Omlyclo Prefilled Syringe

Uses of Omlyclo

Omlyclo is designed to treat several allergic and inflammatory conditions:

Allergic Asthma OMLYCLO (omalizumab) is indicated for adult and pediatric patients (6 years of age and above) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to aperennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.

• Adults and adolescents (12 years of age and older): Omlyclo has been shown to significantly decrease the incidence of asthma exacerbations and improve control of asthma symptoms in these patients.
• Children (6 to <12 years of age): Omlyclo, used as add-on therapy, has been shown tosignificantly decrease asthma exacerbation rates in children who are inadequately controlled and have a documented history of exacerbation.

Chronic Rhinosinusitis with Nasal Polyposis: Omlyclo (omalizumab) is indicated as an add-on maintenance treatment with intranasal corticosteroids in adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP)inadequately controlled by intranasal corticosteroids alone.

Chronic Idiopathic Urticaria: Omlyclo (omalizumab) is indicated for the treatment of adults and adolescents (12 years of age and above) with chronic idiopathic urticaria (CIU) who remain symptomatic despite H1 antihistamine treatment.

Precautions and Warnings

Omlyclo may cause serious allergic reactions, including anaphylaxis. It can happen Immediately after injection or even after a year of regular treatment.

What to watch for:

• Swelling of the face, lips, tongue, or throat
• Difficulty breathing or wheezing
• Fainting or dizziness
• Rapid heartbeat
• Hives or skin rash

Patients should be monitored after each dose. Emergency treatment should be available in case of a reaction.

Malignancy Risk: Some studies suggest a possible increased risk of certain types of cancer (malignancies).

Immune Reactions (Serum Sickness–Like Response): Delayed reactions may occur 1–5 days after an injection. Symptoms may include: Fever, Joint pain or Rash

Risk of Parasitic Infections: Omlyclo may lower your resistance to certain parasitic (helminth) infections.

• Use caution if you live in or plan to travel to areas with common parasitic diseases.
• Inform your healthcare provider if you develop gastrointestinal symptoms.

Corticosteroid Tapering: Do not stop or reduce oral or inhaled corticosteroids suddenly after starting Omlyclo.

Pregnancy & Breastfeeding: Use only if clearly needed. Talk to your doctor about risks.

Children & Older Adults: Use with age-appropriate dosing and monitoring.

Dosage

For allergic asthma and chronic rhinosinusitis with nasal polyps, the dose is calculated based on the patient’s weight and levels of IgE in the blood.

Side Effects

Common Side Effects:

• body aches or pain
• cold or flu-like symptoms
• congestion
• dryness or soreness of the throat
• headache
• hoarseness
• leg pain
• lumps
• pain or tenderness around the eyes and cheekbones
• stuffy or runny nose
• voice changes

Serious Side Effects:

• arm pain
• cracked, dry, or scaly skin
• earache