September 20, 2024 - Vientiane, Laos - BigBearPharma, a leading biopharmaceutical company focused on developing and commercializing innovative therapies for cancer, announced that Letermovir has received approval from the Lao Ministry of Health.
Letermovir
Letermovir tablets are used for the prevention of cytomegalovirus (CMV) infection and CMV disease in adult recipients who are CMV seropositive undergoing allogeneic hematopoietic stem cell transplantation (HSCT).Sold under the brand name LETEDX. Lao Registration No.: 08L1172/24.
Indications
1. CMV Prophylaxis in Hematopoietic Stem Cell Transplant (HSCT) Recipients Letermovir is indicated for the prevention of cytomegalovirus (CMV) infection and disease in adult and pediatric patients aged ≥6 months and weighing ≥6 kg who are CMV seropositive [R+] undergoing allogeneic HSCT.
2. CMV Prophylaxis in Kidney Transplant Recipients Letermovir is indicated for the prevention of CMV disease in adult and pediatric patients aged ≥12 years and weighing ≥40 kg who are at high risk for kidney transplant (donor CMV seropositive/recipient CMV seronegative [D+/R-]).
Dosage and Administration
1. Adult and Pediatric Patients Aged 12 Years and Older Weighing at Least 30 kg Undergoing HSCT, or Weighing at Least 40 kg Undergoing Kidney Transplant
HSCT: 480 mg once daily, orally or by intravenous (IV) infusion over at least 1 hour, until day 100 post-HSCT. For patients at risk of late CMV infection and disease, LETEDX may be continued until day 200 post-HSCT.
Kidney Transplant: 480 mg once daily, orally or by intravenous infusion over at least 1 hour, until day 200 post-transplant.
2. Pediatric Patients Aged 6 Months to 12 Years Undergoing HSCT, or Pediatric Patients Aged 12 Years and Older Weighing Less Than 30 kg Undergoing HSCT
HSCT: Dose is based on body weight, administered once daily orally or by intravenous infusion over at least 1 hour, until day 100 post-HSCT. For patients at risk of late CMV infection and disease, LETEDX may be continued until day 200 post-HSCT.
After completing LETEDX prophylaxis, monitoring for CMV reactivation in HSCT recipients is recommended.
Warnings and Precautions
1. Risk of Adverse Reactions or Reduced Efficacy Due to Drug Interactions
Concomitant use of LETEDX with certain drugs may result in potentially significant drug interactions, some of which may lead to adverse reactions (from LETEDX or the concomitant drug) or reduced efficacy of LETEDX or the concomitant drug. Please refer to the full prescribing information for contraindications and dose recommendations for concomitant drugs.
2. Risks Associated with the Hydroxypropyl Betadex Excipient in the Intravenous Formulation
The intravenous formulation of LETEDX contains the excipient hydroxypropyl betadex. LETEDX injection should be used only in patients unable to take oral therapy. If possible, intravenous administration should not exceed 4 weeks. Accumulation of hydroxypropyl betadex may occur in patients with renal impairment. Animal studies suggest that hydroxypropyl betadex may cause ototoxicity.
Adverse Reactions
1. Adult HSCT Patients
The most common adverse events (occurring in at least 10% of subjects in the LETEDX group and at a rate at least 2% higher than in the placebo group) were nausea, diarrhea, vomiting, peripheral edema, cough, headache, fatigue, and abdominal pain.
2. Adult Kidney Transplant Patients
The most common adverse event (occurring in at least 10% of subjects in the LETEDX group and at a higher rate than in the valganciclovir group) was diarrhea.
3. Pediatric Patients
Adverse events in pediatric patients were similar to those in adults.
