this may increasingly [12:<4 ~80 Source of protein binding data In vitro Ex vivo Blood-to-plasma ratio 0.6 1.0 Metabolism Metabolism Not significantly metabolized Cathepsin A (PBMCs) CES1 (hepatocytes) CYP3A (minimal) Elimination Major route of elimination Glomerular filtration and active tubular secretion Metabolism (> 80% of oral dose) t 1/2 (h) 10 0.51 % Of dose excreted in urine 70 <1 % Of dose excreted in feces 13.7 31.7 Table 4 Multiple Dose PK Parameters of Emtricitabine, Tenofovir Alafenamide and its Metabolite Tenofovir Following Oral Administration with Food in HIV-Infected Adults Parameter Mean (CV%) Emtricitabine * Tenofovir Alafenamide Tenofovir CV=Coefficient of Variation; NA=Not Applicable * From Intensive PK analysis in a phase 2 trial in HIV infected adults treated with FTC+TAF and EVG+COBI. From Population PK analysis in two trials of treatment-naïve adults with HIV-1 infection treated with FTC+TAF with EVG+COBI (N=539). From Population PK analysis in two trials of treatment-naïve adults with HIV-1 infection treated with FTC+TAF with EVG+COBI (N=841). C max (microgram per mL) 2.1 (20.2) 0.16 (51.1) 0.02 (26.1) AUC tau (microgram hour per mL) 11.7 (16.6) 0.21 (71.8) 0.29 (27.4) C trough (microgram per mL) 0.10 (46.7) NA 0.01 (28.5) Specific Populations Patients with Renal Impairment The pharmacokinetics of FTC+TAF combined with EVG+COBI in HIV infected subjects with renal impairment (eGFR 30 to 69 mL per minute by Cockcroft-Gault method) were evaluated in a subset of virologically-suppressed subjects in an open-label trial (Table 5). Table 5 Pharmacokinetics of the Components of Descovy and a Metabolite of TAF (Tenofovir) in HIV-Infected Adults with Renal Impairment Compared to Subjects with Normal Renal Function * AUC tau (microgram hour per mL) Mean (CV%) Creatinine Clearance 90 mL per minute (N=18) 60 89 mL per minute (N=11) 30 59 mL per minute (N=18) * Trial in HIV infected adults with renal impairment treated with FTC+TAF with EVG+COBI. From a phase 2 trial in HIV-infected adults with normal renal function treated with FTC+TAF with EVG+COBI. These subjects had an eGFR ranging from 60 to 69 mL per minute. AUC last Emtricitabine 11.4 (11.9) 17.6 (18.2) 23.0 (23.6) Tenofovir Alafenamide 0.23 (47.2) 0.24 (45.6) 0.26 (58.8) Tenofovir 0.32 (14.9) 0.46 (31.5) 0.61 (28.4) Patients with Hepatic Impairment Emtricitabine: The pharmacokinetics of FTC has not been studied in subjects with hepatic impairment; however, FTC is not significantly metabolized by liver enzymes, so the impact of hepatic impairment should be limited. Tenofovir Alafenamide: Clinically relevant changes in tenofovir pharmacokinetics in subjects with hepatic impairment were not observed in subjects with mild to moderate (Child-Pugh Class A and B) hepatic impairment [see Use in Specific Populations (8.7) ] . Hepatitis B and/or Hepatitis C Virus Coinfection The pharmacokinetics of FTC and TAF have not been fully evaluated in subjects coinfected with hepatitis B and/or C virus. Pediatric Patients Mean exposures of TAF in 24 pediatric subjects aged 12 to less than 18 years who received FTC+TAF with EVG+COBI were decreased (23% for AUC) and FTC exposures were similar compared to exposures achieved in treatment-naïve adults following administration of this dosage regimen. The TAF exposure differences are not thought to be clinically significant based on exposure-response relationships (Table 6). Table 6 Multiple Dose PK Parameters of Emtricitabine, Tenofovir Alafenamide and its Metabolite Tenofovir Following Oral Administration of FTC+TAF with EVG+COBI in HIV-Infected Pediatric Subjects Aged 12 to less than 18 Years * Parameter Mean (CV%) Emtricitabine Tenofovir Alafenamide Tenofovir CV = Coefficient of Variation; NA = Not Applicable * From Intensive PK analysis in a trial in treatment-naïve pediatric subjects with HIV-1 infection (N=24). N=23 C max (microgram per mL) 2.3 (22.5) 0.17 (64.4) 0.02 (23.7) AUC tau (microgram hour per mL) 14.4 (23.9) 0.20 (50.0) 0.29 (18.8) C trough (microgram per mL) 0.10 (38.9) NA 0.01 (21.4) Exposures of FTC and TAF achieved in 23 pediatric subjects between the ages of 6 to less than 12 years and weighing at least 25 kg (55 lbs) who received FTC+TAF with EVG+COBI were higher (20 to 80% for AUC) than exposures achieved in adults following the administration of this dosage regimen; however, the increase was not considered clinically significant (Table 7) [see Use in Specific Populations (8.4) ] . Table 7 Multiple Dose PK Parameters of Emtricitabine, Tenofovir Alafenamide and its Metabolite Tenofovir Following Oral Administration of FTC+TAF with EVG+COBI in HIV-Infected Pediatric Subjects Aged 6 to less than 12 Years * Parameter Mean (CV%) Emtricitabine Tenofovir Alafenamide Tenofovir CV = Coefficient of Variation; NA = Not Applicable * From Intensive PK analysis in a trial in virologically-suppressed pediatric subjects with HIV-1 infection (N=23). N=22 C max (microgram per mL) 3.4 (27.0) 0.31 (61.2) 0.03 (20.8) AUC tau (microgram hour per mL) 20.6 (18.9) 0.33 (44.8) 0.44 (20.9) C trough (microgram per mL) 0.11 (24.1) NA 0.02 (24.9) Geriatric Patients Pharmacokinetics of FTC and TAF have not been fully evaluated in the elderly (65 years of age and older). Population pharmacokinetics analysis of HIV-infected subjects in Phase 2 and Phase 3 trials of FTC+TAF and EVG+COBI showed that age did not have a clinically relevant effect on exposures of TAF up to 75 years of age [see Use in Specific Populations (8.5) ] . Race Based on population pharmacokinetic analyses, no dosage adjustment is recommended based on race. Gender Based on population pharmacokinetic analyses, no dosage adjustment is recommended based on gender. Drug Interaction Studies The effects of coadministered drugs on the exposure of TAF are shown in Table 8 and the effects of Descovy or its components on the exposure of coadministered drugs are shown in Table 9 [these studies were conducted with Descovy or the components of Descovy (FTC or TAF) administered alone]. For information regarding clinical recommendations, see Drug Interactions (7) . Table 8 Drug Interactions: Changes in TAF Pharmacokinetic Parameters in the Presence of Coadministered Drug(s) * Coadministered Drug Coadministered Drug(s) Dosage (once daily) (mg) Tenofovir Alafenamide Dosage (once daily) (mg) N Mean Ratio of TAF PK Parameters (90% CI); No effect = 1.00 C max AUC C min NC=Not Calculated * All interaction studies conducted in healthy volunteers. Study conducted with Descovy (FTC/TAF). Study conducted with FTC+TAF with EVG+COBI. Atazanavir 300 (+100 ritonavir) 10 10 1.77 (1.28, 2.44) 1.91 (1.55, 2.35) NC Cobicistat 150 8 12 2.83 (2.20, 3.65) 2.65 (2.29, 3.07) NC Darunavir 800 (+150 cobicistat) 25 11 0.93 (0.72, 1.21) 0.98 (0.80, 1.19) NC Darunavir 800 (+100 ritonavir) 10 10 1.42 (0.96, 2.09) 1.06 (0.84, 1.35) NC Dolutegravir 50 10 10 1.24 (0.88, 1.74) 1.19 (0.96, 1.48) NC Efavirenz 600 40 11 0.78 (0.58, 1.05) 0.86 (0.72, 1.02) NC Lopinavir 800 (+200 ritonavir) 10 10 2.19 (1.72, 2.79) 1.47 (1.17, 1.85) NC Rilpivirine 25 25 17 1.01 (0.84, 1.22) 1.01 (0.94, 1.09) NC Sertraline 50 (dosed as a single dose) 10 19 1.00 (0.86, 1.16) 0.96 (0.89, 1.03) NC Table 9 Drug Interactions: Changes in PK Parameters for Coadministered Drug in the Presence of Descovy or the Individual Components * Coadministered Drug Coadministered Drug Dosage (once daily) (mg) Tenofovir Alafenamide Dosage (once daily) (mg) N Mean Ratio of Coadministered Drug PK Parameters (90% CI); No effect = 1.00 C max AUC C min NC=Not Calculated * All interaction studies conducted in healthy volunteers. Study conducted with Descovy (FTC/TAF). A sensitive CYP3A4 substrate. Study conducted with FTC+TAF with EVG+COBI. Atazanavir 300 +100 ritonavir 10 10 0.98 (0.89, 1.07) 0.99 (0.96, 1.01) 1.00 (0.96, 1.04) Darunavir 800 +150 cobicistat 25 11 1.02 (0.96, 1.09) 0.99 (0.92, 1.07) 0.97 (0.82, 1.15) Darunavir 800 +100 ritonavir 10 10 0.99 (0.91, 1.08) 1.01 (0.96, 1.06) 1.13 (0.95, 1.34) Dolutegravir 50 mg 10 10 1.15 (1.04, 1.27) 1.02 (0.97, 1.08) 1.05 (0.97, 1.13) Lopinavir 800 +200 ritonavir 10 10 1.00 (0.95, 1.06) 1.00 (0.92, 1.09) 0.98 (0.85, 1.12) Midazolam 2.5 (single dose, orally) 25 18 1.02 (0.92, 1.13) 1.13 (1.04, 1.23) NC 1 (single dose, intravenous) 0.99 (0.89, 1.11) 1.08 (1.04, 1.14) NC Rilpivirine 25 25 16 0.93 (0.87, 0.99) 1.01 (0.96, 1.06) 1.13 (1.04, 1.23) Sertraline 50 (single dose) 10 19 1.14 (0.94, 1.38) 0.93 (0.77, 1.13) NC Microbiology Mechanism of Action Emtricitabine: FTC, a synthetic nucleoside analog of cytidine, is phosphorylated by cellular enzymes to form emtricitabine 5'-triphosphate. Emtricitabine 5'-triphosphate inhibits the activity of the HIV-1 reverse transcriptase by competing with the natural substrate deoxycytidine 5'-triphosphate and by being incorporated into nascent viral DNA which results in chain termination. Emtricitabine 5 -triphosphate is a weak inhibitor of mammalian DNA polymerases α, β, Ɛ, and mitochondrial DNA polymerase γ. Tenofovir Alafenamide: TAF is a phosphonoamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analog). Plasma exposure to TAF allows for permeation into cells and then TAF is intracellularly converted to tenofovir through hydrolysis by cathepsin A. Tenofovir is subsequently phosphorylated by cellular kinases to the active metabolite tenofovir diphosphate. Tenofovir diphosphate inhibits HIV-1 replication through incorporation into viral DNA by the HIV reverse transcriptase, which results in DNA chain-termination. Tenofovir has activity against HIV-1. Cell culture studies have shown that both tenofovir and FTC can be fully phosphorylated when combined in cells. Tenofovir diphosphate is a weak inhibitor of mammalian DNA polymerases that include mitochondrial DNA polymerase γ and there is no evidence of toxicity to mitochondria in cell culture. Antiviral Activity in Cell Culture Emtricitabine: The antiviral activity of FTC against laboratory and clinical isolates of HIV-1 was assessed in T lymphoblastoid cell lines, the MAGI-CCR5 cell line, and primary peripheral blood mononuclear cells. The EC 50 values for FTC were in the range of 0.0013 0.64 micromolar. FTC displayed antiviral activity in cell culture against HIV-1 clades A, B, C, D, E, F, and G (EC 50 values ranged from 0.007 0.075 micromolar) and showed strain specific activity against HIV-2 (EC 50 values ranged from 0.007 1.5 micromolar). In a study of FTC with a broad panel of representatives from the major classes of approved anti-HIV agents (NRTIs, non-nucleoside reverse transcriptase inhibitors [NNRTIs], integrase strand transfer inhibitors [INSTIs], and PIs) no antagonism was observed for these combinations. Tenofovir Alafenamide: The antiviral activity of TAF against laboratory and clinical isolates of HIV-1 subtype B was assessed in lymphoblastoid cell lines, PBMCs, primary monocyte/macrophage cells and CD4-T lymphocytes. The EC 50 values for TAF ranged from 2.0 to 14.7 nM. TAF displayed antiviral activity in cell culture against all HIV-1 groups (M, N, O), including sub-types A, B, C, D, E, F, and G (EC 50 values ranged from 0.10 to 12.0 nM) and strain specific activity against HIV-2 (EC 50 values ranged from 0.91 to 2.63 nM). In a study of TAF with a broad panel of representatives from the major classes of approved anti-HIV agents (NRTIs, NNRTIs, INSTIs, and PIs) no antagonism was observed for these combinations. Resistance In Cell Culture Emtricitabine: HIV-1 isolates with reduced susceptibility to FTC were selected in cell culture and in subjects treated with FTC. Reduced susceptibility to FTC was associated with M184V or I substitutions in HIV-1 RT. Tenofovir Alafenamide: HIV-1 isolates with reduced susceptibility to TAF were selected in cell culture. HIV-1 isolates selected by TAF expressed a K65R substitution in HIV-1 RT, sometimes in the presence of S68N or L429I substitutions; in addition, a K70E substitution in HIV-1 RT was observed. In Clinical Trials The resistance profile of Descovy in combination with other antiretroviral agents for the treatment of HIV-1 infection is based on studies of FTC+TAF with EVG+COBI in the treatment of HIV-1 infection . In a pooled analysis of antiretroviral-naïve subjects, genotyping was performed on plasma HIV-1 isolates from all subjects with HIV-1 RNA greater than 400 copies per mL at confirmed virologic failure, at Week 48, or at time of early study drug discontinuation. Genotypic resistance developed in 7 of 14 evaluable subjects. The resistance-associated substitutions that emerged were M184V/I (N=7) and K65R (N=1). Three subjects had virus with emergent R, H, or E at the polymorphic Q207 residue in reverse transcriptase. One subject was identified with emergent resistance to FTC (M184M/I) out of 4 virologic failure subjects in a clinical study of virologically-suppressed subjects who switched from a regimen containing FTC+TDF to FTC+TAF with EVG+COBI (N=799). Cross-Resistance Emtricitabine : FTC-resistant viruses with the M184V or I substitution were cross-resistant to lamivudine, but retained sensitivity to didanosine, stavudine, tenofovir, and zidovudine. Viruses harboring substitutions conferring reduced susceptibility to stavudine and zidovudine-thymidine analog substitutions (M41L, D67N, K70R, L210W, T215Y/F, K219Q/E) or didanosine (L74V) remained sensitive to FTC. HIV-1 containing the K103N substitution or other substitutions associated with resistance to NNRTIs was susceptible to FTC. Tenofovir Alafenamide: Tenofovir resistance substitutions K65R and K70E result in reduced susceptibility to abacavir, didanosine, emtricitabine, lamivudine, and tenofovir. HIV-1 with multiple thymidine analog substitutions (M41L, D67N, K70R, L210W, T215F/Y, K219Q/E/N/R), or multinucleoside resistant HIV-1 with a T69S double insertion mutation or with a Q151M substitution complex including K65R, showed reduced susceptibility to TAF in cell culture. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility Emtricitabine In long-term carcinogenicity studies of FTC, no drug-related increases in tumor incidence were found in mice at doses up to 750 mg per kg per day (23 times the human systemic exposure at the recommended dose of 200 mg per day in Descovy) or in rats at doses up to 600 mg per kg per day (28 times the human systemic exposure at the recommended dose in Descovy). FTC was not genotoxic in the reverse mutation bacterial test (Ames test), mouse lymphoma or mouse micronucleus assays. FTC did not affect fertility in male rats at approximately 140 times or in male and female mice at approximately 60 times higher exposures (AUC) than in humans given the recommended 200 mg daily dosage in Descovy. Fertility was normal in the offspring of mice exposed daily from before birth (in utero) through sexual maturity at daily exposures (AUC) of approximately 60 times higher than human exposures at the recommended 200 mg daily dosage in Descovy. Tenofovir Alafenamide Since TAF is rapidly converted to tenofovir and a lower tenofovir exposure in rats and mice was observed after TAF administration compared to TDF administration, carcinogenicity studies were conducted only with TDF. Long-term oral carcinogenicity studies of TDF in mice and rats were carried out at exposures up to approximately 10 times (mice) and 4 times (rats) those observed in humans at the recommended dose of TDF (300 mg) for HIV-1 infection. The tenofovir exposure in these studies was approximately 167 times (mice) and 55 times (rat) those observed in humans after administration of the daily recommended dose of Descovy. At the high dose in female mice, liver adenomas were increased at tenofovir exposures approximately 10 times (300 mg TDF) and 167 times (Descovy) the exposure observed in humans. In rats, the study was negative for carcinogenic findings. TAF was not genotoxic in the reverse mutation bacterial test (Ames test), mouse lymphoma or rat micronucleus assays. There were no effects on fertility, mating performance or early embryonic development when TAF was administered to male rats at a dose equivalent to 62 times (25 mg TAF) the human dose based on body surface area comparisons for 28 days prior to mating and to female rats for 14 days prior to mating through Day 7 of gestation. Animal Toxicology and/or Pharmacology Minimal to slight infiltration of mononuclear cells in the posterior uvea was observed in dogs with similar severity after three and nine month administration of TAF; reversibility was seen after a three month recovery period. No eye toxicity was observed in the dog at systemic exposures of 5 (TAF) and 15 (tenofovir) times the exposure seen in humans with the recommended daily TAF dose in Descovy. Clinical Studies In trials of FTC+TAF with EVG+COBI in HIV-1 infected adults as initial therapy in those with no antiretroviral treatment history (N=866) and to replace a stable antiretroviral regimen in those who were virologically-suppressed for at least 6 months with no known resistance substitutions (N=799), 92% and 96% of patients in the two populations, respectively, had HIV-1 RNA less than 50 copies per mL at Week 48. An open-label, single arm trial of FTC+TAF with EVG+COBI enrolled 50 treatment-naïve HIV-1 infected adolescents aged 12 to less than 18 years weighing at least 35 kg (cohort 1) and 23 virologically suppressed children aged 6 to less than 12 years weighing at least 25 kg (cohort 2). In cohort 1, the virologic response rate (i.e., HIV-1 RNA less than 50 copies per mL) was 92% (46/50) and the mean increase from baseline in CD4+ cell count was 224 cells per mm 3 at Week 48. In cohort 2, 100% of subjects remained virologically suppressed at Week 24. From a mean (SD) baseline CD4+ cell count of 966 (201.7), the mean change from baseline in CD4+ cell count was -150 cells/mm 3 and the mean (SD) change in CD4% was -1.5% (3.7%) at Week 24. All subjects maintained CD4+ cell counts above 400 cells/mm 3 [see Adverse Reactions (6.1) and Use in Specific Populations (8.4) ]. In a trial in 248 HIV-1 infected adult patients with estimated creatinine clearance greater than 30 mL per minute but less than 70 mL per minute, 95% (235/248) of the combined population of treatment-naïve subjects (N=6) began on FTC+TAF with EVG+COBI and those previously virologically-suppressed on other regimens (N=242) and switched to FTC+TAF with EVG+COBI had HIV-1 RNA less than 50 copies per mL at Week 24. How Supplied/Storage and Handling Descovy 200 mg/25 mg tablets are blue, rectangular-shaped, and film-coated with "GSI" debossed on one side and "225" on the other side. Each bottle contains 30 tablets (NDC 61958-2002-1), a silica gel desiccant, polyester coil, and is closed with a child-resistant closure. Store below 30 C (86 F). Keep container tightly closed. Dispense only in original container. Patient Counseling Information Advise the patient to read the FDA-approved patient labeling (Patient Information). Post-treatment Acute Exacerbation of Hepatitis B in Patients with HBV Coinfection Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued products containing FTC and/or TDF, and may likewise occur with discontinuation of Descovy [see Warnings and Precautions (5.1) ] . Advise the patient to not discontinue Descovy without first informing their healthcare provider. Immune Reconstitution Syndrome Advise patients to inform their healthcare provider immediately of any symptoms of infection, as in some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started [see Warnings and Precautions (5.2) ] . New Onset or Worsening Renal Impairment Advise patients to avoid taking Descovy with concurrent or recent use of nephrotoxic agents. Renal impairment, including cases of acute renal failure, has been reported in association with the use of tenofovir prodrugs [see Warnings and Precautions (5.3) ]. Lactic Acidosis and Severe Hepatomegaly Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with use of drugs similar to Descovy. Advise patients that they should stop Descovy if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [see Warnings and Precautions (5.4) ] . Missed Dosage Inform patients that it is important to take Descovy on a regular dosing schedule with or without food and to avoid missing doses as it can result in development of resistance [see Dosage and Administration (2.2) ] . Pregnancy Registry Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes of pregnant women exposed to Descovy [see Use in Specific Populations (8.1) ]. Lactation Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in breast milk [see Use in Specific Populations (8.2) ] . Descovy is a trademark of Gilead Sciences, Inc., or its related companies. All other trademarks referenced herein are the property of their respective owners. 2017 Gilead Sciences, Inc. All rights reserved. Patient Information Descovy (des-KOH-vee) (emtricitabine and tenofovir alafenamide) tablets This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 09/2017 Important: Ask your healthcare provider or pharmacist about medicines that should not be taken with Descovy. For more information, see the section " What should I tell my healthcare provider before taking Descovy? " What is the most important information I should know about Descovy? Descovy can cause serious side effects, including: Worsening of Hepatitis B virus infection. Descovy is not for use to treat chronic hepatitis B virus (HBV) infection. If you have hepatitis B virus (HBV) infection and take Descovy, your HBV may get worse (flare-up) if you stop taking Descovy. A "flare-up" is when your HBV infection suddenly returns in a worse way than before. It is not known if Descovy is safe and effective in people who have both HIV-1 and HBV infection. Do not run out of Descovy. Refill your prescription or talk to your healthcare provider before your Descovy is all gone. Do not stop taking Descovy without first talking to your healthcare provider. If you stop taking Descovy, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking Descovy. For more information about side effects, see the section " What are the possible side effects of Descovy? " What is Descovy? Descovy is a prescription medicine that is used to treat Human Immunodeficiency Virus-1 (HIV-1): in adults and children who weigh at least 77 pounds (35 kg) together with other anti-HIV-1 medicines in children who weigh at least 55 pounds (25 kg) and less than 77 pounds (35 kg) together with certain other anti-HIV-1 medicines. Your healthcare provider will determine which other anti-HIV-1 medicines are used with Descovy. HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). Descovy is not for use to help reduce the risk of getting HIV-1 infection by sexual contact in adults at high risk. Descovy contains the prescription medicines emtricitabine (EMTRIVA ) and tenofovir alafenamide. It is not known if Descovy is safe and effective in children who weigh less than 55 pounds (25 kg). What should I tell my healthcare provider before taking Descovy? Before taking Descovy, tell your healthcare provider about all of your medical conditions, including if you: have liver problems, including hepatitis B virus infection have kidney problems are pregnant or plan to become pregnant. It is not known if Descovy can harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with Descovy. Pregnancy Registry: There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry. are breastfeeding or plan to breastfeed. Do not breastfeed if you take Descovy. You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. At least one of the medicines in Descovy can pass to your baby in your breast milk. It is not known if the other medicine in Descovy can pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby during treatment with Descovy. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may interact with Descovy. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. You can ask your healthcare provider or pharmacist for a list of medicines that interact with Descovy. Do not start a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Descovy with other medicines. How should I take Descovy? Take Descovy exactly as your healthcare provider tells you to take it. Descovy must be taken together with other HIV-1 medicines to treat HIV-1 infection. Take Descovy 1 time each day with or without food. Do not change your dose or stop taking Descovy without first talking with your healthcare provider. Stay under a healthcare provider's care during treatment with Descovy. Do not miss a dose of Descovy. If you take too much Descovy, call your healthcare provider or go to the nearest hospital emergency room right away. When your Descovy supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to Descovy and become harder to treat. What are the possible side effects of Descovy? Descovy may cause serious side effects, including: See " What is the most important information I should know about Descovy? " Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine. New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys before you start and during treatment with Descovy. Your healthcare provider may tell you to stop taking Descovy if you develop new or worse kidney problems. Too much lactic acid in your blood (lactic acidosis). Too much lactic acid is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat. Severe liver problems. In rare cases, severe liver problems can happen that can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark "tea-colored" urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain. The most common side effect of Descovy is nausea. These are not all the possible side effects of Descovy. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store Descovy? Store Descovy below 86 F (30 C). Keep Descovy in its original container. Keep the container tightly closed. Keep Descovy and all medicines out of reach of children. General information about the safe and effective use of Descovy. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Descovy for a condition for which it was not prescribed. Do not give Descovy to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about Descovy that is written for health professionals. For more information, call 1-800-445-3235 or go to www.Descovy.com. What are the ingredients in Descovy? Active ingredients: emtricitabine and tenofovir alafenamide. Inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The tablets are film-coated with a coating material containing indigo carmine aluminum lake, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Manufactured and distributed by: Gilead Sciences, Inc. Foster City, CA 94404 Descovy is a trademark of Gilead Sciences, Inc., or its related companies. All other trademarks referenced herein are the property of their respective owners. 2017 Gilead Sciences, Inc. All rights reserved. 208215-GS-002 PRINCIPAL DISPLAY PANEL - 200 mg/25 mg Tablet Bottle Label NDC 61958- 2002 -1 30 tablets Descovy (emtricitabine and tenofovir alafenamide) Tablets 200 mg/25 mg Note to pharmacist: Do not cover ALERT box with pharmacy label. ALERT: Find out about medicines that should NOT be taken with Discovy Descovy emtricitabine and tenofovir alafenamide tablet Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:61958-2002 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength emtricitabine (emtricitabine) emtricitabine 200 mg tenofovir alafenamide fumarate (tenofovir anhydrous) tenofovir alafenamide 25 mg Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE WATER POLYVINYL ALCOHOL, UNSPECIFIED TITANIUM DIOXIDE POLYETHYLENE GLYCOL 3350 TALC FD&C BLUE NO. 2 Product Characteristics Color BLUE Score no score Shape OVAL (rectangular-shaped) Size 13mm Flavor Imprint Code GSI;255 Contains Packaging # Item Code Package Description 1 NDC:61958-2002-1 30 TABLET in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA208215 04/04/2016 Labeler - Gilead Sciences, Inc. (185049848) Revised: 10/2017 Gilead Sciences, Inc. Next Interactions Print this page Add to My Med List More about Descovy (emtricitabine / tenofovir alafenamide) Side Effects During Pregnancy Dosage Information Drug Images Drug Interactions Support Group Pricing & Coupons 1 Review Add your own review/rating Drug class: antiviral combinations Consumer resources Descovy Descovy (Advanced Reading) Related treatment guides HIV Infection> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Gilead Sciences, Inc. Drug Class Antiviral combinations Related Drugs antiviral combinations Harvoni , Truvada , Atripla , Genvoya , Triumeq , Stribild HIV Infection Truvada , Atripla , Norvir , Viread , Isentress , Prezista , Stribild , lamivudine , abacavir , tenofovir , Reyataz , Epzicom , ritonavir , Complera , emtricitabine , darunavir , Kaletra , Intelence , Sustiva , Epivir , efavirenz , nevirapine , atazanavir , raltegravir , Selzentry , More... Descovy Rating 1 User Review 1 User Review Not Rated - Be the first! Descovy Images Descovy 200 mg / 25 mg (GSI 225) View larger images} } get older
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