Doxil

Doxil Manufacturers

• Janssen Products, Lp
  

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  Doxil | Janssen Products, Lp

  

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  2.1 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 (5.2)].

  2.2 Ovarian Cancer

  The recommended dose of DOXIL is 50 mg/m2 intravenously over 60 minutes every 28 days until disease progression or unacceptable toxicity.

  2.3 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.

  2.4 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 (14.3)].

  2.5 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.

  2.6 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

  Inspect parenteral drug products 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 (5.2)]. 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 2.7 Procedure for Proper Handling and Disposal

  DOXIL is a cytotoxic drug. Follow applicable special handling and disposal procedures.1 If DOXIL comes into contact with skin or mucosa, immediately wash thoroughly with soap and water.

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