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Betaseron

Last reviewed on RxList: 4/9/2020
Betaseron Side Effects Center

What Is Betaseron?

Betaseron (interferon beta-1b) is an immunological agent made from human proteins used to treat relapsing multiple sclerosis (MS). Betaseron will not cure MS, it will only decrease the frequency of relapse symptoms.

What Are Side Effects of Betaseron?

Common side effects of Betaseron include:

  • injection site reactions (pain, swelling, redness),
  • abdominal or stomach pain,
  • constipation,
  • diarrhea,
  • upset stomach,
  • weakness,
  • muscle pain,
  • nausea,
  • swelling in your hands or feet,
  • skin rash, or
  • irregular menstrual periods.

Most patients have flu-like symptoms such as headache, tiredness, fever, chills, and muscle aches when they start Betaseron. Symptoms usually last about 1 day after the injection with Betaseron and improve or go away after a few months of continued use. Tell your doctor if you have serious side effects of Betaseron including:

  • mental/mood changes (e.g., new or worsening depression, thoughts of suicide, psychosis),
  • feeling too hot or cold,
  • unusual tiredness,
  • unexplained change in weight,
  • easy bleeding or bruising,
  • persistent nausea or vomiting,
  • pus or change in skin color at the injection site,
  • dark urine,
  • yellowing eyes or skin, or
  • swelling ankles or feet.

Dosage for Betaseron

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.

What Drugs, Substances, or Supplements Interact with Betaseron?

Other drugs may affect Betaseron. Tell your doctor all prescription and over-the-counter medications and supplements you use.

Betaseron During Pregnancy and Breastfeeding

Betaseron is not recommended for use during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

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.

SLIDESHOW

Multiple Sclerosis (MS) Symptoms and Treatment See Slideshow
Betaseron Consumer Information

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

Some patients using interferon medicines have become very depressed or had thoughts of suicide. Report any new or worsening symptoms of depression to your doctor, such as: mood or behavior changes, anxiety, trouble sleeping, hallucinations, or if you feel impulsive, hostile, aggressive, depressed, or have thoughts about suicide or hurting yourself.

Stop using interferon beta-1b and call your doctor at once if you have:

  • fever, chills, body aches, flu symptoms;
  • a seizure;
  • pain, swelling, redness, or skin changes where an injection was given;
  • easy bruising, unusual bleeding, purple or red spots under your skin;
  • heart problems--swelling, rapid weight gain, feeling short of breath;
  • liver problems--nausea, vomiting, tiredness, itching, dark urine, jaundice (yellowing of your skin or eyes); or
  • new or worsening symptoms of lupus--joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

Common side effects may include:

  • headache, weakness;
  • sleep problems (insomnia);
  • stomach pain;
  • muscle pain;
  • abnormal liver function tests;
  • skin rash;
  • flu symptoms; or
  • a skin reaction where the medicine was injected.

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)

QUESTION

What kind of disease is multiple sclerosis? See Answer
Betaseron Professional Information

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 reaction1 26% 78%
Asthenia 48% 53%
Flu-like symptoms (complex)2 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%
1 “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.
2 “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 interferoninducible 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*

*The administration of cytokines to patients with a pre-existing monoclonal gammopathy has been associated with the development of this syndrome.

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

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