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Niraparib Dosage

Applies to the following strength(s): 100 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for Ovarian Cancer

300 mg orally once a day
Duration of Therapy: Until disease progression or unacceptable toxicity

Comments:
-Initiate treatment with this drug no later than 8 weeks after a patient's most recent platinum-containing regimen.
-Bedtime administration may be a potential method for managing nausea.

Use: Maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Usual Adult Dose for Fallopian Tube Cancer

300 mg orally once a day
Duration of Therapy: Until disease progression or unacceptable toxicity

Comments:
-Initiate treatment with this drug no later than 8 weeks after a patient's most recent platinum-containing regimen.
-Bedtime administration may be a potential method for managing nausea.

Use: Maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Usual Adult Dose for Peritoneal Cancer

300 mg orally once a day
Duration of Therapy: Until disease progression or unacceptable toxicity

Comments:
-Initiate treatment with this drug no later than 8 weeks after a patient's most recent platinum-containing regimen.
-Bedtime administration may be a potential method for managing nausea.

Use: Maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Renal Dose Adjustments

-Mild to Moderate Renal Impairment (CrCl 30 to 89 mL/min): No adjustment recommended.
-Severe Renal Impairment: Data not available.

Liver Dose Adjustments

-Mild Hepatic Impairment: No adjustment recommended.
-Moderate to Severe Hepatic Impairment: Data not available.

Dose Adjustments

ADVERSE REACTIONS (ARs): Consider treatment interruption, dose reduction, and/or treatment discontinuation to manage ARs.
-FIRST DOSE REDUCTION: 200 mg orally once a day
-SECOND DOSE REDUCTION: 100 mg orally once a day
-FURTHER DOSE REDUCTION BELOW 100 MG/DAY REQUIRED: Discontinue treatment.

NON-HEMATOLOGIC ARs:
GRADE 3 OR GREATER AR WHERE PROPHYLAXIS IS NOT CONSIDERED FEASIBLE OR AR PERSISTS DESPITE TREATMENT:
-Withhold treatment for a maximum of 28 days or until resolution or AR.
-Resume treatment at a reduced dose; up to 2 dose reductions are permitted.
GRADE 3 OR GREATER TREATMENT-RELATED AR LASTING MORE THAN 28 DAYS WHILE PATIENT IS ADMINISTERED DOSE OF 100 MG/DAY: Discontinue treatment.

HEMATOLOGIC ARs: Monitor complete blood counts weekly for the first month, monthly for the next 11 months of treatment and periodically afterwards.
PLATELET COUNT LESS THAN 100,000/mcL:
FIRST OCCURRENCE:
-Withhold treatment for a maximum of 28 days and monitor blood counts weekly until platelet counts return to 100,000/mcL or more.
-Resume treatment at same or reduced dose.
-If platelets less than 75,000/mcL, resume at a reduced dose.
SECOND OCCURRENCE:
-Withhold treatment for a maximum of 28 days and monitor blood counts weekly until platelet counts return to 100,000/mcL or more.
-Resume treatment at a reduced dose.
-Discontinue treatment if the platelet count has not returned to acceptable levels within 28 days of the dose interruption period, or if the patient has already undergone dose reduction to 100 mg once a day.

NEUTROPHILS LESS THAN 1000/mcL OR HEMOGLOBIN LESS THAN 8 g/dL:
-Withhold treatment for a maximum of 28 days and monitor blood counts weekly until neutrophil counts return to 1500/mcL or more OR hemoglobin returns to 9 g/dL or more.
-Resume treatment at a reduced dose.
-Discontinue treatment if neutrophils and/or hemoglobin have not returned to acceptable levels within 28 days of the dose interruption period, or if the patient has already undergone dose reduction to 100 mg once a day.

HEMATOLOGIC ADVERSE REACTION REQUIRING TRANSFUSION:
-Consider platelet transfusion for patients with platelet counts 10,000/mcL or less.
-If there are other risk factors such as co-administration of anticoagulation or antiplatelet drugs, consider interrupting these drugs and/or transfusion at a higher platelet count.
-Resume treatment at a reduced dose.

MYELODYSPLASTIC SYNDROME OR ACUTE MYELOID LEUKEMIA (MDS/AML) IS CONFIRMED: Discontinue treatment.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

End-Stage Renal Disease Undergoing Hemodialysis: Data not available.

Other Comments

Administration Advice:
-Instruct patients to swallow each capsule whole, and to take their dose at approximately the same time each day.
-Administer this drug with or without food.
-In the case of a missed or vomited dose, advise patients to skip that dose and to take their next dose at the regularly scheduled time.

Storage Requirements:
-Store this drug at 20 to 25 degrees Celsius (68 to 77 degrees Fahrenheit); excursions permitted between 15 to 30 degrees Celsius (59 to 86 degrees Fahrenheit).

General:
-Overdose symptoms are not established, and no specific treatment for overdosage is available.

Monitoring:
-Cardiovascular: Blood pressure and heart rate (monthly for the first year and periodically thereafter during treatment)
-Hematologic: CBC (weekly for the first month, monthly for the next 11 months of treatment, and periodically thereafter)

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