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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             activity indicator 

            Contraindicated (2)

            • lenalidomide

              anakinra increases toxicity of lenalidomide by Other (see comment). Contraindicated. Comment: Avoid concomitant use due to increased risk of infection.

            • thalidomide

              anakinra increases toxicity of thalidomide by Other (see comment). Contraindicated. Comment: Avoid concomitant use due to increased risk of infection.

            Serious - Use Alternative (65)

            • abatacept

              abatacept, anakinra. Mechanism: unspecified interaction mechanism. Contraindicated. Concomitant use not recommended (in mfr. info.).

            • adalimumab

              adalimumab and anakinra both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • adenovirus types 4 and 7 live, oral

              anakinra decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.

            • alefacept

              alefacept and anakinra both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • anthrax vaccine

              anakinra decreases effects of anthrax vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • antithymocyte globulin equine

              anakinra and antithymocyte globulin equine both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • antithymocyte globulin rabbit

              anakinra and antithymocyte globulin rabbit both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • azathioprine

              anakinra and azathioprine both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • baricitinib

              baricitinib, anakinra. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.

            • basiliximab

              anakinra and basiliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • BCG vaccine live

              anakinra decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • canakinumab

              anakinra and canakinumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • certolizumab pegol

              anakinra and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid combination because of an increased risk of serious infection.

            • cyclosporine

              anakinra and cyclosporine both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • diphtheria & tetanus toxoids/ acellular pertussis vaccine

              anakinra decreases effects of diphtheria & tetanus toxoids/ acellular pertussis vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine

              anakinra decreases effects of diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • etanercept

              anakinra and etanercept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              anakinra, etanercept. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Additive immunosuppression; risk of serious infection.

            • everolimus

              anakinra and everolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • glatiramer

              anakinra and glatiramer both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • golimumab

              anakinra and golimumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • hepatitis A vaccine inactivated

              anakinra decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • hepatitis a/b vaccine

              anakinra decreases effects of hepatitis a/b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • hepatitis a/typhoid vaccine

              anakinra decreases effects of hepatitis a/typhoid vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • hepatitis b vaccine

              anakinra decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • human papillomavirus vaccine, nonavalent

              anakinra decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

            • human papillomavirus vaccine, quadrivalent

              anakinra decreases effects of human papillomavirus vaccine, quadrivalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

            • hydroxychloroquine sulfate

              anakinra and hydroxychloroquine sulfate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • infliximab

              anakinra and infliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • influenza virus vaccine quadrivalent

              anakinra decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • influenza virus vaccine quadrivalent, adjuvanted

              anakinra decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

            • influenza virus vaccine quadrivalent, cell-cultured

              anakinra decreases effects of influenza virus vaccine quadrivalent, cell-cultured by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • influenza virus vaccine quadrivalent, intranasal

              anakinra decreases effects of influenza virus vaccine quadrivalent, intranasal by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • influenza virus vaccine trivalent

              anakinra decreases effects of influenza virus vaccine trivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • influenza virus vaccine trivalent, adjuvanted

              anakinra decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

            • Japanese encephalitis virus vaccine

              anakinra decreases effects of Japanese encephalitis virus vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • leflunomide

              anakinra and leflunomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • measles (rubeola) vaccine

              anakinra decreases effects of measles (rubeola) vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • measles mumps and rubella vaccine, live

              anakinra decreases effects of measles mumps and rubella vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • measles, mumps, rubella and varicella vaccine, live

              anakinra decreases effects of measles, mumps, rubella and varicella vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • meningococcal A C Y and W-135 polysaccharide vaccine combined

              anakinra decreases effects of meningococcal A C Y and W-135 polysaccharide vaccine combined by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • muromonab CD3

              anakinra and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • mycophenolate

              anakinra and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • pneumococcal vaccine 13-valent

              anakinra decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • pneumococcal vaccine heptavalent

              anakinra decreases effects of pneumococcal vaccine heptavalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • pneumococcal vaccine polyvalent

              anakinra decreases effects of pneumococcal vaccine polyvalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • procarbazine

              procarbazine, anakinra. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • rabies vaccine

              anakinra decreases effects of rabies vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants may interfere with development of active immunity.

            • rabies vaccine chick embryo cell derived

              anakinra decreases effects of rabies vaccine chick embryo cell derived by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • rilonacept

              anakinra and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • rotavirus oral vaccine, live

              anakinra decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • rubella vaccine

              anakinra decreases effects of rubella vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • sirolimus

              anakinra and sirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • smallpox (vaccinia) vaccine, live

              anakinra decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • tacrolimus

              anakinra and tacrolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • temsirolimus

              anakinra and temsirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • tetanus toxoid adsorbed or fluid

              anakinra decreases effects of tetanus toxoid adsorbed or fluid by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • tick borne encephalitis vaccine

              anakinra decreases effects of tick borne encephalitis vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • tongkat ali

              anakinra and tongkat ali both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • travelers diarrhea and cholera vaccine inactivated

              anakinra decreases effects of travelers diarrhea and cholera vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • typhoid polysaccharide vaccine

              anakinra decreases effects of typhoid polysaccharide vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • typhoid vaccine live

              anakinra decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • ustekinumab

              anakinra and ustekinumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • varicella virus vaccine live

              anakinra decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • yellow fever vaccine

              anakinra decreases effects of yellow fever vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • zoster vaccine live

              anakinra decreases effects of zoster vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            Monitor Closely (22)

            • astragalus

              anakinra increases and astragalus decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • belatacept

              belatacept and anakinra both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

            • denosumab

              anakinra, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

            • echinacea

              anakinra increases and echinacea decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • fingolimod

              anakinra increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • haemophilus influenzae type b vaccine

              anakinra decreases effects of haemophilus influenzae type b vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response might be suboptimal. Patients vaccinated within a 14-day period before starting or during immunosuppressive therapy should be revaccinated =3 months after therapy is discontinued if immune competence has been restored.

            • influenza virus vaccine quadrivalent, recombinant

              anakinra decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • influenza virus vaccine trivalent, recombinant

              anakinra decreases effects of influenza virus vaccine trivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • lomustine

              lomustine and anakinra both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

            • maitake

              anakinra increases and maitake decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • meningococcal group B vaccine

              anakinra decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.

            • mercaptopurine

              anakinra and mercaptopurine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

            • ocrelizumab

              anakinra and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with immunomodulators is expected to increase the risk of immunosuppression.

            • ofatumumab SC

              ofatumumab SC, anakinra. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

            • olaparib

              anakinra and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.

            • ozanimod

              ozanimod, anakinra. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration with immunosuppressive therapies may increase the risk of additive immune effects during therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs in order to avoid unintended additive immunosuppressive effects.

            • poliovirus vaccine inactivated

              anakinra decreases effects of poliovirus vaccine inactivated by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response might be suboptimal. Patients vaccinated within a 14-day period before starting or during immunosuppressive therapy should be revaccinated =3 months after therapy is discontinued if immune competence has been restored. .

            • siponimod

              siponimod and anakinra both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

            • sipuleucel-T

              anakinra decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

            • trastuzumab

              trastuzumab, anakinra. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

            • trastuzumab deruxtecan

              trastuzumab deruxtecan, anakinra. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

            • zoster vaccine recombinant

              anakinra decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant.

            Minor (1)

            • cat's claw

              cat's claw, anakinra. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Possible additive immunosuppr'n.

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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

            BRAND FORM. UNIT PRICE PILL IMAGE
            Kineret subcutaneous
            -
            100 mg/0.67 mL solution

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            anakinra subcutaneous

            ANAKINRA - INJECTION

            (an-a-KIN-ra)

            COMMON BRAND NAME(S): Kineret

            USES: This medication is used alone or with other medications to treat rheumatoid arthritis. It helps to slow joint damage and reduces the joint pain/swelling caused by rheumatoid arthritis so that you can move better. Anakinra is a man-made form of a natural protein (interleukin-1 receptor antagonist) made by the body. It helps to block the effects of another protein (interleukin-1) which can cause joint pain/swelling/stiffness.Anakinra is also used to treat a certain condition called Neonatal-Onset Multisystem Inflammatory Disease (NOMID). It helps to improve symptoms of the disease such as fever, rash, joint pain, vomiting, and headache.This medication is also used to treat a condition where your body does not produce the natural protein interleukin-1 receptor antagonist (Deficiency of Interleukin-1 Receptor Antagonist-DIRA).

            HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using anakinra and each time you get a refill. If you have any questions, consult your doctor or pharmacist.If you are giving the shots yourself, you will be trained by a health care professional on how to properly prepare and inject this product. If any of the information is unclear, consult your health care professional.This medication is injected under the skin (subcutaneously), usually once a day or as directed by your doctor.Dosage is based on your medical condition and response to treatment.Do not shake this medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Let the medication warm to room temperature for 30 minutes before injecting it.Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site daily to avoid problem areas under the skin. Do not inject this medication in an area that is tender, red, bruised, or hard or which has scars or stretch marks.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.Do not reuse the syringe. Learn how to store and discard needles and medical supplies safely. Consult your pharmacist for more details.Tell your doctor if your condition does not improve or if it worsens.

            SIDE EFFECTS: Redness, bruising, swelling, and pain at the injection site may occur. These skin reactions are usually mild and may last 2 to 4 weeks. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Anakinra has caused very serious infections (such as skin/bone/joint infections, pneumonia). Tell your doctor right away if you develop signs of an infection, including: fever/chills, persistent sore throat, cough with mucus, spreading redness/swelling/tenderness of the skin, bone pain.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before using anakinra, tell your doctor or pharmacist if you are allergic to it; or to proteins made from a certain bacteria (E. coli); or to latex; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/past/returning infections (such as tuberculosis), immune system problems (such as HIV disease), kidney disease, asthma.Anakinra can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).Older adults may be at greater risk for infections while using this drug.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: abatacept, TNF blockers (such as adalimumab, certolizumab, etanercept, infliximab).

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

            NOTES: Do not share this medication with others.Laboratory and/or medical tests (including blood tests such as absolute neutrophil count) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

            MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light. Do not freeze. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

            Information last revised January 2021. Copyright(c) 2021 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

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

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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.