Names and pronunciation
(tal′a-zoe′pa-rib) Talzenna
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Drug reference
(tal′a-zoe′pa-rib) Talzenna
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Func. class.: Antineoplastic
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Chem. class.: Poly (ADP-ribose) polymerase (PARP) inhibitors
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ACTION: An inhibitor of (ADP-ribose) (PARP) enzymes (PARP1 and PARP2) that are involved in DNA repair. Cytotoxicity involve inhibition of PARP enzymatic activity and increased formation of PARP- DNA, resulting in DNA damage, decreased cell proliferation, and apoptosis
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USES: Deleterious/suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer
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CONTRAINDICATIONS: Hypersensitivity Precautions: Anemia, bone marrow suppression, breastfeeding, contracep- tion requirements, infertility, leukemia, leukopenia, male-mediated teratogenic- ity, myelodysplastic syndrome, neutrope- nia, new primary malignancy, pregnancy, pregnancy testing, reproductive risk, thrombocytopenia
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SIDE EFFECTS CNS: Fatigue, headache, dizziness GI: Nausea, vomiting, diarrhea, anorexia, abdominal pain HEMA: Anemia, neutropenia, thrombocy topenia META: Hyperglycemia, hypocalcemia MISC: New primary malignancy, leuke mia, MDS/AML
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INTERACTIONS • Increase: effect of talazoparib—P-gp in- hibitors (amiodarone, carvedilol, clarithro- mycin, itraconazole, verapamil); monitor for potential increased adverse reactions • Increase: effect of talazoparib—BCRP inhibitors; monitor for potential in- creased adverse reactions when coad- ministering Drug/Lab: • Increase: glucose, ALT, AST, alk phos • Decrease: hemoglobin, platelets, neu- trophils, lymphocytes, leukocytes, calcium
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DOSAGE AND ROUTES • Adult: PO 1 mg daily until disease progression or unacceptable toxicity Renal dose • Adult: PO Moderate renal impairment (CrCL 30-59 mL/min): 0.75 mg daily; severe impairment (CCl 15-29 mL/min): 0.5 mg PO daily Hematologic toxicity dose • Do not start until patient has ade- quately recovered from hematologic tox- icity caused by previous therapy • Hemoglobin <8 g/dL: Hold, monitor blood counts weekly. When HB recovers to ≥9 g/dL, reduce daily dose by 0.25 mg and resume • Neutrophil count <1000 cells/mm3: Hold, monitor blood counts weekly. When neutrophils recover to ≥1500 cells/mm3, reduce daily dose by 0.25 mg and resume • Platelet count <50,000 cells/mm3: Hold, monitor blood counts weekly. When platelets recover to ≥75,000 cells/ mm3, reduce daily dose by 0.25 mg and resume Nonhematologic toxicity dose • Grade 3 or 4: Hold; when toxicity re- solves to grade ≤1, consider reducing dose by 0.25 mg and resuming
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Available forms: Caps 0.25 mg, 0.5, 0.75, 1 mg
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Administer: • Swallow capsules whole; do not open or dissolve • May be taken with or without food • If patient vomits or misses a dose, an additional dose should not be taken; take the next dose at regularly scheduled time • Storage: At room temperature
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Assess: • Monitor CBC with differential baseline and monthly; serum creatinine; do not start until patient has recovered from hematologic toxicities from other che- motherapy • Pregnancy/breastfeeding: obtain pregnancy test in females of reproductive potential before use; fetal harm may oc cur; effective contraception is needed during treatment and for ≥7 mo after the last dose; male patients with female part ners of reproductive potential or pregnant partners should use effective contracep tion during treatment and for ≥4 mo fol lowing the last dose; fertility may be im paired in males
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Evaluate: • Therapeutic response: decreased growth, spread of breast cancer
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • MDS/AML: to report to health care provider if feeling tired or experiencing symptoms of weakness, fever, weight loss, frequent infections, bruising, bleed ing easily, breathlessness, blood in urine or stool • Myelosuppression: that product may cause anemia, leukopenia/neutropenia, and/or thrombocytopenia; that frequent lab testing will be required • To take daily with or without food; that if a dose is missed, to take next normal dose at the usual time; to swallow each capsule whole; that capsules must not be opened or dissolved • Pregnancy/breastfeeding: to notify health care provider if pregnant or plan ning to become pregnant; that females of reproductive potential must use effective contraception during treatment and for ≥7 mo after last dose; not to breastfeed during treatment or for ≥1 mo after re ceiving the last dose; that male pa tients with female partners of repro ductive potential or who are pregnant should use effective contraception dur ing treatment and for ≥4 mo after last dose • To notify health care provider of nau- sea, vomiting to obtain options to lessen these side effects • To notify health care provider of all Rx, OTC, herbals, or supplements taken; not to add or change medications unless ap- proved by provider HIGH ALERT
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PHARMACOKINETICS 74% protein binding, metabolized in liver, excretion in urine 68.7%, 19.8 % in feces
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• Adult: PO 1 mg daily until disease progression or unacceptable toxicity Renal dose
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• Adult: PO Moderate renal impairment (CrCL 30-59 mL/min): 0.75 mg daily; severe impairment (CCl 15-29 mL/min): 0.5 mg PO daily Hematologic toxicity dose
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