2010 Annual Scientific Meeting and Exposition 2010 Annual ...

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As with other drugs that block angiotensin II or its effects, concomitant use ofpotassium sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassiumsupplements, or salt substitutes containing potassium may lead to increasesin serum potassium and in heart failure patients to increases in serum creatinine.8 USE IN SPECIFIC POPULATIONS8.1 PregnancyPregnancy Category D [see Warnings and Precautions (5.1)].Valturna contains both aliskiren (a direct renin inhibitor) and valsartan (an angiotensinII receptor blocker). When administered during the second or third trimesterof pregnancy, drugs that act directly on the renin-angiotensin-aldosterone systemcan cause fetal and neonatal morbidity and death. Valturna can cause fetalharm when administered to a pregnant woman. If this drug is used during pregnancy,or if the patient becomes pregnant while taking this drug, apprise thepatient of the potential hazard to the fetus.Angiotensin II receptor antagonists, like valsartan, and angiotensin-convertingenzyme (ACE) inhibitors exert similar effects on the renin-angiotensin-aldosteronesystem. In several dozen published cases, ACE inhibitor use during the secondand third trimesters of pregnancy was associated with fetal and neonatal injury,including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversiblerenal failure, and death. Oligohydramnios was also reported, presumably fromdecreased fetal renal function. In this setting, oligohydramnios was associatedwith fetal limb contractures, craniofacial deformation, and hypoplastic lungdevelopment. Prematurity, intrauterine growth retardation, and patent ductusarteriosus were also reported, although it is not clear whether these occurrenceswere due to exposure to the drug. In addition, first trimester use of ACE inhibitors,a specific class of drugs acting on the renin-angiotensin-aldosterone system,has been associated with a potential risk of birth defects in retrospective data.When pregnancy occurs in a patient using Valturna, discontinue Valturna treatmentas soon as possible. Inform the patient about potential risks to the fetusbased on the time of gestational exposure to Valturna (first trimester only orlater). If exposure occurs beyond the first trimester, perform an ultrasoundexamination.In rare cases when another antihypertensive agent cannot be used to treat thepregnant patient, perform serial ultrasound examinations to assess the intraamnioticenvironment. Routine fetal testing with non-stress tests, biophysicalprofiles, and/or contraction stress tests may be appropriate based on gestationalage and standards of care in the community. If oligohydramnios occurs in thesesituations, individualized decisions about continuing or discontinuing Valturnatreatment and about pregnancy management should be made by the patient, herphysician, and experts in the management of high risk pregnancy. Patients andphysicians should be aware that oligohydramnios may not appear until after thefetus has sustained irreversible injury.Closely observe infants with histories of in utero exposure to Valturna for hypotension,oliguria, and hyperkalemia. If oliguria occurs, these infants may requireblood pressure and renal perfusion support. Exchange transfusion or dialysismay be required to reverse hypotension or support decreased renal function.No reproductive toxicity studies have been conducted with the combination ofaliskiren and valsartan. However, these studies have been conducted foraliskiren as well as valsartan alone [see Nonclinical Toxicology (13) in the fullprescribing information].8.3 Nursing MothersIt is not known whether aliskiren is excreted in human milk, but aliskiren wassecreted in the milk of lactating rats. It is not known whether valsartan is excretedin human milk. Valsartan was excreted into the milk of lactating rats; however,animal breast milk drug levels may not accurately reflect human breast milk levels.Because of the potential for adverse effects on the nursing infant, a decisionshould be made whether to discontinue nursing or discontinue the drug, takinginto account the importance of the drug to the mother.8.4 Pediatric UseSafety and effectiveness of Valturna in pediatric patients have not been established.
8.5 Geriatric UseIn 8.5the Geriatric short-term Usecontrolled clinical trials of Valturna, 99 (15.9%) patientstreated In the short-term with Valturna controlled were ≥65 clinical yearstrials andof 14 Valturna, (2.2%) were 99 (15.9%) ≥75 years. patientstreated with Valturna were ≥65 years and 14 (2.2%) were ≥75 years.No overall differences in safety or effectiveness were observed between thesesubjects No overall and differences younger subjects, in safety or andeffectiveness other reported were clinical observed experience between has these notidentified subjects and differences youngerinsubjects, responses andbetween other reported the elderly clinical and younger experience patients, has not butgreater identified sensitivity differences of some in responses older individuals between the cannot elderly beand ruled younger out. patients, butgreater sensitivity of some older individuals cannot be ruled out.10 OVERDOSAGE10 Aliskiren OVERDOSAGELimited Aliskirendata are available related to overdosage in humans. The most likelyLimited manifestation data are of available overdosage related would to be overdosage hypotension. in humans. If symptomatic The most hypotension likelymanifestation occurs, provide ofsupportive overdosagetreatment.would be hypotension. If symptomatic hypotensionoccurs, provide supportive treatment.ValsartanLimited Valsartan data are available related to overdosage in humans. The most likely effectLimited of overdose datawith are available valsartanrelated wouldtobeoverdosage hypotension inand humans. tachycardia; The most bradycardia likely effectof could overdose occur with fromvalsartan parasympathetic would be(vagal) hypotension stimulation. and tachycardia; Depressed level bradycardia of consciousness,occur from circulatory parasympathetic collapse and(vagal) shockstimulation. have been reported. Depressed If symptomatic level of con-couldsciousness, hypotensioncirculatory occurs, provide collapse supportive and shock treatment. have been reported. If symptomatichypotension occurs, provide supportive treatment.Valsartan is not removed from the plasma by hemodialysis.Valsartan is not removed from the plasma by hemodialysis.Valsartan was without grossly observable adverse effects at single oral doses upValsartan to 2000 mg/kg was without in rats and grossly up toobservable 1000 mg/kg adverse in marmosets, effects at except single oral for the doses sali-uvation2000and mg/kg diarrhea in rats in and the rat upand to 1000 vomiting mg/kg in in themarmosets, at except the highest for the dose sali-tovation (60 and and 31diarrhea times, respectively, in the rat and thevomiting maximum in the recommended marmoset at human the highest dose on dose(60 mg/mand 2 basis). 31 times, (Calculations respectively, assume the maximum an oral dose recommended of 320 mg/day human anddose 60-kg on apatient.) mg/m 2 basis). (Calculations assume an oral dose of 320 mg/day and a 60-kgpatient.)16 STORAGE16 Store STORAGE at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) in original container.Store at [See 25°C USP (77°F); Controlled excursions Roompermitted Temperature.] to 15-30°C (59-86°F) in original container.[See USP Controlled Room Temperature.]Protect from moisture.Protect from moisture.Dispense in tight container (USP).Dispense in tight container (USP).REV: FEBRUARY 2010 T2010-12REV: FEBRUARY 2010 T2010-12Manufactured by:Novartis Manufactured Pharma by: Stein AGStein, Novartis Switzerland Pharma Stein AGStein, SwitzerlandDistributed by:Novartis Distributed Pharmaceuticals by: CorporationEast Novartis Hanover, Pharmaceuticals New JerseyCorporation07936East Hanover, New Jersey 07936©Novartis©Novartis
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American Society of Hypertension201
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Valturna offers bothsuperior BP eff
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Figure 2: Probability of Achieving
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potential for other drugs acting on
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aliskiren arms were about one-third
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American Society of Hypertension201
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Program Color KeyThe pages of this
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General InformationThis program boo
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General Information continuedHilton
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2010 ASH Corporate MembersBoehringe
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ASH Leadership2009-2010 Board of Di
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Special LectureMonday, May 3, 2010,
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Special LectureMonday, May 3, 2010,
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Visit TEKTURNA at Booth 1100.and/or
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5.5 HyperkalemiaIncreases in serum
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with Pgp substrates or weak to mode
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ASH Program at a GlanceSaturday, Ma
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Poster Category PresentationPosters
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2010 ASH Faculty continuedJeffrey R
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2010American Societyof Hypertension
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Page 175 and 176: 5.5 HyperkalemiaIncreases in serum
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Page 181 and 182: 4 CONTRAINDICATIONSNone.5 WARNINGS
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Page 201 and 202: Author IndexAAbaunza, Ricardo, 122A
Page 203 and 204: Author IndexCastellano, Maurizio, 1
Page 205 and 206: Author IndexGuarneri, Marco, 146Guo
Page 207 and 208: Author IndexLekakis, John, 118, 122
Page 209 and 210: Author IndexPittaras, Andreas, 149P
Page 211 and 212: Author IndexTello, Susana, 109, 135
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