XOLAIR® 150mg

XOLAIR® 150mg – Key Features and Benefits

XOLAIR® (omalizumab) is an injectable medication indicated for moderate to severe persistent asthma and chronic idiopathic urticaria (CIU) in patients who have inadequate response to other treatments. It works by targeting IgE, a key mediator of allergic inflammation, to reduce allergic reactions and symptoms.

• Active Ingredient: Omalizumab, a monoclonal antibody.
• Indications: Asthma, CIU.
• Administration: Subcutaneous injection.
• Efficacy: Reduces asthma exacerbations and improves symptoms in asthma patients; alleviates hives in CIU patients.
• Side Effects: Includes anaphylaxis, injection site reactions, and gastrointestinal issues.

XOLAIR® 150mg – FDA Approved Indications

XOLAIR® is prescribed for:

• Moderate to Severe Persistent Asthma: This treatment may be suitable for individuals with moderate to severe persistent asthma aged 6 years and older who have a positive skin test or in vitro reactivity to perennial aeroallergens. It may also be suitable for individuals whose asthma symptoms are not well controlled by medications known as inhaled corticosteroids.
• Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): This treatment is for individuals aged 18 and older whose CRSwNP symptoms have not been adequately managed by nasal corticosteroids.
• Food Allergy: XOLAIR is intended for individuals aged 1 year and older to help reduce allergic reactions that may occur after accidentally consuming one or more food to which they are allergic.
• Chronic Idiopathic Urticaria (CIU): XOLAIR is designed for individuals aged 12 and older who continue to experience hives not effectively managed by H1 antihistamine treatment.

Limitations:

However, XOLAIR is not intended for emergency treatment of allergic reactions, including anaphylaxis. It should also not be used for other hives or sudden breathing problems. Other limitations of XOLAIR include the following:

• Not intended for acute bronchospasm or status asthmaticus.
• Not for other allergic conditions or other forms of urticaria.

XOLAIR® 150mg – Ingredients

The primary component of XOLAIR® is omalizumab, a monoclonal antibody. This antibody binds to IgE, reducing its ability to trigger allergic responses.

• Active Ingredient: Omalizumab.
• Inactive Ingredients (Prefilled Syringe or Autoinjector): Arginine Hydrochloride, Histidine, L-histidine Hydrochloride Monohydrate, and Polysorbate 20.
• Inactive Ingredients (Vial): Histidine, L-histidine Hydrochloride Monohydrate, Polysorbate 20 and Sucrose.

XOLAIR® 150mg – How To Use

Each patient must adhere to the instructions on how to receive XOLAIR provided by their doctor to ensure safety and optimal healthcare outcomes. XOLAIR offers two injection types: prefilled syringes and autoinjectors.  The recommended use of these options may depend on the patinet’s age.

• The XOLAIR autoinjector (all doses) is intended exclusively for adults and adolescents aged 12 and older.
• For children 12 and older, the XOLAIR prefilled syringe or autoinjector may be self-injected under adult supervision.
• For children aged 1 to 11, the XOLAIR prefilled syringe should be administered by a healthcare provider or caregiver.

Additionally, according to the updated information from the US FDA and manufacturer, XOLAIR® is administered as a subcutaneous injection, typically once every 2 or 4 weeks for asthma and 4 weeks for CIU. The needle is injected into areas like the thigh, upper arm, or abdomen.

• Individuals with asthma, CRSwNP, and food allergies: Prior to starting XOLAIR, a blood test to measure IgE is required. This test helps determine the appropriate dose and dosing frequency.
• Individuals with Chronic Hives: A blood test is not required to determine the dose or dosing frequency.

Preparation: Only healthcare providers should reconstitute the XOLAIR formulation with sterile water before injection to ensure appropriate preparation, patient safety, and product efficacy.

XOLAIR® 150mg – Side Effects

XOLAIR® can cause side effects, the most serious being anaphylaxis, a life-threatening allergic reaction. Common side effects include injection site reactions and various respiratory and gastrointestinal symptoms.

The common side effects of XOLAIR may vary depending on the patient’s concerns. The following are the potential risks that can occur post-treatment:

• Adults and children aged 12 and older with asthma: Joint pain, particularly in the arms and legs, dizziness, fatigue, itching, skin rash, bone fractures, and ear pain or discomfort.
• Children aged 6 to under 12 with asthma: Swelling of the inside of the nose, throat, or sinuses, headache, fever, throat infection, ear infection, abdominal pain, stomach infection, and nosebleeds.
• Adults with chronic rhinosinusitis with nasal polyps: Headache, injection site reactions, joint pain, upper abdominal pain, and dizziness.
• Individuals with chronic spontaneous urticaria: Nausea, headaches, swelling of the inside of the nose, throat, or sinuses, cough, joint pain, and upper respiratory tract infection.
• People with food allergy: Injection site reactions and fever.

The FDA label and prescribing information also include the possible severe side effects that patients rarely experience during their XOLAIR treatment.

• Cancer
• Inflammation of the blood vessels
• Fever, muscle aches, and rash
• Parasitic infection
• Heart and circulation problems

These symptoms require monitoring after administration. Moreover, the treated patients should consult their trusted healthcare provider when side effects persist or worsen.

XOLAIR® 150mg – Clinical Studies

In clinical trials, XOLAIR® has shown significant efficacy in reducing asthma exacerbations and controlling hives in CIU patients. The treatment significantly reduces asthma exacerbation rates compared to placebo. Other studies have shown the following efficacy results of XOLAIR.

• Nasal Congestion: XOLAIR alleviated nasal congestion as early as week 4 and continued to do so through week 24. The results demonstrated that XOLAIR achieved more than double the improvement in nasal congestion compared to placebo.
• Asthma Trials: In two major trials, XOLAIR® reduced exacerbation rates by 20-30%. Up to 87.6% of XOLAIR treated patients experienced no exacerbations. Additionally, XOLAIR significantly improved both daytime and nighttime symptom scores.
• CIU Trials: Patients experienced relief from hives, with improvement in itch severity. Clinical studies have demonstrated that XOLAIR 300 mg achieved zero itch and zero hives by Week 12.
• IgE-Mediated Food Allergy: XOLAIR reduced moderate to severe allergic reactions to food in 68% of patients, compared to only 5% of patients who received a placebo. For the 600 mg dose of the food protein group, there was a 63% difference between XOLAIR and placebo.

XOLAIR® 150mg – Manufacturer Information

XOLAIR® is developed and marketed by Genentech, a leader in biologics focused on immunology and oncology treatments. The FDA first approved it in 2003 for asthma and later for CIU.

XOLAIR® 150mg – Contraindications

Severe hypersensitivity to omalizumab or any component of XOLAIR®.

XOLAIR® 150mg – Overdosage

Overdosage: There have been no reports of serious toxicity with XOLAIR® overdosage. However, patients should still receive appropriate medical evaluation for any symptoms following an overdose.

XOLAIR® 150mg – Drug Interactions

No formal studies on interactions with other drugs. Caution is advised when XOLAIR® is used alongside other immunotherapies.

XOLAIR® 150mg – FAQ For The Health Care Team

How Should XOLAIR® Be Stored?

• Store in a refrigerator between 2°C and 8°C. Do not freeze.
• Do not remove the autoinjector from its original carton while in storage. Keep your autoinjectors away from direct light.
• Once reconstituted, it can be kept for up to 8 hours at 2°C–8°C or 4 hours at room temperature.

What If I Miss a Dose?

• If you miss a dose, administer it as soon as possible. However, do not exceed the recommended dosing schedule.

Is XOLAIR® Safe During Pregnancy?

• Pregnancy: Data is insufficient to determine the risks; it is recommended to use XOLAIR® only if the benefits outweigh the potential risks.
• Breastfeeding: Consult your healthcare provider, as it is unknown whether omalizumab passes into breast milk.

Can XOLAIR® Be Used with Other Medications?

• No formal drug interaction studies have been conducted. XOLAIR® can be used with inhaled corticosteroids for asthma, but the use in combination with other treatments for CIU has not been thoroughly studied.