KIVEXA [SIN13230P]

Product Info

KIVEXA

[SIN13230P]

Indications

KIVEXA is a combination of two nucleoside analogues (abacavir and lamivudine). It is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and children weighing at least 25 kg.

Additional information on the use of KIVEXA for treatment of HIV-1 infection:

The demonstration of the benefit of the combination abacavir/lamivudine as a once daily regimen in antiretroviral therapy is mainly based on one study performed in primarily asymptomatic treatment-naïve adult patients.

As part of a triple drug regimen, KIVEXA tablets are recommended for use with antiretroviral agents from different pharmacological classes and not with other nucleoside/nucleotide reverse transcriptase inhibitors.

Dosage and Administration

Pharmaceutical Form: Film-coated tablets

Therapy should be initiated by a physician experienced in the management of HIV infection.

KIVEXA should not be administered to patients who weigh less than 25 kg because it is a fixed-dose tablet that cannot be dose reduced. Separate preparations of abacavir (ZIAGEN) and lamivudine (EPIVIR) should be administered to patients weighing less than 25 kg.

KIVEXA can be taken with or without food.

KIVEXA is a fixed-dose tablet and should not be prescribed for patients requiring dosage adjustments, such as those with creatinine clearance less than 30 ml/min or with mild hepatic impairment. Separate preparations of abacavir (ZIAGEN) or lamivudine (EPIVIR) should be administered in cases where discontinuation or dose adjustment is indicated. In these cases, the physician should refer to the individual product information for these medicinal products.

Populations

• Adults and children weighing at least 25 kg

  The recommended dose of KIVEXA in adults and children weighing 25 kg or more is one tablet once daily.

• Children weighing less than 25 kg

  KIVEXA is not recommended for treatment of children weighing less than 25 kg as the necessary dose adjustment cannot be made. Physicians should refer to the individual product information for lamivudine and abacavir.

• Elderly

  The pharmacokinetics of abacavir and lamivudine have not been studied in patients over 65 years of age. When treating elderly patients, consideration needs to be given to the greater frequency of decreased hepatic, renal and cardiac function, concomitant medicinal products or disease.

• Renal impairment

  Whilst no dosage adjustment of abacavir is necessary in patients with renal impairment, a dose reduction of lamivudine is required due to decreased clearance. Therefore KIVEXA is not recommended for use in patients with a creatinine clearance less than 30 ml/min (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Hepatic impairment

  Abacavir is contraindicated in patients with moderate to severe hepatic impairment and dose reduction is required in patients with mild hepatic impairment (Child-Pugh grade A). As dose reduction is not possible with KIVEXA, the separate preparations of ZIAGEN and EPIVIR should be used when this is judged necessary. KIVEXA is contraindicated for patients with moderate and severe hepatic impairment (see Pharmacokinetics – Special Patient Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Contraindications

• KIVEXA is contraindicated in patients with known hypersensitivity to abacavir or lamivudine, or to any of the excipients (see Boxed information on abacavir hypersensitivity reactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• KIVEXA is contraindicated in patients with moderate and severe hepatic impairment.