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• Japan

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Parecoxib sodium salt (a derivative of Parecoxib) is reported as an ingredient of Valdure in the following countries:

• Belize


• Costa Rica


• El Salvador


• Guatemala


• Honduras


• Nicaragua


• Panama

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• Myanmar

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Diclofenac

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Rebif

Generic Name: interferon beta-1a (Intramuscular route, Subcutaneous route)

in-ter-FEER-on BAY-ta-1a

Commonly used brand name(s)

In the U.S.

• Avonex


• Rebif

Available Dosage Forms:

• Solution


• Kit

Therapeutic Class: Immunological Agent

Pharmacologic Class: Interferon, Beta (class)

Uses For Rebif

Interferon beta-1a injection is used to treat the relapsing forms of multiple sclerosis (MS). This medicine will not cure MS, but it may slow some disabling effects and decrease the number of relapses of the disease. Interferons are natural substances that are produced in the body to help fight infections. Interferon beta-1a is a synthetic (man-made) version of these substances.

This medicine is available only with your doctor's prescription.

Before Using Rebif

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of interferon beta-1a injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of interferon beta-1a injection in the elderly. However, elderly patients are more likely to have age-related liver problems, which may require caution in patients receiving interferon beta-1a injection.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Zidovudine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (severe chest pain) or


• Autoimmune disorders (e.g., autoimmune hepatitis, idiopathic thrombocytopenia) or


• Bone marrow problems (decreased amounts of red or white blood cells in your body), history of or


• Congestive heart failure or


• Depression or mental problems, history of or


• Heart disease (e.g., cardiomyopathy) or


• Heart rhythm problems (e.g., arrhythmia) or


• Liver disease or


• Seizures or epilepsy, history of or


• Thyroid problems—Use with caution. May make these conditions worse.

• Infection—May decrease your body's ability to fight infection.

Proper Use of interferon beta-1a

This section provides information on the proper use of a number of products that contain interferon beta-1a. It may not be specific to Rebif. Please read with care.

A nurse or other trained health professional will give you this medicine. You may also be taught how to give your medicine at home. This medicine is given as a shot under your skin or into a muscle.

If you are injecting interferon beta-1a yourself, use it exactly as directed by your doctor. Do not use more or less of it, and do not use it more often than your doctor ordered. Do not change your dose or dosing schedule without checking first with your doctor. The exact amount of medicine you need has been carefully worked out. Using too much will increase the risk of side effects, while using too little may not improve your condition.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Rebif® works best if you use it on the same time (usually in the late afternoon or evening) on the same three days (e.g., Monday, Wednesday, and Friday) at least 48 hours apart each week.

Avonex® comes as a prefilled syringe or a powder. The powder must be mixed with sterile water before it is given. Do not shake the vial after you add the water. Gently swirl the water and medicine together to mix. The mixture should be clear or slightly yellow. Do not use the mixture if you see particles in it. Use the medicine as soon as possible after mixing. If you cannot give your shot right away, you can keep the syringe in the refrigerator for up to 6 hours. After 6 hours, throw the medicine away and mix another dose.

Use a new needle, unopened vial, or syringe each time you inject your medicine.

Each package of interferon beta-1a injection contains a medication guide and patient instruction sheet. Read this sheet carefully and make sure you understand:

• How to prepare the injection.


• Proper use of disposable syringes.


• How to give the injection.


• How long the injection is stable.

If you have any questions about any of this, check with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  
  • For multiple sclerosis (MS):
    
    • Adults—
      
      • For Avonex®:
        
        • 30 micrograms (mcg) injected into a muscle once a week, on the same day (e.g., every Monday right before bedtime). Your doctor may choose a different dose (more or less) if necessary.
        
        
      
      
      • For Rebif®:
        
        • At first, 4.4 or 8.8 micrograms (mcg) injected under the skin three times a week. Your doctor will increase or decrease your dose until you reach the correct amount for you.
        
        
      
      
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose or forget to use your medicine, use it as soon as you can. This will then change the time for your next dose. After using the missed dose, use your next regular dose of Rebif® 48 hours later and go back to your regular schedule the following week. For Avonex®, if your next regular dose is less than 2 days away, call your doctor. For either brand, do not use extra medicine to make up for a missed dose and do not use this medicine two days in a row.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store prefilled syringes or vials in the refrigerator. Do not freeze. If refrigeration is not available, Rebif® prefilled syringes and Avonex® powder vials may be kept for up to 30 days at room temperature, away from heat (temperatures above 77 degrees F) and direct light. Avonex® prefilled syringes may be stored for up to 7 days at room temperature, away from heat (temperatures above 77 degrees F) and direct light. Allow Avonex® prefilled syringes to warm to room temperature (remove from the refrigerator for about 30 minutes) before injection but do not heat in a microwave oven or in hot water.

Throw the used needles away in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using Rebif

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant may cause you to lose your baby or can harm your unborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine. Also, tell your doctor if you are breastfeeding.

This medicine may cause some people to be anxious, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

Check with your doctor right away if you have dark urine, persistent loss of appetite, influenza (flu)-like symptoms, headache, continuing vomiting, general feeling of tiredness or weakness, light-colored stools, right upper stomach pain or tenderness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

You should avoid alcohol while you are taking this medicine. It can cause serious liver problems.

This medicine may cause serious allergic reactions including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may lower the number of white blood cells in the blood. This will increase your chance of getting an infection. It can also lower the number of platelets in the blood. Platelets are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects, such as a safety razor or fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause redness, pain, or swelling at the injection site. Some patients have developed skin infections or a permanent depression (necrosis) under the skin at the injection site. Contact your doctor right away if you notice any of these side effects at the injection site: depressed or indented skin; blue-green to black skin discoloration; or pain, redness, or sloughing (peeling) of the skin.

This medicine commonly causes a flu-like reaction, with aching muscles, chills, fever, headache, joint pain, and nausea. Using your shot at bedtime may allow you to sleep through the symptoms. Your doctor may want you to take a medicine for pain and fever (e.g., acetaminophen or ibuprofen) to help control these effects. Follow your doctor's instructions carefully about how to prevent or treat these symptoms.

This medicine contains albumin, which comes from human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made of human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during manufacture of these medicines. Although the risk is low, talk with your doctor if you have concerns. The Avonex® prefilled syringe does not contain albumin which comes from donated human blood.

Rebif Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Black, tarry stools


• chest pain


• chills


• cough


• diarrhea


• fever


• flu-like symptoms


• headache


• joint pain


• muscle aches


• nausea


• pain


• painful or difficult urination


• shortness of breath


• sores, ulcers, or white spots on the lips or in the mouth


• swollen glands


• unusual bleeding or bruising


• unusual tiredness or weakness

Less common

• Abdominal or stomach pain


• clumsiness or unsteadiness


• convulsions (seizures)


• decreased hearing


• difficulty with swallowing


• dizziness


• fainting


• feeling of warmth


• hives or itching


• mood changes, especially with thoughts of suicide


• muscle spasms


• pain or discharge from the vagina


• pelvic discomfort, aching, or heaviness


• redness of the face, neck, arms, and occasionally, upper chest


• redness, swelling, or tenderness at the injection site


• runny or stuffy nose


• skin lesions


• sneezing


• sore throat


• speech problems


• swelling of the face, lips, or eyelids


• troubled breathing


• wheezing

Rare

• Earache


• general feeling of discomfort or illness


• loss of appetite


• painful blisters on trunk of body


• painful cold sores or blisters on the lips, nose, eyes, or genitals

Incidence not known

• Bleeding gums


• blood in the urine or stools


• bloody nose


• chest discomfort


• confusion


• constipation


• continuing vomiting


• dark urine


• decreased urine output


• depressed mood


• dilated neck veins


• dry skin and hair


• extreme fatigue


• fast, irregular, or pounding heartbeat


• feeling cold


• general tiredness and weakness


• hair loss


• heavier menstrual periods


• high fever


• hoarseness or husky voice


• irregular breathing


• light-colored stools


• loss of bladder control


• mental depression


• mood or other mental changes


• muscle cramps and stiffness


• muscle spasm or jerking of all extremities


• nausea or vomiting


• nervousness


• pale skin


• persistent loss of appetite


• pinpoint red spots on the skin


• puffiness or swelling of the eyelids, or around the eyes, face, lips, or tongue


• redness, blistering, peeling, or loosening of the skin


• sensitivity to heat


• skin rash


• slowed heartbeat


• sudden loss of consciousness


• sweating


• swelling of the face, fingers, feet, or lower legs


• swelling of the mouth or throat


• tightness in the chest


• tightness in the throat


• upper right abdominal or stomach pain or tenderness


• weight gain or loss


• yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Heartburn


• indigestion


• sour stomach

Less common

• Hair loss


• trouble with sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Rebif side effects (in more detail)

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More Rebif resources

• Rebif Side Effects (in more detail)
• Rebif Use in Pregnancy & Breastfeeding
• Rebif Drug Interactions
• Rebif Support Group
• 10 Reviews for Rebif - Add your own review/rating

• Rebif Prescribing Information (FDA)


• Rebif MedFacts Consumer Leaflet (Wolters Kluwer)


• Rebif Consumer Overview


• Interferon Beta-1a Professional Patient Advice (Wolters Kluwer)


• Avonex Consumer Overview


• Avonex Prescribing Information (FDA)


• Avonex Prefilled Syringes MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Rebif with other medications

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