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Omlyclo (omalizumab-igec)
omalizumab
Black Box Warnings .
Anaphylaxis
has occurred after 1st dose and even after >1y on tx; signs/symptoms include bronchospasm, hypotension, syncope, urticaria, and/or tongue/throat angioedema; initiate tx in healthcare setting by healthcare professional prepared for mgmt of anaphylaxis, including life-threatening; observe patients for appropriate period after administration; inform patients of signs/symptoms and to seek immediate medical care should any occur; select patients for self-administration based on criteria to mitigate anaphylaxis risk, including no anaphylaxis history to food (except IgE-mediated food allergy use) or omalizumab or other agents, at least 3 omalizumab doses given with healthcare provider guidance without hypersensitivity reaction, and caregiver or patient ability to administer injection, recognize anaphylaxis signs/symptoms, and treat anaphylaxis appropriately
Adult Dosing .
Dosage forms: INJ (pre-filled syringe): 75 mg per 0.5 mL, 150 mg per mL, 300 mg per 2 mL
Special Note
- [drug name clarification]
- Info: nonproprietary name = omalizumab-igec
moderate-severe allergic asthma, maintenance tx
- [150-375 mg SC q2-4wk]
- Info: for patients with positive skin test or in vitro reactivity to perennial aeroallergen; individualize dose and frequency based on body wt and baseline IgE levels, see pkg insert; periodically reassess need for tx
chronic rhinosinusitis with nasal polyps, maintenance tx
- [75-600 mg SC q2-4wk]
- Info: individualize dose and frequency based on body wt and baseline IgE levels, see pkg insert; periodically reassess need for tx
IgE-mediated food allergy
- [75-600 mg SC q2-4wk]
- Info: individualize dose and frequency based on body wt and baseline IgE levels, see pkg insert; periodically reassess need for tx
chronic spontaneous urticaria
- [150 mg or 300 mg SC q4wk]
- Info: periodically reassess need for tx
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ (pre-filled syringe): 75 mg per 0.5 mL, 150 mg per mL, 300 mg per 2 mL
Special Note
- [drug name clarification]
- Info: nonproprietary name = omalizumab-igec
moderate-severe allergic asthma, maintenance tx
- [6-11 yo]
- Dose: 75-375 mg SC q2-4wk; Info: for patients with positive skin test or in vitro reactivity to perennial aeroallergen; individualize dose and frequency based on body wt and baseline IgE levels, see pkg insert; periodically reassess need for tx
- [12 yo and older]
- Dose: 150-375 mg SC q2-4wk; Info: for patients with positive skin test or in vitro reactivity to perennial aeroallergen; individualize dose and frequency based on body wt and baseline IgE levels, see pkg insert; periodically reassess need for tx
IgE-mediated food allergy
- [1 yo and older]
- Dose: 75-600 mg SC q2-4wk; Info: individualize dose and frequency based on body wt and baseline IgE levels, see pkg insert; periodically reassess need for tx
chronic spontaneous urticaria
- [12 yo and older]
- Dose: 150 mg or 300 mg SC q4wk; Info: periodically reassess need for tx
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- bronchospasm, acute
- status asthmaticus
- caution: anaphylaxis history
- caution: geohelminth infection risk
Drug Interactions .
Overview
omalizumab
IgE antagonist
-
None
No significant interactions known or found for this drug. Caution always advised with multiple medications.
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction
- anaphylaxis
- angioedema
- serum sickness-like reaction
- eosinophilia
- thrombocytopenia
- Churg-Strauss syndrome
- malignancy risk
- cardiovascular event risk
- cerebrovascular event risk
Common Reactions
- injection site reaction
- headache
- nasopharyngitis
- arthralgia
- pain
- fever
- sinusitis
- URI
- upper abdominal pain
- dizziness
- fatigue
- otitis media
- gastroenteritis (peds patients)
- epistaxis (peds patients)
- nausea
- cough
- UTI
- myalgia
- edema, peripheral
- anxiety
- urticaria
- alopecia
- pruritus
- dermatitis
- fractures
- geohelminth infection
Safety/Monitoring .
Monitoring Parameters
no routine tests recommended
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no known risk of teratogenicity, though possible risk of low birth wt based on limited human data; no known risk of fetal harm based on animal data at 5x MRHD
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no known risk of infant harm based on limited human data; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for omalizumab: other, liver; CYP450: unknown
Excretion: for omalizumab: bile; Half-life: 24 days (chronic spontaneous urticaria use), 26 days (asthma use)
Subclass: IgE Antagonists ; Pruritus/Urticaria, Systemic Nonsteroidal Agents
Mechanism of Action
for omalizumab: inhibits IgE binding to mast cells, basophils, and dendritic cells, down-regulating IgE receptors; in allergic asthma, inhibits IgE-mediated inflammation, decreasing eosinophils and multiple inflammatory mediators; exact mechanism of action in chronic spontaneous urticaria unknown (monoclonal antibody)
Formulary .
No Formulary Selected
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