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Rebif

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Generic Name: Interferon beta-1a
Product Name: Rebif

Indication

Rebif belongs to a class of medications called interferons. It is used to treat patients with relapsing or remitting forms of multiple sclerosis (MS). This a chronic and disabling disease of the central nervous system thought to be caused by the body’s immune system attacking cells of the brain and spinal cord and leading to demyelination (removal of the electrical conducting layer of nerve cells). It can have various affects on vision, sensation, speech, mood and muscular strength. If left untreated the disease can lead to severe impairments in mobility. Rebif is used only to treat the relapsing form where patients have transient attacks of symptoms. Generally if you experience more than two attacks per year you will be considered for this medication. Rebif has been proven effective in reducing the frequency of attacks and delaying the progression of disability. Several clinical trials and experience with the drug in other countries have also confirmed its safety along with its efficacy.

Action

The active component of Rebif is a drug called Interferon beta-1a. This is synthesized using Chinese hamster ovary cells. Interferons are types of cytokines that are usually present in your body and act to regulate the body’s immune response to viruses, bugs and other noxious stimuli. When administered in patients with multiple sclerosis, Rebif is thought to thought to regulate the body’s immune response to prevent it from attacking its own nerve cells. The drug does this by binding to specific receptors and changing the amounts of certain substances produced.

Dose advice

Rebif comes as a clear, preservative-free solution packaged in pre-filled syringes, connected to a needle, ready for use. Each pre-filled syringe contains 0.5mL of solution. Rebif comes as a single strength of 44 micrograms (12×106 units) of Interferon beta-1a. Packs of 1, 3 or 12 pre-filled syringes have been marketed but only the latter is currently available in Australia.Rebif is intended for self-administration by subcutaneous injection which refers to injection beneath the skin. You will need to have a doctor or nurse instruct you on how to administer the medication. The drug can be injected into sites where there is sufficient ‘flabby’ skin. The back of the arms, stomach (except around the naval or waist line), buttocks or fronts or sides of the thighs are suitable sites for injection. You should rotate your injection site each time you administer the medication to avoid injury to the tissues. In addition, you should not inject at any sites where you notice lumps, firm knots, depressions, pain or discolouration. Before you inject the chilled syringe, you should wait until it reaches room temperature. Each syringe is intended for single use only and any unused portions should be discarded. Careful and safe disposal of needles should be practised. Rebif should be prescribed by a doctor with experience and expertise in treating multiple sclerosis. They will decide if this medication and its dose (44 micrograms) is suitable for you. Rebif should be administered three times per week, preferably on the same three days each week (for example Monday, Wednesday, Friday). There needs to be at least 48 hours between each week’s doses. The best time to administer the drug is late afternoon or early evening. When you are first started on the medication it is common for your doctor to slowly titrate up your dose over several weeks to minimise side effects. Your doctor will explain this process in detail to you. The best duration of treatment for Rebif is not known. The studies of the drug to date have only examined the effects of treatment for up to four years. Therefore it is important you are reviewed regularly by your doctor, at least every two years to monitor the effects of the medication. In addition, regular checks of your blood cell counts, liver function tests and thyroid function tests will be performed. These are performed at 1, 3 and 6 months following commencement of the medication also. After four years your doctor will decide if it is worthwhile continuing the treatment. You should always use Rebif as prescribed by your doctor as they will know what is best for you personally. Do not stop using Rebif or change the dose without consulting your doctor.

Rebif should not be used in the following circumstances:

  • You are pregnant or intend to become pregnant in the near future. Rebif and similar drugs have been shown to cause increased rates of miscarriage in animal studies.
  • You have a known hypersensitivity or allergy to interferon beta, albumin, or any other inactive ingredients (mannitol, sodium acetate, acetic acid and/or sodium hydroxide).
  • You are depressed or are having thoughts of suicide as this class of drugs can increase your risk of these disorders. Likewise if you develop any symptoms of severe sadness, worthlessness or hopelessness during your treatment seek medical help immediately.
  • You have epilepsy or other fitting disorders not adequately controlled by treatment.
  • Rebif is not recommended for use in patients under 16 years of age as there is insufficient evidence of its safety and efficacy in this age group.

Schedule

S4 (prescription required)

Common side effects

Common reported side effects of Rebif include:


  • Reactions at the injection site such as redness, swelling bruising, pain or itching.
  • Flu-like symptoms including fever, chills, and muscular pain may affect nearly a third of patients. These may be relieved if paracetamol is taken just before injecting the medication.
  • Abdominal pain
  • Diarrhoea and nausea.
  • Muscle pain and aches, back pain or painful joints.

The above listed side-effects occur in approximately 1/10 to 1/100 patients. However, the majority of patients will tolerate Rebif well and the side-effects experienced will only be minor and self-limiting. Most side-effects tend to decrease over time as the body gets used to the medication. If you are having any side-effects that are worrying you or creating inconvenience discuss them with your doctor.

Uncommon side effects

Like all medications, Rebif has the potential to cause serious side-effects. Fortunately only a very small number of patients taking Rebif will develop the more nasty and serious side-effects which may warrant changing medication or in some cases pose significant risks to the patient’s health and well-being. In most circumstances these side-effects can be treated without any long-term complications. Some of the more serious side-effects of Rebif are discussed below.Very rarely patients can develop an allergic reaction to the drug that can cause difficulty breathing, rashes, swelling of the face, itchy skin, wheezing and other symptoms. Only an isolated number of such cases have been reported in the large numbers of patients who have been treated with this drug. Some patients can develop severe reactions at injection sites causing necrosis (death) of the tissues and infection. (One study showed this occured in 2 out of 560 patients). As previously mentioned, Rebif can also cause damage to your liver, thyroid and other organs such as your heart (occasionally leading to palpitations and heart failure). In a large study of 560 patients, 4 people developed depression with thoughts of suicide whilst taking Rebif, a potentially fatal complication. You should see your doctor immediately if you develop any of the following symptoms (or any other side-effects that are concerning you):

  • Infection at the injection site which will appear as a red, swollen and painful area that may have a discharge.
  • Low mood or difficulties sleeping.
  • Anxiety/nervousness.
  • Thoughts about death or suicide.
  • Fits/convulsions.
  • Yellowing of the skin (jaundice).
  • Severe allergic reaction.
  • Combination of symptoms such as rapid heart beat or palpitations, insomnia, weight loss or weight gain, hair loss, tremor, neck lumps, irritability, abnormal menstrual cycles. These clusters of symptoms may suggest that your thyroid gland is not working properly.

Note that this is not an exhaustive list of all the possible side-effects of Rebif. Every patient is different and you may find that Rebif causes different symptoms for yourself. If you experience any side-effects you can discuss these with your doctor and they may consider changing your dose or trying a completely different medication. On the other token, don’t be alarmed by the long list of side-effects as most patients do not experience any side-effects at all. It is important for you to weigh up the risks and benefits of the drug (with the advice of your doctor) in your individual case to decide if this drug is suited for you.

References

  1. Australian Medicines Handbook- 16.7 Interferon Beta. AMH Pty Ltd. 2006.
  2. MIMS online- Prescribing Information. Rebif. MIMS Australia Pty Ltd 2003.
  3. Rebif (R) (Interferon beta-1a)- Product Information 2005. Available from: [PDF File]
  4. Rebif (R)-Interferon beta-1a (rch)- Consumer Medicine Information 2005.

For further information talk to your doctor.


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Dates

Posted On: 22 July, 2003
Modified On: 31 October, 2015
Reviewed On: 28 September, 2006

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Created by: myVMC