Lamivudine and Zidovudine (Page 2 of 6)

5.7 Immune Reconstitution Syndrome

Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including lamivudine and zidovudine. During the initial phase of combination antiretroviral treatment, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment. Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment.

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.


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 FormulationsIn 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%
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%
Nasal signs & symptoms 20%
Cough 18%
Skin rashes 9%
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 daya
Test(Abnormal Level) EPIVIR plus RETROVIR% (n)
ULN = Upper limit of normal.ANC = Absolute neutrophil count.n = Number of subjects assessed.a Frequencies of these laboratory abnormalities were higher in subjects with mild laboratory abnormalities at baseline.
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)

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