Betaferon 250 micrograms/mL (interferon beta-1b) – medicine for multiple sclerosis

Betaferon contains interferon beta-1b, a protein from the interferon group that modifies the immune response and helps reduce the activity of multiple sclerosis (MS). MS is a long-term disease of the central nervous system in which inflammation damages the protective sheath (myelin) around the nerves.

The medicine comes as a powder and solvent used to make a solution for injection under the skin – after preparation, 1 mL contains 250 micrograms (8 million IU) of interferon beta-1b. It is given every other day, and treatment is started by a doctor experienced in treating MS.

What is Betaferon used for and how is it used correctly?

Key facts about the medicine

What is Betaferon used for?

• in patients who have had first symptoms indicating a high risk of multiple sclerosis (the doctor first rules out other causes) – Betaferon has been shown to delay progression to definite MS
• relapsing-remitting multiple sclerosis with at least two relapses in the last two years – reduces the number and severity of attacks and hospital stays and prolongs the relapse-free period
• secondary progressive multiple sclerosis with active disease evidenced by relapses – may reduce the number and severity of attacks and slow the progression of disability

How is it used and dosed?

• Recommended dose: 1.0 mL of prepared solution (250 micrograms) every other day as an injection under the skin.
• At the start, the dose is increased gradually for better tolerability, e.g. 0.25 mL, then after every third injection 0.5 mL, 0.75 mL and finally the full dose of 1 mL; the doctor may adjust the pace.
• The solution is prepared from the powder and 1.2 mL of solvent – by the doctor or nurse, or by the patient after training.
• The injection site must be changed regularly, using sterile technique; injection site reactions may be less frequent with an autoinjector.
• The duration of treatment is not fixed in advance – the doctor decides together with the patient.

This is the general dosage from the leaflet – your doctor decides your treatment.

Special patient groups

• Children and adolescents: no formal clinical studies; limited data in patients aged 12–16 show a safety profile similar to adults. It should not be used in children under 12.
• Serious kidney problems: the doctor may monitor kidney function.
• Liver disease: severe liver disease is a contraindication; liver enzymes are monitored during treatment.
• Heart disease: flu-like symptoms at the start of treatment may be a strain – caution is needed.

Contraindications – when the medicine must not be used

• allergy to natural or recombinant interferon beta, human albumin or any excipient
• current severe depression and/or suicidal thoughts
• severe liver disease

Warnings and precautions

• Tell your doctor if you have monoclonal gammopathy (risk of capillary leak syndrome), if you have been or are depressed, if you have had seizures, or if you have serious kidney problems.
• Unusual bruising, excessive bleeding or frequent infections may indicate a drop in blood cells or platelets.
• Loss of appetite, tiredness, nausea, repeated vomiting, itching, yellowing of the skin or eyes may indicate liver problems.
• Irregular heartbeat, swelling of the legs or shortness of breath may indicate cardiomyopathy; abdominal pain spreading to the back with nausea or fever may indicate pancreatitis.
• Kidney disorders and blood clots in small blood vessels may occur during treatment – the doctor monitors blood pressure, platelets and kidney function.
• Injection site reactions are likely; if skin breaks with swelling or fluid leakage, stop injections and talk to your doctor (with several painful sites the medicine is not used until the skin heals).
• The medicine contains human albumin – a potential risk of transmitting viral diseases cannot be completely excluded; neutralising antibodies may also develop.

Interactions with other medicines, food and drink

• Use with other medicines that modify the immune system is not recommended, except corticosteroids or ACTH.
• Caution with medicines eliminated via the liver cytochrome P450 system, e.g. antiepileptics such as phenytoin.
• Caution with medicines that affect blood cell production.
• Food and drink do not affect the medicine (injection under the skin).

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning a pregnancy, ask your doctor for advice. According to the SmPC, a large amount of registry data does not indicate a risk of major birth defects with exposure before conception or in the first trimester, and use during pregnancy may be considered if clinically needed. Breast-feeding: no harmful effects on the infant are expected – Betaferon can be used during breast-feeding.

Driving and using machines

Betaferon may cause side effects on the central nervous system; in particularly sensitive people this may affect the ability to drive or use machines.

Possible side effects

Side effects are common at the start of treatment but decrease with continued treatment.

• Most common: flu-like symptoms (fever, chills, joint and muscle pain, weakness, sweating, headache) – according to the leaflet they may be relieved with paracetamol or ibuprofen; injection site reactions (redness, swelling, discolouration, inflammation, pain, rarely necrosis).
• Very common in clinical trials: infections, low white blood cell count, swollen lymph nodes, low blood sugar, depression, anxiety, headache, dizziness, insomnia, migraine, tingling, conjunctivitis, visual disturbance, ear pain, palpitations, flushing, high blood pressure, runny nose, cough, sinusitis, shortness of breath, diarrhoea, constipation, nausea, vomiting, abdominal pain, raised liver enzymes, rash, muscle stiffness and pain, back pain, urinary disorders, menstrual disorders, impotence, chest pain, swelling, joint pain.
• Common: anaemia, underactive thyroid, weight change, confusion, fast heartbeat, raised bilirubin, hives, itching, hair loss, heavy menstruation.
• Uncommon: low platelet count, raised triglycerides, suicide attempt, mood changes, convulsions, hepatitis, skin discolouration.
• Rare: serious allergic reactions, overactive thyroid, pancreatitis, blood clots in small vessels (TTP/HUS), anorexia, cardiomyopathy, bronchospasm, liver injury.
• Frequency not known: capillary leak syndrome, drug-induced lupus, pulmonary arterial hypertension; occasionally glomerulosclerosis.

Report suspected side effects to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Overdose: doses higher than recommended have not led to life-threatening situations; if you have injected too much or too often, talk to your doctor.
• Missed dose: give the injection as soon as you remember and the next one 48 hours later. Do not use a double dose.
• Stopping treatment: talk to your doctor; stopping is not known to cause acute withdrawal symptoms.

Related information

For further information on the treatment of multiple sclerosis, ask the neurologist managing your therapy; non-prescription products do not replace the medicine you have been prescribed.

Composition, pack and manufacturer

• Active substance: interferon beta-1b; the vial contains 300 micrograms (9.6 million IU), and 1 mL of prepared solution contains 250 micrograms (8.0 million IU).
• Excipients – powder: mannitol, human albumin, hydrochloric acid and sodium hydroxide (for pH adjustment); solvent: sodium chloride solution 5.4 mg/mL (0.54%), water for injections.
• Pack: box with 15 individual kits (3 mL powder vial, 2.25 mL pre-filled syringe with 1.2 mL solvent, vial adapter with needle, 2 alcohol swabs).
• Marketing authorisation holder: BAYER D.O.O. BEOGRAD, Omladinskih brigada 88b, Belgrade. Manufacturer: Bayer AG, Muellerstrasse 178, Berlin, Germany.

Storage

• Store below 25 °C. Do not freeze.
• Use the prepared solution immediately; it may be stored for up to 3 hours at 2–8 °C.
• Do not use if the solution contains particles or is discoloured.
• Keep out of the sight and reach of children; shelf life of the powder: 2 years.

Frequently asked questions

How often is Betaferon given?

The recommended dose is 250 micrograms (1 mL of prepared solution) every other day as an injection under the skin. At the start the dose is increased gradually.

What should I do if I miss an injection?

Give the injection as soon as you remember and the next one 48 hours later. Do not use a double dose.

Why do flu-like symptoms occur at the start?

This is the most common side effect of interferon and is most pronounced at the start of treatment; gradual dose increase helps, and according to the leaflet the symptoms may be relieved with paracetamol or ibuprofen.

Can I breast-feed during treatment?

According to the leaflet, no harmful effects on the infant are expected and Betaferon can be used during breast-feeding.

Sources

• ALIMS – Patient leaflet Betaferon®, 250 micrograms/mL, powder and solvent for solution for injection (June 2020, Serbian)
• ALIMS – Summary of Product Characteristics Betaferon®, 250 micrograms/mL (Serbian)

Sources checked on: 25 October 2026.