Talzenna (talazoparib)

What is Talzenna?

Talzenna is a brand-name prescription medication that’s used to treat certain types of breast cancer in adults.

It’s used to treat breast cancer with each of the following characteristics:

• Hormone receptor-positive or hormone receptor-negative. These cancer cells may or may not have receptors (attachment sites) for estrogen or progesterone.
• Mutations in BRCA1 or BRCA2 genes (types of breast cancer genes). These mutations (abnormal changes) increase the risk of having certain types of cancer. Cancer with BRCA gene mutations is called BRCA-positive.
• HER2-negative breast cancer. These cancer cells don’t have HER2 (human epidermal growth factor receptor 2) proteins on their surface.
• Advanced disease. This type of cancer has spread near your breast (called locally advanced disease) or to other parts of your body (called metastatic disease).

Talzenna comes as capsules that are taken by mouth once daily. It’s available in two strengths: 1 mg and 0.25 mg.

Talzenna contains the drug talazoparib, which belongs to a class of drugs called poly ADP-ribose polymerase (PARP) inhibitors. It’s considered a targeted therapy because it attacks specific parts of cancer cells. It works differently than chemotherapy (standard drugs used to treat cancer), which can affect all rapidly growing cells in your body.

Effectiveness

One clinical study looked at people with BRCA-positive, HER2-negative breast cancer. People taking Talzenna had longer times without their cancer growing or spreading than people who were using chemotherapy drugs.

In this study, 62.6% of the people taking Talzenna had their cancer reduced by 30% or more. In people taking chemotherapy drugs, 27.2% had their cancer reduced by 30% or more.

FDA approval

Talzenna was approved by the Food and Drug Administration (FDA) in October 2018. It was the second PARP inhibitor to be approved by the FDA. The first FDA-approved drug in this class is called Lynparza (olaparib). It was approved to treat breast cancer in January 2018.

Talzenna generic

Talzenna is available only as a brand-name medication. It’s not currently available in generic form.

Talzenna contains the drug talazoparib.

Talzenna side effects

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

For more information on the possible side effects of Talzenna, or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.

More common side effects

The more common side effects of Talzenna can include:

• diarrhea
• headache
• hair loss
• nausea
• vomiting
• tiredness
• feeling weak
• loss of appetite

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Serious side effects from Talzenna can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Serious side effects, which are described below in “Side effect details,” can include the following:

• anemia (low levels of red blood cells)
• neutropenia (low levels of certain white blood cells)
• thrombocytopenia (low levels of platelets)
• myelodysplastic syndrome or acute myeloid leukemia (cancer in your blood or bone marrow)
• severe allergic reaction

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on several of the side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Talzenna. It’s not known for sure how often people taking Talzenna have an allergic reaction. Symptoms of a mild allergic reaction can include:

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

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 a severe allergic reaction to Talzenna. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Hair loss

Hair loss (called alopecia) was a commonly reported side effect during clinical studies. In one study, 25% of people who took Talzenna had hair loss.

Most of these people lost less than 50% of their hair. In these people, the hair loss wasn’t noticeable from a distance. It could only be seen up close. A small percentage of people lost larger amounts of hair. These people may have needed to wear a wig or hairpiece to disguise their hair loss.

In this same study, 28% of the people using chemotherapy (standard drugs used to treat cancer) had hair loss.

Hair loss caused by cancer treatments is usually temporary. Most of the time, hair grows back after treatment is finished. If you’re concerned about hair loss, talk with your doctor about ways to reduce this side effect. They may recommend that you use scalp cooling caps or try other ways to improve the health of your scalp and hair.

Anemia

Anemia was a common side effect seen in people taking Talzenna during clinical studies. With anemia, your body has low levels of red blood cells.

In one study, 53% of people taking Talzenna had anemia. About 18% of people using chemotherapy (standard drugs used to treat cancer) had anemia. In 39% of people taking Talzenna, anemia was considered severe enough to possibly need treatment with a blood transfusion. Less than 1% of people taking Talzenna stopped the drug because of anemia.

Anemia is usually a temporary side effect of cancer treatments such as Talzenna and similar drugs. It typically improves once treatment is finished. However, it can cause symptoms that affect your quality of life.

Symptoms of anemia include:

• fatigue (lack of energy)
• feeling weak
• constipation
• trouble breathing
• bleeding from your nose or gums
• pale-colored skin
• feeling cold
• trouble concentrating
• dizziness
• headache

Your doctor will check you for anemia. They’ll do this by ordering red blood cell counts before you start Talzenna and every month while you’re taking the drug.

If your red blood cell count becomes too low, your doctor may adjust your treatment. They may lower your dose of Talzenna or temporarily stop Talzenna treatment until your blood cell levels improve.

If you have symptoms of anemia while using Talzenna, talk with your doctor. They can recommend ways to minimize your symptoms during treatment.

Neutropenia

Neutropenia was a common side effect seen in people taking Talzenna during studies. With neutropenia, your body has very low levels of neutrophils (a type of white blood cell that fights infections).

In a clinical study, 35% of people taking Talzenna had neutropenia. About 43% of people using chemotherapy (standard drugs used to treat cancer) had neutropenia. This condition was the main reason that 0.3% of people taking Talzenna stopped treatment with the drug.

If you have low levels neutrophils, you have an increased risk of infection. A fever is often the first symptom of neutropenia. This may be followed by infections such as respiratory infections or skin infections.

Your doctor will check your neutrophil levels before you start taking Talzenna, and then monthly while you’re using the drug. If your neutrophil levels are too low, your doctor may adjust your treatment. They may have you wait to start the drug, reduce your current dose of Talzenna, or temporarily stop your treatment, until your blood counts return to a safe level.

If you have symptoms of neutropenia (such as a fever) while taking Talzenna, let your doctor know right away. You may need treatment if you have an infection.

Thrombocytopenia

Thrombocytopenia is another common side effect of Talzenna. With thrombocytopenia, your body has low platelet levels in your blood. Platelets help you form clots when you’re bleeding. If you have low levels of platelets, you’re at an increased risk of having a serious bleed.

Less serious symptoms of low platelet levels include:

• frequent bruising
• easily bleeding (often from your gums; blood may also appear in your stool)
• bleeding from wounds that lasts longer than normal or doesn’t stop on its own
• nosebleeds

In a clinical study, 27% of people taking Talzenna had thrombocytopenia. Only 7% of people using chemotherapy (standard drugs used to treat cancer) had anemia. Thrombocytopenia was the main reason that 0.3% of people taking Talzenna stopped treatment with the drug.

Your doctor will check your platelet count before you start treatment, and every month while you’re taking Talzenna. If your platelet levels are too low, your doctor may adjust your treatment until your platelet counts return to a safe level. They may delay your next dose of Talzenna, reduce your current dose of Talzenna, or temporarily stop your treatment.

Myelodysplastic syndrome/Acute myeloid leukemia

Myelodysplastic syndrome (MDS) is a form of cancer in your blood and bone marrow. MDS can progress into acute myeloid leukemia (AML). In MDS and AML, your bone marrow produces abnormal blood cells that don’t work the right way.

These conditions occurred in 2 of the 584 people who received Talzenna during clinical studies. Both of these people had received chemotherapy drugs before they took Talzenna. Chemotherapy drugs may have played a role in the development of this cancer.

Cancer in your blood and bone marrow can cause you to have low levels of different types of blood cells. This can lead to symptoms such as:

• frequent bruising
• easily bleeding (from nose and gums; may also have blood in stool)
• trouble breathing
• weight loss
• fatigue (lack of energy)
• weakness
• frequent infections
• fever
• pain in your bones

Your doctor will test your blood levels of red blood cells, white blood cells, and platelets before you start taking Talzenna and during your treatment. Low levels of any of these could be a sign of blood or bone marrow cancer.

If you have low blood cell counts before starting Talzenna, you may need to wait to start treatment until your blood counts improve to safe levels. Some people may need to see a doctor who specializes in blood disorders before starting Talzenna.

If your blood levels become too low while you’re taking Talzenna, your doctor may adjust your treatment. They may delay your next dose of Talzenna, reduce your current dose of Talzenna, or temporarily stop your treatment, until your platelet counts return to a safe level.

If you have symptoms of blood/bone marrow cancer while taking Talzenna, let your doctor know right away.

Talzenna cost

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

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

Financial and insurance assistance

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

Pfizer Oncology, the manufacturer of Talzenna, offers a program called Pfizer Oncology Together. For more information and to find out if you’re eligible for support, call 877-744-5675 or visit the program website.

Talzenna for breast cancer

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

Talzenna is FDA-approved to treat certain types of breast cancer in adult males and females.

About breast cancer

Breast cancer types are determined by testing cancer cells for certain receptors (attachment sites). Receptors are found on the surface of cancer cells. Different people can have different types of receptors on their cells. The following receptors may be found on breast cancer cells:

• estrogen receptors (a type of hormone receptor)
• progesterone receptors (a type of hormone receptor)
• HER2 (human epidermal growth factor receptor 2) receptors

If your cancer cells have a large number of any of these receptors, your cancer is considered “positive” for that receptor. For example, if your cancer cells have a lot of HER2 receptors, the cancer is called “HER2-positive.”

If your cancer cells have a low number of receptors, your cancer is considered “negative” for that receptor. For example, if your cancer cells have very few HER2 receptors, the cancer is called “HER2-negative.”

Your doctor uses information about receptors to know more about the specific type of breast cancer you have. This helps them choose the best treatment for you.

The type of treatment you receive may also depend on your genetics. People with mutations in their Breast Cancer gene 1 (BRCA1) or Breast Cancer gene 2 (BRCA2) genes have an increased risk of breast cancer. Everyone has BRCA genes, but in some people, these genes are mutated. Abnormal genes are passed down in families.

Your doctor may order a test to check for BRCA mutations. This will help them personalize your cancer treatment.

Sometimes breast cancer spreads outside of the breast. It may spread near your breast (locally advanced cancer) or to other parts of your body (metastatic cancer). Your doctor will order imaging tests to see where cancer has spread in your body. This also helps your doctor choose the best treatment option for you.

Talzenna treatment for breast cancer

Talzenna is used to treat breast cancer with each of the following characteristics (some of which are described in more detail in the section above):

• Hormone receptor-positive or hormone receptor-negative. These cancer cells may or may not have receptors (attachment sites) for estrogen or progesterone.
• Mutations in BRCA1 or BRCA2 genes (types of breast cancer genes). These mutations (abnormal changes) increase the risk of having certain types of cancer. Cancer with BRCA gene mutations is called BRCA-positive.
• HER2-negative breast cancer. These cancer cells don’t have many HER2 (human epidermal growth factor receptor 2) proteins on their surface.
• Advanced disease. This type of cancer has spread near your breast (called locally advanced disease) or to other parts of your body (called metastatic disease).

Effectiveness

One clinical study looked at people with BRCA-positive, HER2-negative breast cancer. People taking Talzenna had longer times without their cancer growing or spreading than people had who were using chemotherapy drugs.

In this study, 62.6% of the people taking Talzenna had their cancer reduced by 30% or more. In people taking chemotherapy drugs, 27.2% had their cancer reduced by 30% or more.

Other uses being studied

Talzenna is being studied in phase III clinical trials as a treatment for conditions other than breast cancer. Phase III trials are done to compare a new treatment to other drugs already used to treat a certain condition. Some of these phase III trials are described below.

Prostate cancer

Talzenna is being studied as a treatment for advanced prostate cancer. In this study, Talzenna is being tested in combination with Xtandi (enzalutamide), which is a hormone-lowering drug approved to treat prostate cancer.

Ovarian cancer

Talzenna is also being studied as a treatment for ovarian cancer. In this study, Talzenna is being used in combination with other anticancer drugs or following treatment with anticancer drugs. This study isn’t accepting new participants any longer.

Lung cancer

An ongoing study is testing the effectiveness of Talzenna to treat advanced lung cancer. In this study, Talzenna is being compared to several other chemotherapy and anticancer drugs.

Talzenna dosage

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

• how well your body tolerates Talzenna’s side effects (such as low red blood cell or white blood cell counts)
• your kidney function
• other drugs you are taking that may interact with Talzenna

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Talzenna comes as capsules that are taken by mouth. It’s available in two strengths: 0.25 mg and 1 mg.

Dosage for breast cancer

The usual recommended dosage of Talzenna is 1 mg, taken by mouth once daily.

The dosage of Talzenna for breast cancer treatment can be changed if needed. Your doctor may give you a lower dosage depending on several factors, such as side effects you may have and whether you have kidney disease.

If you have questions about the dosage that’s right for you, talk with your doctor.

What if I miss a dose?

If you miss a dose of Talzenna, just take your next dose at the regular time. Don’t take more than one dose at a time. This can increase your risk of serious side effects.

Will I need to use this drug long term?

It depends on how your body responds to Talzenna. If Talzenna is preventing your cancer from growing or spreading, and you’re able to manage its side effects, your doctor may recommend that you use this drug long term (several months to several years).

Talzenna and alcohol

There aren’t any known interactions between Talzenna and alcohol at this time. However, Talzenna does cause some of the same side effects that can occur after drinking too much alcohol. These side effects include:

• headache
• diarrhea
• nausea
• vomiting
• fatigue (lack of energy)

Drinking alcohol while taking Talzenna may increase your risk of these side effects. Talk with your doctor about whether drinking alcohol is safe for you during your treatment with Talzenna.

Talzenna interactions

Talzenna can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some can interfere with how well a drug works, while others can cause increased side effects.

Talzenna and other medications

Below are lists of medications that can interact with Talzenna. These lists do not contain all the drugs that may interact with Talzenna.

Before taking Talzenna, be sure to tell your doctor and pharmacist 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.

Certain blood pressure or heart rate medications

Taking Talzenna with certain blood pressure or heart rate medications can increase Talzenna levels in your body. This can increase your risk of serious side effects.

Examples of blood pressure or heart rate medications that can increase Talzenna levels include:

• amiodarone (Nexterone, Pacerone)
• carvedilol (Coreg, Coreg CR)
• verapamil (Calan, Verelan)
• diltiazem (Cardizem, Cartia XR, Diltzac)
• felodipine

If you need to take these medications during your Talzenna treatment, your doctor will lower your Talzenna dose until you’re no longer at risk for this interaction.

Certain anti-infectives

Taking Talzenna with certain antibiotics or antifungals can increase the levels of Talzenna in your body. This can increase your risk of serious side effects.

Examples of these anti-infectives include:

• azithromycin (Zithromax)
• clarithromycin (Biaxan XL)
• itraconazole (Onmel, Sporanox, Tolsura)
• ketoconazole (Extina, Nizoral, Xolegel)

If you need to take one of these antibiotics or antifungals while you’re taking Talzenna, your doctor may lower your Talzenna dose until you’re no longer taking the antibiotic or antifungal.

Alternatives to Talzenna

Other drugs are available that can treat breast cancer. Some may be better suited for you than others. If you’re interested in finding an alternative to Talzenna, talk to your doctor to learn more about other medications that may work well for you.

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

Talzenna is used to treat breast cancer that’s HER2-negative and locally advanced or metastatic in people with mutated BRCA genes. Examples of other drugs that may be used to treat this type of breast cancer include:

• doxorubicin (Doxil, Lipodox)
• paclitaxel (Abraxane, Taxol)
• gemcitabine (Gemzar, Infugem)
• capecitabine (Xeloda)
• vinorelbine (Navelbine)
• bevacizumab (Avastin, Mvasi)
• eribulin (Halaven)
• carboplatin
• cyclophosphamide
• docetaxel (Taxotere)

Talzenna vs. Lynparza

You may wonder how Talzenna compares to other medications that are prescribed for similar uses. Here we look at how Talzenna and Lynparza are alike and different.

General

Talzenna contains the drug talazoparib. Lynparza contains the drug olaparib. Both medications belong to the same class of drugs: poly ADP-ribose polymerase (PARP) inhibitors.

Uses

Talzenna and Lynparza are both FDA-approved for use in adults. These drugs are used to treat breast cancer that has all of the following characteristics:

• Hormone receptor-positive or hormone receptor-negative. These cancer cells may or may not have receptors (attachment sites) for estrogen or progesterone.
• Mutations in BRCA1 or BRCA2 genes (types of breast cancer genes). These mutations (abnormal changes) increase the risk of having certain types of cancer. Cancer with BRCA gene mutations is called BRCA-positive.
• HER2-negative breast cancer. These cancer cells don’t have HER2 (human epidermal growth factor receptor 2) proteins on their surface.
• Advanced disease. This type of cancer has spread near your breast (called locally advanced disease) or to other parts of your body (called metastatic disease).

(See the “Talzenna for breast cancer” section above for more information about this type of cancer.)

Lynparza is approved for use in people whose breast cancer hasn’t responded well enough to chemotherapy drugs.

Lynparza is also approved as:

• maintenance treatment of BRCA-mutated advanced ovarian cancer
• maintenance treatment of recurrent ovarian cancer
• treatment of advanced BRCA-mutated ovarian cancer, in people whose cancer hasn’t responded well enough to three or more different chemotherapy drugs

Drug forms and administration

Talzenna comes as capsules, which are available in two strengths: 0.25 mg and 1 mg. The usual recommended dosage of Talzenna is 1 mg taken by mouth once daily.

Lynparza comes as a tablets, which are available in two strengths: 150 mg and 100 mg. The usual recommended dosage of Lynparza is 300 mg taken by mouth twice daily.

The dosage of Talzenna and Lynparza may need to be lowered in some people. Your doctor may lower your dosage if you have kidney disease, side effects that can’t be managed, or drug interactions with other medications you’re taking.

Side effects and risks

Talzenna and Lynparza contain different drugs, but they act in similar ways in your body. Therefore, both medications can cause very similar side effects and some different side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Talzenna, with Lynparza, or with both drugs (when taken individually).

• Can occur with Talzenna:
  • hair loss
• Can occur with Lynparza:
  • stomach pain or upset
  • dizziness
  • upper respiratory infections, such as common cold or sinusitis
  • sores in your mouth or on your lips
  • impaired taste
• Can occur with both Talzenna and Lynparza:
  • nausea
  • diarrhea
  • fatigue (lack of energy)
  • headache
  • loss of appetite
  • vomiting

Serious side effects

These lists contain examples of serious side effects that can occur with Talzenna, with Lynparza, or with both drugs (when taken individually).

• Can occur with Talzenna:
  • few unique serious side effects
• Can occur with Lynparza:
  • pneumonitis (inflammation in your lungs)
• Can occur with both Talzenna and Lynparza:
  • anemia (low red blood cells)
  • thrombocytopenia (low platelets)
  • neutropenia (low white blood cells)
  • myelodysplastic syndrome/acute myeloid leukemia (cancer in your blood or bone marrow)

Effectiveness

Talzenna and Lynparza have different FDA-approved uses, but they’re both used to treat HER2-negative, BRCA-positive, metastatic breast cancer.

These drugs haven’t been directly compared in clinical studies. However, studies have found that Talzenna and Lynparza are each effective for treating this type of breast cancer.

According to treatment guidelines, Lynparza and Talzenna are both first-choice options for people with HER2-negative, BRCA-positive, metastatic breast cancer.

Costs

Talzenna and Lynparza are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

The actual price you’ll pay for either drug depends on your dose, your insurance plan, and the pharmacy you use.

How to take Talzenna

You should take Talzenna according to your doctor or healthcare provider’s instructions.

When to take

Talzenna should be taken once daily, around the same time each day.

Taking Talzenna with food

Talzenna can be taken with or without food.

Can Talzenna be crushed?

No, Talzenna capsules shouldn’t be crushed. They should be swallowed whole so that the drug is released into your body over the right amount of time.

If you have trouble swallowing pills, talk to your doctor about other treatment options or ways to make swallowing your pills easier for you.

How Talzenna works

Talzenna contains the active drug talazoparib. It belongs to a drug class called poly ADP-ribose polymerase (PARP) inhibitors. It’s used to treat HER2-negative, BRCA-positive breast cancer that’s either locally advanced (spread near your breast) or metastatic (spread to other areas of your body).

About this type of breast cancer

Talzenna is used to treat a certain forms of breast cancer that have all of the following characteristics:

• Hormone receptor-positive or hormone receptor-negative. These cancer cells may or may not have receptors (attachment sites) for estrogen or progesterone.
• Mutations in BRCA1 or BRCA2 genes (types of breast cancer genes). These mutations (abnormal changes) increase the risk of having certain types of cancer. Cancer with BRCA gene mutations is called BRCA-positive.
• HER2-negative breast cancer. These cancer cells don’t have HER2 (human epidermal growth factor receptor 2) proteins on their surface.
• Advanced disease. This type of cancer has spread near your breast (called locally advanced disease) or to other parts of your body (called metastatic disease).

What Talzenna does

Cancer cells typically grow rapidly inside your body. The process of growing (making more cancer cells) can lead to damage in DNA (genetic material) inside the cells. Cells use enzymes (certain proteins) to help repair their DNA so that more cells can be made.

Talzenna works by blocking the activity of PARP, which is one of the enzymes that helps cells repair their broken DNA.

Talzenna is used to treat breast cancer in people who have mutated BRCA genes. The BRCA gene is also involved in DNA repair inside cells, but it works in a different way than PARP. People with mutated BRCA genes can’t repair some forms of DNA damage in their cells.

Blocking PARP in people with mutated BRCA genes helps stop two ways that cells are able to repair their DNA. This leads to more damaged DNA in the cells. When the DNA becomes too damaged, chemical messengers in your body tell the cells to die.

By preventing DNA repair, Talzenna helps decrease the number of cancer cells in your body. This slows the growth and spread of breast cancer.

How long does it take to work?

Talzenna starts working in your body shortly after you take it. However, the goal of Talzenna treatment is to stop the growth of cancer. It’s not possible to say for sure how quickly the drug will stop cancer cells from growing and spreading.

In a clinical study of people taking Talzenna, the drug was effective for some people. In these people, about 45% had a smaller tumor size 49 days after they started taking Talzenna. Not everyone in this study had a response to treatment.

Your doctor will discuss ways to monitor your progress during treatment. This will help you know if the drug is working for you.

Talzenna and pregnancy

There haven’t been enough studies in humans to know if Talzenna is safe to take during pregnancy. However, animal studies did show harm (including skeletal malformations and death) to the fetus when the mother received the drug during pregnancy. Keep in mind that animal studies don’t always predict how a drug will affect humans.

Before you start treatment with Talzenna, your doctor will recommend a pregnancy test if you’re a women of child-bearing age. If you’re pregnant, you may not be able to take Talzenna. Your doctor will likely recommend that you wait until after you give birth before you start treatment with the drug.

Talzenna and birth control

Because Talzenna can be harmful to a pregnancy, it’s important to prevent pregnancy while using this drug.

Women of childbearing-age who are taking Talzenna should use birth control (contraception) during treatment. They should continue to use contraception for at least seven months after their last dose of Talzenna.

Men taking Talzenna who are sexually active with females who could become pregnant should also use birth control (such as condoms) during treatment. They should continue to use contraception for at least four months after their last dose. This is important even if their female partner is using birth control.

Talzenna and breastfeeding

It’s not known if Talzenna passes into human breast milk. However, breastfeeding while taking Talzenna isn’t recommended. This is because Talzenna’s side effects could be serious if the drug is consumed in breast milk by a child. You should wait one full month after receiving your last dose of Talzenna before breastfeeding.

If you’re considering Talzenna treatment while breastfeeding, talk to your doctor about other healthy ways to feed your child.

Common questions about Talzenna

Here are answers to some frequently asked questions about Talzenna.

Is Talzenna a type of chemotherapy?

No, Talzenna isn’t considered a type of chemotherapy (standard drugs used to treat cancer). Chemotherapy drugs work differently than Talzenna does.

Chemotherapy drugs work by killing or stopping the growth of rapidly growing cells, such as cancer cells. Chemotherapy drugs are active against all fast-growing cells, which means they can affect noncancerous (healthy) cells in your body. Common areas of your body that may be affected by chemotherapy drugs include your hair follicles and the lining of your intestines.

Talzenna works differently than chemotherapy. It’s a type of targeted therapy that is designed to attack specific cancer cells or certain parts of cancer cells. Because targeted drugs are made to work on specific substances, they may do less harm to normal cells in your body.

Can I use this drug if I’ve had a mastectomy?

Yes, you can. If you need additional treatment after you’ve had a mastectomy, your doctor may consider prescribing Talzenna or other cancer treatments.

Can Talzenna be used for males and females?

Yes. Talzenna can be used for males or females with certain types of breast cancer.

In the clinical study used for Talzenna’s FDA approval, 1.6% of people taking Talzenna were male. In the general population, breast cancer is less common in men than in women.

Talzenna warnings

Before taking Talzenna, talk with your doctor about your health history. Talzenna may not be right for you if you have the following medical condition:

• Blood disorders. Talzenna can cause decreased levels of certain blood cells, including red blood cells, white blood cells, and platelets. These conditions can increase your risk of infections, bleeding, and anemia. Blood disorders may be associated with certain blood cancers (myelodysplastic syndrome/acute myeloid leukemia). If you have low levels of certain blood cells before treatment, your doctor will wait to start treatment until your blood counts have returned to a healthy level.

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

Talzenna overdose

Taking too much Talzenna can increase your risk of serious side effects. It can also make common side effects worse.

Overdose symptoms

Symptoms of an overdose can include:

• diarrhea
• nausea
• vomiting
• lack of appetite
• headache
• fatigue (lack of energy)

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor or seek guidance from the American Association of Poison Control Centers at 800-222-1222 or through their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

Talzenna expiration, storage, and disposal

When you get Talzenna from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically one year from the date they dispensed the medication.

The expiration date helps guarantee the effectiveness of the medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Talzenna capsules should be stored at room temperature (68°F to 77°F/20°C to 25⁰C) in a tightly sealed container away from light. Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.

Disposal

If you no longer need to take Talzenna and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.