Emergency Use Authorization | kineret

Authorized Use

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to make KINERET^® (anakinra) available during the COVID-19 pandemic.

Anakinra has not been approved, but has been authorized for emergency use by FDA under an EUA, for the treatment of COVID-19 in hospitalized adults with positive results of direct SARS-CoV-2 viral testing with pneumonia requiring supplemental oxygen (low- or highflow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated suPAR.

The emergency use of Kineret is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization revoked sooner.

Read this Fact Sheet for information about KINERET and talk to your healthcare provider about your options or if you have any questions. It is your choice for you to take KINERET or stop it at any time.

Fact Sheet for Patients & Caregivers

Fact Sheet for Patients & Caregivers
(Spanish/Español)

FDA Emergency Use Authorization Letter

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WHAT IS KINERET^® (anakinra)?

KINERET is a prescription medicine called an interleukin-1 receptor antagonist (IL-1Ra). KINERET is an FDA-approved medicine used to reduce the signs and symptoms and slow the damage of moderate to severe active rheumatoid arthritis (RA) in people age 18 years and older when one or more other medicines for RA have not worked, to treat people with a form of Cryopyrin-Associated Periodic Syndromes (CAPS) called Neonatal-Onset Multisystem Inflammatory Disease (NOMID) and to treat people with Deficiency of Interleukin-1 Receptor Antagonist (DIRA).

EMERGENCY USE AUTHORIZATION (EUA) OF KINERET FOR COVID-19

The FDA has issued an authorization for the emergency use of KINERET during the COVID-19 pandemic for the treatment of COVID-19 in hospitalized adults with positive results of direct SARS-CoV-2 viral testing with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure, and are likely to have an increased blood level of a certain substance called urokinase plasminogen activator receptor (suPAR) that may be a sign of increased risk of worsening of the disease. However, KINERET is not FDA-approved to treat COVID-19. KINERET is not authorized for COVID-19 patients younger than 18 years of age. Talk to your healthcare provider about your options or if you have any questions. It is your choice for you to take KINERET or stop it at any time.

COVID-19 is an illness caused by a virus called a coronavirus. You can get COVID-19 through close contact with another person who has the virus. To learn more about COVID-19, ask your healthcare provider. You may also visit https://www.cdc.gov/COVID19 or contact your local or state public health department.

IMPORTANT SAFETY INFORMATION

Before starting KINERET, tell your healthcare provider if you:

Have any allergies
Have kidney problems
Are pregnant, plan to become pregnant, are breastfeeding or plan to breastfeed.
Have any serious illnesses
Are scheduled to receive any vaccines. People using KINERET should not receive live vaccines.
Are taking any medicines (prescription, over-the-counter, vitamins, or herbal supplements). KINERET and other medicines may affect each other and cause serious side effects. Especially, tell your healthcare provider if you take certain other medicines that affect your immune system called Tumor Necrosis Factor (TNF) blockers or anti-cytokines.

Do not take KINERET if you are allergic to:

Proteins made from bacteria called E. coli. Ask your healthcare provider if you are not sure
Anakinra or any of the ingredients in KINERET. For a complete list of ingredients in KINERET, refer to the Package Insert for KINERET at www.KineretRx.com

KINERET may cause serious side effects, including:

Allergic reactions. Stop using KINERET and call your healthcare provider or get emergency help right away if you have any of these symptoms of an allergic reaction such as swelling of your face, lips, mouth or tongue, trouble breathing, wheezing, severe itching skin rash, hives, redness, or swelling outside of the injection site area, dizziness or fainting, fast heartbeat or pounding in your chest (tachycardia), and/or sweating.

Low white blood cell count (neutropenia). KINERET may cause you to have a lower number of certain white blood cells (neutrophils). Neutrophils are important in fighting infections. You should have blood tests before starting treatment with KINERET.

The most common side effects of KINERET include:

Increased levels of liver enzymes. KINERET may cause you to have increased levels of the liver enzymes as determined after a blood test.

Rash.

Injection site skin reactions. The symptoms of injection site skin reactions may include redness, swelling, bruising, itching, and/or stinging.

Contact your health care provider if there are any side effects that bother you or do not go away.

Report side effects to FDA MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Sobi by calling 1-866-773-5274.