Talzenna
Pronunciation: tal-ZEN-ah
Generic name: talazoparib
Dosage form: capsule (0.1 mg, 0.25 mg, 0.35 mg, 0.5 mg, 0.75 mg, 1 mg)
Drug class: PARP inhibitors
What is 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.
What is Talzenna used for?
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: It is also used for metastatic castration-resistant prostate cancer (mCRPC) that is locally advanced or metastatic and has mutations in homologous recombination repair (HRR) genes. For prostate cancer, Talzeena is used together with enzalutamide (Xtandi), and patients should also receive a gonadotropic-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.
Warnings
Bone marrow problems called Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). MDS/AML has occurred in some patients who have used Talzenna, which has been fatal. Patients should be monitored for hematological toxicity, and Talzenna should be discontinued if MDS/AML is confirmed
Myelosuppression: These capsules may may affect blood cell production (hematopoiesis) and can cause low levels of white blood cells (neutropenia), red blood cells (anaemia) and/or low 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 treatments may be delayed based on the results.
Embryo-Fetal Toxicity: Talzenna can cause fetal harm. Avoid pregnancy by using effective contraception.
Before taking this medicine
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.
How should I take Talzenna?
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).
Dosing information
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 taken orally once daily in combination with enzalutamide; it can be used until disease progression or unacceptable toxicity. Patients taking Talzenna and enzalutamide should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.
Comment: Select patients for the treatment based on the presence of the HRR gene-mutated mCRPC.
Use: For the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
Dose modifications
Dose will be modified due to adverse reaction, renal impairment, and when used with medications that are P-glycoprotein inhibitors.
Talzenna Capsules are available as: 0.1 mg, 0.25 mg, 0.35 mg, 0.5 mg, 0.75 mg, and 1 mg.
What happens if I miss a dose?
Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Talzenna side effects
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.
Related/similar drugs
What other drugs will affect Talzenna?
You should not take Talzenna with the following P-glycoprotein (P-gp) inhibitors:
If coadministration of Talzenna with these P-gp inhibitor medicines cannot be avoided, then your dose will be modified.
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.
Ingredients
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.
Storage
Store at 20°C to 25°C (68°F to 77°F).
Popular FAQ
What type of drug is Talzenna?
Talzenna (talazoparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor that blocks PARP, a protein that is involved with cancer cell growth, regulation and repair. PARP inhibitors stop the cancer cells from being repaired which leads to cell death and a reduction in tumor growth.
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