Source: FDA, National Drug Code (US) Revision Year: 2020
ALIQOPA is indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
Accelerated approval was granted for this indication based on overall response rate [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
The recommended dose of ALIQOPA is 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). Continue treatment until disease progression or unacceptable toxicity [see Warnings and Precautions (5)].
Reduce ALIQOPA dose to 45 mg in patients with moderate hepatic impairment (Child-Pugh B) [see Hepatic Impairment (8.6)].
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)].
Manage toxicities per Table 1 with dose reduction, treatment delay, or discontinuation of ALIQOPA. Discontinue ALIQOPA if life-threatening ALIQOPA-related toxicity occurs.
Table 1. Dose Modification and Toxicity Managementa:
| Toxicities | Adverse Reaction Gradeb | Recommended Management |
|---|---|---|
| Infections | Grade 3 or higher | Withhold ALIQOPA until resolution. |
| Suspected pneumocystis jiroveci pneumonia (PJP) infection of any grade | Withhold ALIQOPA. If confirmed, treat infection until resolution, then resume ALIQOPA at previous dose with concomitant PJP prophylaxis. | |
| Hyperglycemia | Pre-dose fasting blood glucose 160 mg/dL or more or random/non-fasting blood glucose of 200 mg/dL or more | Withhold ALIQOPA until fasting glucose is 160 mg/dL or less, or a random/non-fasting blood glucose of 200 mg/dL or less. |
| Pre-dose or post-dose blood glucose 500 mg/dL or more | On first occurrence, withhold ALIQOPA until fasting blood glucose is 160 mg/dL or less, or a random/non-fasting blood glucose of 200 mg/dL or less. Then reduce ALIQOPA from 60 mg to 45 mg and maintain. On subsequent occurrences, withhold ALIQOPA until fasting blood glucose is 160 mg/dL or less, or a random/non-fasting blood glucose of 200 mg/dL or less. Then reduce ALIQOPA from 45 mg to 30 mg and maintain. If persistent at 30 mg, discontinue ALIQOPA. | |
| Hypertension | Pre-dose blood pressure (BP) 150/90 or greater c | Withhold ALIQOPA until BP is less than 150/90 based on two consecutive BP measurements at least 15 minutes apart. |
| Post-dose BP 150/90 or greater c (non-life-threatening): | If anti-hypertensive treatment is not required, continue ALIQOPA at previous dose. If anti-hypertensive treatment is required, consider reduction of ALIQOPA from 60 mg to 45 mg or from 45 mg to 30 mg. Discontinue ALIQOPA if BP remains uncontrolled (BP greater than 150/90) despite anti-hypertensive treatment [see Warnings and Precautions (5.3)]. | |
| Post-dose elevated BP with life-threatening consequences | Discontinue ALIQOPA. | |
| Non-infectious pneumonitis (NIP) | Grade 2 | Withhold ALIQOPA and treat NIP. If NIP recovers to Grade 0 or 1, resume ALIQOPA at 45 mg. If Grade 2 NIP recurs, discontinue ALIQOPA. |
| Grade 3 or higher | Discontinue ALIQOPA. | |
| Neutropenia | Absolute neutrophil count (ANC) 0.5 to 1.0 × 103 cells/mm3 | Maintain ALIQOPA dose. Monitor ANC at least weekly. |
| ANC less than 0.5 × 10 3 cells/mm3 | Withhold ALIQOPA. Monitor ANC at least weekly until ANC 0.5 × 103 cells/mm3 or greater, then resume ALIQOPA at previous dose. If ANC 0.5 × 103 cells/mm3 or less recurs, then reduce ALIQOPA to 45 mg. | |
| Severe cutaneous reactions | Grade 3 | Withhold ALIQOPA until toxicity is resolved and reduce ALIQOPA from 60 mg to 45 mg or from 45 mg to 30 mg. |
| Life-threatening | Discontinue ALIQOPA. | |
| Thrombocytopenia | Less than 25 × 109/L | Withhold ALIQOPA; resume when platelet levels return to 75.0 × 109/L or greater. If recovery occurs within 21 days, reduce ALIQOPA from 60 mg to 45 mg or from 45 mg to 30 mg. If recovery does not occur within 21 days, discontinue ALIQOPA. |
| Other severe and non-life-threatening toxicities | Grade 3 | Withhold ALIQOPA until toxicity is resolved and reduce ALIQOPA from 60 mg to 45 mg or from 45 mg to 30 mg. |
aEnsure a minimum of 7 days between any two consecutive infusions.
bNational Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03.
cBoth systolic of less than 150 mmHg and diastolic of less than 90 mmHg are required.
For intravenous infusion only.
Administer ALIQOPA as a single agent, following reconstitution and dilution. Mix only with 0.9% sodium chloride (NaCl) solution. Do not mix or inject ALIQOPA with other drugs or other diluents.
Reconstitute ALIQOPA with 4.4 mL of sterile 0.9% NaCl solution leading to a concentration of 15 mg/mL.
Further dilute the reconstituted solution in 100 mL sterile 0.9% NaCl solution for injection. With a sterile syringe, withdraw the required amount of the reconstituted solution for the desired dosage:
60 mg: Withdraw 4 mL of the reconstituted solution with a sterile syringe.
45 mg: Withdraw 3 mL of the reconstituted solution with a sterile syringe.
30 mg: Withdraw 2 mL of the reconstituted solution with a sterile syringe.
Inject the contents of the syringe into the patient infusion bag of 100 mL sterile 0.9% NaCl solution. Mix the dose well by inverting.
Discard any unused reconstituted or diluted solution appropriately.
Use reconstituted and diluted ALIQOPA immediately or store the reconstituted solution in the vial or diluted solution in the infusion bag at 2°C to 8°C (36°F to 46°F) for up to 24 hours before use. Allow the product to adapt to room temperature before use following refrigeration. Avoid exposure of the diluted solution to direct sunlight.
ALIQOPA vials must be refrigerated at 2°C to 8°C (36°F to 46°F).
Administer reconstituted and diluted solution immediately. If not, refrigerate at 2°C to 8°C (36°F to 46°F) and use within 24 hours. After refrigeration, allow the product to adapt to room temperature before use. Avoid exposure of the diluted solution to direct sunlight.
Mix only with 0.9% NaCl solution. Do not mix or inject ALIQOPA with other drugs or other diluents [see Dosage and Administration (2.5)].
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