Talzenna

Talzenna (talazoparib) is a type of targeted cancer therapy used to treat certain breast cancers and prostate cancers that are locally advanced or metastatic and have specific gene mutations. Talzenna works by slowing the growth of cancer cells and helping to destroy them.

Talzenna belongs to a class of medications called PARP inhibitors. It blocks the PARP enzyme from repairing damaged DNA in cancer cells, which prevents cancer cells from multiplying and leads to their death.

Talzenna capsules are taken once a day, with or without food.

Your doctor will test your tumor type to make sure that Talzenna is the right treatment for you.

Talzenna is FDA-approved to treat:

• Breast Cancer: Talzenna is approved for treating locally advanced or metastatic breast cancer that is HER2-negative and has a germline BRCA (gBRCA) mutation.
• Prostate Cancer: Talzenna is used together with enzalutamide (Xtandi) to treat metastatic prostate cancer that has mutations in homologous recombination repair (HRR) genes, as detected by an FDA-authorized test. It is approved for two treatment settings: metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer, previously known as metastatic castration-resistant prostate cancer (mCRPC); and metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer, an earlier treatment setting previously known as metastatic castration-sensitive prostate cancer. Patients taking Talzenna for prostate cancer should also receive a gonadotropin-releasing hormone (GnRH) analog at the same time, or should have had both testicles removed (bilateral orchiectomy).

Talzenna capsules are usually taken once a day, with or without food. Swallow the capsule whole and do not open or dissolve it. If you vomit shortly after taking this medicine, do not take another dose. Take your next dose as scheduled.

Do not change your dose or stop using this medicine without your doctor's advice.

Take Talzenna exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Talzenna is usually given until your body no longer responds to the medication.

You may get infections or bleed more easily. Your blood will be tested before and during treatment, and your cancer treatments may be delayed based on the results.

For prostate cancer, Talzenna is taken in combination with enzalutamide (Xtandi). You should start or continue a gonadotropin-releasing hormone (GnRH) analog therapy during your treatment with Talzenna and enzalutamide, unless you have had surgery to lower the amount of testosterone in your body (surgical castration).

Bone marrow problems called Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). MDS and AML have occurred in some people who used Talzenna and have been fatal in some cases. In clinical studies of 1,096 patients treated with Talzenna alone or in combination with enzalutamide, about 1% developed MDS or AML, including 0.6% with a fatal outcome. Your blood will be monitored during treatment, and Talzenna will be stopped if MDS or AML is confirmed.

Myelosuppression (low blood cell counts): Talzenna may affect blood cell production and can cause low levels of white blood cells (neutropenia), red blood cells (anemia), and/or platelets (thrombocytopenia). You may get infections or bleed more easily. Call your doctor if you have unusual bruising or bleeding, blood in your urine or stools, weight loss, fever, weakness, tiredness, or trouble breathing. Your blood will be tested before and during treatment, and your cancer treatment may be delayed based on the results.

Embryo-Fetal Toxicity: Talzenna can cause harm to an unborn baby. Avoid pregnancy by using effective contraception.

To make sure Talzenna is safe for you, tell your doctor if you have or have ever had:

• kidney disease.

Using Talzenna may increase your risk of developing bone marrow problems or leukemia. Ask your doctor about your individual risk.

Pregnancy

Talzenna can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 7 months after your last dose.
• If you are a man, use birth control if your sexual partner is able to get pregnant. Keep using birth control for at least 4 months after your last dose.
• Tell your doctor right away if a pregnancy occurs.

It may be harder for you to get a woman pregnant while you are using this medicine. You should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Breastfeeding

Do not breastfeed while using this medicine, and for at least 1 month after your last dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Common Talzenna side effects may include:

• low blood cell counts;
• an electrolyte imbalance (such as low blood levels of potassium or magnesium);
• bone injuries, low levels of calcium in your blood (hypocalcemia);
• high levels of bilirubin in the blood;
• high blood sugar;
• changes in your sense of taste;
• nausea, vomiting, diarrhea, loss of appetite;
• hair loss;
• dizziness, headache, or feeling weak or tired.

Serious Talzenna side effects

Get emergency medical help if you have signs of an allergic reaction to Talzenna: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Talzenna may cause other serious side effects. Call your doctor at once if you have:

• blood in your urine or stools;
• easy bruising, unusual bleeding, purple or red spots under your skin;
• weight loss;
• frequent infections;
• low red blood cells (anemia): pale skin, weakness, tiredness, feeling light-headed or short of breath, cold hands and feet; or
• low white blood cell counts: fever, mouth sores, skin sores, sore throat, cough.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Talzenna Adult Dose for Breast Cancer

Dose: 1 mg orally once a day until disease progression or unacceptable toxicity.

Comment: Select patients based on the presence of germline BRCA mutations as determined by an FDA-approved test.

Use: For the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer.

Usual Talzenna Adult Dose for Prostate Cancer

Dose: 0.5 mg orally once daily in combination with enzalutamide until disease progression or unacceptable toxicity. Patients taking Talzenna and enzalutamide should also receive a gonadotropin-releasing hormone (GnRH) analog at the same time, or should have had a bilateral orchiectomy.

Comment: Select patients based on the presence of HRR gene mutations as detected by an FDA-authorized test.

Use: For the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer, or HRR gene-mutated metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer.

Dose modifications

The dose may be modified because of adverse reactions, kidney (renal) impairment, or when Talzenna is used with certain medications that are P-glycoprotein (P-gp) inhibitors.

For prostate cancer, the recommended dose in moderate kidney impairment (creatinine clearance 30 to 59 mL/min) is 0.35 mg once daily with enzalutamide, and in severe kidney impairment (creatinine clearance 15 to 29 mL/min) is 0.25 mg once daily with enzalutamide.

Talzenna capsules are available as: 0.1 mg, 0.25 mg, 0.35 mg, 0.5 mg, 0.75 mg, and 1 mg.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

You should avoid taking Talzenna with the following P-glycoprotein (P-gp) inhibitors:

• amiodarone;
• carvedilol;
• clarithromycin;
• itraconazole; or
• verapamil.

If taking Talzenna with one of these P-gp inhibitors cannot be avoided, your dose will be modified. For prostate cancer, the effect of P-gp inhibitors when Talzenna is taken with enzalutamide has not been studied; your doctor will monitor you for side effects and may adjust your dose.

Taking Talzenna with a breast cancer resistance protein (BCRP) inhibitor may also increase the level of talazoparib in your body and raise your risk of side effects. Your doctor will monitor you and may adjust your dose.

Tell your doctor about all your other medicines. This list is not complete. Other drugs may interact with talazoparib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Store at 20°C to 25°C (68°F to 77°F).

Active ingredient: talazoparib tosylate

Inactive ingredients: silicified microcrystalline cellulose (sMCC). The capsule shells contain hypromellose (HPMC), yellow iron oxide, red iron oxide, and titanium dioxide. The printing ink contains shellac, black iron oxide, potassium hydroxide, ammonium hydroxide, and propylene glycol.