A causal relationship has not been established.QTc prolongation has been observed with the use of EFV The following adverse reactions are discussed in other sections of the labeling:Because clinical studies are conducted under widely varying conditions, the adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.In Trial 903, 600 antiretroviral-naïve subjects received TDF (N = 299) or stavudine (d4T) (N = 301) administered in combination with 3TC and EFV for 144 weeks. In general, caution should be exercised in the administration of 3TC in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.SYMFI is not recommended for patients with impaired renal function (i.e., creatinine clearance less than 50 mL/min) or patients with end-stage renal disease (ESRD) requiring hemodialysis because it is a fixed-dose combination formulation that cannot be adjusted SYMFI is not recommended for patients with moderate or severe hepatic impairment because there are insufficient data to determine whether dose adjustment is necessary. Based on limited data at delivery, median (range) amniotic fluid concentrations of 3TC were 3.9 (1.2 to 12.8)-fold greater compared with paired maternal serum concentration (n = 8). In addition, fetal and embryonic toxicities occurred in rats, at a dose ten times less than the human exposure at recommended clinical dose. Mylan Specialty, Morgantown, WV. The malformations that occurred in these three monkey fetuses included anencephaly and unilateral anophthalmia in one fetus, microophthalmia in a second, and cleft palate in the third. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. Tablets: 400 mg of efavirenz, 300 mg of lamivudine, and 300 mg of tenofovir disoproxil fumarate (equivalent to 245 mg of tenofovir disoproxil). See full prescribing information for complete boxed warning.Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with HBV and human immunodeficiency virus (HIV-1) and have discontinued lamivudine and tenofovir disoproxil fumarate. Methodological limitations of the APR include the use of MACDP as the external comparator group. The mean baseline CD4+ cell count was 279 cells/mm3 (range 3-956) and median baseline plasma HIV-1 RNA was 77,600 copies/mL (range 417−5,130,000). EFV and 3TC have been evaluated in a limited number of women as reported to the APR. Efavirenz/Lamivudine/Tenofovir Disoproxil Fumarate 600mg/300 mg/300 mg Tablets may interact with other medicines, including herbal preparations such as Ginkgo biloba extracts. (See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Prior to initiation of SYMFI, test patients for hepatitis B virus infection It is recommended that serum creatinine, serum phosphorus, estimated creatinine clearance, urine glucose, and urine protein be assessed before initiating SYMFI and during therapy in all patients as clinically appropriate Monitor hepatic function prior to and during treatment with SYMFI SYMFI is a three-drug fixed-dose combination product containing 600 mg of efavirenz (EFV), 300 mg of lamivudine (3TC), and 300 mg of tenofovir disoproxil fumarate (TDF). Samples of breast milk obtained from 20 mothers receiving 3TC monotherapy, 300 mg twice daily (2 times the dose in SYMFI), had measurable concentrations of 3TC.
The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15% to 20%.