Aliqopa (copanlisib): Cancer Treatment Side Effects & Warnings

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:
- 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.

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 Management^a

Toxicities
Adverse Reaction Grade^b
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.

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