Niranib
Everest Medicines, Bangladesh
$283.00-
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INDICATIONS AND USAGE（适应症）
First-Line Maintenance Treatment of Advanced Ovarian Cancer
ZEJULA is indicated for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.
Maintenance Treatment of Recurrent Ovarian Cancer
ZEJULA is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
Treatment of Advanced Ovarian Cancer after 3 or More Chemotherapies
ZEJULA is indicated for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with 3 or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either:
a deleterious or suspected deleterious BRCA mutation, or
genomic instability and who have progressed more than 6 months after response to the last platinum-based chemotherapy.
Select patients for therapy based on an FDA-approved companion diagnostic for ZEJULA.
DOSAGE（服用剂量）
Continue treatment with ZEJULA until disease progression or unacceptable toxicity.
Instruct patients to take their dose of ZEJULA at approximately the same time each day. Advise patients to swallow each capsule whole and not to chew, crush, or split ZEJULA prior to swallowing. ZEJULA may be taken with or without food. Bedtime administration may be a potential method for managing nausea.
In the case of a missed dose of ZEJULA, instruct patients to take their next dose at its regularly scheduled time. If a patient vomits or misses a dose of ZEJULA, an additional dose should not be taken.
First-Line Maintenance Treatment of Advanced Ovarian Cancer
For patients weighing <77 kg (<170 lbs) OR with a platelet count of <150,000/mcL, the recommended dosage is 200 mg (two 100-mg capsules) taken orally once daily.
For patients weighing ≥77 kg (≥170 lbs) AND who have a platelet count ≥150,000/mcL, the recommended dosage is 300 mg (three 100-mg capsules) taken orally once daily.
For the maintenance treatment of advanced ovarian cancer, patients should start treatment with ZEJULA no later than 12 weeks after their most recent platinum-containing regimen.
Maintenance Treatment of Recurrent Ovarian Cancer
The recommended dosage of ZEJULA is 300 mg (three 100-mg capsules) taken orally once daily.
For the maintenance treatment of recurrent ovarian cancer, patients should start treatment with ZEJULA no later than 8 weeks after their most recent platinum-containing regimen.
Treatment of Advanced Ovarian Cancer after 3 or More Chemotherapies
The recommended dosage of ZEJULA is 300 mg (three 100-mg capsules) taken orally once daily.
ADVERSE REACTIONS（不良反应）
MDS/AML
Bone marrow suppression
Hypertension and cardiovascular effects
Posterior reversible encephalopathy syndrome
For full information, please refer to:
https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/c15c7b7e-4b7f-4489-bbbc-884caeee0669/spl-doc?hl=niraparib
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