Talazoparib

Talazoparib is a prescription medication used for the treatment of adults with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer.

• Talazoparib is available under the following different brand names: Talzenna

Common side effects of Talazoparib include:

• fatigue
• anemia
• nausea
• low white blood cell count (neutropenia)
• headache
• low blood platelets (thrombocytopenia)
• vomiting
• hair loss
• diarrhea
• decreased appetite

Serious side effects of Talazoparib include:

• none

Rare side effects of Talazoparib include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsule

• 0.25 mg
• 1 mg

Breast Cancer

Adult dosage

• 1 mg orally every day with or without food
• Continue until disease progression or unacceptable toxicity occurs

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Talazoparib has severe interactions with no other drugs
• Talazoparib has serious interactions with at least 32 drugs
• Talazoparib has moderate interactions with at least 39 drugs
• Talazoparib has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Talazoparib?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Talazoparib?”

Cautions

• Myelosuppression (e.g., anemia, leukopenia/neutropenia, and/or thrombocytopenia) reported; monitor CBC count for cytopenia at baseline and monthly thereafter; do not start until patients have adequately recovered from hematological toxicity caused by previous therapy
• Based on its mechanism of action and findings from animal data, fetal harm may occur when administered to a pregnant woman
• Myelodysplastic syndrome/acute myeloid leukemia
• Myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) reported; MDS/AML reported (0.3%) in solid tumors in clinical studies; duration of treatment in these patients prior to developing MDS/AML was 4 months and 24 months, respectively
• Do not start until patients have adequately recovered from hematological toxicity caused by previous chemotherapy
• For prolonged hematological toxicities, interrupt and monitor blood cell counts weekly until recovery; if levels do not recover after 4 weeks, refer the patient to a hematologist for further investigations
• If MDS/AML is confirmed, discontinue treatment
• Drug interactions overview
  • P-gp and BCRP transporters substrate
• Effect of P-gp inhibitors
  • Coadministration with P-gp inhibitors may increase talazoparib exposure
  • In clinical studies, coadministration with P-gp inhibitors (i.e., amiodarone, carvedilol, clarithromycin, itraconazole, verapamil) resulted in an ~45% increase in talazoparib exposure and an increase in the rate of talazoparib dose reduction
  • When coadministering with P-gp inhibitors not listed above, monitor for potential increased adverse reactions
• Effect of BCRP inhibitors
  • Coadministration with BCRP inhibitors may increase talazoparib exposure
  • If coadministration cannot be avoided, monitor potential increased adverse reactions when coadministering

Pregnancy and Lactation

Based on findings from animal studies and its mechanism of action, embryofetal harm may occur when administered to pregnant women

No data available on use in pregnant women to inform a drug-associated risk

Recommend a pregnancy test for women of reproductive potential before initiating treatment

Contraception

• Women of reproductive potential: Use effective contraception during treatment and for 7 months and more following the last dose
• Men with women partners of reproductive potential and pregnant partners: Use effective contraception during treatment and for 4 months or more following the last dose

Infertility

• Based on animal studies, impaired fertility in men of reproductive potential may occur

Lactation

• There are no data on the presence of talazoparib in human milk, its effects on milk production, or on breastfed children
• Advise lactating women not to breastfeed during treatment and for 1 month and more after the final dose