Zejula 100mg Tablet

Niraparib with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA2 -mutated ( BRCA2 m) metastatic castration-sensitive prostate cancer (mCSPC). Niraparib with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved test for Niraparib. Niraparib is a combination of niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor indicated with prednisone for the treatment of adult patients with: deleterious or suspected deleterious BRCA2 -mutated ( BRCA2 m) metastatic castration-sensitive prostate cancer (mCSPC). deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC).

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): MDS/AML, including a case with fatal outcome, has been observed in patients treated with Niraparib. Monitor patients for hematological toxicity and discontinue if MDS/AML is confirmed. Myelosuppression: Test complete blood counts weekly for the first month, every two weeks for the next two months, monthly for the remainder of the first year, then every other month, and as clinically indicated. Hypokalemia, Fluid Retention, and Cardiovascular Adverse Reactions: Monitor patients for hypertension, hypokalemia, and fluid retention at least weekly for the first two months, then once a month. Closely monitor patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalemia, or fluid retention. Control hypertension and correct hypokalemia before and during treatment with Niraparib. Hepatotoxicity: Can be severe and fatal. Monitor liver function and modify, interrupt, or discontinue treatment as recommended. Adrenocortical insufficiency: Monitor for symptoms and signs of adrenocortical insufficiency. Increased dosage of corticosteroids may be indicated before, during and after stressful situations. Hypoglycemia: Severe hypoglycemia has been reported when abiraterone acetate, a component of Niraparib, was administered to patients receiving medications containing thiazolidinediones (including pioglitazone) or repaglinide. Monitor blood glucose in patients with diabetes during and assess if antidiabetic agent dose modifications are required. Increased fractures and mortality in combination with radium Ra 223 dichloride: Use of Niraparib plus prednisone in combination with radium Ra 223 dichloride is not recommended. Posterior Reversible Encephalopathy Syndrome (PRES): PRES has been observed in patients treated with niraparib, a component of Niraparib. Discontinue Niraparib if PRES is confirmed. Embryo-Fetal Toxicity: Niraparib can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception. Myelodysplastic Syndrome/Acute Myeloid Leukemia Niraparib may cause myelodysplastic syndrome/acute myeloid leukemia (MDS/AML). In the individual AMPLITUDE and MAGNITUDE studies, MDS or AML, including cases with fatal outcomes, were reported in 0.6% (2/347) and 0.5% (1/212) of patients treated with Niraparib plus prednisone, respectively. All patients in other tumor types treated with niraparib, a component of Niraparib, who developed secondary MDS/cancer-therapy-related AML had received previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy. For suspected MDS/AML or prolonged hematological toxicities, refer the patient to a hematologist for further evaluation. Discontinue Niraparib if MDS/AML is confirmed. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following adverse reactions are discussed elsewhere in the labeling: Myelodysplastic syndrome/acute myeloid leukemia Myelosuppression Hypokalemia, fluid retention, and cardiovascular adverse reactions Hepatotoxicity Adrenocortical insufficiency Hypoglycemia Increased fractures and mortality in combination with Radium 223 Dichloride Posterior reversible encephalopathy syndrome The most common adverse reactions (≥20%), including laboratory abnormalities, are decreased hemoglobin, decreased lymphocytes, musculoskeletal pain, fatigue, decreased platelets, increased alkaline phosphatase, constipation, hypertension, nausea, decreased neutrophils, increased creatinine, increased potassium, decreased potassium, increased AST, fluid retention/edema, increased bilirubin, respiratory tract infection and arrhythmia. at ( ) or FDA Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety population described in the WARNINGS and PRECAUTIONS reflect exposure to Niraparib (niraparib 200 mg and abiraterone acetate 1,000 mg) in BRCA2 m patients (N=162) in the AMPLITUDE study and in BRCA m patients in Cohort 1 (N=113) in the MAGNITUDE study unless otherwise specified. BRCA2 -mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) The safety of Niraparib in patients with BRCA2 m mCSPC was evaluated in AMPLITUDE. Patients were randomized to receive either Niraparib (niraparib 200 mg and abiraterone acetate 1,000 mg once daily) (n=162), or placebo and abiraterone acetate (n=161) until unacceptable toxicity or progression. Patients in both arms also received prednisone 5 mg daily. The median duration of exposure for Niraparib was 26 months (range: 0 to 48 months). Serious adverse reactions occurred in 36% of patients who received Niraparib. Serious adverse reactions reported in >2% of patients included anemia (4.9%), and pneumonia (3.7%). Fatal adverse reactions occurred in 4.9% of patients who received Niraparib, including sudden death (1.9%), COVID-19 pneumonia (1.2%), pneumocystis jirovecii pneumonia (0.6%), pneumonia (0.6%), and cardio-respiratory arrest (0.6%). Permanent discontinuation of any component of Niraparib due to an adverse reaction occurred in 13% of patients. Dosage interruptions of any component of Niraparib due to an adverse reaction occurred in 67% of patients. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.