Poteligeo is a brand-name prescription drug. It’s FDA-approved to treat certain forms of lymphoma in adults. Lymphoma is a type of cancer that develops from lymphocytes (white blood cells) that become abnormal.

Specifically, Poteligeo is used to treat:

  • mycosis fungoides that has relapsed (comes back after being treated) or that’s refractory (hasn’t gotten better after other treatments)
  • Sézary syndrome in adults who’ve received at least one other systemic therapy (treatment that affects your entire body)

Mycosis fungoides and Sézary syndrome are T-cell lymphomas that affect the skin. T-cell lymphomas develop from abnormal T cells that become cancerous. T cells are lymphocytes (white blood cells) that are a part of your immune system.

Sézary syndrome can be more aggressive and is found in the lymph nodes and blood.

Drug details

Poteligeo contains a monoclonal antibody called mogamulizumab-kpkc. A monoclonal antibody is a type of drug that’s made from live cells from the immune system in a lab. It attaches to certain proteins in your body to block their activity.

Poteligeo is a targeted immunotherapy. This means that the drug targets cancerous T cells in your body. Once Poteligeo attaches to certain proteins on these cancer cells, it sends a signal to healthy immune cells to destroy those cancer cells.

Poteligeo is available in one strength: 4 milligrams per milliliter (4 mg/mL) of liquid solution.

The drug comes as a liquid solution in a single-dose vial. It’s given by your doctor or another healthcare professional as an intravenous (IV) infusion. (An IV infusion means that the drug is injected into your vein over time.) You’ll likely have Poteligeo infusions every week when you first start treatment.

For details, see the “How Poteligeo is given” section below.

FDA approval

The Food and Drug Administration (FDA) first approved Poteligeo in 2018. It’s approved for use in adults with relapsed or refractory mycosis fungoides and in adults with Sézary syndrome who’ve received at least one other systemic therapy.

Effectiveness

For information about the effectiveness of Poteligeo, see the “Poteligeo uses” section below.

Poteligeo contains the active ingredient mogamulizumab-kpkc. Poteligeo is available only as a brand-name medication. It’s not currently available in generic or biosimilar form.

Drugs made from chemicals can have generics, which are exact copies of the active drug in the brand-name medication. But biologics, such as Poteligeo, are treatments made using living cells, so it’s not possible to make exact copies of them. Instead of a generic, biologics sometimes have biosimilars. Biosimilars are “similar” to the parent drug, and they’re considered to be just as effective and safe. Biosimilars and generics usually cost less than brand-name drugs.

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

  • the type and severity of the condition you’re treating with Poteligeo
  • other medical conditions you may have
  • your weight in kilograms (kg)*

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

* 1 kg is about 2.2 pounds.

Drug forms and strengths

Poteligeo comes as a liquid solution. It’s available in one strength: 4 milligrams per milliliter (4 mg/mL) of liquid solution. Poteligeo comes in a vial containing 20 mg/5 mL.

The solution is given by your healthcare professional as an intravenous (IV) infusion. (An IV infusion means that the drug is injected into your vein over time.)

Your dose of Poteligeo will usually be prescribed based on your body weight in kg. The typical dose is 1 mg of Poteligeo per 1 kg of body weight.

Dosage for mycosis fungoides

To treat mycosis fungoides, your dose will usually be your body weight in kg multiplied by 1. For example, someone who weighs 68 kg (about 150 pounds) would receive a dose of 68 mg of Poteligeo.

Your infusion will typically last 60 minutes. The length of your infusion may vary depending on how you react to Poteligeo.

For the first month of treatment, you’ll likely receive your dose every 7 days. After 1 month of treatment, most people receive their doses twice a month (usually on day 1 and day 15 of the month).

You’ll receive Poteligeo infusions for as long as your doctor prescribes them. You’ll likely continue treatment with Poteligeo as long as it’s effective for you. You and your doctor may decide to stop treatment if your cancer gets worse or if you develop side effects that affect your daily life.

If you experience bothersome side effects with Poteligeo, your doctor may slow down your next infusion. They may also have you skip an infusion or completely end your Poteligeo treatment.

Dosage for Sézary syndrome

The dosage for Sézary syndrome is the same as it is for mycosis fungoides. See the section directly above for details.

What if I miss a dose?

If you miss a dose of Poteligeo or need to change your infusion appointment, it’s recommended that you receive the drug within 2 days of your scheduled dose. To help make sure you don’t miss an appointment, try setting a reminder on your phone or downloading a reminder app. If you can’t make your appointment, call your doctor’s office as soon as possible to reschedule.

Will I need to use this drug long term?

Poteligeo is meant to be used as a long-term treatment. If you and your doctor determine that Poteligeo is safe and effective for you, your treatment will likely be long term.

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

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

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

Mild side effects

Mild side effects* of Poteligeo can include:

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 Poteligeo. To learn about other mild side effects, talk with your doctor or pharmacist or view Poteligeo’s patient information.

Serious side effects

Serious side effects from Poteligeo 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 you think you’re having a medical emergency.

Serious side effects may include:

For more information on these side effects, see “Side effect details” below.

Side effect details

Here’s some detail on certain side effects this drug may cause.

Skin rash

Some people may experience skin rash during their Poteligeo treatment. This may be serious and even life threatening. Examples of life threatening skin rashes include those associated with Stevens-Johnson syndrome and toxic epidermal necrolysis.

To find out how often skin rash occurred in clinical studies, see Poteligeo’s prescribing information.

Symptoms of mild skin rash can include itching that’s specific to one area of the body.

Symptoms of severe skin rash can include:

  • skin pain
  • widespread rash that’s red, purple, or discolored
  • blistering or peeling of the skin

If you experience skin rash while receiving Poteligeo, talk with your doctor. They may be able to suggest ways to help relieve this side effect.

Infusion reactions

Poteligeo is given as an intravenous (IV) infusion. (An IV infusion is when the drug is injected into your vein over time.) It’s possible to have an infusion-related reaction to Poteligeo. This side effect may occur during or soon after your infusion.

To find out how often infusion reactions occurred in clinical studies, see Poteligeo’s prescribing information.

Common symptoms of infusion-related reactions include:

If you experience any of these symptoms during your infusion, your doctor may stop the infusion and treat your symptoms. They may also have you skip your next infusion, or they may give it to you over a longer period of time rather than the typical 1 hour. Doing so may help treat this side effect and prevent it from occurring again.

Your doctor may also give you medications such as acetaminophen (Tylenol) and diphenhydramine (Benadryl) before your first infusion. If the symptoms continue and are untreatable, your doctor may recommend ending your Poteligeo treatment.

Autoimmune reactions

Some people receiving Poteligeo have developed autoimmune reactions. These reactions can be life threatening and even fatal. Examples of autoimmune reactions include hepatitis (inflammation of the liver) and pneumonitis (inflammation of the lung tissue).

If you develop any of these reactions during your infusion, your doctor may stop the infusion. They may also decide to completely end your Poteligeo treatment.

To learn how often autoimmune reactions occurred in clinical studies, see Poteligeo’s prescribing information.

Symptoms of an autoimmune reaction can include:

  • trouble breathing
  • nausea
  • fatigue (lack of energy)

If you have concerns about developing an autoimmune reaction during your Poteligeo treatment, talk with your doctor.

Infections

Some people receiving Poteligeo have experienced infections. These infections can be life threatening and even fatal.

To find out how often infections occurred in clinical studies, see Poteligeo’s prescribing information.

Symptoms of an infection may vary depending on the infection you have, but they can include:

If you experience any of these symptoms, tell your doctor right away. They can determine the type of infection you have and prescribe the right drug to treat your infection.

Allergic reaction

As with most drugs, some people can have an allergic reaction after receiving Poteligeo.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction 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

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

The Food and Drug Administration (FDA) approves prescription drugs such as Poteligeo to treat certain conditions.

Poteligeo for mycosis fungoides

Poteligeo is approved to treat mycosis fungoides in adults whose cancer has relapsed (comes back after being treated) or is refractory (hasn’t gotten better after other treatments).

Mycosis fungoides occurs when T cells in the body become cancerous and attack your skin. It’s a type of T-cell lymphoma. T cells are lymphocytes (white blood cells) that are a part of your immune system.

The most common symptom of mycosis fungoides is a red rash or discoloration on the skin that doesn’t go away. If you get a rash during your Poteligeo treatment, talk with your doctor.

Effectiveness for mycosis fungoides

In clinical studies, Poteligeo was effective in treating the symptoms of mycosis fungoides in adults. It also limited the progression (worsening) of the condition. To learn more about clinical study results, see Poteligeo’s prescribing information.

The National Cancer Institute recommends the active drug in Poteligeo (mogamulizumab-kpkc) as a treatment for relapsed or refractory mycosis fungoides in adults.

Poteligeo for Sézary syndrome

Poteligeo is also approved to treat Sézary syndrome in adults who’ve received at least one other systemic therapy (treatment that affects your entire body).

Sézary syndrome is a type of T-cell lymphoma that occurs when T cells in the body become cancerous and attack your skin. T cells are lymphocytes (white blood cells) that are a part of your immune system.

Sézary syndrome is different from mycosis fungoides because cancerous T cells are in the lymph nodes and blood rather than in skin tissue.

Rash and redness or discoloration also occur with Sézary syndrome. These side effects may be more severe than with mycosis fungoides.

Symptoms of Sézary syndrome may include:

  • skin redness over most or all of your body
  • skin pain
  • itching or peeling skin

Effectiveness for Sézary syndrome

In clinical studies, Poteligeo was effective in treating the symptoms of Sézary syndrome in adults. It also limited the progression (worsening) of the condition. For Poteligeo clinical study results, see the Poteligeo’s prescribing information.

The National Cancer Institute recommends the active drug in Poteligeo (mogamulizumab-kpkc) as a treatment for Sézary syndrome in certain people.

Poteligeo and children

Poteligeo isn’t approved for use in children. This drug has only been studied in adults. It’s not known if Poteligeo is safe or effective for children.

If you’re interested in learning about mycosis fungoides or Sézary syndrome treatments for your child, talk with their doctor.

Your doctor will likely give you acetaminophen (Tylenol) and diphenhydramine (Benadryl) before your first infusion of Poteligeo. This is to help prevent and treat any side effects you may have during your infusion.

Your doctor may give you these medications before each infusion, depending on how you reacted to your previous infusion. These medications can help with bothersome side effects during your infusion, such as itching, skin rash, and fever.

For more information on the side effects of Poteligeo, see the “Poteligeo side effects” section above.

Poteligeo isn’t known to interact with alcohol.

If you drink alcohol, talk with your doctor about how much may be safe for you to drink during your Poteligeo treatment.

Poteligeo isn’t known to interact with other medications, herbs, supplements, or foods. The manufacturer of Poteligeo didn’t look at interactions in clinical studies of the drug.

But this doesn’t mean that interactions can’t happen with Poteligeo.

Before using Poteligeo, 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, ask your doctor or pharmacist.

As with all medications, the cost of Poteligeo can vary. To find current prices for Poteligeo in your area, check out WellRx.com.

The cost you find on WellRx.com is what you may pay without insurance. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Before approving coverage for Poteligeo, 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 Poteligeo, contact your insurance company.

Financial and insurance assistance

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

Kyowa Kirin, Inc., the manufacturer of Poteligeo, offers a program called Kyowa Kirin Cares. This program offers cost assistance on the drug in addition to other resources.

For more information and to find out if you’re eligible for support, call 833-KK-CARES (833-552-2737) or visit the program website.

Generic or biosimilar

Poteligeo contains the active ingredient mogamulizumab-kpkc. Poteligeo is available only as a brand-name medication. It’s not currently available in generic or biosimilar form.

Drugs made from chemicals can have generics, which are exact copies of the active drug in the brand-name medication. But biologics, such as Poteligeo, are treatments made using living cells, so it’s not possible to make exact copies of them. Instead of a generic, biologics sometimes have biosimilars. Biosimilars are “similar” to the parent drug, and they’re considered to be just as effective and safe. Biosimilars and generics usually cost less than brand-name drugs.

Poteligeo is given by your doctor or another healthcare professional as an intravenous (IV) infusion. (An IV infusion means that the drug is injected into your vein over time.)

Your infusions will typically last 1 hour. The length of your infusion may vary depending on how you react to Poteligeo.

When it’s given

For the first month of treatment, you’ll likely receive your dose of Poteligeo every 7 days. After 1 month of treatment, most people receive their doses twice a month (usually on day 1 and day 15 of the month).

You’ll receive Poteligeo infusions for as long as your doctor prescribes them. You’ll likely continue treatment with Poteligeo as long as it’s effective for you. You and your doctor may decide to stop treatment if your cancer gets worse or if you develop side effects that affect your daily life.

To make sure you don’t miss an appointment, try setting a reminder on your phone or downloading a reminder app. If you can’t make your appointment, call your doctor’s office as soon as possible to reschedule.

For more information about dosage, see the “Poteligeo dosage” section above.

Poteligeo is approved to treat the following conditions:

  • mycosis fungoides in adults whose cancer has relapsed (come back after being treated) or is refractory (hasn’t gotten better after other treatments)
  • Sézary syndrome in adults who’ve tried at least one other systemic therapy (treatment that affects your entire body)

What happens with mycosis fungoides and Sézary syndrome

Mycosis fungoides and Sézary syndrome are T-cell lymphomas. T-cell lymphomas develop from abnormal T cells that become cancerous. T cells are lymphocytes (white blood cells) that are a part of your immune system.

With mycosis fungoides and Sézary syndrome, certain lymphocytes in the body become cancerous and affect the skin. Sézary syndrome can be more aggressive and is found in the lymph nodes and blood.

A red or discolored skin rash that doesn’t go away may be a symptom of mycosis fungoides. If a skin rash is present and T cells are found in the lymph nodes or blood, it’s usually a sign of Sézary syndrome.

What Poteligeo does

Poteligeo contains a monoclonal antibody called mogamulizumab-kpkc. A monoclonal antibody is a type of drug that’s made from live cells from the immune system in a lab. It attaches to certain proteins in your body to block their activity.

Poteligeo is a targeted immunotherapy. This means that the drug targets cancerous T cells in your body. Once Poteligeo attaches to certain proteins on these cancer cells, it sends a signal to healthy immune cells to destroy those cancer cells .

How long does it take to work?

Poteligeo begins working in your body right away. You’ll receive Poteligeo infusions more often when you first start treatment. This allows Poteligeo to start working quickly by reaching a steady level in your body. You may notice that Poteligeo is working if the redness or discoloration on your skin begins improving.

For more information on the effectiveness of Poteligeo, see “Poteligeo uses” above.

It’s not known if Poteligeo is safe to receive during pregnancy. Animal studies showed no risk to the fetus when Poteligeo was given to a pregnant female. But animal studies don’t always predict what will happen with humans.

For females using Poteligeo

You shouldn’t receive Poteligeo if you’re a female* who’s pregnant or planning to become pregnant. If you can become pregnant, your doctor will make sure you’re not pregnant before starting your treatment.

If you’re sexually active, you should use contraception the entire time you’re receiving treatment with Poteligeo. After stopping treatment with Poteligeo, you should wait at least 3 months before trying to become pregnant.

If you’re pregnant or planning to become pregnant, talk with your doctor before using Poteligeo.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

It’s not known if Poteligeo is safe to receive 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 receiving Poteligeo.

For more information about receiving Poteligeo during pregnancy, see the “Poteligeo and pregnancy” section above.

It isn’t known if Poteligeo is safe to receive while breastfeeding. It’s also not known if Poteligeo passes into breast milk.

If you’re considering Poteligeo treatment while breastfeeding, talk with your doctor about the benefits and risks.

Here are answers to some frequently asked questions about Poteligeo.

Will Poteligeo cure my condition?

No, Poteligeo doesn’t cure mycosis fungoides or Sézary syndrome. There’s currently no cure for these conditions.

Poteligeo may help people with mycosis fungoides or Sézary syndrome manage their symptoms. It may also help limit the progression (worsening) of these conditions.

For more information on how the drug is used, see “Poteligeo uses” above.

If you have questions about what to expect from Poteligeo treatment, talk with your doctor.

Is Poteligeo a chemotherapy drug?

No, Poteligeo isn’t a chemotherapy drug. Chemotherapy is a type of systemic therapy that’s used to treat cancer. (A systemic therapy treats your entire body.) Chemotherapy damages both healthy cells and cancer cells, which can lead to side effects.

Poteligeo is a targeted immunotherapy. This means that the drug targets certain cancer cells and destroys them. Poteligeo contains a monoclonal antibody called mogamulizumab-kpkc that targets cancerous T cells. A monoclonal antibody is a type of drug that’s made from live cells from the immune system in a lab. It attaches to certain proteins in your body to block their activity.

Poteligeo works by attaching to cancerous T cells in your body. Once Poteligeo attaches to certain proteins on cancer cells, it sends a signal for healthy cells to destroy those cancer cells.

How long will I need to receive Poteligeo?

Poteligeo is meant to be used as a long-term treatment. You’ll receive Poteligeo infusions for as long as your doctor prescribes them. You’ll likely continue treatment with Poteligeo as long as it’s effective for you. You and your doctor may decide to stop treatment if your cancer gets worse or if you develop side effects that affect your daily life.

For more information on how Poteligeo performed in clinical studies, see Poteligeo’s prescribing information.

If you experience bothersome side effects with Poteligeo, your doctor may adjust your dosage to better fit your needs.

For more information about Poteligeo’s dosage, see the “Poteligeo dosage” section above.

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

  • Stem cell transplant complications. Treatment with Poteligeo may increase your risk for serious complications if you receive an allogeneic hematopoietic stem cell transplantation (HSCT) (a stem cell transplant from a donor). These complications can include your body rejecting your transplant or even death. If you plan to receive an allogeneic HSCT, talk with your doctor. They may recommend a drug other than Poteligeo.
  • Allergic reaction. If you’ve had an allergic reaction to Poteligeo or any of its ingredients, you shouldn’t receive Poteligeo. Ask your doctor what other medications are better options for you.
  • Pregnancy. It’s not recommended that you receive Poteligeo while pregnant. For more information, see the “Poteligeo and pregnancy” section above.
  • Breastfeeding. It’s not recommended that you receive Poteligeo while breastfeeding. For more information, see the “Poteligeo and breastfeeding” section above.

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

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.