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Irinotecan Liposomal Dosage

Applies to the following strength(s): 4.3 mg/mL

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Pancreatic Cancer

70 mg/m2 IV infusion over 90 minutes every 2 weeks

Comments:
-This drug should be administered prior to leucovorin and fluorouracil.
-A corticosteroid and an anti-emetic should be given 30 minutes prior to administration of this drug.
-This drug should not be substituted for other drugs containing irinotecan HCl.

Use: Indicated in combination with fluorouracil and leucovorin for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Serum Bilirubin Above Upper Limit of Normal: Data not available; the manufacturer product information indicates that there is no recommended dose for this patient population.

Dose Adjustments

HOMOZYGOUS UGT1A1*28 ALLELE:
-Initial Dose: 50 mg/m2 IV infusion over 90 minutes
-Maintenance Dose: Increase dose to 70 mg/m2 IV infusion over 90 minutes as tolerated in subsequent cycles.

GRADE 3 or 4 ADVERSE REACTIONS:
-Occurrence: This drug should be withheld; For Late Onset Diarrhea of Any Severity: Loperamide should be initiated; For Early Onset Diarrhea of Any Severity: IV or subcutaneous atropine 0.25 to 1 mg should be administered unless clinically contraindicated.
-For Patients Receiving 70 mg/m2: This drug can be resumed upon recovery to Grade 1 or less at 50 mg/m2 (first occurrence) or 43 mg/m2 (second occurrence).
-For Patients Homozygous for UGT1A1*28 Allele: This drug can be resumed upon recovery to Grade 1 or less at 43 mg/m2 (first occurrence) or 35 mg/m2 (second occurrence).
-This drug should be discontinued in all patients who experience a third occurrence.

INTERSTITIAL LUNG DISEASE OR ANAPHYLACTIC REACTION:
-This drug should be discontinued in all patients who experience either of these adverse reactions.

STRONG CYP450 3A4 INDUCER or INHIBITOR and STRONG UGT1A1 INHIBITOR:
-Avoid concomitant use if possible.
-Substitute non-enzyme inducing therapies at least 2 weeks prior and discontinue strong CYP450 3A4 inhibitors at least 1 week prior to initiation of this drug.

Precautions

US BOXED WARNINGS: Severe Neutropenia and Severe Diarrhea

SEVERE NEUTROPENIA:
-In patients receiving this drug, fatal neutropenic sepsis occurred in 0.8% and severe or life-threatening neutropenic fever or sepsis occurred in 3%.
-In patients receiving this drug in combination with fluorouracil and leucovorin, severe or life-threatening neutropenia occurred in 20%.
-This drug should be withheld for absolute neutrophil count below 1500/mm3 or neutropenic fever.
-Blood cell counts should be monitored periodically during treatment.

SEVERE DIARRHEA:
-In patients receiving this drug in combination with fluorouracil and leucovorin, severe diarrhea occurred in 13%.
-This drug should not be administered to patients with bowel obstruction.
-This drug should be withheld for diarrhea of Grade 2 to 4 severity.
-Loperamide should be given for late diarrhea of any severity.
-If not contraindicated, atropine should be given for early diarrhea of any severity.

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:
-The manufacturer product information should be consulted for any recommended dosing adjustments to fluorouracil or leucovorin.
-The diluted solution of this drug should be administered within 4 hours of preparation when stored at room temperature or within 24 hours when stored under refrigerated conditions (2 to 8 Celsius/36 to 46 Fahrenheit).
-The diluted solution should be allowed to come to room temperature prior to administration.
-In-line filters should not be used.

Storage Requirements:
-The diluted solution should be protected from light and not frozen.
-Any unused portion should be discarded.

Reconstitution/Preparation Techniques:
-The manufacturer product information should be consulted.
-Preparation, handling, and disposal of this drug should be performed in a manner consistent with safe procedures for cytotoxic agents.

General:
-This drug is not indicated as a single agent for metastatic adenocarcinoma of the pancreas.
-There are no known effective treatment interventions for overdosage.

Monitoring:
-Hematologic: CBC (Days 1 and 8 of every cycle and more frequently if clinically indicated)

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