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Prevymis Injection Generic Name & Formulations
Legal Class
Rx
General Description
Letermovir 240mg/12mL, 480mg/24mL; soln for IV infusion after dilution; contains hydroxypropyl betadex; preservative-free.
Pharmacological Class
CMV DNA terminase complex inhibitor.
See Also
How Supplied
Tabs—14, 28; Single-dose vial—1
Manufacturer
Generic Availability
NO
Prevymis Injection Indications
Indications
Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT).
Prevymis Injection Dosage and Administration
Adult
Give as IV infusion over 1hr; do not give as IV bolus. Start between Days 0 and 28 post-transplantation (before or after engraftment) and continue through Day 100 post-transplant. 480mg once daily. Concomitant cyclosporine: 240mg once daily. Switch to oral therapy as soon as able to take oral meds.
Children
<18yrs: not established.
Prevymis Injection Contraindications
Contraindications
Concomitant pimozide, ergot alkaloids. Concomitant pitavastatin, simvastatin when co-administered with cyclosporine.
Prevymis Injection Boxed Warnings
Not Applicable
Prevymis Injection Warnings/Precautions
Warnings/Precautions
Monitor for CMV reactivation after therapy completion. Renal impairment (CrCl <50mL/min): closely monitor serum creatinine (in IV use). Severe hepatic impairment (Child-Pugh C): not recommended. Pregnancy. Nursing mothers.
Prevymis Injection Pharmacokinetics
See Literature
Prevymis Injection Interactions
Interactions
See Contraindications. Specific interactions with cyclosporine: see full labeling. Concomitant inducers of P-gp and/or UGT, nafcillin, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, thioridazine, bosentan, St. John's wort, efavirenz, etravirine, nevirapine, pitavastatin, simvastatin, modafinil: not recommended. May be potentiated by OATP1B1/3 inhibitors. Potentiates CYP3A substrates (eg, midazolam, alfentanil, fentanyl, quinidine), OATP1B1/3 substrates: see full labeling for dose adjustment. Concomitant amiodarone, voriconazole, sirolimus, tacrolimus, omeprazole, pantoprazole: monitor frequently and adjust dose if necessary. Monitor INR with warfarin. Concomitant glyburide, repaglinide, rosiglitazone: monitor glucose levels; avoid repaglinide if co-administered with cyclosporine. Concomitant atorvastatin (max 20mg daily): monitor closely; avoid if co-administered with cyclosporine. Concomitant fluvastatin, lovastatin, pravastatin, rosuvastatin: monitor and reduce statin dose if necessary; avoid lovastatin if co-administered with cyclosporine.
Prevymis Injection Adverse Reactions
Adverse Reactions
Nausea, diarrhea, vomiting, peripheral edema, cough, headache, fatigue, abdominal pain, lab abnormalities.
Prevymis Injection Clinical Trials
See Literature
Prevymis Injection Note
Not Applicable
Prevymis Injection Patient Counseling
See Literature
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