Kivexa

Kivexa

abacavir + lamivudine

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
Concise Prescribing Info
Contents
Abacavir sulfate 600 mg, lamivudine 300 mg
Indications/Uses
Combination antiretroviral therapy (CART) for the treatment of HIV infection in adults, adolescents & childn ≥25 kg.
Dosage/Direction for Use
Administration
May be taken with or without food.
Contraindications
Special Precautions
Residual risk of HIV transmission. High risk for abacavir hypersensitivity reactions (HSR) in patients who test +ve for HLA-B*5701 allele. Do not initiate treatment in patients w/ +ve HLA-B*5701 status, nor in patients w/ -ve HLA-B*5701 status who had suspected abacavir HSR on previous abacavir-containing regimen. Discontinue treatment if HSR is suspected. Increase in wt & blood lipid & glucose levels may occur. Reports of pancreatitis. Reports of virological failure & emergence of resistance at an early stage when combined w/ tenofovir disoproxil fumarate as a once daily regimen. Increased frequency of liver function abnormalities in patients w/ pre-existing liver dysfunction, including chronic active hepatitis. Consider interruption or discontinuation of treatment if there is evidence of worsening liver disease. Increased risk of severe & potentially fatal hepatic adverse reactions in HIV patients co-infected w/ chronic HBV or HCV. Periodic monitoring of both LFTs & markers of HBV replication is recommended if discontinuing treatment in patients co-infected w/ HBV. Reports of mitochondrial dysfunction in HIV -ve infants following exposure in utero &/or postnatally to nucleoside analogues. Risk of immune reactivation syndrome. Reports of osteonecrosis, particularly in patients w/ advanced HIV disease &/or long-term exposure to CART. Opportunistic infections & other HIV complications may still develop. Observational studies have shown an association between MI & abacavir use. Do not take w/ any other medicinal products containing lamivudine or emtricitabine. Combination of lamivudine w/ cladribine is not recommended. Contains azo colouring agent (sunset yellow). Not recommended in patients w/ CrCl <50 mL/min, & moderate or severe hepatic impairment. Pregnancy. HIV-infected women should not breast-feed to avoid HIV transmission. Elderly >65 yr. Do not administer to childn <25 kg.
Adverse Reactions
Headache; nausea, vomiting, diarrhoea; fatigue, fever. Abacavir: Hypersensitivity; anorexia; rash (w/o systemic symptoms); lethargy. Lamivudine: Insomnia; cough, nasal symptoms; abdominal pain/cramps; rash, alopecia; arthralgia, muscle disorders; malaise.
Drug Interactions
Abacavir: Altered exposure w/ UGT inducers/inhibitors or w/ compd eliminated through alcohol dehydrogenase. Riociguat dose may need to be reduced. Lamivudine: Increased exposure w/ OCT inhibitors. Do not co-administer w/ other cytidine analogues eg, emtricitabine. Increased AUC w/ co-trimoxazole. Potential risk of cladribine loss of efficacy. Occasionally methadone re-titration may be required. Decreased AUC & Cmax w/ sorbitol soln (3.2 g, 10.2 g, 13.4 g).
MIMS Class
Antivirals
ATC Classification
J05AR02 - lamivudine and abacavir ; Belongs to the class of antivirals for treatment of HIV infections, combinations.
Presentation/Packing
Form
Kivexa FC tab
Packing/Price
30's
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