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Descovy

Generic Name: emtricitabine and tenofovir alafenamide (em trye SYE ta been & ten OF oh vir al a FEN a mide)
Brand Names: Descovy
Descovy (emtricitabine and tenofovir alafenamide) is used to treat HIV infection, and for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection. Includes Descovy side effects, interactions and indications.
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Drug Information:
This is not a list of all drugs or health problems that interact with emtricitabine and tenofovir alafenamide. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Descovy with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor. Use Descovy as ordered by your doctor. Read all information given to you. Follow all instructions closely. Learn more

Descovy Side Effects

Descovy Side Effects

Note: This document contains side effect information about emtricitabine / tenofovir alafenamide. Some of the dosage forms listed on this page may not apply to the brand name Descovy.

For the Consumer

Applies to emtricitabine/tenofovir alafenamide: oral tablet

Warning

Oral route (Tablet)

Emtricitabine/tenofovir alafenamide is not approved for the treatment of chronic hepatitis B virus (HBV) infection. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of emtricitabine / tenofovir alafenamide. Hepatic function should be monitored closely in these patients. If appropriate, initiation of antihepatitis B therapy may be warranted.

Along with its needed effects, emtricitabine / tenofovir alafenamide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking emtricitabine / tenofovir alafenamide:

Incidence not known

  • Bloody urine
  • bone pain
  • dark urine
  • decreased appetite
  • decreased frequency or amount of urine
  • diarrhea
  • fast, shallow breathing
  • general feeling of discomfort
  • increased thirst
  • light-colored stools
  • loss of appetite
  • lower back or side pain
  • muscle pain or cramping
  • nausea
  • sleepiness
  • stomach discomfort
  • swelling of the face, fingers, or lower legs
  • troubled breathing
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • vomiting
  • weight gain
  • yellow eyes and skin

For Healthcare Professionals

Applies to emtricitabine / tenofovir alafenamide: oral kit, oral tablet

General

In clinical trials, the most common side effects reported with emtricitabine and tenofovir alafenamide (with elvitegravir and cobicistat) were nausea, diarrhea, and headache.

Side effects have been reported for emtricitabine and/or tenofovir disoproxil fumarate (DF) when taken in combination with other antiretroviral agents. The most common side effects reported in HIV-1-infected patients during a clinical study of efavirenz, emtricitabine, and tenofovir DF included diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. In this trial, emtricitabine-tenofovir DF (with efavirenz) was used from weeks 96 to 144, replacing emtricitabine plus tenofovir DF (with efavirenz).

In HIV-1-uninfected individuals in HIV-1 preexposure prophylaxis trials, the most common side effect reported with emtricitabine-tenofovir alafenamide was diarrhea while the most common side effects reported with emtricitabine-tenofovir DF were headache, abdominal pain, and decreased weight.

Other

Emtricitabine-tenofovir alafenamide:

-Common (1% to 10%): Fatigue

-Frequency not reported: Decreased high-density lipoprotein (HDL) cholesterol (fasted), increased triglycerides (fasted), increased total cholesterol to HDL ratio

Emtricitabine-tenofovir DF:

-Very common (10% or more): Increased fasting cholesterol (up to 22%)

-Common (1% to 10%): Fatigue, syphilis, secondary syphilis, decreased phosphorus, increased fasting triglycerides, weight decreased, increased alkaline phosphatase

-Frequency not reported: Decreased total cholesterol (fasted), decreased HDL cholesterol (fasted), decreased low-density lipoprotein (LDL) cholesterol (fasted), decreased triglycerides (fasted), increased total cholesterol to HDL ratio

Emtricitabine plus tenofovir alafenamide:

-Common (1% to 10%): Fatigue, increased fasting total cholesterol, increased fasting LDL cholesterol

-Frequency not reported: Increased HDL cholesterol, increased triglycerides

Emtricitabine:

-Very common (10% or more): Asthenia

-Common (1% to 10%): Pain

Tenofovir DF:

-Very common (10% or more): Pain, asthenia, increased triglycerides

-Common (1% to 10%): Chest pain, fever, weight loss

-Frequency not reported: Higher 1,25 vitamin D levels

Antiretroviral therapy:

-Frequency not reported: Increased weight, increased blood lipid levels

Increased fasting cholesterol (greater than 240 mg/dL: up to 22%), decreased phosphorus (2.5 to less than the lower limit of normal: up to 7%; less than 2 mg/dL: up to 10%), increased fasting triglycerides (greater than 750 mg/dL: up to 5%), and increased alkaline phosphatase (greater than 550 units/L: 1%) have been reported with emtricitabine-tenofovir DF.

In clinical trials, the following mean increases were reported in antiretroviral therapy-naive patients after using emtricitabine plus tenofovir alafenamide with elvitegravir plus cobicistat for 48 weeks: total cholesterol increased by 30 mg/dL, LDL cholesterol by 15 mg/dL, HDL cholesterol by 7 mg/dL, triglycerides by 29 mg/dL. In clinical trials, the following mean increases were reported in patients using emtricitabine plus tenofovir alafenamide and emtricitabine plus tenofovir DF, respectively, each with elvitegravir plus cobicistat for 96 weeks: fasted total cholesterol increased by 31 and 14 mg/dL, fasted LDL cholesterol by 18 and 7 mg/dL, fasted HDL cholesterol by 7 and 4 mg/dL, fasted triglycerides by 31 and 13 mg/dL.

Increased fasting LDL cholesterol (greater than 190 mg/dL) has been reported in 8% and 4% of patients using emtricitabine plus tenofovir alafenamide and emtricitabine plus tenofovir DF, respectively, each with elvitegravir plus cobicistat. Increased fasting total cholesterol (greater than 300 mg/dL) has been reported in 3% and 2% of patients using emtricitabine plus tenofovir alafenamide and emtricitabine plus tenofovir DF, respectively, each with elvitegravir plus cobicistat.

Asthenia has also been reported during postmarketing experience with tenofovir DF.

Hepatic

Increased AST (1.25 to less than 2.5 times the upper limit of normal [1.25 to less than 2.5 x ULN]: up to 14%; greater than 2.6 x ULN: up to 5%) and ALT (1.25 to less than 2.5 x ULN: up to 14%; greater than 2.6 x ULN: up to 7%) have been reported with emtricitabine-tenofovir DF.

Increased AST (greater than 180 units/L) and ALT (greater than 215 units/L) have been reported in 3% and 2% of males using emtricitabine-tenofovir DF, respectively. Increased AST (greater than 170 units/L) and ALT (greater than 170 units/L) have been reported in 3% and 2% of females using emtricitabine-tenofovir DF, respectively.

Increased AST (greater than 5 x ULN) has been reported in 2% and 2% of patients using emtricitabine plus tenofovir alafenamide and emtricitabine plus tenofovir DF, respectively, each with elvitegravir plus cobicistat.

Severe acute exacerbations of hepatitis have been reported in patients with hepatitis B after discontinuation of this drug and were associated with liver failure and liver decompensation in some emtricitabine-treated patients.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.

Hepatic steatosis and hepatitis have also been reported during postmarketing experience with tenofovir DF.

Emtricitabine-tenofovir DF:

-Very common (10% or more): Increased AST (up to 14%), increased ALT (up to 14%)

-Frequency not reported: Severe acute exacerbations of hepatitis B

Emtricitabine plus tenofovir alafenamide:

-Common (1% to 10%): Increased AST

Emtricitabine:

-Common (1% to 10%): Increased serum AST and/or increased serum ALT, hyperbilirubinemia

-Frequency not reported: Liver failure, liver decompensation, severe hepatomegaly with steatosis

Tenofovir DF:

-Common (1% to 10%): Increased transaminases (AST and/or ALT)

-Rare (less than 0.1%): Hepatic steatosis, hepatitis

-Frequency not reported: Severe hepatomegaly with steatosis

-Postmarketing reports: Increased liver enzymes (primarily AST, ALT, GGT)

Hematologic

Decreased neutrophils (1000 to 1300/mm3: up to 13%; less than 750/mm3: up to 5%) and hemoglobin (8.5 to 10 mg/dL: 4%; less than 9.4 mg/dL: up to 2%) have been reported with emtricitabine-tenofovir DF.

Anemia was common in pediatric patients using emtricitabine.

Emtricitabine-tenofovir DF:

-Very common (10% or more): Decreased neutrophils (up to 13%)

-Common (1% to 10%): Decreased hemoglobin

Emtricitabine:

-Common (1% to 10%): Neutropenia

-Uncommon (0.1% to 1%): Anemia

Tenofovir DF:

-Common (1% to 10%): Decreased neutrophils

Respiratory

Emtricitabine-tenofovir DF:

-Very common (10% or more): Pharyngitis (up to 13%)

-Common (1% to 10%): Sinusitis, upper respiratory tract infections, nasopharyngitis

Emtricitabine:

-Very common (10% or more): Rhinitis, increased cough

Tenofovir DF:

-Common (1% to 10%): Pneumonia

-Postmarketing reports: Dyspnea

Gastrointestinal

Emtricitabine-tenofovir alafenamide:

-Common (1% to 10%): Diarrhea, nausea, abdominal pain (included abdominal pain, upper abdominal pain, lower abdominal pain, gastrointestinal pain, abdominal discomfort)

Emtricitabine-tenofovir DF:

-Common (1% to 10%): Diarrhea, nausea, increased serum amylase, abdominal pain (included abdominal pain, upper abdominal pain, lower abdominal pain, gastrointestinal pain, abdominal discomfort), vomiting

-Frequency not reported: Flatulence

Emtricitabine plus tenofovir alafenamide:

-Very common (10% or more): Nausea

-Common (1% to 10%): Diarrhea, vomiting, abdominal pain, flatulence, increased amylase

-Uncommon (0.1% to 1%): Dyspepsia

Emtricitabine:

-Very common (10% or more): Diarrhea, nausea, abdominal pain

-Common (1% to 10%): Increased amylase (including increased pancreatic amylase), increased serum lipase, vomiting, dyspepsia

Tenofovir DF:

-Very common (10% or more): Diarrhea, vomiting, nausea

-Common (1% to 10%): Abdominal pain, abdominal distension, flatulence, dyspepsia, increased serum amylase

-Uncommon (0.1% to 1%): Pancreatitis

Increased serum amylase (greater than 175 units/L) has been reported in up to 8% of patients using emtricitabine-tenofovir DF.

In clinical trials, nausea was the most common side effect reported in antiretroviral therapy-naive HIV-1-infected patients using emtricitabine plus tenofovir alafenamide with elvitegravir plus cobicistat.

Increased amylase (greater than 2 x ULN) has been reported in 2% and 4% of patients using emtricitabine plus tenofovir alafenamide and emtricitabine plus tenofovir DF, respectively, each with elvitegravir plus cobicistat.

Pancreatitis, abdominal pain, and increased amylase have also been reported during postmarketing experience with tenofovir DF.

Musculoskeletal

In clinical trials of HIV-1-uninfected individuals, decreased BMD was reported. During treatment with emtricitabine-tenofovir DF, 13% of patients lost at least 5% of BMD at the spine.

Increased creatine kinase (males: greater than 990 units/L; females: greater than 845 units/L) has been reported in up to 9% of patients using emtricitabine-tenofovir DF.

Increased creatine kinase (at least 10 x ULN) has been reported in 9% and 7% of patients using emtricitabine plus tenofovir alafenamide and emtricitabine plus tenofovir DF, respectively, each with elvitegravir plus cobicistat.

In virologically-suppressed tenofovir DF-treated patients who switched to emtricitabine plus tenofovir alafenamide with elvitegravir plus cobicistat, mean BMD increased between baseline and week 48; decreased BMD was also reported.

Rhabdomyolysis, osteomalacia, muscular weakness, and myopathy may occur as a result of proximal renal tubulopathy.

Rhabdomyolysis, muscular weakness, and myopathy have also been reported during postmarketing experience with tenofovir DF.

Emtricitabine-tenofovir alafenamide:

-Common (1% to 10%): Decreased bone mineral density (BMD)

-Frequency not reported: Increased BMD

Emtricitabine-tenofovir DF:

-Very common (10% or more): Decreased BMD

-Common (1% to 10%): Increased creatine kinase, bone fractures, back pain

Emtricitabine plus tenofovir alafenamide:

-Very common (10% or more): Decreased BMD

-Common (1% to 10%): Increased creatine kinase

-Uncommon (0.1% to 1%): Arthralgia

-Frequency not reported: Increased biochemical markers of bone metabolism, increased BMD, fractures (excluding fingers and toes)

Emtricitabine:

-Very common (10% or more): Increased creatine kinase

-Common (1% to 10%): Myalgia, arthralgia

Tenofovir DF:

-Very common (10% or more): Increased creatine kinase

-Common (1% to 10%): Myalgia, arthralgia, back pain

-Uncommon (0.1% to 1%): Rhabdomyolysis, muscular weakness

-Rare (less than 0.1%): Myopathy

-Frequency not reported: Decreased BMD, increased biochemical markers of bone metabolism

-Postmarketing reports: Osteomalacia (manifested as bone pain and which may contribute to fractures)

Combination antiretroviral therapy:

-Frequency not reported: Osteonecrosis

Metabolic

Hyperglycemia (greater than 250 mg/dL) has been reported in up to 2% of patients using emtricitabine-tenofovir DF.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.

Hypokalemia and hypophosphatemia may occur as a result of proximal renal tubulopathy.

Hypokalemia, lactic acidosis, and hypophosphatemia have also been reported during postmarketing experience with tenofovir DF.

Emtricitabine-tenofovir DF:

-Common (1% to 10%): Hyperglycemia

Emtricitabine:

-Common (1% to 10%): Hyperglycemia, hypertriglyceridemia, increased or decreased serum glucose

-Frequency not reported: Lactic acidosis

Tenofovir DF:

-Very common (10% or more): Hypophosphatemia

-Common (1% to 10%): Anorexia, increased serum glucose

-Uncommon (0.1% to 1%): Hypokalemia

-Rare (less than 0.1%): Lactic acidosis

Antiretroviral therapy:

-Frequency not reported: Redistribution of body fat (lipodystrophy), increased glucose levels

Psychiatric

Emtricitabine-tenofovir DF:

-Common (1% to 10%): Depression, insomnia, abnormal dreams, anxiety

Emtricitabine plus tenofovir alafenamide:

-Common (1% to 10%): Abnormal dreams

Emtricitabine:

-Very common (10% or more): Insomnia, abnormal dreams

-Common (1% to 10%): Depressive disorders

Tenofovir DF:

-Very common (10% or more): Depression

-Common (1% to 10%): Insomnia, anxiety

Nervous system

Emtricitabine-tenofovir alafenamide:

-Common (1% to 10%): Headache

Emtricitabine-tenofovir DF:

-Common (1% to 10%): Dizziness, headache

-Frequency not reported: Somnolence

Emtricitabine plus tenofovir alafenamide:

-Common (1% to 10%): Headache, dizziness

Emtricitabine:

-Very common (10% or more): Dizziness, headache

-Common (1% to 10%): Neuropathy/peripheral neuritis, paresthesia

Tenofovir DF:

-Very common (10% or more): Dizziness, headache

-Common (1% to 10%): Peripheral neuropathy (including neuropathy, peripheral neuritis)

Dermatologic

Skin discoloration (hyperpigmentation) was very common in pediatric patients using emtricitabine.

Rash has also been reported during postmarketing experience with tenofovir DF.

Emtricitabine-tenofovir DF:

-Common (1% to 10%): Rash event (including rash, maculopapular rash, exfoliative rash, generalized rash, macular rash, pruritic rash, vesicular rash)

Emtricitabine plus tenofovir alafenamide:

-Common (1% to 10%): Rash

-Uncommon (0.1% to 1%): Pruritus

Emtricitabine:

-Very common (10% or more): Rash event (including rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, pustular rash, allergic reaction)

-Common (1% to 10%): Skin discoloration (palmar-plantar hyperpigmentation)

-Frequency not reported: Lipodystrophy

-Postmarketing reports: Angioedema

Tenofovir alafenamide-containing products:

-Postmarketing reports: Angioedema, urticaria, rash

Tenofovir DF:

-Very common (10% or more): Rash event (including rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, pustular rash)

-Common (1% to 10%): Sweating

-Uncommon (0.1% to 1%): Lipodystrophy

-Rare (less than 0.1%): Angioedema

Renal

Increased creatinine (1.1 to 1.3 x ULN: up to 2%; greater than 1.4 x ULN: less than 1%) has been reported with emtricitabine-tenofovir DF.

In 2 trials in antiretroviral therapy-naive HIV-1-infected patients (median estimated glomerular filtration rate [eGFR] 115 mL/min at baseline) using emtricitabine plus tenofovir alafenamide with elvitegravir plus cobicistat, mean serum creatinine increased by 0.1 mg/dL from baseline to week 48; median UPCR was 44 mg/g at baseline and at week 48. In a trial in virologically-suppressed tenofovir DF-treated patients (mean eGFR 112 mL/min at baseline) who switched to emtricitabine plus tenofovir alafenamide with elvitegravir plus cobicistat, mean serum creatinine was similar to baseline; median UPCR was 61 mg/g at baseline and 46 mg/g at week 48. In a trial in renal dysfunction patients (baseline eGFR 30 to 69 mL/min) using emtricitabine plus tenofovir alafenamide with elvitegravir plus cobicistat, mean serum creatinine was 1.5 mg/dL at baseline and week 24; median UPCR was 161 mg/g at baseline and 93 mg/g at week 24.

Proximal renal tubulopathy generally resolved or improved after tenofovir DF was stopped; however, decreased CrCl did not completely resolve in some HIV-1-infected patients after stopping the drug. Rhabdomyolysis, osteomalacia, bone abnormalities (infrequently contributing to fractures), hypokalemia, muscular weakness, myopathy, and hypophosphatemia may occur as a result of proximal renal tubulopathy.

Renal failure, acute renal failure, Fanconi syndrome, proximal renal tubulopathy, increased creatinine, nephrogenic diabetes insipidus, and acute tubular necrosis have also been reported during postmarketing experience with tenofovir DF.

Emtricitabine-tenofovir alafenamide:

-Uncommon (0.1% to 1%): Increased urine protein-to-creatinine ratio (UPCR)

-Frequency not reported: Decreased serum creatinine, increased estimated glomerular filtration rate (eGFR)

Emtricitabine-tenofovir DF:

-Common (1% to 10%): Increased creatinine, increased UPCR

-Frequency not reported: Decreased eGFR

Emtricitabine plus tenofovir alafenamide:

-Frequency not reported: Increased serum creatinine, decreased UPCR, worsening renal function

Tenofovir DF:

-Uncommon (0.1% to 1%): Increased creatinine, proximal renal tubulopathy (including Fanconi syndrome)

-Rare (less than 0.1%): Renal failure (acute and chronic), acute tubular necrosis, nephrogenic diabetes insipidus

-Frequency not reported: New onset or worsening renal impairment

-Postmarketing reports: Renal insufficiency, interstitial nephritis (including acute cases)

Tenofovir prodrugs:

-Frequency not reported: Renal impairment (including renal failure, Fanconi syndrome)

Genitourinary

Emtricitabine-tenofovir DF:

-Common (1% to 10%): Proteinuria, urethritis, urinary tract infection, hematuria, genital ulceration, anogenital warts

-Uncommon (0.1% to 1%): Glycosuria

Emtricitabine plus tenofovir alafenamide:

-Common (1% to 10%): Hematuria

Tenofovir DF:

-Common (1% to 10%): Glycosuria, hematuria

-Uncommon (0.1% to 1%): Proteinuria

-Postmarketing reports: Polyuria

Hematuria (greater than 75 RBC/high power field: up to 3%) and glycosuria (3+ or greater: less than 1%) have been reported with emtricitabine-tenofovir DF.

Hematuria (greater than 75 RBC/high power field) has been reported in 3% and 3% of patients using emtricitabine plus tenofovir alafenamide and emtricitabine plus tenofovir DF, respectively, each with elvitegravir plus cobicistat.

Proteinuria has also been reported during postmarketing experience with tenofovir DF.

Immunologic

Emtricitabine-tenofovir DF:

-Frequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome, autoimmune hepatitis)

Hypersensitivity

Emtricitabine:

-Common (1% to 10%): Allergic reaction

Tenofovir DF:

-Postmarketing reports: Allergic reaction (including angioedema)

Endocrine

Tenofovir DF:

-Frequency not reported: Higher serum parathyroid hormone levels

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Descovy