ADVERSE REACTIONS
Lamivudine Plus Zidovudine Administered As Separate Formulations
In 4 randomized, controlled trials of EPIVIR 300 mg per day plus RETROVIR 600 mg per day, the following selected clinical and laboratory adverse events were observed (see Tables 4 and 5).
Table 4. Selected Clinical Adverse Events (≥5% Frequency) in 4 Controlled Clinical Trials With EPIVIR 300 mg/day and RETROVIR 600 mg/day |
Adverse Event
|
EPIVIR plus RETROVIR
(n = 251)
|
|
Body as a whole
| |
|
Headache
|
35%
|
|
Malaise & fatigue
|
27%
|
|
Fever or chills
|
10%
|
|
Digestive
| |
|
Nausea
|
33%
|
|
Diarrhea
|
18%
|
|
Nausea & vomiting
|
13%
|
|
Anorexia and/or decreased appetite
|
10%
|
|
Abdominal pain
|
9%
|
|
Abdominal cramps
|
6%
|
|
Dyspepsia
|
5%
|
|
Nervous system
| |
|
Neuropathy
|
12%
|
|
Insomnia & other sleep disorders
|
11%
|
|
Dizziness
|
10%
|
|
Depressive disorders
|
9%
|
|
Respiratory
| |
|
Nasal signs & symptoms
|
20%
|
|
Cough
|
18%
|
|
Skin
| |
|
Skin rashes
|
9%
|
|
Musculoskeletal
| |
|
Musculoskeletal pain
|
12%
|
|
Myalgia
|
8%
|
|
Arthralgia
|
5%
|
Pancreatitis was observed in 3 of the 656 adult patients (<0.5%) who received EPIVIR in controlled clinical trials.
Selected laboratory abnormalities observed during therapy are listed in Table 5.
|
Test
(Abnormal Level)
|
EPIVIR plus RETROVIR
% (n)
|
|
Neutropenia (ANC<750/mm3)
|
7.2% (237)
|
|
Anemia (Hgb<8.0 g/dL)
|
2.9% (241)
|
|
Thrombocytopenia (platelets<50,000/mm3)
|
0.4% (240)
|
|
ALT (>5.0 x ULN)
|
3.7% (241)
|
|
AST (>5.0 x ULN)
|
1.7% (241)
|
|
Bilirubin (>2.5 x ULN)
|
0.8% (241)
|
|
Amylase (>2.0 x ULN)
|
4.2% (72)
|
ULN = Upper limit of normal.
ANC = Absolute neutrophil count.
n = Number of patients assessed.
* Frequencies of these laboratory abnormalities were higher in patients with mild laboratory abnormalities at baseline.
Observed During Clinical Practice
In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of EPIVIR, RETROVIR, and/or COMBIVIR. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to EPIVIR, RETROVIR, and/or COMBIVIR.
Body as a Whole
Redistribution/accumulation of body fat (see PRECAUTIONS: Fat Redistribution).
Cardiovascular
Cardiomyopathy.
Endocrine and Metabolic
Gynecomastia, hyperglycemia.
Gastrointestinal
Oral mucosal pigmentation, stomatitis.
General
Vasculitis, weakness.
Hemic and Lymphatic
Anemia, (including pure red cell aplasia and severe anemias progressing on therapy), lymphadenopathy, splenomegaly.
Hepatic and Pancreatic
Lactic acidosis and hepatic steatosis, pancreatitis, posttreatment exacerbation of hepatitis B (see WARNINGS).
Hypersensitivity
Sensitization reactions (including anaphylaxis), urticaria.
Musculoskeletal
Muscle weakness, CPK elevation, rhabdomyolysis.
Nervous
Paresthesia, peripheral neuropathy, seizures.
Respiratory
Abnormal breath sounds/wheezing.
Skin
Alopecia, erythema multiforme, Stevens-Johnson syndrome.
|
