Savene
dexrazoxane
Dexrazoxane
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or nurse.
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See Section 4.
What Savene is and what it is used for
What you need to know before you use Savene
How to use Savene
Possible side effects
5 How to store Savene
6. Contents of the pack and other information
Savene contains the active substance dexrazoxane, which acts as an antidote to anti-cancer medicines called anthracyclines.
Most anti-cancer medicines are administered intravenously (into a vein). Occasionally an accident occurs and the medicine is infused outside the vein and into the surrounding tissue or leaks from the vein into the surrounding tissue. This event is called extravasation. It is a serious complication as it can cause severe tissue damage.
Savene is used to treat anthracyline extravasation in adults. It can reduce the amount of tissue damage caused by anthracycline extravasation.
If you are allergic to dexrazoxane or any of the other ingredients of this medicine (listed in
section 6)
If you are planning to become pregnant and do not use adequate contraceptive measures
If you are breast-feeding
If you are given yellow-fever vaccine
Talk to your doctor or nurse before using Savene:
Savene should only be given to you if you have an extravasation in connection with anthracycline-containing chemotherapy.
During treatment with Savene the area where the extravasation has occurred will be examined
on a regular basis and you will have blood tests taken regularly to check your blood cells.
If you have liver problems, your doctor will monitor your liver function during treatment.
If you have kidney problems, your doctor will monitor for signs of changes to your blood cells.
Savene should not be administered to children below the age of 18 years.
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
In particular, tell your doctor or nurse if you are taking or may take any of the following medicines:
Vaccines: you must not use Savene if you are going to receive yellow fever vaccine and it is not recommended that you use Savene if you are going to receive a vaccine containing live virus
particles.
A product called DMSO (which is a cream to treat some skin diseases).
Phenytoin (a treatment against seizures) (Savene may reduce the effectiveness of this medicine).
Anticoagulants (blood thinners) (your blood may need to be monitored more frequently).
Ciclosporin or tacrolimus (both treatments lower the body's immune system and are used to prevent organ rejection after an organ transplant).
Myelosuppressive medicines (decrease production of red, white, or coagulating blood cells).
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor for advice before taking this medicine.
Savene should not be administered if you are pregnant.
You must not breast-feed while you are treated with Savene.
If you are sexually active, you are advised to use effective birth control to prevent pregnancy during and for six months after treatment, whether you are male or female (see section 2 ‘Do not use
Savene’).
There is limited information about the effect of Savene on fertility – if you have a concern about this speak to you doctor.
Dizziness, tiredness and sudden fainting have been reported in a few patients treated with Savene. The
treatment is considered to have a limited influence on the ability to drive and use machines.
The Savene solvent contains 98 mg potassium in each 500 ml bottle which may be harmful to people on a low-potassium diet or who have kidney problems. If you are at risk of high potassium levels in
your blood, your doctor will monitor this.
Savene solvent also contains 1.61 g sodium (main component of cooking/table salt) in each 500 ml bottle. This is equivalent to 81% of the recommended maximum daily dietary intake of sodium for an
adult.
Savene will be given to you under the control of a doctor experienced in the use of anti-cancer treatments.
The dose will depend on your height, weight and kidney function. Your doctor will calculate your body surface area in square meter (m2) to determine the dose you should receive. The recommended adult dose (with normal kidney function) is:
Day 1: 1000 mg/m2
Day 2: 1000 mg/m2
Day 3: 500 mg/m2
Your doctor may reduce your dose if you have kidney problems.
Savene will be given by infusion into one of your veins. The infusion will last 1-2 hours.
You will receive your infusion once daily for 3 consecutive days. The first infusion will be given as soon as possible and within the first six hours after extravasation of an anthracycline medicine. Savene
infusion will be given at the same time every day of your treatment.
Savene will not be used again at the time of your next anthracycline cycle, except if extravasation occurs again.
If you receive more Savene than you should, you will be closely monitored with specific attention to your blood cells, potential gastro-intestinal signs, skin reactions and hair loss.
If Savene comes into contact with the skin, the affected area should immediately be rinsed thoroughly with water.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following serious side effect has been reported in patients during treatment with Savene
(frequency not known):
Allergic reactions, symptoms of which could be itching (pruritis), rash, facial/throat swelling, wheezing, breathlessness or difficult breathing, changes in levels of consciousness, hypotension, sudden fainting
Other possible side effects are listed below:
Very common: may affect more than 1 in 10 people
Nausea
Reactions at the site of injection (pain at the site, red, swollen or painful skin at the site or hardening of the skin at the site)
Reduction in the number of white blood cells and platelets
Infection (after an operation or other infections)
Common: may affect up to 1 in 10 people
Vomiting
Diarrhoea
Feeling tired, feeling sleepy, feeling dizzy, sudden fainting
Reduction in any of your senses (sight, smell, hearing, touch, taste)
Fever
Inflammation of the blood vessel where the treatment is given (phlebitis)
Inflammation of a blood vessel just under the skin, often with a small blood clot
Blood clot in the vein, usually in an arm or leg
Inflammation in the mouth
Dry mouth
Hair loss
Itching (pruritus)
Weight loss, loss of appetite
Muscle pain, tremor (uncontrolled muscle movement)
Vaginal bleeding
Difficulties in breathing
Pneumonia (lung infection)
Swelling in arms or legs (oedema)
Wound complications
Changes in liver function (these may be seen in test results)
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, powder vial label, and solvent bottle label after ‘EXP’. The expiry date refers to the last day of that month.
Store below 25 °C.
Keep the powder vials and solvent bottles in the outer carton in order to protect from light.
The active substance is dexrazoxane. Each vial contains 500 mg dexrazoxane as 589 mg
dexrazoxane hydrochloride.
The other ingredient(s) are: The solvent which contains sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate, sodium gluconate, sodium
hydroxide and water for injections.
The Savene kit consists of Savene powder for concentrate (white to off-white powder) and Savene
solvent. One emergency kit contains 10 vials of Savene powder and 3 bottles of Savene solvent supplied with 3 bottle hangers.
The concentration of dexrazoxane following reconstitution with 25 ml Savene solvent is 20 mg/ml. The concentrate is slightly yellow.
Clinigen Healthcare B.V.
Schiphol Boulevard 359
WTC Schiphol Airport, D Tower 11th floor 1118BJ Schiphol
The Netherlands
Cenexi-Laboratoires Thissen SA
Rue de la Papyrée 2-4-6 B-1420 Braine-L’Alleud Belgium
The following information is intended for healthcare professionals only.
It is important that you read the entire content of this procedure prior to the preparation of Savene.
Savene is supplied as:
Savene powder for concentrate
Solvent for Savene
Savene powder must be reconstituted in 25 ml Savene solvent to obtain a concentrate that must be further diluted in the remaining Savene solvent prior to administration.
Savene is an anti-cancer agent and the normal procedures for proper handling and disposal of anti- cancer medicines should be adopted, namely:
Personnel should be trained to reconstitute the medicine
Pregnant staff should be excluded from working with this medicine
Personnel handling this medicine during reconstitution should wear protective clothing including mask, goggles and gloves
Accidental contact with the skin or eyes should be treated immediately and thoroughly with
copious amounts of water
Using a syringe fitted with a needle, withdraw aseptically 25 ml from the Savene solvent bottle.
Inject the entire contents of the syringe into the vial containing the Savene powder.
Remove the syringe and needle and mix manually by repeated inversions until the powder is fully dissolved. Do not shake.
Allow the vial with the concentrate to stand for 5 minutes at room temperature and check if the solution is homogenous and clear. The concentrate is slightly yellow.
The concentrate contains 20 mg dexrazoxane per ml and should be used immediately for further dilution. It contains no antibacterial preservative.
Keep and store the opened solvent bottle under aseptic conditions because it is needed for
dilution of the concentrate.
Up to four vials containing Savene concentrate may be necessary to obtain the required dose for
the patient. Based on the required dose for the patient expressed in mg, withdraw aseptically the corresponding volume containing 20 mg dexrazoxane per ml from the appropriate number of vials containing concentrate. Use a graduated syringe filled with a needle.
Inject the required volume back into the opened Savene solvent bottle (see point 3.1.5). The solution must not be mixed with any other medicines.
Mix the solution by agitating gently the infusion bottle.
Savene should be administered aseptically as a 1-2 hours infusion under room temperature and normal light conditions.
As with all parenteral products, Savene concentrate and infusion solution should be inspected visually for particulate matter and discoloration prior to administration. Solutions containing a
precipitate should be discarded.
Store below 25 °C.
Keep the powder vials and solvent bottles in the outer carton in order to protect from light.
Chemical and physical in-use stability after reconstitution and subsequent dilution in the solvent
has been demonstrated for 4 hours when stored at 2 to 8 °C.
In order to avoid the potential contamination of the medicine by microbes, the product should be used immediately.
If the medicine is not used immediately, it should be kept at a temperature of 2 to 8 °C (in the refrigerator) and no longer than 4 hours.
All items for preparation, administration or cleaning, including gloves, as well as liquid waste should be disposed of in accordance with local requirements.