Talzenna

Talzenna is a prescription medication used to treat locally advanced or metastatic HER2-negative breast cancer with an inherited BRCA1 or BRCA2 mutation. Locally advanced breast cancer is cancer that has spread to tissues near the breast, whereas metastatic cancer has spread to other parts of the body away from the breast.

Talzenna belongs to a group of drugs called poly ADP-ribose polymerase (PARP) inhibitors. The PARP enzyme fixes DNA damage in both healthy and cancer cells. PARP inhibitors, like Talzenna, interfere with the PARP enzyme so that cancer cells with a BRCA1 or BRCA2 mutation are unable to fix DNA damage. These damaged cells are less likely to survive.

This medication comes in capsule form and is taken once daily, with or without food. Swallow Talzenna capsules whole. Do not chew, divide, or break Talzenna capsules.

Common side effects of Talzenna include low red blood cell count, low white blood cell count, and nausea/vomiting. Talzenna can also cause extreme tiredness. Do not drive or operate heavy machinery until you know how Talzenna affects you.

Talzenna is a prescription medicine used to treat adults with:

• a certain type of breast cancer (human epidermal growth factor receptor 2 [HER2]-negative), and
• an abnormal inherited BRCA gene, and
• whose cancer has spread to other parts of the body (locally advanced or metastatic).

Your healthcare provider will perform a test to make sure that Talzenna is right for you.

It is not known if Talzenna is safe and effective in children.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Talzenna. See the “Talzenna Precautions” section.

Common side effects of Talzenna include the following:

• tiredness or weakness
• low number of red or white blood cells
• nausea
• low number of platelets
• headache
• loss of appetite
• diarrhea
• vomiting
• hair loss

Talzenna may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if this is a concern for you. These are not all of the possible side effects of Talzenna.

This is not a complete list of Talzenna side effects. Ask your doctor or pharmacist for more information.Tell your doctor if you have any side effects that bother you or that do not go away call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Heart medications like amiodarone, carvedilol, and verapamil
• Clarithromycin
• Itraconazole
• Promazine
• Chemotherapy agents like mitoxantrone, methotrexate, and topotecan

This is not a complete list of Talzenna drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Talzenna including:

Bone marrow problems called Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). Some people who have cancer and who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed MDS or AML during or after treatment with Talzenna. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with Talzenna.

Symptoms of low blood cell counts are common during treatment with Talzenna, but can be a sign of serious problems, including MDS or AML. Tell your healthcare provider if you have any of the following symptoms during treatment with Talzenna:

• weakness
• weight loss
• fever
• frequent infections
• blood in urine or stool
• shortness of breath
• feeling very tired
• bruising or bleeding more easily

Your healthcare provider will do blood tests to check your blood cell counts:

• before treatment with Talzenna
• every month during treatment with Talzenna
• weekly if you have low blood cell counts that last a long time. Your healthcare provider may stop treatment with Talzenna until your blood cell counts improve.

Talzenna can cause extreme tiredness. Do not drive or operate heavy machinery until you know how Talzenna affects you.

Do not take Talzenna if you are allergic to Talzenna or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Talzenna, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Talzenna, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have kidney problems
• are pregnant or plan to become pregnant. Talzenna can harm your unborn baby, and may cause loss of pregnancy (miscarriage). You should not become pregnant during treatment with Talzenna. Tell your healthcare provider right away if you are pregnant or become pregnant during treatment with Talzenna.
  • If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with Talzenna.
  • Females who are able to become pregnant should use effective birth control (contraception) during treatment with Talzenna and for at least 7 months after receiving the last dose of Talzenna. Talk to your healthcare provider about forms of birth control that may be right for you. 
  • Males with female partners who are pregnant or are able to become pregnant should use effective birth control during treatment with Talzenna and for at least 4 months after receiving the last dose of Talzenna.
• are breastfeeding or plan to breastfeed. It is not known if Talzenna passes into your breast milk. Do not breastfeed during treatment with Talzenna and for at least 1 month after receiving the last dose of Talzenna. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Based on how Talzenna works, it can cause babies to be born with problems if given to pregnant women. 

• If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with Talzenna.
• Females who are able to become pregnant should use effective birth control (contraception) during treatment with Talzenna and for at least 7 months after receiving the last dose of Talzenna. Talk to your healthcare provider about forms of birth control that may be right for you. 
• Males with female partners who are pregnant or are able to become pregnant should use effective birth control during treatment with Talzenna and for at least 4 months after receiving the last dose of Talzenna.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Talzenna crosses into human milk. Do not breastfeed during treatment with Talzenna and for at least 1 month after receiving the last dose of Talzenna. Talk to your healthcare provider about the best way to feed your baby during this time.

• Take Talzenna exactly as your healthcare provider tells you.
• Do not change your dose or stop taking Talzenna without first talking with your healthcare provider.
• Take Talzenna 1 time a day.
• Take Talzenna with or without food. 
• Swallow Talzenna capsules whole. Do not dissolve or open Talzenna capsules. 
• Your healthcare provider may change your dose of Talzenna or tell you to stop taking Talzenna depending on how you respond to treatment.
• If you miss a dose of Talzenna or vomit, take your next dose at your regular time. Do not take an extra dose to make up for a missed dose.
• If you take too much Talzenna, call your healthcare provider or go to the nearest hospital emergency room right away.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Talzenna is 1 mg taken as a single oral daily dose, with or without food. The dose may be reduced by 0.25mg-0.75 mg depending on side effects experienced. For people with moderate renal impairment (kidney disease), the recommended dose of Talzenna is 0.75 mg once daily.

If you take too much Talzenna, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store Talzenna at 68°F to 77°F (20°C to 25°C ).
Keep Talzenna and all medicines out of the reach of children.