nts weekly until platelet counts return to ≥100,000/µL.
Resume ZEJULA at a reduced dose per Table 1.
Discontinue ZEJULA 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 daily.*
Neutrophil <1,000/µL or Hemoglobin <8 g/dL
Withhold ZEJULA for a maximum of 28 days and monitor blood counts weekly until neutrophil counts return to ≥1,500/µL or hemoglobin returns to ≥9 g/dL.
Resume ZEJULA at a reduced dose per Table 1.
Discontinue ZEJULA 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 daily.*
Hematologic adverse reaction requiring transfusion
For patients with platelet count ≤10,000/μL, platelet transfusion should be considered. 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 ZEJULA at a reduced dose.
3 DOSAGE FORMS AND STRENGTHS
100 mg capsule having a white body with "100 mg" printed in black ink, and a purple cap with "Niraparib" printed in white ink.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Myelodysplastic Syndrome/Acute Myeloid Leukemia
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including cases with fatal outcome, have been reported in patients who received ZEJULA. In Trial 1 (NOVA), MDS/AML occurred in 5 out of 367 (1.4%) of patients who received ZEJULA and in 2 out of 179 (1.1%) patients who received placebo. Overall, MDS/AML has been reported in 7 out of 751 (0.9%) patients treated with ZEJULA in clinical studies.
The duration of ZEJULA treatment in patients prior to developing MDS/AML varied from <1 month to 2 years. All patients had received previous chemotherapy with platinum and some had also received other DNA damaging agents and radiotherapy. Discontinue ZEJULA if MDS/AML is confirmed.
5.2 Bone Marrow Suppression
Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia) have been reported in patients treated with ZEJULA. Grade ≥3 thrombocytopenia, anemia and neutropenia were reported, respectively, in 29%, 25%, and 20% of patients receiving ZEJULA. Discontinuation due to thrombocytopenia, anemia, and neutropenia occurred, respectively, in 3%, 1%, and 2% of patients.
Do not start ZEJULA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts weekly for the first month, monthly for the next 11 months of treatment, and periodically after this time. If hematological toxicities do not resolve within 28 days following interruption, discontinue ZEJULA, and refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics [see DOSAGE AND ADMINISTRATION (2.2)].
5.3 Cardiovascular Effects
Hypertension and hypertensive crisis have been reported in patients treated with ZEJULA. Grade 3-4 hypertension occurred in 9% of ZEJULA treated patients compared to 2% of placebo treated patients in Trial 1. Discontinuation due to hypertension occurred in <1% of patients.
Monitor blood pressure and heart rate monthly fo |
