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Important
information
about Kineret® 

What should I know about Kineret?

Kineret may cause serious side effects, including:

Serious Infections. Kineret® is a medicine that affects your immune system. Kineret® can lower the ability of your immune system to fight infections. Serious infections have happened in patients taking Kineret®. Taking Kineret® may give you a higher chance for getting an infection or make any infection you have worse. You should not start taking Kineret if you have any kind of infection unless your doctor says it is okay. During treatment with Kineret®, call your healthcare provider right away if you get an infection, any sign of an infection including a fever, chills, or have any open sores on your body.

Blood problems. Kineret® may cause certain white blood cells called neutrophils to decrease in number (neutropenia). Neutrophils are important in fighting infections. You will need to have blood tests before starting treatment with Kineret®, then monthly for three months. After the first three months you will be asked to have your blood tested every three months for up to one year.

Serious side effects that are rare include:

Malignancies. Patients with rheumatoid arthritis (RA) may be at higher risk for lymphoma (a type of cancer).

Allergic reactions. If you develop a severe rash, swollen face or difficulty breathing while taking Kineret®, call your doctor right away or seek emergency care immediately.

You should not take Kineret® if you have an allergy to:

  • proteins made from bacterial cells (E. coli ). Ask your healthcare provider if you are not sure.
  •  any of the ingredients in Kineret®. See the end of the patient leaflet for a complete list of ingredients.


The most common side effect with Kineret® is injection site reaction.

Most injection-site reactions are mild, happen early during treatment, and last about 14 to 28 days. Other common side effects of Kineret® for RA include sore throat or runny nose (including sinus infections), joint pain, headaches, nausea, diarrhea, pain in your stomach area, feeling like you have the flu, and worsening of RA.

If you take other medicines that affect the immune system while you are taking Kineret®, you could also have an increased risk for getting a serious infection. It is recommended that you do not take these medications (TNF-blocking agents) while taking Kineret®

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Kineret may not be right for you. Tell your healthcare provider about all of your medical conditions, including if you:

  • have an infection, a history of infections that keep coming back or other conditions that can increase your risk of infections. See “What is the most important information I should know about Kineret?”
  • have an allergy to rubber or latex. The inner needle cover on the prefilled syringe contains latex. Do not handle the needle cover if you are allergic to latex.
  • have kidney problems
  • are scheduled to receive any vaccines. Patients taking Kineret should not receive live vaccines.
  • are pregnant or plan to become pregnant. It is not known if Kineret will harm your unborn baby

  • are breastfeeding or plan to breastfeed. It is not known if Kineret passes into your breast milk. You and your healthcare provider should decide if you will use Kineret or breastfeed


 

These are not all of the possible side effects of Kineret®. For more information, see the Full Prescribing Information and Patient Information 

 

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How to take Kineret®

Instructions on how to administer Kineret®

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INDICATIONS

Kineret® is a prescription medicine called an interleukin-1 receptor antagonist (IL-1ra) 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 1 or more other drugs for RA have not worked
  • Treat people with a form of Cryopyrin-Associated Periodic Syndromes (CAPS) called Neonatal-Onset Multisystem Inflammatory Disease (NOMID)

Kineret is not for children with Juvenile Rheumatoid Arthritis

IMPORTANT SAFETY INFORMATION

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. See the end of the patient leaflet for a complete list of ingredients in Kineret

Before you use Kineret, tell your healthcare provider if you:

  • have an infection, a history of infections that keep coming back, or other problems that can increase your risk of infections
  • have an allergy to rubber or latex. The inner needle cover on the prefilled syringe contains latex. Do not handle the needle cover if you are allergic to latex
  • have kidney problems
  • are scheduled to receive any vaccines. People using Kineret should not receive live vaccines
  • are pregnant or plan to become pregnant. It is not known if Kineret will harm your unborn baby
  • are breastfeeding or plan to breastfeed. It is not known if Kineret passes into your breast milk. You and your healthcare provider should decide if you will take Kineret or breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and 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. Ask your healthcare provider for a list of these medicines if you are not sure.

Kineret may cause serious side effects, including:

  • serious infections. Kineret may lower your ability to fight infections. During treatment with Kineret, call your healthcare provider right away if you get an infection, have any sign of an infection including a fever or chills, or have any open sores on your body. You may get an infection if you receive live vaccines while you use Kineret. You should not receive live vaccines while you use Kineret.
  • 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: 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.
  • decreased ability of your body to fight infections (immunosuppression). It is not known if treatment with medicines that cause immunosuppression, like Kineret, affect your risk of getting cancer.
  • low white blood cell count (neutropenia). 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.

The most common side effects of Kineret for RA include:

  • injection site skin reactions, including redness, swelling, bruising, itching, and stinging. Most injection site reactions are mild, happen early during treatment, and last about 14 to 28 days
  • rheumatoid arthritis (RA) gets worse with treatment
  • sore throat or runny nose
  • headache
  • nausea
  • diarrhea
  • sinus infection
  • joint pain
  • feeling like you have the flu
  • pain in your stomach area

The most common side effects of Kineret for NOMID include:

  • injection site skin reactions, including redness, swelling, bruising, itching, and stinging. Most injection site reactions are mild, happen early during treatment, and last about 14 to 28 days. Injection site reactions have been observed less frequently in people with NOMID
  • headache
  • vomiting
  • joint pain
  • fever
  • feeling like you have the flu
  • sore throat or runny nose

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of Kineret. For more information ask your healthcare provider or pharmacist.

Please see full Prescribing Information