Betaferon 250 mcg/ml. 15 vials
What is Betaferon?
Betaferon is a drug known as interferon that is used to treat multiple sclerosis. Interferons are proteins synthesized by the body that help him fight attacks against the immune system such as, for example, Viral infections.
How does Betaferon work?
Multiple sclerosis (MS) is a chronic condition affecting the central nervous system (CNS) and especially the function of the brain and spinal cord. In MS, an inflammatory process destroys the protective envelope (called myelin) of CNS nerves and stops their normal functioning. This process is called demyelination.
The exact cause of MS's appearance is unknown. It is believed that an abnormal response to the human immune system plays an important role in the process of CNS damage.
CNS damage can develop during an MS attack. It may cause temporary disability such as Difficulty walking. Symptoms may resolve completely or partially.
It has been shown that interferon beta-1b changes the response of the immune system and helps to reduce the activity of the disease.
How Betaferon helps treat your illness
Single clinical episode indicative of a high risk of developing multiple sclerosis:
Betaferon has been shown to delay progression to multiple sclerosis.
Recurrent-remitting multiple sclerosis:
Patients with relapsing-remitting MS have occasional seizures during which symptoms are clearly deteriorating.
Betaferon has been shown to reduce the number of seizures and make them lighter. Reduces the number of hospitalizations due to the disease and prolongs the seizure free time.
Secondary progressive multiple sclerosis:
In some cases, patients with relapsing-remitting MS have seen an increase in their symptoms and progression to another form of MS called secondary progression MS. In these cases, patients find that their disability is increasing regardless of whether or not they have seizures. Betaferon may reduce the number and severity of seizures and delay the progression of disability.
What Betaferon is used for
Betaferon is used in patients:
Who for the first time have symptoms indicative of a high risk of developing multiple sclerosis. Before starting treatment, your doctor will exclude all other causes for which these symptoms are characteristic;
Who suffer from relapsing-remitting multiple sclerosis with at least two attacks over the last two years;
Who suffer from a secondary progressive form of multiple sclerosis with active disease, proven by seizures.
2. What you need to know before using Betaferon
Do not use Betaferon:
If you are pregnant. You should not start treatment with Betaferon (see "Pregnancy");
If you are allergic (hypersensitive) to natural or recombinant interferon beta, human albumin or to any of the other ingredients of this medicine (listed in section 6;
If you suffer from severe depression and / or have suicidal thoughts (see "Warnings and precautions" and section 4. "Possible side effects");
If you have severe hepatic impairment (see "Warnings and precautions", "Other medicines and Betaferon" and section 4. "Possible side effects").
Tell your doctor if any of the conditions listed above apply to you.
Warnings and precautions
Talk to your doctor before using Betaferon:
If you have monoclonal gammopathy. This is a disorder of the immune system, in which an abnormal protein is found in the blood. When using medicines like Betaferon, you may experience problems (systemic capillary leak syndrome) with small blood vessels (capillaries). This can lead to shock (collapse) or even fatal;
If you have had a depression in the past, if you have depression or if you have been thinking about suicide in the past. Your doctor will monitor you closely during treatment. If your depression and / or your suicidal thoughts are severe, you will not be prescribed Betaferon (see also "Do not use Betaferon");
If you have ever had seizures or if you are taking medicines to treat epilepsy (anti-epileptic medication), your doctor will monitor your treatment carefully (see also "Other medicines and Betaferon" and section 4. "Possible side effects");
If you suffer from severe kidney problems, your doctor may monitor your kidney function during treatment.
While using Betaferon, your doctor should also know:
If you experience symptoms such as itching around the body, swelling of the face and / or tongue and sudden shortness of breath. These may be the symptoms of a severe allergic reaction (hypersensitivity) that can become life-threatening;
If you feel noticeably more sad or depressed than the time before treatment with Betaferon or if you think of suicidal thoughts. If you develop depression during treatment with Betaferon, you may need special treatment and your doctor will carefully monitor you and may also suggest stopping your treatment. If you suffer from severe depression and / or suicidal thoughts, you will not be treated with Betaferon (see also "Do not use Betaferon");
If you notice unusual bruising, increased bleeding after trauma or if you often have infections. These may be symptoms of a decrease in the number of blood cells or the number of platelets (the cells responsible for blood clotting). You may need additional supervision from your doctor;
If you have a decreased appetite, fatigue, feeling unwell (nausea), vomiting periodically, especially if you notice itching all over the body, yellowing of the skin or eyes or easily occurring bruising. These symptoms may indicate problems with your liver. In clinical studies, changes in liver function tests were observed in patients treated with Betaferon. As with other interferons, rare hepatic impairment has been reported in patients receiving Betaferon, including cases of hepatic insufficiency. The most severe of these have been seen in patients taking other medicines or suffering from diseases that may affect the liver (eg alcohol abuse, severe infection);
If you experience symptoms such as an irregular heartbeat, ankle or leg swelling or shortness of breath. These may be the symptoms of heart disease (cardiomyopathy), which has rarely been seen in patients taking Betaferon;
If you notice pain in the abdomen that spreads to the back and / or you feel sick or have fever. These may be symptoms of inflammation of the pancreas (pancreatitis) that has been reported with Betaferon. Often this is accompanied by an increase in some blood fats (triglycerides).
Stop using Betaferon and tell your doctor immediately if you experience any of these symptoms.
Other things to keep in mind when using Betaferon:
You will need blood tests to measure the number of blood cells, biochemical parameters and liver enzymes. This should be done before you start using Betaferon regularly after starting treatment with Betaferon and periodically during treatment, even if you do not have any special symptoms. This will be additional blood tests, except those usually done for MS follow-up;
If you suffer from heart disease, flu-like symptoms that often occur at the beginning of treatment may be stressful for you. Betaferon should be used with caution and your doctor will monitor your condition for possible worsening of heart function, especially at the beginning of treatment. Betaferon itself does not affect the heart directly;
You will be tested for thyroid function periodically or if your doctor thinks necessary for other reasons;
Betaferon contains human albumin and therefore has a potential risk of transmission of viral infections. The danger of transmitting Creutzfeld-Jacob disease (CJD) can not be ruled out;
During treatment with Betaferon your body may be able to synthesize substances called neutralizing antibodies that can interact with Betaferon (a neutralizing effect). It is not yet known whether these neutralizing antibodies reduce the effectiveness of the treatment. Not neutralizing antibodies are synthesized in all patients. Currently, it is not possible to predict which patients fall within this group;
During treatment with Betaferon, kidney problems may occur that may reduce renal function, including scarring (glomerulosclerosis). Your doctor may perform tests to check your kidney function;
During the treatment, blood clots may appear in small blood vessels. These blood clots could affect the kidneys. This can happen from a few weeks to several years after initiating treatment with Betaferon. Your doctor may want to check your blood pressure, blood (platelet count) and kidney function.
Injection site reactions
During treatment with Betaferon, it is expected that you will develop reactions at the injection site. Symptoms include redness, swelling, skin discolouration, inflammation, pain and hypersensitivity. Less commonly, skin destruction and tissue damage (necrosis) around the injection site have been reported. Usually, the frequency of reactions at the injection site decreases with time.
Disturbance of the integrity of the skin and the tissue at the injection site may
To reduce the risk of developing an injection site reaction, you should:
Use sterile (aseptic) injection technique;
Change the injection site each time (see "Self-injection procedure").
Instances of application site reactions may be reduced by using an autoinjector. Your doctor or nurse can give you more information about this.
If you experience any disruption of the skin's integrity, which may be associated with swelling or leakage from the injection site:
Stop the injection of Betaferon and consult your doctor;
If you have only one inflamed area of injection (lesion) and tissue damage (necrosis) is not very severe, you can continue to use Betaferon;
If more than one injection site is inflamed (multiple lesions), you should stop using Betaferon to heal your skin.
Your doctor will periodically check for self-injection, especially if you have had reactions at the injection site.
Children and adolescents
No targeted clinical trials have been conducted in children or adolescents.
However, there are some data available for children and adolescents between 12 and 16 years of age. Based on these data, it can be assumed that the safety profile for this age group is the same as for adults when administering Betaferon 8.0 million IU subcutaneously every other day. There is no information on the use of Betaferon in children under 12 years of age. Therefore, Betaferon should not be used in this population.
Other medicines and Betaferon
Tell your doctor or pharmacist if you are using, have recently used or are likely to use other medicines, including medicines obtained without a prescription.
No directed studies have been conducted on whether or not Betaferon affects other medicines.
Concomitant administration of Betaferon with medicines affecting the immune response of the body, with the exception of anti-inflammatory drugs called corticosteroids or ACTH, is not recommended.
Betaferon should be used with caution with:
Medicines whose metabolism needs a certain liver enzyme system (known as the cytochrome P450 system) to remove them from the body, Medicines for epilepsy (such as phenytoin);
Medicines that affect the production of blood cells.
Betaferon with food and beverages
Betaferon is injected subcutaneously, so it is not expected to affect Betaferon from any of your drinks or foods.
Pregnancy and breastfeeding
If you are able to become pregnant, use appropriate contraception during treatment with Betaferon.
If you are pregnant or think you may be pregnant, tell your doctor. Therapy with Betaferon should not be started if you are pregnant (see also "Do not use Betaferon");
If you intend to become pregnant, discuss this with your doctor first;
If you become pregnant during treatment with Betaferon, stop the treatment and contact your doctor immediately. Together with you, the doctor will decide whether to continue with Betaferon or not.
Ask your doctor or pharmacist for advice before taking any medicine.
It is not known whether interferon beta-1b passes into human breast milk. However, there is a theoretical possibility of occurrence of serious adverse reactions to Betaferon in infants
You should first discuss with your doctor to decide whether to stop breast-feeding or stop using Betaferon.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Betaferon may cause central nervous system adverse reactions (see section 4. "Possible side effects"). If you are particularly sensitive, this may affect your ability to drive and use machines.
Betaferon contains mannitol and human albumin
Inactive ingredients of Betaferon include small amounts of mannitol (naturally occurring sugar) and human albumin, protein. If you know you are allergic (hypersensitive) or become allergic to any of these ingredients, you should not use Betaferon.
How to use Betaferon
Treatment with Betaferon should be started under the supervision of a physician experienced in the treatment of multiple sclerosis.
Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor, pharmacist or nurse.
The recommended dose is:
Day 1 (once every two days) of the prepared Betaferon solution (see Annex "Self-injection procedure" in the second section of this leaflet) is injected 1.0 ml subcutaneously (subcutaneously). This is equivalent to 250 micrograms (8.0 million IU) of interferon beta-1b.
In general, treatment should be started at a low dose of 0.25 ml (62.5 micrograms). The dose will then be gradually increased to the full dose of 1.0 ml (250 micrograms).
The dose should be increased every four times in four steps (0.25 ml, 0.5 ml, 0.75 ml, 1.0 ml). Your doctor may decide, together with you, to change the dose-incrementing time intervals according to the side effects that may occur with you at the beginning of therapy.
Preparation of the injection:
Preparation of the injection
Prior to injection, the Betaferon solution should be prepared from the Betaferon powder vial and 1.2 ml of the liquid from the pre-filled syringe with solvent. All of this will be done by your doctor or nurse or by yourself after you have been carefully trained.
Detailed instructions for subcutaneous self-injection of Betaferon are provided on the back of this leaflet. These instructions tell you how to make the solution for injection.
The injection site should be changed regularly. See section 2 "Warnings and precautions" and follow the instructions for "Changing the injection sites" in the application on the back of this leaflet.
Duration of treatment
It is not known how long to continue treatment with Betaferon. The duration of treatment will be determined by your doctor with you.
If you use more Betaferon than you should
The administration of Betaferon doses repeatedly exceeding the recommended dose for the treatment of multiple sclerosis did not result in life-threatening conditions.
Ask your doctor if you have injected too much Betaferon or too often.
If you forget to use Betaferon
If you forget to put your injection at the right time, do it as soon as you remember and then put the next injection after 48 hours.
Do not inject a double dose to make up for the forgotten dose.
If you stop using Betaferon
Discuss with your doctor if you stop or want to stop treatment. It is not known that stopping Betaferon therapy will lead to acute withdrawal symptoms.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Betaferon can cause severe side effects. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor, pharmacist or nurse.
Instantly tell your doctor and stop using Betaferon:
If you experience symptoms such as itching all over the body, swelling of the face and / or tongue and sudden shortness of breath;
If you feel noticeably more sad or depressed than you were before treatment with Betaferon or if you think of suicidal thoughts;
If you notice unusual bruising, increased bleeding after a trauma, or if you often have infections;
If you have decreased appetite, fatigue, feeling unwell (nausea), vomiting periodically, especially if you notice itchy skin, yellowing of the skin or eyes or easily occurring bruising;
If you experience symptoms such as an irregular heartbeat, ankle or leg swelling or shortness of breath;
If you notice pain in the abdomen that spreads to the back and / or you feel sick or have fever.
Tell your doctor immediately:
If you experience any or all of these symptoms: foamy urine, fatigue, swelling, especially of the ankles and eyelids, and weight gain, as these may be signs of a possible kidney problem.
At the beginning of treatment, undesirable effects are common, but they usually decrease during the course of therapy.
The most common side effects are:
Flu-like symptoms such as fever, chills, soreness in the joints, malaise, sweating, headache or muscle pain. These symptoms can be reduced by taking paracetamol or non-steroidal anti-inflammatory drugs such as ibuprofen;
Injection site reactions. Symptoms may include redness, swelling, change in color, inflammation, pain, hypersensitivity, tissue damage (necrosis). See "Warnings and precautions
The following list of adverse reactions is based on reports from clinical trials with Betaferon (Table 1) and adverse reactions to the marketed product (Table 2)
Table 1: Very common side effects that occurred in clinical trials with Betaferon (at least> 10%) and reactions with a frequency higher than placebo. The table also includes undesirable effects that occur in less than 10% of cases but which have a significant association with treatment.
Decreased white blood cell count, enlarged lymph nodes (lymphadenopathy);
Reducing blood sugar (hypoglycaemia);
Headache, dizziness, insomnia, migraine, numbness or numbness (paresthesia);
Eye inflammation (conjunctivitis), impaired vision;
Irregular or fast pulse (palpitation);
Flushing and / or redness of the face due to vasodilatation, increased blood pressure (hypertension);
Rash, cough, hoarseness due to upper respiratory tract infection, sinusitis, increased cough, shortness of breath (dyspnoea);
Diarrhea, constipation, nausea, vomiting, abdominal pain;
Increase in liver enzyme levels (found in blood tests);
Skin disorders, rash;
Muscular stiffness (hypertonus), painful muscles (myalgia), muscle weakness (myasthenia), back pain, pain in the extremities such as in the toes and feet;
Urinary retention (urinary retention), urinary protein (urinalysis), urinary frequency (urinary incontinence), urinary incontinence;
Painful monthly bleeding (dysmenorrhea), menstrual disorders, abnormal uterine bleeding (metrorrhagia), especially between menstruation, impotence;
Injection site reaction (including redness, swelling, paleness, inflammation, pain, allergic reaction (hypersensitivity), skin breakdown or tissue damage (necrosis) (see section 2 "Warnings and Precautions");
Flu-like symptoms, fever, pain, chest pain, fluid retention in the hand, leg or face (peripheral edema), asthenia / loss of strength, chills, sweating, malaise
Additionally, the following adverse reactions were identified in post-marketing experience:
Table 2: Adverse reactions reported for the marketed product (from spontaneous reports, frequency - where known - based on clinical trials)
Very common (may affect more than 1 user in 10):
Joint pain (arthralgia).
Common (may affect up to 1 in 10 users):
Decrease in the number of red blood cells in the blood (anemia);
Impaired thyroid function (severely reduced production of hormones) (hypothyroidism);
Increase or decrease in weight;
Abnormally fast heart rate (tachycardia);
A rise in the level of yellow-red pigment (bilirubin) that is synthesized by the liver (established by blood tests);
Swollen and usually itchy plaques on the skin or mucous membranes (urticaria);
Hair loss (alopecia);
Menstruation disorders (menorrhagia).
Uncommon (may affect up to 1 in 100 users):
Decreased platelet counts (which promote blood coagulation) (thrombocytopenia);
Increased blood levels of certain fats (triglycerides) (as determined by blood tests), see section 2 "Warnings and Precautions";
Increasing the level of a specific hepatic enzyme (gamma GT) that is synthesized by the liver (established by blood tests);
Inflammation of the liver (hepatitis);
Changing the color of the skin.
Rare (may affect up to 1 to 1,000 users):
Serious allergic (anaphylactic) reactions;
Impaired thyroid function (thyroid disorders), severely increased production of hormones (hyperthyroidism);
Inflammation of the pancreas (pancreatitis), see section 2 "Warnings and Precautions";
Blood clots in small blood vessels that may affect your kidneys (thrombotic thrombocytopenic purpura or haemolytic uraemic syndrome). Symptoms may include more frequent bruising, bleeding, fever, excessive weakness, headache, dizziness or vertigo. Your doctor may experience changes in your blood and kidney function.
Adverse reactions found only in post-marketing experience:
Kidney problems, including scarring (glomerulosclerosis), which may reduce renal function, uncommon;
Severe loss of appetite leading to weight loss (anorexia), seldom;
Heart muscle damage (cardiomyopathy), seldom;
Sudden onset of shortness of breath (bronchospasm), rarely;
Impaired hepatic function (liver damage (including hepatitis), hepatic failure), rarely;
When using medicines such as Betaferon, problems with small blood vessels (capillaries) (systemic capillary leak syndrome) may not occur with frequency.
How to store Betaferon
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not store above 25 ° C. Do not freeze.
Use the solution as soon as it is prepared. If this is not possible, it is suitable for use up to 3 hours at 2-8 ° C (in the refrigerator).
Do not use this medicine if you notice it contains particles or if it is discolored.
Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Betaferon contains:
The active substance is: interferon beta-1b 250 micrograms per ml of reconstituted solution.
The other ingredients are:
In the powder: mannitol and human albumin;
In the solvent (sodium chloride solution 5.4 mg / ml (0.54% (w / v)): sodium chloride, water for injections.
Betaferon powder is available in a 3 ml 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 solvent for Betaferon is supplied in 1.2 ml pre-filled syringes and contains 1.2 ml of sodium chloride solution 5.4 mg / ml (0.54% w / v).
What Betaferon looks like and contents of the pack
Betaferon is a sterile white to off-white powder for solution for injection.
Betaferon is available in packs of:
5 vials of interferon beta-1b and 5 pre-filled syringes containing solvent (sodium chloride solution);
15 vials of interferon beta-1b and 15 pre-filled syringes containing solvent (sodium chloride solution).