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Akeega Dosage

Drug Detail:Akeega (Niraparib and abiraterone acetate)

Generic Name: NIRAPARIB TOSYLATE MONOHYDRATE 100mg, ABIRATERONE ACETATE 500mg

Drug Class:

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Patient Selection

Select patients for the treatment of mCRPC with AKEEGA based on the presence of a BRCAgene alteration [see Clinical Studies (14)] .

Information on FDA-approved tests is available at: http://www.fda.gov/CompanionDiagnostics.

Recommended Dosage

The recommended dosage of AKEEGA is 200 mg niraparib/1,000 mg abiraterone acetate orally once daily in combination with 10 mg prednisone daily until disease progression or unacceptable toxicity.

Patients receiving AKEEGA should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. Take AKEEGA on an empty stomach. Do not eat food two hours before and one hour after taking AKEEGA. Swallow tablets whole with water. Do not break, crush, or chew tablets.

If a patient misses a dose, instruct patients to take the dose as soon as possible on the same day and resume their next dose at the normal schedule the following day.

Dosage Modification for Adverse Reactions

The recommended dosage modifications for AKEEGA are provided in Table 1.

Treatment with AKEEGA should not be reinitiated until the toxicity has resolved to Grade 1 or baseline. If the toxicity is attributed to one component of AKEEGA, the other component of AKEEGA may be continued as a single agent at the current dose until the adverse reaction resolves and AKEEGA can be resumed (see Table 1).

Table 1: Dosage Modifications for Adverse Reactions
Adverse Reaction Severity Dosage Modification
*
If myelodysplastic syndrome or acute myeloid leukemia (MDS/AML) is confirmed, discontinue AKEEGA [see Warnings and Precautions (5.1)].
†
Discontinue AKEEGA in patients who develop hypertensive crisis or other severe cardiovascular adverse reactions [see Warnings and Precautions (5.3)] .
Myelosuppression
[see Warnings and Precautions (5.2)]		 Hemoglobin <8 g/dL
  • Withhold AKEEGA and monitor blood counts weekly.
  • When hemoglobin returns to ≥9 g/dL, resume at the reduced dose of AKEEGA 100 mg/1,000 mg once daily and monitor blood counts weekly for 28 days and as clinically indicated.
  • Permanently discontinue AKEEGA if hemoglobin 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/1,000 mg once daily. *
Platelet count <100,000/mcL First occurrence:
  • Withhold AKEEGA for a maximum of 28 days and monitor blood counts weekly until platelet counts return to ≥100,000/mcL.
  • Resume AKEEGA at same or the reduced dose of 100 mg/1,000 mg once daily.
  • If platelet count is <75,000/mcL, resume at the reduced dose of AKEEGA 100 mg/1,000 mg once daily.
Second occurrence:
  • Withhold AKEEGA for a maximum of 28 days and monitor blood counts weekly until platelet counts return to ≥100,000/mcL.
  • Resume at the reduced dose of AKEEGA 100 mg/1,000 mg once daily.
  • Permanently discontinue AKEEGA 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/1,000 mg once daily. *
Neutrophil <1,000/mcL
  • Withhold AKEEGA and monitor blood counts weekly.
  • When neutrophil counts return to ≥1,500/mcL, resume at the reduced dose of AKEEGA 100 mg/1,000 mg once daily and monitor blood counts weekly for 28 days and as clinically indicated.
  • Permanently discontinue AKEEGA if neutrophils 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/1,000 mg once daily. *
Hematologic adverse reaction requiring transfusion
  • Consider platelet transfusion for patients with platelet count ≤10,000/mcL. If there are other risk factors such as coadministration of anticoagulation or antiplatelet drugs, consider interrupting these drugs and/or transfusion at a higher platelet count.
  • Resume at the reduced dose of AKEEGA 100 mg/1,000 mg once daily.
Hepatotoxicity
[see Warnings and Precautions (5.4)]		 ALT and/or AST greater than 5 × ULN or total bilirubin greater than 3 × ULN
  • Withhold AKEEGA and closely monitor liver function.
  • Permanently discontinue AKEEGA if:
    ALT or AST ≥ 20 times the ULN
    – OR–
    ALT > 3 × ULN and total bilirubin > 2 × ULN in the absence of biliary obstruction or other causes responsible for the concurrent elevation
    -OR-
    Hepatotoxicity recurs at the reduced dose 100 mg/500 mg.
  • When AST and ALT resolves to less ≤ 2.5 × ULN and total bilirubin ≤ 1.5 × ULN, AKEEGA may be resumed at the reduced dose of 100 mg/500 mg once daily. When resumed, monitor serum transaminases every two weeks for three months, monthly thereafter, and as clinically indicated.
Other non-hematological adverse reactions that persist despite medical management [see Warnings and Precautions (5)and Adverse Reactions (6.1)] Grade 3 or 4 †
  • Withhold AKEEGA until resolution of adverse reaction or for a maximum of 28 days.
  • If resolves in 28 days or less, AKEEGA may be resumed at the reduced dose.
  • Permanently discontinue AKEEGA if adverse reaction(s) has not resolved after 28 days or Grade 3 or 4 adverse reaction reoccurs after dose reduction.
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