Usual Adult Dose for Ovarian Cancer

NOTE: Several dosage regimens exist for this drug. The information presented here is manufacturer recommended dosing. Some cancers are more responsive to this drug than others. Always consult institutional protocol.

50 mg/m2 IV at an initial rate of 1 mg/min to minimize the risk of infusion reactions; if no infusion-related adverse events are observed, the rate of infusion can be increased to complete administration over 60 minutes; the patient should be dosed once every 28 days until disease progression or unacceptable toxicity

Use: For the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy

Usual Adult Dose for Kaposi's Sarcoma

NOTE: Several dosage regimens exist for this drug. The information presented here is manufacturer recommended dosing. Some cancers are more responsive to this drug than others. Always consult institutional protocol.

20 mg/m2 IV at an initial rate of 1 mg/min to minimize the risk of infusion reactions; if no infusion-related adverse events are observed, the rate of infusion can be increased to complete administration over 60 minutes; the patient should be dosed once every 21 days until disease progression or unacceptable toxicity

Use: For AIDS-related Kaposi's sarcoma after failure of prior systemic chemotherapy or intolerance to such therapy

Usual Adult Dose for Multiple Myeloma

NOTE: Several dosage regimens exist for this drug. The information presented here is manufacturer recommended dosing. Some cancers are more responsive to this drug than others. Always consult institutional protocol.

30 mg/m2 IV at an initial rate of 1 mg/min to minimize the risk of infusion reactions; if no infusion-related adverse events are observed, the rate of infusion can be increased to complete administration over 60 minutes on day 4 of each 21-day cycle for 8 cycles or until disease progression or unacceptable toxicity; administer this drug after bortezomib on day 4 of each cycle

Use: This drug 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

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

This drug is eliminated in large part by the liver. Reduce the dose for serum bilirubin of 1.2 mg/dL or higher.

Dose Adjustments

DO NOT INCREASE THE DOSE OF THIS DRUG AFTER A DOSE REDUCTION FOR TOXICITY.

For neuropathic pain or peripheral neuropathy, no dosage adjustments are required for this drug.

Refer to bortezomib manufacturer prescribing information for dose adjustments.

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 recommended.
• 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 or 1.
• Discontinue therapy if no resolution after 2 weeks.
• If resolved to Grade 0 to 1 within 2 weeks:
• And no previous Grade 3 or 4 HFS: Continue therapy 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 or 1, then decrease dose by 25%.
• Discontinue therapy 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 or 1, then decrease dose by 25%.
• Discontinue therapy if no resolution after 2 weeks.

STOMATITIS:
GRADE 1 (painless ulcers, erythema, or mild soreness):

• Delay dosing up to 2 weeks or until resolved to Grade 0 or 1.
• Discontinue therapy if there is no resolution after 2 weeks.
• If resolved to Grade 0 to 1 within 2 weeks:
• And no previous Grade 3 or 4 stomatitis: Resume therapy at previous dose.
• And previous Grade 3 or 4 toxicity: 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 or 1.
• Discontinue therapy if there is no resolution after 2 weeks.
• If resolved to Grade 0 to 1 within 2 weeks:
• And no previous Grade 3 or 4 stomatitis: Resume therapy at previous dose.
• And previous Grade 3 or 4 toxicity: Decrease dose by 25%.

GRADE 3 (painful erythema, edema or ulcers, and unable to eat):

• Delay dosing up to 2 weeks or until resolved to Grade 0 or 1.
• Decrease dose by 25% and return to original dose interval.
• If after 2 weeks there is no resolution, discontinue therapy.

GRADE 4 (requires parenteral or enteral support):

• Delay dosing up to 2 weeks or until resolved to Grade 0 or 1.
• Decrease dose by 25% and return to original dose interval.
• If after 2 weeks there is no resolution, discontinue therapy.

NEUTROPENIA OR THROMBOCYTOPENIA:
GRADE 1: No dose reduction recommended.
GRADE 2: Delay until ANC 1500 or greater and platelets 75,000 or more; resume therapy at previous dose.
GRADE 3: Delay until ANC 1500 or greater and platelets 75,000 or more; resume therapy at previous dose.
GRADE 4: Delay until ANC 1500 or greater and platelets 75,000 or more; resume at 25% dose reduction or continue previous dose with prophylactic granulocyte growth factor.

RECOMMENDED DOSE MODIFICATIONS OF THIS DRUG FOR TOXICITY WHEN ADMINISTERED IN COMBINATION WITH BORTEZOMIB:
FEVER 38C or greater and ANC less than 1000/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 less than 25,000/mm3, hemoglobin less than 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 nonhematologic drug related toxicity: Do not dose until recovered to Grade less than 2, then reduce dose by 25%.

MANAGEMENT OF SUSPECTED EXTRAVASATION:
Discontinue this drug 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 minutes 4 times a day for 3 days.
• If the extravasation is in an extremity, elevate the extremity.

Precautions

US BOXED WARNINGS:
CARDIOMYOPATHY:

• This drug can cause myocardial damage, including congestive heart failure, as the total cumulative dose approaches 550 mg/m2. In a clinical study of 250 patients with advanced cancer who were treated with this drug, the risk of cardiotoxicity was 11% when the cumulative anthracycline dose was between 450 to 550 mg/m2. Prior use of other anthracyclines or anthracenediones should be included in calculations of total cumulative dosage. The risk of cardiomyopathy may be increased at lower cumulative doses in patients with prior mediastinal irradiation.

INFUSION-RELATED REACTIONS:

• Acute infusion-related reactions (e.g., flushing, shortness of breath, facial swelling, headache, chills, back pain, tightness in the chest or throat, hypotension) occurred in 11% of patients with solid tumors treated with this drug. Serious, life-threatening and fatal infusion reactions have been reported.

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients

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:

• Do not substitute doxorubicin hydrochloride liposome injection for doxorubicin hydrochloride injection.
• Do not administer as an undiluted suspension.
• Do not administer as an IV bolus.
• This drug should be diluted and given as a slow IV infusion through a peripheral vein or a central; use of inline filters is not recommended.

Storage requirements:

• Refrigerate diluted drug at 2C to 8C (36F to 46F) and administer within 24 hours.

Reconstitution/preparation techniques:

• Dilute this drug in doses up to 90 mg in 250 mL of 5% dextrose injection prior to administration.
• Dilute doses exceeding 90 mg in 500 mL of 5% dextrose injection prior to administration.

IV compatibility:

• This drug is compatible with 5% dextrose injection.

General:

• This drug is cytotoxic. Follow applicable special handling and disposal procedures.
• If this drug contacts skin or mucosa, immediately wash thoroughly with soap and water.
• 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 rapidly flush the infusion line.
• Do not mix this drug with other drugs.

Administer the first dose 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.

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