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Copanlisib (United States: Withdrawn from market): Drug information

Copanlisib (United States: Withdrawn from market): Drug information
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For additional information see "Copanlisib (United States: Withdrawn from market): Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Aliqopa [DSC]
Pharmacologic Category
  • Antineoplastic Agent, Phosphatidylinositol 3-Kinase Inhibitor
Dosing: Adult

Dosage guidance:

Safety: Achieve optimal serum glucose control and optimize BP control prior to each copanlisib infusion.

Clinical considerations: Consider Pneumocystis jirovecii pneumonia (PCP) prophylaxis in patients at risk for PCP.

Follicular lymphoma, relapsed

Follicular lymphoma, relapsed:

Note: Copanlisib received approval under the FDA's Accelerated Approval Program in September 2017 for the treatment of relapsed follicular lymphoma in adults who have received at least 2 prior systemic therapies based on data from the open-label, single-arm, phase 2 CHRONOS-1 study. In the FDA-required confirmatory, phase 3 CHRONOS-4 study, in patients with relapsed follicular lymphoma, the addition of copanlisib to standard chemoimmunotherapy did not meet the primary efficacy end point of progression-free survival. Given the results of the CHRONOS-4 study, the manufacturer has elected to voluntarily withdraw copanlisib for the treatment of relapsed follicular lymphoma from the market. Access options for patients currently receiving copanlisib are being explored; however, no new patients should be prescribed copanlisib.

IV: 60 mg on days 1, 8, and 15 of a 28-day treatment cycle; continue until disease progression or unacceptable toxicity (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Note: Kidney function estimated using the Cockcroft-Gault formula.

CrCl ≥15 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling; however, CrCl ≥15 mL/minute did not significantly affect the pharmacokinetics of copanlisib.

CrCl <15 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

End-stage kidney disease with or without dialysis: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Liver Impairment: Adult

Hepatic impairment at treatment initiation :

Mild impairment (total bilirubin ≤ ULN and AST > ULN or total bilirubin 1 to 1.5 times ULN and any AST): No dosage adjustment necessary.

Moderate impairment (Child-Turcotte-Pugh class B): Reduce dose to 45 mg.

Severe hepatic impairment (Child-Turcotte-Pugh class C): Reduce dose to 30 mg.

Dosing: Adjustment for Toxicity: Adult

Note: A minimum of 7 days should elapse between any 2 consecutive infusions.

Copanlisib Dosage Modification and Toxicity Management

Adverse reaction

Adverse reaction severity

Recommended management

a Both systolic <150 mm Hg and diastolic <90 mm Hg are required.

b PCP = Pneumocystis jirovecii pneumonia; CMV = cytomegalovirus.

Hematologic toxicity

Neutropenia

ANC 500 to 1,000/mm3

Continue current copanlisib dose; monitor ANC at least weekly.

ANC <500/mm3

First occurrence: Interrupt copanlisib therapy. Monitor ANC at least weekly until ANC ≥500/mm3; resume at the previous dose.

Recurrent: Interrupt copanlisib therapy. Monitor ANC at least weekly until ANC ≥500/mm3; reduce copanlisib dose to 45 mg.

Thrombocytopenia

Platelets <25,000/mm3

Interrupt copanlisib therapy. May resume copanlisib when platelets recover to ≥75,000/mm3; if recovery occurs within 21 days, reduce dose from 60 to 45 mg (or from 45 to 30 mg). If recovery does not occur within 21 days, discontinue copanlisib.

Nonhematologic toxicity

Dermatologic toxicity

Grade 3 cutaneous reaction

Withhold copanlisib until toxicity is resolved; reduce dose from 60 to 45 mg (or from 45 to 30 mg).

Life-threatening

Discontinue copanlisib.

Hyperglycemia

Predose fasting blood glucose ≥160 mg/dL or random/nonfasting blood glucose ≥200 mg/dL

Withhold copanlisib until fasting glucose is ≤160 mg/dL, or a random (nonfasting) blood glucose is ≤200 mg/dL.

Predose or postdose blood glucose ≥500 mg/dL

First occurrence: Withhold copanlisib until fasting blood glucose is ≤160 mg/dL, or a random (nonfasting) blood glucose is ≤200 mg/dL; reduce dose from 60 to 45 mg.

Subsequent occurrences: Withhold copanlisib until fasting blood glucose is ≤160 mg/dL, or a random (nonfasting) blood glucose is ≤200 mg/dL; reduce dose from 45 to 30 mg. If hyperglycemia persists at the 30 mg dose, discontinue copanlisib.

Hypertension

Predose BP ≥150/90

Withhold copanlisib until BP is <150/90 (both systolic and diastolic) based on 2 consecutive measurements at least 15 minutes apart.a

Postdose BP ≥150/90 (non–life-threatening)

If antihypertensive treatment is not required, continue copanlisib at previous dose. If antihypertensive treatment is necessary, consider dose reduction from 60 to 45 mg (or from 45 to 30 mg). Discontinue copanlisib if BP remains uncontrolled (>150/90) despite appropriate antihypertensive treatment.a

Postdose elevated BP with life-threatening consequences

Discontinue copanlisib.

Infection

≥ Grade 3

Withhold copanlisib until resolution.

Suspected PCPb infection of any grade

Withhold copanlisib. If confirmed, treat infection until resolution; resume copanlisib at previous dose with concomitant PCP prophylaxis.

CMVb infection or viremia of any grade

Withhold copanlisib until infection or viremia resolves; resume copanlisib at the previous dose.

Pulmonary toxicity

Pulmonary symptoms (eg, cough, dyspnea, hypoxia, interstitial infiltrates on exam)

Withhold copanlisib and conduct a diagnostic exam to determine cause.

Noninfectious pneumonitis: grade 2

Withhold copanlisib and treat pneumonitis appropriately. If noninfectious pneumonitis recovers to grade 0 or 1, resume copanlisib at 45 mg.

If grade 2 toxicity recurs, discontinue copanlisib.

Noninfectious pneumonitis: ≥ grade 3

Discontinue copanlisib. May require management with systemic corticosteroids.

Other severe and non–life-threatening toxicities

Grade 3

Withhold copanlisib until toxicity is resolved; reduce dose from 60 to 45 mg (or from 45 to 30 mg).

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Cardiovascular: Hypertension (35%)

Central nervous system: Fatigue (36%)

Dermatologic: Skin rash (15%)

Endocrine & metabolic: Hyperglycemia (54% to 95%), hypertriglyceridemia (58%), hypophosphatemia (44%), hyperuricemia (25%)

Gastrointestinal: Diarrhea (36%), nausea (26%), increased serum lipase (21%), stomatitis (14%), vomiting (13%)

Hematologic & oncologic: Decreased hemoglobin (78%; grade 3: 4%), leukopenia (36%; grade 3: 12%; grade 4: 15%), decreased absolute lymphocyte count (78%; grade 3: 27%; grade 4: 2%), neutropenia (32%; grade 3: 10% to ≤24%; grade 4: 15% to ≤24%), thrombocytopenia (22%; grade 3: 7%; grade 4: 1%)

Infection: Serious infection (19%)

Respiratory: Lower respiratory tract infection (21%)

1% to 10%:

Central nervous system: Dysesthesia (≤7%), paresthesia (≤7%)

Endocrine & metabolic: Severe hyperglycemia (3% to 5%)

Gastrointestinal: Mucosal inflammation (8%)

Hematologic & oncologic: Severe neutropenia (1%)

Respiratory: Pneumonitis (5% to 9%), pneumonia (8%)

<1%, postmarketing and/or case reports: Exfoliative dermatitis, pneumonia due to pneumocystis, pruritus

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: Leukopenia, neutropenia, thrombocytopenia, lymphopenia, and anemia (including grade 3 or 4 events), have been reported with copanlisib therapy. Grade 3 or 4 neutropenia has occurred in close to one quarter of patients receiving copanlisib; serious neutropenic events also were reported.

• Dermatologic toxicity: Dermatologic toxicities, including grade 3 and 4 cutaneous events, have been observed with copanlisib monotherapy. Toxicities included exfoliative dermatitis, exfoliative rash, pruritus, and rash (including maculopapular rash).

• Hyperglycemia: Grade 3 or 4 hyperglycemia was reported commonly in patients treated with copanlisib monotherapy, including serious hyperglycemic events; infusion-related hyperglycemia may occur. Serum glucose levels typically peaked at 5 to 8 hours post infusion, and then declined to baseline levels in the majority of patients; some patients had elevated serum glucose levels one day after the infusion. In patients with baseline HbA1c <5.7%, 10% had HbA1c >6.5% at the conclusion of copanlisib therapy. Patients with diabetes mellitus should only be treated with copanlisib if adequate glucose control is achieved; monitor closely.

• Hypertension: Hypertension (including grade 3 and serious events) has occurred during copanlisib therapy; infusion-related hypertension may occur. Grade 3 hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) was reported in over one quarter of patients treated with copanlisib monotherapy. Systolic and diastolic blood pressures increased 16.8 mm Hg and 7.8 mm Hg, respectively, from baseline to 2 hours post infusion (in cycle 1 day 1); the mean blood pressure began decreasing ~2 hours post infusion, however, blood pressure remained elevated for 6 to 8 hours after the start of infusion.

• Infection: Serious and fatal infections have occurred during treatment with copanlisib. The most commonly reported infection was pneumonia. Serious Pneumocystis jirovecii pneumonia (PCP) has also been reported (rarely). Cytomegalovirus infection or reactivation (grade 1 or 2) has occurred with copanlisib.

• Pulmonary toxicity: Noninfectious pneumonitis has been reported with copanlisib monotherapy. Signs and symptoms of noninfectious pneumonitis may include cough, dyspnea, hypoxia, or interstitial infiltrates on radiologic exam.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution Reconstituted, Intravenous:

Aliqopa: 60 mg (1 ea [DSC])

Generic Equivalent Available: US

No

Pricing: US

Solution (reconstituted) (Aliqopa Intravenous)

60 mg (per each): $6,304.32

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

IV: Infuse over 1 hour. Do not mix with or administer with any other medications. Do not infuse with any solutions other than NS.

Hazardous Drugs Handling Considerations

This medication is not on the NIOSH (2024) list; however, it may meet the criteria for a hazardous drug. Copanlisib may cause reproductive toxicity.

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).

Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.

Use: Labeled Indications

Follicular lymphoma, relapsed: Treatment of relapsed follicular lymphoma in adults who have received at least 2 prior systemic therapies.

Note: Copanlisib received approval under the FDA's Accelerated Approval Program in September 2017 for the treatment of relapsed follicular lymphoma in adults who have received at least 2 prior systemic therapies based on data from the open-label, single-arm, phase 2 CHRONOS-1 study. In the FDA-required confirmatory, phase 3 CHRONOS-4 study, in patients with relapsed follicular lymphoma, the addition of copanlisib to standard chemoimmunotherapy did not meet the primary efficacy end point of progression-free survival. Given the results of the CHRONOS-4 study, the manufacturer has elected to voluntarily withdraw copanlisib for the treatment of relapsed follicular lymphoma from the market. Access options for patients currently receiving copanlisib are being explored; however, no new patients should be prescribed copanlisib.

Medication Safety Issues
Sound-alike/look-alike issues:

Copanlisib may be confused with alpelisib, crizotinib, duvelisib, idelalisib

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).

Metabolism/Transport Effects

Substrate of BCRP, CYP3A4 (Major), P-glycoprotein (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Androgens: Hypertension-Associated Agents may increase hypertensive effects of Androgens. Risk C: Monitor

Antidiabetic Agents: Hyperglycemia-Associated Agents may decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor

Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor

Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid

BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor

Brivudine: May increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid

Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor

Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid

Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid

Clofazimine: May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor

CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor

Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Miscellaneous Oncologic Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor

COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor

CYP3A4 Inducers (Moderate): May decrease serum concentration of Copanlisib. Risk C: Monitor

CYP3A4 Inducers (Strong): May decrease serum concentration of Copanlisib. Risk X: Avoid

CYP3A4 Inhibitors (Moderate): May increase serum concentration of Copanlisib. Risk C: Monitor

CYP3A4 Inhibitors (Strong): May increase serum concentration of Copanlisib. Management: If concomitant use of copanlisib and strong CYP3A4 inhibitors cannot be avoided, reduce the copanlisib dose to 45 mg. Monitor patients for increased copanlisib effects/toxicities. Risk D: Consider Therapy Modification

Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Denosumab: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification

Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid

Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification

Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor

Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification

Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification

Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

MetFORMIN: Copanlisib may decrease therapeutic effects of MetFORMIN. Copanlisib may increase serum concentration of MetFORMIN. Risk C: Monitor

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Mumps- Rubella- or Varicella-Containing Live Vaccines may increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid

Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid

Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor

Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor

Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor

Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor

Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification

Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification

Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid

Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification

Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid

Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification

Solriamfetol: May increase hypertensive effects of Hypertension-Associated Agents. Risk C: Monitor

Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor

Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid

Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid

Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid

Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid

Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor

Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid

Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification

Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Zoster Vaccine (Live/Attenuated): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid

Food Interactions

Grapefruit juice may increase serum copanlisib levels.

Reproductive Considerations

Pregnancy testing should be conducted prior to therapy in patients who could become pregnant. Highly effective contraception (contraception with a failure rate of <1% per year) is recommended during treatment and for at least 1 month after the last copanlisib dose for patients who could become pregnant. Patients with partners who could become pregnant should also use highly effective contraception during treatment and for at least 1 month after the last copanlisib dose.

Pregnancy Considerations

Based on the mechanism of action and data from animal reproduction studies, in utero exposure to copanlisib may cause fetal harm.

Breastfeeding Considerations

It is not known if copanlisib is present in breast milk.

Due to the potential for serious adverse events in the breastfed infant, the manufacturer does not recommend breastfeeding during therapy and for at least 1 month after treatment is discontinued.

Monitoring Parameters

Monitor blood counts at least weekly during treatment; blood glucose pre- and postdose and more frequently if clinically indicated (monitor patients with diabetes closely). BP pre- and postdose and more frequently if clinically indicated. Evaluate pregnancy status prior to treatment in patients who could become pregnant. Monitor for signs/symptoms of infection, including Pneumocystis jirovecii pneumonia (PCP), cytomegalovirus (CMV) infection, and viremia; if CMV occurs, monitor for CMV reactivation at least monthly via PCR or antigen testing. Monitor for signs/symptoms of noninfectious pneumonitis, hyperglycemia, and dermatologic toxicity.

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Copanlisib inhibits phosphatidylinositol 3-kinase (PI3K), primarily the P13K-alpha and P13K-delta isoforms which are expressed in malignant B-cells. Copanlisib induces tumor cell death through apoptosis and inhibition of proliferation of primary malignant B cell lines. In addition, copanlisib inhibits several signaling pathways, including B-cell receptor signaling, CXCR12 mediated chemotaxis of malignant B cells, and NFκB signaling in lymphoma cell lines.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: 871 L (range: 423 to 2,150 L)

Protein binding: 84.2%, primarily to albumin

Metabolism: Primarily hepatic (>90%) though CYP3A and <10% through CYP1A1; the M-1 metabolite has pharmacologic activity comparable to the parent compound (against P13K-alpha and P13K-beta)

Half-life elimination: 39.1 hours (range: 14.6 to 82.4 hours)

Excretion: 12 mg IV dose: Feces (~64%; ~30% as unchanged drug); urine (~22%; ~15% as unchanged drug); metabolites account for 41% of the administered dose

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Hepatic function impairment: In a pharmacokinetic study evaluating a single 12 mg IV copanlisib dose in subjects with hepatic impairment, the geometric mean of total copanlisib Cmax and AUC increased 1.38- and 1.71-fold, respectively, in subjects with moderate impairment (Child-Pugh class B) and 1.44- and 2.71-fold, respectively, in subjects with severe impairment (Child-Pugh class C) when compared to subjects with normal hepatic function. The geometric mean unbound AUC of copanlisib was increased by 1.23-fold and 3.77-fold in patients with moderate and severe impairment, respectively. The geometric mean unbound Cmax of copanlisib did not increase in patients with moderate impairment, but increased 1.92-fold in patients with severe impairment.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (PR) Puerto Rico: Aliqopa;
  • (TW) Taiwan: Aliqopa
  1. Aliqopa (copanlisib) [prescribing information]. Whippany, NJ: Bayer Healthcare Pharmaceuticals Inc; September 2023.
  2. Dreyling M, Santoro A, Mollica L, et al. Long-term safety and efficacy of the PI3K inhibitor copanlisib in patients with relapsed or refractory indolent lymphoma: 2-year follow-up of the CHRONOS-1 study. Am J Hematol. 2020;95(4):362-371. doi:10.1002/ajh.25711 [PubMed 31868245]
  3. Dreyling M, Santoro A, Mollica L, et al. Phosphatidylinositol 3-kinase inhibition by copanlisib in relapsed or refractory indolent lymphoma. J Clin Oncol. 2017;35(35):3898-3905. doi:10.1200/JCO.2017.75.4648 [PubMed 28976790]
  4. Hodson L, Ovesen J, Couch J, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. Managing hazardous drug exposures: information for healthcare settings, 2023. https://doi.org/10.26616/NIOSHPUB2023130. Updated April 2023. Accessed December 27, 2024.
  5. Hwang JP, Feld JJ, Hammond SP, et al. Hepatitis B virus screening and management for patients with cancer prior to therapy: ASCO provisional clinical opinion update. J Clin Oncol. 2020;38(31):3698-3715. doi:10.1200/JCO.20.01757 [PubMed 32716741]
  6. Ovesen JL, Sam­mons D, Connor TH, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. NIOSH list of hazardous drugs in healthcare settings, 2024. https://doi.org/10.26616/NIOSHPUB2025103. Updated December 18, 2024. Accessed December 20, 2024.
  7. United States Pharmacopeia. <800> Hazardous Drugs—Handling in Healthcare Settings. In: USP-NF. United States Pharmacopeia; July 1, 2020. Accessed January 16, 2025. doi:10.31003/USPNF_M7808_07_01
Topic 114897 Version 167.0