Dosing & Uses
Dosage Forms & Strengths
solution for SC injection
- 300mg/2mL (single-dose prefilled syringe or pen)
- 200mg/1.14mL (single-dose prefilled syringe or pen)
Atopic Dermatitis
Indicated for moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies or when those therapies not advisable
600 mg (ie, two 300-mg injections) SC once, and then 300 mg SC every other week
Can be used with or without topical corticosteroids
Topical calcineurin inhibitors may be used, for topical dermatitis, but should be reserved for problem areas only (eg, face, neck, intertriginous, and genital areas)
Moderate-to-Severe Asthma
Indicated as add-on maintenance treatment for patients with eosinophilic phenotype or PO corticosteroid dependent asthma
400 mg SC once, then 200 mg q2weeks, OR
600 mg SC once, then 300 mg q2weeks
600 mg initial, then 300 mg q2weeks for patients with PO corticosteroid-dependent asthma or comorbid moderate-to-severe atopic dermatitis (for which dupilumab is indicated)
Chronic Obstructive Pulmonary Disease
Indicated as an add-on maintenance treatment of inadequately controlled chronic obstructive pulmonary disease (COPD) in adults with an eosinophilic phenotype
300 mg SC q2Weeks
Severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Indicated as add-on maintenance treatment in adult and pediatric patients aged ≥12 years with inadequately controlled chronic rhinosinusitis with nasal polyps
300 mg SC q2Weeks
Eosinophilic Esophagitis
Indicated for eosinophilic esophagitis
300 mg SC qWeek
Prurigo Nodularis
Indicated for treatment of prurigo nodularis (PN)
600 mg SC once, followed by 300 mg q2Weeks
Chronic Spontaneous Urticaria
Indicated for chronic spontaneous urticaria (CSU) in patients who remain symptomatic despite H1 antihistamine treatment
600 mg SC once, followed by 300 mg q2Weeks
Bullous Pemphigoid
Indicated of treatment of adults with bullous pemphigoid (BP)
600 mg SC once, followed by 300 mg q2Weeks
Concomitant oral corticosteroids
- Use in combination with a tapering course of oral corticosteroids
- Once disease control has occurred, gradually taper corticosteroids and continue dupilumab as monotherapy
- If relapse occurs, corticosteroids may be added if medically advisable
Dosing Considerations
Limitations of use
- Asthma: Not indicated for acute bronchospasm or status asthmaticus
- COPD, CSU: Not indication for relief of acute bronchospasm
Vaccinations
- Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines before initiating treatment
Orphan Designations
Bullous pemphigoid
Orphan sponsor
- Regneron Pharmaceuticals, Inc; 777 Old Saw Mill River Road; Tarrytown, New York 10591
Dosage Forms & Strengths
solution for SC injection
- 300mg/2mL (single-dose prefilled syringe or pen)
- 200mg/1.14mL (single-dose prefilled syringe or pen)
- Prefilled pen for use in aged ≥2 years
- Prefilled syringe for use in aged ≥6 months
Atopic Dermatitis
Indicated for children aged ≥6 months with moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies or when those therapies not advisable
Can be used with or without topical corticosteroids
Topical calcineurin inhibitors may be used, for topical dermatitis, but should be reserved for problem areas only (eg, face, neck, intertriginous, and genital areas)
<6 months: Safety and efficacy not established
6 months through 5 years
- No initial loading dose recommended
- 5 to <15 kg: 200 mg SC q4weeks
- 15 to <30 kg: 300 mg SC q4weeks
6-17 years
- ≥60 kg: 600 mg (ie, two 300-mg injections) SC once, and then 300 mg SC every other week
- 30 kg to <60 kg: 400 mg (ie, two 200-mg injections) SC once, and then 200 mg SC every other week
- 15 kg to <30 kg: 600 mg (ie, two 300-mg injections) SC once, and then 300 mg SC q4weeks
- May be used with or without topical corticosteroids
Moderate-to-Severe Asthma
Indicated as add-on maintenance treatment for patients aged ≥6 years with eosinophilic phenotype or PO corticosteroid dependent asthma
<6 years: Safety and efficacy not established
6-11 years
- No initial loading dose recommended
- 15 to <30 kg: 300 mg SC q4Weeks
- ≥30 kg: 200 mg SC q2Weeks
- Patients with asthma and comorbid moderate-to-severe atopic dermatitis, follow the recommended dosage for atopic dermatitis, including initial loading dose
≥12 years
- 400 mg SC once, then 200 mg q2weeks, OR
- 600 mg SC once, then 300 mg q2weeks
- Patients with PO corticosteroid-dependent asthma or comorbid moderate-to-severe atopic dermatitis: 600 mg SC once, then 300 mg q2weeks
Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Indicated as add-on maintenance treatment in adult and pediatric patients aged ≥12 years with inadequately controlled chronic rhinosinusitis with nasal polyps
<12 year: Safety and efficacy not established
≥12 years: 300 mg SC q2Weeks
Eosinophilic Esophagitis
Indicated for eosinophilic esophagitis in children aged ≥1 year who weigh at least 15 kg
<1 year: Safety and efficacy not established
Age ≥1 year and weight at least 15 kg
- 15 to <30 kg: 200 mg SC q2Weeks
- 30 to <40 kg: 300 mg SC q2Weeks
- ≥40 kg: 300 mg SC qWeek
Chronic Spontaneous Urticaria
Indicated for chronic spontaneous urticaria (CSU) in patients aged ≥12 years who remain symptomatic despite H1 antihistamine treatment
30 to <60 kg: 400 mg SC once, followed by 200 mg q2Weeks
≥60 kg: 600 mg SC once, followed by 300 mg q2Weeks
Dosing Considerations
Limitations of use
- Asthma: Not indicated for acute bronchospasm or status asthmaticus
- CSU: Not indicated for the relief of acute bronchospasm
Vaccinations
- Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines before initiating treatment
Interactions
Interaction Checker
No Results
Contraindicated
Serious
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious (17)
- adenovirus types 4 and 7 live, oral
dupilumab, adenovirus types 4 and 7 live, oral. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating dupilumab, complete all age appropriate immunizations. Avoid use of live vaccines in patients treated with dupilumab.
- axicabtagene ciloleucel
dupilumab, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- BCG vaccine live
dupilumab, BCG vaccine live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating dupilumab, complete all age appropriate immunizations. Avoid use of live vaccines in patients treated with dupilumab.
- brexucabtagene autoleucel
dupilumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- cholera vaccine
dupilumab, cholera vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating dupilumab, complete all age appropriate immunizations. Avoid use of live vaccines in patients treated with dupilumab.
- ciltacabtagene autoleucel
dupilumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- idecabtagene vicleucel
dupilumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- influenza virus vaccine quadrivalent, intranasal
dupilumab, influenza virus vaccine quadrivalent, intranasal. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating dupilumab, complete all age appropriate immunizations. Avoid use of live vaccines in patients treated with dupilumab.
- influenza virus vaccine trivalent, intranasal
dupilumab, influenza virus vaccine trivalent, intranasal. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating dupilumab, complete all age appropriate immunizations. Avoid use of live vaccines in patients treated with dupilumab.
- lisocabtagene maraleucel
dupilumab, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- measles mumps and rubella vaccine, live
dupilumab, measles mumps and rubella vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating dupilumab, complete all age appropriate immunizations. Avoid use of live vaccines in patients treated with dupilumab.
- smallpox and mpox (vaccinia) vaccine, live
dupilumab, smallpox and mpox (vaccinia) vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating dupilumab, complete all age appropriate immunizations. Avoid use of live vaccines in patients treated with dupilumab.
- tisagenlecleucel
dupilumab, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- typhoid polysaccharide vaccine
dupilumab, typhoid polysaccharide vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating dupilumab, complete all age appropriate immunizations. Avoid use of live vaccines in patients treated with dupilumab.
- typhoid vaccine live
dupilumab, typhoid vaccine live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating dupilumab, complete all age appropriate immunizations. Avoid use of live vaccines in patients treated with dupilumab.
- yellow fever vaccine
dupilumab, yellow fever vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating dupilumab, complete all age appropriate immunizations. Avoid use of live vaccines in patients treated with dupilumab.
- zoster vaccine live
dupilumab, zoster vaccine live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating dupilumab, complete all age appropriate immunizations. Avoid use of live vaccines in patients treated with dupilumab.
Monitor Closely (15)
- carbamazepine
dupilumab, 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, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- clonidine
dupilumab, 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, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- cyclosporine
dupilumab, 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, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- dengue vaccine
dupilumab 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
dupilumab, 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, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- fosphenytoin
dupilumab, 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, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- phenobarbital
dupilumab, 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, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- phenytoin
dupilumab, 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, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- primidone
dupilumab, 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, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- quinidine
dupilumab, 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, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- quinine
dupilumab, 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, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- sirolimus
dupilumab, 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, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- tacrolimus
dupilumab, 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, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- theophylline
dupilumab, 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, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
- valproic acid
dupilumab, 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, dupilumab could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of dupilumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.
Minor (0)
Adverse Effects
>10%
Asthma
- Injection site reactions (14-18%)
1-10%
Atopic dermatitis
- Injection site reactions (10%)
- Conjunctivitis (9-10%)
- Blepharitis (<1-5%)
- Oral herpes (3-4%)
- Keratitis (<1-4%)
- Immunogenicity, neutralizing (2%)
- Eye pruritus (1-2%)
- Other herpes simplex virus infection (1-2%)
- Dry eye (<1-2%)
Asthma (adults)
- Oropharyngeal pain (2%)
- Eosinophilia (2%)
Asthma (6-11 years)
- Helminth infections (2.2%)
CRSwNP
- Infection site reaction (6%)
- Arthralgia (3%)
- Conjunctivitis (2%)
- Gastritis (2%)
- Insomnia (1%)
- Eosinophilia (1%)
- Toothache (1%)
PN
- Nasopharyngitis (5%)
- Conjunctivitis (4%)
- Herpes infections (3%)
- Dizziness (3%)
- Myalgia (3%)
- Diarrhea (3%)
<1%
Keratitis
Hypersensitivity reactions
Eczema herpeticum
Herpes zoster
Postmarketing Reports
Immune system disorders: Angioedema
Musculoskeletal system disorders: Psoriatic arthritis
Skin and subcutaneous tissue disorders: Facial skin reactions, including erythema, rash,scaling, edema, papules, pruritus, burning, and pain; new-onset psoriasis, vasculitis
Warnings
Contraindications
Known hypersensitivity to dupilumab or its excipients
Cautions
Hypersensitivity
- Hypersensitivity reactions reported, including anaphylaxis, acute generalized exanthematous pustulosis (AGEP), serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme
- If clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue dupilumab
Conjunctivitis and keratitis
- Conjunctivitis and keratitis adverse reactions reported
- Conjunctivitis and keratitis occurred more frequently in AD patients with atopic dermatitis who received dupilumab compared with placebo; conjunctivitis was the most frequently reported eye disorder; most patients with conjunctivitis or keratitis recovered during treatment period
- Among patients with asthma, frequencies of conjunctivitis and keratitis were similar between dupilumab and placebo
- In patients with CRSwNP, frequency of conjunctivitis was higher in those receiving dupilumab compared with placebo; no cases of keratitis were reported during CRSwNP clinical trials
- Conjunctivitis and keratitis also reported in postmarketing settings, predominantly in patients with atopic dermatitis; some patients reported visual disturbances (eg, blurred vision) associated with conjunctivitis or keratitis
- Advise patients or their caregivers to report new onset or worsening eye symptoms to their healthcare provider; consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate
Eosinophilic conditions
- Patients being treated for asthma may present with clinical features of eosinophilic pneumonia or eosinophilic granulomatosis with polyangiitis (EGPA)
- These events may be associated with reduction of oral corticosteroids
- Clinicians should be alert to development of vasculitic rash, worsening pulmonary symptoms, cardiac complications, kidney injury, and/or neuropathy
- Cases of eosinophilic pneumonia were reported in adults who participated in asthma clinical trials
- Additionally, cases of EGPA reported in adults who participated in asthma clinical trials as well as in adults with comorbid asthma in CRSwNP clinical trials
- Advise patients to report signs of eosinophilic pneumonia and EGPA to their physician
- Consider withholding dupilumab if eosinophilic pneumonia or EGPA suspected
Acute symptoms of asthma or COPD or acute deteriorating disease
- Do not use dupilumab to treat acute symptoms or acute exacerbations of asthma or COPD
- Do not use dupilumab to treat acute bronchospasm or status asthmaticus
- Instruct patients to seek immediate medical care if their asthma or COPD remains uncontrolled or worsens after initiation of treatment with dupilumab
Risk of abrupt corticosteroid dose reduction
- Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon dupilumab initiation
- If appropriate, reduce corticosteroid doses gradually and under direct medical supervision
- Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy
Patients with comorbid asthma
- Advise patients with comorbid asthma not to adjust or stop their asthma treatments without consultation with their physicians
Psoriasis
- Cases of new-onset psoriasis reported with use of dupilumab for atopic dermatitis and asthma, including in patients without a family history of psoriasis
- In postmarketing reports, onset of psoriasis varied from weeks to months after initiating dupilumab and resulted in partial or complete resolution of psoriasis with discontinuation of dupilumab, with or without use of supplemental treatment for psoriasis (topical or systemic)
- Those who continued on dupilumab received supplemental treatment for psoriasis to improve associated symptoms
- Advise patients to report new-onset psoriasis symptoms to their physician
- If symptoms persist or worsen, consider dermatologic evaluation and/or discontinuation
Arthralgia and psoriatic arthritis
- Arthralgia reported with the use of dupilumab with some patients reporting gait disturbances or decreased mobility associated with joint symptoms; some cases resulted in hospitalization
- In postmarketing reports, onset of arthralgia was variable, ranging from days to months after initial dose
- Some symptoms resolved while continuing treatment with dupilumab, and other patients recovered or were recovering following discontinuation
- Advise patients to report new onset or worsening joint symptoms to their healthcare provider
- If symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation
Parasitic (helminth) injections
- Patients with known helminth infections were excluded from participation in clinical studies
- Unknown if dupilumab influences immune response against helminth infections
- Treat patients with pre-existing helminth infections before initiating
- If patients become infected during treatment and do not respond to antihelminth treatment, discontinue treatment dupilumab until infection resolves
Drug interaction overview
-
Vaccinations
- Avoid administration of live vaccines during treatment
- Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines before initiating dupilumab
Pregnancy
Pregnancy
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to drug during pregnancy
Healthcare providers and patients may call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/ to enroll in or to obtain information about the registry
Available data from case reports and case series on use in pregnant women have not identified drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; human IgG antibodies are known to cross the placental barrier; therefore, drug may be transmitted from mother to developing fetus; there are adverse effects on maternal and fetal outcomes associated with asthma in pregnancy
In women with poorly or moderately controlled asthma, evidence demonstrates there is an increased risk of preeclampsia in mother and prematurity, low birth weight, and small for gestational age in the neonate; level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control
Lactation
There are no data on presence of dupilumab in human milk, effects on breastfed infant, or on milk production; maternal IgG is known to be present in human milk; effects of local gastrointestinal exposure and limited systemic exposure to dupilumab on breastfed infant are unknown; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from 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
Monoclonal antibody that inhibits interleukin-4 (IL-4) and IL-13 signaling by specifically binding to the IL-4R-alpha subunit shared by the IL-4 and IL-13 receptor complexes
Blocking the IL-4R-alpha subunit inhibits IL-4 and IL-13 cytokine-induced responses, including the release of proinflammatory cytokines, chemokines, and IgE
Absorption
Bioavailability: 64%
Peak plasma time: ~1 week
Peak plasma concentration: 70.1 mcg/mL
Distribution
Vd: 4.8 L
Metabolism
Metabolic pathway has not been characterized
Administration
SC Preparation
Remove drug from refrigerator and allow to reach room temperature (45 min for 300-mg prefilled syringe/pen or 30 min for 200-mg prefilled syringe/pen and 100-mg prefilled syringe) without removing needle cap
Inspect visually for particulate matter and discoloration before administration; solution is clear to slightly opalescent, colorless-to-pale yellow; discard if liquid appears discolored, cloudy, or contains visible particulate matter
Does not contain preservatives; discard any remaining drug
SC Administration
For SC injection only
Prefilled pen: Use only in adults and adolescents aged ≥2 years; ≥12 years patient may administer injection and parental supervision is recommended for patients aged 12-17 yr
Prefilled syringe: Use in children aged ≥6 months; caregivers should administer injection in patients aged 6 months to <12 years
May self-administer SC into the thigh or abdomen, except for the 2 inches around the navel
May inject in the upper arm if administered by a caregiver
For atopic dermatitis and asthma initial doses (ie, two 300-mg or two 200-mg injection), administer each injection at different injection sites
Rotate injection site with each injection
Do not inject into skin that is tender, damaged, bruised, or scarred
Provide proper training to patients and/or caregivers on preparation and administration
Missed dose
-
Weekly dose missed
- Administer dose as soon as possible
- Start new weekly schedule from date of last administered dose
-
Dose missed for every 2- or 4-week schedule
- Dose missed within 7 days: Administer dose and resume original schedule
- Dose missed >7 days: Administer dose and start new schedule based on this date
Storage
Refrigerate at 36-46ºF (2-8ºC) in the original carton to protect from light
If necessary, prefilled syringes or pens may be kept at room temperature up to 77°F (25°C) for up to 14 days; do not store above 77°F (25°C)
After removal from the refrigerator, discard after 14 days
Protect from heat or direct sunlight
Do not freeze, expose to heat, or shake
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.
