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Rebif (Interferon Beta-1a) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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



REPORTS OF SUSPECTED REBIF SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Rebif. The information is not vetted and should not be considered as verified clinical evidence.

Possible Rebif side effects / adverse reactions in 42 year old female

Reported by a consumer/non-health professional from Germany on 2011-10-04

Patient: 42 year old female

Reactions: Breast Cancer, Impaired Healing

Adverse event resulted in: hospitalization

Suspect drug(s):
Rebif



Possible Rebif side effects / adverse reactions in 60 year old female

Reported by a consumer/non-health professional from Greece on 2011-10-04

Patient: 60 year old female

Reactions: Breast Cancer

Adverse event resulted in: hospitalization

Suspect drug(s):
Rebif



Possible Rebif side effects / adverse reactions in 55 year old male

Reported by a consumer/non-health professional from Greece on 2011-10-04

Patient: 55 year old male

Reactions: Laryngeal Cancer

Adverse event resulted in: hospitalization

Suspect drug(s):
Rebif



See index of all Rebif side effect reports >>

Drug label data at the top of this Page last updated: 2006-09-09

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