Dosing & Uses
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
COVID-19 (EUA)
November 9, 2023: Emergency use authorization (EUA) issued by the FDA for treatment of COVID-19 disease in hospitalized adults with positive results of direct SARS-CoV-2 viral testing with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR)
100 mg SC qDay x 10 days
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
- RA, CAPS, DIRA: Consider reducing frequency to every other day
- COVID-19: Consider reducing frequency to every other day for a total of 5 doses over 10 days
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
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
Rheumatoid Arthritis
Safety and efficacy not established
COVID-19
Safety and efficacy not established
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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 (73)
- 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.
- axicabtagene ciloleucel
anakinra, axicabtagene ciloleucel. Either increases effects of the other by 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.
- brexucabtagene autoleucel
anakinra, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- 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.
- ciltacabtagene autoleucel
anakinra, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- cyclosporine
anakinra and cyclosporine both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- diphtheria & tetanus toxoids
anakinra decreases effects of diphtheria & tetanus toxoids by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- 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.
- idecabtagene vicleucel
anakinra, idecabtagene vicleucel. Either increases effects of the other by 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.
- lisocabtagene maraleucel
anakinra, lisocabtagene maraleucel. Either increases effects of the other by 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.
- tisagenlecleucel
anakinra, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- 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.
- upadacitinib
anakinra, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- 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 (24)
- 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.
- isavuconazonium sulfate
anakinra and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.
- 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. .
- ublituximab
ublituximab and anakinra both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
- 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.
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%)
COVID-19
- Transaminases increased (30.8%)
- GGT increased (13.8%)
1-10%
Nausea (7%)
Diarrhea (7%)
COVID-19
- Hypernatremia (9.6%)
- Constipation (9.1%)
- Hyperkalemia (9.1%)
- Anxiety (8.1%)
- Hypothermia (7.4%)
- Acute kidney injury (6.3%)
- Rash (3.7%)
- Leukopenia (3.5%)
- Neutropenia (3%)
<1%
Neutropenia (0.3%) especially with TNF antagonists
Postmarketing Reports
Hepatobiliary disorders: Elevated transaminases, noninfectious hepatitis
Hematologic events: Thrombocytopenia, including severe thrombocytopenia (platelet count <10x 109/L)
Warnings
Contraindications
Hypersensitivity to drug or excipients, including E coli-derived proteins
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 continued treatment in patients with NOMID or DIRA against potential risks versus benefits
- Consider risks and benefits of treatment in patients with COVID-19 who have other concurrent infections
- Do not initiate in patients with RA, NOMID, CAPS, or DIRA who have active infections
- Safety and efficacy in immunosuppressed patients or in patients with chronic infections have not been evaluated
- Drugs that affect the immune system by blocking tumor necrosis factor (TNF) have been associated with an increased risk of reactivation of latent tuberculosis (TB); it is possible that taking drugs that block IL-1, such as this medication, increases risk of TB or other atypical or opportunistic infections; health care providers should follow current CDC guidelines both to evaluate for and to treat possible latent tuberculosis infections before initiating therapy
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 with etanercept alone
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.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
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Kineret subcutaneous - | 100 mg/0.67 mL solution |  | |
| Kineret subcutaneous - | 100 mg/0.67 mL solution |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
anakinra subcutaneous
ANAKINRA - INJECTION
(an-a-KIN-ra)
COMMON BRAND NAME(S): Kineret
USES: Anakinra is used to treat rheumatoid arthritis. It helps to slow joint damage and reduces the joint pain/swelling so that you can move better. It is also used to treat a certain group of inherited disorders called cryopyrin-associated periodic syndromes (CAPS), including neonatal-onset multisystem inflammatory disease (NOMID). It helps to improve symptoms of NOMID such as fever, rash, joint pain, vomiting, and headache. Anakinra may also be used to treat another condition called Deficiency of Interleukin-1 Receptor Antagonist (DIRA), a condition where your body does not produce the natural protein interleukin-1 receptor antagonist.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 symptoms such as joint pain/swelling/stiffness.The FDA is allowing the emergency use of anakinra to treat coronavirus disease (COVID-19) in hospitalized patients with pneumonia and who also need supplemental oxygen. If anakinra is used to treat coronavirus disease, more information about the drug is available from the patient information sheet provided by your health care professional.
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) as directed by your doctor, usually once a day. The dosage is based on your medical condition, weight, 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 last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor 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: sore throat that doesn't go away, fever/chills, cough with mucus, spreading redness/swelling/tenderness of the skin, bone pain.A very serious allergic reaction to this drug is rare. However, get medical help right away 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 make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using anakinra before having any immunizations/vaccinations. 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.Lab and/or medical tests (such as absolute neutrophil count) should be done while you are using this medication. Keep all medical and lab appointments. 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 away from light. Do not freeze. Keep all medications 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.
Information last revised April 2023. Copyright(c) 2023 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.
Formulary
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.
