Dexrazoxane

Dexrazoxane is a prescription medication indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control

• Dexrazoxane is available under the following different brand names: Totect, Zinecard

Common side effects of Dexrazoxane include:

• nausea
• vomiting
• loss of appetite
• trouble swallowing 
• diarrhea
• temporary hair loss
• swelling in the hands or feet 
• sore throat 
• dizziness
• tired feeling, or injection site reactions (pain, irritation, swelling, or redness)

Serious side effects of Dexrazoxane include:

• fever
• chills
• tiredness
• mouth sores
• skin sores
• easy bruising
• unusual bleeding
• sore throat 
• cough trouble breathing
• bruising
• swelling, warmth, redness, oozing, or bleeding of any surgical incision

Rare side effects of Dexrazoxane include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Powder for injection

• 250 mg
• 500 mg

Doxorubicin-induced cardiomyopathy

Adult dosage

• Zinecard, Totect, and generic
  • Do not use with initiation of doxorubicin therapy
  • Infuse IV over 15 minutes before doxorubicin administration
  • Do not administer via an IV push
  • Dosage ratio of dexrazoxane to doxorubicin is 10:1 (. eg, 500 mg/m2 dexrazoxane to 50 mg/m2 doxorubicin)
  • Administer doxorubicin within 30 minutes after completion of Dexrazoxane infusion

Extravasation

Adult dosage

• Totect only
  • Infuse IV over 1-2 hr once daily for 3 consecutive days; begin treatment within 6 hours of extravasation
  • Initiate first infusion as soon as possible and within 6 hours after extravasation
  • Day 1: 1000 mg/m2 IV; not to exceed 2000 mg  
  • Day 2: 1000 mg/m2 IV; not to exceed 2000 mg
  • Day 3: 500 mg/m2 IV; not to exceed 1000 mg

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Dexrazoxane has severe interactions with no other drugs
• Dexrazoxane has serious interactions with the following drug:
  • ropeginterferon alfa 2b
• Dexrazoxane has moderate interactions with the following drugs:
  • acalabrutinib
  • hydroxyurea
  • lomustine
  • zidovudine
• Dexrazoxane has minor interactions with the following drugs:
  • aspirin rectal
  • choline magnesium trisalicylate

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity
• Use (Zinecard) in chemotherapy when an anthracycline is not being administered

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Dexrazoxane?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Dexrazoxane?”

Cautions

• May interfere with the activity of antineoplastic drugs; do NOT initiate until cumulative doxorubicin dose reaches 300 mg/m²
• Do NOT give doxorubicin before dexrazoxane
• Does not eliminate the potential for anthracycline-induced cardiac toxicity; monitor cardiac function carefully
• Secondary malignancies (eg, acute myeloid leukemia, myelodysplastic syndromes) reported with combination chemotherapy
• Treatment is associated with leukopenia, neutropenia, and thrombocytopenia; grade 2-4 decreased white blood cells (73%), decreased neutrophils (61%), and decreased platelets (26%) occurred in patients; febrile neutropenia occurred in 2.5% of patients; monitor complete blood counts during treatment; myelosuppression and cytotoxic potential and cytotoxic chemotherapy (with a nadir occurring on days 10-12) may be additive to that of chemotherapy administered alone
• Hypersensitivity reactions including anaphylactic reaction, angioedema, skin reactions, bronchospasm, respiratory distress, hypotension, and loss of consciousness have occurred in patients treated with dexrazoxane products and anthracyclines; previous history of allergy to dexrazoxane products should be carefully considered before administration; consider permanent discontinuation in patients with severe hypersensitivity reactions
• Therapy has not been studied in patients with hepatic impairment; since liver dysfunction (increases in transaminases and bilirubin) may occur (especially after doses of above 1000 mg/m² dexrazoxane), it is recommended that routine liver function tests be performed before each administration of dexrazoxane in patients with known liver function disorders; use in patients with hepatic impairment not recommended

Pregnancy and Lactation

Based on findings from animal studies and mechanism of action, therapy can cause fetal harm when administered to a pregnant woman; limited available data on pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes

In animal reproduction studies, intravenous administration of dexrazoxane to pregnant rats and rabbits during organogenesis resulted in teratogenicity at maternal doses that were approximately 0.1 and 0.2 times, respectively, the human dose of 1000 mg/m²; advise pregnant women of the potential risk to the fetus

Pregnancy testing

• Perform pregnancy testing before initiation of chemotherapy; repeat pregnancy testing before administration of therapy is not recommended because treatment of extravasation of anthracycline chemotherapy should not be delayed

Contraception

• Females: Therapy can cause fetal harm when administered to a pregnant woman; because of the potential for genotoxicity, advise womens of reproductive potential to use effective contraception during treatment and for 6 months following the final dose
• Males: Because of the potential for genotoxicity, advise men’s with womens partners of reproductive potential to use effective contraception during treatment and for 3 months following the final dose

Infertility

• Males: Based on findings in animal studies, therapy may impair fertility in men’s reproductive potential; not known whether these effects on fertility are reversible

Lactation

• There are no data on the presence of human milk, its effects on the breastfed child, or milk production; because of the potential for serious adverse reactions, such as myelosuppression, in a breastfed child, advise women not to breastfeed during treatment and for 2 weeks following final dose