Omalizumab-Igec: uses, dosing, side effects & brands
Omalizumab-Igec is a medicine sold in the U.S. under one brand, for asthma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Asthma
- Available as
- Injectable
- Sold as
- Omlyclo
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How omalizumab-igec is dosed
From the FDA label for Omlyclo (application BLA761399). Other omalizumab-igec products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For subcutaneous (SC) administration only. ( 2.2 , 2.3 , 2.4 , 2.5 ) See full prescribing information for administration instructions ( 2.6 , 2.7 ). Asthma: OMLYCLO 75 to 375 mg SC every 2 or 4 weeks. Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). See the dose determination charts. ( 2.2 ) Chronic Rhinosinusitis with Nasal Polyps : OMLYCLO 75 to 600 mg SC every 2 or 4 weeks. Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). See the dose determination charts. ( 2.3 ) IgE-Mediated Food Allergy : OMLYCLO 75 mg to 600 mg SC every 2 or 4 weeks. Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). See the dose determination chart. ( 2.4 ) Chronic Spontaneous Urticaria : OMLYCLO 150 or 300 mg SC every 4 weeks. Dosing in CSU is not dependent on serum IgE level or body weight. ( 2.5 ) 2.1 Overview of Dosage Determination Asthma, and Chronic Rhinosinusitis with Nasal Polyps, and IgE-Mediated Food Allergy Determine dosage of OMLYCLO by serum total IgE level (IU/mL) measured before the start of treatment, and by body weight (kg). For patients with asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and IgE-mediated food…
Omalizumab-Igec side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylaxis [see Boxed Warning and Warnings and Precautions (5.1) ] Malignancies [see Warnings and Precautions (5.2) ] Asthma: The most common adverse reactions (≥ 1% of patients) in clinical studies with adult and adolescent patients ≥12 years of age were arthralgia, pain (general), leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, and earache. In clinical studies with pediatric patients 6 to <12 years of age, the most common adverse reactions (≥ 3% of patients) were nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bites, and epistaxis. ( 6.1 ) Chronic Rhinosinusitis with Nasal Polyps : The most common adverse reactions (≥ 3% of patients) in clinical studies with adult patients included the following: headache, injection site reaction, arthralgia, upper abdominal pain, and dizziness. ( 6.1 ) IgE-Mediated Food Allergy: The most common adverse reactions (≥3% of patients) were injection site reactions and pyrexia. ( 6.1 ) Chronic Spontaneous Urticaria: The most common adverse reactions (≥2% of patients) included the following: nausea, nasopharyngitis, sinusitis, upper respiratory tract infection, viral upper respiratory tract infection, arthralgia, headache, and cough. ( 6.1 ) To…
Who shouldn’t take omalizumab-igec
OMLYCLO is contraindicated in patients with severe hypersensitivity reaction to omalizumab products or any ingredient of OMLYCLO [see Warnings and Precautions (5.1) ] . Severe hypersensitivity reaction to omalizumab products or any ingredient of OMLYCLO ( 4 , 5.1 )
Omalizumab-Igec drug interactions
No formal drug interaction studies have been performed with omalizumab products. In patients with asthma, CRSwNP, and IgE-mediated food allergy the concomitant use of omalizumab products and allergen immunotherapy has not been evaluated. In patients with CSU, the use of omalizumab products in combination with immunosuppressive therapies has not been studied. No formal drug interaction studies have been performed. ( 7 )
Every omalizumab-igec product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Omlyclo.
Related calculators
Frequently asked questions
What is omalizumab-igec?
Omlyclo (Omalizumab-Igec) is a medication used to treat Asthma.
Can you take omalizumab-igec with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run omalizumab-igec against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does omalizumab-igec come in?
Across the brands we track, omalizumab-igec is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic omalizumab-igec?
We do not currently list a generic-labelled omalizumab-igec product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Omalizumab-Igec: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/omalizumab-igec
- MLA
- “Omalizumab-Igec: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/omalizumab-igec.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for omalizumab-igec on DailyMed (NIH) ↗ — including its boxed warning in full.