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Aliqopa Dosage

Generic name: COPANLISIB 15mg in 1mL
Dosage form: injection, powder, lyophilized, for solution
Drug class: PI3K inhibitors

Medically reviewed by Drugs.com. Last updated on Sep 7, 2023.

Recommended Dosage

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)].

Dose Modification for Moderate or Severe Hepatic Impairment ​

Reduce ALIQOPA dose to 45 mg in patients with moderate hepatic impairment (Child-Pugh B). Reduce ALIQOPA dose to 30 mg in patients with severe hepatic impairment (Child-Pugh C) [see Use in Specific Populations (8.6)].

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)].

Dosage Modifications for Toxicities

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: Dosage Modification and Toxicity Managementa
Toxicities Adverse Reaction Gradeb Recommended Management

Infections [see Warnings and Precautions (5.1)]

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.

​Cytomegalovirus (CMV) infection or viremia of any grade

​Withhold ALIQOPA until infection or viremia resolves, then resume at previous dose.

Hyperglycemia [see Warnings and Precautions (5.2)]

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 [see Warnings and Precautions (5.3)]

Pre-dose blood pressure (BP) 150/90 or greaterc

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 greaterc (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

Post-dose elevated BP with life-threatening consequences

Discontinue ALIQOPA.

Non-infectious pneumonitis (NIP) [see Warnings and Precautions (5.4)]

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 [see Warnings and Precautions (5.5)]

Absolute neutrophil count (ANC) 0.5 to 1.0 x 103 cells/mm3

Maintain ALIQOPA dose. Monitor ANC at least weekly.

ANC less than 0.5 x 103 cells/mm3

Withhold ALIQOPA. Monitor ANC at least weekly until ANC 0.5 x 103 cells/mm3 or greater, then resume ALIQOPA at previous dose. If ANC 0.5 x 103 cells/mm3 or less recurs, then reduce ALIQOPA to 45 mg.

Severe cutaneous reactions [see Warnings and Precautions (5.6)]

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 [see Adverse Reactions (6.1)]

Less than 25 x 109/L

Withhold ALIQOPA; resume when platelet levels return to 75.0 x 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 [see Adverse Reactions (6.1)]

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.

Preparation and Administration

For intravenous infusion only.

Administer ALIQOPA as a single agent, following reconstitution and dilution. Mix only with sterile 0.9% Sodium Chloride Injection, USP solution. Do not mix or inject ALIQOPA with other drugs or other diluents.

Reconstitution Instructions

Reconstitute ALIQOPA with 4.4 mL of sterile 0.9% Sodium Chloride Injection, USP solution leading to a concentration of 15 mg/mL.

•
Withdraw 4.4 mL of sterile 0.9% Sodium Chloride Injection, USP solution by using a 5 mL sterile syringe with needle.
•
Inject the measured volume through the disinfected stopper surface into the vial of ALIQOPA.
•
Dissolve the lyophilized solid by gently shaking the injection vial for 30 seconds.
•
Allow to stand for one minute to let bubbles rise to the surface.
•
Check if any undissolved substance is still seen. If yes, repeat the gentle shaking and settling procedure.
•
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. After reconstitution, the solution should be colorless to slightly yellowish.
•
Once the solution is free of visible particles, withdraw the reconstituted solution for further dilution.

Dilution Instructions for Intravenous Use

Further dilute the reconstituted solution in 100 mL sterile 0.9% Sodium Chloride Injection, USP 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% Sodium Chloride Injection, USP 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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