250 micrograms / ml, powder and solvent for solution for injection 
interferon beta-1b

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Betaferon is and what it is used for 
2. What you need to know before using Betaferon 
3. How to use Betaferon 
4. Possible side effects 
5. How to store Betaferon 
6. Contents of the packaging and other information 

1. What Betaferon is and what it is used for

What Betaferon is

Betaferon is a type of medicine called interferon, which is used to treat multiple sclerosis. Interferons are proteins produced in the body that help fight attacks on the immune system, e.g. viral infections.

How Betaferon works

Multiple sclerosis (MS) is a long-term condition that affects the central nervous system ( CNS ), especially the function of the brain and spinal cord. In MS, inflammation destroys the protective sheath (called myelin ) around the nerves in the CNS and prevents the nerves from functioning properly. This is called demyelination.

The exact cause of MS is unknown. It is believed that an abnormal reaction in the body’s immune system plays an important role in the CNS- damaging process.

CNS damage can occur in an MS attack ( relapse ). It can cause temporary disabilities, such as difficulty walking. The symptoms may disappear completely or partially.

Interferon beta-1b has been shown to alter the immune system’s response and help reduce disease activity.

How Betaferon helps you fight the disease:

Isolated clinical events indicating a high risk of developing multiple sclerosis: Betaferon has been shown to delay the development of definitive multiple sclerosis.

Relapsing multiple sclerosis: People with relapsing-remitting MS have sporadic attacks or relapses during which the symptoms become noticeably worse. Betaferon has been shown to reduce the number of attacks and make them less serious. It reduces the number of hospital stays due to the disease and prolongs the time without relapse .

Secondary progressive multiple sclerosis : In some cases, people with relapsing-remitting MS notice that their symptoms worsen and that they develop another form of MS called secondary progressive MS. With this, they notice that they are getting worse, regardless of whether they get a relapse or not. Betaferon can reduce the number of attacks and the severity of the attacks, as well as delay the progression of the disability.

What Betaferon is used for

Betaferon is intended for use in patients

  • who for the first time have had symptoms that indicate that they are at high risk of developing multiple sclerosis . Before any treatment is given, doctors will rule out any other conditions that may explain the symptoms.
  • suffering from relapsing-remitting MS, with at least two relapses in the last two years.
  • suffering from secondary progressive MS with active disease, manifested by relapse.

What you need to know before using Betaferon

Do not use Betaferon

  • if you are allergic ( hypersensitive ) to natural or recombinant interferon beta-1b, human albumin or any of the other ingredients of this medicine (listed in section 6).
  • if you are currently suffering from severe depression and / or have suicidal ideation (see “Warnings and Precautions” and section 4 “Possible Side Effects”).
  • if you have severe liver disease (see “Warnings and precautions”, “Other medicines and Betaferon” and section 4 “Possible side effects”).
    • Tell your doctor if any of the above apply to you.

Warnings and cautions

Talk to your doctor before using Betaferon:

  • If you have monoclonal gammopathy. This is a disorder of the immune system in which there are abnormal proteins in the blood . Problems with the thin blood vessels ( capillaries ) can occur when using drugs such as Betaferon ( systemic capillary leakage syndrome ). This can lead to a state of shock ( collapse), and can even be life-threatening.
  • If you have had depression or have depression or have previously had suicidal thoughts. Your doctor will monitor you closely during the treatment. If your depression and/or suicidal ideation are severe, you will not be prescribed Betaferon (see also “Do not use Betaferon”).
  • If you have ever had a seizure or if you are taking medicines to treat epilepsy ( antiepileptic drugs ). Your doctor will then monitor your treatment closely (see also “Other medicines and Betaferon” and section 4 “Possible side effects”).
  • If you have severe kidney problems , your doctor will check your kidney function during treatment.

Your doctor also needs to know the following while you are taking Betaferon:

  • If you experience symptoms such as itching all over your body, swollen face and/or swollen tongue, or sudden shortness of breath. This can be a symptom of a severe allergic reaction ( hypersensitivity ) that can be life-threatening.
  • If you feel significantly more sad or despairing than you did before you started treatment or if you have suicidal thoughts . If you become depressed while taking Betaferon, you may need special treatment and your doctor will monitor you closely and may also consider stopping your treatment. If you suffer from severe depression and / or suicidal ideation, you will not be treated with Betaferon (see also section “Do not use Betaferon”).
  • If you notice that you get bruises more easily, bleed more than usual after an injury or if it seems like you get a lot of infection . This may be a symptom of a decrease in the number of blood cells or platelets (cells that help the blood to coagulate). You may need extra monitoring by your doctor.
  • If you suffer from loss of appetite, fatigue, nausea, repeated vomiting, especially if you notice widespread itching , yellowing of the skin or whites of the eyes or bruising easily. These symptoms may indicate liver problems. Altered liver function values ​​were observed in patients treated with Betaferon in clinical trials . As with other beta- interferons , severe liver damage, including cases of liver failure, has been reported rarely in patients taking Betaferon. The most severe cases were reported in patients taking other medicines or suffering from diseases affecting the liver (eg alcohol abuse, severe infection ).
  • If you get symptoms such as irregular heartbeat, swelling e.g. in ankles or legs, or shortness of breath. This may indicate a heart muscle disease ( cardiomyopathy ), which has been reported rarely in patients taking Betaferon.
  • If you experience abdominal pain that radiates to the back and/or you feel unwell or have a fever. This may indicate an inflammation of the pancreas ( pancreatitis ), which has been reported with the use of Betaferon. This is often associated with an increase of certain blood fats ( triglycerides s ).
    • Stop using Betaferon and tell your doctor immediately if any of these happen to you.

Other things to consider when using Betaferon:

  • You will need blood tests for blood cell counts, tests for blood chemistry, and liver enzymes. This will be done before you start using Betaferon, regularly after starting treatment with Betaferon, and at regular intervals while you are taking the medicine, even if you have no specific symptoms. These blood tests will be taken in addition to the tests that are normally performed to check your MS.
  • If you have heart disease, the flu-like symptoms that often occur at the beginning of treatment can prove to be stressful for you. Betaferon must be used with caution and your doctor will monitor you for any worsening of your heart disease, especially at the beginning of treatment. Betaferon itself has no direct effect on the heart.
  • The function of your thyroid gland will be checked regularly or when your doctor deems it necessary for other reasons.
  • Betaferon contains human albumin and therefore there is a potential risk of transmitting viral diseases. The risk of transmission of Creutzfeldt-Jakob disease (CJD) cannot be ruled out.
  • During treatment with Betaferon, the body can produce substances, so-called neutralizing antibodies, that can react with Betaferon ( neutralizing activity ). It is not yet known whether these neutralizing antibodies reduce the effect of the treatment. Neutralizing antibodies are not produced in all patients. It is currently not possible to predict which patients belong to this group.
  • During treatment with Betaferon, kidney problems may occur which reduce kidney function and may result in subsequent scarring (glomerulosclerosis). Your doctor may take samples to check your kidney function.
  • During treatment, blood clots may form in the small blood vessels. Blood clots can affect your kidneys. This can happen for several weeks or up to several years after you start taking Betaferon. Your doctor may want to check your blood pressure , blood count ( platelet count ), and kidney function.

Injection site reactions

During treatment with Betaferon, you are likely to experience reactions at the injection site. Symptoms include redness, swelling, discoloration, inflammation, pain, and hypersensitivity. Degradation of skin and tissue damage ( necrosis ) around the injection site is not as common. Over time, the reactions at the injection site tend to become less common.

Skin and tissue degradation at the injection site may cause scarring. If this is severe, a doctor may need to remove foreign matter and dead tissue ( debridement ), and in rare cases, a skin transplant is required. Healing can take up to 6 months.

To reduce the risk of injection site reactions, you should :

  • use a sterile ( aseptic ) injection technique
  • change the injection site for each injection (see Annex “Procedure for self-injection” Section II, in the latter part of this leaflet)

The use of an auto-injector may reduce the frequency of injection site reactions. Your doctor or nurse can tell you more about this.

If you get stretch marks in the skin, which may be associated with swelling or fluid leaking from the injection site:

  • Cancel injection engines with Betaferon and talk to your doctor.
  • If you only have a sore injection site ( lesion ) and the tissue damage ( necrosis ) is not too extensive, you can continue to use Betaferon.
  • If you have more than one sore injection site ( multiple lesions s ) you must stop using Betaferon until your skin has healed.

Your doctor will regularly check your injection technique, especially if you get reactions at the injection site.

Children and young people

No formal clinical trials have been performed in children or adolescents. However, there are some data available from the treatment of children and adolescents between 12 and 16 years of age. These data suggest that the safety profile for this age group is similar to the safety profile for adults when Betaferon is given 8.0 million IU under the skin every other day. There is no information on the use of Betaferon in children under 12 years of age. Betaferon should therefore not be used in this age group.

Other medicines and Betaferon

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

No formal interaction studies have been performed to investigate whether Betaferon affects or is affected by other medicines.

Using Betaferon with other medicines that affect the immune system is not recommended, except anti-inflammatory medicines called corticosteroids you or adrenocorticotropic hormone (ACTH).

Betaferon should be used with caution along with:

  • drugs that need a certain enzyme system in the liver (the so-called cytochrome P450 system ) to be removed from the body, e.g. drugs used to treat epilepsy (such as phenytoin ).
  • drugs that affect the production of blood cells.

Betaferon with food and drink

Betaferon is injected under the skin. Therefore, it is not believed that food and drink have any effect on Betaferon.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

No harmful effects on the breast-fed infant/infant are expected. Betaferon can be used during breast-feeding.

Driving and using machines

Betaferon may cause side effects in the central nervous system (see section 4 “Possible side effects”). If you are particularly sensitive, this may affect your ability to drive or use machines.

Betaferon contains mannitol, human albumin, and sodium

The excipients in Betaferon include

  • small amounts of mannitol (a natural sugar) and human albumin (a protein ).
  • Sodium – This medicine contains less than 1 mmol (23 mg) sodium per ml, ie essentially ‘sodium-free’.

If you are allergic ( hypersensitive ) to any of the excipients or if you become one during treatment, do not take Betaferon.

3. How to use Betaferon

Betaferon treatment should always be started under the supervision of a doctor who has experience in the treatment of multiple sclerosis.

Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.

The recommended dose is:

Every other day (once every other day), 1.0 ml of the reconstituted Betaferon solution for injection under the skin ( subcutaneously ) (see appendix “Procedure for self-injection” in the latter part of this leaflet). 1.0 ml is equivalent to a dose of 250 micrograms (8.0 million IU) of interferon beta-1b.

When starting treatment with Betaferon, it is best tolerated by gradually increasing the dose , ie starting with only 0.25 ml of the medicine and then increasing after every third injection to 0.5 ml, 0.75 ml and finally to the full Betaferon dose (1 ml). Your doctor may decide with you to change the time intervals for dose escalation depending on the side effects you may experience at the beginning of treatment. To easily increase the dosage one during the first 12 injections , you can be offered a titration pack containing four different-colored packages with specially marked syringes and with detailed instructions in a separate package leaflet for the introduction of the titration package.

Preparation for injection

Prior to injection , a ready-to-use Betaferon solution must be prepared from a vial of Betaferon powder and 1.2 ml of liquid from the pre-filled syringe of diluent . Either your doctor or nurse does it or you do it yourself after you have first received careful instructions and practiced. For instructions on how to prepare Betaferon solution for injection, see Appendix “Procedure for self-injection”, Part I.

Detailed instructions on how to inject Betaferon yourself under the skin can be found in Part IE of the “Self-Injection Procedure” appendix.

Change the injection site at regular intervals. See section 2 “Warnings and Precautions” and follow the instructions in Part II “Switching the Injection Site” and Part III “Betaferon Treatment Calendar” in the Annex “Procedure for Self-Injection”.

Treatment time

It is not known how long Betaferon treatment should last. Your doctor will decide with you how long the treatment should last.

If you use more Betaferon than you should

No life-threatening symptoms occurred even when a dose was given that was many times higher than that recommended for the treatment of MS.

  • Contact your doctor if you have injected too much Betaferon or injected too often.

If you forget to use Betaferon

If you forget to give yourself an injection at the right time, do so as soon as you can. The next injection should be taken 48 hours later.

Do not inject a double dose to make up for a forgotten dose.

If you stop using Betaferon

Discuss with your doctor if you stop or want to stop treatment. Betaferon is not known to cause acute withdrawal symptoms at the end of treatment.

  • If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Betaferon can cause serious side effects. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist, or nurse.

  • Tell your doctor immediately and stop using Betaferon:
  • if you experience symptoms such as itching all over your body, swollen face and/or swollen tongue, or sudden shortness of breath.
  • if you feel significantly more sad or despairing than you did before you started treatment or if you have suicidal thoughts.
  • if you notice that you get bruises more easily, bleed more than usual after an injury or if it seems like you get a lot of infection.
  • if you suffer from loss of appetite, fatigue, nausea, repeated vomiting, especially if you notice widespread itching, yellowing of the skin or whites of the eyes, or bruising easily.
  • if you get symptoms such as irregular heartbeat, swelling e.g. in ankles or legs, or shortness of breath.
  • if you experience abdominal pain radiating to the back and/or you feel unwell or have a fever.
  • Tell your doctor immediately:
  • If you get any or all of the following symptoms: sore urine, fatigue, swelling, mainly of the ankles and eyelids, and weight gain, then it may be a sign of a possible kidney disease.

Side effects are common at the beginning of a treatment, but in general they become less common during treatment.

The most common side effects are

  • flu-like symptoms such as fever, chills, joint pain, general malaise, sweating, headache and muscle aches. These symptoms can be relieved by taking paracetamol or non-steroidal anti-inflammatory drugs such as ibuprofen.
  • injection site reactions. Symptoms such as redness, swelling, discoloration, inflammation, pain, hypersensitivity, tissue damage ( necrosis ). See “Warnings and Precautions” in section 2 for more information and what to do if you get reactions at the injection site. These can be reduced if an auto-injector is used. Talk to a doctor, pharmacist, or nurse for more information.

To reduce the side effects at the beginning of treatment, your doctor should start giving you a low dose of Betaferon and increase it gradually (see section 3 “How to use Betaferon”).

The following list of adverse reactions is based on reports from clinical trials with Betaferon (list 1) and from reported side effects of the marketed medicinal product (list 2).

List 1: Very common side effects that have occurred in clinical trials with Betaferon (at least 10% of cases) and that were more common than those who received placebo. The table also includes adverse reactions that occurred in less than 10% of cases but was significantly associated with treatment.

  • infection, boils
  • decreased white blood cell s, swollen lymph nodes ( lymphadenopathy )
  • decreased blood sugar ( hypoglycemia )
  • depression, anxiety
  • headache, dizziness, insomnia, migraine, numbness, or tingling ( paresthesia )
  • eye inflammation (conjunctivitis), visual disturbances
  • ear pain
  • irregular, rapid heartbeat or palpitations ( palpitation )
  • redness and/or facial redness due to dilation of the blood vessels (vasodilation), high blood pressure ( hypertension )
  • runny nose, cough, hoarseness due to infection of the upper airways, sinusitis, cough (increased), shortness of breath ( dyspnea )
  • diarrhea, constipation, nausea, vomiting, abdominal pain
  • elevated levels of liver enzymes in the blood (shown in blood tests)
  • skin effects, rash
  • muscle stiffness ( hypertension ), muscle aches ( myalgia ), muscle weakness ( myasthenia ), back pain, pain in the extremities you like fingers and toes
  • difficulty urinating ( urinary retention ), protein in the urine (manifested in urine samples), frequent urination, inability to restrain urination (urinary incontinence), urinary incontinence
  • menstrual cramps ( dysmenorrhea ), menstrual disorders , heavy uterine bleeding ( metrorrhagia ) especially between menstruations, impotence
  • injection site reactions (including redness, swelling, discoloration, inflammation, pain, allergic reaction ( hypersensitivity ), skin degradation, and tissue damage ( necrosis ) at the injection site (see section 2 “Warnings and precautions”)
  • flu-like symptoms, fever, aches, chest pain, fluid accumulation in arms, legs, or face (peripheral edema ), lack energy or weakness ( asthenia ), chills, sweating, general malaise

In addition, the following side effects have been identified after the launch of the drug.

List 2: Adverse reaction reports for the launched product (spontaneous reports, frequencies are based – if known – on clinical trials ).

  • Very common (may affect more than 1 user in 10):
  • painful joints ( arthralgia )
  • Common (may affect up to 1 in 10 people):
  • the number of red blood cells in the blood can drop ( anemia )
  • disorders of thyroid function (too little hormone is produced) ( hypothyroidism )
  • weight gain or weight loss
  • confusion
  • Abnormally fast heartbeat ( tachycardia )
  • a red-yellow dye ( bilirubin ), made by your liver, may increase (this is shown in blood tests)
  • swollen and usually itchy spots on the skin or mucous membranes ( urticaria )
  • itching ( pruritus )
  • hair loss ( alopecia )
  • menstrual disorders ( menorrhagia ).
  • Uncommon (may affect 1 in 100 people):
  • the number of platelets (which help the blood to clot) can decrease ( thrombocytopenia )
  • a certain type of blood fat ( triglycerides ) may increase (this is shown in blood tests), see section 2 “Warnings and Precautions”
  • suicide attempt
  • Mood swings
  • seizures
  • a specific liver enzyme (gamma GT) produced by your liver may increase (this is shown in blood tests)
  • liver inflammation ( hepatitis )
  • discoloration of the skin.
  • Rare (may affect up to 1 in 1,000 people):
  • severe allergic (anaphylactic) reactions
  • disorders of thyroid function (thyroid disease), too much hormone is produced ( hyperthyroidism )
  • pancreatitis ( see pancreatitis ) see section 2 “Warnings and precautions”.
  • Blood clots in the small blood vessels, which can affect the kidneys (thrombotic thrombocytopenic purpura or hemolytic uremic syndrome ). Symptoms may include bruising, bleeding, fever, extreme weakness, headache, dizziness, or fainting. Your doctor may notice changes in your blood and kidney function.

Side effects that have only been reported after launch:

  • kidney disease with subsequent scarring (glomerulosclerosis) that may reduce your kidney function, less common
  • severe loss of appetite leading to weight loss ( anorexia ), rare
  • heart muscle disease ( cardiomyopathy ), rare
  • sudden shortness of breath ( bronchospasm ), rare
  • the liver does not function properly ( liver damage (including hepatitis ), liver failure ), rare
  • problems with your smaller blood vessels ( capillaries ) can develop when drugs such as Betaferon are used (capillary leakage syndrome ), no known frequency
  • rash, facial flushing, joint pain, fever, weakness, and other conditions caused by the medicine (drug-induced lupus erythematosus ), no known frequency
  • severe narrowing of the blood vessels of the lungs leading to high blood pressure in the blood vessels that carry blood from the heart to the lungs ( Pulmonary arterial hypertension ), no known frequency. Pulmonary arterial hypertension has been observed at different times during treatment, even up to several years after initiating treatment with Betaferon.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Betaferon

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.

Do not store above 25 ° C. Do not freeze.

You should use the solution immediately after reconstitution. If you are unable to do so, however, it will last for 3 hours if stored at 2-8 ºC (in a refrigerator).

Do not use Betaferon if it contains particles or is discolored.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is interferon beta-1b, 250 micrograms per milliliter after dilution

Other ingredients are

  • in the powder: mannitol and human albumin
  • in the diluent: (sodium chloride solution 5.4 mg / ml (0.54% w / v)): sodium chloride, water for injections

Betaferon powder is supplied in a 3-milliliter vial containing 300 micrograms (9.6 million IU) of interferon beta-1b per vial. After reconstitution, each milliliter contains 250 micrograms (8.0 million IU) of interferon beta-1b.

The diluent is supplied in a 2.25 milliliter pre-filled syringe and contains 1.2 ml of sodium chloride 5.4 mg / ml solution (0.54% w / v).

What the medicine looks like and the contents of the pack

Betaferon is a sterile white to off-white powder for injection.

Betaferon is available in pack sizes:

  • multipack with 5 disposable packs each containing 1 vial of powder, 1 pre-filled syringe of diluent, 1 adapter of the vial of the cannula and 2 alcohol swabs, or
  • multipack containing 12 disposable packs, each containing 1 vial of powder, 1 pre-filled syringe of diluent, 1 adapter of the vial of the cannula and 2 spirit compresses, or
  • multipack containing 14 disposable packs, each containing 1 vial of powder, 1 pre-filled syringe of diluent, 1 adapter of the vial of the cannula and 2 alcohol swabs, or
  • multipack with 15 disposable packs each containing 1 vial of powder, 1 pre-filled syringe of diluent, 1 adapter of the vial of a cannula and 2 alcohol swabs, or
  • 2-month pack of 2 x 14 single-use packs, each containing 1 vial of powder, 1 pre-filled syringe of diluent, 1 adapter of the vial of a cannula and 2 spirit compresses, or
  • 3-month pack of 3 x 15 single-use packs, each containing 1 vial of powder, 1 pre-filled syringe of diluent, 1 adapter of the vial of the cannula and 2 spirit compresses, or
  • 3-month pack of 3×14 disposable packs each containing 1 vial of powder, 1 pre-filled syringe of diluent, 1 adapter of the vial of the cannula and 2 spirit compresses, or
  • titration pack for the first 12 injections consisting of 4 triple packs, each containing 3 vials of powder, 3 pre-filled syringes of diluent, 3 adapters of a vial of needles, and 6 alcohol swabs.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorisation Holder

Bayer AG

51368 Leverkusen

Germany

Manufacturer

Bayer AG

Müllerstraße 178

13353 Berlin

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Muhammad Nadeem

Leave a Reply