Generic drug: copanlisib

Brand name: Aliqopa

What is Aliqopa (copanlisib), and how does it work?

Aliqopa is a prescription medicine used to treat adults with follicular lymphoma (FL) when the disease has come back after treatment with at least two prior medicines.

What are the side effects of Aliqopa?

What are the possible side effects of Aliqopa?

Aliqopa can cause serious side effects, including:

  • Infections. Aliqopa can cause serious infections that may lead to death. The most common serious infection was pneumonia. Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with Aliqopa.
  • High blood sugar (hyperglycemia). High blood sugar is common following Aliqopa infusion and can sometimes be serious. Tell your healthcare provider if you develop any symptoms of hyperglycemia during treatment with Aliqopa. Symptoms of hyperglycemia may include:
  • High blood pressure (hypertension). High blood pressure is common following Aliqopa infusion and can sometimes be serious. Lung or breathing problems. Your healthcare provider may do tests to check your lungs if you have breathing problems during treatment with Aliqopa. Tell your healthcare provider right away if you develop new or worsening cough, shortness of breath, or difficulty breathing.
  • Low white blood cell count (neutropenia). Neutropenia is common with Aliqopa treatment and can sometimes be serious. Your healthcare provider will check your blood counts regularly during treatment with Aliqopa. Tell your healthcare provider right away if you have a fever or any signs of infection during treatment with Aliqopa.
  • Severe skin reactions. Skin peeling, rash, and itching are common with Aliqopa and can sometimes be serious. Tell your healthcare provider if you develop skin peeling, itching, or rash during treatment with Aliqopa. Your healthcare provider may withhold treatment, decrease your dose, or permanently stop treatment if you develop severe skin reactions during treatment with Aliqopa.

The most common side effects of Aliqopa include:

These are not all of the possible side effects of Aliqopa. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088.

What is the dosage for Aliqopa?

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.

Dose Modification For Moderate Hepatic Impairment

  • Reduce Aliqopa dose to 45 mg in patients with moderate hepatic impairment (Child-Pugh B).

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.

Dose Modification 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: 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/nonfasting 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 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 (nonlife-threatening): If anti-hypertensive treatment is not required, continue Aliqopa at previous dose. If antihypertensive 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) 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 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 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 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 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.

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What drugs interact with Aliqopa?

Effect Of Other Drugs On Copanlisib

Table 4 lists the potential effects of coadministration of Aliqopa with strong CYP3A inhibitors and inducers.

Table 4: Drug Interactions with Aliqopa that affect Copanlisib Concentrations

Strong CYP3A inducers
Clinical impact
  • Concomitant use of Aliqopa with strong CYP3A inducers may decrease copanlisib AUC and Cmax.
Prevention management
  • Avoid concomitant use of Aliqopa with strong CYP3A inducers
Strong CYP3A inhibitors
Clinical impact
  • Concomitant use of Aliqopa with strong CYP3A inhibitors increases the copanlisib AUC.
  • An increase in the copanlisib AUC may increase the risk of adverse reactions
Prevention management
  • If concomitant use with strong CYP3A inhibitors cannot be avoided, reduce the Aliqopa dose to 45 mg

Is Aliqopa safe to use while pregnant or breastfeeding?

  • Based on findings from animal studies and the mechanism of action, Aliqopa can cause fetal harm when administered to a pregnant woman.
  • There are no data on the presence of copanlisib and/or metabolites in human milk, the effects on the breastfed child, or on milk production.
  • Following administration of radiolabeled copanlisib to lactating rats, approximately 2% of the radioactivity was secreted into milk; the milk to plasma ratio of radioactivity was 25- fold.
  • Because of the potential for serious adverse reactions in a breastfed child from copanlisib, advise a lactating woman not to breastfeed during treatment with Aliqopa and for at least 1 month after the last dose.

Summary

Aliqopa is a prescription medicine used to treat adults with follicular lymphoma (FL) when the disease has come back after treatment with at least two prior medicines. Serious side effects of Aliqopa include infections, high blood sugar (hyperglycemia), high blood pressure (hypertension), low white blood cell count (neutropenia), and severe skin reactions.

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Medically Reviewed on 6/29/2021
References
All sections courtesy of the U.S. Food and Drug Administration