Kineret

What is Kineret used for?

Kineret is a prescription medicine that is used to treat rheumatoid arthritis. It is used to treat Neonatal-Onset Multisystem Inflammatory Disease (NOMID). Kineret may be given to you for other reasons.

Description

KINERET (anakinra) is a recombinant, nonglycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra). KINERET differs from native human IL-1Ra in that it has the addition of a single methionine residue at its amino terminus. KINERET consists of 153 amino acids and has a molecular weight of 17.3 kilodaltons. It is produced by recombinant DNA technology using an E coli bacterial expression system.

KINERET is supplied in single use prefilled glass syringes with 29 gauge needles as a sterile, clear, colorless-to-white, preservative free solution for daily subcutaneous (SC) administration. The solution may contain trace amounts of small, translucent-to-white amorphous proteinaceous particles. Each prefilled glass syringe contains: 0.67 mL (100 mg) of anakinra in a solution (pH 6.5) containing anhydrous citric acid (1.29 mg), disodium EDTA (0.12 mg), polysorbate 80 (0.70 mg), and sodium chloride (5.48 mg) in Water for Injection, USP.

The prefilled syringe contains an outer rigid plastic needle shield attached to an inner needle cover. The syringe or needle shield components are not made with natural rubber latex.

Mechanism of Action

KINERET blocks the biologic activity of IL-1 alpha and beta by competitively inhibiting IL-1 binding to the interleukin-1 type I receptor (IL-1RI), which is expressed in a wide variety of tissues and organs.

IL-1 production is induced in response to inflammatory stimuli and mediates various physiologic responses including inflammatory and immunological responses. IL-1 has a broad range of activities including cartilage degradation by its induction of the rapid loss of proteoglycans, as well as stimulation of bone resorption. The levels of the naturally occurring IL-1Ra in synovium and synovial fluid from RA patients are not sufficient to compete with the elevated amount of locally produced IL-1.

Spontaneous mutations in the CIAS1/NLRP3 gene have been identified in a majority of patients with cryopyrin-associated periodic syndromes such as NOMID. CIAS1/NLRP3 encodes for cryopyrin, a component of the inflammasome. The activated inflammasome results in proteolytic maturation and secretion of IL-1β, which has an important role in the systemic inflammation and manifestations of NOMID.

DIRA is an autosomal recessive monogenic autoinflammatory disease caused by mutations in the IL1RN gene leading to loss of secretion of the interleukin-1 receptor antagonist (IL-1Ra). The deficiency of IL-1Ra results in unopposed IL-1α and IL-1β pro-inflammatory signaling causing systemic inflammation with skin and bone involvement.

Before taking Kineret, tell your doctor:

• If you are allergic to Kineret; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have an infection.
• If you are taking any of these drugs: Adalimumab, certolizumab, etanercept, golimumab, or infliximab.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Kineret with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Kineret?

• Tell all of your health care providers that you take Kineret. This includes your doctors, nurses, pharmacists, and dentists.
• If you have asthma, talk with your doctor. You may have a chance of a very bad infection.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Talk with your doctor before getting any vaccines. Use of some vaccines with Kineret may either raise the chance of an infection or make the vaccine not work as well.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• Very bad infections have been reported with use of Kineret. If you have any infection, are taking antibiotics now or in the recent past, or have many infections, talk with your doctor.
• TB (tuberculosis) has been seen in patients started on Kineret. These patients were exposed to TB in the past, but never got the infection. You will be tested to see if you have been exposed to TB before starting Kineret.
• The chance of lymphoma may be raised in people with rheumatoid arthritis. It is not known if Kineret may also raise the chance. Talk with the doctor.
• If you are 65 or older, use Kineret with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Kineret while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Kineret best taken?

Use Kineret as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin.
• Keep taking Kineret as you have been told by your doctor or other health care provider, even if you feel well.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Take Kineret at the same time of day.
• Before using Kineret, take it out of the refrigerator and leave it at room temperature for 30 minutes.
• Wash your hands before and after use.
• Move the site where you give the shot with each shot.
• Do not give into red or irritated skin.
• Do not use Kineret if it has been dropped or if it is broken.
• Do not shake.
• Throw away any part left over after the dose is given.
• Throw syringe away after use. Do not use the same syringe more than one time.
• This product may contain small white particles. Do not use if the solution is cloudy, leaking, or has large lumps, flakes, or other particles.
• Do not use if solution changes color.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Kineret that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Very bad irritation where the shot was given.
• Dizziness or passing out.
• A fast heartbeat.
• A heartbeat that does not feel normal.
• Sweating a lot.

What are some other side effects of Kineret?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Redness or swelling where the shot is given.
• Itching where the shot is given.
• Bruising where the shot is given.
• Stinging.
• Headache.
• Upset stomach or throwing up.
• Diarrhea.
• Joint pain.
• Nose or throat irritation.
• Sore throat.
• Runny nose.
• Flu-like signs.
• Sinus pain.
• Stomach pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Kineret?

• Store in a refrigerator. Do not freeze.
• Store in the original container to protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

Principal Display Panel – Carton Label

• 4 x 7 Syringe Dispensing Packs (28 x 100 mg/0.67 mL Prefilled Glass Syringes) NDC 66658-234-28
• sobi
• Kineret®
  (anakinra)
• Injecton
• 100 mg/0.67 mL
• Single Use: Discard Any Unused Portion
• Subcutaneous Use Only
• Graduated Prefilled Glass Syringes with 29 Gauge Needles
• Sterile Solution – No Preservative
• Manufactured by Swedish Orphan Biovitrum AB (publ)
• SE-112 76 Stockholm, Sweden
• License # 1859 Rx Only