TM Owner Roche / Genentech / Novartis
Xolair 150mg/mL Injection
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Indications & Clinical Uses
- Xolair 150 mg/mL (omalizumab) is an anti-IgE monoclonal antibody given by subcutaneous injection.
- In the US it is approved for moderate to severe persistent asthma in patients aged 6 and older not controlled by inhaled corticosteroids, chronic rhinosinusitis with nasal polyps in adults 18 and older, IgE-mediated food allergy in patients aged 1 and older, and chronic spontaneous urticaria in patients aged 12 and older.
- It is supplied as prefilled syringes (75 mg/0.5 mL, 150 mg/mL, 300 mg/2 mL), autoinjectors (not approved under age 12) and a 150 mg powder vial, so check the exact presentation and dose.
- Injections are normally given by a healthcare provider; self-injection is allowed only in selected patients after at least 3 supervised doses without a hypersensitivity reaction.
- Genentech is the US label holder.
Side Effects
- BOXED WARNING: Xolair can cause anaphylaxis, with bronchospasm, low blood pressure, fainting, hives and swelling of the throat or tongue.
- It can occur after the first dose or after more than a year of treatment.
- About 0.1% to 0.2% of patients had anaphylaxis, and most cases occur within the first three doses.
- Common side effects vary by condition.
- In asthma these include joint pain (8%), pain (7%), leg pain (4%) and fatigue (3%); in nasal polyps, headache (8.1%) and injection site reactions (5.2%); in food allergy, injection site reactions (15.5%) and fever (6.4%); and in urticaria, headache, colds and sinusitis.
- Injection site reactions are usually mild and last under 8 days.
- Malignancies, Churg-Strauss-type eosinophilic conditions and parasitic infections were also reported.
Precautions & Warnings
- BOXED WARNING: anaphylaxis.
- Patients must be watched for an appropriate time after each injection in a healthcare setting able to treat anaphylaxis; most reactions occur within 2 hours but may happen later.
- Xolair is contraindicated in patients with a severe hypersensitivity reaction to omalizumab or any ingredient.
- Self-injection requires at least 3 supervised doses without hypersensitivity, no prior history of anaphylaxis (except to foods for the food allergy use), and the ability to recognise and manage anaphylaxis.
- Do not suddenly stop steroid medicines when starting Xolair.
- Tell your provider if you are at high risk of worm (geohelminth) infection.
- Registry data show no increase in birth defects, though IgG crosses the placenta; breastfeeding data are limited.
- Store syringes in a refrigerator at 2 to 8 degrees C.
Avoid Interactions
- No formal drug interaction studies have been performed with Xolair.
- Do not abruptly stop systemic or inhaled corticosteroids when starting Xolair; any reduction should be gradual and supervised by your healthcare provider, not by you.
- The reviewed label does not identify specific medicines that increase or reduce the effect of Xolair.
- Tell your healthcare provider about all prescription medicines, over-the-counter products and supplements, before treatment.
- Because no formal interaction studies were done, review any new medicine, including herbal products, with your provider or pharmacist, and report any new symptoms after starting one.
References
Frequently Asked Questions
Xolair (omalizumab) is an injection for allergic asthma from age 6, nasal polyps in adults, IgE-mediated food allergy from age 1, and chronic spontaneous hives from age 12. It works by blocking IgE, a key allergy antibody. It is given as an injection under the skin.
Xolair (omalizumab) is injected under the skin, usually by a healthcare provider. Some patients can self-inject syringes or autoinjectors after at least 3 supervised doses without an allergic reaction. Never inject it into a vein. Dose and schedule depend on your condition.
Common Xolair side effects include injection site reactions, joint pain, headache, fatigue, fever, and colds or sinus infections, depending on the condition treated. Anaphylaxis, a severe allergic reaction, is the serious risk. Call emergency services for wheezing, faintness, hives or throat swelling.
Xolair (omalizumab) carries a boxed warning for anaphylaxis, which can be life-threatening and can occur after the first dose or after more than a year. You are watched after each injection. Do not use it if you had a severe allergic reaction to omalizumab.
Store Xolair (omalizumab) prefilled syringes in the refrigerator at 2 to 8 degrees C. Do not use them if you are unsure how long they have been out of the fridge; ask your pharmacist. Reconstituted vials are prepared by healthcare professionals.
Do not suddenly stop your steroid medicine, including inhaled or tablet steroids, when you start Xolair (omalizumab). Any reduction should be gradual and supervised by your healthcare provider, who will decide how and when to lower the dose. Keep taking your steroid exactly as prescribed until then.
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