Lamivudine and Zidovudine (Page 2 of 6)

5.8 Lipoatrophy

Treatment with zidovudine, a component of lamivudine and zidovudine, has been associated with loss of subcutaneous fat. The incidence and severity of lipoatrophy are related to cumulative exposure. This fat loss, which is most evident in the face, limbs, and buttocks, may be only partially reversible and improvement may take months to years after switching to a non-zidovudine-containing regimen. Patients should be regularly assessed for signs of lipoatrophy during therapy with zidovudine-containing products, and if feasible, therapy should be switched to an alternative regimen if there is suspicion of lipoatrophy.

6 ADVERSE REACTIONS

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

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

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 adverse reactions and laboratory abnormalities were observed (Tables 1 and 2).

Table 1. Selected Clinical Adverse Reactions (Greater than or Equal to 5% Frequency) in 4 Controlled Clinical Trials with EPIVIR 300 mg per day and RETROVIR 600 mg per day
Adverse Reaction 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 9 of the 2,613 adult subjects (0.3%) who received EPIVIR in controlled clinical trials [see Warnings and Precautions (5.6)].

Selected laboratory abnormalities observed during therapy are listed in Table 2.

Table 2. Frequencies of Selected Laboratory Abnormalities among Adults in 4 Controlled Clinical Trials of EPIVIR 300 mg per day plus RETROVIR 600 mg per day *
ULN = Upper limit of normal. ANC = Absolute neutrophil count. n = Number of subjects assessed.
*
Frequencies of these laboratory abnormalities were higher in subjects with mild laboratory abnormalities at baseline.

Test (Abnormal Level)

EPIVIR plus RETROVIR % (n)

Neutropenia (ANC<750/mm 3)

7.2% (237)

Anemia (Hgb<8.0 g/dL)

2.9% (241)

Thrombocytopenia (platelets<50,000/mm 3)

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)

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