HHE Haematology supplement 2018 - Page 2

Discover the antidote to anthracycline extravasation in adults • Highly effective in reducing tissue damage 1 • Eliminated the need for surgery in 98% of patients 1 • Allows for the majority of patients to continue their next scheduled dose of cancer therapy on time 1,2 • Easy to use anthracycline extravasation emergency kit The ONLY licensed anthracycline extravasation antidote 3 1 IDENTIFY Know how to recognise and respond to an anthracycline extravasation 2 TREAT Savene ® Administer as indicated within 6 hours of the extravasation 3 3 RESUME Treatment can continue once extravasation symptoms are relieved 1,2 References 1. Mouridsen HT et al. Ann Oncol 2007;18(3):546-50 2. Fontaine C et al. Support Care Cancer 2012;20(5):1109-12 3. Savene ® Summary of Product Characteristics. Available at www.medicines.org.uk - accessed May 2018 PRESCRIBING INFORMATION Savene 20 mg/ml powder for concentrate and diluent for solution for infusion Please refer to Summary of Product Characteristics (SmPC) before prescribing. Active Ingredient: vial contains 500 mg dexrazoxane, each ml contains 20 mg of dexrazoxane after reconstitution with 25 ml of diluent. Presentation: Each kit contains 10 vials of Savene Powder and 3 bottles of Savene Diluent (500 ml each) and 3 bottle hangers. Indication: Treatment of anthracycline extravasation in adults. Posology and Method of Administration: Administration should begin as soon as possible and within 6 hours after the accident. Savene should be given as an intravenous infusion over 1-2 hours once daily for 3 consecutive days according to body surface area: day one, 1000 mg/m 2 ; day two, 1000 mg/m 2 ; day three, 500 mg/m 2 . For patients with a body surface area of more than 2 m 2 the single dose should not exceed 2000 mg. Treatment Day 2 and Day 3 should start at the same hour ± 3 hours as Day 1. In patients with moderate to severe renal impairment (creatinine clearance <40 mL/min) the Savene dose should be reduced by 50%. Cooling procedures should have been removed from the affected area at least 15 min before administration. Before infusion, Savene Powder must be reconstituted and diluted with Savene Diluent. Warnings and Precautions: Local examination should be performed on a regular basis after treatment until resolution and haematological monitoring should be undertaken regularly. 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. Previous history of allergy to dexrazoxane should be carefully considered prior to administration. 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 (1.16 g/500 ml) which may be harmful to patients on a low sodium diet. Contraindications: Hypersensitivity to the active ingredient or to any of the excipients, women of childbearing potential not using contraceptive measures, breast-feeding or concomitant vaccination with yellow fever vaccine. Undesirable Effects: (Consult the SmPC for further details about adverse reactions). Potentially serious adverse reactions include anaphylactic reactions. The most common adverse reactions are postoperative infection, infection, neutropenic infection, decreased appetite, dizziness, sensory loss, syncope, tremor, phlebitis, superficial thrombophlebitis, limb venous thrombosis, dyspnea, pneumonia, nausea, vomiting, diarrhoea, stomatitis, dry mouth, alopecia, pruritus, myalgia, vaginal haemorrhage, injection site pain, pyrexia, injection site phlebitis, injection site erythema, fatigue, injection site induration, injection site swelling, peripheral oedema, somnolence, decreased weight, wound complication. Neutropenia, thrombocytopenia, hyponatraemia, hypocalcaemia and increased concentrations of liver enzymes (ALT/AST) have been reported as common laboratory findings. Interactions: Patients treated with anticoagulants should be monitored more frequently as cytotoxic agents may interact with oral anticoagulants. Concomitant use of immunosuppressives such as ciclosporin and tacrolimus receive extra consideration due to excessive immunosuppression. Savene is not recommended in combination with live attenuated vaccines or with phenytoin and is contraindicated with yellow fever vaccine. Dimethyl sulfoxide (DMSO) should not be used in patients who are administered Savene. Savene may add to the toxicity of the chemotherapy cycle therefore haematological monitoring is necessary. Pregnancy and Lactation: Savene should not be administered to pregnant women unless clearly necessary. Women of childbearing potential should use contraceptive measures during treatment. Breast-feeding is contraindicated. Men are advised not to father a child during and up to 3 months after treatment. Basic NHS Price: £6,750. Legal Category: POM. Marketing Authorisation Number: EU/1/06/350/001. Marketing Authorisation Holder: Clinigen Healthcare Ltd, Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW, United Kingdom Date of Preparation: 17 January 2018 Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Clinigen Healthcare Ltd. (address as above) Tel: +44 (0) 1283 494 340; email: PatientSafety@clinigengroup.com Date of preparation: May 2018 v2.0 SAV-103b www.clinigengroup.com