SAVENE® - Abbreviated prescribing information
PRESCRIBING INFORMATION: SAVENE® 20mg/ml powder for concentrate and diluent for solution for infusion
Presentation: 500mg vials of dexrazoxane powder and 500ml bottles diluent.
Indication: For the treatment of anthracycline extravasation in adults.
Dosage and administration: SAVENE® must be administered under the supervision of a physician experienced in the use of anti-cancer medicines. Treatment should be given once daily for 3 consecutive days. Day 1: 1000 mg/m2; Day 2: 1000 mg/m2; Day 3: 500 mg/m2. The first infusion should be initiated as soon as possible within the first six hours after the accident. Treatment Day 2 and Day 3 should start at the same hour (+/- 3 hours) as Day 1. For patients with a body surface area of >2m2 the single dose should not exceed 2000mg. Dose administered as an intravenous infusion over 1-2 hours into a large vein of an area other than the one affected by the extravasation. Cooling procedures must be removed 15 minutes before administration.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Women of childbearing potential not using contraceptive measures. Breast-feeding. Concomitant vaccination with yellow fever vaccine.
Warnings and precautions: In patients with impaired renal function or impaired hepatic function so monitoring is recommended. Continuous monitoring should be performed after treatment until resolution. Plasma potassium level must be closely monitored in patients at risk of hyperkalaemia. May be harmful to patients on a controlled sodium diet.
Interactions: Yellow fever vaccine, other live attenuated vaccines, dimethylsulfoxide, phenytoin, cyclosporine, tacrolimus. Patients treated with anticoagulants should be monitored. Haematological parameters should be monitored due to possible increased toxicity of chemotherapy.
Pregnancy and lactation: Dexrazoxane should not be administered to pregnant women unless clearly necessary. Mothers must discontinue breast-feeding during dexrazoxane therapy. Women of childbearing potential must use contraceptive measures during treatment. Men are advised not to father a child during and up to three months following treatment and should use contraceptives for this period.
Undesirable effects: Very common adverse reactions (≥1/10) include: Postoperative infection, nausea, injection site pain. Prescribers should consult country approved prescribing information for further information in relation to undesirable effects.
Overdose: Symptoms are likely to consist of leucopenia, thrombocytopenia, nausea, vomiting, diarrhoea, skin reactions and alopecia. Treatment should be symptomatic.
Price and pack sizes: Prices vary according to country. An emergency kit consists of 10 glass vials of dexrazoxane powder and 3 glass bottles of diluent.
Legal category: Prescription only medicine.
Marketing authorisation holder: Norgine B.V., Hogehilweg 7, 1101 CA Amsterdam ZO,
Product licence number: EU/1/06/350/001.
Date International Prescribing Information prepared: 2 October 2013
Company reference: INT/SAV/1013/0019
Adverse events should be reported to your regulatory agency. Adverse events should also be reported to: Email: firstname.lastname@example.org. Freephone number: 00 800 1200 2222. Alternative Telephone Number +44 (0) 1748 828890 (calls charged at international rate).