HIGHLIGHTS OF PRESCRIBING INFORMATION 

These highlights do not include all the information needed to use ALIQOPA safely and effectively. See full prescribing information for ALIQOPA. 

ALIQOPA™ (copanlisib) for injection, for intravenous use 

Initial U.S. Approval: 2017 

 

INDICATIONS AND USAGE 

 

ALIQOPA is a kinase inhibitor indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies (1). 

 

Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 

 

DOSAGE AND ADMINISTRATION 

 

• Recommended dosage: 60 mg administered as a 1-hour intravenous infusion on Days 1, 8, and 15 of a 28-day treatment cycle on an intermittent schedule (three weeks on and one week off). Modify dosage for toxicity ( 2.1, 2.5). • See full prescribing information for important preparation and administration information ( 2.2, 2.3, 2.4). 

 

DOSAGE FORMS AND STRENGTHS 

 

For injection: 60 mg as a lyophilized solid in single-dose vial for reconstitution (3). 

 

CONTRAINDICATIONS 

 

None (4). 

 

WARNINGS AND PRECAUTIONS 

 

• Infections: Monitor patients for signs and symptoms of infection. Withhold treatment for Grade 3 and higher infections until resolution ( 5.1). • Hyperglycemia: Start each infusion once optimal blood glucose control is achieved. Withhold treatment, reduce dose or discontinue treatment depending on the severity and persistence of hyperglycemia ( 5.2). • Hypertension: Withhold treatment in patients until both the systolic blood pressure (BP) is less than 150 mmHg and the diastolic BP is less than 90 mmHg. Consider reducing dose if anti-hypertensive treatment is required. Discontinue in patients with BP that is uncontrolled or with life-threatening consequences ( 5.3). • Non-infectious pneumonitis (NIP): Treat NIP and reduce dose. Discontinue treatment if Grade 2 NIP recurs or in patients experiencing Grade 3 or higher NIP ( 5.4). • Neutropenia: Monitor blood counts at least weekly while under treatment. Withhold treatment until ANC ≥0.5 x 10 3 cells/mm 3 ( 5.5). • Severe Cutaneous Reactions: Withhold treatment, reduce dose, or discontinue treatment depending on the severity and persistence of severe cutaneous reactions ( 5.6). • Embryo-Fetal Toxicity: ALIQOPA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception ( 5.7, 8.1, 8.3). 

 

ADVERSE REACTIONS 

 

The most common adverse reactions (≥20%) are hyperglycemia, diarrhea, decreased general strength and energy, hypertension, leukopenia, neutropenia, nausea, lower respiratory tract infections, thrombocytopenia (6.1). 

 

To report SUSPECTED ADVERSE REACTIONS, contact Bayer at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 

 

DRUG INTERACTIONS