Formulary
Omalizumab: Indications, Dosing, Side Effects and Interactions
Omalizumab clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 3 min read
Omalizumab: Indications, Dosing, Side Effects and Interactions
Omalizumab clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Prophylaxis of severe persistent allergic asthma**
- **Adult** (By Subcutaneous Injection): Dose according to immunoglobulin E concentration and body-weight (consult product literature).
**Add-on therapy**
- **Adult** (By Subcutaneous Injection): for chronic spontaneous urticaria in patients who have had an inadequate response to H 1 antihistamine treatment 300 mg every 4 weeks.
**Prophylaxis of severe persistent allergic asthma for omalizumab**
- **Child 6-17 years** (By subcutaneous injection): Dose according to immunoglobulin E concentration and body-weight (consult product literature).
**Add-on therapy for chronic spontaneous urticaria in patients who have had an inadequate response to H1 antihistamine treatment for omalizumab**
- **Child 12-17 years** (By subcutaneous injection): 300 mg every 4 weeks.
Cautions
Autoimmune disease; susceptibility to helminth infection-discontinue if infection does not respond to anthelmintic
Side effects
Common or very common Headache; skin reactions Uncommon Cough; diarrhoea; dizziness; drowsiness; dyspepsia; fatigue; flushing; increased risk of infection; influenza like illness; limb swelling; nausea; paraesthesia; photosensitivity reaction; postural hypotension; respiratory disorders; syncope; weight increased Rare or very rare Angioedema; hypersensitivity; systemic lupus erythematosus (SLE) Frequency not known Alopecia; eosinophilic granulomatosis with polyangiitis; immune thrombocytopenic purpura; joint disorders; lymphadenopathy; myalgia Side-effects, further information Eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome) Churg-Strauss syndrome has occurred rarely in patients given omalizumab; the reaction is usually associated with the reduction of oral corticosteroid therapy. Churg-Strauss syndrome can present as eosinophilia, vasculitic rash, cardiac complications, worsening pulmonary symptoms, or peripheral neuropathy. Hypersensitivity reactions Hypersensitivity reactions can also occur immediately following treatment with omalizumab or sometimes more than 24 hours after the first injection.
Interactions
**Other interactions (15):**
- Since IgE may be involved in the immunological response to some helminth infections, omalizumab may indirectly reduce the efficacy of medicinal products for the treatment of helminthic or other...
- Cytochrome P450 enzymes, efflux pumps and protein-binding mechanisms are not involved in the clearance of omalizumab; thus, there is little potential for drug-drug interactions.
- Medicinal product or vaccine interaction studies have not been performed with omalizumab.
- There is no pharmacological reason to expect that commonly prescribed medicinal products used in the treatment of asthma, CRSwNP or CSU will interact with omalizumab.
- Allergic asthma In clinical studies omalizumab was commonly used in conjunction with inhaled and oral corticosteroids, inhaled short-acting and long-acting beta agonists, leukotriene modifiers,...
- There was no indication that the safety of omalizumab was altered with these other commonly used anti-asthma medicinal products.
Pregnancy
Manufacturer advises avoid unless essential-crosses the placenta.
Breast feeding
Manufacturer advises avoid-present in milk in animal studies.
Hepatic impairment
Manufacturer advises caution (no information available).
Renal impairment
Manufacturer advises caution-no information available.
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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