Health Guide
Drug Guide

Interferon Beta-1b (Subcutaneous route)

Pronunciation:

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

Brand Names:

Dosage Forms:

Classifications:

Therapeutic

Immunological Agent

Pharmacologic

Interferon, Beta (class)

Uses of This Medicine:

Interferon beta-1b injection is used to treat the relapsing-remitting form of multiple sclerosis (MS). 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.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal 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

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

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:

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.

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.

Using interferon beta-1b at bedtime may help lessen the flu-like symptoms. Your doctor may want you to take medicines to prevent flu-like symptoms.

This medicine comes with a Medication Guide and patient directions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

It is important to follow several steps to prepare your interferon beta-1b injection correctly. Before injecting the medicine, you need to:

In order to keep everything sterile, it is important that you do not touch the tops of the vials or the needles. If you do touch a stopper, clean it with a fresh alcohol wipe. If you touch a needle, or if the needle touches any surface, throw away the entire syringe and start over with a new syringe. Also, use only the diluent (sodium chloride 0.54%) provided with the interferon beta-1b to dilute the medicine for injection.

To mix the contents of one vial:

To prepare the injection syringe:

The injection should be administered immediately after mixing. If the injection is delayed, refrigerate the mixed solution and inject it within 3 hours. Do not freeze.

To give yourself the injection:

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.

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.

If refrigeration is not available, vials may be kept for up to 3 months at room temperature, as long as the temperature does not go above 86 °F.

Precautions While Using This Medicine:

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.

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. 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 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 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.

Check with your doctor if you notice any signs of fever, chills, or sore throat. These could be symptoms of an infection resulting from low white blood cell counts.

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.

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.

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
Abdominal or stomach pain
break in the skin at the injection site, with blue-black discoloration, swelling, or drainage of fluid
flu-like symptoms including chills, fever, generalized feeling of discomfort or illness, increased sweating, and muscle pain
headache or migraine
hives, itching, or swelling at the injection site
irregular or pounding heartbeat
redness, pain, or feeling of heat at the injection site
stuffy nose
Less common
Bloody or cloudy urine
breast pain
changes in vision
cold hands and feet
difficult, burning, or painful urination
fast or racing heartbeat
frequent urge to urinate
pain
pelvic pain
swollen glands
troubled breathing
unusual weight gain
Rare
Abnormal growth in the breast
benign lumps in the breast
bleeding problems
bloating or swelling
changes in menstrual periods
confusion
convulsions (seizures)
cyst (abnormal growth filled with fluid or semisolid material)
decreased sexual ability in males
dry, puffy skin
feeling cold
hyperactivity
increased muscle tone
increased urge to urinate
loss of memory
mental depression with thoughts of suicide
problems with speaking
red, itching, or swollen eyes
swelling of the front part of the neck
unusual weight loss

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
diarrhea
dizziness
loss of voice
menstrual pain or other changes
unusual tiredness or weakness
Less common
Anxiety
drowsiness
hair loss
vomiting

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.


Last Updated: 10/12/2016

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