Betaferon

Drugs

Generic Name: Interferon beta-1b
Product Name: Betaferon

Indication of Betaferon
Action of Betaferon
Dose advice of Betaferon
Schedule of Betaferon
Common side effects of Betaferon
Uncommon side effects of Betaferon
Reference

Indication of Betaferon:

Betaferon (interferon-1b) is a specially modified preparation of interferon beta. This is a naturally occurring cytokine found in the body which has several immune functions. Betaferon is used to treat patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis (MS). MS is a chronic and disabling disease of the central nervous system (CNS) thought to be caused by the body's immune system attacking cells of the brain and spinal cord. This leads to demyelination (removal of the electrical conducting layer of nerve cells) and various neurological problems (such as visual disturbances, arm or leg weakness and bowel/bladder problems). If left untreated the disease can lead to severe impairments in mobility and disability. Betaferon is used to treat the relapsing form of MS where patients experience separated episodes of neurological symptoms with resolution in between attacks. If you have experienced more than two attacks of symptoms in the last two years you will be considered suitable for treatment with Betaferon. In addition, you must be ambulatory (be able to walk) to be suitable for this treatment. Betaferon reduces the frequency and severity of attacks and delays the overall progression of disability. Betaferon is also now used for the treatment of patients with secondary progressive multiple sclerosis. In this type of multiple sclerosis, patients have a progressive deterioration in signs and symptoms. In these patients, Betaferon has been shown to delay the progression of disease. In both types of disease, Betaferon reduces the number of lesions detected in the brain during brain scanning.

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Action of Betaferon:

The active component of Betaferon is a drug called Interferon beta-1a. This is synthesised form of a naturally occurring compound within the body. The interferon family is important in regulating the body's immune response to viruses, bugs and other noxious stimuli. When administered in patients with multiple sclerosis, Betaferon 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, although the precise mechanism of action is not entirely understood.

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Dose advice of Betaferon:

Before taking Betaferon you should tell your doctor:

If you are allergic to any medications, foods or dyes- Betaferon should not be used in patients allergic to this type of medication (interferon beta), albumin or any of the other components. Note that as the drug contains human albumin, there is a small risk of transmission of infection.
If you are pregnant or intend on becoming pregnant- Betaferon is not recommended in these circumstances due to the risk of miscarriage. All women of child-bearing age should take birth control during their treatment.
If you have any other medical conditions- In particular tell your doctor if you have depression, seizure disorders, heart or kidney disease, or bone marrow suppression as these can increase your risk of certain adverse effects. Betaferon has been associaeted with depression or suicidal thoughts so you should be wary of the early warning signs of these disorders. If you develop any symptoms of severe sadness, worthlessness or hopelessness during your treatment seek medical help immediately.
Any other medications you are taking (including those bought from supermarkets or the chemist)- Betaferon should not be used with other drugs that can affect the bone marrow (except steroids and ACTH).
Betaferon is not recommended for use in patients under 18 years of age due to the lack of experience in his age group.

Dose administration:Betaferon is intended for injection under the skin (subcutaneous) of the abdomen (except around navel and waistline), thighs (front and sides), buttocks and arms (upper, back section). Betaferon should always be commenced under the supervision of an experienced doctor but later you can be taught self-administration techniques. Injection sites need to be carefully rotated to avoid injections site reactions. Prior to administration, Betaferon needs to be carefully prepared. Detailed instructions will be provided in your drug pamphlet but the basic procedure involves mixing the active component (interferon beta-1b which comes as powder glass vials) with the solvent (0.54% sodium chloride solution in pre-filled syringes of 1.2mL). The final solution should be clear with no particulate matter and will contain 250 micrograms (8x10⁶ IU) of interferon beta-1b per mL. Each pack of Betaferon contains 15 of each of the vials and syringes ready for mixing. The dose should be administered immediately following mixing. The usual dose of Betaferon is 250 micrograms (8x10⁶ IU) every second day starting early following the diagnosis of multiple sclerosis. This dose is equivalent to one mL of the prepared solution. Betaferon should always be taken as prescribed by your doctor and treatment should usually continue for at least two years. During your treatment with Betaferon you will require regular monitoring of blood cell counts, platelet counts and liver function tests as Betaferon has been shown to disrupt these parameters in some patients. These tests allow your doctor to monitor your progress and avoid unnecessary side effects. In addition you should be careful drinking alcohol as there is a theoretical risk that this may increase the risk of liver damage.

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Schedule of Betaferon:

S4 (prescription required). Please refer to the PBS for authority indications.

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Common side effects of Betaferon:

Betaferon helps most people with MS but like all medications may have unwanted side effects in some people. The majority of these side effects are mild and temporary early in the course of treatment as the body gets used to the drug. Most occur 3-6 hours after administering the injection and may last for up to 24 hours. The most commonly reported side effects of Betaferon (occurring in greater than 2% of patients) include:

Injections site reactions- Redness, swelling, discolouration, inflammation, pain and necrosis can occur at the site of injection. These tend to be more frequent early in treatment and can be minimised by rotating injections sites, using non-sensitive areas, avoiding rubbing the injection site and applying ice to the area following injection.
Influenza-like symptoms such as muscle aches, chills and fever. These symptoms can be treated or avoided with paracetamol or ibuprofen at the time of injection.
Excess sweating and rash.
Headache.
Nausea.Constipation.Diarrhoea.
Abdominal pain.
Dizziness.Anxiety.
Depression.Anaemia.

In most patients however, Betaferon is well tolerated and side-effects are only minor. If you are having any side-effects that are worrying you or creating inconvenience, make sure you discuss them with your doctor.

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Uncommon side effects of Betaferon:

Like all medications, Betaferon has the potential to cause serious side-effects. Fortunately only a small number of patients (less than 1%) taking Betaferon will develop the more serious side-effects that may require changing medication or specific treatment. Some of the more serious side-effects of Betaferon include:Uncommon (less than 1/100 patients) but potentially serious side effects of Betaferon include:

Allergic reactions- If you develop difficulty breathing, rashes, swelling of the face, itchy skin or wheezing seek medical advice immediately.
Cardiovascular disorders- Palpitations, heart failure, hypertension and cardiomyopathies are rare side effects of interferon beta drugs. If you notice breathlessness, persistent cough, swelling in hands or feet, or palpitations (sensation of an irregular heartbeat) see your doctor.
Severe depression with thoughts of suicide- If you experience these see your doctor immediately.
Seizures.
Blood disorders- You may notice you become tired and your skin pale (anaemia) or you may develop signs of frequent infections such as fever and sore throat (due to neutropenia).
Necrosis or infection at the injection site.
Thyroid dysfunction.
Hepatitis- A small percentage of patients using Betaferon may develop severe liver damage.
Pancreatitis.

These lists provide information on the most serious and most common side effects which have been reported with Betaferon. However, these lists are not necessarily exhaustive as Betaferon can affect all patients differently and other side effects may occur that have not yet been identified. You should discuss all side effects with your doctor. However, do not be alarmed by these long lists as most patients taking Betaferon 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.

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Reference:

Australian Medicines Handbook- 16.7 Interferon Beta. AMH Pty Ltd. 2006.
Betaferon- Consumer Medicine Information, Schering Pty Limited, 2000. Available [online] at URL: http://www.appco.com.au/appguide/drug.asp?drug_id=00097277&t=cmi
MIMS online- Prescribing Information. Betaferon. MIMS Australia Pty Ltd 2003.
MS Australia- About MS - Treatment and management of MS - (Betaferon), Immunotherapy Program Coordinator 2003. Available [online] at URL: http://www.msaustralia.org.au/msinformation/betaferon.htm

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