Savene® - Abbreviated prescribing information
(based on the Summary of Product Characteristics SPC)
Please refer to the SPC for full prescribing information.
Each Savene® box contains 10 vials of Savene® (dexrazoxane) Powder (10 x 500 mg each) and 3 bags of Savene® Diluent (3 x 500 ml each) for infusion. Indications: Treatment of anthracycline extravasation. Dosage and administration: Administration of Savene® should begin as soon as possible and within 6 hours after the accident. Savene® should be given as an intravenous infusion once daily for 3 consecutive days according to body surface area: day one, 1000 mg/m2; day two, 1000 mg/m2; day three, 500 mg/m2. For patients with a body surface area of more than 2 m2 the single dose should not exceed 2000 mg. Cooling procedures such as ice packs should have been removed from the affected area at least 15 min before administration. Before infusion, Savene® Powder must be reconstituted with sterile water before further dilution in Savene® Diluent. Savene® is not recommended in children and patients with renal and hepatic impairment. Safety and efficacy have not been evaluated in the elderly. Contraindications: Hypersensitivity to the active substance or to any of the excipients, women of childbearing potential not using contraceptive measures, lactation or concomitant vaccination with yellow fever vaccine. Precautions: Local examination should be performed on a regular basis after treatment until resolution and haematological monitoring should be undertaken regularly. Savene® should be administered only under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Routine liver function tests are recommended before each administration of Savene® in patients with known liver function disorders. Patients with renal dysfunction should be monitored for signs of haematological toxicity. Men are advised not to father a child during and up to 3 months after treatment. Women of childbearing potential must use contraceptive measures during treatment. This product is generally not recommended in combination with live attenuated vaccines or with phenytoin. Dimethyl sulfoxide (DMSO) should not be used in patients who are administered Savene®. As the Savene® diluent contains potassium (98 mg/500 ml) the plasma potassium level of the patient must be closely monitored in patients at risk of hyperkalaemia. It also contains sodium (1.61 g/500 ml) which may be harmful to patients on a low sodium diet. Interactions: Interactions common to all cytotoxics, which may also react with oral anticoagulants. Concomitant use of immunosuppressives such as cyclosporine and tacrolimus receive extra consideration due to excessive immunosuppression. Pregnancy and lactation: Savene® should not be administered to pregnant women unless clearly necessary. Women of childbearing potential should use contraceptive measures during treatment. Mothers should discontinue nursing during Savene® therapy.
Side-effects: Very common: nausea, injection site pain, postoperative infection. Common: vomiting, diarrhoea, stomatitis, dry mouth, pyrexia, injection site phlebitis, injection site erythema, fatigue, injection site induration, injection site swelling, peripheral oedema, somnolence, infection, neutropenic infection, wound complication, weight decrease, decreased appetite, myalgia, dizziness, sensory loss, syncope, tremor, vaginal haemorrhage, dyspnoea, pneumonia, alopecia, pruritus, phlebitis, superficial thrombophlebitis, limb venous thrombosis. All adverse reactions have been rapidly reversible. More rarely increased concentrations of liver enzymes (ALT/AST) have been reported. Refer to the SPC for additional information. MA: EU/1/06/350/001. Date of Preparation: July 2010. SpePharm Holding BV, Kingsfordweg 151, 1043 GR Amsterdam, The Netherlands