COPANLISIB INJ,LYPHL
Clinical Criteria Summary
Exclusion Criteria
- Care not provided by a VA/VA Community Care hematology/oncology provider
- CrCl <15 mL/minute
- Severe hepatic impairment (Child-Pugh class C or total bilirubin 3 to 10x ULN)
- Patients receiving concomitant therapy with strong CYP3A inducers
- Uncontrolled hypertension with blood pressure ≥ 150/90 mmHg despite optimal medical management
- History or concurrent condition of interstitial lung disease
- Ongoing or active systemic infection, including hepatitis B or C or known HIV
- Pregnancy
- Breastfeeding
Inclusion Criteria
- Diagnosis of follicular lymphoma
- Relapsed or refractory disease after ≥ 2 prior lines of therapy (patients must have received rituximab and alkylating agents unless contraindicated)
- ECOG performance status 0, 1, or 2
- Patients with diabetes mellitus are willing and able to have close monitoring due to risk of hyperglycemia
Reproductive Health & Contraception Requirements
- Women of childbearing potential: Pregnancy must be excluded prior to receiving copanlisib; provide contraceptive counseling on potential risks vs. benefits if pregnancy occurs during therapy; advise use of highly effective contraception during treatment and for at least one month after the last dose.
- Men with partners of childbearing potential: Advise use of highly effective contraception during treatment and for at least one month after the last dose.