Betaseron

DRUG DESCRIPTION

Betaseron® (Interferon beta-lb) is a purified, sterile, lyophilized protein product produced by recombinant DNA techniques. Interferon beta-1b is manufactured by bacterial fermentation of a strain of Escherichia coli that bears a genetically engineered plasmid containing the gene for human interferon betaser17. The native gene was obtained from human fibroblasts and altered in a way that substitutes serine for the cysteine residue found at position 17. Interferon beta-1b has 165 amino acids and an approximate molecular weight of 18,500 daltons. It does not include the carbohydrate side chains found in the natural material.

The specific activity of Betaseron (interferon beta-1b) is approximately 32 million international units (IU)/mg Interferon beta-lb. Each vial contains 0.3 mg of Interferon beta-lb. The unit measurement is derived by comparing the antiviral activity of the product to the World Health Organization (WHO) reference standard of recombinant human interferon beta. Mannitol, USP and Albumin (Human), USP (15 mg each/vial) are added as stabilizers.

Lyophilized Betaseron (interferon beta-1b) is a sterile, white to off-white powder, for subcutaneous injection after reconstitution with the diluent supplied (Sodium Chloride, 0.54% Solution).

What are the possible side effects of interferon beta-1b (Betaseron, Extavia)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using interferon beta-1b and call your doctor at once if you have any of these serious side effects:

  • depressed mood, anxiety, trouble sleeping, restlessness, or thoughts of suicide or hurting yourself;
  • bruising, swelling, oozing, or skin changes where the injection was given;
  • weight changes, pounding heartbeats, feeling too...

Read All Potential Side Effects and See Pictures of Betaseron »

What are the precautions when taking interferon beta-1b (Betaseron)?

Before using interferon, tell your doctor or pharmacist if you are allergic to it; or to products containing human albumin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood cell disorders (e.g., anemia, neutropenia, thrombocytopenia), heart disease (e.g., angina, irregular heartbeat, congestive heart failure), liver disease, mental/mood disorders (e.g., depression, psychosis, suicidal thoughts), seizure disorder, thyroid disease, use/abuse of alcohol.

This medication is not recommended for use during pregnancy. Consult your doctor for more...

Read All Potential Precautions of Betaseron »


Betaseron Consumer (continued)

SIDE EFFECTS: Injection site reactions (pain/swelling/redness), abdominal pain, constipation, diarrhea, upset stomach, and nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Most patients have flu-like symptoms such as headache, tiredness, fever, chills, and muscle aches when they first start this medication. These symptoms usually last about 1 day after the injection and improve or go away after a few months of continued use. You can reduce these side effects by injecting this medicine at bedtime and using fever reducers/pain relievers such as acetaminophen or ibuprofen before each dose. Consult your doctor or pharmacist for more information.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (e.g., new or worsening depression, thoughts of suicide, psychosis), feeling too hot or cold (more than others around you), persistent tiredness, gradual change in weight (without a change in diet or exercise), easy bleeding/bruising, persistent nausea/vomiting, signs of infection (e.g., fever, persistent sore throat), stomach/abdominal pain, dark urine, yellowing eyes/skin.

Get medical help right away if any of these rare but very serious side effects occur: chest pain, seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using interferon, tell your doctor or pharmacist if you are allergic to it; or to products containing human albumin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood cell disorders (e.g., anemia, neutropenia, thrombocytopenia), heart disease (e.g., angina, irregular heartbeat, congestive heart failure), liver disease, mental/mood disorders (e.g., depression, psychosis, suicidal thoughts), seizure disorder, thyroid disease, use/abuse of alcohol.

This medication is not recommended for use during pregnancy. Consult your doctor for more details.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Betaseron Patient Information Including Side Effects

Brand Names: Betaseron, Extavia

Generic Name: interferon beta-1b (Pronunciation: in ter FEAR on BAY ta 1b)

  • What is interferon beta-1b (Betaseron)?
  • What are the possible side effects of interferon beta-1b (Betaseron)?
  • What is the most important information I should know about interferon beta-1b (Betaseron)?
  • What should I discuss with my healthcare provider before using interferon beta-1b (Betaseron)?
  • How should I use interferon beta-1b (Betaseron)?
  • What happens if I miss a dose (Betaseron)?
  • What happens if I overdose (Betaseron)?
  • What should I avoid while using interferon beta-1b (Betaseron)?
  • What other drugs will affect interferon beta-1b (Betaseron)?
  • Where can I get more information?

What is interferon beta-1b (Betaseron)?

Interferon beta-1b is made from human proteins. Interferons help the body fight viral infections.

Interferon beta-1b is used to treat relapsing multiple sclerosis (MS). This medication will not cure MS, it will only decrease the frequency of relapse symptoms.

Interferon beta-1b may also be used for other purposes other than those listed in this medication guide.

What are the possible side effects of interferon beta-1b (Betaseron)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using interferon beta-1b and call your doctor at once if you have any of these serious side effects:

  • depressed mood, anxiety, trouble sleeping, restlessness, or thoughts of suicide or hurting yourself;
  • bruising, swelling, oozing, or skin changes where the injection was given;
  • weight changes, pounding heartbeats, feeling too hot or cold;
  • fever, chills, body aches, flu symptoms; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • weakness;
  • headache;
  • muscle pain or weakness;
  • sleep problems (insomnia);
  • stomach pain;
  • swelling in your hands or feet;
  • skin rash; or
  • irregular menstrual periods.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about interferon beta-1b (Betaseron)?

This medication may be harmful to an unborn baby, or may cause a miscarriage. Do not use interferon beta-1b if you are pregnant. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Before using interferon beta-1b, tell your doctor if you are allergic to any drugs, or if you have liver disease, a thyroid disorder, epilepsy or other seizure disorder, a bleeding or blood-clotting disorder, anemia (low red blood cells), or a history of depression or suicidal behavior.

Some patients using interferon medications have become very depressed or had thoughts of suicide. Stop using interferon beta-1b if you have symptoms of depression (sadness, crying, loss of interest in things you once liked) or if you have any thoughts of hurting yourself.

Interferon beta-1b is given as an injection under the skin, usually at bedtime every 48 hours (2 days). You may be given instructions on how to use your injections at home. You may be shown how to inject your medicine at home.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

To be sure this medication is not causing harmful effects, your blood and liver function will need to be tested on a regular basis. Your thyroid function may also need to be tested. Do not miss any scheduled appointments.

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