Kineret

anakinra

Kineret

Pharmacologic class: Interleukin-1 (IL-1) blocker

Therapeutic class: Immunomodulator, antirheumatic

Pregnancy risk category B

Action

Inhibits binding of IL-1 with IL type I receptors, thereby mediating immunologic, inflammatory, and other physiologic responses

Availability

Prefilled glass syringes: 100 mg/0.67 ml

Indications and dosages

Moderately to severely active rheumatoid arthritis in patients ages 18 and older who don't respond to disease-modifying antirheumatics alone

Adults: 100 mg/day subcutaneously, given at same time each day

Contraindications

• Hypersensitivity to drug or Escherichia coli-derived protein
• Serious infections

Precautions

Use cautiously in:
• immunosuppression, active infection, chronic illness, renal impairment
• elderly patients
• pregnant or breastfeeding patients
• children.

Administration

Withhold drug and notify prescriber if patient shows signs or symptoms of active infection.

Use extreme caution if patient is concurrently receiving drugs that block tumor necrosis factor (TNF), because of increased risk of serious infection.
• Give entire dose from prefilled syringe.
• Don't freeze or shake syringe.

Adverse reactions

CNS: headache

EENT: sinusitis

GI: nausea, diarrhea, abdominal pain

Hematologic: thrombocytopenia, neutropenia

Respiratory: upper respiratory tract infection

Skin: rash, pruritus, injection site reaction or bruising, rash, erythema, inflammation

Other: flulike symptoms, infections

Interactions

Drug-drug.Etanercept, infliximab, other drugs that block TNF: increased risk of serious infection

Live-virus vaccines: vaccine inefficacy

Drug-diagnostic tests.Neutrophils: decreased count

Patient monitoring

• Monitor CBC with white cell differential.
• Assess injection site for reactions.

Patient teaching

Tell patient to immediately report signs or symptoms of infection.
• Advise patient to report signs and symptoms of allergic response.
• Instruct patient to take drug at same time each day for best response.
• Teach patient about proper drug disposal (in puncture-resistant container). Also caution him against reusing needles, syringes, and drug product.
• Tell patient not to freeze or shake drug.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

anakinra

(a-na-kin-ra) ,

Kineret

(trade name)

Classification

Therapeutic: antirheumatics
Pharmacologic: interleukin antagonists
Pregnancy Category: B

Indications

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)

Action

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

Therapeutic effects

Slowed progression of rheumatoid arthritis.
Reduction in NOMID symptoms

Pharmacokinetics

Absorption: Well absorbed (95%) following subcut administration.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: 4–6 hr.

Time/action profile (clinical response)

ROUTEONSETPEAKDURATION
Subcutwithin 12 wkunknownunknown

Contraindications/Precautions

Contraindicated in: Active infections; Hypersensitivity; Hypersensitivity to other Escherichia coli–derived products.
Use Cautiously in: Other chronic debilitating illness; Underlying immunosuppression; Renal impairment; Obstetric / Lactation / Pediatric: Safety not established; Geriatric: May be more sensitive to toxicity due to age-related decline in renal function; increased incidence of infection in geriatric population.
Exercise Extreme Caution in: Concurrent use of TNF blocking agents such as etanercept (higher risk of serious infections).

Adverse Reactions/Side Effects

Central nervous system

  • headache

Gastrointestinal

  • diarrhea
  • nausea

Hematologic

  • neutropenia

Local

  • injection site reactions (most frequent)

Miscellaneous

  • infections (life-threatening)
  • hypersensitivity reactions (rare)

Interactions

Drug-Drug interaction

↑ 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.

Route/Dosage

Rheumatoid Arthritis

Subcutaneous (Adults ≥18 yr) 100 mg/day.

Neonatal-Onset Multisystem Inflammatory Disease

Subcutaneous (Adults and Children) 1–2 mg/kg/day given in 1–2 divided doses; may be ↑ by 0.5–1 mg/kg/day as needed (maximum = 8 mg/kg/day)

Availability

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

Nursing implications

Nursing assessment

  • 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.
  • Lab Test Considerations: Monitor neutrophil count prior to and during therapy, then monthly for 3 mo and quarterly thereafter for up to 1 yr.

Potential Nursing Diagnoses

Impaired physical mobility (Indications)
Acute pain (Indications)

Implementation

  • Administration of higher than recommended doses did not result in higher responses.
  • Subcutaneous: Administer 1 dose/day. Do not administer solutions that are discolored or contain particulate matter or are beyond expiration date. Provided in single-use prefilled syringes. 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.

Patient/Family Teaching

  • 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.
  • Inform patient of the signs and symptoms of hypersensitivity reactions and injection site reactions (pain, erythema, swelling, purities, brusing, 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.

Evaluation/Desired Outcomes

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

Kineret

A brand name for ANAKINRA.
References in periodicals archive ?
Kineret (anakinra) is a recombinant protein drug that blocks the biological activity of IL-1a and IL -1b by binding to interleukin-1 type 1 receptor (IL-R 1), expressed in a variety of tissues and organs, and thereby blocking the interleukin-1 (IL-1) signalling.
The Bloc also took home Gold in the Direct-To-Patient Campaign category, for its work on Kineret with Swedish Orphan Biovitrum (Sobi).
Swedish Orphan Biovitrum AB have acquired the full rights to develop and commercialize Kineret (anakinra) from American biotechnology company Amgen for all therapeutic indications.
Their research shows Kineret relieved rheumatoid arthritis conditions in 42 percent of those who used it.
Biogeneric erosion of Enbrel, the first biologic DMARD to go off patent in the US, in 2009, would force Amgen to push new candidates, such as Humax IL-15, currently in Phase II, to fill the revenue gap left by under-performing Kineret.
Investors are also awaiting the approval of Kineret, a drug that combats rheumatoid arthritis, a condition that leads to joint inflammation and bone erosion.
The Company also announced it had reached an understanding to sell its Kineret and Kosherific(R) brands with an anticipated closing date of June 30, 2005.
Food and Drug Administration Arthritis Advisory Committee has recommended approval of the drug Kineret for treating rheumatoid arthritis.
There has been speculation among analysts that the company is close to seeking federal approval for two of its in-development drugs: red blood cell stimulator NESP and the rheumatoid arthritis drug Kineret.
On the immediate horizon, in addition to NESP, are Abarelix, a prostate cancer treatment, and a rheumatoid arthritis drug, Kineret.
And last week, Salomon Smith Barney analyst Meirav Chovav upped her price target from $56 to $70, based on her belief that Amgen already has filed for approval of both NESP and its rheumatoid arthritis drug, Kineret.