Schedule H

Subcutaneous (SC)

• Injection: 75 mg/0.5 mL solution in single-use prefilled syringe

• Injection: 150 mg/mL solution in single-use prefilled syringe

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Moderate to Severe Persistent Allergic Asthma (IgE-Mediated) — Adults & Adolescents ≥12 years

Eligibility Criteria:

• Positive skin prick test or in vitro reactivity to perennial aeroallergen

• Baseline serum total IgE: 30–700 IU/mL

• Inadequately controlled despite optimized ICS + LABA therapy

Parameter Recommendation

Starting dose 75–375 mg SC; dose determined by pre-treatment body weight and serum IgE level (refer to CDSCO-approved dosing nomogram)

Titration Not applicable; dose is fixed based on baseline parameters

Usual maintenance dose 150–375 mg SC every 2 or 4 weeks (as per nomogram)

Maximum dose 375 mg every 2 weeks

Dose Determination Reference:

Pre-treatment IgE (IU/mL) Body Weight 30–60 kg Body Weight 60–90 kg Body Weight >90 kg

30–100 150 mg Q4W 150 mg Q4W 300 mg Q4W

100–200 300 mg Q4W 300 mg Q4W 225 mg Q2W

200–300 300 mg Q4W 225 mg Q2W 300 mg Q2W

300–500 300 mg Q2W 300 mg Q2W 375 mg Q2W

500–700 375 mg Q2W Do not dose Do not dose

Clinical Notes:

• Do not re-measure IgE during treatment for dose adjustment; use only pre-treatment value

• Assess clinical response after 12–16 weeks; discontinue if no improvement

• Not a rescue therapy — ineffective for acute bronchospasm

• Administered in healthcare setting with anaphylaxis monitoring capability

1. Chronic Spontaneous Urticaria (CSU) — Adults & Adolescents ≥12 years

Eligibility Criteria:

• Persistent symptoms despite H1-antihistamines at licensed or up-dosed levels

Parameter Recommendation

Starting dose 150 mg or 300 mg SC every 4 weeks

Titration Start at 300 mg if symptoms severe; may reduce to 150 mg if controlled

Usual maintenance dose 300 mg SC every 4 weeks

Maximum dose 300 mg every 4 weeks

Clinical Notes:

• Dosing independent of serum IgE or body weight

• Reassess need for continued therapy every 6 months

• Discontinue if no response after 6 months of 300 mg dosing

• May be reinitiated if symptoms recur after stopping

Secondary Indications — Adults Only (Off-label)

Indication Dose Duration Notes Evidence Basis

Severe Allergic Rhinitis (OFF-LABEL) 150–300 mg SC every 4 weeks Seasonal or perennial as guided Specialist only; limited Indian data International RCTs; not in Indian standard guidelines

Allergic Bronchopulmonary Aspergillosis (ABPA) (OFF-LABEL) Weight and IgE-based dosing as per asthma nomogram Long-term Specialist only Case series and small trials; emerging evidence

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Moderate to Severe IgE-Mediated Allergic Asthma — Children 6 to <12 years

Parameter Recommendation

Starting dose 75–375 mg SC; based on pre-treatment weight and IgE (30–1300 IU/mL)

Titration Not applicable; dose fixed at initiation

Usual maintenance dose 75–375 mg SC every 2 or 4 weeks (as per paediatric dosing chart)

Maximum dose 375 mg every 2 weeks

Paediatric Dosing Reference (Age 6 to <12 years):

Pre-treatment IgE (IU/mL) Weight 20–40 kg Weight 40–60 kg Weight >60 kg

30–100 75 mg Q4W 150 mg Q4W 150 mg Q4W

100–200 150 mg Q4W 300 mg Q4W 300 mg Q4W

200–500 300 mg Q4W 225 mg Q2W 300 mg Q2W

500–1300 225 mg Q2W 300 mg Q2W 375 mg Q2W

Safety Monitoring:

• Administer in supervised setting with resuscitation equipment available

• Post-injection observation for minimum 2 hours after first 3 doses

• Assess efficacy at 16 weeks; discontinue if no improvement

Age Restriction: Not recommended below 6 years of age

Chronic Spontaneous Urticaria — Children ≥12 years

Parameter Recommendation

Starting dose 150 mg or 300 mg SC every 4 weeks

Titration Not applicable

Usual maintenance dose 300 mg SC every 4 weeks

Maximum dose 300 mg every 4 weeks

Age Restriction: Not approved for CSU in children <12 years in India

Secondary Indications — Paediatrics (Off-label)

Indication Dose Notes Evidence Basis

Chronic Spontaneous Urticaria in children 6–<12 years (OFF-LABEL) 150–300 mg SC every 4 weeks Specialist (paediatric allergist/immunologist) only Limited international data; not approved in India

Clear Statement: Off-label use in children <6 years is not recommended except under formal clinical trial protocols or exceptional specialist supervision.

• No dose adjustment required across all stages of renal impairment

• Limited pharmacokinetic data in severe renal failure (eGFR <30 mL/min)

• Haemodialysis/Peritoneal dialysis: No specific data; drug unlikely to be dialyzable due to large molecular weight

• Known hypersensitivity to omalizumab or any formulation excipient

• Prior severe anaphylactic reaction to omalizumab

• History of anaphylaxis to other monoclonal antibody therapies (relative contraindication; assess risk-benefit)

• History of anaphylaxis to any cause or systemic mastocytosis — increased risk of severe hypersensitivity

• Active or high-risk parasitic (helminthic) infections — IgE-mediated immunity may be impaired; treat infection before initiating

• Concurrent systemic corticosteroid use — do not abruptly discontinue; taper gradually to avoid adrenal crisis or asthma flare

• Churg-Strauss syndrome (eosinophilic granulomatosis with polyangiitis) — may be unmasked during corticosteroid tapering; not caused by omalizumab

• Delayed onset of action — not suitable for acute exacerbation management

• Malignancy history — theoretical concern; observe for new malignancies during long-term therapy

Aspect Recommendation

Safety category No formal category; limited human data; animal studies show no teratogenicity

Preferred alternatives ICS ± LABA as first-line; systemic corticosteroids if needed for severe exacerbations

When it may be used Only if clearly indicated and benefit outweighs potential risk; specialist input mandatory

Monitoring Fetal growth surveillance; maternal asthma control; avoid initiation during first trimester unless compelling indication

Aspect Recommendation

Compatibility Likely compatible; specialist supervision advised

Preferred alternatives Standard ICS ± LABA inhalation therapy

Drug levels in milk Expected to be low; large molecular weight (~150 kDa) limits transfer

Infant monitoring Observe for gastrointestinal disturbance, allergic manifestations, or feeding difficulties

Aspect Recommendation

Starting dose Same as adult dosing; no age-specific adjustment

Titration Not applicable

Special risks Increased susceptibility to injection site reactions; consider cumulative immunosuppression from other comorbidities/medications

Additional considerations Evaluate baseline renal and hepatic function; ensure adequate monitoring facilities

Interacting Drug/Class Mechanism/Effect Clinical Action

Live vaccines (BCG, oral polio, yellow fever, MMR, varicella) Theoretical risk of inadequate immune response or vaccine-related infection Avoid concurrent administration; complete vaccination before starting omalizumab or defer until treatment completed

Other biologics (rituximab, other monoclonal antibodies) Increased immunosuppression Avoid concurrent use unless under specialist protocol

Interacting Drug/Class Clinical Consideration

Allergen immunotherapy (subcutaneous/sublingual) May be used together but requires careful monitoring for hypersensitivity; specialist supervision

Systemic corticosteroids Can be co-administered; ensure gradual taper of steroids — do not discontinue abruptly

Other biologics (belimumab, mepolizumab) Theoretical additive immunosuppression; use under specialist guidance only

Inhaled corticosteroids and LABAs Safe to co-administer; continue baseline asthma therapy

• Injection site reactions (pain, erythema, swelling, pruritus) — up to 45%

• Headache

• Upper respiratory tract infections

• Nasopharyngitis

• Fatigue

• Arthralgia

• Pyrexia (particularly in paediatric patients)

Adverse Effect Clinical Action

Anaphylaxis May occur within minutes to 2 hours; delayed reactions reported up to 24 hours post-injection; discontinue permanently; ensure emergency epinephrine availability

Eosinophilic granulomatosis with polyangiitis (EGPA/Churg-Strauss) Rare; typically unmasked during corticosteroid tapering; not causally linked to omalizumab

Serum sickness-like reactions Fever, arthralgia, rash occurring days after injection; discontinue and manage supportively

Thrombocytopenia Rare; monitor if clinical suspicion arises

Malignancy Theoretical concern from long-term immunomodulation; causality not established

Post-injection (first 3 doses) Observation for anaphylaxis for minimum 2 hours in facility with resuscitation capability

Subsequent doses 30-minute post-injection observation; patient should carry epinephrine auto-injector

Long-term (every 4–6 months) Clinical assessment of asthma/urticaria control, adverse effect review, body weight monitoring

Efficacy assessment At 12–16 weeks for asthma; at 6 months for CSU

• Xolair (Novartis)

Notes:

• Not included in NLEM; not under NPPA price control

• Limited availability through government tertiary care centres (AIIMS, PGIMER, select medical colleges)

• Patient assistance programs may be available through manufacturer

• Pre-treatment IgE determines dose for asthma; do not remeasure IgE during therapy as levels are artificially elevated by omalizumab-IgE complexes

• CSU dosing is fixed (150 or 300 mg) and independent of IgE or weight — simpler than asthma dosing

• Clinical benefit in asthma may take 12–16 weeks to manifest; counsel patients appropriately regarding delayed onset

• Anaphylaxis can occur even after months of uneventful therapy — maintain vigilance with every dose

• When tapering systemic steroids, watch for emergence of eosinophilic conditions (EGPA) previously masked by steroids

• Not a rescue medication — always continue standard bronchodilators and ICS

• Specialist initiation mandatory (pulmonologist, allergist, or dermatologist depending on indication)

Omalizumab; asthma; allergic asthma; chronic urticaria; CSU; anti-IgE; monoclonal antibody; biologic therapy; specialist-use; subcutaneous injection; Schedule H; anaphylaxis risk

RxIndia v1.0 — 22 May 2025

• CDSCO Product Insert — Omalizumab (Xolair)

• Indian Pharmacopoeia / National Formulary of India

• AIIMS Formulary (Specialist Use Medications)

• ICMR Guidelines for Asthma Management

• Indian Consensus Guidelines on Chronic Urticaria Management

• API Textbook of Medicine

• Harrison's Principles of Internal Medicine, 21st Edition

• Goodman & Gilman's The Pharmacological Basis of Therapeutics, 14th Edition

• IAP Guidelines (for paediatric age thresholds)