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Rebif

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Rebif

Rebif

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 Rebif (interferon beta-1a) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No formal drug interaction studies have been conducted with Rebif®. Due to its potential to cause neutropenia and lymphopenia, proper monitoring of patients is required if Rebif® is given in combination with myelosuppressive agents.

Also, the potential for hepatic injury should be considered when Rebif® is used in combination with other products associated with hepatic injury, or when new agents are added to the regimen of patients already on Rebif® (see WARNINGS: Hepatic injury).

Immunization

In a nonrandomized prospective clinical study, 86 multiple sclerosis (MS) patients on Rebif® 44 mcg three times per week for at least 6 months and 77 patients not receiving interferon received influenza vaccination. The proportion of patients achieving a positive antibody response (defined as a titer > 1:40 measured by a hemagglutination inhibition assay) was similar in the two groups (93% and 91%, respectively). The exact relationship of antibody titers to vaccine efficacy was not studied and is not known in patients receiving Rebif®. Therefore, while patients receiving Rebif® may receive concomitant vaccination, the overall effectiveness of such vaccination is unknown.

Last reviewed on RxList: 5/3/2013
This monograph has been modified to include the generic and brand name in many instances.

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