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: [email protected]
Date of preparation: May 2018
v1.0
SAV-103
www.clinigengroup.com