Pitavastatin

What is Pitavastatin?

• Pitavastatin (Livalo) is a HMG-CoA reductase inhibitor used as blood cholesterol lowering medication.

Pitavastatin

Pitavastatin ball and spoke

What are the uses of this medicine?

Pitavastatin (Livalo) is indicated as an adjunctive therapy to diet in:

• Adult patients with primary hyperlipidemia or mixed dyslipidemia 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).
• Pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated TC, LDL-C, and Apo B.

Limitations of Use:

• The effect of Livalo on cardiovascular morbidity and mortality has not been determined.

How does this medicine work?

• Pitavastatin (pi ta" va stat' in) is a potent, orally available inhibitor of hepatic 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase the major rate limiting enzyme in cholesterol synthesis.
• Like other members of its class (the “statins”), pitavastatin lowers total serum cholesterol and low density lipoprotein (LDL) concentrations, thereby reducing the risk of atherosclerosis and its complications – myocardial infarction and stroke.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Known hypersensitivity to pitavastatin or any inactive ingredient in Livalo.
• use of cyclosporine
• Active liver disease including unexplained persistent elevations of hepatic transaminase levels
• Pregnancy
• Lactation

What drug interactions can this medicine cause?

• Cyclosporine significantly increases pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis. Concomitant use of cyclosporine with Livalo is contraindicated.
• The risk of myopathy and rhabdomyolysis is increased with concomitant use of gemfibrozil with statins, including Livalo. Avoid concomitant use of gemfibrozil with Livalo.
• In patients taking erythromycin, do not exceed Livalo 1 mg once daily.
• In patients taking rifampin, do not exceed Livalo 2 mg once daily.
• The risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with statins, including Livalo.
• The risk of myopathy and rhabdomyolysis may be increased with concomitant use of lipid-modifying doses (≥1 g/day) of niacin with Livalo.
• Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with statins, including Livalo. Consider the risk/benefit of concomitant use of colchicine with Livalo.

Is this medicine FDA approved?

• Pitavastatin was approved for use in the United States in 2009 but experience with its use is limited.

How should this medicine be used?

Recommended dosage: Recommended Dosage for Adults and Pediatric Patients Aged 8 Years and Older:

• The recommended starting Livalo dosage is 2 mg once daily.
• The maximum recommended dosage is Livalo 4 mg once daily.

Recommended Dosage in Patients with Renal Impairment:

• The recommended staring dosage for adults with moderate and severe renal impairment (estimated glomerular filtration rate 30-59 and 15-29 mL/min/1.73 m2, respectively) as well as end-stage renal disease on hemodialysis is Livalo 1 mg once daily and the maximum dose is 2 mg once daily.

There are Livalo dosage adjustments due to drug interactions for:

• Patients taking erythromycin, do not exceed 1 mg once daily.
• Patients taking rifampin, do not exceed 2 mg once daily.

Administration:

• Take Livalo orally once daily with or without food at the same time each day.
• Individualize the dose of Livalo according to patient characteristics, goal of therapy, and response.
• After initiation or upon titration of Livalo, analyze lipid levels after 4 weeks and adjust the dosage accordingly.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 1 mg, 2 mg, and 4 mg

This medicine is available in fallowing brand namesː

• Livalo

What side effects can this medication cause?

The most common side effects of this medicine include:

• myalgia
• back pain
• diarrhea
• constipation
• pain in extremity

What special precautions should I follow?

• Livalo may cause myopathy (muscle pain, tenderness, or weakness with creatine kinase (CK) above ten times the upper limit of normal) and rhabdomyolysis (with or without acute renal failure secondary to myoglobinuria). Risk factors include age 65 and greater, renal impairment, inadequately treated hypothyroidism, and higher doses of Livalo. Discontinue Livalo if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue Livalo in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis, e.g., sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the Livalo dosage. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever
• There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant inflammation; and improvement with immunosuppressive agents.
• Increases in serum transaminases can occur. Rare postmarketing reports of fatal and non-fatal hepatic failure have occurred. Consider liver enzyme testing before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue Livalo.
• Increases in HbA1c and fasting serum glucose levels have been reported with statins, including Livalo. Optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Livalo is contraindicated for use in pregnant women since safety in pregnant women has not been established.

Can this medicine be used in children?

• The safety and effectiveness of Livalo as an adjunctive therapy to diet to reduce elevated TC, LDL-C, and Apo B in pediatric patients aged 8 years and older with HeFH have been established.
• The safety and effectiveness of Livalo have not been established in pediatric patients younger than 8 years of age with HeFH or in pediatric patients with other types of hyperlipidemia (other than HeFH).

What are the active and inactive ingredients in this medicine?

Active ingredient:

• pitavastatin calcium

Inactive ingredients:

• lactose monohydrate
• hydroxypropyl cellulose, low substituted
• hypromellose, unspecified
• magnesium aluminometasilicate type i-b
• magnesium stearate
• titanium dioxide
• triethyl citrate
• silicon dioxide

Who manufactures and distributes this medicine?

Manufactured for:

• Kowa Company, Limited Tokyo Japan

Manufactured by:

• Patheon Pharmaceuticals, Inc. Cincinnati, OH 45237 USA or by Kowa Company, LTD Nagoya, 462-0024 Japan

Marketed and Distributed by:

• Kowa Pharmaceuticals America, Inc. Montgomery, AL USA

What should I know about storage and disposal of this medication?

• Store at room temperature between 15°C and 30°C (59° to 86° F).
• Protect from light.

Lipid lowering medications

• Bile Acid Resins/Sequestrants

• • Cholestyramine
  • Colesevelam
  • Colestipol

• Fibrates
  • Clofibrate
  • Fenofibrate
  • Gemfibrozil

• Monoclonal Antibodies - Anti-PCSK9
  • Alirocumab
  • Evolocumab

• Niacin (Nicotinic Acid)

• • Omega-3 Fatty Acids,
  • Icosapent Ethyl
  • Omega-3 Acid Ethyl Esters
  • Omega-3 Carboxylic Acids

• Statins
  • Atorvastatin
  • Fluvastatin
  • Lovastatin
  • Pitavastatin
  • Pravastatin
  • Rosuvastatin
  • Simvastatin

• Miscellaneous
  • Ezetimibe
  • Lomitapide
  • Mipomersen

• Dailymed label info on Pitavastatin
• FDA Pitavastatin

Pitavastatin Resources
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