treatment. And the drug won’t be prescribed for you again.

Note: In some cases, anaphylaxis can occur as an infusion-related reaction to Adcetris. (This is a side effect that occurs during or soon after an infusion). For details, see the “Infusion-related reactions” section below.

Nerve damage

Adcetris can sometimes cause peripheral neuropathy, which is nerve damage in your hands or feet. In fact, peripheral neuropathy is one of the most common side effects of Adcetris.

Different types of peripheral neuropathy can affect different types of nerves. For example:

• Peripheral sensory neuropathy affects nerves responsible for your sense of touch. This condition can cause symptoms such as:
  • burning or tingling sensations
  • reduced sensation or numbness
  • stabbing pain
• Peripheral motor neuropathy affects nerves that communicate with your muscles and help you move. This condition can cause muscle weakness.

In clinical studies of Adcetris, both of these types of peripheral neuropathy were reported as side effects. In the studies, the following results were seen:

Nerve damage can get worse as you receive more doses of Adcetris. So, make sure to tell your doctor right away if you have any symptoms of nerve damage while taking Adcetris.

If you do develop nerve damage while taking Adcetris, depending on how severe your symptoms are, your doctor may delay your next infusion. Or they may reduce your Adcetris dosage. In some cases, your doctor may have you completely stop Adcetris treatment.

* A placebo is a treatment with no active drug.
† These study results varied depending on the condition being treated.

Blood disorders

One of the most common side effects of Adcetris is problems with blood cells. This is also a common side effect of other cancer treatments that you might have with Adcetris, such as chemotherapy.

Before each of your Adcetris infusions, you’ll have a blood test to check for any problems with your blood cells. This is because Adcetris can cause:

• neutropenia (low levels of white blood cells called neutrophils)
• lymphopenia (low levels of white blood cells called lymphocytes)
• anemia (low levels of red blood cells)
• thrombocytopenia (low levels of platelets, which are cells that help the blood to clot)

Below is some more information about these specific blood disorders.

Neutropenia and lymphopenia

With neutropenia, you have a low level of neutrophils in your body. And with lymphopenia, you have a low level of lymphocytes. Neutrophils and lymphocytes are white blood cells that help your body fight infections.

Neutropenia and lymphopenia both increase your risk for getting infections. You’re also more likely to have infections that become serious, such as pneumonia or sepsis (an infection in your bloodstream). Possible symptoms of infections include:

• fever
• chills
• cough
• sore throat
• mouth ulcers
• pain when urinating

In clinical studies, both neutropenia and lymphopenia were side effects of Adcetris.

Specifically, in studies of Adcetris for classical Hodgkin lymphoma (cHL), neutropenia occurred in:

• 54% to 91% of people who took Adcetris (either with or without chemotherapy)*
• 89% of people who took chemotherapy alone
• 34% of people who took a placebo (a treatment with no active drug)

Also, in clinical studies of Adcetris for T-cell lymphomas, neutropenia occurred in:

• 21% to 55% of people who took Adcetris (either with or without chemotherapy)*
• 24% to 58% of people who took chemotherapy alone*

In clinical studies of Adcetris for peripheral T-cell lymphoma, lymphopenia occurred in:

• 51% of people who took Adcetris with chemotherapy
• 57% of people who took chemotherapy alone

Lymphopenia wasn’t reported in studies in which Adcetris was used to treat other conditions.

In certain situations, your doctor may prescribe a drug called G-CSF (granulocyte-colony stimulating factor). This drug is used to help prevent or treat neutropenia while you’re taking Adcetris. For examples of G-CSF drugs and to learn when it’s used, see the “Adcetris with other drugs” section below.

If you have any symptoms of an infection while you’re taking Adcetris, tell your doctor right away. This is important because if you have a low white blood cell count, an infection can quickly become serious or even life threatening. Make sure to call your doctor immediately so that your blood cell levels can be checked.

If you do develop an infection while you’re taking Adcetris, your doctor will likely prescribe medication to treat your infection. And to help prevent infections while you’re taking Adcetris, try to avoid germs as much as possible. Wash your hands often. And stay away from crowded places and people who are sick.

* These study results varied depending on the condition being treated.

Anemia

Taking Adcetris may cause anemia to develop in some people. With anemia, you have low levels of red blood cells, which carry oxygen in your body.

Symptoms of anemia may include:

• feeling tired or lacking energy
• shortness of breath
• feeling cold
• skin, fingernails, or gums looking paler than usual

In clinical studies of Adcetris for cHL, anemia occurred in:

• 27% to 98% of people who took Adcetris (either with or without chemotherapy)*
• 92% of people who took chemotherapy alone
• 19% of people who took a placebo (a treatment with no active drug)

In clinical studies of Adcetris for T-cell lymphomas, anemia occurred in:

• 52% to 66% of people who took Adcetris (either with or without chemotherapy)*
• 59% to 65% of people who took chemotherapy alone*

If you have symptoms of anemia while you’re taking Adcetris, tell your doctor. They’ll likely check your blood cell levels. Severe anemia may sometimes need to be treated with a blood transfusion.

* These study results varied depending on the condition being treated.

Thrombocytopenia

Adcetris can cause you to develop thrombocytopenia, which is a low level of platelets in your blood. Platelets are blood cells that help your blood clot, such as after you have an injury. Symptoms of thrombocytopenia may include bruising or bleeding more easily than usual.

In clinical studies of Adcetris for cHL, thrombocytopenia occurred in:

• 16% to 41% of people who took Adcetris without chemotherapy*
• 20% of people who had placebo (a treatment with no active drug)

And in clinical studies of Adcetris for T-cell lymphomas, thrombocytopenia occurred in:

• 15% to 16% of people who took Adcetris (either with or without chemotherapy)*
• 2% to 13% of people who took chemotherapy alone

If you have symptoms of thrombocytopenia (such as bleeding that takes longer than usual to stop), talk with your doctor. They’ll likely test your blood cell levels. Very low platelet levels may sometimes need to be treated with a platelet transfusion.

* These study results varied depending on the condition being treated.

High blood sugar level

Adcetris can sometimes cause hyperglycemia (high blood sugar level). Hyperglycemia has been reported in people taking Adcetris who don’t have diabetes and in people who have diabetes. In some people with diabetes, blood sugar levels have increased to dangerous levels while taking Adcetris.

In clinical studies of Adcetris, hyperglycemia occurred in 8% of people who took Adcetris without chemotherapy. It’s not known how often hyperglycemia may have occurred in people who either took Adcetris with chemotherapy, took chemotherapy alone, or took a placebo. (A placebo is a treatment with no active drug.)

In these studies, hyperglycemia occurred more frequently in people with diabetes. It also occurred more often in people with a high body mass index (BMI).

Tell your doctor if you have symptoms of hyperglycemia, which may include:

• feeling more thirsty than usual
• urinating more often than usual

If you have hyperglycemia symptoms while taking Adcetris, your doctor may test your blood sugar level. If you have high blood sugar, your doctor may prescribe medication to lower it. And if you have diabetes, your doctor may recommend increasing the dosage of your diabetes medication while you’re taking Adcetris.

Infusion-related reactions

It’s possible to have an infusion-related reaction to Adcetris. This refers to side effects that occur either during, or soon after, an Adcetris infusion. (Adcetris is given as an intravenous [IV] infusion. An IV infusion is when the drug is injected into your vein over time.)

In clinical studies of Adcetris, infusion-related reactions occurred in 4% to 13%* of people taking Adcetris. It’s not known how often these reactions may have occurred in people who either took Adcetris with chemotherapy, took chemotherapy alone, or took a placebo. (A placebo is a treatment with no active drug.)

The most common symptoms of infusion-related reactions include:

• fever
• chills
• nausea
• rash
• itchiness
• shortness of breath
• cough

If you have any of these symptoms during your Adcetris infusion, or during 24 hours after your infusion, tell your doctor right away. They may give medication to treat your symptoms.

If you have a reaction during an infusion, your healthcare provider will stop the infusion temporarily and give you medication to treat your symptoms as needed. They’ll resume your Adcetris infusions if they feel it’s safe to do so.

If you’ve had an infusion-related reaction to Adcetris, you’ll be given premedications before any additional doses. These are drugs given before your next infusion, to help prevent another reaction. You’ll likely be given acetaminophen (Tylenol), an antihistamine, and a corticosteroid.

Note: It’s possible to have a severe allergic reaction, called anaphylaxis, during an infusion of Adcetris. If this happens, your infusion will be stopped. And your doctor will stop your Adcetris treatment completely. For more information, see “Allergic reaction” above.

* These study results varied depending on the condition being treated.

Digestive problems

Digestive problems are among the most common side effects of Adcetris. These include nausea, vomiting, diarrhea, constipation, and abdominal (belly) pain.

Digestive problems are also a common side effect of other cancer treatments that you might have with Adcetris, such as chemotherapy.

Below are details about some of the digestive problems that can occur while taking Adcetris.

Nausea and vomiting

Nausea and vomiting are possible digestive side effects of Adcetris. In clinical studies of Adcetris, the following results were seen:

Your doctor will typically prescribe medication to help prevent nausea and vomiting while you’re taking Adcetris. It’s important to take this medication as prescribed, even if you’re not currently having nausea or vomiting.

This is because it’s generally easier to prevent nausea and vomiting than it is to treat these side effects after they develop. (For more information about drugs for nausea and vomiting, see the “Adcetris use with other drugs” section below.)

If you’re taking medication to prevent nausea and vomiting, but you’re still having these side effects with Adcetris, talk with your doctor. They may prescribe a different drug to help reduce these side effects.

Your doctor may also recommend other ways you might be able to help prevent or relieve nausea. For example, eating small amounts often throughout the day (instead of eating three larger meals) may help reduce nausea.

* A placebo is a treatment with no active drug.
† These study results varied depending on the condition being treated.

Diarrhea

Diarrhea is a possible digestive side effect of Adcetris treatment. In clinical studies, diarrhea occurred in

• 20% to 38% of people who took Adcetris (either with or without chemotherapy)*
• 6% to 20% of people who took chemotherapy alone*
• 10% of people who took a placebo (a treatment with no active drug)

If you have diarrhea while taking Adcetris, it’s important to drink plenty of fluids to avoid dehydration (low fluid level). Talk with your doctor if you can’t keep fluids down, or if you have diarrhea that’s severe or doesn’t improve after a couple of days. In these cases your doctor may recommend taking anti-diarrheal medication.

However, don’t take any antidiarrheal medications or other medications without first checking with your doctor. They can make sure that it’s safe for you to take the medication while you’re taking Adcetris.

* These study results varied depending on the condition being treated.

Constipation

You may have constipation while you’re taking Adcetris. In clinical studies, constipation occurred in:

• 13% to 42% of people who took Adcetris (either with or without chemotherapy)*
• 30% to 37% of people who took chemotherapy alone*
• 3% of people who took a placebo

If you have constipation while taking Adcetris, there are some things you can try at home to help relieve this side effect. These include:

• drinking plenty of fluids
• exercising gently (such as walking)
• eating foods that are high in fiber, such as fruit and vegetables

If you try these things and your constipation is not relieved within a few days, talk with your doctor. They may recommend taking a laxative medication. But don’t take any laxatives or other medications while taking Adcetris without first talking with your doctor.

* These study results varied depending on the condition being treated.

Abdominal pain

Abdominal (belly) pain was a side effect seen in clinical studies of Adcetris. In studies:

• 14% to 25% of people who took Adcetris (either with or without chemotherapy)*
• 10% to 13% of people who took chemotherapy alone*
• 3% of people who took a placebo

Severe abdominal pain can sometimes be a symptom of more severe digestive side effects caused by Adcetris. These side effects can include pancreatitis (inflammation of your pancreas), ulcers, bleeding, inflammation, tears, or blockages in your stomach or intestines.

If you have abdominal pain while taking Adcetris, talk with your doctor. But if your pain is severe, see your doctor right away. Your doctor may be able to determine and treat the cause of your pain.

* These study results varied depending on the condition being treated.

Progressive multifocal leukoencephalopathy

Taking Adcetris can increase your risk for a rare but serious condition called progressive multifocal leukoencephalopathy (PML).* PML is caused by a viral infection in your brain. This infection can lead to severe disability and may even be life threatening.

PML wasn’t reported in clinical studies of Adcetris.

However, PML has occurred in some people who’ve taken Adcetris since this drug was approved. In some of these cases, people experienced PML symptoms right after their first dose of Adcetris, or within 3 months of taking the drug. But exactly how many people may have developed PML while taking Adcetris isn’t known.

Symptoms of PML can include:

• unexplained changes in mood or behavior
• problems with thinking, memory, or speech
• confusion
• vision changes
• clumsiness or trouble walking
• weakness on one side of your body

If you have any PML symptoms, call your doctor right away. Your doctor may recommend that you stop taking Adcetris.

*Adcetris has a boxed warning for progressive multifocal leukoencephalopathy (PML). This is the most serious warning from the Food and Drug Administration (FDA).

Adcetris dosage

The Adcetris dosage your doctor prescribes will depend on several factors. These include:

• the condition you’re using Adcetris to treat and any past treatments you’ve had for this condition
• your body weight
• how well your liver functions
• whether you have certain side effects from treatment, such as nerve damage or low levels of certain blood cells

The following information describes dosages that are commonly used or recommended. However, your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Adcetris comes as a powder in a single-dose vial. It’s available in one strength: 50 milligrams (mg).

Adcetris powder is mixed into a liquid solution. The solution is then given by your healthcare provider as an intravenous (IV) infusion. (An IV infusion means the drug is injected into your vein over time.)

Adcetris is prescribed in doses of mg of medication per kilogram (kg) of body weight. Your dosage will be written as mg/kg. One kilogram of body weight is equal to 2.2 pounds (lb) of body weight.

Dosage for classical Hodgkin lymphoma

Adcetris is approved for use in adults to treat certain forms of classical Hodgkin lymphoma (cHL). Recommended dosages for these uses are described below.

Dosage for untreated stage 3 or stage 4 classical Hodgkin lymphoma

Adcetris is approved to treat cHL that’s stage 3 or stage 4 and hasn’t yet been treated.

For this use, the recommended dosage of Adcetris is 1.2 mg/kg, given every 2 weeks. The maximum dosage is 120 mg per infusion. You may receive up to 12 doses of Adcetris, as long as the drug is effective or doesn’t cause side effects that are bothersome or severe.

In addition to Adcetris, you’ll also have chemotherapy treatment every 2 weeks. You’ll receive the chemotherapy drugs doxorubicin, vinblastine, and dacarbazine.

Note: To learn more about the conditions that Adcetris is approved to treat, see the “Adectris uses” section below.

Dosage for classical Hodgkin lymphoma at risk of relapse or progression after stem cell transplant

Adcetris is approved to treat cHL that has a high risk of either relapse (coming back) or progression (getting worse) after a certain form of stem cell transplant. This type of stem cell transplant is called an autologous hematopoietic stem cell transplant (auto-HSCT).

For this use, the recommended dosage of Adcetris is 1.8 mg/kg, given every 3 weeks. The maximum dosage is 180 mg per infusion. You may receive up to 16 doses of Adcetris, as long as the drug is effective or doesn’t cause side effects that are bothersome or severe.

You’ll receive your first dose of Adcetris when you’ve recovered from your stem cell transplant. This is typically 4 to 6 weeks after the transplant.

Note: To learn more about the conditions that Adcetris is approved to treat and auto-HSCT, see the “Adcetris uses” section below.

Dosage for relapsed classical Hodgkin lymphoma

Adcetris is approved to treat cHL that has relapsed (come back) after either:

• a stem cell transplant, or
• at least two courses of chemotherapy with multiple drugs

For this use, the recommended dosage of Adcetris is 1.8 mg/kg, given every 3 weeks. The maximum dosage is 180 mg per infusion. You may have Adcetris treatment for as long as the drug is effective or doesn’t cause side effects that are bothersome or severe.

Note: To learn more about the conditions that Adcetris is approved to treat, see the “Adectris uses” section below.

Dosage for T-cell lymphoma

Adcetris is approved for use in adults to treat certain forms of T-cell lymphoma (a type of non-Hodgkin lymphoma). Recommended dosages for these uses are described below.

Dosage for untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas

Adcetris is approved to treat certain types of peripheral T-cell lymphoma, including sALCL, that haven’t been treated yet.

The recommended dosage of Adcetris for this use is 1.8 milligrams per kilogram of body weight (1.8 mg/kg). This is given every 3 weeks, for up to 6 to 8 doses. The maximum dosage is 180 mg per infusion.

In addition to Adcetris, you’ll also have chemotherapy treatment every 3 weeks. You’ll receive the chemotherapy drugs cyclophosphamide and doxorubicin, as well as a corticosteroid called prednisone.

Note: To learn more about the conditions that Adcetris is approved to treat, see the “Adcetris uses” section below.

Dosage for relapsed systemic anaplastic large cell lymphoma (sALCL)

Adcetris is approved to treat sALCL that has relapsed (come back) after at least one course of chemotherapy with multiple drugs.

For this use, the recommended dosage of Adcetris is 1.8 mg/kg every 3 weeks. The maximum dosage is 180 mg per infusion. You may have Adcetris treatment for as long as the drug is effective or doesn’t cause side effects that are bothersome or severe.

Note: To learn more about the conditions that Adcetris is approved to treat, see the “Adcetris uses” section below.

Dosage for relapsed primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides

Adcetris is approved to treat primary cutaneous anaplastic large cell lymphoma and a type of mycosis fungoides. Adcetris is approved to treat these lymphomas if they’ve relapsed (come back) after systemic treatment.*

The recommended dosage of Adcetris for this use is 1.8 mg/kg that’s given every 3 weeks. The maximum dosage is 180 mg per infusion. You may have Adcetris treatment for as long as the drug is effective or doesn’t cause side effects that are bothersome or severe.

Note: To learn more about the conditions that Adcetris is approved to treat, see the “Adcetris uses” section below.

* Systemic treatment is treatment that affects your entire body.

Dosage questions

Below are answers to some common questions related to Adcetris dosages.

What if I miss a dose?

If you miss an appointment to have an Adcetris infusion, call your doctor right away to reschedule. To help make sure you don’t miss a dose, try setting a reminder on your phone for your appointments.

Will I need to use this drug long term?

Adcetris is meant to be used as a long-term treatment. But the length of time you’ll take it depends on the condition you’re taking it for. You may have Adcetris treatment for as long as the drug is effective or doesn’t cause side effects that are bothersome or severe.

For example, based on your condition, you may have Adcetris treatment for 18 weeks, 24 weeks, 48 weeks, or longer. For more information, see the “Dosage for classical Hodgkin lymphoma” and “Dosage for T-cell lymphoma” sections above.

If you and your doctor determine that Adcetris is safe and effective for you, you should continue treatment for as long as your doctor recommends. If you have questions about how long you should take Adcetris, talk with your doctor.

Why might I need to stop or change my dosage?

Your doctor may temporarily stop your Adcetris treatment, or reduce your dosage, if you have certain side effects. These side effects include low white blood cell levels and nerve problems.

But in some cases, your doctor may stop your Adcetris treatment completely. Your doctor may do this if you have severe side effects, including a serious viral infection called PML*, or side effects that don’t improve when you stop Adcetris or take a lower dosage.

For more information about possible side effects of Adcetris, see the “Adcetris side effects” section above. And if you have questions or if you develop side effects while taking Adcetris, talk with your doctor.

*Adcetris has a boxed warning for progressive multifocal leukoencephalopathy (PML), which is caused by a viral infection in your brain. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warnings” at the beginning of this article.

Common questions about Adcetris

Here are answers to some frequently asked questions about Adcetris.

Is Adcetris a chemotherapy drug?

Sort of. Adcetris is made up of a chemotherapy drug linked to a targeted therapy drug.

Traditional chemotherapy drugs work by killing all cells that are dividing and multiplying in your body. (Cells that are multiplying are making more cells.) So these drugs can kill healthy cells as well as cancer cells. When these chemotherapy drugs kill healthy cells, they can often cause side widespread effects such as hair loss and low levels of certain blood cells.

Adcetris, on the other hand, is a targeted cancer treatment. This means it targets (works precisely on) cancer cells. The targeted therapy drug used in Adcetris is a monoclonal antibody. Antibodies are proteins that help your immune system fight infections. Monoclonal antibodies are human-made, and they’re designed to attach to specific proteins in the body.

The antibody linked to the chemotherapy drug in Adcetris attaches directly to a protein that’s mainly found on lymphoma cancer cells. Then the chemotherapy drug is released into the lymphoma cell to kill the cell.

Adcetris has less of an effect on healthy cells, compared with traditional chemotherapy drugs. But, Adcetris can still affect healthy cells and can cause side effects, some of which can be serious. (For details, see the “Adcetris side effects” section above.)

Does Adcetris cause erectile dysfunction (ED)?

It’s unlikely that Adcetris causes erectile dysfunction (ED). This side effect wasn’t reported in clinical studies of Adcetris.

However, for some types of cancer, Adcetris is taken with chemotherapy drugs or after a stem cell transplant. And these other treatments can affect reproductive function, fertility, and sexual desire. They could even cause ED symptoms. In addition, having cancer and receiving cancer treatment can cause depression that may also lead to erection problems.

If you’re taking Adcetris and you have concerns about ED or think you may have symptoms of ED, talk with your doctor.

Will Adcetris cure my cancer?

No, unfortunately, Adcetris won’t cure your condition. However, Adcetris can help extend the amount of time you live without your cancer getting worse or coming back.

In clinical studies, some people with newly diagnosed T-cell lymphomas or relapsed classical Hodgkin lymphoma (cHL) had a complete response to Adcetris. This means their cancer went away completely during the study. (This is also called being in “remission.”)

However, it’s important to note that having a complete response or being in remission doesn’t necessarily mean your cancer is cured. It’s possible for your cancer to come back after a complete response, sometimes years later.

Talk with your doctor about what you can expect from Adcetris treatment.

Will I need to have lab tests done while I’m taking Adcetris?

Yes. Because Adcetris can cause various side effects, your doctor will test your blood to check for these side effects throughout your treatment. Lab tests will also be used to monitor how well Adcetris is working to treat your condition.

Generally, the most important lab tests you’ll have during Adcetris treatment are blood tests to check your levels of certain blood cells. Before each infusion, you’ll have a blood test to check that you have enough of certain blood cells to safely receive the drug.

You’ll also have other blood tests from time to time throughout your treatment. For example, you may have tests check your liver and kidney function, and your blood sugar levels.

What precautions should I take after I receive an infusion of Adcetris?

After you have an infusion of Adcetris, you should:

• Drink plenty of fluids. This is important to do, because Adcetris is mainly removed from your body by your kidneys. And drinking plenty of fluids helps your kidneys work effectively to remove the drug from your system. Drinking lots of fluids also helps to prevent dehydration (low fluid level), especially if you have vomiting or diarrhea with Adcetris.
• Be extra careful to avoid infections. You should do this because Adcetris can sometimes cause your white blood cell levels to decrease. And having a low white blood cell level can make your body less able to fight off infections. So after you have an infusion of Adcetris, make sure to wash your hands often. And try to avoid close contact with people who are sick.
• Note any side effects you’re having. Do this after each infusion you have. And make sure you know which side effects you should tell your doctor about right away. If you aren’t sure, talk with your doctor.

To learn more about possible side effects, including low white blood cell levels, see the “Adcetris side effects” section above. And if you have questions about what precautions to take after your infusions, talk with your doctor.

Does Adcetris cause hair loss?

It might. Some people have had some hair loss or hair thinning while taking Adcetris in clinical studies. But keep in mind that hair loss is also a common side effect of other cancer treatments that you may be taking with Adcetris, such as chemotherapy.

In clinical studies of Adcetris, hair loss was reported in 26% of people who took Adcetris with chemotherapy. In comparison, 25% of people who took chemotherapy alone had hair loss. And 13% to 15% of people who took Adcetris without chemotherapy had hair loss.

If you’re concerned about hair loss with Adcetris, talk with your healthcare provider.

How Adcetris is given

Adcetris is administered by a healthcare provider. It’s given as an intravenous (IV) infusion. An IV infusion is an injection into a vein that’s given slowly over a period of time.

Each Adcetris infusion typically lasts at least 30 minutes. Your infusions may be done at a hospital or clinic, or at your doctor’s office.

How long do treatment appointments last

Each Adcetris treatment appointment will likely last 3 to 4 hours or longer. If you’re also receiving chemotherapy, you’ll have chemotherapy infusions separately from Adcetris infusions.

During your appointments, you’ll have blood tests to check that it’s safe for you to take Adcetris. Your temperature, pulse, and blood pressure will also be checked. And you may be given medication to help prevent side effects from Adcetris, such as nausea.

When it’s given

You may have an Adcetris infusion once every 2 or 3 weeks, depending on your condition. For more information, see the “Adcetris dosage” section above.

It’s important to keep your appointments for your Adcetris infusions. If you miss an appointment, call your doctor right away to reschedule. To help make sure you don’t miss a dose, try setting a reminder on your phone for your appointments.

Adcetris uses

The Food and Drug Administration (FDA) approves prescription drugs such as Adcetris to treat certain conditions. Adcetris may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Adcetris is approved to treat certain forms of classical Hodgkin lymphoma (cHL) and T-cell lymphoma.

Lymphoma is a type of cancer that develops in your lymphatic system*. Your lymphatic system is part of your immune system. It helps your body use lymphocytes (a type of white blood cell) to fight infection and disease.

Lymphoma causes certain lymphocytes to become abnormal (these abnormal cells may be called lymphoma cells). Specifically, lymphoma can cause the cells to not function correctly and to grow and multiply faster than usual. (Cells that multiply are making more cells.)

Different types of lymphoma affect different types of lymphocytes. The types of lymphoma that Adcetris is approved to treat are described in more detail below.

* The lymphatic system includes your lymph vessels, lymph nodes (also called lymph glands), spleen, thymus, and tonsils. Your lymph vessels carry a fluid called lymph around your body, which contains lymphocytes.

Adcetris for classical Hodgkin lymphoma

Adcetris is FDA-approved to treat certain forms of classical Hodgkin lymphoma (cHL) in adults. (Adcetris is also approved to treat certain forms of T-cell lymphoma in adults. For more information, see the “Adcetris for T-cell lymphoma” section below.)

cHL affects white blood cells called B lymphocytes, causing them to become abnormal. The abnormal B lymphocytes are called Reed-Sternberg cells. Symptoms of cHL can include swollen lymph nodes, night sweats, fever, feeling very tired, and unexplained weight loss.

Adcetris is approved to treat cHL in the following situations:

• cHL that’s stage 3 or stage 4 and has not been treated yet. (Stage 3 and stage 4 cHL are advanced forms of cHL.) For this use, Adcetris is taken with the chemotherapy drugs doxorubicin, vinblastine, and dacarbazine.
  • With stage 3 cHL, lymphoma cells may be located in your lymph nodes above and below your diaphragm. Or the lymphoma cells may be in your lymph nodes above your diaphragm, and also in your spleen. (Your spleen is an organ near your stomach that filters your blood and also stores lymphocytes.)
  • With stage 4 cHL, lymphoma cells have spread to organs outside your lymphatic system, such as your liver, lungs, or bone marrow.
• cHL that has a high risk of either relapsing (coming back) or progressing (getting worse) after an autologous hematopoietic stem cell transplant (auto-HSCT). When used this way, Adcetris treatment is called consolidation therapy.
• cHL that’s relapsed after either:
  • auto-HSCT, or
  • if a stem cell transplant isn’t possible, at least two courses of chemotherapy with multiple drugs

About auto-HSCT

Auto-HSCT is a possible treatment for lymphoma. With auto-HSCT, hematopoietic stem cells are collected from your blood or bone marrow before you have chemotherapy or radiation therapy. (Hematopoietic stem cells are immature blood cells that can develop into any type of blood cell.)

Then, after you have chemotherapy or radiation therapy, your stem cells are returned to your body by intravenous (IV) infusion*. The stem cells can then develop into healthy blood cells. These healthy blood cells can replace those that are killed by chemotherapy or radiation therapy.

* With an IV infusion, the stem cells are injected into your vein over a period of time.

Effectiveness for untreated stage 3 or stage 4 classical Hodgkin lymphoma

In studies, Adcetris was effective in treating certain forms of cHL.

One clinical study looked at people with stage 3 or 4 cHL that hadn’t been treated in the past. This study involved 1,334 people who were split into two treatment groups. One group was given Adcetris and chemotherapy (using the drugs doxorubicin, vinblastine, and dacarbazine). The other group was given traditional chemotherapy alone (using the drugs bleomycin, doxorubicin, vinblastine, and dacarbazine).

Compared with people who took traditional chemotherapy alone, people who took Adcetris and chemotherapy were 23% less likely to:

• have their cancer progress (get worse)
• need additional treatment for their cancer
• die due to their cancer or another cause

Other clinical studies have also shown Adcetris to be effective in treating the other forms of cHL that it’s approved for. (Specifically, cHL at high risk of relapse or progression after auto-HSCT, and certain types of relapsed cHL.) For more information, see the drug’s prescribing information.

Adcetris for T-cell lymphoma

Adcetris is FDA-approved to treat certain forms of T-cell lymphoma in adults.

There are two main types of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. T-cell lymphoma is a type of non-Hodgkin lymphoma. It affects white blood cells called T lymphocytes. (Adcetris is also approved to treat certain forms of classical Hodgkin lymphoma [cHL]. For more information, see “Adcetris for classical Hodgkin lymphoma,” above.)

Symptoms of T-cell lymphoma can include swollen lymph nodes, night sweats, fever, feeling very tired, and unexplained weight loss. Some T-cell lymphomas can also affect the skin, causing symptoms such as bumps, ulcers, or a red rash on the skin. And some T-cell lymphomas only affect the skin.

Adcetris is approved to treat the following forms of T-cell lymphoma:

• Untreated CD30-expressing* peripheral T-cell lymphomas, including untreated systemic anaplastic large cell lymphoma (sALCL). For this use, Adcetris is taken with the chemotherapy drugs cyclophosphamide and doxorubicin. It’s also taken with a corticosteroid called prednisone.
• sALCL that’s relapsed (come back) after at least one course of chemotherapy with multiple drugs.
• Primary cutaneous anaplastic large cell lymphoma and CD30-expressing* mycosis fungoides that have relapsed after systemic treatment (treatment that affects the whole body).These types of lymphoma mainly affect your skin.

* CD30-expressing means the cancer cells have a protein called CD30 on their surface.

Effectiveness for untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas

In studies, Adcetris was effective in treating certain forms of T-cell lymphoma.

One clinical study looked at people with untreated sALCL or other CD30-expressing peripheral T-cell lymphomas.

This study involved 452 people who were split into two treatment groups. One group was given Adcetris and chemotherapy (using the drugs cyclophosphamide, doxorubicin, and prednisone). The other group was given traditional chemotherapy alone (using the drugs cyclophosphamide, doxorubicin, vincristine, and prednisone).

Compared with people who took traditional chemotherapy alone, people who took Adcetris and chemotherapy were 29% less likely to:

• have their cancer progress (get worse)
• need additional treatment for their cancer
• die due to their cancer or another cause

Additional clinical studies have shown Adcetris to be effective in treating the other forms of T-cell lymphoma that it’s approved for. (Specifically, any of these conditions that have relapsed after certain treatments: sALCL, primary cutaneous anaplastic large cell lymphoma and CD-30 expressing mycosis fungoides.) For more information, see the drug’s prescribing information.

Adcetris and children

Adcetris isn’t approved for use in children. However, Adcetris is currently being studied as a treatment for Hodgkin lymphomas and T-cell (non-Hodgkin) lymphomas in children. But currently, these conditions are considered off-label uses of the drug.

For these uses, children should only be given Adcetris if they’re participating in a clinical study.

Adcetris use with other drugs

Your doctor may have you take Adcetris with other drugs, depending on your condition and other factors. Below is information about some of the drugs that you might receive along with Adcetris.

Adcetris with chemotherapy

You’ll take chemotherapy drugs with Adcetris if you’re taking Adcetris to treat any of the following forms of classical Hodgkin lymphoma (cHL):

• cHL that’s stage 3 or stage 4 and has not been treated yet. For this use, Adcetris is taken with the chemotherapy drugs doxorubicin, vinblastine, and dacarbazine. You’ll have Adcetris and chemotherapy as separate infusions during the same appointment.
• Untreated CD30-expressing* peripheral T-cell lymphomas, including untreated systemic anaplastic large cell lymphoma (sALCL). For this use, Adcetris is taken with the chemotherapy drugs cyclophosphamide and doxorubicin. It’s also taken with a corticosteroid called prednisone. You’ll have Adcetris and chemotherapy as separate infusions during the same appointment. And you’ll take prednisone tablets by mouth at the same time.

For more information about the types of lymphoma that are treated with Adcetris and chemotherapy, see the “Adcetris uses” section above.

* CD30-expressing means the cancer cells have a protein called CD30 on their surface.

Adcetris with premedications

If you’ve had an infusion-related reaction to an Adcetris infusion in the past, you’ll likely be given drugs before your next Adcetris infusion to help prevent another reaction. You’ll likely take acetaminophen (Tylenol), an antihistamine, and a corticosteroid.

For information about infusion-related reactions with Adcetris, see the “Adcetris side effects” section above.

Adcetris with medications for nausea and vomiting

Your doctor will probably prescribe medication to help prevent nausea and vomiting while you’re taking Adcetris. This is especially likely if you’re taking chemotherapy with Adcetris. You’ll likely take this medication before your Adcetris infusions, and you’ll be given medication to take for a few days after the infusions.

It’s important to take this drug as prescribed, even if you’re not currently having nausea or vomiting. This is because it’s generally easier to prevent nausea and vomiting than it is to treat these side effects after they develop.

There are many different kinds of medications for preventing nausea and vomiting. Some are given as an injection by your healthcare provider, while some are taken by mouth.

Adcetris with G-CSF

In certain situations, your doctor may prescribe a drug called granulocyte-colony stimulating factor (G-CSF) for you to take with Adcetris. This drug is used to prevent or treat neutropenia while you’re taking Adcetris.

With neutropenia, you have low levels of certain white blood cells called neutrophils. Neutropenia is a possible side effect of Adcetris. (For details, see the “Adcetris side effects” section above.) G-CSF works to increase your neutrophil levels. It does this by causing neutrophils to be made in your bone marrow.

Your doctor may prescribe G-CSF in either of the following situations:

• If you’re taking Adcetris with chemotherapy. Adcetris is taken with chemotherapy when it’s used to treat:
  • classical Hodgkin lymphoma (cHL) that’s stage 3 or stage 4 and has not been treated yet, and
  • certain types of peripheral T-cell lymphoma, including systemic anaplastic large cell lymphoma (sALCL), that haven’t been treated yet
• If you develop low neutrophil levels while taking Adcetris.

G-CSF drugs are typically by your healthcare provider as a subcutaneous injection (an injection that goes under the skin). Examples of these drugs include tbo-filgrastim (Granix) and pegfilgrastim (Neulasta).

Adcetris and alcohol

Adcetris isn’t known to interact with alcohol. However, drinking alcohol while you’re taking Adcetris could worsen certain side effects of the drug. These side effects include nausea, fatigue (lack of energy), and liver problems.

If you’re concerned about whether drinking alcohol is safe for you during Adcetris treatment, talk with your doctor. They can recommend whether there’s a safe amount of alcohol for you to drink while taking Adcetris.

Adcetris interactions

Adcetris can interact with some other medications. Different interactions can cause different effects. For example, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Adcetris and other medications

Below are examples of some medications that can interact with Adcetris. This article does not list all of the drugs that may interact with Adcetris.

Before taking Adcetris, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, talk with your doctor or pharmacist.

Adcetris and certain antimicrobial drugs

Certain antimicrobial drugs (drugs to treat infections) may reduce your liver’s ability to break down Adcetris. This could cause Adcetris to build up in your body, which could increase your risk for side effects.

Examples of antimicrobial drugs that could increase your risk for side effects with Adcetris include:

• certain antibiotics, such as:
  • clarithromycin
  • telithromycin (Ketek)
• certain antifungals, such as:
  • ketoconazole (Nizoral)
  • itraconazole (Sporanox)
  • posaconazole (Noxafil)
  • voriconazole (Vfend)
• certain antivirals used for HIV treatment, such as:
  • atazanavir (Reyataz)
  • cobicistat (Tybost)
  • ritonavir (Norvir)
  • indinavir sulfate (Crixivan)
  • nelfinavir mesylate (Viracept)
  • saquinavir mesylate (Invirase)

If you need to take certain antimicrobial drugs with Adcetris, your doctor will monitor you closely for possible side effects.

Adcetris and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Adcetris. However, you should still check with your doctor or pharmacist before using any of these products while taking Adcetris. Checking with your doctor can help you avoid potential interactions.

Adcetris and foods

There aren’t any foods that have been specifically reported to interact with Adcetris. If you have any questions about eating certain foods with Adcetris, talk with your doctor.

Adcetris and vaccines

You shouldn’t have live vaccines while you’re taking Adcetris. With live vaccines, you receive a small amount of a live virus. (This is unlike inactive vaccines, which don’t contain any live virus.) In general, vaccines help protect your body from certain infections.

Some examples of live vaccines that should be avoided while taking Adcetris include:

• measles, mumps, and rubella (MMR)
• yellow fever
• chickenpox
• shingles
• rotavirus
• the nasal spray flu vaccine (FluMist)

While you’re taking Adcetris, you should also avoid close contact with people who’ve had a live vaccine during the past 2 weeks.

You should avoid live vaccines during Adcetris treatment because a possible side effect of the drug is a low white blood cell level. White blood cells kill germs that can cause infections. White blood cells also produce antibodies (proteins) that help your immune system fight infections. So having a low white blood cell level can affect how your body reacts to vaccines.

Vaccines work by causing your white blood cells to produce antibodies. If you have a low white blood cell level with Adcetris, your body may not be able to produce as many antibodies as normal after you get a vaccine. This means that during your Adcetris treatment and for about 6 months after you stop treatment:

• vaccines may be less effective
• live vaccines can cause you to develop serious infections

Because of these possible effects, you may not be able to receive certain vaccines while using Adcetris. Talk with your doctor about vaccines before you start taking Adcetris. They may recommend having certain vaccines before you start treatment.

Alternatives to Adcetris

Other drugs are available that can treat certain forms of classical Hodgkin lymphoma (cHL) and T-cell lymphoma. Some of these may be a better fit for you than others. If you’re interested in finding an alternative to Adcetris, talk with your doctor. They can tell you about other medications that may work well for you.

Adcetris is a targeted therapy for lymphoma. This means that the drug targets (works precisely on) cancer cells and has less of an effect on healthy cells, compared with traditional chemotherapy. Some of the alternatives to Adcetris may also be targeted therapies. Or they may work slightly differently to treat cancer.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Alternatives for classical Hodgkin lymphoma

Examples of other drugs that may be used to treat classical Hodgkin lymphoma (cHL) include:

• other targeted therapies, such as:
  • rituximab (Rituxan)
• chemotherapy drugs, such as:
  • doxorubicin
  • bleomycin
  • vinblastine
  • dacarbazine
  • etoposide
  • cyclophosphamide
  • vincristine
• immunotherapy (drugs that help your immune system fight cancer cells) such as:
  • pembrolizumab (Keytruda)
  • nivolumab (Opdivo)

Alternatives for T-cell lymphoma

Examples of other drugs that may be used to treat T-cell lymphoma include:

• other targeted therapies, such as:
  • mogamulizumab (Poteligeo)
  • belinostat (Beleodaq)
  • romidepsin (Istodax)
  • vorinostat (Zolinza)
• chemotherapy drugs such as:
  • doxorubicin
  • cyclophosphamide
  • vincristine
  • methotrexate
  • L-asparaginase
  • cytarabine
  • etoposide
• immunotherapy such as:
  • alemtuzumab (Campath)
• retinoids such as:
  • bexarotene (Targretin)
  • acitretin

How Adcetris works

Adcetris is used to treat certain forms of classical Hodgkin lymphoma (cHL) and certain forms of T-cell lymphoma.

What happens with cHL and T-cell lymphoma

Lymphoma is a cancer that affects your lymphocytes (a type of white blood cell). It causes lymphocytes to not function correctly and to grow and multiply faster than regular, healthy lymphocytes. (Cells that multiply are making more cells.)

Different types of lymphoma affect different types of lymphocytes. With cHL, your B lymphocytes are abnormal. And with T-cell lymphoma, your T lymphocytes are abnormal. (For more information about the types of cancer Adcetris is approved to treat, see the “Adcetris uses” section above.)

What Adcetris does

Adcetris works to lower the number of lymphoma cells in your body. It does this by attacking abnormal B and T lymphocytes.

Adcetris is made up of a chemotherapy drug linked to a targeted therapy drug. Targeted therapy means the drug targets (works precisely on) cancer cells and has less of an effect on healthy cells, compared with traditional chemotherapy.

The targeted therapy part of Adcetris is a monoclonal antibody. Antibodies are proteins that help your immune system fight infections. Monoclonal antibodies are human-made, and they’re designed to attach to specific proteins in the body. The monoclonal antibody in Adcetris attaches to a protein called CD30.

CD30 is found on the surface of abnormal B and T lymphocytes. (This protein isn’t commonly found on healthy cells. So Adcetris is able to precisely attack only your cancer cells, in most cases.)

Once the antibody in Adcetris attaches to the lymphoma cell, the chemotherapy drug can enter the cell and kill it.

How long does it take to work?

Adcetris starts working right after your first infusion. It’s unlikely that you’ll notice the drug working, however. This is because of how the drug works gradually to treat certain types of cancer.

Your doctor will likely monitor your treatment progress with tests every few weeks. If you have questions about what to expect from Adcetris treatment, talk with your doctor.

Adcetris and pregnancy

Adcetris shouldn’t be taken during pregnancy. The drug may harm a developing fetus.

There aren’t any clinical studies of Adcetris use in humans during pregnancy.*

However, in animal studies, Adcetris caused miscarriage and birth defects. Keep in mind that animal studies don’t always predict what will happen in people. But because of fetal harm seen in animals, and considering how the drug works, Adcetris isn’t considered safe to take during pregnancy.

If you’re able to become pregnant, your doctor will have you take a pregnancy test before starting Adcetris treatment to make sure you’re not pregnant. You should also use an effective form of birth control to prevent pregnancy during and for some time after your treatment. (See the “Adcetris and birth control” section below for details.)

If you’re pregnant or planning to become pregnant, talk with your doctor. They’ll likely recommend a treatment other than Adcetris for your condition. If you become pregnant during treatment with Adcetris, tell your doctor right away.

* There are only case reports of Adcetris use in pregnant humans. And case reports don’t provide data that’s reliable enough to be used to help people make informed decisions about using the drug during pregnancy.

Adcetris and fertility

Adcetris may cause fertility problems (trouble getting someone pregnant) in males. In animal studies, the drug caused side effects such as decreased sperm count and damage to body parts involved in sperm production in males.

It isn’t known if Adcetris affects fertility in females. But the drug should not be taken during pregnancy.

If you plan to have children after finishing treatment with Adcetris, talk with your doctor. Before starting Adcetris, it may be possible for men to store sperm and women to store eggs for future use in conceiving a child.

If you have any questions about fertility while taking Adcetris, talk with your doctor.

Adcetris and birth control

Adcetris shouldn’t be taken during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Adcetris. For more information, see the “Adcetris and pregnancy” section above.

For women using Adcetris

If you’re able to become pregnant while taking Adcetris, you should use an effective form of birth control during treatment. And for 6 months after your last dose of Adcetris, you should continue using effective birth control.

For men using Adcetris

If you have a sexual partner who’s able to become pregnant, you should use effective birth control while you’re taking Adcetris. And for 6 months after your last dose of Adcetris, you should continue using effective birth control. This is because Adcetris can damage sperm. So if you conceive a child while you’re taking Adcetris, the child could have genetic abnormalities or birth defects.

Adcetris and breastfeeding

Adcetris shouldn’t be taken while breastfeeding.

Adcetris use during breastfeeding hasn’t been studied. And it’s not known if the drug passes into breast milk. However, Adcetris can cause serious side effects that could be harmful to a child who’s breastfed.

If you’re breastfeeding or planning to breastfeed, talk with your doctor about the safest feeding options for your child while you’re taking Adcetris. Your doctor may recommend a treatment other than Adcetris for your condition.

Adcetris precautions

This drug comes with several precautions.

FDA warning: Progressive multifocal leukoencephalopathy (PML)

This drug has a boxed warning. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Taking Adcetris can raise your risk for a rare but serious condition called progressive multifocal leukoencephalopathy (PML). PML is a brain infection that’s caused by a virus. PML can result in severe disability and may be life threatening.

Symptoms of PML can include:

• unexplained changes in mood or behavior
• problems with thinking, memory or speech
• confusion
• changes in vision
• clumsiness or trouble walking
• weakness on one side of your body

If you have any of these symptoms, call your doctor right away. You may need to stop treatment with Adcetris.

Other precautions

Before taking Adcetris, talk with your doctor about your health history. Adcetris may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

• Liver problems. Your liver helps break down Adcetris so it can be cleared from your system. If you have liver problems, Adcetris could build up in your body. This buildup can increase your risk for side effects from the drug. Adcetris can also worsen existing liver problems and can cause liver damage. If you have liver problems, talk with your doctor about whether Adcetris is right for you. If you have mild liver problems, your doctor may prescribe a lower than usual dose of Adcetris. But Adcetris treatment is usually avoided in people who have moderate to severe liver problems.
• Kidney problems. Your kidneys help remove Adcetris from your body. If you have severe kidney problems, Adcetris could build up in your body. This buildup can increase your risk for side effects. If you have kidney problems, talk with your doctor about whether Adcetris is right for you. Adcetris treatment should be avoided in people with severe kidney problems.
• Diabetes. Adcetris can sometimes cause hyperglycemia (high blood sugar). If you have diabetes, taking Adcetris could make it harder to manage your blood sugar. And the dosage of your diabetes medication may need to be adjusted during your Adcetris treatment. If you have diabetes, talk with your doctor before starting Adcetris. They can recommend how often you should check your blood sugar level and what you should do if it’s higher than usual.
• Allergic reaction. If you’ve had a serious allergic reaction called anaphylaxis to Adcetris or any of its ingredients, you shouldn’t take Adcetris. (Anaphylaxis causes life threatening symptoms such as trouble breathing and a sudden drop in blood pressure.) If you’ve had a mild or moderate allergic reaction to Adcetris, you may be given premedications to prevent this from occurring again. (Premedications are drugs given before an infusion). Talk with your doctor about what medications other than Adcetris might be better options for you.
• Current treatment with bleomycin (a chemotherapy drug). If you’re currently being treated with bleomycin, you shouldn’t take Adcetris. Taking these drugs together raises your risk for serious side effects that affect your lungs. Talk with your doctor about drugs other than Adcetris that may be better options for you.
• Pregnancy. Adcetris shouldn’t be used during pregnancy. For more information, see the “Adcetris and pregnancy” section above.
• Breastfeeding. Adcetris shouldn’t be taken while breastfeeding. For more information, see the “Adcetris and breastfeeding” section above.

Note: For more information about the potential negative effects of Adcetris, see the “Adcetris side effects” section above.