What is it and how is it used?
Rebif belongs to a class of medicines known as interferons. These are natural substances that transmit messages between cells. Interferons are produced by the body and play an essential role in the immune system. Through mechanisms that are not totally understood, interferons help to limit the damage of the central nervous system associated with multiple sclerosis.
Rebif is a highly purified soluble protein that is similar to the natural interferon beta that is produced in the human body.
Rebifis used for the treatment of multiple sclerosis. It has been shown to reduce the number and the severity of relapses and to slow the progression of disability.
What do you have to consider before using it?
Do not use Rebif
Take special care with Rebif
Using other medicines
Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
In particular you should tell your doctor if you are using antiepileptics or antidepressants.
Pregnancy and breast-feeding
You must not start treatment with Rebif if you are pregnant. While taking Rebif, you must use effective methods of contraception if you are a woman of child-bearing potential. If you become pregnant or plan to become pregnant while using Rebif ask your doctor for advice.
Prior to taking the medicine, please inform your doctor if you are breast-feeding. The use of Rebif is not recommended if you are breast-feeding.
Driving and using machines
Effects of the disease itself or of its treatment might influence your ability to drive or to use machines. You should discuss this with your doctor if you are concerned.
Important information about some of the ingredients of Rebif
This medicinal product contains 2.5 mg benzyl alcohol per dose.
Must not be given to premature babies or neonates.
May cause toxic reactions and allergic reactions in infants and children up to 3 years old.
How is it used?
Always use Rebif exactly as your doctor has told you. You should check with your doctor if you are not sure.
Dose
The usual dose is 44 micrograms (12 million IU) given three times per week for adults and adolescents from 16 years of age. A lower dose of 22 micrograms (6 million IU) given three times per week is recommended for:
- patients who cannot tolerate the higher dose.
- adolescents from the age of 12 years.
Rebif should be administered, if possible:
- three times per week
- on the same three days (at least 48 hours apart)
- at the same time (preferably in the evening).
Method of administration
Rebif is intended for subcutaneous (under the skin) injection.
The first injection(s) must be performed under the supervision of an appropriately qualified healthcare professional. After receiving adequate training, you, a family member, friend or carer can use Rebif pre-filled pen to administer the medicine at home.
For instructions for handling of Rebif in pre-filled pen, please read the separate RebiDose user guide enclosed in the box.
This medicinal product is for single use.
Only clear to opalescent solution without particles and without visible signs of deterioration should be used.
If you use more Rebif than you should
In case of overdose, contact your doctor immediately.
If you forget to use Rebif
If you miss a dose, continue to inject from the day of the next scheduled dose. Do not take a double dose to make up for a forgotten dose.
If you stop using Rebif
The effects of Rebif may not be noticed immediately. Therefore you should not stop using Rebif but continue to use it regularly to achieve the desired result. If you are uncertain about the benefits, please consult your doctor.
You should not discontinue the treatment without first contacting your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
What are possible side effects?
Like all medicines, Rebif can cause side effects, although not everybody gets them.
Tell your doctor immediately and stop using Rebif if you experience any of the following serious side effects:
Other possible side effects include:
Very common:
- Headache
You should not stop or alter the medication without your doctor’s advice.
If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
How should it be stored?
Keep out of the reach and sight of children.
Do not use Rebif after the expiry date which is stated on the label after EXP.
Store in a refrigerator (2°C – 8°C).
Do not freeze. (To prevent accidental freezing, avoid placing near the freezer compartment).
For the purpose of ambulatory use, you may remove Rebif from the refrigerator and store it not above 25°C for one single period of up to 14 days. Rebif must then be returned to the refrigerator and used before the expiry date.
Store in the original package in order to protect from light.
Do not use Rebif if you notice any visible signs of deterioration such as if the solution is no longer clear or if it contains particles.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
