This tool was designed to help you assess the grade of the adverse event reported by your patient and to get dosing modifications recommendations based on the grade of the event as per the approved TALZENNA Prescribing Information.
If you need additional information (including the incidence of the adverse events occurring in the pivotal talazoparib randomized clinical trials), please consult the approved
TALZENNA Prescribing Information,
search through our collection of approved scientific response documents or contact us directly (
submit a request online, or call
(800) 438-1985).
Recommended Dosage for HRR Gene-mutated mCRPC:
The recommended dosage of TALZENNA is 0.5 mg taken orally once daily in combination with enzalutamide until disease progression or unacceptable toxicity.
Recommended Dosage for gBRCAm HER2-negative Locally Advanced or Metastatic Breast Cancer:
The recommended dosage of TALZENNA is 1 mg taken orally once daily, until disease progression or unacceptable toxicity.
Adverse reactions of TALZENNA in combination with Xtandi in TALAPRO-2 that were reported in >10% of patients included: (49%) fatigue (including asthenia), (21%) nausea, (20%), decreased appetite, (14 %) fractures (including similar terms), (13%) dizziness (dizziness postural, vertigo) and (10%) dysgeusia (includes ageusia and anosmia).
Laboratory abnormalities occurring in >10% of the safety population of patients in TALAPRO-2 included hemoglobin decreased (79%), neutrophils decreased (60%), lymphocyte decreased (58%), platelets decreased (45%), calcium decreased (25%), sodium decreased (22%), phosphate decreased (17%), magnesium decreased (14%), bilirubin increased (11%) and potassium decreased (11%).
Adverse reactions of TALZENNA in EMBRACA that were reported in >20% of patients included: fatigue (includes asthenia) (62%), nausea (49%), vomiting (25%), diarrhea (22%), headache (33%), alopecia (25%) and decreased appetite (21%).
Laboratory abnormalities occurring in >25% of the safety population of patients in EMBRACA included hemoglobin decreased (90%), neutrophils decreased (68%), lymphocyte decreased (76%), platelets decreased (55%), non-fasting glucose increased (54%), aspartate aminotransferase increased (37%, alanine aminotransferase increased (36%) and calcium decreased (28%).
Pfizer is unable to make any specific dosage and/or treatment recommendations for individual patients beyond talazoparib dosage modifications as described in the TALZENNA Prescribing Information; clinical judgment based on the medical history and the clinical status of a specific patient will dictate the appropriate actions to be taken.
Dosing interruption and/or dose reductions for TALZENNA are recommended based on individual safety and tolerability. Please refer to the full TALZENNA Prescribing Information for dosing recommendations and dose adjustment guidelines in the event of toxicity.
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this medication, click the link below to submit your information:
Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer medication, please call (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or by calling (800) 332-1088.