- Approval Id
- 531bd11e19b2a909
- Drug Name
- MUREST-DR 360 DELAYED-RELEASE TABLETS 360MG
- Product Name
- MUREST-DR 360 DELAYED-RELEASE TABLETS 360MG
- Approval Number
- SIN16637P
- Approval Date
- 2022-11-09
- Registrant
- DKSH SINGAPORE PTE. LTD.
- Licence Holder
- DKSH SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, DELAYED RELEASE
- Dosage
- **DOSAGE AND ADMINISTRATION**
**Dosage regimen**
The recommended dose is 720 mg (four 180 mg or two 360 mg Murest-DR tablets administered twice daily (1440 mg daily dose). Murest-DR tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent.
**General target population**
**Transplant patient**
Treatment with Murest-DR tablets should be initiated and maintained by appropriately qualified transplant specialists.
Murest-DR tablets should be initiated in de-novo patients within 48 hours following transplantation. Murest-DR tablets can be taken with or without food.
**Lupus nephritis patients**
Adequate dose finding studies have not been performed. The prescriber should adjust the dose based on clinical response. The dose may be tapered for maintenance purposes following a complete or partial response (see Clinical Studies section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Induction treatment with Murest-DR tablets is usually initially administered in combination with corticosteroids.
**Special populations**
**Renal impairment**
No dose adjustments are needed in patients experiencing delayed renal graft function post-operatively (see section CLINICAL PHARMACOLOGY – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Patients with severe chronic renal impairment (glomerular filtration rate 25 mL.min-1.1.73 m-2) should be carefully monitored.
**Hepatic impairment**
No dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease.
**Pediatric patients (below 18 years old)**
Safety and efficacy in pediatric patients have not been established. Limited pharmacokinetic data are available for pediatric renal transplant patients (see section CLINICAL PHARMACOLOGY – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
**Geriatric patients (65 years of age or above)**
No dose adjustment is required in this patient population.
**Treatment during rejection episodes**
Renal transplant rejection does not lead to changes in mycophenolic acid pharmacokinetics; dosage reduction or interruption of Murest-DR is not required.
**Method of administration**
Murest-DR should not be crushed in order to maintain the integrity of the enteric coating (see sections CLINICAL PHARMACOLOGY and PHARMACEUTICAL INFORMATION – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
- Route Of Administration
- ORAL
- Indication Info
- **INDICATIONS**
Murest-DR tablets are indicated in combination with ciclosporin for microemulsion and corticosteroids for the prophylaxis of acute transplant rejection in adult patients receiving allogeneic renal transplants.
Murest-DR tablets are indicated for induction and maintenance treatment of adult patients with ISN/RPS Class III, IV or V lupus nephritis.
The evidence for efficacy was based on surrogate endpoints in studies where the majority of patients with lupus nephritis were ISN/RPS (2003) Class IV (see Clinical Studies section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
- Contraindications
- **CONTRAINDICATIONS**
Murest-DR tablets are contraindicated in patients with a hypersensitivity to mycophenolate sodium, mycophenolic acid or mycophenolate mofetil or to any of the excipients, and in pregnant women. (see section DESCRIPTION AND COMPOSITION – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
- Atc Code
- L04AA06
- Atc Item Name
- mycophenolic acid
- Pharma Manufacturer Name
- DKSH SINGAPORE PTE. LTD.
- Company Detail Path
- /organization/cbda6ad0d0b82155/dksh-singapore-pte-ltd
