A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Emtriva Side Effects, and Drug Interactions - Emtricitabine
Emtriva Side Effects, and Drug Interactions - Emtricitabine
SIDE EFFECTS
More than 2000 adult patients with HIV infection have been
treated with EMTRIVA alone or in combination with other antiretroviral agents
for periods of 10 days to 200 weeks in Phase I-III clinical trials.
Assessment of adverse reactions is based on data from studies
301A and 303 in which 571 treatment naïve (301A) and 440 treatment experienced
(303) patients received EMTRIVA 200 mg (n=580) or comparator drug (n=431) for
48 weeks.
The most common adverse events that occurred in patients receiving
EMTRIVA with other antiretroviral agents in clinical trials 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 events 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 events
in studies 301A and 303 is provided in Table 6 below.
|
Table 6. Selected Treatment-Emergent Adverse Events
(All Grades, Regardless of Causality) Reported in ³
3% of EMTRIVA-Treated Patients in Either Study 301A or 303 (0-48 weeks)
|
|
Adverse event
|
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
|
4%
|
3%
|
4%
|
13%
|
|
Neuritis
|
|
Paresthesia
|
5%
|
7%
|
6%
|
12%
|
|
Respiratory
|
|
Increased cough
|
14%
|
11%
|
14%
|
8%
|
|
Rhinitis
|
18%
|
12%
|
12%
|
10%
|
|
Skin
|
|
Rash event1
|
17%
|
14%
|
30%
|
33%
|
|
1. Rash event includes rash, pruritus, maculopapular
rash, urticaria, vesiculobullous rash, pustular rash, and allergic reaction.
|
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 7 below.
|
Table 7. Treatment-Emergent Grade 3 / 4 Laboratory
Abnormalities Reported in ³ 1% of EMTRIVA-Treated
Patients in Either Study 301A or 303
|
|
Number of Patients Treated
|
303
|
301A
|
|
EMTRIVA + ZDV/d4T + NRTI/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
|
31%
|
28%
|
34%
|
38%
|
|
Grade 4 laboratory abnormality
|
|
ALT (>5.0 x ULN1)
|
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%
|
|
1. ULN=Upper limit of normal
|
DRUG INTERACTIONS
The potential for drug interactions with EMTRIVA has been studied
in combination with indinavir, stavudine, famciclovir, and tenofovir disoproxil
fumarate. There were no clinically significant drug interactions for any of
these drugs (see CLINICAL PHARMACOLOGY,
Drug Interactions).
Fat Redistribution
Redistribution/accumulation of body fat including central obesity,
dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting,
breast enlargement, and "cushingoid appearance" have been observed
in patients receiving antiretroviral therapy. The mechanism and long-term consequences
of these events are unknown. A causal relationship has not been established.
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