Aliqopa (copanlisib)

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:
  • being very hungry
  • headaches
  • being very thirsty
  • frequent urination
• 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:

• low white blood cell count (leukopenia)
• low platelets in your blood (thrombocytopenia)
• diarrhea
• decreased strength and tiredness
• lower respiratory tract infection
• nausea

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.

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 Management^a

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

• 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.