Lipo-Dox

Lipo-Dox Dosage/Direction for Use

doxorubicin

Manufacturer:

TTY Biopharm

Distributor:

Onco Care Pharma

Marketer:

American Taiwan Biopharma
Full Prescribing Info
Dosage/Direction for Use
Pegylated liposomal doxorubicin exhibits unique pharmacokinetic properties and must not be used interchangeably with other formulations of doxorubicin HCl.
Lipo-Dox should only be administered under the supervision of a qualified oncologist specialized in the administration of cytotoxic agents.
Breast/Ovarian Cancer: Doxorubicin HCl (Lipo-Dox) should be administered intravenously at a dose of 50 mg/m2 once every 4 weeks for as long as the disease does not progress and the patient continues to tolerate treatment.
For dose <90 mg: dilute Doxorubicin HCl (Lipo-Dox) in 250 mL Dextrose 5% in Water.
For dose ≥90 mg: dilute Doxorubicin HCl (Lipo-Dox) in 500 mL Dextrose 5% in Water.
To minimize the risk of infusion reactions, the initial dose should be administered at a rate no more than 1 mg/min. If no infusion reaction was observed, subsequent Doxorubicin HCl (Lipo-Dox) infusions can be increased to complete administration over a 60-minute period. In the breast cancer trial program, modification of the infusion was permitted for those patients experiencing an illusion reaction as follows: 5% of the total dose should be administered slowly over 15 minutes. If tolerated without reactions, the infusion rate could be doubled for the next 15 minutes. If tolerated, the infusion was completed over the next hour for total infusion time of 90 minutes.
Subsequent pegylated liposomal doxorubicin infusion might be administered over a 60-minute period.
AIDS-KS Patients: Doxorubicin HCl (Lipo-Dox) should be administered intravenously at 20 mg/m2 every 2 to 3 weeks. The intervals should not be shorter than 10 days to avoid drug accumulation and increased toxicity. Patients should be treated for 2 to 3 months to achieve a therapeutic response.
Dilute Doxorubicin HCl (Lipo-Dox) in 250 mL Dextrose 5% in Water and complete administration by intravenous infusion over 30 minutes.
All patients: If any signs or early symptoms of infusion reaction occur, the infusion should be discontinued immediately. Appropriate premedications (antihistamine and/or short-acting corticosteroid) should be given when restarting the infusion at a slower rate.
Do not administer as a bolus injection or an undiluted solution. It is recommended that the pegylated liposomal doxorubicin infusion line should be connected through the side port of an intravenous infusion of Dextrose 5% in Water to achieve further dilution and minimize the risk of thrombosis and extravasation. The infusion might be given through a peripheral vein. Pegylated liposomal doxorubicin must not be given by intramuscular or subcutaneous route. Do not use with in-line filters.
Adverse events, such as palmar-plantar erythrodysesthesia (PPE), hematologic toxicity or stomatitis, may be managed by dose-reducing or delay. Guidelines for dose secondary to these adverse effects are provided in the following table. The toxicity grading is based on the National Cancer Institute Common Toxicity Criteria (NCI-CTC).
Guidelines for Lipo-Dox Dose Modification: See Tables 2, 3 and 4.

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Patients with Impaired Hepatic Function: Based on reports, in the small amount of patients with elevated total bilirubin levels, the pharmacokinetics is similar to patients with normal total bilirubin levels. However, until further experience is gained, the pegylated liposomal doxorubicin dosage in patients with impaired hepatic function should be reduced based on the experience from the breast and ovarian cancer clinical trial programs as follows: at initiation of therapy, if the bilirubin ranges from 1.2 to 3.0 mg/dL, the initial dose should be reduced by 50%. If the patient tolerates the initial dose without an increase in serum bilirubin or liver enzymes, the dosage in cycle 2 can be increased to the next dose level, i.e. when reduced by 25% for the initial dose, increase to 75% of full dose for cycle 2. Then, if the patient tolerates well, the dosage can be increased to full dose for the subsequent cycles. In the liver metastases patients with concurrent elevation of bilirubin and liver enzymes up to 4x the upper limit of the normal range, pegylated liposomal doxorubicin could be administered. Before pegylated liposomal doxorubicin administration, evaluation of hepatic function using conventional clinical laboratory tests such as ALT/AST, alkaline phosphatase, and bilirubin is necessary.
Patients with Impaired Renal Function: Since doxorubicin is metabolized by the liver and excreted in bile, dosage adjustment is not necessary. From the pharmacokinetic analysis of special population, it is confirmed that the pharmacokinetic properties are not different in the patients with the creatinine clearance between 30-156 mL/min. No pharmacokinetic data are available in patients with the creatinine less than 30 mL/min.
AIDS-KS Patients with Splenectomy: There is no experience with pegylated liposomal doxorubicin in patients with splenectomy. Lipo-Dox is not recommended.
Pediatric Patients: Limited Phase I safety clinical data indicated that doses up to 60 mg/m2 pegylated liposomal doxorubicin every 4 weeks is well-tolerated in pediatric patients; however the efficacy in patients under 18 years old has not been established.
Geriatric Patients: Based on the population analysis, the pharmacokinetics of pegylated liposomal doxorubicin in 21-75 year old patients is not changed.
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