Classes
DEA Class; Rx
Common Brand Names; Livalo, Zypitamag
- Lipid-Lowering Agents, Statins;
- HMG-CoA Reductase Inhibitors
Description
HMG-CoA reductase inhibitor, inhibits rate-limiting step in cholesterol biosynthesis by competitively inhibiting HMG-CoA reductase
Indications
To reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C)
Indicated for heterozygous familial hypercholesterolemia (HeFH) to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B (Apo B) in children aged ≥8 years
Contraindications
Hypersensitivity to drug or excipients
Active liver disease or persistent unexplained elevations of hepatic transaminases
Concurrent use with cyclosporine
Adverse Effects
Back pain (1.4-3.9%)
Constipation (1.5-3.6%)
Diarrhea (1.5-2.6%)
Myalgia (1.9-3.1%)
Pain in extremity (0.6-2.3%)
Gastrointestinal disorders: Abdominal discomfort, abdominal pain, dyspepsia, nausea
General disorders: Asthenia, fatigue, malaise, dizziness
Hepatobiliary disorders: Hepatitis, jaundice, fatal and nonfatal hepatic failure
Immune system disorders: Immune-mediated necrotizing myopathy-associated with statin use; angioedema
Metabolism and nutrition disorders: Increases in HbA1c, fasting serum glucose levels
Musculoskeletal and connective tissue disorders: Muscle spasms, myopathy, rhabdomyolysis
Nervous system disorders: Hypoesthesia, peripheral neuropathy
Psychiatric disorders: Insomnia, depression; rare reports of cognitive impairment (eg, memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use; cognitive impairment was generally nonserious, and reversible upon discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks)
Reproductive system and breast disorders: Erectile dysfunction
Respiratory, thoracic and mediastinal disorders: Interstitial lung disease
Skin and subcutaneous tissue disorders: Lichen planus
Warnings
Increased HbA1c and fasting serum glucose levels reported with statins; optimize lifestyle measures, including regular exercise, maintaining healthy body weight, and making healthy food choices
Pregnancy and Lactation
Owing to HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, fetal harm may occur when administered to pregnant females
There is no available information about prescence of pitavastatin in human or animal milk, effects of drug on breastfed infant, or on milk production
Maximum Dosage
Primary Hyperlipidemia and Mixed Dyslipidemia Adjunct to Diet
To reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C)
Recommended starting dose: 2 mg PO qDay
May increase to 4 mg PO qDay if necessary
Pediatric
Heterozygous Familial Hypercholesterolemia
Livalo only
Indicated for heterozygous familial hypercholesterolemia (HeFH) to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B (Apo B) in children aged ≥8 years
<8 years: Safety and efficacy not established
≥8 years
- Recommended starting dose: 2 mg PO qDay
- May increase to 4 mg PO qDay if necessary
How supplied
Livalo is the calcium salt of pitavastatin
Zypitamag is the magnesium salt of pitavastatin
tablet
- 1mg
- 2mg
- 4mg
