Dosing & Uses
Dosage Forms & Strengths
prefilled autoinjector, single-dose
- 80mg/mL
prefilled syringe, single-dose
- 80mg/mL
Psoriasis
Indicated for moderate-to-severe plaque psoriasis
Week 0: 160 mg SC (two 80-mg injections), THEN
Weeks 2, 4, 6, 8, 10, and 12: 80 mg SC q2Weeks, THEN
Week 16 and thereafter: 80 mg SC q4Weeks
Psoriatic Arthritis
Indicated for active psoriatic arthritis
May be administered alone or in combination with a conventional DMARD (eg, methotrexate)
160 mg SC (ie, as two 80-mg injections) at Week 0, THEN 80 mg SC q4Weeks
For patients with coexisting moderate-to-severe plaque psoriasis, use the dosing regimen for plaque psoriasis
Ankylosing Spondylitis
Indicated for active ankylosing spondylitis
160 mg SC (ie, as two 80-mg injections) at Week 0, THEN 80 mg SC q4Weeks
May be administered with conventional (nonbiologic) DMARDs (eg, sulfasalazine), corticosteroids, NSAIDs, and/or analgesics
Non-radiographic Axial Spondyloarthritis
Indicated for active non-radiographic axial spondyloarthritis with objective signs of inflammation
80 mg SC q4Weeks
Dosage Modifications
Hepatic or renal impairment
- No formal trial of the effect of hepatic or renal impairment on the pharmacokinetics of ixekizumab was conducted
Dosing Considerations
Before initiating treatment
- Evaluate for tuberculosis (TB)
- Complete all age-appropriate vaccinations as recommended by current immunization guidelines
Plaque Psoriasis
Indicated for moderate-to-severe plaque psoriasis in children and adolescents aged ≥6 years who are candidates for systemic therapy or phototherapy
<6 years: Safety and efficacy not established
≥6 years
- <25 kg: 40 mg SC at Week 0, THEN 20 mg SC q4Weeks thereafter
- 25 to 50 kg: 80 mg SC at Week 0, THEN 40 mg SC q4Weeks thereafter
- >50 kg: 160 mg SC (ie, as two 80-mg injections) at Week 0, THEN 80 mg SC q4Weeks
Dosage Modifications
Hepatic or renal impairment
- No formal trial of the effect of hepatic or renal impairment on the pharmacokinetics of ixekizumab was conducted
Dosing Considerations
Before initiating treatment
- Evaluate for tuberculosis (TB)
- Complete all age-appropriate vaccinations as recommended by current immunization guidelines
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (12)
- adenovirus types 4 and 7 live, oral
ixekizumab decreases effects of adenovirus types 4 and 7 live, oral by immunosuppressive effects; risk of infection. Contraindicated. Ixekizumab may interfere with immune response of live vaccines and increase risk for vaccine adverse effects; prior to initiating ixekizumab, complete all age appropriate immunizations.
- BCG vaccine live
ixekizumab decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Contraindicated. Ixekizumab may interfere with immune response of live vaccines and increase risk for vaccine adverse effects; prior to initiating ixekizumab, complete all age appropriate immunizations.
- influenza virus vaccine quadrivalent, intranasal
ixekizumab decreases effects of influenza virus vaccine quadrivalent, intranasal by immunosuppressive effects; risk of infection. Contraindicated. Ixekizumab may interfere with immune response of live vaccines and increase risk for vaccine adverse effects; prior to initiating ixekizumab, complete all age appropriate immunizations.
- measles mumps and rubella vaccine, live
ixekizumab decreases effects of measles mumps and rubella vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Ixekizumab may interfere with immune response of live vaccines and increase risk for vaccine adverse effects; prior to initiating ixekizumab, complete all age appropriate immunizations.
- measles, mumps, rubella and varicella vaccine, live
ixekizumab decreases effects of measles, mumps, rubella and varicella vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Ixekizumab may interfere with immune response of live vaccines and increase risk for vaccine adverse effects; prior to initiating ixekizumab, complete all age appropriate immunizations.
- rotavirus oral vaccine, live
ixekizumab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Ixekizumab may interfere with immune response of live vaccines and increase risk for vaccine adverse effects; prior to initiating ixekizumab, complete all age appropriate immunizations.
- smallpox (vaccinia) vaccine, live
ixekizumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Ixekizumab may interfere with immune response of live vaccines and increase risk for vaccine adverse effects; prior to initiating ixekizumab, complete all age appropriate immunizations.
- typhoid polysaccharide vaccine
ixekizumab decreases effects of typhoid polysaccharide vaccine by immunosuppressive effects; risk of infection. Contraindicated. Ixekizumab may interfere with immune response of live vaccines and increase risk for vaccine adverse effects; prior to initiating ixekizumab, complete all age appropriate immunizations.
- typhoid vaccine live
ixekizumab decreases effects of typhoid vaccine live by immunosuppressive effects; risk of infection. Contraindicated. Ixekizumab may interfere with immune response of live vaccines and increase risk for vaccine adverse effects; prior to initiating ixekizumab, complete all age appropriate immunizations.
- varicella virus vaccine live
ixekizumab decreases effects of varicella virus vaccine live by immunosuppressive effects; risk of infection. Contraindicated. Ixekizumab may interfere with immune response of live vaccines and increase risk for vaccine adverse effects; prior to initiating ixekizumab, complete all age appropriate immunizations.
- yellow fever vaccine
ixekizumab decreases effects of yellow fever vaccine by immunosuppressive effects; risk of infection. Contraindicated. Ixekizumab may interfere with immune response of live vaccines and increase risk for vaccine adverse effects; prior to initiating ixekizumab, complete all age appropriate immunizations.
- zoster vaccine live
ixekizumab decreases effects of zoster vaccine live by immunosuppressive effects; risk of infection. Contraindicated. Ixekizumab may interfere with immune response of live vaccines and increase risk for vaccine adverse effects; prior to initiating ixekizumab, complete all age appropriate immunizations.
Serious - Use Alternative (21)
- anthrax vaccine adsorbed
ixekizumab decreases effects of anthrax vaccine adsorbed by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating ixekizumab, complete all age appropriate immunizations; non-live vaccinations received during treatment with ixekizumab may not elicit an immune response sufficient to prevent disease.
- axicabtagene ciloleucel
ixekizumab, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- brexucabtagene autoleucel
ixekizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ciltacabtagene autoleucel
ixekizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- diphtheria & tetanus toxoids
ixekizumab decreases effects of diphtheria & tetanus toxoids by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating ixekizumab, complete all age appropriate immunizations; non-live vaccinations received during treatment with ixekizumab may not elicit an immune response sufficient to prevent disease.
- diphtheria & tetanus toxoids/ acellular pertussis vaccine
ixekizumab decreases effects of diphtheria & tetanus toxoids/ acellular pertussis vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating ixekizumab, complete all age appropriate immunizations; non-live vaccinations received during treatment with ixekizumab may not elicit an immune response sufficient to prevent disease.
- diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine
ixekizumab decreases effects of diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating ixekizumab, complete all age appropriate immunizations; non-live vaccinations received during treatment with ixekizumab may not elicit an immune response sufficient to prevent disease.
- idecabtagene vicleucel
ixekizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- influenza virus vaccine quadrivalent, recombinant
ixekizumab decreases effects of influenza virus vaccine quadrivalent, recombinant by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating ixekizumab, complete all age appropriate immunizations; non-live vaccinations received during treatment with ixekizumab may not elicit an immune response sufficient to prevent disease.
- influenza virus vaccine trivalent, recombinant
ixekizumab decreases effects of influenza virus vaccine trivalent, recombinant by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating ixekizumab, complete all age appropriate immunizations; non-live vaccinations received during treatment with ixekizumab may not elicit an immune response sufficient to prevent disease.
- lisocabtagene maraleucel
ixekizumab, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- meningococcal A C Y and W-135 diphtheria conjugate vaccine
ixekizumab decreases effects of meningococcal A C Y and W-135 diphtheria conjugate vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating ixekizumab, complete all age appropriate immunizations; non-live vaccinations received during treatment with ixekizumab may not elicit an immune response sufficient to prevent disease.
- meningococcal A C Y and W-135 polysaccharide vaccine combined
ixekizumab decreases effects of meningococcal A C Y and W-135 polysaccharide vaccine combined by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating ixekizumab, complete all age appropriate immunizations; non-live vaccinations received during treatment with ixekizumab may not elicit an immune response sufficient to prevent disease.
- meningococcal group B vaccine
ixekizumab decreases effects of meningococcal group B vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating ixekizumab, complete all age appropriate immunizations; non-live vaccinations received during treatment with ixekizumab may not elicit an immune response sufficient to prevent disease.
- pneumococcal vaccine 13-valent
ixekizumab decreases effects of pneumococcal vaccine 13-valent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating ixekizumab, complete all age appropriate immunizations; non-live vaccinations received during treatment with ixekizumab may not elicit an immune response sufficient to prevent disease.
- pneumococcal vaccine heptavalent
ixekizumab decreases effects of pneumococcal vaccine heptavalent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating ixekizumab, complete all age appropriate immunizations; non-live vaccinations received during treatment with ixekizumab may not elicit an immune response sufficient to prevent disease.
- pneumococcal vaccine polyvalent
ixekizumab decreases effects of pneumococcal vaccine polyvalent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating ixekizumab, complete all age appropriate immunizations; non-live vaccinations received during treatment with ixekizumab may not elicit an immune response sufficient to prevent disease.
- tetanus & reduced diphtheria toxoids/ acellular pertussis vaccine
ixekizumab decreases effects of tetanus & reduced diphtheria toxoids/ acellular pertussis vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating ixekizumab, complete all age appropriate immunizations; non-live vaccinations received during treatment with ixekizumab may not elicit an immune response sufficient to prevent disease.
- tetanus toxoid adsorbed or fluid
ixekizumab decreases effects of tetanus toxoid adsorbed or fluid by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating ixekizumab, complete all age appropriate immunizations; non-live vaccinations received during treatment with ixekizumab may not elicit an immune response sufficient to prevent disease.
- tisagenlecleucel
ixekizumab, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- upadacitinib
ixekizumab, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Contraindicated.
Monitor Closely (24)
- carbamazepine
ixekizumab, carbamazepine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, ixekizumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of ixekizumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- clonidine
ixekizumab, clonidine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, ixekizumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of ixekizumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- cyclosporine
ixekizumab, cyclosporine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, ixekizumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of ixekizumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- dengue vaccine
ixekizumab decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- disopyramide
ixekizumab, disopyramide. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, ixekizumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of ixekizumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- ethosuximide
ixekizumab, ethosuximide. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, ixekizumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of ixekizumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- fosphenytoin
ixekizumab, fosphenytoin. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, ixekizumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of ixekizumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- haemophilus influenzae type b vaccine
ixekizumab 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 at least 3 months after therapy is discontinued if immune competence has been restored. .
- ifosfamide
ifosfamide, ixekizumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor.
- lomustine
lomustine and ixekizumab 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.
- mechlorethamine
mechlorethamine, ixekizumab. 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. .
- ofatumumab SC
ofatumumab SC, ixekizumab. 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.
- phenobarbital
ixekizumab, phenobarbital. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, ixekizumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of ixekizumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- phenytoin
ixekizumab, phenytoin. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, ixekizumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of ixekizumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- primidone
ixekizumab, primidone. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, ixekizumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of ixekizumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- quinidine
ixekizumab, quinidine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, ixekizumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of ixekizumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- quinine
ixekizumab, quinine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, ixekizumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of ixekizumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- sirolimus
ixekizumab, sirolimus. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, ixekizumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of ixekizumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- tacrolimus
ixekizumab, tacrolimus. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, ixekizumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of ixekizumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- theophylline
ixekizumab, theophylline. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, ixekizumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of ixekizumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- trastuzumab
trastuzumab, ixekizumab. 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, ixekizumab. 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. .
- valproic acid
ixekizumab, valproic acid. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, ixekizumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of ixekizumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- zoster vaccine recombinant
ixekizumab decreases effects of zoster vaccine recombinant by pharmacodynamic synergism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant.
Minor (0)
Adverse Effects
>10%
Injection site reactions (17%)
Upper respiratory tract infections (14%)
1-10%
Thrombocytopenia, Grade 1 (3%)
Nausea (2%)
Tinea infections (2%)
<1%
Serious hypersensitivity reactions
Serious infections
Neutropenia
Rhinitis
Oral candidiasis
Urticaria
Influenza
Conjunctivitis
Inflammatory bowel disease
Angioedema
Postmarketing Reports
Immune system disorders: Anaphylaxis
Warnings
Contraindications
Hypersensitivity reaction (eg, anaphylaxis) to drug or excipients
Cautions
Serious hypersensitivity reactions reported, including angioedema and urticaria; anaphylaxis reported, some requiring hospitalization; if a serious hypersensitivity reaction occurs, discontinue drug immediately and initiate appropriate therapy
Patients receiving treatment may be at increased risk of inflammatory bowel disease; in clinical trials, Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in treated group than placebo control group; during treatment, monitor for onset or exacerbation of inflammatory bowel disease and if IBD occurs, discontinue therapy and initiate appropriate medical management
Risk of infections
- May increase risk of infection; upper respiratory tract infections, oral candidiasis, conjunctivitis, and tinea infections reported
- Instruct patients to seek medical advice if signs or symptoms of infection occur
- If a serious infection develops or infection is not responding to standard therapy, monitor patient closely and discontinue therapy until infection resolves
Tuberculosis evaluation
- Evaluate patients for TB prior to initiating treatment
- Do not administer to patients with active TB
- Initiate treatment of latent TB prior to administering therapy
- Consider anti-TB therapy prior to initiating in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed
- Monitor closely for signs and symptoms of active TB during and after treatment
Drug interaction overview
- Prior to initiating drug, consider completion of all age-appropriate immunizations; avoid use of live vaccines; no data are available on the response to live vaccines while taking ixekizumab
-
Altering CYP450 enzymes
- Formation of CYP450 enzymes can be altered by increased levels of certain cytokines (eg, IL-1, IL-6, IL-10, TNF-alpha, IFN) during chronic inflammation; thus, ixekizumab, an IL-17A antagonist, could normalize the formation of CYP450 enzymes
- Upon initiating or discontinuing ixekizumab in patients receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (eg, warfarin) or drug concentration (eg, cyclosporine) and consider dosage modification of the CYP450 substrate
Pregnancy
Pregnancy
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to this medication during pregnancy; pregnant women exposed to this medication are encouraged to enroll in the TALTZ Pregnancy Registry by calling 1-800-284-1695; contact information for the registry is also available on https://www.taltz.com
Available data from the published literature and pharmacovigilance database with use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes
Human IgG is known to cross the placental barrier; therefore, the drug may be transmitted from the mother to the developing fetus
Animal studies
- Unknown if distributed in human breast milk
- Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Lactation
There are no available data on presence of this drug in human milk, effects on breastfed infant, or on milk production; the drug was detected in the milk of lactating cynomolgus monkeys; when a drug is present in animal milk, it is likely that the drug will be present in human milk
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from the drug or from underlying maternal condition
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
Humanized monoclonal IgG4 antibody that targets interleukin-17A (IL-17A) and neutralizes the proinflammatory effects of IL-17A
IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses and plays a key role in the pathogenesis of plaque psoriasis
Absorption
Bioavailability: 60-81%; higher when administered in thigh vs arm or abdomen
Peak plasma time: 4 days
Peak plasma concentration: 16.2 mcg/mL
Steady-state
- 60 mg once, THEN 80 mg q2 Weeks dosing regimen: Reached at Week 8
- Switching from 80 mg q2Weeks to 80 mg q4Weeks dosing regimen: Reached at Week 12
Steady-state trough plasma concentration
- 60 mg once, THEN 80 mg q2 Weeks dosing regimen: 9.3 mcg/mL
- Switching from 80 mg q2Weeks to 80 mg q4Weeks dosing regimen: 3.5 mcg/mL
Distribution
Vd (steady-state): 7.11 L (increased with increased weight)
Metabolism
The metabolic pathway has not been characterized
Humanized IgG4 monoclonal antibodies are expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG
Elimination
Half-life: 13 days
Systemic clearance: 0.39 L/day (increased with increased weight)
Administration
SC Preparation
Remove autoinjector or prefilled syringe from the refrigerator and allow to reach room temperature (30 min) without removing the needle cap
Inspect visually for particulate matter and discoloration before administration; solution should appear as a clear and colorless to slightly yellow
Do not use if the liquid contains visible particles or is discolored or cloudy (other than clear and colorless to slightly yellow)
Does not contain preservatives; therefore, discard any unused product remaining in the autoinjector or prefilled syringe
Pediatric patients weighing <50 kg
- Use only the commercial ixekizumab 80 mg/1 mL prefilled syringe when preparing the prescribed 20 mg and 40 mg pediatric dose
- Expel the entire contents of the prefilled syringe into a sterile vial; DO NOT shake or swirl the vial
- Do not add any other medications to ixekizumab
- Using 0.5 or 1 mL disposable syringe and sterile needle, withdraw dose from vial (0.25 mL for 20 mg; 0.5 mL for 40 mg)
- Replace needle with a 27-gauge needle from syringe before administration
SC Administration
Intended for use under the guidance and supervision of a physician
Patients may self-inject after training in SC injection technique using the autoinjector or prefilled syringe
Instruct patients using the autoinjector or prefilled syringe to inject the full amount (1 mL), which provides 80 mg, according to the directions provided in the Instructions for Use provided in the Medication Guide supplied provided
Administer each injection at a different anatomic location (eg, upper arms, thighs, or any quadrant of abdomen) than the previous injection, and not into areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis
Administration in the upper, outer arm may be performed by a caregiver or healthcare provider
Missed dose: Administer as soon as possible; thereafter, resume dosing at the regular scheduled time
Storage
Sterile and preservative-free solution
Protect from light until use
Prepared syringe
- Store at room temperature for up to 4 hr (from first puncturing vial)
Prefilled syringe or autoinjector
- Refrigerate at 2-8ºC (36-46ºF)
- Do not freeze; do not use if drug has been frozen
- Do not shake
- Discard used syringe/autoinjector in a puncture-resistant container
- Not made with natural rubber latex
Images
Formulary
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Adding plans allows you to:
- View the formulary and any restrictions for each plan.
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