US FDA approved new drug Prevymis that contains Letermovir as an active pharmaceutical ingredient for the prophylaxis and treatment of infection caused by virus known as cytomegalovirus (CMV) in adult patients. US FDA also indicated this drug for the treatment of viral infection occurs after allogeneic hematopoietic stem cell transplant (HSCT). This drug will be available in two dosage form one is oral dosage form (Tablets) and second is parenteral dosage form (Injection) with potency of 240mg and 480mg.
Cytomegalovirus (CMV) belongs to a group of viruses known as Herpesviridae. It is known by the the name of human herpesvirus 5. Cytomegalovirus may cause infection at any site inside the human body but most commonly infect salivary glands. This virus may remain dormant in a human body until patient becomes immunocompromised. Cytomegalovirus (CMV) spreads rapidly inside the human body in case of weak immune system specifically in conditions like HIV infection, organ transplant and newly born infant.
Most commonly observed problems with such viral infection are liver damage (liver necrosis), retinitis, colitis, pneumonitis, esophagitis, pyloradiculopathy etc. These problems may become worse with weak immune system or immunocompromised adults. This kind of viral infection is more common in developing countries with lower socioeconomic status.
Prevymis/Letermovir belongs to a class of anti-viral drugs. It works by inhibiting the CMV DNA terminase complex which is required for viral DNA processing and packaging. US FDA also indicated this drug for prophylactic treatment of infection occurs after stem cell transplant.
Prevymis/Letermovir Side effects
Following side effects were observed during clinical trails of this drug.
- Edema like condition
- Dry Cough
- Abdominal discomfort
- Skin irritation
- Hypersensitivity Reactions
Prevymis/Letermovir Uses/Prescribing Information
US FDA approved this drug for the treatment of infection caused by virus known as cytomegalovirus (CMV) in adult patients or prophylactic treatment of infection occurs after stem cell transplant. This drug must not be used with any immunosuppressant drug or ergot alkaloids.
Standard dosage frequency of Prevymis/Letermovir is 480mg orally (PO) once a day or intravenously via infusion over 1 hour through 100 days post-transplant. Dose adjustment must be kept under consideration in case of intolerance, toxicity renal or hepatic impairment.