General Information
Manufacturer: Genentech and Novartis Pharmaceuticals
Medical Name: Omalizumab
Purpose: Xolair is a FDA-approved biologic treatment for chronic hives with no known trigger.
Possible Side Effects
| Side Effect | Likelihood |
|---|---|
| Injection site reactions (pain, swelling, itching, redness, bruising) | Up to 45% (severe reactions in up to 12%) |
| Viral infections (e.g., common cold) | Up to 37% |
| Headache | Up to 27% |
| Sinus infection (sinusitis) | ~16% (in one study) |
| Back pain | Up to 13% |
| Sore throat (pharyngitis/nasopharyngitis) | 9% - 11% |
| Joint pain (arthralgia), general pain | 7% - 8% |
| Leg pain | 4% |
| Fatigue | 3% |
| Dizziness | 3% |
| Earache | 2% |
Serious but Less Common Side Effects
- Breathing problems or wheezing
- Swelling of the face, lips, mouth, tongue, or throat
- Fainting, dizziness, or feeling lightheaded
- Fast pulse
- Swollen lymph nodes, joint pain, or fever in conjunction with a rash
Preconditions and Warnings
| Precondition | Description |
|---|---|
| Severe hypersensitivity reaction (such as anaphylaxis) to omalizumab or any of its ingredients | This is the only absolute contraindication mentioned in the prescribing information. |
| Acute Bronchospasm or Status Asthmaticus | Xolair is a maintenance treatment and is not indicated for the relief of sudden breathing problems, acute asthma symptoms, or severe, life-threatening allergic reactions, including anaphylaxis. |
| Other Forms of Urticaria (Hives) | It is not indicated for treatment of forms of hives other than chronic spontaneous urticaria (CSU). |
| Other Allergic Conditions | Xolair is only indicated for specific conditions (allergic asthma, CSU, chronic rhinosinusitis with nasal polyps, and IgE-mediated food allergy) and not for other allergic conditions. |
Preconditions Requiring Caution/Medical Consultation
| Precondition | Description |
|---|---|
| Latex Allergy | The needle cap on the Xolair prefilled syringe contains a type of natural rubber latex, which may cause allergic reactions in latex-sensitive individuals. A different administration method (e.g., the vial presentation) may be necessary. |
| Current or Past Parasitic (Helminth) Infection | Patients at high risk for parasitic infections should be monitored while on Xolair therapy, as treatment may increase the risk of developing an infection. |
| Cancer (Past or Present) | Malignancies were observed in some patients in clinical studies. It is not known if Xolair worsens an existing cancer or causes a previous one to return, so the risk should be discussed with a doctor. |
| Pregnancy/Breastfeeding | Data on Xolair use during pregnancy or breastfeeding are insufficient. A healthcare provider should be consulted to weigh the risks and benefits. |
| History of Anaphylaxis (to agents other than Xolair) | A history of anaphylaxis to foods, medications, or other causes may put a patient at increased risk of anaphylaxis associated with Xolair. |