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Trade Names:
Zinecard
- Powder for injection, lyophilized 250 mg (10 mg/mL reconstituted)
- Powder for injection, lyophilized 500 mg (10 mg/mL reconstituted)

Mechanism of Action

Pharmacology

Dexrazoxane is a potent intracellular chelating agent. The mechanism by which dexrazoxane exerts its cardioprotective activity is not fully understood.

Pharmacokinetics

Absorption

C _max is 36.5 mcg/mL (at end of infusion).

Distribution

Vd approximately 22 L/m ² . Not bound to plasma proteins.

Metabolism

Metabolized to a diacid-diamide cleavage product and 2 monoacid-monoamide ring products.

Elimination

Elimination t _½ is 2.1 to 2.5 h. Plasma Cl is 6.25 to 7.88 L/h/m ² . Renal Cl is 3.35 L/h/m ² ; 42% excreted in urine.

Indications and Usage

Reduce incidence and severity of cardiomyopathy in female breast cancer patients who have received a cumulative doxorubicin dose of 300 mg/m ² and who may benefit from additional doxorubicin therapy. It is not recommended for use with the initiation of doxorubicin therapy.

Unlabeled Uses

Cardioprotectant for other anthracyclines.

Contraindications

Do not use with chemotherapy regimens that do not contain an anthracycline.

Dosage and Administration

IV The recommended IV dosage ratio of dexrazoxane:doxorubicin is 10:1 (eg, 500 mg/m ² dexrazoxane would be given with 50 mg/m ² doxorubicin). Doxorubicin must be administered within 30 min of starting the dexrazoxane infusion.

General Advice

• Only for use in combination with chemotherapy regimens containing anthracyclines.
• For IV administration only.
• Follow institutional procedures for handling, administration, and disposal of anticancer drugs. Use caution in preparing and handling the reconstituted solution; use of gloves is recommended. If dexrazoxane powder or solution contact the skin or mucosa, immediately wash exposed area with soap and water.
• Reconstitute powder for injection using the provided sodium lactate solution to give a dexrazoxane concentration of 10 mg/mL. This solution may be administered without further dilution or further diluted with dextrose 5% injection or sodium chloride 0.9% injection to provide a final dexrazoxane concentration of 1.3 to 5 mg/mL.
• Do not administer if cloudiness or particulate matter is noted.
• Administer prescribed dose by either slow IV push or rapid IV infusion.

Storage/Stability

Store powder for injection at controlled room temperature (59° to 86°F). Reconstituted and diluted solutions are stable for 6 h at controlled room temperature or under refrigeration (36° to 46°F). Discard any unused solution.

Drug Interactions

May increase the myelosuppressive effects of other chemotherapeutic agents.

Incompatibility

Do not mix with other drugs.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Dermatologic

Alopecia; urticaria; streaking/erythema; recall skin reaction.

CNS

Fatigue; malaise; neurotoxicity.

GI

Nausea; vomiting; dysphagia; stomatitis; diarrhea; elevated transaminases; anorexia; esophagitis.

Hematologic

Dose-related additive myelosuppression; leukopenia; thrombocytopenia; granulocytopenia.

Miscellaneous

Pain on injection; sepsis; phlebitis; hemorrhage; infection; fever.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Hepatic Function

Dose reduction is recommended.

Fertility

Testicular atrophy.

Anthracycline-induced cardiac toxicity

Carefully monitor cardiac function.

Antitumor interference

The use of dexrazoxane concurrently with the initiation of fluorouracil, doxorubicin, cyclosporine (FAC) therapy may interfere with the antitumor efficacy of the regimen; this use is not recommended.

Carcinogenesis

Secondary malignancies (primarily acute myeloid leukemia) have been reported in patients treated chronically with razoxane.

Extravasation risk

Local irritation or phlebitis may occur. Refer to institution-specific protocol.

Patient Information

• Advise patient, family, or caregiver that medication will be prepared and administered by health care provider in a health care setting.
• Review dosing schedule with patient, family, or caregiver.
• Advise patient, family, or caregiver to immediately report any of the following to health care provider: rash; hives; flushing; fever, chills, or other signs of infection; sores in mouth; unusual bleeding or bruising.
• Advise patient, family, or caregiver to report any of the following to health care provider: persistent nausea, vomiting, diarrhea, or appetite loss; persistent or worsening general body weakness; pain, redness, or swelling at injection site; streaking or redness of skin.