Pitavastatin

Eat a low-fat, low-cholesterol diet. Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. You can also visit the National Cholesterol Education Program (NCEP) website for additional dietary information at http://www.nhlbi.nih.gov/health/public/heart/chol/chol_tlc.pdf.

Avoid eating foods that are high in fat or cholesterol. Pitavastatin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

Pitavastatin may be found in some form under the following brand names:

• Livalo

Take pitavastatin exactly as prescribed.

Pitavastatin comes in tablet form and is usually given once a day. Pitavastatin can be taken with or without food.

If you miss a dose, take the missed dose as soon as you remember. If it almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of pitavastatin at the same time.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, pitavastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Also call your doctor at once if you have:

• confusion, memory problems;

• kidney problems--vomiting, pain in your side or lower back, little or no urinating, swelling, rapid weight gain; or

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• mild muscle pain;

• pain in your arms or legs;

• back pain; or

• diarrhea, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Hyperlipidemia:

Initial dose: 2 mg orally once a day
Maintenance dose: 1 mg to 4 mg orally once a day
Maximum dose: 4 mg/day

Comments:
-Doses greater than 4 mg once a day have been associated with an increased risk for severe myopathy in premarketing studies and thus doses should not exceed 4 mg/day.

Use: As an adjunct to diet to reduce total cholesterol, low density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides, and to increase high density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia or mixed dyslipidemia

Usual Adult Dose for Dyslipidemia:

Initial dose: 2 mg orally once a day
Maintenance dose: 1 mg to 4 mg orally once a day
Maximum dose: 4 mg/day

Comments:
-Doses greater than 4 mg once a day have been associated with an increased risk for severe myopathy in premarketing studies and thus doses should not exceed 4 mg/day.

Use: As an adjunct to diet to reduce total cholesterol, low density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides, and to increase high density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia or mixed dyslipidemia

Tell your doctor about all other medicines you use. Certain other drugs can increase your risk of serious muscle problems, and it is very important that your doctor knows if you are using any of them:

• colchicine;

• gemfibrozil;

• fenofibric acid;

• fenofibrate; or

• medicines that contain niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others).

This list is not complete. Other drugs may interact with pitavastatin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pitavastatin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to pitavastatin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of pitavastatin in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pitavastatin in the elderly. However, elderly patients are more sensitive to the effects of Zypitamag tablets than younger adults. Elderly patients are also more likely to have age-related kidney and muscle problems, which may require caution and an adjustment in the dose for patients receiving Livalo® tablets.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using pitavastatin.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking pitavastatin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using pitavastatin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Cyclosporine

Using pitavastatin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bezafibrate
• Ciprofibrate
• Clofibrate
• Colchicine
• Darunavir
• Erythromycin
• Fenofibrate
• Fenofibric Acid
• Gemfibrozil
• Niacin
• Rifampin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of pitavastatin. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, or history of or
• Diabetes or
• Liver disease, history of—Use with caution. May cause side effects to become worse.

• Convulsions (seizures), not well-controlled or
• Dehydration or
• Electrolyte disorders, severe or
• Endocrine disorders, severe or
• Hypotension (low blood pressure) or
• Hypothyroidism (underactive thyroid), not adequately treated or
• Kidney disease, severe or
• Major surgery, recent or
• Major trauma (injury), recent or
• Metabolic disorders, severe or
• Sepsis (severe infection in the blood)—Patients with these conditions may be at risk of developing muscle and kidney problems.

• Liver disease, active or
• Liver enzymes, persistently high levels—Should not be used in patients with these conditions.

Pitavastatin tablets for oral administration are provided as white, film-coated tablets that contain 1 mg, 2 mg, or 4 mg of Pitavastatin. Each tablet has "OP" debossed on one side and a code number specific to the tablet strength on the other.

Packaging

Packaging

Pitavastatin tablets are supplied as:

•      1 mg: White to off-white circular biconvex film-coated tablets, debossed with the logo "OP" on one side and "57" on the other side. Supplied as follows:

NDC 76333-157-14: HDPE bottles of 90 tablets

NDC 76333-157-12: HDPE bottles of 1000 tablets

•      2 mg: White to off-white circular biconvex film-coated tablets, debossed with the logo "OP" on one side and "58" on the other side. Supplied as follows:

NDC 76333-158-14: HDPE bottles of 90 tablets

NDC 76333-158-12: HDPE bottles of 1000 tablets

•      4 mg: White to off-white circular biconvex film-coated tablets, debossed with the logo "OP" on one side and "59" on the other side. Supplied as follows:

NDC 76333-159-15: HDPE bottles of 30 tablets

NDC 76333-159-14: HDPE bottles of 90 tablets

NDC 76333-159-12: HDPE bottles of 1000 tablets

Storage

Storage

Store at 25°C (77° F), excursions permitted from 15°C -30°C (59°F-86°F). [See USP Controlled Room Temperature]. Protect from light.

Half-life was 15 and 10 hours for patients with moderate and mild impairment, respectively.

Primary hyperlipidemia and mixed dyslipidemia: As an adjunctive therapy to diet to reduce elevated total cholesterol, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B), and triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in adults with primary hyperlipidemia or mixed dyslipidemia

GFR ≥60 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer’s labeling.

GFR 15 to 59 mL/minute/1.73 m2 (not receiving hemodialysis): Initial: 1 mg once daily; maximum: 2 mg/day

ESRD receiving hemodialysis: Initial: 1 mg once daily; maximum: 2 mg/day

1% to 10%:

Central nervous system: Headache (<2%)

Endocrine & metabolic: Increased serum glucose (<2%)

Gastrointestinal: Constipation (4%), diarrhea (3%)

Hepatic: Increased serum alkaline phosphatase (<2%), increased serum bilirubin (<2%), increased serum transaminases (<2%; usually transient)

Infection: Influenza (<2%)

Neuromuscular & skeletal: Back pain (4%), myalgia (2% to 3%), arthralgia (<2%), increased creatine phosphokinase (<2%)

Respiratory: Nasopharyngitis (<2%)

<1%, postmarketing, and/or case reports: Abdominal distress, abdominal pain, cognitive dysfunction (reversible; including amnesia, confusion, forgetfulness, memory impairment), depression, dizziness, elevated glycosylated hemoglobin (Hb A1c), erectile dysfunction, fatigue, hepatic failure, hepatitis, hypoesthesia, immune-mediated necrotizing myopathy, insomnia, interstitial pulmonary disease, jaundice, malaise, muscle spasm, nausea, peripheral neuropathy, pruritus, myopathy, rhabdomyolysis (with acute renal failure), skin rash, urticaria, weakness

Initial dose: 2 mg orally once a day
Maintenance dose: 1 mg to 4 mg orally once a day
Maximum dose: 4 mg/day

Comments:
-Doses greater than 4 mg once a day have been associated with an increased risk for severe myopathy in premarketing studies and thus doses should not exceed 4 mg/day.

Use: As an adjunct to diet to reduce total cholesterol, low density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides, and to increase high density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia or mixed dyslipidemia

Active liver disease (including unexplained persistent elevations in hepatic transaminase levels): Contraindicated

ESRD receiving hemodialysis:
-Initial dose: 1 mg orally once a day
-Maximum dose: 2 mg orally once a day