Lamzitrio

Rx

Indications

Treatment of HIV-1 infected adults, and for adolescents that are either above 16 years of age or weight at least 50 kg.

Dosage

Adults and adolescents ≥ 16 years of age or weight ≥ 50 kg: 1 tablet twice daily.

Dose adjustment:

• Severe hepatic impairment or impaired renal function (ClCr ≤ 50 ml/min): Should not use.
• Mild to moderate hepatic impairment: Dose adjustments are not necessary.

Usage

Lamzitrio is taken orally with or without food.

Lamzitrio is only used when treatment must be started with lamivudine, zidovudine and nevirapine separately for the first 6 – 8 weeks until the patient is stable on nevirapine 200 mg twice daily.

• Known hypersensitivity to any of the ingredients.
• Patients with severe hepatic impairment.
• Patients with an abnormally low neutrophil counts (< 0.75 x 10⁹/l) or an abnormally low hemoglobin levels (< 7.5 g/dl or 4.65 mmol/l).
• Patients with history of severe rash, rash accompanied by constitutional symptoms or liver toxicity due to nevirapine.

Common

• Anaemia, neutropenia, leucopenia;
• Headache, dizziness, insomnia;
• Nausea, vomiting, abdominal pain and diarrhea;
• Hepatitis, elevated liver enzymes, alkaline phosphatase and bilirubin;
• Rrash (also severe), hair loss;
• Myalgia;
• Allergic reactions, malaise, fatigue.

Should investigate:

• Adverse skin reactions and hepatotoxicity during the first 18 weeks of treatment; extra vigilance is advised during the first 6 weeks of treatment.
• Blood lipids and glucose.
• Liver function tests and markers of HBV replication in patients discontinued Lamzitrio and co-infected with hepatitis B virus.
• Liver transaminases if the patient experiences signs or symptoms suggestive of liver toxicity (e.g. anorexia, nausea, jaundice, bilirubinuria, acholic stools, hepatomegaly or liver tenderness).

Use with caution in:

• Patients with anaemia or bone-marrow suppression.
• Patients with moderate hepatic impairment.
• Patients with hepatomegaly or other known risk factors for liver disease.
• Patients with high CD4+ cell counts (greater than 250 cells/microlitre in women or 400 cells/microlitre in men), as well as patients co-infected with chronic hepatitis B or C are at increased risk of hepatotoxicity.

Treatment should be discontinued in case of:

• Signs/ symptoms or laboratory abnormalities suggestive of pancreatitis occur.
• Develop abdominal pain, nausea, or vomiting or with abnormal biochemical test results until pancreatitis has been excluded.
• A rapid increase in aminotransferase concentrations, progressive hepatomegaly, or metabolic or lactic acidosis of unknown aetiology.
• A severe rash, rash accompanied by constitutional symptoms (such as fever, blistering, oral lesions, conjunctivitis, facial oedema, muscle or joint aches, or general malaise), hypersensitivity reactions, or clinical hepatitis.

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.

Lamzitrio should be used during pregnancy only if the potential benefit justifies the potential risk. HIV infected mothers should be instructed not to breastfeed.

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