Pitavastatin
Generic Name: pitavastatin
Brand Names:
Pitavastatin Calcium
11 DESCRIPTION Pitavastatin tablets for oral use are an HMG-CoA reductase inhibitor. The chemical name for pitavastatin is (+)Monocalcium bis [(3R,5S,6E)-7-[2-cyclopropyl- 4-(4- fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-heptenoate]. The structural formula is: The molecular formula for pitavastatin is (C 25 H 23 FNO 4 ) 2. Ca and the molecular weight is 880.98. Pitavastatin is odorless and occurs as off-white to pale yellow color powder.
Overview
11 DESCRIPTION Pitavastatin tablets for oral use are an HMG-CoA reductase inhibitor. The chemical name for pitavastatin is (+)Monocalcium bis [(3R,5S,6E)-7-[2-cyclopropyl- 4-(4- fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-heptenoate]. The structural formula is: The molecular formula for pitavastatin is (C 25 H 23 FNO 4 ) 2. Ca and the molecular weight is 880.98. Pitavastatin is odorless and occurs as off-white to pale yellow color powder.
Uses
1 INDICATIONS AND USAGE Pitavastatin tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: • Adults with primary hyperlipidemia. • Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). Pitavastatin tablets are a HMG-CoA reductase inhibitor (statin) indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: ( 1 ) • Adults with primary hyperlipidemia. • Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
Dosage
2 DOSAGE AND ADMINISTRATION • Take orally once daily with or without food at the same time each day. ( 2.1 ) • For patients requiring a high-intensity statin or are unable to achieve their LDL-C goal receiving pitavastatin tablets 4 mg daily, prescribe alternative LDL-C-lowering treatment. ( 2.1 ) • Assess LDL-C when clinically appropriate, as early as 4 weeks after initiation of pitavastatin tablets, and adjust the dosage if necessary. ( 2.1 ) • Recommended dosage is 2 mg to 4 mg once daily. Maximum recommended dosage is 4 mg once daily. ( 2.2 ) • Recommended starting dosage for patients with moderate and severe renal impairment and end-stage renal disease on hemodialysis is 1 mg once daily. Maximum recommended dosage is 2 mg once daily.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in other sections of the labeling: • Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1) ] • Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2) ] • Hepatic Dysfunction [see Warnings and Precautions (5.3) ] • Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.4) ] The most frequent adverse reactions (rate ≥ 2%) were myalgia, constipation, diarrhea, back pain, and pain in extremity. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Interactions
7 DRUG INTERACTIONS Table 2 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when administered concomitantly with pitavastatin tablets and instructions for preventing or managing drug interactions [see Warnings and Precautions (5.1) , Clinical Pharmacology (12.3) ] . Table 2. Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Pitavastatin Tablets Cyclosporine Clinical Impact: Cyclosporine significantly increases pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis. Intervention: Concomitant use of cyclosporine with pitavastatin tablets is contraindicated [see Contraindications (4) ] . Gemfibrozil Clinical Impact: Gemfibrozil may cause myopathy when given alone.
Warnings
5 WARNINGS AND PRECAUTIONS • Myopathy and Rhabdomyolysis: Risk factors include age 65 or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher pitavastatin tablets dosage. Discontinue pitavastatin tablets if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue pitavastatin tablets in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the pitavastatin tablets dosage. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever. 4 CONTRAINDICATIONS Pitavastatin tablets are contraindicated in the following conditions: • Concomitant use of cyclosporine [see Drug Interactions (7) ] . • Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3) ] . • Hypersensitivity to pitavastatin or any excipients in pitavastatin tablets.
Pregnancy
8.1 Pregnancy Risk Summary Discontinue pitavastatin tablets when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Pitavastatin tablets decrease synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, pitavastatin tablets may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1) ] . In addition, treatment of hyperlipidemia is not generally necessary during pregnancy.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Pitavastatin Tablets are available containing 1.045 mg, 2.09 mg or 4.18 mg of pitavastatin calcium equivalent to 1 mg, 2 mg or 4 mg of pitavastatin, respectively. The 1 mg tablets are white to off-white, film-coated, round, unscored tablets debossed with M on one side of the tablet and PU1 on the other side.
Frequently Asked Questions
What is Pitavastatin used for?▼
1 INDICATIONS AND USAGE Pitavastatin tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: • Adults with primary hyperlipidemia. • Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). Pitavastatin tablets are a HMG-CoA reductase inhibitor (statin) indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: ( 1 ) • Adults with primary hyperlipidemia. • Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
What are the side effects of Pitavastatin?▼
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in other sections of the labeling: • Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1) ] • Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2) ] • Hepatic Dysfunction [see Warnings and Precautions (5.3) ] • Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.4) ] The most frequent adverse reactions (rate ≥ 2%) were myalgia, constipation, diarrhea, back pain, and pain in extremity. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Pitavastatin during pregnancy?▼
8.1 Pregnancy Risk Summary Discontinue pitavastatin tablets when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Pitavastatin tablets decrease synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, pitavastatin tablets may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1) ] . In addition, treatment of hyperlipidemia is not generally necessary during pregnancy.
What are the important warnings for Pitavastatin?▼
5 WARNINGS AND PRECAUTIONS • Myopathy and Rhabdomyolysis: Risk factors include age 65 or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher pitavastatin tablets dosage. Discontinue pitavastatin tablets if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue pitavastatin tablets in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the pitavastatin tablets dosage. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever. 4 CONTRAINDICATIONS Pitavastatin tablets are contraindicated in the following conditions: • Concomitant use of cyclosporine [see Drug Interactions (7) ] . • Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3) ] . • Hypersensitivity to pitavastatin or any excipients in pitavastatin tablets.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.