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EfficacyEfficacyOSOS in patient subgroupsrPFS: Primary and follow-uprPFS in patient subgroupsORRPSASafetySafetyWarnings and precautionsAdverse reactionsDosingDosingDosing and administrationDose modificationsSoft gelatin capsuleTherapy management strategiesSupportSupportCoverage and accessPatient supportResourcesContact a rep
Prescribing Information for Soft Gelatin CapsulesPrescribing Information for Hard CapsulesIndicationPatient SiteSee Information on a Different Indication
Soft Gelatin CapsuleSwitching formulations is simple

Pill images are not actual size.

Pill images are not actual size.

The soft gelatin formulation is therapeutically equivalent to the original hard capsule formulation. There is no change to the active ingredient, available dosage strengths, or administration.1,2

The soft gelatin formulation is therapeutically equivalent to the original hard capsule formulation. There is no change to the active ingredient, available dosage strengths, or administration.1,2

The soft gelatin formulation is available for newly prescribed and currently prescribed patients. Patients currently prescribed hard capsules can be switched at their next refill to soft gelatin capsules without adjustments or interruptions.1,2

The soft gelatin formulation is available for newly prescribed and currently prescribed patients. Patients currently prescribed hard capsules can be switched at their next refill to soft gelatin capsules without adjustments or interruptions.1,2

The soft gelatin formulation is available for newly prescribed and currently prescribed patients. Patients currently prescribed hard capsules can be switched at their next refill to soft gelatin capsules without adjustments or interruptions.1,2

The soft gelatin formulation is available for newly prescribed and currently prescribed patients. Patients currently prescribed hard capsules can be switched at their next refill to soft gelatin capsules without adjustments or interruptions.1,2Once-daily oral dosing1,2

TALZENNA soft gelatin capsules are available in the same dosage strengths and follow the same dosing and administration as hard capsules.

Remember to indicate TALZENNA soft gelatin capsules, including the appropriate NDC code, on all prescriptions so patients receive this formulation. Consider including a letter of medical necessity along with the TALZENNA prescription to help support the approval process. View a sample letter here.

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Capsule strength2NDC2
0.5 mg0069-0546-30
0.35 mg0069-0454-30
0.25 mg0069-0353-30
0.1 mg0069-0252-30
  • To manage adverse reactions, consider interruption of treatment with or without dose reduction based on severity and clinical presentation2
  • Treatment with TALZENNA should be discontinued if more than 3 dose reductions are required2
  • See the Full Prescribing Information for more information on dosage modifications for adverse reactions
Frequently asked questionsWill transitioning from hard capsules to soft gelatin capsules affect the dosing and administration for TALZENNA?

There are no changes to the dosing and administration. Patients prescribed hard capsules can be switched at their next refill to the soft gelatin capsule without adjustments or interruptions.1,2

  • No change to the active ingredient1,2
  • Same available dosage strengths (0.5 mg, 0.35 mg, 0.25 mg, and 0.1 mg)1,2
  • Continue to take orally with or without food1,2
  • Identical storage and handling1,2
Are there any additional side effects or safety concerns with the TALZENNA soft gelatin capsules?

The soft gelatin formulation is therapeutically equivalent to the original formulation. The efficacy and safety data in the soft gelatin label are based on the clinical trials conducted with the hard capsule formulation. The benefit and risk profile of the TALZENNA soft gelatin capsule is similar to that of the approved hard capsules.1,2

When will patients start receiving the soft gelatin capsule?

The soft gelatin formulation of TALZENNA is currently available. Please remember to specify TALZENNA soft gelatin capsules, along with the corresponding NDC code, on all TALZENNA prescriptions.

How will packaging differ?

The outer box has been eliminated for the soft gelatin formulation. The soft gelatin capsule bottle is a square shape, whereas the hard capsule bottle is round.

Are there any changes to patients’ out-of-pocket costs?

Most patients will not see a change in out-of-pocket (OOP) costs. Based on individual insurance plans, there may be specific instances where patients’ OOP costs are impacted. There are financial assistance resources available to your patients, subject to the program’s limits, terms, and conditions.

Learn more about TALZENNA + XTANDI coverage and access.

Explore dose modifications for adverse reactions

Learn more about dosing
LoadingReferences: TALZENNA [package insert] for Hard Capsule. New York, NY: Pfizer Inc. TALZENNA [package insert] for Soft Gelatin Capsule. New York, NY: Pfizer Inc.  Dosing See therapy management strategies

Including dose modifications and adverse reaction management

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INDICATION

TALZENNA (talazoparib) is indicated in combination with XTANDI (enzalutamide) for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

IMPORTANT SAFETY INFORMATION

WARNINGS and PRECAUTIONS

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including cases with a fatal outcome, has been reported in patients who received TALZENNA. Overall, MDS/AML has been reported in 0.4% (3 out of 788) of solid tumor patients treated with TALZENNA as a single agent in clinical studies. In TALAPRO-2, MDS/AML occurred in 2 out of 511 (0.4%) patients treated with TALZENNA and enzalutamide and in 0 out of 517 (0%) patients treated with placebo and enzalutamide. The durations of TALZENNA treatment in these 5 patients prior to developing MDS/AML were 0.3, 1, 2, 3, and 5 years. Most of these patients had received previous chemotherapy with platinum agents and/or other DNA damaging agents including radiotherapy.

Do not start TALZENNA until patients have adequately recovered from hematological toxicity caused by previous chemotherapy. Monitor blood counts monthly during treatment with TALZENNA. For prolonged hematological toxicities, interrupt TALZENNA 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 TALZENNA.

Myelosuppression consisting of anemia, neutropenia, and/or thrombocytopenia, have been reported in patients treated with TALZENNA. In TALAPRO-2, Grade ≥3 anemia, neutropenia, and thrombocytopenia were reported, respectively, in 48%, 19%, and 9% of patients receiving TALZENNA and enzalutamide. Forty-two percent of patients (216/511) required a red blood cell transfusion, including 25% (127/511) who required more than one transfusion. Discontinuation due to anemia, neutropenia, and thrombocytopenia occurred, respectively, in 8%, 3%, and 0.4% of patients.

Withhold TALZENNA until patients have adequately recovered from hematological toxicity caused by previous therapy. Monitor blood counts monthly during treatment with TALZENNA. If hematological toxicities do not resolve within 28 days, discontinue TALZENNA and refer the patient to a hematologist for further investigations including bone marrow analysis and blood sample for cytogenetics.

Embryo-Fetal Toxicity TALZENNA can cause fetal harm when administered to pregnant women. Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 4 months following the last dose of TALZENNA.
ADVERSE REACTIONS

Serious adverse reactions reported in >2% of patients included anemia (9%) and fracture (3%). Fatal adverse reactions occurred in 1.5% of patients, including pneumonia, COVID infection, and sepsis (1 patient each).

The most common adverse reactions (≥ 10%, all Grades), including laboratory abnormalities, for patients in the TALAPRO-2 study who received TALZENNA with enzalutamide vs patients receiving placebo with enzalutamide were hemoglobin decreased (79% vs 34%), neutrophils decreased (60% vs 18%), lymphocytes decreased (58% vs 36%), fatigue (49% vs 40%), platelets decreased (45% vs 8%), calcium decreased (25% vs 11%), nausea (21% vs 17%), decreased appetite (20% vs 14%), sodium decreased (22% vs 20%), phosphate decreased (17% vs 13%), fractures (14% vs 10%), magnesium decreased (14% vs 12%), dizziness (13% vs 9%), bilirubin increased (11% vs 7%), potassium decreased (11% vs 7%), and dysgeusia (10% vs 4.5%).

Clinically relevant adverse reactions in <10% of patients who received TALZENNA with enzalutamide included abdominal pain (9%), vomiting (9%), alopecia (7%), dyspepsia (4%), venous thromboembolism (3%) and stomatitis (2%).
DRUG INTERACTIONS

Coadministration with P-gp inhibitors The effect of coadministration of P-gp inhibitors on talazoparib exposure when TALZENNA is taken with enzalutamide has not been studied. Monitor patients for increased adverse reactions and modify the dosage as recommended for adverse reactions when TALZENNA is coadministered with a P-gp inhibitor.

Coadministration with BCRP inhibitors Monitor patients for increased adverse reactions and modify the dosage as recommended for adverse reactions when TALZENNA is coadministered with a BCRP inhibitor. Coadministration of TALZENNA with BCRP inhibitors may increase talazoparib exposure, which may increase the risk of adverse reactions.

USE IN SPECIFIC POPULATIONS

Males of Reproductive Potential Based on animal studies, TALZENNA may impair fertility.

Renal Impairment The recommended dosage of TALZENNA for patients with moderate renal impairment (CLcr 30 - 59 mL/min) is 0.35 mg taken orally once daily with enzalutamide. The recommended dosage of TALZENNA for patients with severe renal impairment (CLcr 15 - 29 mL/min) is 0.25 mg taken orally once daily with enzalutamide. No dose adjustment is required for patients with mild renal impairment. TALZENNA has not been studied in patients requiring hemodialysis.

Please see the Full Prescribing Information for soft gelatin capsules and hard capsules for TALZENNA.

Please see the XTANDI Prescribing Information for safety information about XTANDI.
INDICATIONTALZENNA (talazoparib) is indicated in combination with XTANDI (enzalutamide) for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).