Product image of Inzolfi (Fingolimod) supplied by GNH India

Inzolfi

Active Ingredient:
Fingolimod
Origin:
EU

Inzolfi (Fingolimod)

Fingolimod, the active ingredient in Inzolfi, is a sphingosine‑1‑phosphate (S1P) receptor modulator presented as an oral formulation for oral use. It treats relapsing‑remitting multiple sclerosis and other active forms of multiple sclerosis in adult patients.

GNH India supplies Inzolfi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

1a Farma A/S

1
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Indications & Clinical Uses

  • Inzolfi is a disease‑modifying therapy that acts on the sphingosine‑1‑phosphate pathway to manage multiple sclerosis.
  • Relapsing‑remitting multiple sclerosis: reduces relapse frequency and slows disability progression.
  • Active secondary progressive multiple sclerosis: decreases disease activity and relapse risk.
  • Clinically isolated syndrome: may lower the chance of conversion to definite multiple sclerosis.

How It Works

  • Fingolimod selectively binds to sphingosine‑1‑phosphate (S1P) receptors, especially S1P1, on lymphocytes. This interaction causes internalisation of the receptor, preventing lymphocytes from exiting lymph nodes and thereby reducing their migration into the central nervous system, which diminishes inflammatory demyelination in multiple sclerosis.

Side Effects

Common Side Effects

  • Headache: mild to moderate intensity.
  • Nausea: transient gastrointestinal discomfort.
  • Fatigue: general tiredness reported by many patients.
  • Lymphopenia: reduced lymphocyte count observed in routine labs.

Serious or Rare Side Effects

  • Cardiac arrhythmia: bradycardia or heart block, especially after first dose.
  • Macular edema: swelling of the retina that may affect vision.
  • Severe infections: opportunistic or serious bacterial infections.
  • Liver enzyme elevation: significant increase in ALT/AST levels.

Precautions & Warnings

  • Patients should be evaluated for several safety considerations before and during treatment.
  • Monitor lymphocyte count: perform baseline and periodic CBC to detect lymphopenia.
  • Assess cardiac function: obtain baseline ECG and monitor heart rate after initiation.
  • Screen for infections: ensure no active infection before starting therapy.
  • Avoid use in pregnancy: contraindicated; effective contraception required.
  • Store at ambient temperature: keep below 25°C in the original pack, protect from moisture.

Avoid Interactions

Fingolimod may interact with other medicines, requiring careful management.

Major Interactions (Avoid)

  • Live vaccines: contraindicated due to immunosuppression risk.
  • Strong CYP4F2 inhibitors: may increase fingolimod exposure.
  • Concomitant bradycardic agents: can exacerbate heart rate reduction.

Moderate Interactions (Monitor Closely)

  • Anticholinergic drugs: may increase urinary retention risk.
  • Other immunosuppressants: additive infection risk.
  • Non‑live vaccines: possible reduced efficacy, monitor response.

Frequently Asked Questions

Inzolfi contains fingolimod and is indicated for the treatment of relapsing‑remitting multiple sclerosis and active forms of multiple sclerosis, including active secondary progressive disease, in adult patients. It is prescribed to reduce the frequency of clinical relapses and to slow the progression of disability associated with the disease.

Fingolimod is a selective modulator of sphingosine‑1‑phosphate receptors on lymphocytes. By binding to S1P1 receptors, it causes receptor internalisation, preventing lymphocytes from leaving lymph nodes. This reduces the number of circulating lymphocytes that can enter the central nervous system, thereby diminishing inflammatory attacks that lead to demyelination in multiple sclerosis.

The dosing regimen for Inzolfi is determined by the prescribing physician based on the patient’s clinical condition, laboratory values, and applicable regulatory guidelines. The prescriber selects the appropriate strength and administration schedule, and patients should follow the healthcare professional’s instructions without deviation.

Fingolimod is contraindicated during pregnancy because it may cause fetal harm, and it is not recommended for breastfeeding mothers as it can be excreted in breast milk. Women of child‑bearing potential should use effective contraception and discuss family planning with their healthcare provider before starting therapy.

To request Inzolfi, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements) and necessary import documentation.

The primary alternative to fingolimod is dimethyl fumarate or other disease‑modifying therapies such as interferon‑β. Compared with interferon‑β, fingolimod offers oral administration and a mechanism that directly reduces lymphocyte egress, but it carries distinct safety considerations, including cardiac monitoring and infection risk, which must be weighed by the treating physician.

Inzolfi should be stored at ambient temperature, below 25 °C, in the original packaging to protect it from moisture and light. Keep the product out of reach of children and do not store in bathrooms or near heat sources. No refrigeration is required for this oral formulation.

Inzolfi is taken orally, usually as a tablet swallowed whole with water. The medication is intended for once‑daily use, and patients should take it at the same time each day to maintain consistent blood levels. It may be taken with or without food as directed by the prescribing clinician.

The most serious risks associated with fingolimod include severe infections, cardiac events such as bradyarrhythmia or heart block, macular edema affecting vision, and significant liver enzyme elevations. Patients should promptly report persistent fever, chest pain, visual changes, or jaundice to their healthcare provider.

Inzolfi is contraindicated in patients with known hypersensitivity to fingolimod, those with active infections, severe cardiac conditions, or a history of stroke. It is also prohibited during pregnancy and in women who are breastfeeding. Individuals with significant liver impairment or uncontrolled hypertension should be evaluated carefully before use.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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