Emtriva
SIDE EFFECTS
The following adverse reactions are discussed in other sections of the labeling:
- Lactic acidosis/severe hepatomegaly with steatosis [See Boxed Warning, WARNINGS and PRECAUTIONS].
- Severe acute exacerbations of Hepatitis B [See Boxed Warning, WARNINGS and PRECAUTIONS].
- Immune reconstitution syndrome [See WARNINGS and PRECAUTIONS]
Adverse Reactions from Clinical Trials Experience
Adult Patients
More than 2,000 adult patients 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 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 patients receiving EMTRIVA with other antiretroviral agents in clinical studies 301A and 303 were headache, diarrhea, nausea, and rash, which were generally of mild to moderate severity. Approximately 1% of patients discontinued participation in the clinical studies 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 Patients
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, maculopapularrash, urticaria, vesiculobullous rash, pustular rash, and allergic reaction. | ||||
Studies 301A and 303 - Laboratory Abnormalities
Laboratory abnormalities in these studies occurred with similar frequency in the EMTRIVA and comparator groups. A summary of Grade 3 and 4 laboratory abnormalities is provided in Table 3 below.
Table 3: Treatment-Emergent Grade 3/4 Laboratory Abnormalities
Reported in ≥ 1% of EMTRIVA-Treated Patients 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 antiretroviral-naïve patients 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 study were generally consistent with those seen in previous studies in treatment-experienced or treatment-naïve patients (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 | AZT/3TC + EFV | |
| N=257 | 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% |
| Skinand Subcutaneous Tissue Disorders | ||
| Rash eventc | 7% | 9% |
| a. Frequencies of adverse reactions are based onall
treatment-emergent adverse events, regardless of relationship to study drug. b. From Weeks 96 to 144 of the study, patients received TRUVADA with efavirenz inplace of VIREAD + EMTRIVA with efavirenz. c.Rash event includes rash, exfoliative rash, rash generalized, rash macular, rashmaculo-papular, rash pruritic, and rash vesicular. |
||
Study 934 - Laboratory Abnormalities: Significant laboratory abnormalities observed in this study are shown in Table 5.
Table 5: Significant Laboratory Abnormalities Reported in
≥ 1% of Patients in Any Treatment Group in Study 934 (0-144 Weeks)
| TDFa + EMTRIVA + EFV | AZT/3TC + EFV | |
| N=257 | 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/mm3) | 3% | 5% |
| Fasting Triglycerides (>750 mg/dL) | 4% | 2% |
| a. From Weeks 96 to 144 of the study, patients received TRUVADA with efavirenz inplace of VIREAD + EMTRIVA with efavirenz. | ||
Pediatric Patients
Assessment of adverse reactions is based on data from Study 203, an open label, uncontrolled study of 116 HIV-1-infected pediatric patients who received emtricitabine through 48 weeks. The adverse reaction profile in pediatric patients was generally comparable to that observed in clinical studies of EMTRIVA in adult patients [See ADVERSE REACTIONS]. Hyperpigmentation was more frequent in children. Additional adverse reactions identified from this study include anemia.
Selected treatment-emergent adverse events, regardless of causality, reported in patients 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 grade 3/4 laboratory abnormalities were experienced by 9% of pediatric patients, including amylase > 2.0 x ULN (n=4), neutrophils < 750/mm3 (n=3), ALT > 5 x ULN (n=2), elevated CPK ( > 4 x ULN) (n=2) and one patient 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).
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 studies are described elsewhere in the labeling [See CLINICAL PHARMACOLOGY]
Generic Name: Emtricitabine
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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