Adult Dosing
Primary hyperlipidemia and mixed dyslipidemia
- Start 2 mg PO qd; the starting dose and maintenance doses should be individualized according to patient characteristics (goal of therapy and response). After initiation or upon titration, monitor lipid levels after 4 wks and adjust accordingly
- Dose range: 1-4 mg PO qd; [Max: 4 mg/day]
- If on erythromycin: Do not exceed 1 mg PO qd
- If on rifampin: Do not exceed 2 mg PO qd
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established
[Outline]
Renal Dose Adjustment: (Based on glomerular filtration rate)
- Moderate renal impairment and end-stage renal disease (ESRD) receiving hemodialysis (30 to <60 mL/min/1.73 m2): 1 mg PO qd [Max: 2 mg/day]
- Severe renal impairment not receiving hemodialysis (<30 mL/min/1.73 m2): Avoid use
Hepatic Dose Adjustment
- Active hepatic disease: Contraindicated
See Supplemental Patient Information
- Myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have occurred
- Discontinue therapy if creatine kinase (CK) levels are markedly elevated or if myopathy is suspected/diagnosed
- Temporarily withheld doses in patients with acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g. sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic, endocrine, and electrolyte disorders, or uncontrolled seizures)
- Immune-mediated necrotizing myopathy (IMNM) characterized by proximal muscle weakness and elevated serum creatine kinase has been reported with statin use, and may persist despite discontinuation of statin treatment
- Doses >4 mg once daily were associated with an increased risk for severe myopathy in premarketing clinical studies
- Effect on cardiovascular morbidity and mortality have not been studied
- Avoid using with the protease inhibitor combinations such as lopinavir/ritonavir
- Usage is not determined in Fredrickson Type I, III, and V dyslipidemias
- Transient elevations in LFTs may occur
- Perform LFTs at baseline, before initiation of therapy and at 12 wks following both the initiation of therapy and any elevation of doses, and semiannually thereafter
- Monitor patients with elevated transaminase levels until resolution of abnormalities
- Consider reduction of dose or withdrawal of therapy with persistent increase in alanine aminotranferease (ALT ) or aspartate aminotransferase (AST) >3 times the upper limit of normal
Cautions: Use cautiously in
- Renal impairment
- History of hepatic disease
- Myopathy
- Hypothyroidism
- Concomitant use with fibrates or lipid-modifying doses of niacin
- Alcohol abuse
- Geriatric patients
Supplemental Patient Information
- Advise patients to consult their physician on occurrence of unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever
- Advise women of childbearing age to use an effective method of birth control to prevent pregnancy; also advise them to consult their physician if they have an intention of becoming pregnant
- Advise nursing mothers to avoid use
Pregnancy Category:X
Breastfeeding: Probably unsafe; No relevant literature exists on the use of pitavastatin during breastfeeding. May disrupt infant's lipid metabolism; avoid use during breastfeeding. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACTlast accessed 22 December 2010. Unknown whether excreted in human milk. Another drug in this class is excreted in human milk and exhibits potential to cause serious adverse reactions in nursing infants. Manufacturer advises to discontinue nursing or to discontinue therapy based on the importance of the drug to the mother.
Pricing data from www.DrugStore.com in U.S.A.
- Livalo 1 MG TABS [Bottle] (LILLY)
30 mg = $125.3
90 mg = $356.45 - Livalo 2 MG TABS [Bottle] (LILLY)
30 mg = $124.99
90 mg = $351.99 - Livalo 4 MG TABS [Bottle] (LILLY)
30 mg = $125.3
90 mg = $356.45
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
