Schedule H

Oral

Formulation Strengths Available

Capsules 0.25 mg, 0.5 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India):

1. Relapsing-Remitting Multiple Sclerosis (RRMS)

Approved for adults with highly active disease despite adequate treatment with at least one disease-modifying therapy (DMT), or rapidly evolving severe RRMS.

Parameter Recommendation

Starting dose 0.5 mg orally once daily

Titration Not required

Usual maintenance dose 0.5 mg once daily

Maximum dose 0.5 mg once daily

Clinical Notes:

• First-dose cardiac monitoring (minimum 6 hours) is mandatory due to bradyarrhythmia risk

• Varicella zoster virus (VZV) antibody testing required before initiation; vaccinate if seronegative (wait 1 month before starting therapy)

• Defer initiation during active infections

• Avoid live attenuated vaccines during treatment and for 2 months after discontinuation

• Can be taken with or without food

Secondary Indications – Adults (Off-label):

Not applicable. No off-label indications are supported in current Indian practice or guidelines.

PAEDIATRIC DOSING (Specialist Only)

Primary Indication: Relapsing-Remitting Multiple Sclerosis (RRMS)

Approved for children ≥10 years by select international regulators. In India, use is restricted to specialist paediatric neurologists only.

Age & Weight Starting Dose Titration Maximum Dose

≥10 years and ≤40 kg 0.25 mg once daily Not required 0.25 mg/day

≥10 years and >40 kg 0.5 mg once daily Not required 0.5 mg/day

Safety & Monitoring:

• First-dose ECG and heart rate monitoring (minimum 6 hours) mandatory

• VZV antibody screening and vaccination if seronegative (as per adult protocol)

• Baseline and periodic LFTs, CBC with differential

• Fundoscopy if diabetic or history of uveitis

• Not recommended in children <10 years except within clinical trials under specialist supervision

Secondary Indications – Paediatrics (Off-label):

Not applicable. No paediatric off-label use beyond RRMS is supported in Indian practice.

Mild to severe impairment No adjustment required

Haemodialysis No specific data; use with caution

• Known hypersensitivity to fingolimod or any excipient

• Myocardial infarction, unstable angina, stroke, or TIA within the preceding 6 months

• Decompensated heart failure (current or within preceding 6 months)

• Mobitz type II second-degree or third-degree AV block, or sick sinus syndrome (unless functional pacemaker in place)

• Severe active infection (acute or chronic)

• Active malignancy (except treated basal cell carcinoma)

• Pregnancy (teratogenic risk)

• Concurrent use with Class Ia or Class III antiarrhythmics

• First-dose bradycardia and AV conduction delays — enhanced monitoring in patients with pre-existing cardiac conditions

• Risk of macular oedema — increased in patients with diabetes mellitus or history of uveitis

• Hepatotoxicity — monitor LFTs; discontinue if symptomatic liver injury occurs

• Lymphopenia — expected pharmacological effect; increases infection risk

• Latent infection reactivation — screen for tuberculosis, hepatitis B, and herpes zoster before initiation

• Progressive multifocal leukoencephalopathy (PML) — rare but reported; maintain vigilance for new neurological symptoms

• Posterior reversible encephalopathy syndrome (PRES) — rare; discontinue if suspected

• Avoid abrupt discontinuation — risk of severe rebound MS disease activity

• Women of childbearing potential — effective contraception mandatory during and for 2 months after treatment

Parameter Recommendation

Risk Category Contraindicated (equivalent to Category X)

Teratogenicity Confirmed in animal studies (cardiac defects, skeletal abnormalities)

Preferred Alternatives Interferon-beta or Glatiramer acetate (considered safer in pregnancy)

Pre-conception Advice Discontinue at least 2 months before planned conception

If Inadvertent Exposure Urgent referral to maternal-fetal medicine specialist for fetal assessment

Parameter Recommendation

Compatibility Not recommended during breastfeeding

Milk Excretion No human data; high lipophilicity suggests likely excretion

Preferred Alternatives Glatiramer acetate or Interferon-beta

Infant Monitoring Not applicable if drug avoided during lactation

Parameter Recommendation

Starting Dose 0.5 mg once daily (same as younger adults)

Titration Not required, but closer clinical observation advised

Key Concerns Increased risk of bradycardia, infections, macular oedema, and hepatotoxicity

Monitoring More frequent LFTs, CBC, ophthalmologic assessments; ECG at initiation

Note: Clinical experience in patients >65 years is limited.

Interacting Drug/Class Effect & Recommendation

Class Ia antiarrhythmics (quinidine, procainamide) Additive risk of bradycardia and torsades de pointes — avoid concomitant use

Class III antiarrhythmics (amiodarone, sotalol) Additive bradycardia and QT prolongation — avoid concomitant use

Beta-blockers Enhanced bradycardia risk — if unavoidable, initiate fingolimod in hospital with overnight monitoring

Non-dihydropyridine calcium channel blockers (verapamil, diltiazem) Additive AV nodal depression — avoid or monitor very closely

Live attenuated vaccines Risk of vaccine-induced infection — avoid during treatment and for 2 months post-discontinuation

Other immunosuppressants (natalizumab, alemtuzumab) Additive immunosuppression — ensure adequate washout before switching

Interacting Drug/Class Effect & Recommendation

Ketoconazole and other strong CYP3A4 inhibitors May increase fingolimod exposure by ~70% — monitor for toxicity and LFTs

Carbamazepine, phenytoin (CYP3A4 inducers) May reduce fingolimod plasma levels — monitor clinical efficacy

Rifampicin May significantly reduce fingolimod levels — avoid if possible; monitor efficacy if co-administered

Methotrexate, azathioprine Additive immunosuppression — monitor closely for infections

QT-prolonging drugs (fluoroquinolones, ondansetron, antipsychotics) Additive QT prolongation risk — use with caution; ECG monitoring if combined

• Headache

• Influenza-like symptoms

• Diarrhoea

• Back pain

• Cough

• Fatigue

• Hypertension

• Elevated hepatic transaminases (ALT/AST)

• Lymphopenia (expected pharmacological effect)

• Sinusitis

Adverse Effect Clinical Action

Symptomatic bradycardia / AV block (first dose) May require atropine, isoprenaline, or temporary pacing; extended monitoring

Macular oedema Discontinue treatment; ophthalmology referral

Severe infections (herpes zoster, opportunistic infections) Withhold therapy; initiate appropriate antimicrobial treatment

Progressive multifocal leukoencephalopathy (PML) Rare but potentially fatal; discontinue immediately if suspected

Hepatotoxicity (transaminases >5× ULN or symptomatic) Discontinue and do not rechallenge

Posterior reversible encephalopathy syndrome (PRES) Discontinue; supportive management

Severe rebound MS activity (upon abrupt discontinuation) Taper or plan transition to alternative DMT under specialist guidance

First dose Continuous heart rate and blood pressure monitoring for minimum 6 hours; ECG before dosing and at end of observation period; extended overnight monitoring if bradyarrhythmia, symptoms, or ECG abnormalities

Reinitiation after interruption >14 days Repeat first-dose cardiac monitoring

Ongoing (long-term) CBC and LFTs every 3 months for first year, then every 6 months; ophthalmologic review at 3–4 months and annually thereafter if at risk; clinical vigilance for infections, neurological changes (PML), and visual symptoms

Gilenya Novartis 0.5 mg

Fingomod Sun Pharma 0.5 mg

Fingospan Cipla 0.5 mg

Fingo Zydus 0.5 mg

Note: Generic availability from multiple domestic manufacturers.

0.5 mg capsule (per unit) ₹600 – ₹1,200

• Not included in NLEM 2022

• Not under NPPA price control

• May be available under state health schemes or patient assistance programmes for MS

• First-dose observation is non-negotiable — ensure ECG monitoring setup and access to resuscitation equipment during initial 6 hours

• VZV immunity — always confirm or vaccinate before starting; primary varicella infection on fingolimod can be severe

• Do not stop abruptly — rebound disease activity can be severe; plan transition to alternative DMT with specialist input

• Lymphopenia is expected — absolute lymphocyte counts typically drop to 20–30% of baseline; this is a pharmacodynamic effect, not necessarily toxicity

• Screen for latent TB — particularly relevant in Indian settings before initiating any immunomodulator

• Macular oedema screening — essential in diabetics and patients with prior uveitis; early detection prevents vision loss

• Not interchangeable with other S1P modulators — siponimod, ozanimod have different kinetics and receptor selectivity

fingolimod; multiple sclerosis; RRMS; S1P modulator; immunomodulator; oral DMT; pregnancy-contraindicated; first-dose monitoring; bradycardia risk; NLEM-excluded; neurology

RxIndia v1.0 — 21 May 2025

• CDSCO approved product information

• Indian Pharmacopoeia 2022

• National Formulary of India (NFI) 2021

• API Textbook of Medicine, 12th Edition

• AIIMS Neurology MS Treatment Protocols

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

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

• European Medicines Agency (EMA) — paediatric RRMS data (supportive reference)