a-na-KIN-ra

Therapeutic Classification: antirheumatics (DMARD)

Pharmacologic Classification: interleukin antagonists

• Reduction of the signs and symptoms of moderately to severely active rheumatoid arthritis in patients who have failed other DMARDs (may be used in combination with other DMARDs other than tumor necrosis factor [TNF] blocking agents).
• Neonatal-onset multisystem inflammatory disease (NOMID).
• Deficiency of interleukin-1 receptor antagonist (DIRA).

• Blocks the destructive effects of interleukin-1 on cartilage and bone resorption by inhibiting its binding at specific tissue receptor sites.

• Slowed progression of rheumatoid arthritis.
• Reduction in NOMID symptoms.
• Achievement of inflammatory remission in DIRA.

Absorption: Well absorbed (95%) following SUBQ administration.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-life: 4–6 hr.

(clinical response)

Contraindicated in:

• Active infections
• Hypersensitivity
• Hypersensitivity to other Escherichia coli–derived products
• OB: Not recommended for use during pregnancy.

Use Cautiously in:

• Other chronic debilitating illness
• Underlying immunosuppression
• Renal impairment
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Pedi: Safety and effectiveness not established in children with juvenile rheumatoid arthritis
• Geri: Older adults may be more sensitive to toxicity due to age-related ↓ in renal function; ↑ incidence of infection.

Exercise Extreme Caution in:

• Concurrent use of TNF blocking agents such as etanercept (higher risk of serious infections).

GI: diarrhea, nausea.

Hemat: neutropenia.

Local: injection site reactions.

Neuro: headache.

Misc: hypersensitivity reactions (↑ risk in patients with DIRA), INFECTIONS.

Drug-Drug:

• ↑ risk of serious infection with TNF blocking agents, such as etanercept.
• May ↓ antibody response to and increase the risk of adverse reactions from vaccines; avoid concurrent administration of live vaccines.

Rheumatoid Arthritis

• SC (Adults): 100 mg/day.

Neonatal-Onset Multisystem Inflammatory Disease

• SC (Adults and Children): 1–2 mg/kg/day given in 1–2 divided doses; may ↑ by 0.5–1 mg/kg/day, as needed (maximum = 8 mg/kg/day).

Deficiency of Interleukin-1 Receptor Antagonist

• SC (Children): 1–2 mg/kg/day; may ↑ by 0.5–1 mg/kg/day, as needed (maximum = 8 mg/kg/day).

• Solution for injection (prefilled syringes): 100 mg/0.67 mL;

• Assess for signs and symptoms of infection (fever, elevated WBC) prior to and periodically during therapy. Screen for latent TB prior to beginning therapy; treat if screen is positive. Anakinra should not be instituted in patients with active infections and should be discontinued if patient develops a serious infection.
• Observe patient for hypersensitivity reactions (urticaria, dyspnea, hypotension). Discontinue anakinra if severe reaction occurs. Medications (antihistamines, acetaminophen, corticosteroids, epinephrine) and equipment should be readily available in the event of a severe reaction.
• Rheumatoid Arthritis: Assess patient’s range of motion and degree of swelling and pain in affected joints before and periodically during therapy.
• Neonatal-Onset Multisystem Inflammatory Disease: Assess symptoms of NOMID (fever, rash, joint pain, vomiting, headache) prior to and periodically during therapy.
• DIRA: Assess symptoms of DIRA (respiratory distress, joint swelling, stomatitis, pustular psoriasis) prior to and periodically during therapy.

• May cause ↓ neutrophil counts. Monitor neutrophil count prior to and during therapy, then monthly for 3 mo and quarterly thereafter for up to 1 yr.

• Administration of higher than recommended doses did not result in higher responses.
• SC: Administer 1 dose/day. Provided in single-use prefilled syringes. Solution may contain trace amounts of small, translucent-to-white amorphous particles of protein in the solution. Do not use if solution is discolored or cloudy, contains particulate matter, if number of translucent-to-white amorphous particles is excessive, or if beyond expiration date. Store in refrigerator; do not freeze. Remove from refrigerator and allow to reach room temperature for 30 min prior to injection. Avoid injecting into areas that are red or swollen.

• Instruct patient in correct technique for injection and care and disposal of equipment. Advise patient/parent to read Patient Information and Instructions for Use prior to starting therapy and with each Rx refill, in case of changes.
• Advise patient to notify health care professional if signs and symptoms of infection (fever, sore throat, cough, headache, nausea, vomiting, abdominal pain) occur.
• Inform patient of the signs and symptoms of hypersensitivity reactions and injection site reactions (pain, erythema, swelling, purities, bruising, mass, inflammation, dermatitis, edema, urticaria, vesicles, warmth, and hemorrhage). Advise patient of appropriate actions if reactions occur.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Advise patients not to receive live vaccines during therapy with anakinra without consulting health care professional.
• Advise female patients to notify health care professional if pregnancy is planned or suspected, or if breastfeeding.
• Home Care Issues: Instruct patient and family on preparation and correct technique for administration of injection and care and disposal of equipment. Caution patients and caregivers not to reuse needles, syringes, or drug product.

• Reduction of signs and symptoms and slowed progression of moderate to severe active rheumatoid arthritis.
• Decrease in signs and symptoms of NOMID.
• Achievement of inflammatory remission in DIRA.

Kineret

NDC Code^*

• 66658- Swedish Orphan Biovitrum AB (publ)
  • 66658-234- Kineret
    • 66658-234-07- 7 SYRINGE, GLASS in 1 CARTON (66658-234-07) >.67 mL in 1 SYRINGE, GLASS

• 66658- Swedish Orphan Biovitrum AB (publ)
  • 66658-234- Kineret
    • 66658-234-28- 4 CARTON in 1 CASE (66658-234-28) > 7 SYRINGE, GLASS in 1 CARTON (66658-234-07) >.67 mL in 1 SYRINGE, GLASS