Uses
Rheumatoid Arthritis in Adults
Used alone or in combination with DMARDs other than tumor necrosis factor (TNF) blocking agents (e.g., adalimumab, etanercept, infliximab) for the management of signs and symptoms of rheumatoid arthritis and to inhibit progression of structural damage associated with the disease in adults with moderately to severely active disease who have had an inadequate response to therapy with one or more DMARDs. (See Interactions.)
Dosage and Administration
General
- Monitor neutrophil counts prior to and during anakinra therapy. (See Neutropenia under Cautions.)
Administration
Sub-Q Administration
Administer sub-Q at approximately the same time each day.
Administer sub-Q injections into the thighs, abdomen, upper arms, or buttocks. Rotate injection sites. Do not make injections into areas where the skin is tender, bruised, red, or hard; into scars or stretch marks; or close to a vein.
Allow anakinra prefilled syringe to reach room temperature (about 60–90 minutes) prior to administration. Do not remove the needle cover until the prefilled syringe has reached room temperature.
Intended for use under the guidance and supervision of a clinician, but may be self-administered if the clinician determines that the patient and/or their caregiver is competent to prepare and safely administer the drug.
Dosage
Adults
Rheumatoid Arthritis
Sub-Q
100 mg (entire contents [0.67 mL] of one prefilled syringe) daily.
Prescribing Limits
Adults
Rheumatoid Arthritis
Sub-Q
Dosages >100 mg daily do not appear to provide additional benefit.
Special Populations
Dosage in Renal Impairment
Rheumatoid Arthritis
Sub-Q
Consider decreasing dosage to 100 mg every other day in patients with severe renal insufficiency or end-stage renal disease (Clcr <30 mL/minute, as estimated from Scr). (See the Special Populations sections under Pharmacokinetics and under Cautions.)
Cautions
Contraindications
Warnings/Precautions
Warnings
Infectious Complications
Increased incidence of serious infections reported. (See Infection under Cautions.) Do not initiate anakinra therapy in patients with active infections. Discontinue the drug in patients who develop a serious infection. Safety and efficacy have not been evaluated in immunosuppressed patients or patients with chronic infections.
Interactions
Concomitant use of TNF blocking agents (e.g., adalimumab, etanercept, infliximab) not recommended. Increased incidence of serious infections and lack of additional clinical benefit with combined anakinra and etanercept therapy.
Sensitivity Reactions
Hypersensitivity Reactions
Anaphylaxis and anaphylactoid reactions reported rarely.
If a severe hypersensitivity reaction occurs, discontinue anakinra immediately and institute appropriate interventions as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway, oxygen, IV fluids, antihistamines, maintenance of BP).
Latex Sensitivity
The needle cover of the prefilled syringe contains dry natural rubber (latex); individuals sensitive to latex should not handle the needle cover.
Major Toxicities
Infection
The incidence of infection, including serious infections, is increased in patients receiving anakinra. Infections of bacterial origin (e.g., cellulitis, pneumonia, bone and joint) most common. Opportunistic infections (fungal, mycobacterial, bacterial, viral) reported rarely. Patients with asthma may be at a higher risk for developing serious infections.
Risk of serious infection and neutropenia increased in patients receiving concomitant anakinra and etanercept compared with etanercept alone.
Hematologic Effects
Small reductions reported in WBC, ANC, and platelet counts; small increases in eosinophil counts reported.
General Precautions
Immunologic Effects
Effect of anakinra in patients with active and/or chronic infections or on the subsequent development of malignancy not fully elucidated.
Anti-anakinra antibodies reported after therapy; not associated with increased adverse events. Effect of neutralizing antibodies on clinical response not fully elucidated.
Do not administer live-virus vaccines to patients receiving anakinra. (See Vaccines under Interactions.)
Neutropenia
Neutropenia (ANC < 1000/mm2) and/or reduced neutrophil counts reported. Monitor ANC before therapy is initiated, monthly for 3 months, and then every 3 months for a period up to 1 year during anakinra therapy.
Malignancies and Lymphoproliferative Disorders
Increased incidence of lymphoma compared with general population reported in patients with rheumatoid arthritis receiving anakinra. However, patients with rheumatoid arthritis, especially those with highly active disease, may be at increased risk of lymphoma. Role of human interleukin-1 receptor antagonist (IL-1Ra)-induced immunosuppression in the development of malignancies is unknown.
Increased incidence of malignancies involving the breast and respiratory and digestive systems has been reported. Increased incidence of melanoma also reported; clinical importance unknown.
Specific Populations
Pregnancy
Category B.
Lactation
Not known whether anakinra is distributed into milk. Caution if used in nursing women.
Pediatric Use
Evaluated in a limited number of children 2–17 years of age with polyarticular course juvenile rheumatoid arthritis†; efficacy not established (insufficient numbers of children have been enrolled in trials). Adverse effects observed in children similar to those in adults. Use of anakinra in pediatric patients is not recommended. The currently available prefilled syringes are not designed to deliver pediatric doses accurately.
Geriatric Use
No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.
Geriatric patients may be at increased risk of serious infection; use with caution.
Geriatric patients may be at increased risk of toxic reactions due to impaired renal function; use with caution. (See Renal Impairment under Cautions.)
Hepatic Impairment
Not studied in patients with severe hepatic impairment.
Renal Impairment
Risk of toxic reactions increased; consider dosage reduction. (See Renal Impairment under Dosage and Administration.)
Elimination reduced in patients with renal insufficiency. (See Special Populations under Pharmacokinetics.)
Common Adverse Effects
Injection-site reaction, infections (principally bacterial origin), headache, nausea, neutropenia, diarrhea, influenza-like symptoms, abdominal pain.
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