Combivir Adverse Reactions

Adverse events have been reported during therapy for HIV disease with lamivudine and zidovudine separately or in combination. With many it is unclear whether they are related to lamivudine, zidovudine, or to the wide range of medicinal products used in the management of HIV disease or are as a result of the underlying disease process. As COMBIVIR contains lamivudine and zidovudine the type and severity of adverse reactions associated with each of the compounds, which are listed as follows may be expected. There is no evidence of added toxicity following concurrent administration of the two compounds.
The following convention has been utilised for the classification of undesirable effects: Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1,000, <1/100), rare (>1/10,000, <1/1,000) very rare (<1/10,000).
Lamivudine: Blood and lymphatic systems disorders: Uncommon: Neutropenia, anaemia, thrombocytopenia. Very rare: Pure red cell aplasia.
Metabolism and nutrition disorders: Common: Hyperlactataemia. Rare: Lactic acidosis (see Precautions).
Nervous system disorders: Common: Headache. Very rare: Paraesthesia. Peripheral neuropathy has been reported although a causal relationship to treatment is uncertain.
Gastrointestinal disorders: Common: Nausea, vomiting, upper abdominal pain, diarrhoea. Rare: Pancreatitis, although a causal relationship to treatment is uncertain. Rises in serum amylase.
Hepatobiliary disorders: Uncommon: Transient rises in liver enzymes (AST, ALT).
Skin and subcutaneous tissue disorders: Common: Rash, alopecia.
Musculoskeletal and connective tissue disorders: Common: Arthralgia, muscle disorders. Rare: Rhabdomyolysis.
General disorders and administration site conditions: Common: Fatigue, malaise, fever.
Zidovudine: Blood and lymphatic system disorders: Common: Anaemia (which may require transfusions), neutropenia and leucopenia.
These occur more frequently at higher dosages (1200-1500 mg/day) and in patients with advanced HIV disease (especially when there is poor bone marrow reserve prior to treatment), and particularly in patients with CD4 cell counts less than 100/mm³. Dosage reduction or cessation of therapy may become necessary (see Precautions). The incidence of neutropenia was also increased in those patients whose neutrophil counts, haemoglobin levels and serum vitamin B₁₂ levels were low at the start of zidovudine therapy. Uncommon: Thrombocytopenia and pancytopenia (with marrow hypoplasia). Rare: Pure red cell aplasia. Very rare: Aplastic anaemia.
Metabolism and nutrition disorders: Common: Hyperlactataemia. Rare: Lactic acidosis (see Precautions), anorexia.
Treatment with zidovudine has been associated with loss of subcutaneous fat (see Precautions).
Psychiatric disorders: Rare: Anxiety and depression.
Nervous system disorders: Very common: Headache. Common: Dizziness. Rare: Insomnia, paraesthesia, somnolence, loss of mental acuity, convulsions.
Cardiac disorders: Rare: Cardiomyopathy.
Respiratory, thoracic and mediastinal disorders: Uncommon: Dyspnoea. Rare: Cough.
Gastrointestinal disorders: Very common: Nausea. Common: Vomiting, abdominal pain, and diarrhoea. Uncommon: Flatulence. Rare: Oral mucosa pigmentation, taste disturbance and dyspepsia. Pancreatitis.
Hepatobiliary disorders: Common: Raised blood levels of liver enzymes and bilirubin. Rare: Liver disorders such as severe hepatomegaly with steatosis.
Skin and subcutaneous tissue disorders: Uncommon: Rash and pruritus. Rare: Nail and skin pigmentation, urticaria and sweating.
Musculoskeletal and connective tissue disorders: Common: Myalgia. Uncommon: Myopathy.
Renal and urinary disorders: Rare: Urinary frequency.
Reproductive system and breast disorders: Rare: Gynaecomastia.
General disorders and administration site conditions: Common: Malaise. Uncommon: Fever, generalised pain and asthenia. Rare: Chills, chest pain and influenza-like syndrome.