Amevive Side Effects

Generic Name: alefacept

Please note - some side effects for Amevive may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Amevive - for the Consumer

Amevive

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Amevive:

Dizziness; increased cough; muscle aches or pain; nausea; pain or swelling at the injection site; sore throat or throat inflammation.

Seek medical attention right away if any of these SEVERE side effects occur when using Amevive:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; chills; fever; new or altered skin lesions or spots; painful or frequent urination; persistent sore throat; serious infections; swollen glands; unusual lumps; unusual vaginal discharge ; white patches in the mouth (oral thrush).

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Amevive Side Effects - for the Professional

Amevive

The most serious adverse reactions were:

• Lymphopenia
• Malignancies
• Serious Infections requiring hospitalization
• Hypersensitivity Reactions

Commonly observed adverse events seen in the first course of placebo-controlled clinical trials with at least a 2% higher incidence in the Amevive®-treated patients compared to placebo-treated patients were: pharyngitis, dizziness, increased cough, nausea, pruritus, myalgia, chills, injection site pain, injection site inflammation, and accidental injury. The only adverse event that occurred at a 5% or higher incidence among Amevive®-treated patients compared to placebo-treated patients was chills (1% placebo vs. 6% Amevive®), which occurred predominantly with intravenous administration.

The adverse reactions which most commonly resulted in clinical intervention were cardiovascular events including coronary artery disorder in <1% of patients and myocardial infarct in <1% of patients. These events were not observed in any of the 413 placebo-treated patients. The total number of patients hospitalized for cardiovascular events in the Amevive®-treated group was 1.2% (11/876).

The most common events resulting in discontinuation of treatment with Amevive® were CD4+ T lymphocyte levels below 250 cells/µL, headache (0.2%), and nausea (0.2%).

Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information does, however, provide a basis for identifying the adverse events that appear to be related to drug use and a basis for approximating rates.

The data described below reflect exposure to Amevive® in a total of 1869 psoriasis patients, of whom 1315 (70%) received 1 to 2 courses of therapy and 554 (30%) received 3 or more courses. The median duration of follow-up was 8.4 months for the patients who received 1 to 2 courses and 27.7 months for the patients who received 3 or more courses of Amevive®. Of the 1869 total patients, 876 received their first course in placebo-controlled studies. The population studied ranged in age from 16 to 84 years, and included 69% men and 31% women. The patients were mostly Caucasian (88%), reflecting the general psoriatic population. Disease severity at baseline was moderate to severe psoriasis.

Effect on Lymphocyte Counts

In the intramuscular study (Study 2), 4% of patients temporarily discontinued treatment and no patients permanently discontinued treatment due to CD4+ T lymphocyte counts below the specified threshold of 250 cells/µL. In Study 2, 10%, 28%, and 42% of patients had total lymphocyte, CD4+, and CD8+ T lymphocyte counts below normal, respectively. Twelve weeks after a course of therapy (12 weekly doses), 2%, 8%, and 21% of patients had total lymphocyte, CD4+, and CD8+ T cell counts below normal.

In the first course of the intravenous study (Study 1), 10% of patients temporarily discontinued treatment and 2% permanently discontinued treatment due to CD4+ T lymphocyte counts below the specified threshold of 250 cells/µL. During the first course of Study 1, 22% of patients had total lymphocyte counts below normal, 48% had CD4+ T lymphocyte counts below normal and 59% had CD8+ T lymphocyte counts below normal. The maximal effect on lymphocytes was observed within 6 to 8 weeks of initiation of treatment. Twelve weeks after a course of therapy (12 weekly doses), 4% of patients had total lymphocyte counts below normal, 19% had CD4+ T lymphocyte counts below normal, and 36% had CD8+ T lymphocyte counts below normal.

For patients receiving a second course of Amevive® in Study 1, 17% of patients had total lymphocyte counts below normal, 44% had CD4+ T lymphocyte counts below normal, and 56% had CD8+ T lymphocyte counts below normal. Twelve weeks after completing dosing, 3% of patients had total lymphocyte counts below normal, 17% had CD4+ T lymphocyte counts below normal, and 35% had CD8+ T lymphocyte counts below normal.

In an open-label postmarketing study, subjects with psoriasis were treated with up to three courses of Amevive: each course consisted of Amevive 15mg IM weekly for twelve weeks, followed by twelve weeks of observation. Lymphocyte counts were assessed at regular intervals during the post-treatment observation period. For subjects whose counts went below 75% of the baseline at any time after the last dose in the study, the time from the last dose to the time that their lymphocyte count returned to ≥75% of baseline was analyzed. Of 115 evaluable subjects for total lymphocyte counts, the median time of recovery was 2.1 months with a range of 0.6 to 11.1 months. Of the 123 evaluable subjects for CD4+ T cell counts, the median time to recovery was 2.3 months with the range of 0.6 to 12.4 months. Of the 105 evaluable subjects for CD8+ T cell counts, the median time to recovery was 1.6 months with a range of 0.6 to 8.7 months.

Malignancies

In the 24-week period constituting the first course of placebo-controlled studies, 13 malignancies were diagnosed in 11 Amevive®-treated patients. The incidence of malignancies was 1.3% (11/876) for Amevive®-treated patients compared to 0.5% (2/413) in the placebo group.

Among 1869 patients who received Amevive® at any dose in clinical trials, 43 patients were diagnosed with 63 treatment-emergent malignancies. The majority of the malignancies were non-melanoma skin cancers: 46 cases (20 basal cell, 26 squamous cell carcinomas) in 27 patients. Other malignancies observed in Amevive®-treated patients included melanoma (n=3), solid organ malignancies (n=12 in 11 patients), and lymphomas (n=5); the latter consisted of two Hodgkin’s and two non-Hodgkin’s lymphomas, and one cutaneous T cell lymphoma (mycosis fungoides).

Infections

In the 24-week period constituting the first course of placebo-controlled studies, serious infections (infections requiring hospitalization) were seen at a rate of 0.9% (8/876) in Amevive®-treated patients and 0.2% (1/413) in the placebo group. In patients receiving repeated courses of Amevive® therapy, the rates of serious infections remained similar across courses of therapy. Serious infections among 1869 Amevive®-treated patients included cellulitis, abscesses, wound infections, toxic shock, pneumonia, appendicitis, cholecystitis, gastroenteritis and herpes infections.

Hypersensitivity Reactions

In clinical studies, 4 of 1869 (0.2%) patients were reported to experience angioedema: two of these patients were hospitalized. In the 24-week period constituting the first course of placebo-controlled studies, urticaria was reported in 6 (<1%) Amevive®-treated patients vs. 1 patient in the control group. Urticaria resulted in discontinuation of therapy in one of the Amevive®-treated patients.

Hepatic Injury

In post-marketing experience there have been reports of asymptomatic transaminase elevation, fatty infiltration of the liver, hepatitis, and severe liver failure.

In the 24-week period constituting the first course of placebo-controlled studies, 1.7% (15/876) of Amevive®-treated patients and 1.2% (5/413) of the placebo group experienced ALT and/or AST elevations of at least 3 times the upper limit of normal.

Injection Site Reactions

In the intramuscular study (Study 2), 16% of Amevive®-treated patients and 8% of placebo-treated patients reported injection site reactions. In patients receiving repeated courses of Amevive® IM therapy, the incidence of injection site reactions remained similar across courses of therapy. Reactions at the site of injection were generally mild, typically occurred on single occasions, and included either pain (7%), inflammation (4%), bleeding (4%), edema (2%), non-specific reaction (2%), mass (1%), or skin hypersensitivity (<1%). In the clinical trials, a single case of injection site reaction led to the discontinuation of Amevive®.

Immunogenicity

Approximately 3% (40/1357) of patients receiving Amevive® developed low-titer antibodies to alefacept as determined by an ELISA. When anti-alefacept antibodies were assessed using a dual specificity Biacore assay, 72% (72/100) of patients receiving Amevive® were positive for anti-alefacept antibodies. The long-term immunogenicity of Amevive® is unknown.

Results are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody 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 alefacept with the incidence of antibodies to other products may be misleading.

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Side Effects by Body System - for Healthcare Professionals

Immunologic

Immunologic side effects including dose-dependent reductions in circulating CD4+ and CD8+ T lymphocyte counts have been reported.

Cardiovascular

Cardiovascular side effects including coronary artery disorder (<1%) and myocardial infarction (<1%) have been the adverse reactions which most commonly resulted in clinical intervention.

The total percentage of alefacept-treated patients hospitalized for cardiovascular events was 1.2%.

Oncologic

Oncologic side effects including malignancies have been reported.

Twenty five of the 1,357 patients who received alefacept were diagnosed with a total of 35 treatment-emergent malignancies. Six cases were basal cell and seventeen cases were squamous cell cancers of the skin. Three cases of lymphoma have been reported; one was classified as non-Hodgkin's follicle-center cell lymphoma and two were classified as Hodgkin's disease.

General

Chills have been reported to occur predominantly with intravenous administration.

General side effects including chills (6%), dizziness, headache, and accidental injury have been reported.

Local

Local side effects including injection site pain and injection site inflammation have been reported.

Gastrointestinal

Gastrointestinal side effects including nausea have been reported.

Respiratory

Respiratory side effects including pharyngitis and increased cough have been reported.

Dermatologic

Dermatologic side effects including pruritus have been reported.

Musculoskeletal

Musculoskeletal side effects including myalgia have been reported.

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