cBoth systolic of less than 150 mmHg and diastolic of less than 90 mmHg are required.

 

2.6 Dose Modification for Use with Strong CYP3A Inhibitors 

 

Reduce ALIQOPA dose to 45 mg if a strong CYP3A inhibitor must be used. Concomitant use of ALIQOPA with strong CYP3A inhibitors increases copanlisib exposure (AUC) and may increase the risk for toxicity [see Drug Interactions (7.1)].

 

3 DOSAGE FORMS AND STRENGTHS 

 

ALIQOPA is a lyophilized solid in a single-dose vial for reconstitution and further dilution for infusion. The labeled amount is 60 mg ALIQOPA per vial (reconstituted concentration of 15 mg/mL).

 

4 CONTRAINDICATIONS 

 

None. 

 

5 WARNINGS AND PRECAUTIONS 

 

5.1 Infections 

 

Serious, including fatal, infections occurred in 19% of 317 patients treated with ALIQOPA monotherapy. The most common serious infection was pneumonia [see Adverse Reactions (6.1)]. Monitor patients for signs and symptoms of infection and withhold ALIQOPA for Grade 3 and higher infection [see Dosage and Administration (2.5)].

 

Serious pneumocystis jiroveci pneumonia (PJP) infection occurred in 0.6% of 317 patients treated with ALIQOPA monotherapy [see Adverse Reactions (6.1)]. Before initiating treatment with ALIQOPA, consider PJP prophylaxis for populations at risk. Withhold ALIQOPA in patients with suspected PJP infection of any grade. If confirmed, treat infection until resolution, then resume ALIQOPA at previous dose with concomitant PJP prophylaxis [see Dosage and Administration (2.5)].

5.2 Hyperglycemia 

 

Grade 3 or 4 hyperglycemia (blood glucose 250 mg/dL or greater) occurred in 41% of 317 patients treated with ALIQOPA monotherapy [see Adverse Reactions (6.1)]. Serious hyperglycemic events occurred in 2.8% of patients. Treatment with ALIQOPA may result in infusion-related hyperglycemia. Blood glucose levels typically peaked 5 to 8 hours post-infusion and subsequently declined to baseline levels for a majority of patients; blood glucose levels remained elevated in 17.7% of patients one day after ALIQOPA infusion. Of 155 patients with baseline HbA1c <5.7%, 16 (10%) patients had HbA1c >6.5% at the end of treatment.

 

Of the twenty patients with diabetes mellitus treated in CHRONOS-1, seven developed Grade 4 hyperglycemia and two discontinued treatment. Patients with diabetes mellitus should only be treated with ALIQOPA following adequate glucose control and should be monitored closely.

 

Achieve optimal blood glucose control before starting each ALIQOPA infusion. Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of hyperglycemia [see Dosage and Administration (2.5)].

 

5.3 Hypertension