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Emtriva

"The U.S. Food and Drug Administration today approved the first rapid Human Immunodeficiency Virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or f"...

Emtriva

SIDE EFFECTS

The following adverse reactions are discussed in other sections of the labeling:

Adverse Reactions from Clinical Trials Experience

Clinical Trials in Adult Subjects

More than 2,000 adult subjects with HIV-1 infection have been treated with EMTRIVA alone or in combination with other antiretroviral agents for periods of 10 days to 200 weeks in clinical trials.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions (incidence greater than or equal to 10%, any severity) identified from any of the 3 large controlled clinical trials include headache, diarrhea nausea, fatigue, dizziness, depression, insomnia, abnormal dreams, rash, abdominal pain, asthenia, increased cough, and rhinitis.

Studies 301A and 303– Treatment Emergent Adverse Reactions: The most common adverse reactions that occurred in subjects receiving EMTRIVA with other antiretroviral agents in clinical trials 301A and 303 were headache, diarrhea, nausea, and rash, which were generally of mild to moderate severity. Approximately 1% of subjects discontinued participation in the clinical trials due to these events. All adverse reactions were reported with similar frequency in EMTRIVA and control treatment groups with the exception of skin discoloration which was reported with higher frequency in the EMTRIVA treated group.

Skin discoloration, manifested by hyperpigmentation on the palms and/or soles was generally mild and asymptomatic. The mechanism and clinical significance are unknown.

A summary of EMTRIVA treatment-emergent clinical adverse reactions in Studies 301A and 303 is provided in Table 2.

Table 2 : Selected Treatment-Emergent Adverse Reactions (All Grades, Regardless of Causality) Reported in ≥ 3% of EMTRIVA-Treated Subjects in Either Study 301A or 303 (0–48 Weeks)

  303 301A
EMTRIVA + ZDV/d4T + NNRTI/PI
(N=294)
Lamivudine + ZDV/d4T + NNRTI/PI
(N=146)
EMTRIVA + didanosine + efavirenz
(N=286)
Stavudine + didanosine + efavirenz
(N=285)
Body as a Whole
  Abdominal pain 8% 11% 14% 17%
  Asthenia 16% 10% 12% 17%
  Headache 13% 6% 22% 25%
Digestive System
  Diarrhea 23% 18% 23% 32%
  Dyspepsia 4% 5% 8% 12%
  Nausea 18% 12% 13% 23%
  Vomiting 9% 7% 9% 12%
Musculoskeletal
  Arthralgia 3% 4% 5% 6%
  Myalgia 4% 4% 6% 3%
Nervous System
  Abnormal dreams 2% < 1% 11% 19%
  Depressive disorders 6% 10% 9% 13%
  Dizziness 4% 5% 25% 26%
  Insomnia 7% 3% 16% 21%
  Neuropathy/peripheral neuritis 4% 3% 4% 13%
  Paresthesia 5% 7% 6% 12%
Respiratory
  Increased cough 14% 11% 14% 8%
  Rhinitis 18% 12% 12% 10%
Skin
  Rash eventa 17% 14% 30% 33%
a Rash event includes rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, pustular rash, and allergic reaction.

Studies 301A and 303– Laboratory Abnormalities: Laboratory abnormalities in these trials occurred with similar frequency in the EMTRIVA and comparator groups. A summary of Grades 3-4 laboratory abnormalities is provided in Table 3 below.

Table 3 : Treatment-Emergent Grades 3-4 Laboratory Abnormalities Reported in ≥ 1% of EMTRIVA-Treated Subjects in Either Study 301A or 303

  303 301A
EMTRIVA + ZDV/d4T + NNRTI/PI
(N=294)
Lamivudine + ZDV/d4T + NNRTI/PI
(N=146)
EMTRIVA + Didanosine + Efavirenz
(N=286)
Stavudine + Didanosine + Efavirenz
(N=285)
Percentage with grade 3 or grade 4 laboratory abnormality 31% 28% 34% 38%
ALT ( > 5.0 x ULNa) 2% 1% 5% 6%
AST ( > 5.0 x ULN) 3% < 1% 6% 9%
Bilirubin ( > 2.5 x ULN) 1% 2% < 1% < 1%
Creatine kinase ( > 4.0 x ULN) 11% 14% 12% 11%
Neutrophils ( < 750 mm³) 5% 3% 5% 7%
Pancreatic amylase ( > 2.0 x ULN) 2% 2% < 1% 1%
Serum amylase ( > 2.0 x ULN) 2% 2% 5% 10%
Serum glucose < 40 or > 250 mg/dL) 3% 3% 2% 3%
Serum lipase ( > 2.0 x ULN) < 1% < 1% 1% 2%
Triglycerides ( > 750 mg/dL) 10% 8% 9% 6%
a ULN = Upper limit of normal

Study 934– Treatment Emergent Adverse Reactions: In Study 934, 511 antiretroviralna´ve subjects received either VIREAD® + EMTRIVA administered in combination with efavirenz (N=257) or zidovudine/lamivudine administered in combination with efavirenz (N=254). Adverse reactions observed in this trial were generally consistent with those seen in previous trials in treatment-experienced or treatment-na´ve subjects (Table 4).

Table 4 : Selected Treatment-Emergent Adverse Reactionsa (Grades 2–4) Reported in ≥ 5% in Any Treatment Group in Study 934 (0–144 Weeks)

  TDFb + EMTRIVA + EFV
N=257
AZT/3TC + EFV
N=254
Gastrointestinal Disorder
  Diarrhea 9% 5%
  Nausea 9% 7%
  Vomiting 2% 5%
General Disorders and Administration Site Condition
  Fatigue 9% 8%
Infections and Infestations
  Sinusitis 8% 4%
  Upper respiratory tract infections 8% 5%
  Nasopharyngitis 5% 3%
Nervous System Disorders 
  Headache 6% 5%
  Dizziness 8% 7%
Psychiatric Disorders
  Depression 9% 7%
  Insomnia 5% 7%
Skin and Subcutaneous Tissue Disorders
  Rash eventc 7% 9%
a Frequencies of adverse reactions are based on all treatment-emergent adverse events, regardless of relationship to study drug.
b From Weeks 96 to 144 of the trial, subjects received TRUVADA with efavirenz in place of VIREAD + EMTRIVA with efavirenz.
c Rash event includes rash, exfoliative rash, rash generalized, rash macular, rash maculo-papular, rash pruritic, and rash vesicular.

Study 934 – Laboratory Abnormalities: Significant laboratory abnormalities observed in this trial are shown in Table 5.

Table 5 : Significant Laboratory Abnormalities Reported in ≥ 1% of Subjects in Any Treatment Group in Study 934 (0–144 Weeks)

  TDFa + EMTRIVA + EFV
N=257
AZT/3TC + EFV
N=254
Any ≥ Grade 3 Laboratory Abnormality 30% 26%
Fasting Cholesterol ( > 240 mg/dL) 22% 24%
Creatine Kinase (M: > 990 U/L) (F: > 845 U/L) 9% 7%
Serum Amylase ( > 175 U/L) 8% 4%
Alkaline Phosphatase ( > 550 U/L) 1% 0%
AST (M: > 180 U/L) (F: > 170 U/L) 3% 3%
ALT (M: > 215 U/L) (F: > 170 U/L) 2% 3%
Hemoglobin ( < 8.0 mg/dL) 0% 4%
Hyperglycemia ( > 250 mg/dL) 2% 1%
Hematuria ( > 75 RBC/HPF) 3% 2%
Glycosuria (3+) < 1% 1%
Neutrophils ( < 750/mm ) 3% 5%
Fasting Triglycerides ( > 750 mg/dL) 4% 2%
a From Weeks 96 to 144 of the trial, subjects received TRUVADA with efavirenz in place of VIREAD + EMTRIVA with efavirenz.

Clinical Trials in Pediatric Subjects

Assessment of adverse reactions is based on data from Study 203, an open label, uncontrolled trial of 116 HIV-1-infected pediatric subjects who received emtricitabine through 48 weeks. The adverse reaction profile in pediatric subjects was generally comparable to that observed in clinical trials of EMTRIVA in adult subjects. Hyperpigmentation was more frequent in children. Additional adverse reactions identified from this trial include anemia.

Selected treatment-emergent adverse events, regardless of causality, reported in subjects during 48 weeks of treatment were the following: infection (44%), hyperpigmentation (32%), increased cough (28%), vomiting (23%), otitis media (23%), rash (21%), rhinitis (20%), diarrhea (20%), fever (18%), pneumonia (15%), gastroenteritis (11%), abdominal pain (10%), and anemia (7%). Treatment-emergent grades 3-4 laboratory abnormalities were experienced by 9% of pediatric subjects, including elevated amylase ( > 2.0 x ULN) (n=4), decreased neutrophils ( < 750/mm³) (n=3), elevated ALT ( > 5 x ULN) (n=2), elevated CPK ( > 4 x ULN) (n=2) and one subject each with elevated bilirubin ( > 3.0 x ULN), elevated GGT ( > 10 x ULN), elevated lipase ( > 2.5 x ULN), decreased hemoglobin ( < 7 g/dL), and decreased glucose ( < 40 mg/dL).

Read the Emtriva (emtricitabine) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

The potential for drug interactions with EMTRIVA has been studied in combination with zidovudine, indinavir, stavudine, famciclovir, and tenofovir disoproxil fumarate. There were no clinically significant drug interactions for any of these drugs. Drug interactions trials are described elsewhere in the labeling [See CLINICAL PHARMACOLOGY].

Read the Emtriva Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 4/22/2013
This monograph has been modified to include the generic and brand name in many instances.

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