Schedule H

Subcutaneous injection

• Injection (pre-filled syringe): 80 mg/mL

• Injection (autoinjector pen): 80 mg/mL

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Moderate to Severe Plaque Psoriasis

Adults (≥18 years):

Parameter Dose

Starting dose 160 mg SC at Week 0 (administered as 2 × 80 mg injections)

Titration 80 mg SC every 2 weeks from Week 2 through Week 12

Usual maintenance dose 80 mg SC every 4 weeks (starting from Week 12)

Maximum dose 80 mg every 4 weeks

Clinical notes: Reserved for patients with inadequate response or intolerance to conventional systemic therapy. Response typically assessed at Week 12.

1. Psoriatic Arthritis (PsA)

Adults — Monotherapy or combination with methotrexate:

Parameter Standard Regimen With Coexistent Moderate-Severe Psoriasis

Starting dose 160 mg SC at Week 0 160 mg SC at Week 0

Titration Not applicable 80 mg SC every 2 weeks (Weeks 2–12)

Usual maintenance dose 80 mg SC every 4 weeks 80 mg SC every 4 weeks

Maximum dose 80 mg every 4 weeks 80 mg every 4 weeks

Clinical notes: May be used with or without methotrexate. Full psoriasis induction regimen may be considered when significant skin involvement coexists.

1. Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis)

Adults with active disease and inadequate response to NSAIDs:

Parameter Dose

Starting dose 160 mg SC at Week 0 (as 2 × 80 mg injections)

Titration Not applicable

Usual maintenance dose 80 mg SC every 4 weeks

Maximum dose 80 mg every 4 weeks

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes Evidence Basis

Non-radiographic Axial Spondyloarthritis 160 mg SC at Week 0, then 80 mg SC every 4 weeks Long-term maintenance OFF-LABEL; Rheumatology specialist only RCT-level evidence; not yet CDSCO-approved for this indication

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. Moderate to Severe Plaque Psoriasis

Age ≥6 years — Weight-based dosing:

Weight Starting Dose (Week 0) Titration Maintenance Dose Maximum Dose

≥50 kg 160 mg SC (2 × 80 mg) Not applicable 80 mg SC every 4 weeks 80 mg per dose

25 to <50 kg 80 mg SC Not applicable 40 mg SC every 4 weeks 40 mg per dose

<25 kg 40 mg SC Not applicable 20 mg SC every 4 weeks 20 mg per dose

Safety monitoring:

• Monitor for infections at each visit

• Assess growth parameters every 6 months

• Baseline and periodic CBC

Prescriber: Paediatric dermatologist or paediatric rheumatologist only

Secondary Indications — Paediatrics (Off-label)

Indication Dose Notes Evidence Basis

Juvenile Psoriatic Arthritis Weight-based dosing as per psoriasis regimen above OFF-LABEL; Specialist only Extrapolated from adult data and limited paediatric studies

Age restriction: Not recommended below 6 years of age except under strict specialist supervision.

• No dose adjustment required in mild, moderate, or severe renal impairment

• Not formally studied in ESRD or dialysis patients — use with caution; specialist supervision advised

• Known hypersensitivity to ixekizumab or any excipients

• Active tuberculosis (pulmonary or extrapulmonary)

• Severe active infections (bacterial, viral, fungal including sepsis)

• Active inflammatory bowel disease (Crohn's disease or ulcerative colitis)

• Latent tuberculosis — mandatory screening before initiation; complete TB treatment prior to starting ixekizumab

• Chronic or recurrent infections — monitor closely throughout therapy

• History of inflammatory bowel disease (even if inactive) — risk of new-onset or exacerbation; monitor GI symptoms

• Prior serious hypersensitivity reactions — anaphylaxis and urticaria reported

• Concurrent live vaccine administration — avoid during and shortly after treatment

• Hepatitis B carriers — risk of reactivation

• Immunocompromised states

Parameter Recommendation

Risk category Limited human data; animal studies show no teratogenicity

When it may be used Only if benefit clearly outweighs risk; requires specialist input (dermatology/rheumatology)

Preferred alternatives Cyclosporine, certolizumab (TNF-inhibitor with minimal placental transfer) for severe disease

What to monitor Signs of infection in mother; fetal growth; neonatal infection risk if used in third trimester

Parameter Recommendation

Compatibility Use with caution — limited human data

Drug levels in milk Likely low (large molecular weight, minimal excretion expected)

Preferred alternatives TNF inhibitors (e.g., certolizumab) if prior adequate response

Infant monitoring Signs of infection, feeding pattern, general wellbeing

• Starting dose: Same as younger adults

• Titration: No age-based modification required

• Extra risks: Increased susceptibility to infections; higher comorbidity burden (subclinical infections, malignancy risk)

• Monitoring: More frequent clinical assessment for infections and injection site reactions

Drug/Class Interaction Recommendation

Live vaccines (BCG, MMR, varicella, oral polio, yellow fever) Risk of disseminated infection; impaired vaccine efficacy Avoid concurrent use; complete vaccination ≥4 weeks before initiating therapy

Other biologics (anti-TNF agents, other IL inhibitors) Additive immunosuppression; significantly increased infection risk Avoid combination; do not use concurrently

Potent immunosuppressants (azathioprine, cyclophosphamide) Additive immunosuppression Avoid or use only under specialist guidance with enhanced monitoring

Drug/Class Interaction Recommendation

Methotrexate No direct pharmacokinetic interaction; approved combination in PsA Can be used concurrently; monitor for infections and LFTs

CYP450-metabolised drugs (warfarin, cyclosporine, theophylline) IL-17 inhibition may normalize CYP450 enzyme expression during inflammation resolution Monitor INR or drug levels when starting or stopping ixekizumab

Systemic corticosteroids Additive immunosuppression Assess cumulative infection risk; taper corticosteroids when possible

• Injection site reactions (erythema, pain, swelling, pruritus)

• Upper respiratory tract infections

• Nasopharyngitis

• Tinea and other superficial fungal infections

• Nausea

• Anti-drug antibody formation (may reduce long-term efficacy)

• Serious infections (cellulitis, pneumonia, herpes zoster) — requires drug discontinuation and appropriate treatment

• New-onset or exacerbation of inflammatory bowel disease — discontinue immediately if suspected; refer to gastroenterology

• Anaphylaxis and severe hypersensitivity reactions — requires immediate medical intervention

• Neutropenia (rare) — monitor CBC if clinically indicated

• Reactivation of latent tuberculosis

Phase Parameters

Baseline TB screening (Mantoux test or IGRA); Chest X-ray if indicated; Hepatitis B and C serology; CBC with differential; LFTs; Complete infection history

After initiation Clinical assessment for infections at each visit; Monitor for GI symptoms (IBD); Injection site reactions; Efficacy assessment at Week 12

Long-term CBC annually; Periodic skin examination for secondary infections; Annual TB screening if high-risk; LFTs if on concurrent hepatotoxic drugs

• Taltz® (Eli Lilly India)

Note: Not included in NLEM; not under NPPA price control. Availability primarily limited to tertiary care centres with dermatology/rheumatology services. Price may vary across institutions.

• Ixekizumab demonstrates rapid onset of action — significant improvement often visible by Week 2–4 in plaque psoriasis

• Mandatory TB screening before initiation; treat latent TB prior to starting therapy

• Avoid in patients with active IBD; use cautiously even with IBD history — risk of flare is significant

• Preferred option in psoriasis patients with axial spondyloarthritis or PsA, especially when TNF inhibitors are contraindicated or have failed

• Injection site reactions are common but typically mild and self-limiting — counsel on site rotation

• Not first-line in India — reserve for moderate to severe disease after failure of conventional systemic agents (methotrexate, cyclosporine, acitretin)

ixekizumab; psoriasis; psoriatic arthritis; ankylosing spondylitis; IL-17 inhibitor; biologic therapy; TB-screening; immunomodulator; dermatology; NLEM-excluded

RxIndia v1.0 — 01 Apr 2025

• CDSCO approval database and product insert

• Eli Lilly India — Approved prescribing information (Taltz®)

• AIIMS Rheumatology protocols

• API Textbook of Medicine

• Indian Association of Dermatologists, Venereologists and Leprologists (IADVL) guidelines

• International RCTs (for off-label non-radiographic axSpA and paediatric PsA — marked accordingly)