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Rebif

Rebif

Rebif Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Rebif (interferon beta-1a) Injection 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 pain, swelling, or redness at the injection site. Flu-like symptoms such as headache, fatigue, fever, chills, and muscle aches may occur when you first start this medication. 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.

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 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

SIDE EFFECTS: Pain, redness, or swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor promptly.

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, 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
(Adverse Reactions)

SIDE EFFECTS

The most frequently reported serious adverse reactions with Rebif® were psychiatric disorders including depression and suicidal ideation or attempt (see WARNINGS). The incidence of depression of any severity in the Rebif®-treated groups and placebo-treated group was approximately 25%. In post-marketing experience, Rebif® administration has been rarely associated with severe liver dysfunction, including hepatic failure requiring liver transplantation (see WARNINGS: Hepatic Injury).

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 symptom) were injection site disorders, influenza-like symptoms, depression and elevation of liver enzymes (see WARNINGS).

In Study 1, 6 patients randomized to Rebif® 44 mcg three times per week (3%), and 2 patients who received Rebif® 22 mcg three times per week (1%) developed injection site necrosis during two years of therapy. Rebif® was continued in 7 patients and interrupted briefly in one patient. There was one report of injection site necrosis in Study 2 during 48 weeks of Rebif® treatment. All events resolved with conservative management; none required skin debridement or grafting.

The rates of adverse reactions and association with Rebif® in patients with relapsing-remitting multiple sclerosis are drawn from the placebo-controlled study (n = 560) and the active comparator-controlled study (n = 339).

The population encompassed an age range 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.

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.

Table 3 enumerates adverse events 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

Body System Preferred Term Placebo tiw
(n=187)
Rebif® 22 mcg tiw
(n=189)
Rebif® 44 mcg tiw
(n=184)
BODY AS A WHOLE
  Influenza-like symptoms 51% 56% 59%
  Headache 63% 65% 70%
  Fatigue 36% 33% 41%
  Fever 16% 25% 28%
  Rigors 5% 6% 13%
  Chest Pain 5% 6% 8%
  Malaise 1% 4% 5%
INJECTION SITE DISORDERS
  Injection Site Reaction 39% 89% 92%
  Injection Site Necrosis 0% 1% 3%
CENTRAL & PERIPH NERVOUS SYSTEM DISORDERS
  Hypertonia 5% 7% 6%
  Coordination Abnormal 2% 5% 4%
  Convulsions 2% 5% 4%
ENDOCRINE DISORDERS
  Thyroid Disorder 3% 4% 6%
GASTROINTESTINAL SYSTEM DISORDERS
  Abdominal Pain 17% 22% 20%
  Dry Mouth 1% 1% 5%
LIVER AND BILIARY SYSTEM DISORDERS
  SGPT Increased 4% 20% 27%
  SGOT Increased 4% 10% 17%
  Hepatic Function Abnormal 2% 4% 9%
  Bilirubinaemia 1% 3% 2%
MUSCULO-SKELETAL SYSTEM DISORDERS
  Myalgia 20% 25% 25%
  Back Pain 20% 23% 25%
  Skeletal Pain 10% 15% 10%
HEMATOLOGIC DISORDERS
  Leukopenia 14% 28% 36%
  Lymphadenopathy 8% 11% 12%
  Thrombocytopenia 2% 2% 8%
  Anemia 3% 3% 5%
PSYCHIATRIC DISORDERS
  Somnolence 1% 4% 5%
SKIN DISORDERS
  Rash Erythematous 3% 7% 5%
  Rash Maculo-Papular 2% 5% 4%
URINARY SYSTEM DISORDERS
  Micturition Frequency 4% 2% 7%
  Urinary Incontinence 2% 4% 2%
VISION DISORDERS
  Vision Abnormal 7% 7% 13%
  Xerophthalmia 0% 3% 1%

The adverse reactions were generally similar in Studies 1 and 2, taking into account the disparity in study durations.

Immunogenicity

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 clinical significance of the presence of NAb to Rebif® is unknown.

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.

Anaphylaxis and other allergic reactions have been observed with the use of Rebif® (see WARNINGS: Anaphylaxis).

Drug Abuse And Dependence

There is no evidence that abuse or dependence occurs with Rebif® therapy. However, the risk of dependence has not been systematically evaluated.

Read the entire FDA prescribing information for Rebif (Interferon beta-1a) »

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Rebif - User Reviews

Rebif 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 Rebif 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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