Find out if REBIF (Interferon Beta-1a) is your best option

WHAT EXACTLY IS REBIF?

This drug is essentially interferon beta-1a which is identical to the body's own natural human interferon beta. It is believed that it fights multiple sclerosis (MS) by:

• Regulating immune cells outside the Central Nervous System (CNS)
• Stopping immune cells from crossing the Brain Blood Barrier (BBB)
• Reducing inflammation in the Central Nervous System (CNS)

Today, there is a new and improved formulation of the drug. Before the New Formulation (RNF), Rebif was basically the same as Avonex (also Interferon beta-1a), but at a higher dose.

The New Formulation is the first and only therapy for multiple sclerosis (MS) that is serum-free both from animal (foetal bovine serum) and human (human serum albumin) derived components in either the manufacturing process or as excipients.

This medication has been shown to be slightly more effective than Avonex at preventing relapses. However, a big difference is that is given three times a week (as opposed to Avonex's once-a-week dosing).

A frequent complain has to do with

• more skin reactions to the injections (85% compared to 33% Avonex)
• more liver disorders (18% vs. 10% Avonex)
• and white blood cell disorders (13.6% vs. 5.3% Avonex).

However, people experience fewer

• flu-like symptoms over time than Avonex (45% vs. 53% Avonex)
• and they seem to last for a shorter period after dosing.

Neurologists usually prescribe it to treat Remitting and Relapsing MS (RRMS). Just like all the other drugs that are out there and are being used to treat RRMS - Copaxone, Avonex or Betaferon - Rebif has been shown to decreased relapses by 33% in initial trial of patients with mild to moderate RRMS.

THE HISTORY BEHIND IT

This is quite interesting: In 1996, Avonex was granted 7-year market exclusivity under the terms of the Orphan Drug Act (until May 2003). In order to market Rebif before that expired, it had to be shown that it had superior efficacy or was safer than Avonex.

In a head-to-head study, Rebif was shown to work better than Avonex in reducing the frequency of relapses, and was granted the first exception in history to the exclusivity rule of the Orphan Drug Act by the Food and Drug Administration (FDA).

SOME NECESSARY PRECAUTIONS YOU NEED TO REMEMBER WHEN TAKING REBIF

You need to do blood tests every three months during the first year to check white blood cell count and liver function. After 12 months, blood work can be reduced to once every four months. Folks with known thyroid problems should be monitored every six months for thyroid dysfunction.

WHAT ARE PATIENTS SAYING ABOUT THIS TREATMENT OPTION?

You should know that patients – just like me - love the fact that Rebif needles are the tiniest of all (0.5 inch 29 gauge needle) and injections are subcutaneous (injected into the fat right under the skin), meaning the needle is easily inserted.

A not-so-cool fact is that injections can be more painful than others, due to a lower pH of 3.8 of Rebif (which makes it acidic).

The drug is the most convenient of all to travel with, as it can be unrefrigerated, and requires no mixing (it comes in prefilled syringes). However, it is the most expensive medicine of what some of us have come to know as the CRAB (Copaxone, Rebif, Avonex and Betaseron) drugs.

Another advantage is that it comes in prefilled syringes. An automatic injection device (Rebiject II) is provided for patients who prefer to use it (I love mine) although can also be injected without the device (did it once ok but made me love more my Rebiject II)

THE MOST FREQUENT SIDE EFFECTS ARE:

The main side effects are similar to those of the other interferon-based therapies (with the exception of Avonex which doesn't cause as many injection-site reactions).

1. Flu-Like Symptoms

About 69% of all MSers using Rebif experienced flu-like symptoms. These symptoms include: fever, chills, sweating, muscle aches and fatigue (but not nausea or stomach upset), and they can last for 8 or more hours.

This side effect is usually the worst after the first injection and gradually lessens with each injection, so that most people do experience it (or it is tolerable) after six months - it can also be reduced by starting with a low dose – Rebif comes in 22 and 44 mgc prefilled syringes - and increasing to a full dose gradually (over several weeks) but only do this under your doctor’ instructions.

It is highly recommended taking ibuprofen or acetaminophen a couple hours before and after to help you with some of these side effects.

2. Red Spots

Are the result of skin reactions usually occurring at the site of injections (in 71% of patients), which may last several weeks. These can break down into sores (injection-site necrosis) in 5% of all cases.

3. Liver Damage

Hepatic injury including elevated serum hepatic enzyme levels and hepatitis has been reported. Regular monitoring is required to prevent such damage from occurring or progressing. If you notice that you begin bruising easily or that your skin or the whites of your eyes begins to look yellow, call your doctor immediately.

4. Blood Counts

A decrease in the numbers of red and white blood cells, as well as a reduction in the number of platelets in the blood is a possible side effect when using rebif.

5. Depression

Caution should be used in patients with depression.

6. Allergic Reactions

Are very rare but some folk have experienced difficulty breathing and loss of consciousness after the first dose or after several doses

7. Thyroid Abnormalities

If you have any thyroid dysfunction, you should alert your doctor before taking this drug. Your doctor will order the necessary test to be monitored for thyroid function every six months while on the medication.

OTHER IMPORTANT INFORMATION YOU SHOULD KNOW

Refrigeration is recommended if it's going to be stored for long periods of time. Otherwise, it can be kept at room temperature for up to 30 days.

Contraindications/Precautions

It is not contraindicated for use with any drug, including high-dose steroids (Solu-Medrol).

Folks with a history of depression should be monitored closely while using this drug – There are no clinical trials showing any link between depression and Rebif although some people have reported depression in conjunction with use of interferons.

Pregnancy:

This drug has a pregnancy category C, which means that it caused some harm to fetuses in animal studies, but the effect in humans is unknown. It should not be used by women who are pregnant and should be stopped before trying to conceive for some time (usually one to three months) - discuss this with your doctor. This medication should not be used by women who are breastfeeding.

It has a comparable safety record to the other interferon-based drugs, which are considered safe for long-term use, as long as adequate monitoring for liver function and blood cell count are maintained.

YOUR DRUG COST

The cost of this medication is between US $25,000 and US $31,000 a year. (You can check exact prices at Destination RX

This drug is covered by most insurance plans. For assistance in figuring out reimbursement, you can call the MS LifeLines Support Program at 1-877-447-3243. According to the MS LifeLines website

"If you have trouble paying for Rebif, MS LifeLines may be able to help. A review of your situation will be conducted and you will be referred to the appropriate state or federal programs."

Your doctor's office or your local chapter of the National MS Society should also be able to assist you in determining financial options for affordable treatment.

Rebif is made by Serono, Inc. (a Swiss company) and comarketed in the United States by Pfizer, Inc. The patient support program is called MS LifeLines. They can be reached by phone at 1-877-447-3243.

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