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Doxorubicin Liposomal Dosage

Applies to the following strength(s): 2 mg/mL

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Kaposi's Sarcoma

20 mg/m2 IV over 30 minutes. The dose should be repeated once every 3 weeks according to patient response.

Usual Adult Dose for Ovarian Cancer

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 of the drug over one hour. The patient should be dosed once every four weeks, for as long as the patient does not progress, shows no evidence of cardiotoxicity, and continues to tolerate treatment. A minimum of four courses is recommended because median time to response in clinical trials was four months.

Pretreatment with or concomitant use of antiemetics should be considered.

Usual Adult Dose for Multiple Myeloma

Initial dose: 30 mg/m2 should be administered as a one hour intravenous infusion on day 4 following bortezomib. With the first doxorubicin liposomal dose, an initial rate of 1 mg/min should be used to minimize the risk of infusion-related reactions.

If no infusion-related adverse reactions are observed, the infusion rate should be increased to complete the administration of the drug over one hour. Patients may be treated for up to 8 cycles until disease progression or the occurrence of unacceptable toxicity.

Renal Dose Adjustments

No adjustment is recommended.

Liver Dose Adjustments

Doxorubicin liposomal dosage should be reduced in patients with liver impairment.
Serum bilirubin 1.2 to 3.0 mg/dL: 50% of normal dosage.
Serum bilirubin greater than 3 mg/dL: 25% of normal dose.

Dose Adjustments

Hematological toxicity:

Grade 1
ANC 1500 to 1900 or platelets 75,000 to 150,000: Resume with no dose reduction

Grade 2
ANC 1000 to less than 1500 or platelets 50,000 to less than 75,000: Wait until ANC at least 1500 and platelets at least 75,000. Resume with no dose reduction.

Grade 3
ANC 500 to 599 or platelets 25,000 to less than 50,000: Wait until ANC at least 1500 and platelets at least 75,000. Resume with no dose reduction.

Grade 4
ANC less than 500 or platelets less than 25,000: Wait until ANC at least 1500 and platelets at least 75,000. Resume at 25% dose reduction or continue with full dose and cytokine support.


Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome):

Grade 1
Mild erythema, swelling or desquamation not interfering with daily activities: Redose unless patient has experienced previous Grade 3 or 4 toxicity. If so, delay up to 2 weeks and decrease dose by 25%. Return to original dose interval.

Grade 2
Erythema, desquamation or swelling interfering with, but not precluding normal physical activities; small blister or ulcerations less than 2 cm in diameter: Delay dosing up to 2 weeks or until resolved to Grade 0-1. If after 2 weeks there is no resolution, discontinue doxorubicin liposomal.

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. Decrease dose by 25% and return to original dose interval. If after 2 weeks there is no resolution, discontinue doxorubicin liposomal.

Grade 4
Diffuse or local process causing infectious complications, or a bedridden state or hospitalization: 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 doxorubicin liposomal.


Stomatitis:

Grade 1
Painless ulcers, erythema, or mild soreness: Redose unless patient has experienced previous Grade 3 or 4 toxicity. If so, delay up to 2 weeks and decrease dose by 25%. Return to original dose interval.

Grade 2
Painful erythema, edema or ulcers, but able to 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 doxorubicin liposomal.

Grade 3
Painful erythema, edema or ulcers, and unable to 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 doxorubicin liposomal.

Grade 4
Requires parenteral or enteral nutrition support: Painful erythema, edema or ulcers, but able to 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 doxorubicin liposomal.

Multiple Myeloma:

For patients treated with doxorubicin liposomal in combination with bortezomib who experience hand-foot syndrome or stomatitis, the doxorubicin liposomal dose should be modified as described above.

The text below describes dosage adjustments for doxorubicin liposomal when given as a part of combination therapy with bortezomib.

Patient status: Fever greater than or equal to 38 degrees C and ANC less than 1000/mm3: Do not dose this cycle if before day 4. If after day 4, reduce next dose by 25%.

Patient status: 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 or ANC less than 500/mm3: Do not dose this cycle if before day 4. If after day 4, reduce next dose by 25% in the following cycles if bortezomib is reduced for hematologic toxicity.

Patient status: Grade 3 or 4 nonhematologic drug related toxicity: Do not dose until recovered to less than grade 2 and reduce dose by 25% for all subsequent doses.

Patient status: Neuropathic pain or peripheral neuropathy: No dosage adjustments.

Precautions

Experience with doxorubicin liposomal injection at high cumulative doses is too limited to have established its effect on the myocardium. It should therefore be assumed that doxorubicin liposomal will have myocardial toxicity similar to conventional formulations of doxorubicin HCl. With these formulations of doxorubicin HCl, serious irreversible myocardial toxicity leading to congestive heart failure often unresponsive to cardiac support therapy may be encountered as the total dosage of doxorubicin approaches 550 mg/m2. The dosages of both doxorubicin liposomal and conventional doxorubicin should be considered when assessing the cumulative dose. Cardiac toxicity may also occur at lower cumulative doses in patients with prior mediastinal irradiation, those who are receiving concurrent cyclophosphamide therapy and those with preexisting heart disease.

Doxorubicin liposomal should not be given by the intramuscular or subcutaneous route.

Do not administer doxorubicin liposomal as a bolus injection or an undiluted solution.

Doxorubicin liposomal should be considered an irritant and precautions should be taken to avoid extravasation.

The safety and efficacy of doxorubicin liposomal in children have not been established.

Complete blood counts, including platelet counts, should be obtained frequently and at a minimum, prior to each dose of doxorubicin liposomal.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

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