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Betaseron

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Betaseron

Betaseron Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Betaseron (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. It is made from human proteins. Common side effects include injection site reactions (pain/swelling/redness), abdominal pain, constipation, diarrhea, upset stomach, and nausea. Most patients have flu-like symptoms such as headache, tiredness, fever, chills, and muscle aches when they start this medication. Symptoms usually last about 1 day after the injection and improve or go away after a few months of continued use.

The recommended dose of Betaseron is 0.25 mg injected subcutaneously every other day. Starting dose is 0.0625 mg (0.25 mL) subcutaneously every other day, and increased over a six-week period to 0.25 mg (1.0 mL) every other day. Other drugs may affect Betaseron. Tell your doctor all prescription and over-the-counter medications and supplements you use. Betaseron is not recommended for use during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Betaseron (interferon beta-1b) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Betaseron in Detail - Patient Information: Side Effects

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.

Read the entire detailed patient monograph for Betaseron (Interferon beta-1b) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Betaseron Overview - Patient Information: Side Effects

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), unusual 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, swelling ankles/feet.

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.

Read the entire patient information overview for Betaseron (Interferon beta-1b)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Betaseron FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed in more details in other sections of labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions and over varying lengths of time, adverse reaction rates observed in the clinical trials of Betaseron cannot be directly compared to rates in clinical trials of other drugs, and may not reflect the rates observed in practice.

Among 1407 patients with MS treated with Betaseron 0.25 mg every other day (including 1261 patients treated for greater than one year), the most commonly reported adverse reactions (at least 5% more frequent on Betaseron than on placebo) were injection site reaction, lymphopenia, flu-like symptoms, myalgia leukopenia, neutropenia, increased liver enzymes, headache, hypertonia, pain, rash, insomnia, abdominal pain, and asthenia. The most frequently reported adverse reactions resulting in clinical intervention (for example, discontinuation of Betaseron, adjustment in dosage, or the need for concomitant medication to treat an adverse reaction symptom) were depression, flu-like symptom complex, injection site reactions, leukopenia, increased liver enzymes, asthenia, hypertonia, and myasthenia.

Table 2 enumerates adverse reactions and laboratory abnormalities that occurred among patients treated with 0.25 mg of Betaseron every other day by subcutaneous injection in the pooled placebo-controlled trials (Study 1-4) at an incidence that was at least 2% more than that observed in the placebo-treated patients [see Clinical Studies].

Table 2: Adverse Reactions and Laboratory Abnormalities in Patients with MS in Pooled Studies 1, 2, 3, and 4

Adverse Reaction Placebo (N=965) Betaseron (N=1407)
Blood and lymphatic system disorders
Lymphocytes count decreased ( < 1500/mm³ ) 66% 86%
Absolute neutrophil count decreased ( < 1500/mm³ ) 5% 13%
White blood cell count decreased ( < 3000/mm³ ) 4% 13%
Lymphadenopathy 3% 6%
Nervous system disorders
Headache 43% 50%
Insomnia 16% 21%
Incoordination 15% 17%
Vascular disorders
Hypertension 4% 6%
Respiratory, thoracic and mediastinal disorders
Dyspnea 3% 6%
Gastrointestinal disorders
Abdominal pain 11% 16%
Hepatobiliary disorders
Alanine aminotransferase increased (SGPT > 5 times baseline) 4% 12%
Aspartate aminotransferase increased (SGOT > 5 times baseline) 1% 4%
Skin and subcutaneous tissue disorders
Rash 15% 21%
Skin disorder 8% 10%
Musculoskeletal and connective tissue disorders
Hypertonia 33% 40%
Myalgia 14% 23%
Renal and urinary disorders
Urinary urgency 8% 11%
Reproductive system and breast disorders
Metrorrhagia 7% 9%
Impotence 6% 8%
General disorders and administration site conditions
Injection site reactiona 26% 78%
Asthenia 48% 53%
Flu-like symptoms (complex)b 37% 57%
Pain 35% 42%
Fever 19% 31%
Chills 9% 21%
Peripheral edema 10% 12%
Chest pain 6% 9%
Malaise 3% 6%
Injection site necrosis 0% 4%
a"Injection site reaction" comprises all adverse reactions occurring at the injection site (except injection site necrosis), that is, the following terms: injection site reaction, injection site hemorrhage, injection site hypersensitivity, injection site inflammation, injection site mass, injection site pain, injection site edema and injection site atrophy.
b "Flu-like symptom (complex)" denotes flu syndrome and/or a combination of at least two adverse reactions from fever, chills, myalgia, malaise, sweating. In addition to the Adverse Reactions listed in Table 2, the following adverse reactions occurred more frequently on Betaseron than on placebo, but with a difference smaller than 2%: alopecia, anxiety, arthralgia, constipation, diarrhea, dizziness, dyspepsia, dysmenorrhea, leg cramps, menorrhagia, myasthenia, nausea, nervousness, palpitations, peripheral vascular disorder, prostatic disorder, tachycardia, urinary frequency, vasodilatation, and weight increase.

Laboratory Abnormalities

In the four clinical trials (Studies 1, 2, 3, and 4), leukopenia was reported in 18% and 6% of patients in Betaseron- and placebo-treated groups, respectively. No patients were withdrawn or dose reduced for neutropenia in Study 1. Three percent (3%) of patients in Studies 2 and 3 experienced leukopenia and were dose-reduced. Other abnormalities included increase of SGPT to greater than five times baseline value (12%), and increase of SGOT to greater than five times baseline value (4%). In Study 1, two patients were dose reduced for increased hepatic enzymes; one continued on treatment and one was ultimately withdrawn. In Studies 2 and 3, 1.5% of Betaseron patients were dose-reduced or interrupted treatment for increased hepatic enzymes. In Study 4, 1.7% of patients were withdrawn from treatment due to increased hepatic enzymes, two of them after a dose reduction. In Studies 1-4, nine (0.6%) patients were withdrawn from treatment with Betaseron for any laboratory abnormality, including four (0.3%) patients following dose reduction.

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. Serum samples were monitored for the development of antibodies to Betaseron during Study 1. In patients receiving 0.25 mg every other day 56/124 (45%) were found to have serum neutralizing activity at one or more of the time points tested. In Study 4, neutralizing activity was measured every 6 months and at end of study. At individual visits after start of therapy, activity was observed in 17% up to 25% of the Betaseron-treated patients. Such neutralizing activity was measured at least once in 75 (30%) out of 251 Betaseron patients who provided samples during treatment phase; of these, 17 (23%) converted to negative status later in the study. Based on all the available evidence, the relationship between antibody formation and clinical safety or efficacy is not known.

These data reflect the percentage of patients whose test results were considered positive for antibodies to Betaseron using a biological neutralization assay that measures the ability of immune sera to inhibit the production of the interferon-inducible protein, MxA. Neutralization assays are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of neutralizing activity in an assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Betaseron with the incidence of antibodies to other products may be misleading.

Anaphylactic reactions have been reported with the use of Betaseron [see WARNINGS AND PRECAUTIONS].

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Betaseron. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and lymphatic system disorders: Anemia, Thrombocytopenia

Endocrine disorders: Hypothyroidism, Hyperthyroidism, Thyroid dysfunction

Metabolism and nutrition disorders: Triglyceride increased, Anorexia, Weight decrease, Weight increase

Psychiatric disorders: Anxiety, Confusion, Emotional lability

Nervous system disorders: Convulsion, Dizziness, Psychotic symptoms

Cardiac disorders: Cardiomyopathy, Palpitations, Tachycardia

Vascular disorders: Vasodilatation

Respiratory, thoracic and mediastinal disorders: Bronchospasm

Gastrointestinal disorders: Diarrhea, Nausea, Pancreatitis, Vomiting

Hepatobiliary disorders: Hepatitis, Gamma GT increased

Skin and subcutaneous tissue disorders: Alopecia, Pruritus, Skin discoloration, Urticaria

Musculoskeletal and connective tissue disorders: Arthralgia

Reproductive system and breast disorder: Menorrhagia

General disorders and administration site conditions: Fatal capillary leak syndrome*

Read the entire FDA prescribing information for Betaseron (Interferon beta-1b) »

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Betaseron - User Reviews

Betaseron User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Betaseron sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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