Kineret Side Effects & Safety

The safety of Kineret has been evaluated in clinical trials conducted in 3,025 patients with RA, including 2,124 who received Kineret for at least 6 months and 884 who received Kineret for at least one year. The most common serious side effects or adverse reactions were serious infections and neutropenia (a decrease in the count of neutrophils, a key type of immune system cell). The most common side effect associated with Kineret was injection site reaction, which was also the most common reason for stopping treatment with Kineret.


Most common side effects occurring in two Kineret RA clinical trials1*

Side effect Kineret 100 mg/day + DMARD** (N=1,565) Placebo + DMARD** (N=733)
Injection site reaction 71% 29%
Worsening RA 19% 29%
Upper respiratory tract infection 14% 17%
Headache 12% 9%
Nausea 8% 7%
Diarrhea 7% 5%
Sinusitis 7% 7%
Arthralgia 6% 6%
Flu-like symptoms 6% 6%
Abdominal pain 5% 5%
*Occurring in at least 5% of patients who received treatment for 6 months.
**Included disease-modifying antirheumatic drugs (DMARDs) methotrexate, sulfasalazine, hydroxychloroquine, gold, penicillamine, leflunomide, and azathioprine.


Warnings and precautions

There are several warnings and precautions related to Kineret that you should be aware of before starting treatment.

Serious infections. There is an increased risk for developing serious infections with Kineret. Anti-tumor necrosis factor-alpha (anti-TNF-α) drugs have been associated with increased risk of reactivation of tuberculosis (TB), and it is possible that by blocking interleukin-1 (IL-1), Kineret may also increase risk for reactivation of TB. Before starting treatment with Kineret, you should be tested for latent TB, and, if positive, you should receive treatment for TB before starting Kineret. All patients should be monitored for active TB during treatment with Kineret.1

The signs of TB include a cough that persists, a low-grade fever, weight loss, and loss of body fat and muscle.

If you develop a serious infection while taking Kineret, you should discontinue the treatment. You should not start treatment with Kineret if you have an active infection. If you have an active infection, before starting treatment, make sure that the infection is controlled.1

Cancers. The potential for increased risk for cancers with Kineret has not been studied.

Other health conditions and concerns. Use of live vaccines should be avoided while taking Kineret.1

Before you start treatment with Kineret, you should have your blood tested to determine your neutrophil count (a neutrophil is a type of white blood cell that plays an important role in the immune system). Additionally, neutrophil counts should be monitored closely during your first year of treatment with Kineret (monthly for the first 3 months of treatment and then quarterly, thereafter, for the first year).1

Kineret can cause hypersensitivity (allergic) reactions including anaphylaxis. If you experience any allergic reactions while taking Kineret, contact your doctor immediately.1

Patients who are being treated with Kineret should not receive live vaccines.1


Pregnancy and nursing

Kineret is a pregnancy category B drug. In animal studies, there was no evidence that Kineret resulted in risk to the fetus. However, there have been no well-controlled studies in pregnant women. Kineret should only be used in pregnant women if clearly needed.1

It is unknown whether Kineret is excreted into human milk. Because of the potential for adverse effects to the nursing infant, Kineret should be used with caution in a women who are nursing.1


Drug interactions

Patients who are being treated with Kineret should not receive live vaccines.1

Human drug interaction studies have not been conducted with Kineret. Toxicology studies have shown that Kineret may be administered together with the DMARD methotrexate without significant interactions that affect exposure to either drug.1

Concurrent use of Kineret with anti-TNF-α treatments (examples include Cimzia (certolizumab pegol), Humira (adalimumab), Remicade (infliximab), and Enbrel (etanercept) is not recommended. Use the anti-TNF-α drug Enbrel (etanercept) in combination with Kineret resulted in an increase in the rate of serious infections.1

Written by: Jonathan Simmons | Last reviewed: September 2013.