severity. Thirty percent of the patients experienced at least one adverse
drug reaction (at least grade 2 in severity and considered by the
investigator at least possibly related to darunavir co-administered with 100
mg ritonavir). The most frequently (greater than or equal to 2 percent) of
those reported adverse reactions were diarrhoea (3.9 percent),
hypertriglyceridaemia (3.8 percent), rash (2.8 percent), nausea (2.6
percent), hypercholesterolaemia (2.5 percent) and headache (2.0 percent). 2.6
percent of the patients discontinued treatment due to adverse reactions.
Before taking darunavir, patients should tell their doctor if they have
any medical conditions, including liver problems, including hepatitis B or C,
diabetes, symptoms of infections, change in body fat, haemophilia,
musculoskeletal problems, or allergy to sulfa medicines and should tell their
doctor if they are pregnant or planning to become pregnant or planning to
become pregnant, or are nursing.
Darunavir should not be used in patients allergic (hypersensitive) to
darunavir or ritonavir or with severe liver problems.
There were some relevant drug-drug interactions with other medications
commonly used in HIV patient populations, such as other antiretroviral
medications. Patients should talk to their healthcare provider about all the
medicines they are taking or plan to take, including prescription and
non-prescription medicines, vitamins, and herbal supplements.
Darunavir does not cure HIV infection or AIDS, and does not prevent
passing HIV to others.
Please see full Summary of Product Characteristics for more details.
About Tibotec Pharmaceuticals
Tibotec Pharmaceuticals, based in Cork, Ireland, is a pharmaceutical
research and development company, with offices in Yardley, PA, USA and its
main research and development operations in Mechelen, Belgium. Tibotec is
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