Indications for PREVYMIS INJECTION:
Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT).
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.
<18yrs: not established.
Concomitant pimozide, ergot alkaloids. Concomitant pitavastatin, simvastatin when co-administered with cyclosporine.
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.
CMV DNA terminase complex inhibitor.
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.
Nausea, diarrhea, vomiting, peripheral edema, cough, headache, fatigue, abdominal pain, lab abnormalities.
Fecal (major), renal. Half-life: 12 hours.
Tabs—14, 28; Single-dose vial—1