Pronunciation:

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

Brand Names:

• Betaseron
• Extavia

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Immunological Agent

Pharmacologic—

Interferon, Beta (class)

Uses of This Medicine:

Interferon beta-1b injection is used to treat the relapsing-remitting forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. This medicine will not cure MS, but it may slow some disabling effects or decrease the number of relapses of the disease.

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

Before Using This Medicine:

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.

Children—

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

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of interferon beta-1b injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other 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 usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Levoketoconazole
• Methotrexate

Other interactions—

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:

• Blood or bone marrow problems (eg, anemia, low white blood cells) or
• Congestive heart failure or
• Depression, or history of or
• Liver problems or
• Seizures, or history of or
• Thyroid problems, history of—Use with caution. May make these conditions worse.

• Infections—May decrease your body's ability to fight infections.

Proper Use of This Medicine:

A nurse or other trained health professional may 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 (usually in the thigh).

If you are injecting interferon beta-1b yourself, use it exactly as directed by your doctor in order to help your condition as much as possible. 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. Do not inject into skin areas that are irritated, reddened, bruised, infected, or scarred in any way.

Each package of the medicine contains a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

• How to prepare the injection.
• How to use disposable syringes.
• How to store the syringes.

You may also receive other medicines (fever medicine, pain medicine) to help prevent or lessen flu-like symptoms (eg, fever, cough, chills, body aches) that may occur during treatment with this medicine.

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—At first, 0.0625 milligram (mg) (0.25 mL) injected under your skin every other day. Over 6 weeks, your doctor may gradually increase your dose to 0.25 mg (1 mL) every other day.
    • 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.

The next injection should be scheduled about 48 hours later.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Store in the refrigerator. Do not freeze.

You may also store Extavia® vials at room temperature, away from heat and direct light, for up 3 months. Throw away any unused medicine after 3 months.

After mixing, if not used immediately, you may refrigerate the mixed solution and must be used within 3 hours. Do not freeze.

Precautions While Using This Medicine:

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.

Check with your doctor right away if you have dark urine, persistent loss of appetite, 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.

This medicine may cause serious allergic reactions, including anaphylaxis, which 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 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.

This medicine may cause redness, pain, or swelling at the injection site. Some patients have developed serious skin infection or damage (necrosis), including a permanent depression under the skin at the injection site. Contact your doctor right away if you notice 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, headaches, 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 to help control the pain or fever (eg, acetaminophen or ibuprofen). Carefully follow your doctor's instructions about how to prevent or treat these symptoms.

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.

Thrombotic microangiopathy, including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome may occur while you are using this medicine. Tell your doctor right away if you have black, tarry stools, blood in the urine, difficulty with speaking, fever, pinpoint red spots on the skin, seizures, stomach pain, unusual bleeding or bruising, or yellow eyes or skin.

This medicine may cause pulmonary arterial hypertension. Check with your doctor right away if you have trouble breathing or unusual tiredness or weakness.

Check with your doctor right away if you have a rash, bloody or cloudy urine, drowsiness, headache, paleness or cold feeling in fingertips and toes, tingling or pain in fingers or toes when exposed to cold, swelling of the face, feet, or lower legs, trouble breathing, or unusual weight gain. These may be symptoms of a drug-induced lupus erythematosus.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor about this risk if you are concerned.

The removable rubber cap of the prefilled syringe contains natural rubber latex, which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this medicine.

Side Effects of This Medicine:

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

Blue-green to black skin discoloration

changes in menstrual periods

chills

cough

decreased sexual ability in males

diarrhea

fever

general feeling of discomfort or illness

headache

irregular or pounding heartbeat

joint pain

loss of appetite

muscle aches and pains

nausea

runny or stuffy nose

shivering

sore throat

stomach pain

sweating

trouble sleeping

unusual tiredness or weakness

vomiting

Less common

Bloody or cloudy urine

changes in vision

cold hands and feet

difficult, burning, or painful urination

frequent urge to urinate

pelvic pain

swollen glands

trouble breathing

unusual weight gain

Incidence not known

Black, tarry stools

bleeding problems

bleeding gums

bloating or swelling

blood in the urine or stools

chest pain, discomfort, or tightness

confusion

dry, puffy skin

feeling cold

hoarseness or husky voice

increased muscle tone

increased urge to urinate

light-colored stools

loss of memory

nervousness

nosebleeds

pale skin

pinpoint red spots on the skin

problems with speaking

red, itching, or swollen eyes

restlessness

seizures

sensitivity to heat

swelling of the feet or lower legs

swelling of the front part of the neck

trouble sitting still

unusual bleeding or bruising

unusual weight loss

upper right abdominal or stomach pain

yellowing 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

Constipation

dizziness

loss of voice

menstrual pain or other changes

Incidence not known

Difficulty in moving

loss or thinning of the hair

muscle stiffness

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.