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Symtuza

Generic Name: cobicistat, darunavir, emtricitabine, and tenofovir alafenamide (koe BIK i stat, dar UE na vir, EM trye SYE ta been, and ten OF oh vir)
Brand Names: Symtuza
Symtuza (cobicistat/darunavir/emtricitabine/tenofovir alafenamide) is a single-tablet regimen for the treatment of HIV-1 infection. Symtuza information includes news, clinical trial results and side effects.
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Drug Information:
Symtuza contains a combination of cobicistat, darunavir, emtricitabine, and tenofovir alafenamide. Cobicistat reduces the action of enzymes in your liver that break down certain antiviral medicines. This allows the antiviral medicines to be used more safely and effectively at lower doses. Darunavir, emtricitabine and tenofovir are antiviral medicines that prevent human immunodeficiency virus (HIV) from multiplying in your body. HIV can cause acquired immunodeficiency syndrome (AIDS). Symtuza is a used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Learn more

Symtuza Side Effects

Symtuza Side Effects

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

For the Consumer

Applies to cobicistat/darunavir/emtricitabine/tenofovir alafenamide: oral tablet

Warning

Oral route (Tablet)

Warning: Post treatment acute exacerbation of hepatitis BSevere acute exacerbations of hepatitis B (HBV) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of darunavir/cobicistat/emtricitabine/tenofovir alafenamide. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue darunavir/cobicistat/emtricitabine/tenofovir alafenamide. If appropriate, anti-hepatitis B therapy may be warranted.

Along with its needed effects, cobicistat / darunavir / 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 cobicistat / darunavir / emtricitabine / tenofovir alafenamide:

More common

  • Rash

Less Common

  • Blistering, peeling, or loosening of the skin
  • bloating
  • blurred vision
  • chills
  • constipation
  • cough
  • dark urine
  • diarrhea
  • dry mouth
  • fast heartbeat
  • fever
  • flushed, dry skin
  • fruit-like breath odor
  • general tiredness and weakness
  • heavy jaw feeling
  • increased hunger
  • increased thirst
  • increased urination
  • indigestion
  • itching
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • light-colored stools
  • loosening of a tooth
  • loss of appetite
  • loss of consciousness
  • nausea
  • pain, swelling, or numbness in the mouth or jaw
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • stomachache
  • sweating
  • troubled breathing
  • unexplained weight loss
  • unusual tiredness or weakness
  • upper right abdominal pain
  • vomiting
  • yellow eyes or skin

Incidence not known

  • Muscle cramps, spasms, or stiffness
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin

Some side effects of cobicistat / darunavir / emtricitabine / tenofovir alafenamide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  • Abnormal dreams
  • belching
  • difficulty in moving
  • excess air or gas in the stomach or bowels
  • headache
  • heartburn
  • passing gas
  • redistribution or accumulation of body fat
  • stomach discomfort, upset, or pain
  • swelling of the breasts or breast soreness in both females and males
  • swollen joints
  • weight loss

For Healthcare Professionals

Applies to cobicistat / darunavir / emtricitabine / tenofovir alafenamide: oral tablet

General

In clinical trials, the most common side effects reported in therapy-naive patients were diarrhea, rash, headache, nausea, and fatigue; in suppressed therapy-experienced patients, diarrhea, headache, and abdominal pain were reported most often. This drug was discontinued due to side effects in 2% and 1% of therapy-naive and therapy-experienced patients, respectively.

Gastrointestinal

Very common (10% or more): Diarrhea (up to 20%), nausea

Common (1% to 10%): Abdominal pain, vomiting, abdominal discomfort, abdominal distension, dyspepsia, flatulence, increased pancreatic enzymes

Uncommon (0.1% to 1%): Acute pancreatitis

Other

Very common (10% or more): Elevated total cholesterol (up to 17%)

Common (1% to 10%): Fatigue, asthenia, elevated low-density lipoprotein (LDL) cholesterol, elevated triglycerides, lipid-lowering drug started

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

Antiretroviral therapy:

-Frequency not reported: Increased weight, increased blood lipids

Elevated total cholesterol (240 to less than 300 mg/dL: 17%; at least 300 mg/dL: 2%), LDL cholesterol (160 to 189 mg/dL: 9%; at least 190 mg/dL: 5%), and triglycerides (301 to 500 mg/dL: 7%; 501 to 1000 mg/dL: 1%; greater than 1000 mg/dL: less than 1%) have been reported.

Musculoskeletal

Very common (10% or more): Decreased bone mineral density (BMD) (up to 16%)

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

Uncommon (0.1% to 1%): Osteonecrosis

Darunavir-containing regimen:

-Postmarketing reports: Rhabdomyolysis (associated with coadministration with HMG-CoA reductase inhibitors)

HIV protease inhibitors:

-Rare (0.01% to 0.1%): Rhabdomyolysis

-Frequency not reported: Increased creatine phosphokinase, myalgia, myositis

In therapy-naive patients, BMD decreases of at least 5% at the lumbar spine were reported in 16% of patients using this drug and 22% of patients using cobicistat-darunavir plus emtricitabine-tenofovir disoproxil fumarate (DF); BMD decreases of at least 7% at the femoral neck were reported in 2% of patients using this drug and 15% of patients using cobicistat-darunavir plus emtricitabine-tenofovir DF. In boosted protease inhibitor and tenofovir DF-treated patients, BMD decreases of at least 5% at the lumbar spine were reported in 2% of patients using this drug and 9% of patients using cobicistat-darunavir plus emtricitabine-tenofovir DF; BMD decreases of at least 7% at the femoral neck were reported in no patients using this drug and 2% of patients using cobicistat-darunavir plus emtricitabine-tenofovir DF.

Dermatologic

Rash was commonly reported with darunavir; rashes were generally mild-to-moderate, often occurring within the first 4 weeks of therapy and resolving with continued use. In trials in therapy-naive patients, 12% of those using this drug reported rash (most were grade 1) and 1.5% of patients discontinued therapy due to rash (1 due to rash and hypersensitivity). In the trial in suppressed therapy-experienced patients, 3.7% of patients using this drug reported rash (most were grade 1) and no patients discontinued therapy due to rash.

Very common (10% or more): Rash (included dermatitis, allergic dermatitis, erythema, photosensitivity reaction, rash, erythematous rash, generalized rash, macular rash, maculopapular rash, morbilliform rash, papular rash, pruritic rash, toxic skin eruption, urticaria; up to 12%)

Common (1% to 10%): Pruritus, urticaria

Uncommon (0.1% to 1%): Angioedema

Frequency not reported: Lipodystrophy

Darunavir-containing regimen:

-Rare (0.01% to 0.1%): Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS)

-Frequency not reported: Severe skin reactions (included conditions accompanied by fever and/or transaminase elevations)

-Postmarketing reports: Toxic epidermal necrolysis, acute generalized exanthematous pustulosis, DRESS

Nervous system

Very common (10% or more): Headache (up to 11.6%)

Common (1% to 10%): Dizziness

Metabolic

Common (1% to 10%): Elevated glucose levels, anorexia, diabetes mellitus, hypercholesterolemia, hypertriglyceridemia, hyperlipidemia

Uncommon (0.1% to 1%): Dyslipidemia, hyperglycemia

Darunavir-containing regimen:

-Postmarketing reports: Redistribution of body fat

Emtricitabine and tenofovir DF:

-Frequency not reported: Lactic acidosis

HIV protease inhibitors:

-Postmarketing reports: New onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, hyperglycemia, diabetic ketoacidosis

Antiretroviral therapy:

-Frequency not reported: Increased glucose, redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance")

Elevated glucose levels (126 to 250 mg/dL: 6%; 251 to 500 mg/dL: less than 1%) have been reported.

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

Renal

Elevated creatinine (greater than 1.3 to 1.8 times the upper limit of normal [1.3 to 1.8 x ULN]: 4%; at least 3.5 x ULN: less than 1%) has been reported.

In a trial in therapy-naive HIV-1-infected patients (median estimated glomerular filtration rate [eGFR] 119 mL/min at baseline), mean serum creatinine increased by 0.05 mg/dL from baseline to week 48; median serum creatinine was 0.9 mg/dL at baseline at 0.95 mg/dL at week 48. Serum creatinine increased by week 2 of therapy and remained stable. Median UPCR was 47 mg/g at baseline and 30 mg/g at week 48. In a trial in virologically-suppressed patients treated with an HIV protease inhibitor and tenofovir DF-containing regimen (mean eGFR 104 mL/min at baseline) who switched to this drug or who remained on initial regimen (mean eGFR 103 mL/min at baseline), mean serum creatinine was similar to baseline for both at week 48; median UPCR was 62 mg/g at baseline and 37 mg/g at week 48 in those who switched to this drug and 63 mg/g at baseline and 53 mg/g at week 48 in those who remained on initial regimen.

Common (1% to 10%): Elevated creatinine

Frequency not reported: Decreased urine protein-to-creatinine ratio (UPCR)

Cobicistat:

-Frequency not reported: Increased serum creatinine

Tenofovir prodrugs:

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

Hepatic

Severe acute exacerbations of hepatitis B (e.g., liver decompensation and liver failure) have been reported in patients coinfected with HIV-1 and hepatitis B virus after discontinuation of products containing emtricitabine and/or tenofovir DF.

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

Common (1% to 10%): Elevated ALT and/or AST, increased hepatic enzyme

Frequency not reported: Acute hepatitis

Darunavir-containing regimen:

-Uncommon (0.1% to 1%): Acute hepatitis, cytolytic hepatitis

-Frequency not reported: Drug-induced hepatitis

-Postmarketing reports: Liver injury

Emtricitabine and/or tenofovir DF:

-Frequency not reported: Severe hepatomegaly with steatosis, severe acute exacerbations of hepatitis B, liver decompensation, liver failure

Hematologic

Common (1% to 10%): Anemia

HIV protease inhibitors:

-Frequency not reported: Increased bleeding (including spontaneous skin hematomas, hemarthrosis) in hemophiliacs

Psychiatric

Common (1% to 10%): Abnormal dreams

Hypersensitivity

Uncommon (0.1% to 1%): Drug hypersensitivity

Immunologic

Uncommon (0.1% to 1%): Immune reconstitution inflammatory syndrome

Combination antiretroviral therapy:

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

Endocrine

Darunavir-containing regimen:

-Uncommon (0.1% to 1%): Gynecomastia

Editorial References and Review

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

Source: Drugs.com Symtuza