July 6, 2015
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Doxil

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Doxil




Indications
Dosage
How Supplied

INDICATIONS

Ovarian Cancer

DOXIL is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.

AIDS-Related Kaposi’s Sarcoma

DOXIL is indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy.

Multiple Myeloma

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].

Ovarian Cancer

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.

Multiple Myeloma

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

Toxicity Dose Adjustment
Hand-Foot Syndrome (HFS)
Grade 1: Mild erythema, swelling, or desquamation not interfering with daily activities
  • If no previous Grade 3 or 4 HFS: no dose adjustment.
  • If previous Grade 3 or 4 HFS: delay dose up to 2 weeks, then decrease dose by 25%.
Grade 2: Erythema, desquamation, or swelling interfering with, but not precluding normal physical activities; small blisters or ulcerations less than 2 cm in diameter
  • Delay dosing up to 2 weeks or until resolved to Grade 0-1.
  • Discontinue DOXIL if no resolution after 2 weeks.
  • If resolved to Grade 0-1 within 2 weeks:
    • And no previous Grade 3 or 4 HFS: continue treatment at previous dose.
    • And previous Grade 3 or 4 toxicity: decrease dose by 25%.
Grade 3: Blistering, ulceration, or swelling interfering with walking or normal daily activities; cannot wear regular clothing
  • Delay dosing up to 2 weeks or until resolved to Grade 0-1, then decrease dose by 25%.
  • Discontinue DOXIL if no resolution after 2 weeks.
Grade 4: Diffuse or local process causing infectious complications, or a bed ridden state or hospitalization
  • Delay dosing up to 2 weeks or until resolved to Grade 0-1, then decrease dose by 25%.
  • Discontinue DOXIL if no resolution after 2 weeks.
Stomatitis
Grade 1: Painless ulcers, erythema, or mild soreness
  • If no previous Grade 3 or 4 toxicity: no dose adjustment.
  • If previous Grade 3 or 4 toxicity: delay up to 2 weeks then decrease dose by 25%.
Grade 2: Painful erythema, edema, or ulcers, but can eat
  • Delay dosing up to 2 weeks or until resolved to Grade 0-1.
  • Discontinue DOXIL if there is no resolution after 2 weeks.
  • If resolved to Grade 0-1 within 2 weeks:
    • And no previous Grade 3 or 4 stomatitis: resume treatment at previous dose.
    • And previous Grade 3 or 4 toxicity: decrease dose by 25%.
Grade 3: Painful erythema, edema, or ulcers, and cannot eat
  • Delay dosing up to 2 weeks or until resolved to Grade 0-1. Decrease dose by 25% and return to original dose interval.
  • If after 2 weeks there is no resolution, discontinue DOXIL.
Grade 4: Requires parenteral or enteral support
  • Delay dosing up to 2 weeks or until resolved to Grade 0-1. Decrease dose by 25% and return to original dose interval.
  • If after 2 weeks there is no resolution, discontinue DOXIL.
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 Bortezomib

Toxicity DOXIL
Fever ≥ 38°C and ANC < 1,000/mm³
  • Withhold dose for this cycle if before Day 4;
  • Decrease dose by 25%, if after Day 4 of previous cycle.

On any day of drug administration after Day 1 of each cycle:

  • Platelet count < 25,000/mm³
  • Hemoglobin < 8 g/dL
  • ANC < 500/mm³
  • Withhold dose for this cycle if before Day 4;
  • Decrease dose by 25%, if after Day 4 of previous cycle AND if bortezomib is reduced for hematologic toxicity.
Grade 3 or 4 non-hematologic drug related toxicity Do not dose until recovered to Grade < 2, then reduce dose by 25%.

For neuropathic pain or peripheral neuropathy, no dosage adjustments are required for DOXIL. Refer to bortezomib manufacturer's prescribing information.

Preparation And Administration

Preparation

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.

Administration

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.

HOW SUPPLIED

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:

Table 14

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

REFERENCES

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.

Last reviewed on RxList: 3/10/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

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