anakinra (Rx)

Brand and Other Names:Kineret
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

prefilled syringes

  • 100mg/0.67mL

Rheumatoid Arthritis

Indicated to reduce signs and symptoms, and slow structural damage progression in moderate-to-severe active rheumatoid arthritis in patients 18 years or older who have failed 1 or more disease modifying antirheumatic drugs (DMARDs)

May use alone or in combo with DMARDs (not TNF-blocking agents)

100 mg SC qDay

Cryopyrin-Associated Periodic Syndromes (CAPS)

Indicated for treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID), also known as chronic infantile neurologic cutaneous articular syndrome (CINCA)

1-2 mg/kg SC qDay (initially); may increase by 0.5-1 mg/kg increments to control active inflammation, not to exceed 8 mg/kg

Once daily administration recommended; may be split into twice daily

Deficiency of Interleukin-1 Receptor Antagonist

Indicated for treatment of deficiency of interleukin-1 receptor antagonist (DIRA)

1-2 mg/kg SC qDay initially; may increase by 0.5- to 1-mg/kg increments to control active inflammation, not to exceed 8 mg/kg/day

Dosage Modifications

Renal Impairment

  • Mild-to-moderate (CrCl 30-80 mL/min): Mean plasma clearance was reduced by 16-50%
  • Severe (CrCl <30 mL/min) or end-stage renal disease: Consider reducing frequency to every other day

Hepatic impairment

  • Pharmacokinetic studies not conducted in this patient population

Dosing Considerations

Measure WBCs before initiating, then qMonth x3 months, then quarterly up to 1 year

Still Disease (Orphan)

Orphan designation for Still disease including systmic juvenile isiopathic arithritis and adult-onset Still disease

Orphan sponsor

  • Swedish Orphan Biovitrum AB, SE-112; 75 Stockholm

Bronchiolitis Obliterans (Orphan)

Orphan designation for treatment of bronchiolitis obliterans

Orphan sponsor

  • Onspira Therapeutics, Inc; 101 Lindenwood Drive, Suite 400; Malvern, PA

Dosage Forms & Strengths

prefilled syringes

  • 100mg/0.67mL

Rheumatoid Arthritis

Safety and efficacy not established

Cryopyrin-Associated Periodic Syndromes (CAPS)

Indicated for treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID), also known as chronic infantile neurologic cutaneous articular syndrome (CINCA)

1-2 mg/kg SC qDay (initially); may increase by 0.5-1 mg/kg increments to control active inflammation, not to exceed 8 mg/kg

Once daily administration recommended; may be split into twice daily

Renal Impairment

CrCl <30 mL/min or ESRD: Consider every other day administration of prescribed dose

Dosing Considerations

Measure WBCs before initiating, then qMonth x3 months, then quarterly up to 1 year

Still Disease (Orphan)

Orphan designation for Still disease including systmic juvenile isiopathic arithritis and adult-onset Still disease

Sponsor

  • Swedish Orphan Biovitrum AB, SE-112; 75 Stockholm
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Interactions

Interaction Checker

and anakinra

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Rheumatoid arthritis

            • Injection-site reaction (71%)
            • Headache (12%)

            Neonatal-onset multisystem inflammatory disease

            • Most common during first 6 months of treatment
            • Injection site reaction (16.3%)
            • Headache (14%)
            • Vomiting (14%)
            • Arthralgia (11.6%)
            • Pyrexia (11.6%)
            • Nasopharyngitis (11.6%)

            1-10%

            Nausea (7%)

            Diarrhea (7%)

            <1%

            Neutropenia (0.3%) especially with TNF antagonists

            Postmarketing Reports

            Hepatobiliary disorders: Elevated transaminases, noninfectious hepatitis

            Cholesterol elevation

            Thrombocytopenia

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            Warnings

            Contraindications

            Hypersensitivity to E coli-derived proteins, Kineret, or to any component of product

            Cautions

            Impact of treatment on active and/or chronic infections and the development of malignancies is unknown

            Decrease in neutrophil counts have been reported; assess neutrophil counts before initiation, monthly for 3 months during treatment, and quarterly thereafter for up to 1 year

            Serious infections

            • Increased incidence of serious infections reported; if serious infection develops in RA patients, discontinue treatment
            • Weigh against potential risks versus benefits of continued treatment in NOMID and DIRA patients
            • Should not be initiated in patients with active infections
            • Safety and efficacy in immunosuppressed patients or in patients with chronic infections have not been evaluated

            Hypersensitivity reactions

            • Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported
            • If a severe hypersensitivity reaction occurs, discontinue treatment and initiate appropriate therapy
            • Increased risk of allergic reactions may occur in patients with DIRA, especially in the initial first several weeks of treatment; closely monitor during this time period
            • If severe allergic reaction occurs, initiate appropriate treatment and consider discontinuation

            Drug interaction overview

            • Immunizations
              • Avoid coadministration of live vaccines
              • Data are unavailable on either effects of live vaccination or secondary transmission of infection by live vaccines in treated patients
            • TNF-blocking agents
              • Use not recommended with anakinra
              • A higher rate of serious infections has been associated with concurrent treatment anakinra and etanercept therapy compared to etanercept alone
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            Pregnancy & Lactation

            Pregnancy

            Insufficient data available on use in pregnant females to identify a drug-associated risks of major birth defects, miscarriage, or maternal and fetal adverse events

            Clinical consideration

            • Published data suggest the risk of adverse pregnancy outcomes in females with rheumatoid arthritis or CAPS is associated with increased disease activity
            • Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (<2500 grams), and small for gestational age at birth

            Lactation

            There are no data on drug presence in either human or animal milk or effects on milk production

            Limited clinical data during lactation precludes a clear determination of risks to infants during lactation

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Interleukin-1 receptor antagonist (recombinant E. coli-derived product)

            Blocks activity of IL-1 alpha and beta by competitively inhibiting IL-1 binding to the IL-1 type I receptor

            IL-1 production is induced in response to inflammatory stimuli and mediates various physiologic responses including inflammatory and immunological responses

            Proteolytic maturation and secretion of IL-1 beta has an important role in the systemic inflammation and manifestations of NOMID

            DIRA is an autosomal recessive monogenic autoinflammatory disease caused by mutations in the IL1RN gene leading to loss of secretion IL-1Ra

            Absorption

            Bioavailability: 95%

            Peak plasma time: 3-7 hr (RA)

            Peak plasma concentration: 3,628 ng/mL (NOMID)

            Elimination

            Half-life: 4-6 hr (RA); 5.7 hr (NOMID)

            Hemodialysis or CAPD: <2.5%

            Excretion: urine

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            Administration

            SC Administration

            SC administration only

            Rotate injection site (thigh, abdomen, upper arm, upper buttocks)

            Each syringe is for single use only; use a new syringe for each dose; discard any unused portion after each dose

            Review instructions on appropriate use to patient and/or caregiver

            Do not use beyond expiration date shown on carton

            Visually inspect solution for particulate matter and discoloration before administration; trace amounts of small, translucent-to-white amorphous particles of protein in the solution may appear

            Do not use if solution is discolored or cloudy, if foreign particulate matter is present, or number of translucent-to-white amorphous particles in a given syringe appears excessive

            Storage

            Refrigerate at 2-8ºC (36-46ºF)

            Do not freeze or shake

            Protect from light

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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.