On July 17, 2026, the Food and Drug Department (FDD) of Laos granted official marketing authorization to Lovesdi (risdiplam), produced by Tongmeng (Lao) Pharmaceutical (TLPH).

1. Basic Information

• Active Ingredient: Risdiplam (an SMN2-directed RNA splicing modifier).

  
  

• Indication: Treatment of spinal muscular atrophy (SMA), a genetic disorder caused by a deficiency of survival motor neuron (SMN) protein leading to motor neuron loss and muscle wasting.

  
  

• Efficacy:

  
  

• In infants with SMA Type 1 treated for 1 year: 85% survived without permanent ventilation (vs. 25% in untreated infants); 83% retained the ability to feed orally.

  
  

• In children (toddlers to adolescents) and adults with SMA Type 2 and 3: May maintain or improve motor function.

  
  

• Regulatory Note: Subject to additional monitoring. Report all suspected side effects.

  
  

2. Contraindications & Important Warnings

1. Absolute Contraindication: Hypersensitivity to risdiplam or any excipient.

   
   

2. Reproductive Safety (Critical Precautions):

   
   

• Pregnancy: Contraindicated in pregnancy. Pregnancy testing required before initiation. Use effective contraception during treatment and for 1 month after the last dose.

  
  

• Male Fertility: May reduce fertility during treatment and for up to 4 months post-treatment. Avoid conception with partners of childbearing potential and do not donate sperm during this period.

  
  

• Breastfeeding: Contraindicated. Discontinue breastfeeding during treatment.

  
  

3. Drug Interactions: Inform your doctor about all medications, especially metformin and other SMA therapies.

   
   

4. Driving/Operating Machinery: Unlikely to impair ability.

   
   

3. Dosage & Administration

• Standard Regimen: Once daily, at approximately the same time, with or without food.

  
  

• Administration Methods:

  
  

• Swallow tablet whole with water. Do not chew, cut, or crush.

  
  

• Alternative: Dissolve in 5 mL of room-temperature non-chlorinated drinking water (e.g., filtered water). Gently swirl until dissolved (may take up to 3 minutes; some particles may remain). Administer immediately within 10 minutes. Rinse cup with ≥15 mL water and administer rinse. Do not administer via NG-tube or G-tube.

  
  

• Missed Dose:

  
  

• If remembered within 6 hours of scheduled time: Take immediately. Resume normal schedule next day.

  
  

• If >6 hours late: Skip the dose. Take the next dose at the regular time.

  
  

• If vomiting occurs or dose is not fully swallowed: Do not re-dose. Take the next dose at the regular time.

  
  

• Spill Management: Wipe with a dry paper towel, clean area with soap and water. Dispose of towel and wash hands thoroughly.

  
  

4. Side Effects

Report any side effect to your doctor or pharmacist.

5. Storage & Disposal

• Storage: Store at controlled room temperature (20°C–25°C / 68°F–77°F); permitted excursions between 15°C–30°C (59°F–86°F). Keep bottle tightly closed to protect from moisture. Keep out of reach of children.

  
  

• Disposal: Do not dispose via wastewater or household trash. Consult your pharmacist for proper disposal methods to protect the environment.

  
  

6. Packaging & Further Information

• Presentation: Pale yellow, round, biconvex film-coated tablets debossed with "TLPH" on one side. Each tablet contains 5 mg risdiplam. Available in HDPE bottles with child-resistant caps containing 30 tablets.

  
  

• Excipients: Colloidal silicon dioxide, crospovidone, mannitol, microcrystalline cellulose, sodium stearyl fumarate, strawberry flavor.

  
  

• Marketing Authorization Holder: Tongmeng (Lao) Pharmaceutical and Food Co., Ltd., Vientiane, Lao PDR.