Talzenna Capsules
Talazoparib
1mg
Pfizer Inc.
| Pack size | 30’s HDPE Bottle |
|---|---|
| Dispensing mode | POM |
| Source | USA |
| Agent | GULF DRUG LLC |
| Retail Price | 39621.00 AED |
Available as:
Indications
Talzenna Capsules is used for:
Breast Cancer
Adult Dose
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
Hepatic impairment
Mild (total bilirubin ?1x ULN and any AST > ULN OR total bilirubin >1-1.5x ULN and any AST): No dosage adjustment
Moderate-to-severe (total bilirubin >1.5x ULN AND any AST): Not studied
Child Dose
<18 years: Safety and efficacy not established
Renal Dose
Renal impairment
Mild (CrCl 60-89 mL/min): No dosage adjustment
Moderate (CrCl 30-59 mL/min): Reduce dose to 0.75 mg qDay
Severe (CrCl <30 mL/min) or patients requiring hemodialysis: Not studied
Administration
Administer orally with or without food
Contra Indications
Precautions
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
Pregnancy-Lactation
Pregnancy
Based on findings from animal studies and its mechanism of action, embryo-fetal harm may occur when administered to a pregnant woman
No data available on use in pregnant women to inform a drug-associated risk
Recommend a pregnancy test for females of reproductive potential prior to initiating treatment
Animal data
In an animal reproduction study, administration of talazoparib to pregnant rats during organogenesis caused fetal malformations and structural skeletal variations and embryo-fetal death at maternal exposures that were 0.24 times the AUC in patients receiving the recommended dose of 1 mg qDay
Contraception
Females: Advise females of reproductive potential to use effective contraception during treatment and for ?7 months following the last dose
Males: Based on genotoxicity and animal reproduction studies, advise males with female partners of reproductive potential and pregnant partners to 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, the drug effects on milk production, or on the breastfed child
Because of the potential for serious adverse reactions in a breastfed child, advise lactating women not to breastfeed during treatment and for ?1 month after the final dose
Interactions
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
Adverse Effects
Side effects of Talazoparib :
>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%)
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
Note
Talzenna 1mg Capsules manufactured by Pfizer Inc.. Its generic name is Talazoparib. Talzenna is availble in United Arab Emirates.
Farmaco UAE drug index information on Talzenna Capsules is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.