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Follicular Lymphoma
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Aliqopa

copanlisib
PI3K InhibitorFDA Approved 2017Bayer
Route
IV
Half-Life
35 hrs
FDA Approved
2017
Manufacturer
Bayer
1. Indications and Usage

Adults with relapsed follicular lymphoma after 2+ prior systemic therapies.

2. Dosage and Administration

60 mg IV over 1 hour on Days 1, 8, 15 of a 28-day cycle.

3. Dosage Forms and Strengths

Injection: 60 mg lyophilized powder in single-dose vial

4. Contraindications

None listed in the prescribing information.

5. Warnings and Precautions
  • Infections: Serious and fatal infections. Provide PJP prophylaxis.
  • Hyperglycemia: Pre- and post-dose glucose monitoring required.
  • Hypertension: Pre- and post-dose BP monitoring.
  • Non-Infectious Pneumonitis: Monitor.
  • Neutropenia: Monitor CBCs.
  • Severe Cutaneous Reactions: Including SJS.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Hyperglycemia (50%), Diarrhea (36%), Fatigue (30%), Hypertension (30%), Neutropenia (24%), Nausea (22%), Infection (18%)

Hyperglycemia
50%
Diarrhea
36%
Fatigue
30%
Hypertension
30%
Neutropenia
24%
Nausea
22%
Infection
18%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

Strong CYP3A4 Inducers: Avoid.
CYP3A Substrates: May increase exposure.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Copanlisib is an IV pan-class I PI3K inhibitor with preferential activity against PI3K-alpha and PI3K-delta, inhibiting PI3K signaling to induce tumor cell apoptosis in B-cell malignancies.

Pharmacokinetics

Protein binding: ~84%. Half-life: ~39 hours. Volume of distribution: ~871 L. Elimination: feces 64%, urine 22%.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Copanlisib Trials on ClinicalTrials.gov ↗ 📚 PubMed: Copanlisib Clinical Trials ↗
FDA-Approved Tumor Types

Aliqopa has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Follicular Lymphoma
External Resources
📋 DailyMed Label ↗🏛️ FDA Drugs@FDA ↗🔬 ClinicalTrials.gov ↗📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Aliqopa. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Aliqopa (copanlisib) approved for?

Aliqopa (copanlisib) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Aliqopa (copanlisib) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Aliqopa (copanlisib) work?

Copanlisib is an IV pan-class I PI3K inhibitor with preferential activity against PI3K-alpha and PI3K-delta, inhibiting PI3K signaling to induce tumor cell apoptosis in B-cell malignancies.

What are the most common side effects?

Hyperglycemia (50%), Diarrhea (36%), Fatigue (30%), Hypertension (30%), Neutropenia (24%), Nausea (22%), Infection (18%) Hyperglycemia 50% Diarrhea 36% Fatigue 30% Hypertension 30% Neutropenia 24% Nausea 22% Infection 18%

← All TherapiesFull Prescribing Information ↗