"June 21, 2011 -- New technology now makes it possible to create atomic-scale drug particles, diagnostic tools, and biological medical devices -- and the FDA is struggling to regulate the fast-growing field.
Noting the "critical need t"...
AIDS-Related Kaposi’s Sarcoma
DOXIL, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.
DOSAGE AND ADMINISTRATION
Important Use Information
Do not substitute DOXIL for doxorubicin HCl injection.
Do not administer as an undiluted suspension or as an intravenous bolus [see WARNINGS AND PRECAUTIONS].
The recommended dose of DOXIL is 50 mg/m² intravenously over 60 minutes every 28 days until disease progression or unacceptable toxicity.
AIDS-Related Kaposi’s Sarcoma
The recommended dose of DOXIL is 20 mg/m² intravenously over 60 minutes every 21 days until disease progression or unacceptable toxicity.
The recommended dose of DOXIL is 30 mg/m² intravenously over 60 minutes on day 4 of each 21-day cycle for eight cycles or until disease progression or unacceptable toxicity. Administer DOXIL after bortezomib on day 4 of each cycle [see Clinical Studies].
Dose Modifications For Adverse Reactions
Do not increase DOXIL after a dose reduction for toxicity.
Table 1: Recommended Dose Modifications for Hand-Foot
Syndrome, Stomatitis, or Hematologic Adverse Reactions
|Hand-Foot Syndrome (HFS)|
|Grade 1: Mild erythema, swelling, or desquamation not interfering with daily activities||
|Grade 2: Erythema, desquamation, or swelling interfering with, but not precluding normal physical activities; small blisters or ulcerations less than 2 cm in diameter||
|Grade 3: Blistering, ulceration, or swelling interfering with walking or normal daily activities; cannot wear regular clothing||
|Grade 4: Diffuse or local process causing infectious complications, or a bed ridden state or hospitalization||
|Grade 1: Painless ulcers, erythema, or mild soreness||
|Grade 2: Painful erythema, edema, or ulcers, but can eat||
|Grade 3: Painful erythema, edema, or ulcers, and cannot eat||
|Grade 4: Requires parenteral or enteral support||
|Neutropenia or Thrombocytopenia|
|Grade 1||No dose reduction|
|Grade 2||Delay until ANC ≥ 1,500 and platelets ≥ 75,000; resume treatment at previous dose|
|Grade 3||Delay until ANC ≥ 1,500 and platelets ≥ 75,000; resume treatment at previous dose|
|Grade 4||Delay until ANC ≥ 1,500 and platelets ≥ 75,000; resume at 25% dose reduction or continue previous dose with prophylactic granulocyte growth factor|
Table 2: Recommended Dose
Modifications of DOXIL for Toxicity When Administered in Combination With
|Fever ≥ 38°C and ANC < 1,000/mm³||
On any day of drug administration after Day 1 of each cycle:
|Grade 3 or 4 non-hematologic drug related toxicity||Do not dose until recovered to Grade < 2, then reduce dose by 25%.|
Preparation And Administration
Dilute DOXIL doses up to 90 mg in 250 mL of 5% Dextrose Injection, USP prior to administration. Dilute doses exceeding 90 mg in 500 mL of 5% Dextrose Injection, USP prior to administration. Refrigerate diluted DOXIL at 2°C to 8°C (36°F to 46°F) and administer within 24 hours.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if a precipitate or foreign matter is present.
Do not use with in-line filters.
Administer the first dose of DOXIL at an initial rate of 1 mg/min. If no infusion-related adverse reactions are observed, increase the infusion rate to complete the administration of the drug over one hour [see WARNINGS AND PRECAUTIONS]. Do not rapidly flush the infusion line.
Do not mix DOXIL with other drugs.
Management of Suspected Extravasation
Discontinue DOXIL for burning or stinging sensation or other evidence indicating perivenous infiltration or extravasation. Manage confirmed or suspected extravasation as follows:
- Do not remove the needle until attempts are made to aspirate extravasated fluid
- Do not flush the line
- Avoid applying pressure to the site
- Apply ice to the site intermittently for 15 min 4 times a day for 3 days
- If the extravasation is in an extremity, elevate the extremity
Procedure For Proper Handling And Disposal
Handle and dispose of DOXIL in accordance with recommendations for the handling and disposal of hazardous drugs.1
If DOXIL comes into contact with skin or mucosa, immediately wash thoroughly with soap and water.
Dosage Forms And Strengths
DOXIL: doxorubicin HCl liposomal injection: single use vials contain 20mg/10 mL and 50mg/25mL doxorubicin HCl as a translucent, red liposomal dispersion.
Storage And Handling
DOXIL is a sterile, translucent, red liposomal dispersion in 10-mL or 30-mL glass, single use vials.
Each 10-mL vial contains 20 mg doxorubicin HCl at a concentration of 2 mg/mL.
Each 30-mL vial contains 50 mg doxorubicin HCl at a concentration of 2 mg/mL.
The following individually cartoned vials are available:
|mg in vial||fill volume||vial size||NDC #s|
|20 mg vial||10-mL||10-mL||59676-960-01|
|50 mg vial||25-mL||30-mL||59676-960-02|
Refrigerate unopened vials of DOXIL at 2°-8°C (36°-46°F). Do not freeze.
Handle and dispose of DOXIL consistent with recommendations for the handling and disposal of hazardous drugs.1
1. “Hazardous Drugs”, OSHA, http://www.osha.gov/SLTC/hazardousdrugs/index.html
Manufactured by: ALZA Corporation Bedford, OH 44146 or TTY Biopharm Company Limited No. 838, Sec. 1, Chung Hwa Rd. Chung-Li, Taoyuan, Taiwan, R.O.C. Manufactured for: Janssen Products, LP Horsham, PA 19044. Revised: Jan 2015.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/10/2015
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