The pharmacokinetics of abacavir have been studied in patients with mild hepatic impairment (Child-Pugh score 5-6) receiving a single 600 mg dose. Approved third parties also use these tools in connection with our display of ads.
No additional types of adverse reactions have been observed beyond those characterised for the adult population.Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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At the time of writing the lowest private sector price for dolutegravir listed on the Medicine Price Registry is R705 (US$50) per month. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000).Table 2: Tabulated summary of adverse reactions associated with the combination of dolutegravir + abacavir/lamivudine in an analysis of pooled data from: Phase IIb to Phase IIIb clinical trials or post-marketing experience; and adverse reactions to treatment with dolutegravir, abacavir and lamivudine from clinical studies and post-marketing experience when used with other antiretroviralssuicidal ideation or suicide attempt (particularly in patients with a pre-existing history of depression or psychiatric illness)vomiting, flatulence, abdominal pain, abdominal pain upper, abdominal distension, abdominal discomfort, gastro-oesophageal reflux disease, dyspepsiaBoth abacavir and dolutegravir are associated with a risk for hypersensitivity reactions (HSR), which were observed more commonly with abacavir. No data are available.Triumeq can be taken with or without food (see section 5.2).Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Lamivudine was not significantly metabolised by CYP enzymes. Week 48 outcomes (including outcomes by key baseline covariates) are shown in Table 3.Table 3: Virologic Outcomes of Randomized Treatment of SINGLE at 48 Weeks (Snapshot algorithm)Discontinued study/study drug due to adverse event or death‡ The STRIIVING study (201147), was a randomized, open-label, active-controlled, multicentre, non-inferiority switch study in virologically suppressed subjects with no documented history of resistance to any class.

A moderate amount of data (more than 1200 outcomes from first trimester) indicates no malformative toxicity for abacavir. Population PK analyses using pooled pharmacokinetic data from Phase IIb and Phase III adult trials revealed no clinically relevant effect of gender on the exposure of dolutegravir. It is unknown if all or part of this is due to unabsorbed active substance or biliary excretion of the glucuronidate conjugate, which can be further degraded to form the parent compound in the gut lumen. Following multiple oral doses of abacavir 300 mg twice a day there is no significant accumulation of abacavir. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.No specific symptoms or signs have been identified following acute overdose with dolutegravir, abacavir or lamivudine, apart from those listed as adverse reactions.Further management should be as clinically indicated or as recommended by the national poisons centre, where available.

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