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Copanlisib Dosage

Medically reviewed by Drugs.com. Last updated on Oct 13, 2017.

Applies to the following strengths: 60 mg

Usual Adult Dose for Follicular Lymphoma

60 mg via 1-hour IV infusion on Days 1, 8, and 15 of a 28-day treatment cycle on an intermittent schedule (3 weeks on and 1 week off).

Duration of Therapy: Until disease progression or unacceptable toxicity

Comments: Accelerated approval was granted based on overall response rate; continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Use: Treatment of relapsed follicular lymphoma (FL) in patients who have received at least 2 prior systemic therapies.

Renal Dose Adjustments

Data not available.

Liver Dose Adjustments

Data not available.

Dose Adjustments

CONCOMITANT USE WITH STRONG CYP450 3A INDUCERS: Not recommended.

CONCOMITANT USE WITH STRONG CYP450 3A INHIBITORS: Reduce dose to 45 mg.

TOXICITY MANAGEMENT:
INFECTIONS:
-Grade 3 or Higher: Withhold this drug until resolution.
-Suspected Pneumocystis Jiroveci Pneumonia (PJP) Infection of Any Grade: Withhold this drug; if PJP confirmed, treat infection until resolution then resume this drug at previous dose with concomitant PJP prophylaxis.

HYPERGLYCEMIA:
-Pre-Dose Fasting Blood Glucose 160 mg/dL or More OR Random/Non-Fasting Blood Glucose of 200 mg/dL or More: Withhold this drug 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: Withhold this drug until fasting glucose is 160 mg/dL or less or a random/non-fasting blood glucose of 200 mg/dL or less; then reduce dose:
--First Occurrence: Reduce dose from 60 mg to 45 mg and maintain.
--Second Occurrence: Reduce dose from 45 mg to 30 mg and maintain.
--If Hyperglycemia Persistent at 30 mg: Discontinue this drug.

HYPERTENSION:
-Pre-Dose Blood Pressure (BP) 150/90 or Greater: Withhold this drug until BP is less than 150/90 based on 2 consecutive BP measurements at least 15 minutes apart.
-Post-Dose BP 150/90 or Greater (Non-Life-Threatening):
--Anti-Hypertensive Treatment Not Required: Continue this drug at previous dose.
--Anti-Hypertensive Treatment Is Required: Consider dose reduction from 60 mg to 45 mg OR from 45 mg to 30 mg.
-If BP Remains Uncontrolled (Greater than 150/90) Despite Anti-Hypertensive Treatment OR Post-Dose Elevated BP with Life-Threatening Consequences: Discontinue this drug.

NON-INFECTIOUS PNEUMONITIS (NIP):
-Grade 2: Withhold this drug and treat NIP; resume this drug at 45 mg if NIP recovers to Grade 0 or 1.
-Grade 2 Recurrence OR Grade 3 or Higher: Discontinue this drug.

NEUTROPENIA:
-Absolute Neutrophil Count (ANC) 0.5 to 1 x 10(3) cells/mm3: Maintain dose, and monitor ANC at least weekly.
-ANC Less Than 0.5 x 10(3) cells/mm3: Withhold this drug. Monitor ANC at least weekly until ANC 0.5 x 10(3) cells/mm3 or greater, then resume at previous dose.
-Recurrence of ANC 0.5 x 10(3) cells/mm3 or Less: Reduce dose to 45 mg.

SEVERE CUTANEOUS REACTIONS:
-Grade 3: Withhold this drug until toxicity is resolved, and reduce dose from 60 mg to 45 mg OR from 45 mg to 30 mg.
-Life-Threatening: Discontinue this drug.

THROMBOCYTOPENIA:
-Less Than 25 x 10(9)/L: Withhold this drug; resume when platelet levels return to 75 x 10(9)/L or greater.
--If Recovery Occurs Within 21 Days: Reduce dose from 60 mg to 45 mg OR from 45 mg to 30 mg.
--If Recovery Does Not Occur Within 21 Days: Discontinue this drug.

OTHER SEVERE AND NON-LIFE THREATENING TOXICITIES:
-Grade 3: Withhold this drug until toxicity is resolved, and reduce dose from 60 mg to 45 mg OR from 45 mg to 30 mg.

Comments: Ensure a minimum of 7 days between any 2 consecutive infusions.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available.

Other Comments

Administration Advice:
-Following reconstitution and dilution, administer this drug as a single agent immediately or refrigerate and use within 24 hours.
-After refrigeration, allow this drug product to adapt to room temperature before use.

Storage Requirements:
-Refrigerate drug vials at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit).
-Avoid exposure of the diluted solution to direct sunlight.

Reconstitution/Preparation Techniques:
-Mix this drug only with 0.9% sodium chloride (NaCl) solution; do not mix or inject with other drugs or other diluents.
-Consult the manufacturer product information for reconstitution and dilution instructions.

Monitoring:
-Cardiovascular: Blood pressure (pre- and post-infusion)
-Endocrine: Blood glucose (before each infusion)
-Hematologic: Blood counts (at least weekly during treatment)
-Infections/Infestations: Infection signs/symptoms (during treatment)

Patient Advice:
-Avoid taking grapefruit/grapefruit juice and/or St. John's Wort during treatment with this drug.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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