20 mg/ml powder and liquid for concentrate for solution for infusion
dexrazoxane
What Savene is and what it is used for
Savene contains the active substance dexrazoxane, which is an antidote to cancer drugs called anthracyclines.
Most anti-cancer drugs are administered intravenously (into a vein). Sometimes an accident occurs and the drug ends up outside the vein and into the surrounding tissue or leaks from the vein into the surrounding tissue one. This event is called extravasation. It is a serious complication as it can cause severe tissue damage.
Savene is used to treat anthracycline extravasation in adults. It can reduce the tissue damage caused by anthracycline extravasation.
What you need to know before you use Savene
Do not use Savene
- 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 are not taking appropriate measures to prevent a pregnancy
- if you are breast-feeding
- if you are getting the yellow fever vaccine.
Warnings and cautions
Talk to your doctor or nurse before using Savene:
- Savene should only be given to you if you have had extravasation in connection with chemotherapy containing anthracycline.
- During treatment with Savene, the area where the extravasation has taken place is examined regularly and blood samples are taken from you 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 in your blood cells.
Children and young people
Savene should not be given to children under 18 years of age.
Other medicines and Savene
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 might be taking any of the following medicines:
- Vaccines: You should not use Savene if you will be vaccinated against yellow fever and it is not recommended that you use Savene if you will be vaccinated with live viruses.
- A product containing DMSO (a cream for certain skin diseases).
- Phenytoin (a medicine used to treat epilepsy ) (Savene may reduce the effect of this medicine).
- Anticoagulants (blood thinners) (your blood may need to be tested more often).
- Ciclosporin or tacrolimus (both inhibit the immune system and are used to prevent the rejection of transplanted organs).
- Myelosuppressive drugs (reduces the production of red, white, or coagulating blood cells ).
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, 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 to you if you are pregnant.
You must not breastfeed while you are being treated with Savene.
If you are sexually active, you should use effective contraception to prevent pregnancy during and up to six months after treatment, whether you are male or female (see section 2 “Do not use Savene”).
There is limited information on the effect of Savene on fertility – talk to your doctor if you have any questions about this.
Driving and using machines
Dizziness, tiredness, and sudden fainting have been reported in a few patients treated with Savene. The treatment is assumed to have a limited effect on the ability to drive and the ability to use machines.
Savene contains potassium and sodium
Savene liquid contains 98 mg of potassium in each 500 ml bottle, which can be harmful to people on a low potassium diet or having kidney problems. If you are at risk of getting high potassium levels in your blood, your doctor will monitor this.
Savene liquid also contains 1.61 g of sodium (the main component in salt for cooking/table salt) in each 500 ml bottle. This corresponds to 81% of the recommended maximum daily dietary intake of sodium for an adult.
How to use Savene
Savene will be given to you under the supervision of a doctor who has experience in the treatment of cancer.
Recommended dose
Dose one is determined based on your height, weight, and kidney function. Your doctor will calculate your body surface area in square meters (m2) to determine the dose you should receive. The recommended adult dose (for normal kidney function) is:
Day 1: 1000 mg / m 2
Day 2: 1000 mg / m 2
Day 3: 500 mg / m 2
Your doctor may reduce your dose if you have kidney problems.
Savene is given by infusion into one of the veins. Infusion one takes 1-2 hours.
Frequency of administration
You will receive an infusion once daily for 3 consecutive days. The first infusion is given as soon as possible and within the first six hours after the extravasation of an anthracycline drug.
The savene infusion will be given at the same time each day during your treatment.
Savene will not be given again on the next anthracycline cycle unless extravasation occurs again.
If you get more Savane than you should
If you receive more Savene than you should, you will be closely monitored for your blood cell counts, potential gastrointestinal effects, skin reactions, and hair loss.
If Savene comes in contact with skin, immediately rinse the affected area thoroughly with water.
If you have any further questions on the use of this product, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious and need to be treated immediately.
The following serious adverse reactions have been reported in patients treated with Savene (frequency not known):
- Allergic reactions, symptoms such as itching, rash, swelling of the face or throat, wheezing, shortness of breath or difficulty breathing, changes in the level of consciousness, low blood pressure, sudden fainting
If you get any of the above symptoms, you should see a doctor immediately.
Other possible side effects are listed below:
Very common: may affect more than 1 in 10 people
- Nausea
- Injection site reactions (injection site pain, red, swollen, or painful skin at the injection site, or hardening of the skin at the injection site)
- Decreased number of white blood cells and platelets
- Infection (after an operation or other infection )
Common: may affect up to 1 in 10 people
- Vomiting
- Diarrhea
- Fatigue, drowsiness, dizziness, sudden fainting
- Impairment of sight, smell, hearing, touch, or 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 a leg
- Inflammation of the mouth
- Dry mouth
- Hair loss
- Itching
- Weight loss decreased appetite
- Muscle pain, tremor (uncontrolled muscle movement)
- Vaginal bleeding
- Breathing difficulties
- Pneumonia ( pneumonia )
- Swollen arms or legs ( edema )
- Wound complications
- Altered liver function (can be seen in test results)
How to store Savene
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 bottle label, and label on the liquid bottle after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Store the powder bottles and the bottles with liquid in the outer carton. Sensitive to light.
Contents of the packaging and other information
Content declaration
- The active substance is dexrazoxane. Each vial contains 500 mg of dexrazoxane as 589 mg of dexrazoxane hydrochloride.
- The other ingredients are The liquid which contains sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate, sodium gluconate, sodium hydroxide, and water for injection.
What the medicine looks like and the contents of the pack
Savene preparation kit consists of Savene powder for concentrate (white to off-white powder) and Savene liquid. An emergency kit formulation contains 10 vials of Savene powder and 3 vials of Savene liquid together with 3 bottle hangers.
The concentration of dexrazoxane after reconstitution with 25 ml of Savene liquid is 20 mg/ml. The concentrate is pale yellow.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Clinigen Healthcare BV
Schiphol Boulevard 359
WTC Schiphol Airport, D Tower 11th floor
1118BJ Schiphol
Netherlands
Manufacturer:
Cenexi-Laboratoires Thissen SA
Rue de la Papyrée2-4-6
B-1420 Braine-L’Alleud
Belgium