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Savene (dexrazoxane hydrochloride) – Package leaflet - V03AF02

Updated on site: 10-Oct-2017

Medication nameSavene
ATC CodeV03AF02
Substancedexrazoxane hydrochloride
ManufacturerClinigen Healthcare Ltd

Package leaflet: Information for the patient

Savene 20 mg/ml powder for concentrate and diluent for solution for infusion

Dexrazoxane

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-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 is in this leaflet

1.What Savene is and what it is used for

2.What you need to know before you use Savene

3.How to use Savene

4.Possible side effects

5 How to store Savene

6.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 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 extravasationin adults. It can reduce the amount of tissue damage caused by anthracycline extravasation.

2. 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 do not use adequate contraceptive measures

-If you are breast-feeding

-If you are given yellow-fever vaccine

Warnings and precautions

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.

Children and adolescents

Savene should not be administered to children below the age of 18 years.

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 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).

Pregnancy, breast-feeding and fertility

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.

Women who could become pregnant must use contraceptive measures during treatment (see section 2 ‘Do not use Savene’).

Men must take adequate contraceptive precautions during therapy and for at least three months after treatment.

Savene should not be administered if you are pregnant. You must not breast-feed while you are treated with Savene.

Driving and using machines

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.

Savene contains potassium and sodium.

The Savene diluent contains potassium (98 mg/500 ml) 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 also contains sodium (1.61 g/500 ml) which may be harmful to people on a low-sodium diet.

3.How to use Savene

Savene will be given to you under the control of a doctor experienced in the use of anticancer treatments.

Recommended dose

The dose will depend on your height and weight. Your doctor will calculate your body surface area in square meter (m2) to determine the dose you should receive. The recommended adult dose is:

Day 1: 1000 mg/m2

Day 2: 1000 mg/m2

Day 3: 500 mg/m2

Savene will be given by 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 after extravasation of an anthracycline medicine. Savene infusion will be given at the sametime 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

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.

4.Possible side effects

Like all medicines, Savene can cause side effects although not everybody gets them.

Some side effects can be serious and need immediate medical attention.

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

If you get any of the above symptoms, seek medical advice immediately.

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)

Reporting of side effects

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.

5.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 vial label, and diluent-bottle label after ‘EXP’. The expiry date refers to the last day of that month.

Store below 25 °C.

Keep the powder vials and diluent bottles in the outer carton in order to protect from light.

6. Contents of the pack and other information

What Savene contains

-The active substance is dexrazoxane. Each vial contains 500 mg dexrazoxane as 589 mg dexrazoxane hydrochloride.

-The other ingredient(s) are: The diluent which contains sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate, sodium gluconate, sodium hydroxide and water for injections.

What Savene looks like and contents of the emergency kit

The Savene kit consists of Savene powder for concentrate (white to off-white powder) and Savene diluent for solution for infusion. One emergency kit contains 10 vials of Savene powder and 3 bottles of Savene diluent

The concentration of dexrazoxane following reconstitution with 25 ml Savene diluent is 20 mg/ml. The concentrate is slightly yellow.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Clinigen Healthcare Ltd

Pitcairn House

Crown Square, First Avenue

Burton-on-Trent, Staffordshire

DE14 2WW

United Kingdom

Manufacturer

Norgine B.V.

Hogehilweg 7

1101 CA Amsterdam ZO

The Netherlands

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

The following information is intended for healthcare professionals only.

Preparation guide for use with Savene powder for concentrate and diluent for solution for infusion

It is important that you read the entire content of this procedure prior to the preparation of Savene.

1.FORMULATION

Savene is supplied as:

1.Savene powder

2.Savene diluent

Savene powder must be reconstituted in 25 ml Savene diluent to obtain a concentrate that must be further diluted in the remaining Savene diluent prior to administration.

2.RECOMMENDATION FOR THE SAFE HANDLING

Savene is an anti-cancer agent and the normal procedures for proper handling and disposal of anticancer 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

3.PREPARATION FOR THE INTRAVENOUS ADMINISTRATION

3.1Reconstitution of Savene powder to prepare a concentrate

3.1.1Using a syringe fitted with a needle, withdraw aseptically 25 ml from the Savene diluent bottle.

3.1.2Inject the entire contents of the syringe into the vial containing the Savene powder.

3.1.3Remove the syringe and needle and mix manually by repeated inversions until the powder is fully dissolved. Do not shake.

3.1.4Allow 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.

3.1.5Keep and store the opened diluent bottle under aseptic conditions because it is needed for dilution of the concentrate.

3.2Dilution of the concentrate

3.2.1Up 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.

3.2.2Inject the required volume back into the opened Savene diluent bottle (see point 3.1.5). The solution must not be mixed with any other medicines.

3.2.3Mix the solution by agitating gently the infusion bottle.

3.2.4Savene should be administered aseptically as a 1-2 hours infusion under room temperature and normal light conditions.

3.2.5As 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.

4.STORAGE

4.1Before reconstitution and dilution:

- Store below 25°C

- Keep the powder vials and diluent bottles in the outer carton in order to protect from light.

4.2After reconstitution and dilution:

-Chemical and physical in-use stability after reconstitution and subsequent dilution in the diluent 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.

5.DISPOSAL

All items for preparation, administration or cleaning, including gloves, as well as liquid waste should be disposed of in accordance with local requirements.

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