Lamzidivir

Rx

Indications

Lamzidivir is indicated in antiretroviral combination therapy for the treatment of HIV infection.

Dosage

• Adults and adolescents weighing at least 30 kg: One tablet twice daily.
• Children weighing 21 – 30 kg: One-half tablet taken in the morning and one whole tablet taken in the evening (if gastrointestinal intolerance occurs, one-half tablet taken three times daily can be applied in attempt to improve tolerability).
• Children weighing 14 – 21 kg: One-half tablet taken twice daily.

Lamzidivir should not be prescribed for patients with reduced renal impairment (ClCr ≤ 50 ml/minute), hepatic impairment, haematological adverse reactions or those experiencing dose-limiting adverse events.

Usage

Lamzidivir may be administered with or without food. The tablet(s) should ideally be swallowed without crushing. For patients who are unable to swallow tablets, tablets may be crushed and added to a small amount of semi-solid food or liquid, all of which should be consumed immediately.

• Known hypersensitivity to any ingredient in the formulation.
• Patients with abnormally low neutrophil counts (< 0.75 x 10⁹/l), or abnormally low haemoglobin levels (< 7.5 g/dl).

Very common

• Headache, nausea.

Common

• Headache, insomnia;
• Cough, nasal symptoms;
• Vomiting, abdominal pain or cramps, diarrhea;
• Rash, alopecia;
• Arthralgia, muscle disorders;
• Fatigue, malaise, fever;
• Anaemia, neutropenia and leucopenia;
• Dizziness;
• Vomiting, abdominal pain and diarrhea;
• Raised blood levels of liver enzymes and bilirubin;
• Myalgia.

Should investigate:

• For possible mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally in case of relevant signs or symptoms.
• Blood lipids and glucose.
• Liver function tests and markers of HBV replication. Interruption or discontinuation of treatment must be considered if there is evidence of worsening liver disease in patients discontinued Lamzidivir and co-infected with hepatitis B virus.

Use Lamzidivir with caution in:

• • Patients with poor bone marrow reserve prior to treatment, particularly with advanced HIV disease.
  • Patients with hepatomegaly, hepatitis or other known risk factors for liver disease and hepatic steatosis (including certain medicinal products and alcohol).
  • Patients co-infected with hepatitis C and treated with alpha interferon and ribavirin.

Lamzidivir should be discontinued in case of:

• Signs/ symptoms or laboratory abnormalities suggestive of pancreatitis occur.
• Symptomatic hyperlactatemia and metabolic/lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.

Osteonecrosis: Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.

Immune reactivation syndrome: Inflammatory symptoms should be evaluated and treatment instituted when necessary. Autoimmune disorders (such as Graves’ disease) have also been reported to occur.

Therapy should be switched to an alternative regimen if there is suspicion of lipoatrophy development.

Lamzidivir contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

Lamzidivir should be given cautiously to pregnant women. Mothers infected by HIV do not breastfeed their infants under any circumstances.

Patients should be aware of how they react to drug before driving or operating machinery.