Drug class: NNRTIs Medically reviewed by Drugs.com. Etravirine is about 99.9% bound to plasma proteins, primarily to albumin (99.6%) and alpha 1-acid glycoprotein (97.66% to 99.02%) in vitro. Severe, potentially life-threatening, and fatal skin reactions have been . TMC125-C234/IMPAACT P1090 is a Phase 1/2 trial in which 20 antiretroviral treatment-experienced HIV-1 infected pediatric subjects 2 years to less than 6 years of age received Intelence in combination with other antiretroviral agents (Week 24 analysis) [see Clinical Studies (14.2)] . Etravirine does not inhibit the human DNA polymerases , , and . Etravirine exhibited activity against laboratory strains and clinical isolates of wild-type HIV-1 in acutely infected T-cell lines, human peripheral blood mononuclear cells, and human monocytes/macrophages with median EC 50 values ranging from 0.9 to 5.5 nM (i.e., 0.4 to 2.4 ng/mL). The highest levels of resistance to etravirine were observed for HIV-1 harboring a combination of substitutions V179F + Y181C (187 fold-change), V179F + Y181I (123 fold-change), or V179F + Y181C + F227C (888 fold-change). No dose adjustment of Intelence is needed. This Patient Information has been approved by the U.S. Food and Drug Administration. Package insert / product label Postmarketing reports of Stevens-Johnson syndrome in pediatric patients receiving Intelence have been reported [see Warnings and Precautions (5.1), and Adverse Reactions (6.2)] . The data are provided to give clinicians information on the likelihood of virologic success based on pre-treatment susceptibility to etravirine in treatment-experienced patients. In a thorough QT/QTc study in 41 healthy subjects, Intelence 200 mg twice daily or 400 mg once daily did not affect the QT/QTc interval. Virologic failure on a rilpivirine-containing regimen with development of rilpivirine resistance is likely to result in cross-resistance to etravirine (see Treatment-Nave HIV-1-Infected Subjects in the Phase 3 Trials for EDURANT (rilpivirine) below). Combining two NNRTIs has not been shown to be beneficial. 25 mg and 100 mg Intelence tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. No unexpected safety findings were observed compared with the known safety profile of Intelence in non-pregnant adults. Each tablet contains 25 mg of etravirine. As etravirine is highly bound to plasma proteins, it is unlikely that it will be significantly removed by hemodialysis or peritoneal dialysis [see Clinical Pharmacology (12.3)] . Co-administration of Intelence with darunavir/cobicistat is not recommended because it may result in loss of therapeutic effect and development of resistance to darunavir. The clinical efficacy of Intelence is derived from the analyses of 48-week data from 2 ongoing, randomized, double-blinded, placebo-controlled, Phase 3 trials, TMC125-C206 and TMC125-C216 (DUET-1 and DUET-2) in subjects with 1 or more NNRTI resistance-associated substitutions. Changes in your immune system (Immune Reconstitution Syndrome). Using cross. Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including Intelence. Keep the bottle tightly closed to protect Intelence from moisture. Clinical studies of Intelence did not include sufficient numbers of subjects aged 65 years of age and over to determine whether they respond differently from younger subjects. Manufactured for: Dapoxetine is prescribed for the treatment of premature ejaculation. ED is often a symptom of another health problem or health-related factor. Thirteen infants were born to 13 HIV-infected pregnant individuals in this study. Subjects eligible for this trial were on an antiretroviral regimen with confirmed plasma HIV-1 RNA of at least 500 copies/mL and viral susceptibility to Intelence at screening. Fluvastatin and pitavastatin are metabolized by CYP2C9 and co-administration with Intelence may result in higher plasma concentrations of the HMG-CoA reductase inhibitor. Five HIV-infected subjects from 1 year to < 2 years of age were enrolled in TMC125-C234/IMPAACT P1090. Intelence and delavirdine should not be co-administered. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Clinical Pharmacology (12.3)] . However, in the rilpivirine adult clinical development program, there was evidence of phenotypic cross-resistance between rilpivirine and etravirine. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Therefore, co-administration of Intelence with drugs that induce or inhibit CYP3A, CYP2C9, and CYP2C19 may alter the therapeutic effect or adverse reaction profile of Intelence (see Table 4) [see Clinical Pharmacology (12.3)]. Additional ADRs of at least moderate intensity observed in other trials were acquired lipodystrophy, angioneurotic edema, erythema multiforme and hemorrhagic stroke, each reported in no more than 0.5% of subjects. Combining two NNRTIs has not been shown to be beneficial. Co-administration of Intelence and fosamprenavir without low-dose ritonavir is not recommended. Narcotic analgesics/treatment of opioid dependence: Phosphodiesterase type 5 (PDE-5) inhibitors, Co-administration with HIV protease inhibitors (PIs), Co-administration with nucleoside reverse transcriptase inhibitors (NRTIs), Co-administration with integrase strand transfer inhibitors, Important: Ask your healthcare provider or pharmacist about medicines that should not be taken with Intelence. The mean systemic exposure (AUC) of etravirine was reduced when Intelence was co-administered with saquinavir/ritonavir. Co-administration of Intelence and atazanavir without low-dose ritonavir is not recommended. Before taking Intelence tell your healthcare provider about all of your medical conditions, including if you: Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Initially 30 mg, to be taken approximately 1-3 hours before sexual activity, subsequent doses adjusted according to response; review treatment after 4 weeks (or 6 doses) and at least every 6 months thereafter, not recommended for adults 65 years and over; maximum 1 dose per day; maximum 60 mg per day. The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 1520%. In the mouse study, statistically significant increases in the incidences of hepatocellular carcinoma and incidences of hepatocellular adenomas or carcinomas combined were observed in treated females. Adult. The most common side-effects include feeling dizzy or faint, and feeling sick (nausea). Immune System Disorders: Severe hypersensitivity reactions including DRESS and cases of hepatic failure have been reported [see Warnings and Precautions (5.1)] . The systemic exposures (AUC) to etravirine were lower in HIV-1-infected subjects (Table 5) than in healthy subjects. A total of 2.2% of HIV-1-infected subjects in Phase 3 trials receiving Intelence discontinued due to rash. The median CD4+ cell count increase and the median CD4+ percentage increase from baseline was 298 10 6 cells/mm 3 and 5%, respectively. Concomitant use of Intelence with tipranavir/ritonavir may cause a significant decrease in the plasma concentrations of etravirine and loss of therapeutic effect of Intelence. . The mean systemic exposure (AUC) of etravirine was reduced after co-administration of Intelence with lopinavir/ritonavir (tablet). The serum digoxin concentrations should be monitored and used for titration of the digoxin dose to obtain the desired clinical effect. In TMC125-C213, the frequency, type and severity of adverse drug reactions in pediatric subjects 6 years to less than 18 years of age were comparable to those observed in adult subjects, except for rash which was observed more frequently in pediatric subjects. Intelence, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and pediatric patients 2 years of age and older [see Microbiology (12.4) and Clinical Studies (14)] . You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. Intelence (etravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of human immunodeficiency virus type 1 (HIV-1). Advise patients to take Intelence following a meal twice a day on a regular dosing schedule, as missed doses can result in development of resistance. No dose adjustment of Intelence or voriconazole is needed. Co-administration of Intelence and other NNRTIs is not recommended. place the tablet(s) in 5 mL (1 teaspoon) of water, or at least enough liquid to cover the medication. The pharmacokinetics of Intelence have not been evaluated in patients with severe hepatic impairment (Child-Pugh Class C) [see Clinical Pharmacology (12.3)] . You can ask your healthcare provider or pharmacist for a list of medicines that interact with Intelence. The highest dose studied in healthy volunteers was 400 mg once daily. In both species, no treatment-related embryo-fetal effects were observed. In general, adverse events reported by Intelence-treated subjects with hepatitis B and/or hepatitis C virus co-infection were similar to Intelence-treated subjects without hepatitis B and/or hepatitis C virus co-infection. Etravirine is an inducer of CYP3A and inhibitor of CYP2C9, CYP2C19 and P-glycoprotein (P-gp). It may harm them. HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). Drinking a full glass of water at the same time as taking the tablet can reduce these effects. The pharmacokinetics of etravirine have not been studied in patients with renal impairment. Cross-resistance to etravirine has been observed after virologic failure on a doravirine-containing regimen with development of doravirine resistance. Etravirine is practically insoluble in water over a wide pH range. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. = not available; = increase; = decrease; = no change, Maraviroc (when co-administered with darunavir/ritonavir), 80/480 mg, 6 doses at 0, 8, 24, 36, 48, and 60 hours, Dolutegravir (when co-administered with darunavir/ritonavir), 50 mg once daily + 600/100 mg twice daily, Dolutegravir (when co-administered with lopinavir/ritonavir, 50 mg once daily + 400/100 mg twice daily, Individual dose regimen ranging from 4/1 mg to 16/4 mg once daily, Individual dose regimen ranging from 60 to 130 mg/day, RASs = Resistance-Associated Substitutions, BR=background regimen, FC = fold change in EC, Median baseline plasma HIV-1 RNA (range), log. If your child takes Intelence, your healthcare provider will prescribe the right dose based on your child's weight. The median baseline plasma HIV-1 RNA was 3.9 log 10 copies/mL, and the median baseline CD4+ cell count was 385 10 6 cells/mm 3. Please see Full Prescribing Information for dosing with oral solution. No interaction between pravastatin, rosuvastatin and Intelence is expected. Co-administration is not recommended. Each tablet contains Last updated on Mar 1, 2023. The mean decrease in plasma HIV-1 RNA from baseline to Week 48 was -2.23 log 10 copies/mL for Intelence-treated subjects and -1.46 log 10 copies/mL for placebo-treated subjects. Daily doses of 50, 200 and 400 mg/kg were administered to mice and doses of 70, 200 and 600 mg/kg were administered to rats in the initial period of approximately 41 to 52 weeks. The effects of co-administration of other drugs on the AUC, C max, and C min values of etravirine are summarized in Table 8 (effect of other drugs on Intelence). These baseline phenotype groups are based on the select subject populations in TMC125-C206 and TMC125-C216 and are not meant to represent definitive clinical susceptibility breakpoints for Intelence. Discontinuations due to adverse drug reactions (ADRs) were 5.2% in the Intelence arm and 2.6% in the placebo arm. The safety profile for subjects who completed 48 weeks of treatment was similar to the safety profile for subjects who completed 24 weeks of treatment. 4 . Eligible subjects were treatment-experienced, PI-nave HIV-1-infected subjects with genotypic evidence of NNRTI resistance at screening or from prior genotypic analysis. Refer to the prescribing information for EDURANT (rilpivirine) for further information. At Week 24, the proportion of subjects with less than 400 HIV-1 RNA copies/mL was 88% (15/17), and the proportion of subjects with less than 50 HIV-1 RNA copies/mL was 50% (7/14), for those with available data. AST and ALT abnormalities occurred more frequently in hepatitis B and/or hepatitis C virus co-infected subjects for both treatment groups. Each bottle contains 3 desiccant pouches. Redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving antiretroviral therapy. The combination of Intelence and atorvastatin can be given without dose adjustments, however, the dose of atorvastatin may need to be altered based on clinical response. The background risk of major birth defects and miscarriage for the indicated population is unknown. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Patients who are unable to swallow the Intelence tablet(s) whole may disperse the tablet(s) in water. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The pharmacokinetics of etravirine in 115 treatment-experienced HIV-1-infected pediatric subjects, 2 years to less than 18 years of age showed that the administered weight-based dosages resulted in etravirine exposure comparable to that in adults receiving Intelence 200 mg twice daily [see Dosage and Administration (2.3)] . In addition, no treatment-related effects were observed in a pre- and postnatal development study performed in rats administered oral doses up to 500 mg/kg/day on gestation days 7 through lactation day 7. What should I tell my healthcare provider before taking Intelence? The type of food does not affect the exposure to Intelence [see Clinical Pharmacology (12.3)] . In clinical trials, the safety, pharmacokinetics, and efficacy were comparable to that observed in adults except for rash (greater than or equal to Grade 2) which was observed more frequently in pediatric subjects [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.2)] . The amount of safety data at these increased etravirine exposures is limited, therefore, etravirine and voriconazole should be co-administered with caution. Etravirine exposure was lower than reported in HIV-infected adults (AUC 12h geometric mean ratio [90% CI] was 0.59 [0.34, 1.01] for pediatric subjects from 1 year to < 2 years of age compared to adults). In these pooled trials, the median exposure for subjects in the Intelence arm and placebo arm was 52.3 and 51.0 weeks, respectively. INTELENCE should be taken orally, following a meal. Intelence 200 mg tablets are available as white to off-white, biconvex, oblong tablets for oral administration. Some NNRTI-resistant viruses are susceptible to etravirine, but genotypic and phenotypic testing should guide the use of etravirine (see Baseline Genotype/Phenotype and Virologic Outcome Analyses below). ()In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use . Tell your healthcare provider if you become pregnant during treatment with Intelence. No dose adjustment of Intelence is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. 25 mg and 100 mg Intelence tablets contain the following inactive ingredients: 200 mg Intelence tablets contain the following inactive ingredients: We comply with the HONcode standard for trustworthy health information. Virologic failure at Week 24 (confirmed HIV-RNA greater than or equal to 400 copies/mL) occurred in 3 of 4 evaluable subjects who discontinued before or had reached Week 24. A total of 2.2% of HIV-1-infected subjects receiving Intelence discontinued from Phase 3 trials due to rash [see Adverse Reactions (6.1)] . The amount of HIV in your blood may increase if the medicine is stopped even for a short time. Lovastatin and simvastatin are CYP3A substrates and co-administration with Intelence may result in lower plasma concentrations of the HMG-CoA reductase inhibitor. 3 DOSAGE FORMS AND STRENGTHS . Rash generally resolved within 1 to 2 weeks on continued therapy. Etravirine was evaluated for carcinogenic potential by oral gavage administration to mice and rats for up to approximately 104 weeks. Given the clinical relevance of these adverse reactions, the following information regarding severe skin and hypersensitivity reactions has been included in the INTELENCE Prescribing Information: 5 Warnings and Precautions. Because of the HMG-CoA reductase inhibitor co-administration with Intelence may result in higher plasma concentrations of and! 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