XOLAIR (Omalizumab) – Complete Information

XOLAIR is an anti-IgE antibody.

It is an injectable prescription medicine used to treat:

• Moderate to severe asthma in people (6 years and older) whose asthma symptoms are not well controlled with the normal asthma medicines called inhaled corticosteroids. A skin or blood test will be performed to see if you have allergies to year-round allergens. It is unknown if XOLAIR is safe and effective in people with asthma under 6 years of age.

• Nasal polyps (Add-on maintenance treatment) in people 18 years of age and older when the normal medicines to treat nasal polyps called nasal corticosteroids have not worked well enough to control them. It is unknown if XOLAIR is safe and effective in people with nasal polyps under 18 years of age.

• Chronic spontaneous urticaria (CSU, also referred to as chronic idiopathic urticaria (CIU)), in people 12 years of age and older who continue to have hives and cannot be controlled with the normal H1 antihistamine treatment. It is unknown if XOLAIR is safe and effective in people with CSU under 12 years of age.

• Allergic bronchopulmonary Aspergillosis (ABPA), allergic rhinitis, and bullous Pemphigoid are also some diseases that omalizumab can treat, but is not FDA-approved.

Limitations of Use:

• Not indicated for acute bronchospasm or status asthmatics.

• Not indicated for other allergic conditions or other forms of urticaria.

• Do not receive XOLAIR if you are allergic to XOLAIR or any of the ingredients in omalizumab.

Before receiving XOLAIR, you should tell your doctor about all of your medical conditions, including:

• If you have a latex allergy, food allergy, or seasonal allergies. This is because the needle cap on the XOLAIR syringe contains a type of natural rubber latex.

• If you have bronchospasm or sudden breathing problems.

• If you got a severe allergic reaction called anaphylaxis before.

• If you have or have had parasitic infections (also cancer).

• If you’re currently pregnant or planning to become pregnant in the future. It is not known if XOLAIR can harm your unborn baby.

• If you are breastfeeding or planning to breastfeed. It is not known if XOLAIR can passe into your breast milk. You should consult your doctor about the best way to feed your baby while you receive omalizumab.

You should also tell your doctor about all the prescriptions, over-the-counter medicines, vitamins, and herbal supplements you’re planning to take.

• If you’re planning to receive XOLAIR on your own, you should make sure to get the proper training from your doctor.

• Do not try to inject your prefilled syringe until you have been shown the right way to give XOLAIR injections by a doctor. Use XOLAIR exactly as prescribed by your doctor. For children 12 years of age and older, the prefilled syringe should be self-injected under adult supervision. For children 6 to 11 years of age, the prefilled syringe should be injected by a caregiver.

• Make sure to read the instructions that come with XOLAIR for information on the right way to inject XOLAIR.

• XOLAIR is given in 1 or more injections under the skin, 1 time every 2 or 4 weeks.

• In people with asthma and nasal polyps, a blood test called Immunoglobulin E (IgE) must be performed before starting XOLAIR (this is to determine the appropriate dose and dosing frequency).

• People who have chronic hives do not need a blood test.

• Do not stop taking any of your other asthma, nasal polyps, or hive medicine unless your doctor tell you to.

• You may not see improvement in your symptoms right away after the XOLAIR treatment (call your doctor if you do not see any improvement.

• If you inject more XOLAIR than prescribed (call your doctor to get the treatment required).

The recommended dosage for treatment of asthma is XOLAIR 75 mg to 375 mg by a subcutaneous injection every 2 or 4 weeks based on serum total IgE level (IU/mL) measured before the start of treatment and by body weight (kg).

Administer XOLAIR 75 mg to 600 mg by subcutaneous injection every 2 or 4 weeks based on serum total IgE level (IU/mL) measured before the start of treatment and by body weight (kg).

Administer XOLAIR 150 mg or 300 mg by subcutaneous injection every 4 weeks. Dosing of XOLAIR in CSU patients is not dependent on serum IgE (free or total) level or body weight.

• Cancer: some people who received XOLAIR got cancer.

• Inflammation of your blood vessels: this type of side effect is very rare, and can happen in people with asthma who receive omalizumab. It is not known whether this is caused by XOLAIR. Tell your doctor right away if you have a rash, chest pain, shortness of breath, or feeling of numbness in your arms or legs.

• Severe allergic reaction: a severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. This reaction can happen after the first dose or after many doses (beyond 1 year). Anaphylaxis is a  life-threatening condition and not receiving the right treatment can lead to death. If you experience any of the following symptoms, go to the nearest hospital to get the required treatment:
  • Wheezing, shortness of breath, cough, tightening of the chest, or trouble breathing.
  • Low blood pressure and dizziness.
  • Fainting, rapid, or weak heartbeat.
  • Anxiety, or feeling of “impending doom”.
  • Flushing, itching, hives, or feeling warm.
  • Throat tightness, swelling of the throat or tongue, hoarse voice, or trouble swallowing.

Do not receive XOLAIR if you are allergic to XOLAIR or any of the ingredients in omalizumab.

• Fever, muscle aches, or rashes: some people get a fever, muscle aches, or rashes in 1 to 5 days after receiving an omalizumab injection.

• Parasitic infection: Some people can also get parasite infections after receiving XOLAIR. Your doctor can check if you have a parasite infection or not by testing your stool.

• Heart and circulation problems: Some people can get chest pain, heart attack, blood clots in the lungs or legs, temporary weakness on one side of the body, slurred speech, or altered vision after receiving XOLAIR.

if you experience any of these side effects, go to your doctor immediately.

What are the common side effects of XOLAIR?

• In adults and children 12 years of age and older with asthma: joint pain (arms and legs), dizziness, feeling tired, itching, rash, bone fractures, and pain or discomfort of your ears.

• In children 6 to less than 12 years of age with asthma: swelling inside your nose, throat, or sinuses, headache, fever, throat and ear infection, abdominal pain, a stomach infection, and nose bleed.

• In adults with nasal polyps: injection site reactions, headaches, joint pain, upper abdominal pain, and dizziness are the common side effects.

• In people with chronic spontaneous urticaria: nausea or vomiting, headaches, swelling inside the nose, throat, or sinuses, joint pain, cough, and upper respiratory tract infection.

There can be more side effects and you can ask your doctor about it for information.

Active ingredient: omalizumab

Inactive ingredients: Prefilled syringe: L-histidine, L-arginine hydrochloride, L-histidine hydrochloride monohydrate, and polysorbate 20

Vial: L-histidine hydrochloride monohydrate, L-histidine, polysorbate 20, and sucrose