Kineret Side Effects

Generic Name: anakinra

Note: This page contains information about the side effects of anakinra. Some of the dosage forms included on this document may not apply to the brand name Kineret.

Not all side effects for Kineret may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to anakinra: subcutaneous solution

In addition to its needed effects, some unwanted effects may be caused by anakinra (the active ingredient contained in Kineret). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking anakinra:

More common
  • Diarrhea
  • fever or chills
  • headache
  • itching, pain, redness, swelling, tenderness or warmth on the skin
  • joint pain
  • muscle aches and pains
  • nausea or vomiting
  • runny nose or sneezing
  • sore throat
Less common or rare
  • Difficulty with swallowing
  • hives, itching, or rash
  • swelling of the face or lips
  • unusual bruising or bleeding
  • unusual tiredness or weakness
Incidence not known
  • Dizziness
  • fast heartbeat
  • hives or welts
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • puffiness or swelling of the eyelids or around the eyes, face, lips or tongue

Some of the side effects that can occur with anakinra may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Abdominal or stomach pain
  • bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • difficulty with moving
  • headache
  • muscle aches or stiffness

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 (the active ingredient contained in Kineret) 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 (the active ingredient contained in Kineret) 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 (the active ingredient contained in Kineret) 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

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

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.

Other

Patients who received both anakinra (the active ingredient contained in Kineret) 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.

Hepatic

Hepatic postmarketing side effects have included elevations of transaminases and non-infectious hepatitis.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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