"April 15, 2010 (Toronto) -- Nearly 71% of people with early relapsing-remitting
multiple sclerosis (MS) treated with the experimental MS drug alemtuzumab showed no evidence of disease activity four years into a study, researchers report./"...
Rebif Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Rebif (interferon beta-1a) Injection is made from human proteins and is used to treat relapsing multiple sclerosis (MS). Rebif will not cure MS; it will only decrease the frequency of relapse symptoms. Common side effects of Rebif include pain, swelling, or redness at the injection site. Flu-like symptoms such as headache, dizziness, fatigue, fever, chills, stomach pain, runny or stuffy nose, and muscle aches may occur when you first start Rebif. These symptoms usually improve or go away after a few months of continued use. Some patients using interferon medications become depressed or have suicidal thoughts. Tell your doctor immediately if this occurs.
The recommended dosage of Rebif is 22 mcg to 44 mcg injected subcutaneously three times per week. Rebif is intended for use under the supervision of a physician. Patients may self-inject only after proper training. Rebif may interact with other drugs. Tell your doctor all medications and supplements you take. Talk to your doctor about how to drink alcohol safely while using this medication. Rebif should not be used during pregnancy. Talk to your doctor if you are pregnant or think you might become pregnant during treatment. Consult your doctor before breastfeeding.
Our Rebif (interferon beta-1a) Injection 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.
Rebif 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.
Call your doctor at once if you have a serious side effect such as:
- depressed mood, anxiety, trouble sleeping, restlessness, or thoughts of suicide or hurting yourself;
- easy bruising or bleeding, weakness;
- seizure (convulsions);
- numbness or tingling in your hands or feet;
- pain or burning when you urinate;
- pain, swelling, or skin changes where the injection was given;
- 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:
- headache, dizziness;
- stomach pain; or
- runny or stuffy nose.
Read the entire detailed patient monograph for Rebif (Interferon beta-1a)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Rebif Overview - Patient Information: Side Effects
Flu-like symptoms such as headache, nausea, fever, chills, tiredness, and muscle aches/pain may occur, especially when you first start this medication. You can reduce these side effects by injecting this medicine at bedtime and using fever reducers/pain relievers such as acetaminophen or ibuprofen. 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., depression, rare thoughts of suicide), vision changes, gradual change in weight, intolerance to cold or heat, increased urination, pus or change in skin color at the injection site, signs of infection (e.g., fever, persistent sore throat, cough), easy bruising/bleeding, fast/irregular heartbeat, sudden increase in weight, swelling hands/legs/feet, severe stomach/abdominal pain, yellowing eyes/skin, dark urine.
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 Rebif (Interferon beta-1a)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Rebif FDA Prescribing Information: Side Effects
The following adverse reactions are discussed in more detail in the WARNINGS AND PRECAUTIONS section of the label:
- Depression and Suicide [see WARNINGS AND PRECAUTIONS]
- Hepatic Injury [see WARNINGS AND PRECAUTIONS]
- Anaphylaxis and Other Allergic Reactions [see WARNINGS AND PRECAUTIONS]
- Injection Site Reactions including Necrosis [see WARNINGS AND PRECAUTIONS]
- Decreased Peripheral Blood Counts [see WARNINGS AND PRECAUTIONS]
- Thrombotic Microangiopathy [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
- Laboratory Tests [see WARNINGS AND PRECAUTIONS]
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of REBIF cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in practice.
A total of 712 patients with relapsing-remitting multiple sclerosis (RRMS) in two controlled clinical trials took REBIF (22 mcg or 44 mcg given three times per week) [see Clinical Studies]. Ages ranged from 18 to 55 years. Nearly three-fourths of the patients were female, and more than 90% were Caucasian, largely reflecting the general demographics of the population of patients with multiple sclerosis.
The most commonly reported adverse reactions were injection site disorders, influenza-like symptoms (headache, fatigue, fever, rigors, chest pain, back pain, myalgia), abdominal pain, depression, elevation of liver enzymes and hematologic abnormalities. The most frequently reported adverse reactions resulting in clinical intervention (e.g., discontinuation of REBIF, adjustment in dosage, or the need for concomitant medication to treat an adverse reaction were injection site disorders, influenza-like symptoms, depression, and elevation of liver enzymes [see WARNINGS AND PRECAUTIONS].
Study 1 was a 2-year placebo-controlled study in RRMS patients treated with REBIF 22 mcg(n=189), 44 mcg (n=184), or placebo (n=187). Table 3 enumerates adverse reactions and laboratory abnormalities that occurred at an incidence that was at least 2% more in either REBIF-treated group than was observed in the placebo group.
Table 3: Adverse Reactions and Laboratory
Abnormalities in Study 1
|REBIF 22 mcg tiw
|REBIF 44 mcg tiw
|BODY AS A WHOLE|
|INJECTION SITE DISORDERS|
|Injection Site Reaction||39||89||92|
|Injection Site Necrosis||0||1||3|
|NERVOUS SYSTEM DISORDERS|
|GASTROINTESTINAL SYSTEM DISORDERS|
|LIVER AND BILIARY SYSTEM DISORDERS|
|MUSCULO-SKELETAL SYSTEM DISORDERS|
|URINARY SYSTEM DISORDERS|
Adverse reactions in Study 2, a 1-year active-controlled (vs. interferon beta-1a, 30 mcg once weekly intramuscular injection, n=338) study including 339 patients with MS treated with REBIF were generally similar to those in Study 1, taking into account the disparity in study durations.
Anaphylaxis and other allergic reactions have been observed with the use of REBIF [see WARNINGS AND PRECAUTIONS]. As with all therapeutic proteins, there is a potential for immunogenicity. In Study 1, the presence of neutralizing antibodies (NAb) to REBIF was determined by collecting and analyzing serum pre-study and at 6 month time intervals during the 2 years of the clinical trial. Serum NAb were detected in 59/189 (31%) and 45/184 (24%) of REBIF-treated patients at the 22 mcg and 44 mcg three times per week doses, respectively, at one or more times during the study. The data reflect the percentage of patients whose test results were considered positive for antibodies to REBIF using an antiviral cytopathic effect assay, and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of NAb positivity 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 REBIF with the incidence of antibodies to other products may be misleading.
The following adverse reactions have been identified during post-approval use of REBIF. 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.
Autoimmune Disorders: Drug-induced lupus erythematosus, autoimmune hepatitis
Eye Disorders: Retinal vascular disorders (i.e. retinopathy, cotton wool spots or obstruction of retinal artery or vein)
Skin and Subcutaneous Tissue Disorders: Erythema multiforme, Stevens-Johnson syndrome
Read the entire FDA prescribing information for Rebif (Interferon beta-1a)
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Report Problems to the Food and Drug Administration
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