Talzenna

/ Pfizer

The recommended dose of Talazoparib is 1 mg taken orally once daily, with or without food.
The 0.25 mg capsule is available for dose reduction.
Patients should be treated until disease progression or unacceptable toxicity occurs.
To avoid contact with the capsule content, Talazoparib capsules should be swallowed whole, and must not be opened or dissolved.
If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time.
Dose Reduction Levels for Adverse Reactions
Recommended starting dose: 1 mg (one 1 mg capsule) once daily.
First dose reduction: 0.75 mg (three 0.25 mg capsules) once daily.
Second dose reduction: 0.5 mg (two 0.25 mg capsules) once daily.
Third dose reduction: 0.25 mg (one 0.25 mg capsule) once daily.
Dose Modification and Management: Complete blood counts should be monitored monthly and as clinically indicated.
Hemoglobin< 8 g/dL: withhold Talazoparib until levels resolve to≥9 g/dL resume Talazoparib at a reduced dose.
Platelet count <50,000/μL: withhold Talazoparib until levels resolve to  ≥75,000/μL resume Talazoparib at a reduced dose.
Neutrophil count <1,000/μL: withhold Talazoparib until levels resolve to  ≥1500/μL resume Talazoparib at a reduced dose.
Non-hematologic Grade 3 or Grade 4: withhold Talazoparib until levels resolve to ≤Grade 1, Consider resuming Talazoparib at a reduced dose or discontinue.
Dose Modifications for Patients with Renal Impairment: Dose Modifications for Patients with Renal Impairment
For patients with moderate renal impairment (CLcr 30 – 59 mL/min), The recommended dose is 0.75 mg once daily. For patients with severe renal impairment (CLcr 15 – 29 mL/min), the recommended dose of TALZENNA is 0.5 mg once daily .
Dose Modifications for Use with P-glycoprotein (P-gp) Inhibitors: Reduce the Talazoparib dose to 0.75 mg once daily when coadministered with certain P-gp inhibitors.
See prescribing information for full details.

Treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer.

Hypersensitivity to the active substance or to any of the excipients.

Myelodysplastic Syndrome/Acute Myeloid Leukemia: 
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) have been reported in patients who received Talazoparib.
Do not start treatment with this medial product until patients have adequately recovered from hematological toxicity caused by previous chemotherapy. Monitor blood counts monthly during treatment with this medical product. For prolonged hematological toxicities, interrupt Talazoparib and monitor blood counts weekly until recovery. If counts do not recover within 4 weeks, refer the patient to a hematologist for further investigations including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue this medical product.
Myelosuppression:
Myelosuppression consisting of anemia, neutropenia, and/or thrombocytopenia, have been reported in patients treated with Talazoparib.
Embryo-Fetal Toxicity:
Based on its mechanism of action and findings from animal data, Talazoparib can cause fetal harm when administered to a pregnant woman.
Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of Talazoparib.
See prescribing information for full details.

Most common (clinical relevant): Abdominal pain, dizziness, dysgeusia, dyspepsia, stomatitis, and febrile neutropenia.
See prescribing information for full details.

Effect of P-gp Inhibitors
Breast Cancer
Coadministration of Talazoparib with these P-gp inhibitors increased talazoparib concentrations, which may increase the risk of adverse reactions.
Avoid coadministration of Talazoparib with the following P-gp inhibitors: itraconazole, amiodarone, carvedilol, clarithromycin, itraconazole, and verapamil. If coadministration of Talazoparib with these P-gp inhibitors cannot be avoided, reduce the dose of Talazoparib. When the P-gp inhibitor is discontinued, increase the dose of Talazoparib.
Effect of Breast Cancer Resistance Protein (BCRP) Inhibitors
Coadministration of Talazoparib with BCRP inhibitors may increase talazoparib exposure, which may increase the risk of adverse reactions. Monitor patients for increased adverse reactions and modify the dosage as recommended for adverse reactions when Talazoparib is coadministered with a BCRP inhibitor.

Pregnancy: There are no available data on Talazoparib use in pregnant women to inform a drug-associated risk.
Talazoparib can cause fetal harm when administered to pregnant women. Verify pregnancy status in females of reproductive potential prior to initiating Talazoparib treatment. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of Talazoparib.
Males: Based on genotoxicity and animal reproduction studies, advise male patients with female partners of reproductive potential and pregnant partners to use effective contraception during treatment with Talazoparib and for 4 months following the last dose.
Lactation: There are no data on the presence of talazoparib in human milk, the effects of the drug on milk production, or the effects of the drug on the breastfed child. Because of the potential for serious adverse reactions in a breastfed child from talazoparib, advise lactating women not to breastfeed during treatment with Talazoparib and for 1 month after the last dose.
See prescribing information for full details.

Storage: Do not store above 30°C.
Shelf life: The expiry date of the product is indicated on the packaging materials. After first opening the bottle can be used for up to six months and no later than the expiry date indicated on the packaging materials.