Full Prescribing Information and Instructions for Use
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KINERET for NOMID Patient Stories Using KINERET KINERET Support Resources

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Rheumatoid Arthritis

Kineret is the only interleukin-1 receptor antagonist (IL-1Ra) that is FDA-approved to reduce the inflammation, joint pain, and joint swelling caused by moderate to severe active rheumatoid arthritis (RA) in patients who have failed one or more treatments of disease modifying anti-rheumatic drugs (DMARDs).

Neonatal Onset Multisystem Inflammatory Disease

Kineret is the first and only FDA-approved treatment for children and adults with neonatal-onset multisystem inflammatory disease (NOMID)—a form of Cryopyrin-Associated Periodic Syndromes (CAPS).

Deficiency of Interleukin-1 Receptor Antagonist

Kineret is used to treat deficiency of interleukin-1 receptor antagonist (DIRA), an ultra-rare autoinflammatory disease.

An older couple stands next to each other and looks into the distance

When may KINERET be the right treatment for people with RA?

If other RA treatments have not worked for you, KINERET may be an option.

Doctors who treat RA know how important it is for patients with RA to be treated with a disease-modifying antirheumatic drug (DMARD) that works for them. Without effective treatment, RA can cause long-term damage, affecting your ability to move around and do the things you enjoy.

Patients have different experiences with RA treatments. There are many treatment options for RA and some people have to try several before they find the right one for them.

Some people may be reluctant to try a new RA treatment even if their current treatment is not working well. KINERET may help you even if other RA treatments have failed, because KINERET works differently than many RA treatments. KINERET is the only FDA-approved RA treatment that blocks IL-1.

A close-up shot of an adult female rheumatoid arthritis patient named Megan looking directly at the screen with a calm expression

MEGAN'S RA JOURNEY ›

Megan has been treating her RA with KINERET since 2013. Watch how she continues to manage her condition with stength and optimism.

Learn more about Megan ›
Older female rheumatoid arthritis patient named Peggy smiles into the camera

PEGGY'S NEW PERSPECTIVE ›

As a nurse, Peggy knows what it's like to be on the other end of the needle. See how her experience with RA and KINERET has given Peggy a new appreciation for her patients and their needs.

Learn more about Peggy ›

How does KINERET work?

KINERET is the only RA treatment that blocks IL-1.

KINERET blocks a protein called interleukin-1 (IL-1). In patients with RA, IL-1 can cause pain, swelling, and damage to joints.

For most people who experienced improvement with KINERET, results were seen within 3 months, but some patients continued to improve between 3 and 6 months after starting treatment.

No other RA treatment specifically blocks IL-1.

In studies, people with RA who were taking KINERET experienced improvement in signs and symptoms of RA, including:

  • Number of swollen joints
  • Number of painful joints
  • Joint damage

What is IL-1?

IL-1 is a protein that causes inflammation.

One of the many types of proteins that can cause inflammation in people with RA is IL-1. IL-1 sends signals that increase inflammation by binding to special receptors on the surface of cells throughout the body.

For some people, IL-1 may be one of the proteins that cause their RA symptoms.

The particular RA symptoms you experience, or the fact that your RA has not responded to other treatments, may suggest to your doctor that IL-1 is an important factor in your RA.

In some RA patients, inflammatory symptoms could be:

Joint pain

Fever

Rash

An illustrated diagram of how KINERET blocks IL-1 signaling

How often do I need to take KINERET?

Your doctor will tell you how often to take KINERET.

The recommended dose of KINERET for the treatment of RA is 1 injection given daily under the skin. The dose should be given at approximately the same time every day. The half-life of KINERET is 4 to 6 hours, which means that the amount of KINERET in your body decreases by half every 4 to 6 hours. Taking KINERET as prescribed will help make sure that there is always enough KINERET in your body.

The KINERET logo and generic name (anakinra)

If you have questions or concerns about injecting KINERET or managing injection site reactions, KINERET On TRACK may be able to help.

Learn more about the services of KINERET On TRACK

What are the side effects of KINERET?

The FDA evaluated the benefits and safety of KINERET and
approved it for the treatment of RA.

The sentence "MORE THAN 16 YEARS EXPERIENCE" presented in a circular shape

KINERET has been used for more than 16 years to treat RA. People who use KINERET often have some skin reactions where they inject. Injection site skin reactions may include redness, swelling, bruising, itching, and stinging. Most injection site reactions are mild, happen early during treatment, and last about 14 to 28 days.

The safety of KINERET has also been studied in RA patients with other health problems, including:

  • Asthma
  • Diabetes
  • Chronic obstructive pulmonary disease
  • Pneumonia

Other common side effects that people taking KINERET have experienced include:

  • Worsening of RA
  • Headache
  • Nausea and vomiting
  • Diarrhea
  • Joint pain
  • Fever
  • Feeling like you have the flu
  • Sore throat or runny nose
  • Sinus infection
  • Pain in your stomach area

In some cases, KINERET can also cause serious side effects. Please see below and read the full KINERET Prescribing Information for a full list of possible side effects.

Serious side effects that people taking KINERET have experienced include:

  • Serious infections
  • Allergic reactions
  • Low white blood cell count (neutropenia)

What is NOMID?

NOMID is a rare disease that can have serious long-term effects.

Neonatal-onset multisystem inflammatory disease (NOMID) is a rare disease that causes persistent inflammation throughout the body, from birth or starting soon afterwards. NOMID is an autoinflammatory disease. In autoinflammatory diseases, the innate immune system—the one we are born with—is not working properly and causes inflammation in the body, even though there is no infection or injury. It is recognized as the most severe form of Cryopyrin-Associated Periodic Syndromes (CAPS), a group of autoinflammatory disorders found in only 1 out of 1,000,000 people. Most people diagnosed with NOMID have no other affected family members.

Throughout life, infections, physical stress, and mental stress can trigger temporary increases in symptoms, known as flares. In some patients, NOMID symptoms can cause damage that progresses over time. Children affected by NOMID may grow more slowly than other children, and over time the constant inflammation can lead to physical and/or intellectual disabilities and organ damage. Those who are not treated early in life, or whose symptoms are poorly controlled while on treatment, are at risk for the most harmful complications.

NOMID symptoms

A diagram of a human body with arrows pointing to areas where NOMID symptoms may appear which include BRAIN, EARS, EYES, BODY, and JOINTS

How is NOMID diagnosed?

For most children, diagnosis requires time and visits to multiple doctors.

Identifying a rare disease, such as NOMID, is challenging.

There may be delays in diagnosing NOMID due to the lack of recognition of its signs and symptoms, the many subspecialists needed to care for patients, and the lack of communication between them.

NOMID is the most severe forms of CAPS. CAPS can be identified with blood tests for signs of inflammation and the presence of at least two symptoms. NOMID is diagnosed based on the severity of these symptoms.

A full evaluation of the signs and symptoms since birth is necessary so that NOMID can be diagnosed and treated.

Range of inflammation in CAPS:

Three rectangles that say: MILD—Familial Cold Autoinflammatory Syndrome (FCAS), MODERATE—Muckle-Wells Syndrome (MWS), SEVERE—Neonatal-Onset Multisystem Inflammatory Disease (NOMID)

Some of the challenges include:

  • Common symptoms: The most common early symptoms of NOMID may be mistaken for other conditions.
  • Varying symptoms and severity: Each patient may experience a range of symptoms, which can worsen and improve over time.
  • Genetic testing does not guarantee a definite answer: Although a genetic marker (NLRP3/CIAS) has been identified, many people with NOMID test negative with traditional genetic testing.
A young female child named Quinn concentrates intently on her homework while sitting at a table

How is NOMID treated?

NOMID is treated with KINERET.

The good news is that once your doctor has identified NOMID as the cause of your child's symptoms, a proven treatment is available. KINERET is the first and only treatment that has been FDA-approved to treat NOMID in the U.S.

Currently, there is no cure for NOMID, but there are ways to manage the symptoms of it. Children with NOMID and their caregivers need to adjust to the demands of a complex, chronic condition.

How does KINERET work?

KINERET blocks IL-1—the underlying cause of inflammation in NOMID.

KINERET blocks a protein called interleukin-1 (IL-1). In patients with NOMID, IL-1 sends a signal that causes inflammation throughout the body.

In clinical studies, KINERET improved or stabilized the following NOMID symptoms:

  • Rash
  • Fever
  • Vomiting
  • Joint pain
  • Headache
  • Vision loss
  • Hearing loss
  • Brain inflammation

In studies, patients taking KINERET reported significant improvement in symptoms in the first three months. The time for improvement varies from patient to patient.

A diagram showing how KINERET blocks IL-1 signaling

How often do I need to give my child KINERET?

Your doctor will tell you how often your child should take KINERET and how much to take each time.

For children with NOMID, once-daily injections are generally recommended, but sometimes your doctor may recommend splitting the dose into twice-daily administrations. The half-life of KINERET is 4 to 6 hours, which means that the amount of KINERET in your child's body decreases by half every 4 to 6 hours. Taking KINERET as prescribed will help make sure that there is always enough KINERET in your child's body.

Two illustrated icons are side by side. The first icon has a syringe encircled by an arrow that says "ONCE DAILY" and the second icon is a stopwatch that says "SHORT HALF-LIFE"

If you have questions or concerns about injecting KINERET or managing injection site reactions, KINERET On TRACK may be able to help.

Learn more about the services of KINERET On TRACK

What are the side effects of KINERET?

The FDA evaluated the benefits and safety of KINERET and approved it for the treatment of NOMID.

The sentence "MORE THAN 13 YEARS EXPERIENCE" presented in a circular shape

Doctors now have more than 13 years of patient and clinical experience treating NOMID with KINERET.

Children treated with KINERET can experience side effects but in clinical trials, most side effects were mild and no patient had to stop treatment because of side effects.

The most common serious side effect was infection.

The most common side effects in the first 6 months of the KINERET NOMID trial were:

  • Injection site skin reactions
  • Headache
  • Vomiting
  • Joint pain
  • Fever
  • Colds

What is DIRA?

DIRA is an ultra-rare, potentially life-threatening pediatric disease.

Deficiency of interleukin-1 receptor antagonist (DIRA) is an autoinflammatory disease, meaning that it affects the body’s immune system. Instead of fighting off viruses, bacteria, and infections, the immune cells attack the child’s own body by mistake. These attacks can lead to severe and dangerous inflammation.

DIRA is caused by mutations, or changes, that have occurred in a baby’s genes before birth. Symptoms of the disease usually begin within the first 8 weeks after a baby is born. Symptoms of DIRA can include swelling of bone tissue, bone pain and deformity, skin rash that can cover most of the body, and elevated CRP* levels.

*C-reactive protein, or CRP, is a type of inflammatory marker in the blood.

An illustrated outline of a baby with arrows that point to areas of the body where DIRA symptoms may manifest including EYES, BONES, JOINTS, and WHOLE BODY

DIRA can be difficult to diagnose.

Because DIRA is so rare, doctors aren’t used to seeing patients who have the disease.

It can take many visits to different specialists before DIRA is diagnosed. There have been times, for example, when doctors have assumed that a patient’s symptoms were caused by an infection, so they prescribed antibiotics. Unfortunately, antibiotics do not help treat DIRA.

A baby sits on the floor and plays with some laundry. He is looking off camera

How is DIRA treated?

DIRA can be treated with an IL-1–blocking medicine, like Kineret.

Kineret blocks the activity of interleukin-1 (IL-1), a protein in the body that causes inflammation. By supplementing the IL-1–blocking protein that DIRA patients lack, Kineret can help relieve painful and sometimes life-threatening symptoms.

How does Kineret work?

In patients with DIRA, a protein called IL-1 sends a signal that causes inflammation throughout the body. Kineret is a medicine that blocks IL-1, which stops it from sending this dangerous signal.

In a clinical study, Kineret improved or stabilized the following DIRA symptoms:

  • Swelling of bone tissue
  • skin rash icon desktop Skin rash
  • bone pain icon desktop Bone pain and deformity
An illustrated diagram of how KINERET blocks IL-1 signaling

How often do I need to give my child Kineret?

Your doctor will tell you how often your child should take Kineret and how much to take each time.

For children with DIRA, once-daily injections are generally recommended.

Two illustrated icons are side by side. The first icon has a syringe encircled by an arrow that says "ONE DOSE" and the second icon is a clock that says "ONCE DAILY"

If you have questions or concerns about injecting Kineret or managing injection site reactions, Kineret On TRACK may be able to help.

Learn more about the services of KINERET On TRACK

What are the side effects of Kineret?

The FDA evaluated the benefits and safety of Kineret and approved it for the treatment of DIRA.

The sentence "MORE THAN 11 YEARS EXPERIENCE" presented in a circular shape

Doctors now have more than 11 years of clinical experience treating young DIRA patients with Kineret. Children treated with Kineret can experience side effects but, in clinical trials, most side effects were mild and no patient had to stop treatment because of side effects.

The most common serious side effect was infection.

The most common side effects reported in the Kineret DIRA trial were:

  • Upper respiratory tract infections
  • Flu-like symptoms
  • Rash
  • Stomach-flu–like symptoms
  • Fever

INDICATIONS

KINERET® (anakinra) 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 aged 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)
  • 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 take KINERET?

People who 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

What information should I know before starting 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
  • Are scheduled to receive any vaccines. People using KINERET should not receive live vaccines
  • Have kidney problems
  • 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

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. Know the medications you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new prescription.

What are the possible side effects of KINERET?

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. People with DIRA may have an increased risk of allergic reactions, especially in the first several weeks
  • 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 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
  • RA gets worse with treatment, if you already have RA
  • Headache
  • Nausea and vomiting
  • Diarrhea
  • Joint pain
  • Fever
  • Feeling like you have the flu
  • Sore throat or runny nose
  • Sinus infection
  • Pain in your stomach area

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.