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| __NOTOC__
| | #REDIRECT [[Pitavastatin#Use in Specific Populations]] |
| {{Pitavastatin}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Use In Specific Populations==
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| ===Pregnancy===
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| '''Teratogenic effects: Pregnancy Category X'''
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| LIVALO is contraindicated in women who are or may become pregnant. Serum [[cholesterol]]and TG increase during normal pregnancy, and [[cholesterol]]products are essential for fetal development. [[Atherosclerosis]] is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on long-term outcomes of primary [[hyperlipidemia]] therapy [see Contraindications (4)].
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| There are no adequate and well-controlled studies of LIVALO in pregnant women, although, there have been rare reports of congenital anomalies following intrauterine exposure to [[HMG-CoA]] reductase inhibitors. In a review of about 100 prospectively followed pregnancies in women exposed to other [[HMG-CoA]] reductase inhibitors, the incidences of congenital anomalies, spontaneous abortions, and fetal deaths/stillbirths did not exceed the rate expected in the general population. However, this study was only able to exclude a three-to-four-fold increased risk of congenital anomalies over background incidence. In 89% of these cases, drug treatment started before pregnancy and stopped during the first trimester when pregnancy was identified.
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| Reproductive toxicity studies have shown that pitavastatin crosses the placenta in rats and is found in fetal tissues at ≤36% of maternal plasma concentrations following a single dose of 1 mg/kg/day during gestation.
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| Embryo-fetal developmental studies were conducted in pregnant rats treated with 3, 10, 30 mg/kg/day pitavastatin by oral gavage during organogenesis. No adverse effects were observed at 3 mg/kg/day, systemic exposures 22 times human systemic exposure at 4 mg/day based on AUC.
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| Embryo-fetal developmental studies were conducted in pregnant rabbits treated with 0.1, 0.3, 1 mg/kg/day pitavastatin by oral gavage during the period of fetal organogenesis. Maternal toxicity consisting of reduced body weight and abortion was observed at all doses tested (4 times human systemic exposure at 4 mg/day based on AUC).
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| In perinatal/postnatal studies in pregnant rats given oral gavage doses of pitavastatin at 0.1, 0.3, 1, 3, 10, 30 mg/kg/day from organogenesis through weaning, maternal toxicity consisting of mortality at ≥0.3 mg/kg/day and impaired lactation at all doses contributed to the decreased survival of neonates in all dose groups (0.1 mg/kg/day represents approximately 1 time human systemic exposure at 4 mg/day dose based on AUC).
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| LIVALO may cause fetal harm when administered to a pregnant woman. If the patient becomes pregnant while taking LIVALO, the patient should be apprised of the potential risks to the fetus and the lack of known clinical benefit with continued use during pregnancy.
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| ===Nursing Mothers===
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| It is not known whether pitavastatin is excreted in human milk, however, it has been shown that a small amount of another drug in this class passes into human milk. Rat studies have shown that pitavastatin is excreted into breast milk. Because another drug in this class passes into human milk and [[HMG-CoA]] reductase inhibitors have a potential to cause serious adverse reactions in nursing infants, women who require LIVALO treatment should be advised not to nurse their infants or to discontinue LIVALO [see Contraindications (4)].
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| ===Pediatric Use===
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| Safety and effectiveness of LIVALO in pediatric patients have not been established.
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| ===Geriatric Use===
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| Of the 2,800 patients randomized to LIVALO 1 mg to 4 mg in controlled clinical studies, 1,209 (43%) were 65 years and older. No significant differences in efficacy or safety were observed between elderly patients and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.
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| ===Renal Impairment===
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| Patients with moderate and severe [[renal impairment]] (glomerular filtration rate 30 – 59 mL/min/1.73 m2 and 15 – 29 mL/min/1.73 m2 not receiving hemodialysis, respectively) as well as end-stage renal disease receiving [[hemodialysis]] should receive a starting dose of LIVALO 1 mg once daily and a maximum dose of LIVALO 2 mg once daily [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)].
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| ===Hepatic Impairment===
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| LIVALO is contraindicated in patients with active liver disease which may include unexplained persistent elevations of hepatic transaminase levels.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = LIVALO (PITAVASTATIN CALCIUM) TABLET, FILM COATED [KOWA PHARMACEUTICALS AMERICA, INC. ] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=44dcbf97-99ec-427c-ba50-207e0069d6d2 | publisher = | date = | accessdate = 14 February 2014 }}</ref>
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| ==References==
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| {{Reflist|2}}
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| {{statins}}
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| [[Category:Statins]]
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| [[Category:Quinolines]]
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| [[Category:Diols]]
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| [[Category:Carboxylic acids]]
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| [[Category:Organofluorides]]
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| [[Category:Cyclopropanes]]
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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