talazoparib (Rx)

Brand and Other Names:Talzenna
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 0.25mg
  • 1mg

Breast Cancer

Indicated for adults with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer

1 mg PO qDay with or without food

Continue until disease progression or unacceptable toxicity occurs

Dosage Modifications

Consider treatment interruption or dosage reduction in the event of adverse reactions

0.25-mg capsule available for dose reduction

Dose reduction levels for adverse reactions

  • First dose reduction: 0.75 mg (three 0.25-mg capsules) qDay
  • Second dose reduction: 0.5 mg (two 0.25-mg capsules) qDay
  • Third dose reduction: 0.25 mg (one 0.25-mg capsule) qDay
  • Discontinue treatment if >3 dose reductions are required

Hemoglobin <8 g/dL

  • Withhold until levels resolve to hemoglobin ≥9 g/dL
  • Resume treatment at reduced dose

Platelet count <50,000/mcL

  • Withhold until levels resolve to platelet count ≥75,000/mcL
  • Resume treatment at reduced dose

Neutrophil count <1000/mcL

  • Withhold until levels resolve to neutrophil count ≥1500/mcL
  • Resume treatment at reduced dose

Nonhematologic Grade ≥3

  • Withhold until resolve to Grade ≤1
  • Consider resuming at a reduced dose or discontinue

Coadministration with P-glycoprotein (P-gp) inhibitors

  • P-gp inhibitors (ie, amiodarone, carvedilol, clarithromycin, itraconazole, verapamil): Avoid use; if coadministration cannot be avoided, reduce talazoparib dose to 0.75 mg qDay
  • Once P-gp inhibitors are discontinued, increase talazoparib dose (after 3-5 half-lives of the inhibitor) to dose used before initiating the P-gp inhibitor
  • Other P-gp inhibitors that were not specifically studied in preclinical trials may also increase talazoparib systemic exposure; if coadministered, cautiously monitor

Renal impairment

  • Mild (CrCl 60-89 mL/min): No dosage adjustment required
  • Moderate (CrCl 30-59 mL/min): Reduce to 0.75 mg qDay
  • Severe (CrCl 15-29 mL/min): Reduce to 0.5 mg qDay
  • Hemodialysis: Not studied

Hepatic impairment

  • Mild-to-severe: No dosage adjustment necessary

Dosing Considerations

Verify pregnancy in females of reproductive potential before initiating treatment

Patient selection

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

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              Serious - Use Alternative (30)

              • acalabrutinib

                acalabrutinib will increase the level or effect of talazoparib by Other (see comment). Avoid or Use Alternate Drug. BCRP inhibitors may increase systemic exposure of talazoparib (a BCRP substrate). If coadministration cannot be avoided, monitor for potential adverse reactions.

              • amiodarone

                amiodarone will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If coadministration with certain P-gp inhibitors (ie, amiodarone, carvedilol, clarithromycin, itraconazole, verapamil) cannot be avoided, reduce talazoparib dose to 0.75 mg qDay. Once P-gp inhibitors are discontinued, increase talazoparib dose (after 3-5 half-lives of the inhibitor) to dose used prior to initiating the P-gp inhibitor(s).

              • carvedilol

                carvedilol will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If coadministration with certain P-gp inhibitors (ie, amiodarone, carvedilol, clarithromycin, itraconazole, verapamil) cannot be avoided, reduce talazoparib dose to 0.75 mg qDay. Once P-gp inhibitors are discontinued, increase talazoparib dose (after 3-5 half-lives of the inhibitor) to dose used prior to initiating the P-gp inhibitor(s).

              • clarithromycin

                clarithromycin will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If coadministration with certain P-gp inhibitors (ie, amiodarone, carvedilol, clarithromycin, itraconazole, verapamil) cannot be avoided, reduce talazoparib dose to 0.75 mg qDay. Once P-gp inhibitors are discontinued, increase talazoparib dose (after 3-5 half-lives of the inhibitor) to dose used prior to initiating the P-gp inhibitor(s).

              • cobicistat

                cobicistat will increase the level or effect of talazoparib by Other (see comment). Avoid or Use Alternate Drug. BCRP inhibitors may increase systemic exposure of talazoparib (a BCRP substrate). If coadministration cannot be avoided, monitor for potential adverse reactions.

              • cyclosporine

                cyclosporine will increase the level or effect of talazoparib by Other (see comment). Avoid or Use Alternate Drug. BCRP inhibitors may increase systemic exposure of talazoparib (a BCRP substrate). If coadministration cannot be avoided, monitor for potential adverse reactions.

              • dabrafenib

                dabrafenib will increase the level or effect of talazoparib by Other (see comment). Avoid or Use Alternate Drug. BCRP inhibitors may increase systemic exposure of talazoparib (a BCRP substrate). If coadministration cannot be avoided, monitor for potential adverse reactions.

              • dipyridamole

                dipyridamole will increase the level or effect of talazoparib by Other (see comment). Avoid or Use Alternate Drug. BCRP inhibitors may increase systemic exposure of talazoparib (a BCRP substrate). If coadministration cannot be avoided, monitor for potential adverse reactions.

              • eltrombopag

                eltrombopag will increase the level or effect of talazoparib by Other (see comment). Avoid or Use Alternate Drug. BCRP inhibitors may increase systemic exposure of talazoparib (a BCRP substrate). If coadministration cannot be avoided, monitor for potential adverse reactions.

              • eluxadoline

                eluxadoline will increase the level or effect of talazoparib by Other (see comment). Avoid or Use Alternate Drug. BCRP inhibitors may increase systemic exposure of talazoparib (a BCRP substrate). If coadministration cannot be avoided, monitor for potential adverse reactions.

              • gefitinib

                gefitinib will increase the level or effect of talazoparib by Other (see comment). Avoid or Use Alternate Drug. BCRP inhibitors may increase systemic exposure of talazoparib (a BCRP substrate). If coadministration cannot be avoided, monitor for potential adverse reactions.

              • imatinib

                imatinib will increase the level or effect of talazoparib by Other (see comment). Avoid or Use Alternate Drug. BCRP inhibitors may increase systemic exposure of talazoparib (a BCRP substrate). If coadministration cannot be avoided, monitor for potential adverse reactions.

              • itraconazole

                itraconazole will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If coadministration with certain P-gp inhibitors (ie, amiodarone, carvedilol, clarithromycin, itraconazole, verapamil) cannot be avoided, reduce talazoparib dose to 0.75 mg qDay. Once P-gp inhibitors are discontinued, increase talazoparib dose (after 3-5 half-lives of the inhibitor) to dose used prior to initiating the P-gp inhibitor(s).

              • ketoconazole

                ketoconazole will increase the level or effect of talazoparib by Other (see comment). Avoid or Use Alternate Drug. BCRP inhibitors may increase systemic exposure of talazoparib (a BCRP substrate). If coadministration cannot be avoided, monitor for potential adverse reactions.

              • lapatinib

                lapatinib will increase the level or effect of talazoparib by Other (see comment). Avoid or Use Alternate Drug. BCRP inhibitors may increase systemic exposure of talazoparib (a BCRP substrate). If coadministration cannot be avoided, monitor for potential adverse reactions.

              • lasmiditan

                lasmiditan increases levels of talazoparib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

                lasmiditan increases levels of talazoparib by Other (see comment). Avoid or Use Alternate Drug. Comment: Lasmiditan inhibits BCRP in vitro. Avoid coadministration of lasmiditan with BCRP substrates.

              • osimertinib

                osimertinib will increase the level or effect of talazoparib by Other (see comment). Avoid or Use Alternate Drug. BCRP inhibitors may increase systemic exposure of talazoparib (a BCRP substrate). If coadministration cannot be avoided, monitor for potential adverse reactions.

              • pantoprazole

                pantoprazole will increase the level or effect of talazoparib by Other (see comment). Avoid or Use Alternate Drug. BCRP inhibitors may increase systemic exposure of talazoparib (a BCRP substrate). If coadministration cannot be avoided, monitor for potential adverse reactions.

              • ponatinib

                ponatinib will increase the level or effect of talazoparib by Other (see comment). Avoid or Use Alternate Drug. BCRP inhibitors may increase systemic exposure of talazoparib (a BCRP substrate). If coadministration cannot be avoided, monitor for potential adverse reactions.

              • regorafenib

                regorafenib will increase the level or effect of talazoparib by Other (see comment). Avoid or Use Alternate Drug. BCRP inhibitors may increase systemic exposure of talazoparib (a BCRP substrate). If coadministration cannot be avoided, monitor for potential adverse reactions.

              • rolapitant

                rolapitant will increase the level or effect of talazoparib by Other (see comment). Avoid or Use Alternate Drug. BCRP inhibitors may increase systemic exposure of talazoparib (a BCRP substrate). If coadministration cannot be avoided, monitor for potential adverse reactions.

              • safinamide

                safinamide will increase the level or effect of talazoparib by Other (see comment). Avoid or Use Alternate Drug. BCRP inhibitors may increase systemic exposure of talazoparib (a BCRP substrate). If coadministration cannot be avoided, monitor for potential adverse reactions.

              • sotorasib

                sotorasib will decrease the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If use is unavoidable, refer to the prescribing information of the P-gp substrate for dosage modifications.

              • stiripentol

                stiripentol will increase the level or effect of talazoparib by Other (see comment). Avoid or Use Alternate Drug. BCRP inhibitors may increase systemic exposure of talazoparib (a BCRP substrate). If coadministration cannot be avoided, monitor for potential adverse reactions.

              • sunitinib

                sunitinib will increase the level or effect of talazoparib by Other (see comment). Avoid or Use Alternate Drug. BCRP inhibitors may increase systemic exposure of talazoparib (a BCRP substrate). If coadministration cannot be avoided, monitor for potential adverse reactions.

              • tepotinib

                tepotinib will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If concomitant use unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.

              • vandetanib

                vandetanib will increase the level or effect of talazoparib by Other (see comment). Avoid or Use Alternate Drug. BCRP inhibitors may increase systemic exposure of talazoparib (a BCRP substrate). If coadministration cannot be avoided, monitor for potential adverse reactions.

              • velpatasvir

                velpatasvir will increase the level or effect of talazoparib by Other (see comment). Avoid or Use Alternate Drug. BCRP inhibitors may increase systemic exposure of talazoparib (a BCRP substrate). If coadministration cannot be avoided, monitor for potential adverse reactions.

              • vemurafenib

                vemurafenib will increase the level or effect of talazoparib by Other (see comment). Avoid or Use Alternate Drug. BCRP inhibitors may increase systemic exposure of talazoparib (a BCRP substrate). If coadministration cannot be avoided, monitor for potential adverse reactions.

              • verapamil

                verapamil will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If coadministration with certain P-gp inhibitors (ie, amiodarone, carvedilol, clarithromycin, itraconazole, verapamil) cannot be avoided, reduce talazoparib dose to 0.75 mg qDay. Once P-gp inhibitors are discontinued, increase talazoparib dose (after 3-5 half-lives of the inhibitor) to dose used prior to initiating the P-gp inhibitor(s).

              Monitor Closely (36)

              • azithromycin

                azithromycin will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

              • berotralstat

                berotralstat will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor or titrate P-gp substrate dose if coadministered.

              • darolutamide

                darolutamide will increase the level or effect of talazoparib by Other (see comment). Modify Therapy/Monitor Closely. Darolutamide is a BCRP inhibitor. Avoid coadministration with BCRP inhibitors. If use is unavoidable, closely monitor for adverse reactions and consider dose reduction of BCRP substrate drug (refer BCRP substrate prescribing information).

              • dronedarone

                dronedarone will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

              • elagolix

                elagolix will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

              • eliglustat

                eliglustat will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

              • erythromycin base

                erythromycin base will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

              • erythromycin ethylsuccinate

                erythromycin ethylsuccinate will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

              • erythromycin lactobionate

                erythromycin lactobionate will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

              • erythromycin stearate

                erythromycin stearate will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

              • flibanserin

                flibanserin will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

              • fostamatinib

                fostamatinib will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

              • fostemsavir

                fostemsavir will increase the level or effect of talazoparib by Other (see comment). Modify Therapy/Monitor Closely. Fostemsavir inhibits BCRP transporters. If possible, avoid coadministration or modify dose of BCRP substrate coadministered with fostemsavir.

              • glecaprevir/pibrentasvir

                glecaprevir/pibrentasvir will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

              • grapefruit

                grapefruit will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

              • ibrutinib

                ibrutinib will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

              • istradefylline

                istradefylline will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of P-gp substrates in clinical trials. Consider dose reduction of sensitive P-gp substrates.

              • ivacaftor

                ivacaftor will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Ivacaftor and its M1 metabolite has the potential to inhibit P-gp; may significantly increase systemic exposure to sensitive P-gp substrates with a narrow therapeutic index.

              • ketoconazole

                ketoconazole will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

              • ledipasvir/sofosbuvir

                ledipasvir/sofosbuvir will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

              • lomitapide

                lomitapide will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

              • lonafarnib

                lonafarnib will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Lonafarnib is a weak P-gp inhibitor. Monitor for adverse reactions if coadministered with P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. Reduce P-gp substrate dose if needed.

              • lopinavir

                lopinavir will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

              • mefloquine

                mefloquine will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

              • neratinib

                neratinib will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

              • ombitasvir/paritaprevir/ritonavir & dasabuvir

                ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

              • posaconazole

                posaconazole will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

              • propafenone

                propafenone will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

              • quinidine

                quinidine will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

              • quinine

                quinine will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

              • ranolazine

                ranolazine will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

              • ritonavir

                ritonavir will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Talazoparib is a P-glycoprotein (P-gp) substrate; coadministration with P-gp inhibitors may increase talazoparib systemic exposure.

              • siponimod

                siponimod and talazoparib both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • tafamidis

                tafamidis will increase the level or effect of talazoparib by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.

              • tafamidis meglumine

                tafamidis meglumine will increase the level or effect of talazoparib by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.

              • tucatinib

                tucatinib will increase the level or effect of talazoparib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.

              Minor (0)

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                Adverse Effects

                Adverse effects include all grades unless otherwise stated

                >10%

                Decreased hemoglobin (90%)

                Decreased leukocytes (84%)

                Decreased lymphocytes (76%)

                Decreased neutrophils (68%)

                Fatigue (62%)

                Decreased platelets (55%)

                Increased glucose (54%)

                Anemia (53%)

                Nausea (49%)

                Increased AST (37%)

                Increased alkaline phosphatase (36%)

                Neutropenia (35%)

                Increased ALT (33%)

                Headache (33%)

                Decreased calcium (28%)

                Thrombocytopenia (27%)

                Vomiting (25%)

                Alopecia (25%)

                Diarrhea (22%)

                Decreased appetite (21%)

                Abdominal pain (19%)

                Dizziness (17%)

                Leukopenia (17%)

                Grade 3

                • Decreased hemoglobin (39%)
                • Anemia (38%)
                • Neutropenia (18%)
                • Decreased neutrophils (17%)
                • Decreased lymphocytes (17%)
                • Decreased leukocytes (14%)
                • Thrombocytopenia (11%)
                • Decreased platelets (11%)

                1-10%

                Dysgeusia (10%)

                Dyspepsia (10%)

                Stomatitis (8%)

                Lymphopenia (7%)

                Grade 3

                • Decreased platelets (4%)
                • Decreased neutrophils (3%)
                • Fatigue (3%)
                • Increased glucose (2%)
                • Increased alkaline phosphate (2%)
                • Vomiting (2%)
                • Headache (2%)
                • Increased AST/ALT (1-2%)
                • Decreased calcium (1%)

                Grade 4

                • Thrombocytopenia (4%)
                • Neutropenia (3%)
                • Anemia (1%)

                <1%

                Decreased appetite, Grade 3

                Nausea, Grade 3

                Decreased lymphocytes, Grade 4

                Decreased leukocytes, Grade 4

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                Warnings

                Contraindications

                None

                Cautions

                Myelosuppression (eg, 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 (see Pregnancy)

                Myelodysplastic syndrome/acute myeloid leukemia

                • Myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) reported; MDS/AML reported (0.3%) in solid tumor 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 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 (ie, 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
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                Pregnancy

                Pregnancy

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

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

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

                Animal data

                • Administration to pregnant rats during organogenesis caused fetal malformations and structural skeletal variations and embryofetal death at maternal exposures that were 0.24 times the AUC in patients receiving the recommended dose of 1 mg qDay

                Contraception

                • Females of reproductive potential: Use effective contraception during treatment and for ≥7 months following the last dose
                • Males with female partners of reproductive potential and pregnant partners: Use effective contraception during treatment and for ≥4 months following the last dose

                Infertility

                • Based on animal studies, impaired fertility in males 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 after the final dose

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                Poly ADP ribose polymerase (PARP) inhibitor; PARP enzymes are involved in normal cellular homeostasis, such as DNA transcription, cell cycle regulation, and DNA repair

                Absorption

                Peak plasma concentration, steady-state: 16.4 ng/mL

                Peak plasma time: 1-2 hr

                AUC, steady-state: 208 ng·hr/mL

                Steady-state reached within 2-3 weeks

                Food effect

                • Following a single oral 0.5-mg dose with high-fat, high-calorie food (~800-1000 calories with 150, 250, and 500-600 calories from protein, carbohydrate, and fat, respectively), mean peak plasma concentration of talazoparib was decreased by 46%, the median peak plasma time was delayed from 1-4 hr, and AUC was not affected

                Distribution

                Vd: 420 L

                Protein bound: 74%

                Metabolism

                Undergoes minimal hepatic metabolism

                Identified metabolic pathways of talazoparib in humans include mono-oxidation, dehydrogenation, cysteine conjugation of mono-desfluoro-talazoparib, and glucuronide conjugation

                Elimination

                Half-life: 90 hr

                Clearance: 6.45 L/hr

                Excretion: Urine (~68.7% [54.6% unchanged]), feces (19.7% [13.6% unchanged])

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                Administration

                Oral Administration

                Administer orally with or without food

                Swallow hard capsules whole; do not open or dissolve

                If patient vomits or misses a dose, do not take an additional dose; take next dose at usual time

                Storage

                Capsules: Store at 20-25ºC (68-77ºF); excursions permitted between 15-30ºC (59-86ºF)

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                Patient Handout

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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.