- Solution 100 mg per 0.67 mL
Blocks the biologic activity of interleukin-1 (IL-1) by competitively inhibiting IL-1 binding to IL-1 type I receptor, which is expressed in a wide variety of organs and tissues.
Bioavailability is 95%; T max is 3 to 7 h.
The t ½ is 4 to 6 h.
Special PopulationsRenal Function Impairment
Mean plasma Cl decreased 70% to 75% in those with Ccr less than 30 mL/min.
Indications and Usage
Reduction in signs and symptoms, and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis in patients who have failed at least 1 disease-modifying antirheumatic drug.
Hypersensitivity to Escherichia coli -derived proteins, anakinra, or any component of product.
Dosage and AdministrationAdults
Subcutaneous 100 mg/day.Renal Function Impairment
Subcutaneous 100 mg every other day for severe renal function impairment (Ccr less than 30 mL/min).
- Rotate injection sites (eg, thigh, abdomen, upper arm). Give new injection at least 1 inch from old site and never into areas where the skin is tender, bruised, red, or hard.
- Do not use prefilled syringe if particulate matter, cloudiness, or discoloration are noted.
- Disease-modifying antirheumatic drugs (except etanercept), glucocorticoids, salicylates, NSAIDs, and analgesics may be continued during treatment with anakinra.
- Discard any unused portion. Do not save unused solution for later administration.
Store prefilled syringes in refrigerator (36° to 46°F). Do not freeze or shake. Protect from light.
None well documented.
Laboratory Test Interactions
None well documented.
Nausea (8%); diarrhea (7%); abdominal pain (5%).
Injection-site reaction (71%).
Upper respiratory tract infection (14%).
Worsening of rheumatoid arthritis (19%); arthralgia, flu-like symptoms (6%); hypersensitivity, serious infections (eg, cellulitis, pneumonia, bone and joint [3%]).
MonitorDisease state activity
Document baseline disease state activity (eg, number of tender or swollen joints, pain, disability). Reassess periodically to document response to therapy.Neutrophil count
Ensure that neutrophil count is assessed prior to starting therapy, then monthly for 3 mo, and thereafter quarterly for a period of up to 1 yr.
Category B .
Safety and efficacy not established.
Use with caution because of higher rate of infection in this population.
Because anakinra is substantially excreted by the kidneys, risk of toxicity is increased in patients with renal function impairment.
Decreased neutrophil count may occur.
Serious infections may occur. Monitor patient for signs and symptoms of infection (eg, persistent fever, sore throat, cellulitis). Immediately report to health care provider if noted. Be prepared to discontinue therapy if a serious infection develops or is suspected.
Do not give live vaccines concomitantly.
- If patient or caregiver is administering at home, provide the Information for Patients and Caregivers insert. Ensure that the patient or caregiver understands how to store, prepare, and administer the dose, and how to dispose of used equipment and supplies. Perform the first injection under the supervision of a qualified health professional.
- Advise patient to administer daily at about the same time.
- Caution patient to discard any unused portions and not to save unused drug for later administration.
- Advise patient to continue other arthritis medications as recommended by health care provider.
- Advise patient or caregiver that beneficial effects develop slowly and may take up to 12 wk to occur.
- Advise patient to immediately report any of the following to health care provider: fever or other signs of infection, sore throat, unusual bruising or bleeding, rash, hives, sudden shortness of breath.
- Advise patient to report intolerable injection site reactions or unusual symptoms to health care provider.
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