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BETAFERON SC inj（Interferon Beta-1b[genetical recombination]）
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The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
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Brand name :
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BETAFERON SC inj.
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Active ingredient:
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Interferon Beta-1b (genetical recombination)
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Dosage form:
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white Lyophilized powder (reconstitution with the diluent supplied before injection), injection
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Effects of this medicine
This medicine suppresses enhancement of immune response by acting on immune cells and prevents activation of inflammatory cells and/or invasion of these cells into the central nervous system.
It is usually used to prevent relapse and delay progression of multiple sclerosis.
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Before using this medicine, be sure to tell your doctor and pharmacist
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If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have a past history of depression or suicidal ideation.
If you have hepatic/renal disease.
If you have autoimmune hepatitis.
If you have convulsive diseases such as epilepsy, psychoneurotic disorder, heart disease or have a past history of these conditions.
If you have hypertension.
If you have diabetes mellitus (including past history and family history).
If you have autoimmune disease or predisposition to autoimmune diseases excluding multiple sclerosis.
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If you are pregnant or breastfeeding.
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If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
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Dosing schedule (How to take this medicine)
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Your dosing schedule prescribed by your doctor is (( to be written by a healthcare professional))
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In general, for adults, the usual dosage is 1 mL (800 x 10^4 IU) of an injection solution containing the preparation dissolved in the solution provided, administered subcutaneously every other day. Strictly follow the instructions.
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Do not inject into to an area which has rash or erosion. Do not inject into an area of skin that is redness, discoloration, swelling, hardness or pain.
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Change the site of injection every time. Be cautious not to inject this medicine to the same spot repeatedly. Read the Self-Injection Manual or Betaferon Diary to check injection sites.
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For details on how to use this medicine, read the Self-Injection Manual or Instructions for Patients. Listen and ask your doctor carefully, and ask your doctor if you have any questions because you will inject the medicine by yourself or have a member of your family inject for you. Do not leave anything unclear.
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If you miss a dose, inject the prescribed dose as soon as possible. Your next dose should be injected 2 days after that dose.
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If you accidentally used more than your prescribed dose, consult with your doctor or pharmacist.
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Do not stop using this medicine unless your doctor instructs you to do so.
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Precautions while taking this medicine
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Possible adverse reactions to this medicine
The most commonly reported adverse reactions include fever, headache, injection site redness, pain or induration, malaise, nausea, and joint pain. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
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being depressed, shallow sleep, excitement, feeling irritated [depression, suicide attempt, manic state, aggressive behavior]
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shortness of breath/breathing difficulty when going up stairs or over working, dry cough, fever [interstitial pneumonia]
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injection site pain, redness or hardening [injection site necrosis]
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general malaise, decreased appetite, yellow discoloration of the skin or the white of the eyes [serious liver disorder]
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fitful shortness of breath, respiratory distress, hives [serious hypersensitive reaction]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
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Storage conditions and other information
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Store it at a temperature of lower than 30 degrees Celsius. Do not place in direct sunlight or in potentially high-temperature places such as inside a car. When storing in the refrigerator, for example in intensely hot times of the summer, do not freeze this medicine. When taking this medicine out from the refrigerator to use it, make sure to let the medicine recover to room temperature before use.
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Keep the medicine out of the reach of children. For other storage methods, see the Self-Injection Manual or Instructions for Patients.
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Discard the remainder. Do not store them. For other disposal methods, read the Self-Injection Manual or Instructions for Patients.
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[To family members] If you notice any unusual behavior or symptoms (no changes in facial expression, speaking less words, looks depressed, etc.) while observing the daily life of the patient, consult a doctor immediately, as these may represent side effects of the medicine.
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