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NEFEGAN MODIFIED RELEASE CAPSULE 4MG [SIN16972P]
Active ingredients: NEFEGAN MODIFIED RELEASE CAPSULE 4MG
Last updated 26 October 2025
Product Info
NEFEGAN MODIFIED RELEASE CAPSULE 4MG
[SIN16972P]
Product information
Active Ingredient and Strength | BUDESONIDE - 4 MG |
Dosage Form | CAPSULE |
Manufacturer and Country | PATHEON PHARMACEUTICALS INC. - UNITED STATES |
Registration Number | SIN16972P |
Licence Holder | EVEREST MEDICINES (SINGAPORE) PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | A07EA06 |
2. INDICATIONS AND USAGE
NEFEGAN is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g.
It has not been established whether NEFEGAN slows kidney function decline in patients with IgAN.
3. DOSAGE AND ADMINISTRATION
The recommended duration of therapy is 9 months, with a dosage of 16 mg administered orally once daily [see Clinical Studies (12.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. When discontinuing therapy, reduce the dosage to 8 mg once daily for the last 2 weeks of therapy [see Warnings and Precautions (5.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].
The modified release capsules should be swallowed whole in the morning, at least 1 hour before a meal. Do not open, crush or chew.
If a dose is missed, take the prescribed dose at the next scheduled time. Do not double the next dose.
Safety and efficacy of treatment with subsequent courses of NEFEGAN have not been established.
4. CONTRAINDICATIONS
NEFEGAN is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of NEFEGAN. Serious hypersensitivity reactions, including anaphylaxis have occurred with other budesonide formulations.