Savene 20 mg/ml powder and solvent for concentrate for infusion solution
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Savene 20 mg/ml powder and solvent for concentrate for solution for infusion
Dexrazoxane
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or nurse.
- If you experience any adverse effects, consult your doctor or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Savene is and what it is used for
- What you need to know before using Savene
- How to use Savene
- Possible side effects
- How to store Savene
- Contents of the pack and other information
1. What Savene is and what it is used for
Savene contains the active substance dexrazoxane, which acts as an antidote to anticancer medicines known as anthracyclines.
Most anticancer medicines are administered intravenously (into a vein). Sometimes an accident occurs and the medicine is infused outside the vein into the surrounding tissue, or leaks out of the vein into the surrounding tissue. This event is called extravasation. It is a serious complication because it can cause severe tissue damage.
Savene is used to treat anthracycline extravasation in adults.
It can reduce the amount of tissue damage caused by anthracycline extravasation.
2. What you need to know before using Savene
Do not use Savene:
- If you are allergic to dexrazoxane or to any of the other components of this medicine (listed in section 6).
- If you are planning to become pregnant and are not using adequate contraceptive measures.
- If you are breastfeeding your baby.
- If you are receiving the yellow fever vaccine.
Warnings and precautions
Talk to your doctor or nurse before starting to use Savene:
- Savene should only be administered to you if you have experienced an extravasation during chemotherapy with anthracyclines.
- During treatment with Savene, the area where the extravasation occurred will be regularly examined, and you will have regular blood tests to monitor 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 any signs of changes in your blood cells.
Children and adolescents
Savene must not be given to children under 18 years of age.
Use of Savene with other medicines
Inform your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines.
In particular, inform your doctor or nurse if you are taking or might take any of the following medicines:
- Vaccines: you must not use Savene if you are due to receive the yellow fever vaccine, and it is not recommended to use Savene if you are due to receive a vaccine containing live virus particles.
- A product called DMSO (a cream used to treat certain skin conditions).
- Phenytoin (a treatment for seizures) (Savene may reduce the effectiveness of this medicine).
- Anticoagulants (medicines that thin the blood) (you may need to be monitored more frequently).
- Cyclosporine or tacrolimus (both are treatments that suppress the body’s immune system and are used to prevent organ rejection after organ transplantation).
- Myelosuppressive medicines (medicines that reduce the production of red blood cells, white blood cells, or platelets).
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
Savene must not be administered if you are pregnant.
Breastfeeding must not be undertaken while undergoing treatment with Savene.
If you are sexually active, you are advised to use an effective method of contraception to prevent pregnancy during treatment and for 6 months after treatment, whether you are male or female (see section 2 “Do not use Savene”).
Information on the effect of Savene on fertility is limited. If you have any concerns about this, speak with your doctor.
Driving and using machines
Dizziness, fatigue, 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.
Savene contains potassium and sodium
The Savene solvent contains 98 mg of potassium per 500 ml vial, which may be harmful for people on a low-potassium diet or those with kidney problems. If you are at risk of having high levels of potassium in your blood, your doctor will monitor your levels.
The Savene solvent also contains 1.61 g of sodium (a main component of table/cooking salt) per 500 ml vial. This corresponds to 81% of the maximum daily recommended dietary intake of sodium for an adult.
3. How to use Savene
Savene will be administered under the supervision of a physician experienced in the use of cancer treatments.
Recommended dose
The dose will depend on height, weight, and renal function. Your doctor will calculate your body surface area in square meters (m²) to determine the dose you should receive. The recommended dose in adults (with normal renal function) is:
Day 1: 1,000 mg/m²
Day 2: 1,000 mg/m²
Day 3: 500 mg/m²
Your doctor may reduce the dose if you have renal problems.
Savene will be administered by intravenous infusion into one of your veins. The infusion will last 1–2 hours.
Frequency of administration
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 following anthracycline extravasation. The Savene infusion will be administered at the same time each day during treatment.
Savene will not be used again during the next anthracycline cycle unless another extravasation occurs.
If you receive more Savene than you should
If you receive more Savene than you should, you will be closely monitored, with special attention to your blood cells, possible gastrointestinal signs, skin reactions, and hair loss.
If Savene comes into contact with the skin, the affected area should immediately be thoroughly rinsed with water.
If you have any further questions about the use of this medicine, ask your doctor or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Some adverse effects may be serious and require immediate medical attention.
The following serious side effects have been reported in patients receiving Savene (frequency unknown):
- Allergic reactions, with symptoms such as itching (pruritus), rash, swelling of the face/throat, wheezing, shortness of breath or difficulty breathing, changes in consciousness levels, hypotension, sudden fainting
If you experience any of the above symptoms, seek immediate medical attention.
The following are other possible side effects:
Very common: may affect more than 1 in 10 people
- Nausea
- Reactions at the injection site (pain, redness, swelling or pain in the skin area, or hardening of the skin at the site)
- Reduction in the number of white blood cells and platelets
- Infection (following surgery or other infections)
Common: may affect up to 1 in 10 people
- Vomiting
- Diarrhea
- Feeling tired, drowsy, dizzy, sudden fainting
- Reduction in any of the senses (vision, smell, hearing, touch, taste)
- Fever
- Inflammation of the blood vessel where the treatment is administered (phlebitis)
- Inflammation of the vein just under the skin, often associated with a small blood clot
- Blood clot in a vein, usually in an arm or leg
- Inflammation of the mouth
- Dry mouth
- Hair loss
- Itching (pruritus)
- Weight loss, decreased appetite
- Muscle pain, tremors (involuntary muscle movements)
- Vaginal bleeding
- Breathing difficulties
- Pneumonia (lung infection)
- Swelling of the arms or legs (edema)
- Wound complications
- Changes in liver function (which may be seen in blood test results)
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Conservation of Savene
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, the label of the powder vial, and the label of the solvent bottle after "EXP". The expiry date refers to the last day of the month indicated.
Store below 25 °C.
Keep the powder vials and solvent bottles in the outer packaging to protect from light.
6. Package contents and other information
Composition of Savene
- The active substance is dexrazoxane. Each vial contains 500 mg of dexrazoxane as 589 mg of dexrazoxane hydrochloride.
- The other components are: the solvent containing sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate, sodium gluconate, sodium hydroxide, and water for injections.
Appearance of Savene and contents of the emergency kit
The Savene emergency kit consists of Savene powder for concentrate (white to off-white powder) and Savene solvent. An emergency kit contains 10 vials of Savene powder and 3 bottles of Savene solvent supplied with 3 bottle hangers.
The concentration of dexrazoxane after reconstitution with 25 ml of Savene solvent is 20 mg/ml. The concentrate is slightly yellow.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Clinigen Healthcare B.V.
Schiphol Boulevard 359
WTC Schiphol Airport, D Tower 11th floor
1118BJ Schiphol
The Netherlands
Manufacturer
Cenexi-Laboratoires Thissen SA
Rue de la Papyrée 2-4-6
B-1420 Braine-L’Alleud
Belgium
Date of the most recent review of this summary: 07/2018
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
This information is intended for healthcare professionals only.
Preparation guide for use with Savene 20 mg/ml powder and solvent for concentrate for infusion solution
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It is important that you carefully read all steps of this procedure before preparing Savene.
- FORMULATION
Savene is supplied as follows:
- Savene powder for concentrate
- Solvent for Savene
Savene powder must be reconstituted with 25 ml of Savene solvent to obtain a concentrate, which must then be further diluted in the remaining Savene solvent before administration.
- RECOMMENDATIONS FOR SAFE HANDLING
Savene is an antineoplastic agent; therefore, standard procedures for safe handling and proper disposal of antineoplastic agents must be followed:
- Personnel must be trained in the reconstitution of the medication.
- Pregnant women should not handle this medication.
- Personnel handling this medication during reconstitution must wear protective clothing, including mask, goggles, and gloves.
- Accidental contact with skin or eyes must be immediately rinsed with copious amounts of water.
- PREPARATION FOR INTRAVENOUS ADMINISTRATION
3.1 Reconstitution of Savene powder to prepare a concentrate
3.1.1 Using a syringe with an attached needle, aseptically withdraw 25 ml from the Savene solvent bottle.
3.1.2 Inject the entire contents of the syringe into the vial containing Savene powder.
3.1.3 Remove the syringe and needle and mix manually by inverting repeatedly until the powder is completely dissolved. Do not shake.
3.1.4 Allow the vial with the concentrate to stand for 5 minutes at room temperature, then check that the solution is homogeneous and clear. The concentrate is slightly yellow.
The concentrate contains 20 mg of dexrazoxane per ml and must be used immediately for further dilution. It contains no antibacterial preservatives.
- Keep the opened solvent bottle under aseptic conditions, as it is required for dilution of the concentrate.
3.2 Dilution of the concentrate
3.2.1 Up to four vials of Savene concentrate may be needed to achieve the required patient dose. Aseptically withdraw the required volume containing 20 mg of dexrazoxane per ml from the appropriate number of concentrate vials, based on the required dose expressed in mg. Use a graduated syringe equipped with a needle.
3.2.2 Re-inject the required reconstituted volume into the opened Savene solvent bottle (see section 3.1.5). The solution must not be mixed with any other medication.
3.2.3 Mix the solution by gently agitating the infusion bottle.
3.2.4 Savene must be administered aseptically as a 1–2 hour infusion at room temperature and under normal light conditions.
3.2.5 As with all parenteral products, the Savene concentrate and the infusion solution should be inspected visually prior to use to ensure there are no particles or discoloration. Any solution in which precipitate is observed should be discarded.
- STORAGE
4.1 Before reconstitution and dilution:
- Store below 25°C.
- Keep powder vials and solvent bottles in the outer packaging to protect from light.
4.2 After reconstitution and dilution:
- Chemical and physical in-use stability has been demonstrated for 4 hours when stored between 2 and 8°C after reconstitution and subsequent dilution in solvent.
- To avoid possible microbial contamination, the product should be used immediately.
- If not used immediately, the product should normally be stored at 2 to 8°C (in the refrigerator) for no longer than 4 hours.
- DISPOSAL
All materials used for preparation, administration, or cleaning, including gloves, as well as any leftover liquid, must be disposed of in accordance with local regulations.