Vemlidy Patient Counseling Information

Severe Acute Exacerbation of Hepatitis after Discontinuation of Treatment: Inform patients that discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. Advise the patient to not discontinue VEMLIDY without first informing their healthcare provider [see Severe Acute Exacerbation of Hepatitis B after Discontinuation of Treatment under Precautions].
Risk of Development of HIV-1 Resistance in Patients with HIV-1 Coinfection: Inform patients that if they have or develop HIV infection and are not receiving effective HIV treatment, VEMLIDY may increase the risk of development of resistance to HIV medication [see Testing Prior to Initiation of VEMLIDY under Dosage & Administration and Risk of Development of HIV-1 Resistance in Patients Coinfected with HBV and HIV-1 under Precautions].
New Onset or Worsening Renal Impairment: Postmarketing cases of renal impairment, including acute renal failure, have been reported [see New Onset or Worsening Renal Impairment under Precautions].
Lactic Acidosis and Severe Hepatomegaly: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with use of drugs similar to VEMLIDY. Advise patients to contact their healthcare provider immediately and stop VEMLIDY if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [see Lactic Acidosis/Severe Hepatomegaly with Steatosis under Precautions].
Drug Interactions: Advise patients to report to their healthcare provider the use of any other prescription or non-prescription medication or herbal products including St. John's wort, as VEMLIDY may interact with other drugs [see Interactions].
Missed Dosage: Inform patients that it is important to take VEMLIDY on a regular dosing schedule with food and to avoid missing doses, as it can result in development of resistance [see Recommended Dosage in Adults under Dosage & Administration].
Pregnancy Registry: Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes of pregnant women exposed to VEMLIDY [see Pregnancy under Use in Pregnancy & Lactation].