Anakinra Side Effects

Some side effects of anakinra may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to anakinra: subcutaneous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking anakinra: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious infections may occur during treatment with anakinra. Stop using this medicine and call your doctor right away if you have signs of infection such as:

• fever, sweating, chills, tired feeling;

• feeling short of breath;

• cough, sore throat;

• sores in your mouth and throat; or

• flu symptoms, weight loss.

Less serious side effects of anakinra may include:

• nausea, diarrhea, stomach pain;

• headache;

• cold symptoms such as stuffy nose, sneezing, sore throat; or

• redness, bruising, pain, or swelling where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to anakinra: subcutaneous solution

General

In general, the most serious side effects have included infections and neutropenia, while the most common side effects have included injection site reactions.

Local

Five patients with rheumatoid arthritis developed inflammatory lesions at the injection site coincident with anakinra therapy. The onset of the reaction was within the first month of therapy and appeared well-defined erythema and edema. The treatment had been discontinued in two patients, and in one patient it was associated with systemic involvement.

Local side effects have been reported the most frequently. These have included injection site reactions (55.83% to 72.6%) including erythema, ecchymosis, inflammation, and pain. The majority were characterized as mild severity and lasted for 14 to 28 days. At least 5 cases of inflammatory lesions at the injection site have also been reported.

Hematologic

Hematologic side effects have included decreases in absolute neutrophil count (8%), total white blood cell count, and platelets, and small increases in the eosinophil differential percentage. Neutropenia has been reported in 0.3% of study patients receiving anakinra monotherapy and in 3% of patients receiving combination therapy with etanercept.

Immunologic

Immunologic side effects have included development of immunogenicity. Twenty-eight percent of study patients tested positively for anti-anakinra antibodies at 6 months and less than 1% of patients tested seropositive for anakinra neutralizing antibodies.

Gastrointestinal

Gastrointestinal side effects have included nausea (8%), diarrhea (7%), and abdominal pain (5%).

Respiratory

Respiratory side effects have included upper respiratory tract infections (13%) sinusitis (6%), and bronchitis (3.4%).

Nervous system

Nervous system side effects have included headache (12%).

Musculoskeletal

Musculoskeletal side effects have included arthralgia (6%).

Genitourinary

Genitourinary side effects including urinary tract infections have been reported in 4.6% of patients.

Dermatologic

A 75-year-old female with a history of rheumatoid arthritis experienced psoriasis coincident with anakinra therapy. She was administered anakinra therapy 100 mg daily subcutaneously. Nine months later, the patient presented with typical psoriatic, scaly, erythematous plaques on the elbows. Skin biopsy from the patient's left elbow revealed psoriasiform hyperplasia, parakeratosis and lymphocytic infiltrate in the upper dermis, consistent with psoriasis. Therapy with anakinra was discontinued, and the psoriatic lesions improved significantly with the addition of topical steroids and vitamin D. The implication of anakinra in the development of psoriasis seems likely given the temporal relationship between the initiation of anakinra therapy and the onset of the skin condition; and the absence of other known triggering factors for the onset of psoriasis.

Dermatologic side effects including at least one case of psoriasis have been reported.

Other

Patients who received both anakinra and etanercept had a higher incidence of serious infections (7%).

Asthmatic patients had a higher risk of serious infections (5% vs. less than 1% for placebo).

Other side effects including Influenza-like symptoms have been reported in 5.8% of patients. Serious infections that were primarily bacterial have been reported in 1.8% of patients vs. 0.6% for placebo. These have included cellulitis, pneumonia, and bone and joint infections.

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