United States - English - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - tolvaptan (unii: 21g72t1950) (tolvaptan - unii:21g72t1950) - tolvaptan tablets are indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 meq/l or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and syndrome of inappropriate antidiuretic hormone (siadh). limitations of use: patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan tablets. it has not been established that raising serum sodium with tolvaptan tablets provide a symptomatic benefit to patients. tolvaptan tablets are contraindicated in the following conditions: • patients with autosomal dominant polycystic kidney disease (adpkd) outside of fda-approved rems [see warnings and precautions ( 5.2)] • unable to sense or respond to thirst • hypovolemic hyponatremia

United States - English - NLM (National Library of Medicine)

ascend laboratories, llc - tolvaptan (unii: 21g72t1950) (tolvaptan - unii:21g72t1950) - tolvaptan tablets are indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 meq/l or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and syndrome of inappropriate antidiuretic hormone (siadh). limitations of use patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan tablets. it has not been established that raising serum sodium with tolvaptan tablets provides a symptomatic benefit to patients. tolvaptan is contraindicated in the following conditions: - patients with autosomal dominant polycystic kidney disease (adpkd) outside of fda-approved rems [see warnings and precautions (5.2)] - unable to sense or respond to thirst - hypovolemic hyponatremia - taking strong cyp3a inhibitors [see warnings and precautions (5.5)] - anuria - hypersensitivity (e.g., anaphylactic shock

United States - English - NLM (National Library of Medicine)

apotex corp. - tolvaptan (unii: 21g72t1950) (tolvaptan - unii:21g72t1950) - tolvaptan tablets are indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 meq/l or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and syndrome of inappropriate antidiuretic hormone (siadh). patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan tablets. it has not been established that raising serum sodium with tolvaptan tablets provides a symptomatic benefit to patients. tolvaptan tablets are contraindicated in the following conditions: - patients with autosomal dominant polycystic kidney disease (adpkd) outside of fda-approved rems [see warnings and precautions (5.2)] - unable to sense or respond to thirst - hypovolemic hyponatremia - taking strong cyp3a inhibitors [see warnings and precautions (5.5)] - anuria - hypersensitivity (e.g., anaphylactic shock, rash gen

United States - English - NLM (National Library of Medicine)

par pharmaceutical, inc. - tolvaptan (unii: 21g72t1950) (tolvaptan - unii:21g72t1950) - tolvaptan tablets are indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 meq/l or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and syndrome of inappropriate antidiuretic hormone (siadh). limitations of use : patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan tablets. it has not been established that raising serum sodium with tolvaptan tablets provides a symptomatic benefit to patients. tolvaptan tablets are contraindicated in the following conditions: - patients with autosomal dominant polycystic kidney disease (adpkd) outside of fda-approved rems [see warnings and precautions (5.2) ] - unable to sense or respond to thirst - hypovolemic hyponatremia - taking strong cyp3a inhibitors [see warnings and precautions (5.5) ] - anuria - hypersensitivity (e.g., anap

United States - English - NLM (National Library of Medicine)

apotex corp. - tolvaptan (unii: 21g72t1950) (tolvaptan - unii:21g72t1950) - tolvaptan is indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 meq/l or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and syndrome of inappropriate antidiuretic hormone (siadh). limitations of use patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan. it has not been established that raising serum sodium with tolvaptan provides a symptomatic benefit to patients. tolvaptan is contraindicated in the following conditions: - patients with autosomal dominant polycystic kidney disease (adpkd) outside of fda-approved rems [see warnings and precautions (5.2)] - unable to sense or respond to thirst - hypovolemic hyponatremia - taking strong cyp3a inhibitors [see warnings and precautions (5.5)] - anuria - hypersensitivity (e.g., anaphylactic shock, rash generalized) to tolvaptan or any components of the product [see adverse reactions (6)] risk summary available data with tolvaptan tablet use in pregnant women are insufficient to determine if there is a drug-associated risk of adverse developmental outcomes. tolvaptan did not cause any developmental toxicity in rats or in rabbits at exposures approximately 2.8 and 0.8 times, respectively, the exposure in congestive heart failure (chf) patients at the maximum recommended human dose (mrhd) of 60 mg once daily. however, effects on embryo-fetal development occurred in both species at doses causing significant maternally toxic doses. in rats, reduced fetal weights and delayed fetal ossification occurred at 11 times the exposure in chf patients, based on auc. in rabbits, increased abortions, embryo-fetal death, fetal microphthalmia, open eyelids, cleft palate, brachymelia and skeletal malformations occurred at approximately 1.6 times the exposure in chf patients (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage in the u.s. general population is 2 to 4% and 15 to 20% of clinically recognized pregnancies, respectively. data animal data oral administration of tolvaptan during the period of organogenesis in sprague-dawley rats produced no evidence of teratogenesis at doses up to 100 mg/kg/day. delayed ossification was seen at 1000 mg/kg, which is approximately 11 times the exposure in chf patients at the mrhd of 60 mg (auc24h  10271 ng*h/ml). the fetal effects are likely secondary to maternal toxicity (decreased food intake and low body weights). in a prenatal and postnatal study in rats, tolvaptan had no effect on physical development, reflex function, learning ability or reproductive performance at doses up to 1,000 mg/kg/day (11 times the exposure in chf patients at the mrhd of 60 mg). in rabbits, teratogenicity (microphthalmia, embryo-fetal mortality, cleft palate, brachymelia and skeletal malformations) was observed in rabbits at 1,000 mg/kg (approximately 1.6 times the exposure in chf patients at the mrhd of 60 mg dose). this dose also caused maternal toxicity (lower body weight gains and food consumption). risk summary there are no data on the presence of tolvaptan or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. tolvaptan is present in rat milk (see data). when a drug is present in animal milk, it is possible that the drug will be present in human milk, but relative levels may vary (see data ). because of the potential for serious adverse reactions, including electrolyte abnormalities (e.g., hypernatremia), hypotension, and volume depletion in breastfed infants, advise women not to breastfeed during treatment with tolvaptan tablets. data in lactating rats administered radiolabeled tolvaptan, lacteal radioactivity concentrations reached the highest level at 8 hours after administration and then decreased gradually with time with a half-life of 27.3 hours. the level of activity in milk ranged from 1.5- to 15.8-fold those in maternal blood over a period of 72 hours post-dose. increased perinatal death and decreased body weight of the offspring were observed during the lactation period and after weaning at approximately 11 times the exposure in chf patients at the mrhd of 60 mg. safety and effectiveness of tolvaptan in pediatric patients have not been established. of the total number of hyponatremic subjects treated with tolvaptan in clinical studies, 42% were 65 years old and over, while 19% were 75 years old and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. increasing age has no effect on tolvaptan plasma concentrations. moderate and severe hepatic impairment do not affect exposure to tolvaptan to a clinically relevant extent. avoid use of tolvaptan in patients with underlying liver disease. no dose adjustment is necessary based on renal function. there are no clinical trial data in patients with crcl <10 ml/min, and, because drug effects on serum sodium levels are likely lost at very low levels of renal function, use in patients with a crcl <10 ml/min is not recommended. no benefit can be expected in patients who are anuric [see contraindications (4) and clinical pharmacology (12.3)].

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - tolvaptan - inappropriate adh syndrome - diuretics, - tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (siadh).

United States - English - NLM (National Library of Medicine)

otsuka america pharmaceutical, inc. - tolvaptan (unii: 21g72t1950) (tolvaptan - unii:21g72t1950) - tolvaptan 15 mg - samsca® is indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 meq/l or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and syndrome of inappropriate antidiuretic hormone (siadh). limitations of use patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with samsca. it has not been established that raising serum sodium with samsca provides a symptomatic benefit to patients. samsca is contraindicated in the following conditions: - patients with autosomal dominant polycystic kidney disease (adpkd) outside of fda-approved rems [see warnings and precautions (5.2)] - unable to sense or respond to thirst - hypovolemic hyponatremia - taking strong cyp3a inhibitors [see warnings and precautions (5.5)] - anuria - hypersensitivity (e.g., anaphylactic shock, rash generalized) to tolvaptan or

United States - English - NLM (National Library of Medicine)

otsuka america pharmaceutical, inc. - tolvaptan (unii: 21g72t1950) (tolvaptan - unii:21g72t1950) - jynarque is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (adpkd). jynarque is contraindicated in patients: - with a history, signs or symptoms of significant liver impairment or injury. this contraindication does not apply to uncomplicated polycystic liver disease [see warnings and precautions (5.1)] - taking strong cyp 3a inhibitors - with uncorrected abnormal blood sodium concentrations [see warnings and precautions (5.3)] - unable to sense or respond to thirst [see warnings and precautions (5.3)] - hypovolemia [see warnings and precautions (5.3)] - hypersensitivity (e.g., anaphylaxis, rash) to tolvaptan or any component of the product [see adverse reactions (6)] - uncorrected urinary outflow obstruction - anuria risk summary available data with jynarque use in pregnant women are insufficient to determine if there is a drug associated risk of adverse developmental outcomes. in embryo-fetal development studies, pregnant rats a

Australia - English - Department of Health (Therapeutic Goods Administration)

otsuka australia pharmaceutical pty ltd - tolvaptan, quantity: 90 mg - tablet - excipient ingredients: hyprolose; lactose monohydrate; maize starch; microcrystalline cellulose; indigo carmine aluminium lake; magnesium stearate - jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (adpkd) in adults with chronic kidney disease (ckd) stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease (see pharmacology).

Australia - English - Department of Health (Therapeutic Goods Administration)

otsuka australia pharmaceutical pty ltd - tolvaptan, quantity: 60 mg - tablet - excipient ingredients: hyprolose; lactose monohydrate; maize starch; microcrystalline cellulose; indigo carmine aluminium lake; magnesium stearate - jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (adpkd) in adults with chronic kidney disease (ckd) stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease (see pharmacology).