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A N N O U N C I N G A T R I P L A

ne
A w e r a

in HIV therapy *

efavirenz600mg/emtricitabine200mg/
tenofovirdisoproxil(asfumarate)245mgTablets
One pill. All HAART

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ribavirin –monitor closely C aution in administering Atripla to patients with mild or moderate liver disease. Patients with pre-existing significantly increased. Avoid in antiretroviral experienced patients with strains harbouring K65R, M184V/I or K103N mutations. advanced HIV disease or long term exposure to CART), lactic acidosis, hepatitis, hepatic failure, completed suicide, psychosis and
liver dysfunction should be monitored; interruption or discontinuation of treatment must be considered if evidence of worsening liver Contains sodium – c onsider in patients on sodium-restricted diet. Interactions: Efavirenz is an inducer of CYP3A4 and an inhibitor of neurosis. Combination antiretroviral therapy has been associated with metabolic abnormalities including hypercholesterolaemia,
disease or persistent elevations of serum transaminases >5 times ULN. HBV Co-infection: Patients with HIV co-infected with either some CYP450 isoenzymes including CYP3A4. Other compounds that are substrates of CYP3A4 may have decreased plasma insulin-resistance and hyperlactataemia as well as lipodystrophy.HIV patients with severe immunodeficiency at the time of initiation
HBV or HCV treated with combination antiretroviral therapy are at increased risk of severe and potentially fatal hepatic adverse concentrationswhenco-administeredwithefavirenz.Efavirenzexposuremayalsobealteredwhengivenwithmedicinalproductsor of CART may experience Immune Reactivation Syndrome. Refer to SPC for further information on adverse events. Overdosage: If
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reactions. Co-infected HIV/HBV patients should be closely monitored for at least four months following discontinuation of Atripla for foods (e.g. grapefruit juice) which affect CYP3A4 activity – s ee contraindications above. Atripla should not be co-administered with overdosage occurs, monitor for evidence of toxicity A pply standard supportive treatment if necessary E mtricitabine and tenofovir,
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symptomsofexacerbationofhepatitis.Psychiatric:Advisepatientstocontacttheirdoctorimmediatelyiftheyexperiencepsychiatric lamivudine, atazanavir/ritonavir or didanosine. Avoid co-administration of Atripla with medicinal products that reduce renal function but not efavirenz, can be removed by haemodialysis. Administration of activated charcoal may be used to aid removal of unabsorbed
symptoms such as severe depression, psychosis or suicidal ideation. Nervous system symptoms such as dizziness, insomnia, or compete for active tubular secretion (e.g. cidofovir). Avoid use of Atripla with concurrent or recent use of nephrotoxic medicinal efavirenz. Pharmaceutical Precautions: No special requirements for use and handling. Store in the original package in order to
somnolence, impaired concentration and abnormal dreams may begin during the first 1 o r 2 d ays of therapy and generally resolve product. Refer to SPC for drug interaction details for protease inhibitors, NRTIs, NNRTIs, antimicrobial and antifungal agents, protect from moisture. Keep the bottle tightly closed. Package Quantities: Bottle of 30 film-coated tablets. Price: 9823,60 NOK.
afterthefirst2-4weeks.Exercisecautioninanypatientwithahistoryofseizures.Renal:Atriplaisnotrecommendedforpatientswith anticonvulsants, antidepressants, cardiovascular agents, lipid-lowering agents, hormonal contraceptives, opioids and herbal Prescription Group: C. Therapy should be initiated by a physician experienced in the management of human immunodeficiency virus
moderate or severe renal impairment. Avoid use if Atripla with concurrent or recent use of nephrotoxic medicinal product. If products. Use in pregnancy and lactation: Atripla should not be used in pregnancy unless clearly necessary B arrier contraception (HIV) infection.
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concomitant use of Atripla with a n ephrotoxic agent is unavoidable, monitor renal function weekly R enal failure and impairment, should always be used in combination with other methods of contraception. Avoid breast-feeding. Side effects: Very commonly Atripla (efavirenz 600mg/emtricitabine 200mg/tenofovir disoproxil (as fumarate) 245mg tablets) is a p rescription only medication.
elevated creatinine, hypophosphataemia and proximal tubulopathy (including Fanconi syndrome) have been reported with use of reported adverse events (≥1/10): dizziness, headache, diarrhoea, nausea, vomiting, elevated creatine kinase, rash (all grades), This text is based on the December 2007 Atripla Summary of Product Characteristics.
tenofovirdisoproxilfumarateinclinicalpractice.ItisrecommendedthatCrCliscalculatedinallpatientspriortotherapyinitiationand hypophosphataemia,abnormaldreams.Commonlyreportedadverseevents(≥1/100,<1/10):neutropenia,stupor,lethargy,disturbance CONSULTTHESUMMARYOFPRODUCTCHARACTERISTICSBEFOREPRESCRIBINGPARTICULARLYINRELATIONTOSIDEEFFECTS,
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renal function monitored every 4 w eeks for the first year and every 3 m onths thereafter I n p atients at risk of renal impairment, of attention, somnolence, dyspepsia, abdominal pain and distension, flatulence, dry mouth, elevated serum lipase, elevated amylase PRECAUTIONS AND CONTRAINDICATIONS.
consideration should be given to more frequent monitoring of renal function. If CrCl is decreased to <50ml/min or serum phosphate is including elevated pancreatic amylase, allergic reaction, pruritus, maculopapular rash, urticaria, vesiculobullous rash, pustular rash, Gilead Sciences, Hemvärnsgatan 9, 17154 Solna, Stockholm, Sweden. Tel: +46(0) 85057 1800.
decreased to <1.5 mg/dl, renal function should be re-evaluated within one week. Treatment with Atripla should be interrupted if CrCl skinhyperpigmentation,dermatitis,decreasedorincreasedappetite,hypertriglyceridaemia,hyperglycaemia,hotflush,fatigue,fever, Bristol-Myers Squibb, Kjørboveien 29, Postboks 244, 1301 Sandvika. Tel: +47 (0) 67 55 53 50.
is confirmed to be <50ml/min. Refer to SPC for further recommendations regarding monitoring, dose adjustment and discontinuation pain, asthenia, hyperbilirubinaemia, increased AST and ALT, anxiety d epression (including severe), suicide ideation, nightmares, Atripla is aregistered trademark.
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oftherapy.Skinreactions:DiscontinueAtriplainpatientswhodevelopsevererashassociatedwithblistering,desquamation,mucosal insomnia, sleep disorder e uphoric mood, vertigo. Uncommonly reported adverse events (≥1/1,000, <1/100): Stevens-Johnson Date of API Preparation: April 2008.
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involvement or fever.Lipodystrophy and metabolic: Combination antiretroviral therapy has been associated with lipodystrophy in HIV syndrome and erythema multiforme. Refer to SPC for full list. Adverse events of unknown frequency: pancreatitis, renal failure (acute Date of preparation: April 2008.
patients.Considermonitoringfastingserumlipidsandbloodglucoseandmanagelipiddisordersasappropriate.Other:Administration and chronic), acute tubular necrosis, proximal tubulopathy including Fanconi syndrome, nephritis (including acute interstitial
of Atripla with food may increase efavirenz exposure. Mitochondrial dysfunction. Immune Reactivation Syndrome. Osteonecrosis. nephritis), nephrogenic diabetes insipidus, increased creatinine, proteinuria, photoallergic dermatitis, myopathy and osteomalacia
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Decreased bone mineral density C o-administration of Atripla and didanosine is not recommended as exposure to didanosine is (both associated with proximal renal tubulopathy), osteonecrosis (particularly in patients with generally acknowledged risk factors, Please refer to the full SPC before prescribing. ATR-NO-0804-2