KINERET

Generic Name/API: anakinra

Manufacturer: Swedish Orphan Biovitrum

Dosage Forms & Strength & Pack Size:
Injection: 100 mg/0.67 mL solution in a single-use prefilled syringe for subcutaneous injection. Graduated syringe allows for doses between 20 mg and 100 mg.

Storage:
KINERET should be stored in the refrigerator at 2°C to 8°C (36°F to 46°F). DO NOT FREEZE OR SHAKE. Protect from light.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATIONS

What is KINERET (anakinra)?

KINERET is a prescription medicine called an interleukin-1 receptor antagonist (IL-1Ra) used to:

  • Reduce signs and symptoms and slow the damage of moderate to severe active rheumatoid arthritis (RA) inadults when one or more other drugs for RA have not worked
  • Treat people with a form of Cryopyrin-Associated Periodic Syndromes (CAPS) called Neonatal-OnsetMultisystem Inflammatory Disease (NOMID)
  • Treat people with Deficiency of Interleukin-1 Receptor Antagonist (DIRA)

Kineret is not for children with Juvenile Rheumatoid Arthritis.

IMPORTANT SAFETY INFORMATION

Who should not receive KINERET?

You should not receive KINERET if you are allergic to proteins made from bacteria called E. coli or any of the ingredients in KINERET.

What should I tell my healthcare provider before taking KINERET?

You should tell your doctor if you:

  • Have an infection, a history of infections that keep coming back, or other problems that can increase your risk of infections.
  • Are scheduled to receive any vaccines since people using KINERET should not receive live vaccines.
  • Have kidney problems.
  • Are pregnant, planning to become pregnant, or breastfeeding. It is not known if KINERET will harm your unborn baby or passes into your breastmilk. You and your healthcare provider should decide if you will use KINERET or breastfeed.

What are the serious side effects of KINERET?

KINERET can lead to serious infections, including tuberculosis (TB). Because KINERET is a medicine that affects your immune system and may lower your risk to fight infection, your doctor may test for TB and treat new or unknown TB, before you start taking KINERET.

You Should Know: Signs and symptoms of a serious infection could include fever, chills, or excessive sweating, open sores on your body, nausea, lightheadedness, or vomiting, dizziness or lightheadedness.

You should tell your healthcare provider or get medical help if new symptoms of an infection appear. They can be life-threatening or cause death.

You should 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: swelling of your face, lips, mouth, or tongue; trouble breathing; wheezing; severe itching; skin rash, redness, or swelling outside of the injection site area; dizziness or fainting; fast heartbeat or pounding in your chest (tachycardia); or sweating. People with DIRA may have an increased risk of allergic reactions, especially in the first several weeks.

It is not known if treatment with medicines that cause immunosuppression, like KINERET, affect your risk of getting cancer.

KINERET may cause you to have a lower number of certain white cells (neutrophils). Neutrophils are important in fighting infections. You should have blood tests before starting treatment with KINERET, then monthly for 3 months. After the first 3 months you should have your blood tested every 3 months for up to 1 year.

Before taking KINERET, you should tell your healthcare provider about all your medical conditions and medicines including prescription and over-the-counter medicines, vitamins, supplements, and herbal remedies.

What are other possible side effects of KINERET?

The most common side effects of KINERET include injection site skin reactions, worsening RA (if you already have RA), headache, nausea and vomiting, diarrhea, joint pain, fever, general feeling of discomfort, sore throat or runny nose, sinus infection, and pain in your stomach area.

In KRYSTEXXA clinical trials:
The most common side effects of KRYSTEXXA when given together with methotrexate were gout flares, joint pain, coronavirus disease 2019 (COVID-19), nausea, and fatigue.
The most common side effects of KRYSTEXXA were gout flares, allergic reactions (including infusion reactions). See “What is the most important information I should know about KRYSTEXXA?”, nausea, bruising, sore throat, constipation, chest pain, coronavirus disease 2019 (COVID-19), and vomiting.
This is not a complete list of all possible side effects. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch or call 1-800-FDA-1088.

For additional Important Safety Information, please see the Medication Guide and discuss with your doctor.

USE
KRYSTEXXA is a prescription medicine used in adults to help reduce the signs and symptoms of gout that are not controlled by other treatments.

KRYSTEXXA is not for use in people with too much uric acid in their bodies who do not have symptoms (asymptomatic hyperuricemia).

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