Truvada

Posted by glbgn754 on July 17, 2014
Uncategorized

GILEAD 701 (Truvada 200 mg / 300 mg)

Generic Name: emtricitabine/tenofovir

Pill imprint GILEAD 701 has been identified as Truvada 200 mg / 300 mg.

Truvada is used in the treatment of pre-exposure prophylaxis; hiv infection; nonoccupational exposure and belongs to the drug class antiviral combinations. There is no proven risk in humans during pregnancy. Truvada 200 mg / 300 mg is not subject to the Controlled Substances Act.


Truvada Side Effects

Generic Name: emtricitabine / tenofovir

Overview
Side Effects
Dosage
Interactions
For Professionals
More

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

Some side effects of Truvada may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer

Applies to emtricitabine / tenofovir: oral tablet

Along with its needed effects, emtricitabine / tenofovir 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:
Less common

Blisters under the skin
rash with flat lesions or small raised lesions on the skin
redness of the skin
skin rash, itching skin, hives or welts
spots on your skin resembling a blister or pimple

Rare

Blindness or vision changes
burning of the face or mouth
burning, crawling, itching, numbness, painful, prickling, “pins and needles”, or tingling feelings in the hands, arms, feet, or legs
chest pain
clumsiness or unsteadiness
sensation of pins and needles
sneezing
sore throat
stabbing pain
weakness in the hands or feet

Incidence not known

Abdominal or stomach discomfort
agitation
bloating
bloody or cloudy urine
bone pain
chills
coma
confusion
constipation
convulsions or seizures
cough
darkened urine
decreased appetite
decreased frequency or amount of urine
depression
diarrhea
difficult or labored breathing
difficult or painful urination
difficulty with swallowing
dizziness
fast heartbeat
fast, shallow breathing
fever
general feeling of discomfort
headache
hostility
increase in the amount of urine
increased blood pressure
increased thirst
indigestion
irritability
lethargy
loss of appetite
lower back or side pain
muscle pain or cramping
muscle twitching
nausea
pains in the stomach, side, or abdomen, possibly radiating to the back
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rapid weight gain
sleepiness
stupor
sudden decrease in the amount of urine
swelling of the face, fingers, hands, lower legs, or ankles
tightness in the chest
trouble breathing
unusual tiredness or weakness
vomiting
weight gain
yellow eyes or skin

Some side effects of emtricitabine / tenofovir 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

Lack or loss of strength
passing of gas
weight loss

Rare

Acid or sour stomach
back pain
belching
difficulty with moving
discouragement
feeling sad or empty
heartburn
increased cough
joint pain
loss of interest or pleasure
muscle aching or cramping
muscle pain or stiffness
pain
runny nose
stomach upset
stuffy nose
sweating
swollen joints
tiredness
trouble concentrating
trouble sleeping

For Healthcare Professionals

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

Side effects have been reported for emtricitabine and/or tenofovir when taken in combination with other antiretroviral agents. The most common side effects (10% or more; any severity) reported in HIV-1-infected patients during a clinical study of efavirenz, emtricitabine, and tenofovir included diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash.

In HIV-1-uninfected individuals in preexposure prophylaxis trials, the most common side effects (greater than 2%) reported were headache, abdominal pain, and decreased weight.
Gastrointestinal

Common (1% to 10%): Diarrhea (Grades 2 to 4: up to 9%; all Grades: up to 7%), nausea (Grades 2 to 4: up to 9%), abdominal pain (all Grades: up to 4%), vomiting (Grades 2 to 4: up to 2%)
Frequency not reported: Flatulence

Emtricitabine or tenofovir:
Common (1% to 10%): Dyspepsia (at least 5%)

Tenofovir:
Postmarketing reports: Pancreatitis, abdominal pain, increased amylase
Metabolic

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

Very common (10% or more): Increased fasting cholesterol (greater than 240 mg/dL: up to 22%)
Common (1% to 10%): Decreased phosphorus (2.5 to less than lower limit of normal: up to 7%; less than 2 mg/dL: up to 10%), increased creatine kinase (greater than 990 units/L in males and 845 units/L in females: up to 9%), increased serum amylase (greater than 175 units/L: up to 8%), increased fasting triglycerides (greater than 750 mg/dL: 4%), increased pancreatic amylase (greater than 2 times upper limit of normal [ULN]: up to 3%), increased serum lipase (greater than 2 times ULN: up to 3%), altered serum glucose (less than 40 mg/dL or greater than 250 mg/dL: up to 3%), weight loss (up to 3%), hyperglycemia (greater than 250 mg/dL: up to 2%), increased alkaline phosphatase (greater than 550 units/L: 1%)
Frequency not reported: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, “cushingoid appearance”)

Tenofovir:
Postmarketing reports: Hypokalemia, lactic acidosis, hypophosphatemia
Hepatic

Very common (10% or more): Elevated AST (1.25 to less than 2.5 times ULN: up to 14%), elevated ALT (1.25 to less than 2.5 times ULN: up to 14%)
Common (1% to 10%): Elevated AST (greater than 180 units/L in males and 170 units/L in females: 3%; greater than 2.6 times ULN: up to 5%), elevated ALT (greater than 215 units/L in males and 170 units/L in females: 2%; greater than 2.6 times ULN: up to 7%), bilirubin (greater than 2.5 times ULN: up to 3%)
Frequency not reported: Severe acute exacerbations of hepatitis B

Emtricitabine:
Frequency not reported: Liver failure, liver decompensation

Tenofovir:
Frequency not reported: Lactic acidosis/severe hepatomegaly with steatosis
Postmarketing reports: Hepatic steatosis, hepatitis, increased liver enzymes (primarily AST, ALT, gamma glutamyltransferase)

Severe acute exacerbations of hepatitis have been reported in patients with hepatitis B after discontinuation of emtricitabine-tenofovir 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, including tenofovir, in combination with other antiretroviral agents.
Hematologic

Very common (10% or more): Decreased neutrophils (1000 to 1300/mm3: up to 13%)
Common (1% to 10%): Decreased neutrophils (less than 750/mm3: up to 5%), hemoglobin (8.5 to 10 mg/dL: 4%; less than 9.4 mg/dL: up to 2%)
Respiratory

Very common (10% or more): Pharyngitis (all Grades: up to 13%)
Common (1% to 10%): Sinusitis (Grades 2 to 4: up to 8%), upper respiratory tract infections (Grades 2 to 4: up to 8%), nasopharyngitis (Grades 2 to 4: up to 5%)

Emtricitabine or tenofovir:
Common (1% to 10%): Increased cough (at least 5%), pneumonia (at least 5%), rhinitis (at least 5%)

Tenofovir:
Postmarketing reports: Dyspnea
Psychiatric

Common (1% to 10%): Depression (Grades 2 to 4: up to 9%; all Grades: up to 6%), insomnia (Grades 2 to 4: up to 5%), anxiety (all Grades: up to 3%)
Frequency not reported: Abnormal dreams

Emtricitabine or tenofovir:
Common (1% to 10%): Anxiety (at least 5%)
Nervous system

Common (1% to 10%): Dizziness (Grades 2 to 4: 8%), headache (Grades 2 to 4: up to 6%; all Grades: up to 7%)
Frequency not reported: Somnolence

Emtricitabine or tenofovir:
Common (1% to 10%): Peripheral neuropathy (including neuropathy and peripheral neuritis; at least 5%), paresthesia (at least 5%)
Other

Common (1% to 10%): Fatigue (Grades 2 to 4: up to 9%)

Emtricitabine or tenofovir:
Common (1% to 10%): Asthenia (at least 5%), pain (at least 5%), abdominal pain (at least 5%), back pain (at least 5%), fever (at least 5%)

Tenofovir:
Frequency not reported: Higher 1,25 vitamin D levels
Postmarketing reports: Asthenia
Dermatologic

Common (1% to 10%): Rash event (including rash, maculopapular rash, exfoliative rash, generalized rash, macular rash, pruritic rash, vesicular rash; Grades 2 to 4: up to 7%)

Emtricitabine:
Frequency not reported: Skin discoloration (palmar-plantar hyperpigmentation)

Tenofovir:
Frequency not reported: Sweating
Postmarketing reports: Rash
Musculoskeletal

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

Common (1% to 10%): Bone fractures (1.7%)
Frequency not reported: Decreased bone mineral density

Emtricitabine or tenofovir:
Common (1% to 10%): Myalgia (at least 5%), arthralgia (at least 5%), back pain (all Grades: up to 5%)

Tenofovir:
Frequency not reported: Decreased bone mineral density, increased biochemical markers of bone metabolism
Postmarketing reports: Rhabdomyolysis, osteomalacia (manifested as bone pain and which may contribute to fractures), muscular weakness, myopathy
Renal

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

Common (1% to 10%): Increased creatinine (1.1 to 1.3 times ULN: up to 2%)
Uncommon (0.1% to 1%): Increased creatinine (greater than 1.4 times ULN: less than 1%)

Tenofovir:
Frequency not reported: New onset or worsening renal impairment
Postmarketing reports: Renal insufficiency, renal failure, acute renal failure, Fanconi syndrome, proximal renal tubulopathy, increased creatinine, nephrogenic diabetes insipidus, acute tubular necrosis, interstitial nephritis (including acute cases)
Genitourinary

Common (1% to 10%): Proteinuria (Grade 1: up to 6%), syphilis (all Grades: up to 6%), secondary syphilis (all Grades: up to 6%), urethritis (all Grades: up to 5%), urinary tract infection (all Grades: up to 5%), hematuria (greater than 75 RBC/HPF: up to 3%), genital ulceration (all Grades: 2%), anogenital warts (all Grades: up to 2%)
Uncommon (0.1% to 1%): Proteinuria (Grade 2 to 3: less than 1%), glycosuria (3 plus or greater: less than 1%)

Tenofovir:
Postmarketing reports: Proteinuria, polyuria
Immunologic

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

Tenofovir:
Postmarketing reports: Allergic reaction (including angioedema)
Endocrine

Tenofovir:
Frequency not reported: Higher serum parathyroid hormone levels

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