Anakinra

What is Anakinra?

• Anakinra (KINERET) is an interleukin-1 receptor antagonist used to treat rheumatoid arthritis, cryopyrin-associated periodic syndromes, Deficiency of Interleukin-1 Receptor Antagonist (DIRA).

Structure of Anakinra

What are the uses of this medicine?

This medicine is 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 medicines 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).

How does this medicine work?

• 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with known hypersensitivity to E coli-derived proteins, KINERET, or any components of the product.

What drug interactions can this medicine cause?

• No drug-drug interaction studies in human subjects have been conducted.
• Use of KINERET in combination with TNF blocking agents is not recommended.

Is this medicine FDA approved?

• Anakinra was approved for use in the United States in 2001 and its current formal indications are for severe rheumatoid arthritis and the autoinflammatory conditions known as cryopyrin-associated periodic syndomres (CAPS).
• It is used off label for idiopathic juvenile arthritis and other autoimmune forms of arthritis such as adult onset Still disease.

How should this medicine be used?

Recommended Dosage: Active Rheumatoid Arthritis

• The recommended dose of KINERET for the treatment of patients with rheumatoid arthritis is 100 mg/day administered daily by subcutaneous injection. Higher doses did not result in a higher response. The dose should be administered at approximately the same time every day.

Cryopyrin-Associated Periodic Syndromes (CAPS)

• The recommended starting dose of KINERET is 1-2 mg/kg for NOMID patients. The dose can be individually adjusted to a maximum of 8 mg/kg daily to control active inflammation.
• Adjust doses in 0.5 to 1 mg/kg increments.

Deficiency of Interleukin-1 Receptor Antagonist (DIRA)

• The recommended starting dose of KINERET is 1-2 mg/kg daily for patients with DIRA. The dose can be individually adjusted to a maximum of 8 mg/kg daily to control active inflammation. Adjust doses in 0.5 to 1 mg/kg increments.

Administration

• Use Kineret exactly as your healthcare provider tells you to.
• You may not have to use all of the liquid medicine in the prefilled syringe. Your healthcare provider will show you how to find the correct dose of Kineret for you or your child.
• Kineret is given by injection under your skin.
• Inject Kineret at about the same time each day.
• If you have a kidney problem your healthcare provider may need to change how often you use your Kineret injections.
• If you miss a dose of Kineret, talk to your healthcare provider to find out when you should use your next injection.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As 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.

This medicine is available in fallowing brand namesː

• KINERET

What side effects can this medication cause?

The most common side effects of this medicine include:

• injection site skin reactions
• rheumatoid arthritis (RA) gets worse even 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

Kineret may cause serious side effects, including:

• serious infections
• allergic reactions
• decreased ability of your body to fight infections (immunosuppression)
• low white blood cell count (neutropenia)

What special precautions should I follow?

• In RA, discontinue use if serious infection develops. In KINERET-treated NOMID or DIRA patients, the risk of a disease flare when discontinuing KINERET treatment should be weighed against the potential risk of continued treatment. Do not initiate KINERET in patients with active infections.
• Use in combination with Tumor Necrosis Factor (TNF) blocking agents is not recommended.
• Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported. Patients with DIRA may have an increased risk of allergic reactions, particularly in the first several weeks after starting KINERET treatment.
• The impact of treatment with KINERET on active and/or chronic infections and the development of malignancies is not known.
• Live vaccines should not be given concurrently with KINERET.
• Neutrophil counts should be assessed prior to initiating KINERET treatment, and while receiving KINERET, monthly for 3 months, and thereafter quarterly for a period up to 1 year.

What to do in case of emergency/overdose?

• There have been no cases of overdose reported with KINERET.

Can this medicine be used in pregnancy?

• Available data from retrospective studies and case reports on KINERET use in pregnant women are insufficient to identify a drug associated risk of major birth defects, miscarriage, or maternal and fetal adverse events.

Can this medicine be used in children?

• The safety and effectiveness of KINERET in the treatment of pediatric patients with Juvenile Rheumatoid Arthritis (JRA) have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: anakinra
• Inactive ingredients: anhydrous citric acid, disodium EDTA, polysorbate 80, and sodium chloride in Water for Injection, USP

Who manufactures and distributes this medicine?

• Manufactured by:

Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sweden

What should I know about storage and disposal of this medication?

• Store Kineret in the refrigerator between 36F to 46°F (2°C to 8°C).
• Do not freeze or shake Kineret.
• Keep Kineret in its original carton and away from light.Keep Kineret and all medicines out of the reach of children.

antirheumatic agents

• gold preparations
  • auranofin, gold salts, gold sodium thiomalate

• interleukin receptor antagonists
  • anakinra, canakinumab, rilonacept, sarilumab, tocilizumab

• major immunosuppressive agents (also used in transplant medicine)
  • cyclosporine, mycophenylate, sirolimus, tacrolimus

• monoclonal antibodies
  • adalimumab, canakinumab, certolizumab, golimumab, infliximab, rituximab, sarilumab, tocilizumab, ustekinumab

• thiopurines
  • azathioprine, mercaptopurine, thioguanine

• tumor necrosis factor antagonists
  • adalimumab, certolizumab, etanercept, golimumab, infliximab

• tyrosine (janus) kinase inhibitors
  • baricitinib, tofacitinib

• miscellaneous
  • abatacept, flavocoxid, hydroxychloroquine, leflunomide, methotrexate, penicillamine

• Dailymed label info on Anakinra
• FDA Anakinra