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    Active Ingredient
    Talazoparib Tosylate 0.25 mg, 1 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Hard Capsules

    60 X 0.25 mg

    partial basket chart

    Hard Capsules

    30 X 1 mg

    partial basket chart

    Dosage

    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: For patients with moderate renal impairment (CLcr 30 – 59 mL/min), the recommended dose of Talazoparib is 0.75 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.


    Indications

    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.


    Contra-Indications

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


    Special Precautions

    Myelodysplastic Syndrome/Acute Myeloid Leukemia: Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) have been reported in patients who received Talazoparib.
    Myelosuppression: Myelosuppression consisting of anemia, leukopenia/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 at least 7 months following the last dose of Talazoparib.
    See prescribing information for full details.


    Side Effects

    Most common: Abdominal pain, dizziness, leukopenia, dysgeusia, dyspepsia, stomatitis, and lymphopenia.
    See prescribing information for full details.


    Drug interactions

    Effect of Other Drugs on Talazoparib
    Effect of P-gp inhibitors:
    In patients with advanced solid tumors, coadministration of a P-gp inhibitor (multiple 100 mg twice-daily doses of itraconazole) with a single 0.5 mg talazoparib dose increased talazoparib AUCinf and Cmax by approximately 56% and 40%, respectively. Population PK analysis showed that coadministration with P-gp inhibitors including amiodarone, carvedilol, clarithromycin, itraconazole, and verapamil in clinical studies increased talazoparib exposure by 45%.
    Coadministration with P-gp inhibitors including azithromycin, atorvastatin, diltiazem, felodipine, fluvoxamine, and quercetin in clinical studies increased talazoparib exposure by 8%.
    Effect of P-gp inducers: In patients with advanced solid tumors, coadministration of a P-gp inducer (multiple 600 mg once-daily doses of rifampin) with a single 1 mg talazoparib dose increased talazoparib Cmax by 37% with no effect on talazoparib exposure.
    Effect of BCRP inhibitors: The effect of BCRP inhibitors on PK of talazoparib has not been studied. Coadministration with BCRP inhibitors may increase talazoparib exposure.
    Effect of acid-reducing agents on talazoparib: Coadministration of acid-reducing agents including proton pump inhibitors (PPI), histamine receptor 2 antagonists (H2RA), or other acid reducing agents has no effect on the absorption of talazoparib.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: There are no available data on Talazoparib use in pregnant women to inform a drug-associated risk.
    A pregnancy test is recommended for females of reproductive potential prior to initiating Talazoparib treatment.
    Talazoparib can cause fetal harm when administered to pregnant women. Advise females of reproductive potential to use effective contraception during treatment and for at least 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 at least 4 months following the last dose.
    LactationThere 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 at least 1 month after the final dose.
    See prescribing information for full details.       


    Overdose

    There is no specific treatment in the event of Talazoparib overdose, and symptoms of overdose have not been established. In the event of overdose, discontinue treatment with Talazoparib, consider gastric decontamination, follow general supportive measures, and treat symptomatically.


    Important notes

    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.


    Manufacturer
    Excella GmbH, Germany
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