Nikita (Oral)

Pitavastatin is used along with a healthy diet to lower high cholesterol and triglyceride (fat) levels in the blood, and to raise good cholesterol (HDL) in patients with primary hyperlipidemia or mixed dyslipidemia. This medicine may help prevent health issues (like heart attacks and strokes) caused by fat blocking the blood vessels. Livalo® is also used to treat heterozygous familial hypercholesterolemia in children 8 years and older.

Pitavastatin is part of a group of medicines called HMG-CoA reductase inhibitors, or statins. It works by blocking an enzyme that is necessary for making cholesterol, which helps to lower cholesterol levels in the blood.

This medicine is available only with your doctor's prescription.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol and triglyceride levels and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent pregnancy. If you think you have become pregnant while using the medicine, tell your doctor right away.

Do not use cyclosporine (Gengraf®, Neoral®, Sandimmune®) while you are using this medicine. Using these medicines together may cause serious side effects.

Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. These may be symptoms of serious muscle problems, including myopathy or immune-mediated necrotizing myopathy (IMNM).

Call your doctor right away if you have dark urine, diarrhea, a fever, muscle cramps or spasms, muscle pain or stiffness, or feel very tired or weak. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.

Call your doctor right away if you have stomach pain, bloating, nausea, vomiting, dark urine, light-colored stools, or yellow eyes or skin. These could be symptoms of a liver problem.

Make sure any doctor or dentist who treats you knows that you use this medicine. You may need to stop using this medicine if you have major tests, major surgery, a major injury, or if you develop other serious health problems.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you may have, 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 done to see how Livalo® affects children younger than 8 years with heterozygous familial hypercholesterolemia or in children with other types of high cholesterol. Safety and effectiveness have not been established.

Appropriate studies have not been done to see how Nikita™ and Zypitamag™ affect children. Safety and effectiveness have not been established.

Geriatric

Studies done so far have not shown any specific problems in elderly patients that would limit the usefulness of pitavastatin. However, elderly patients may be more sensitive to the effects of Zypitamag tablets than younger adults. Elderly patients are also more likely to have age-related issues with their liver, kidneys, heart, and muscles, which may require caution and a dose adjustment for patients taking Livalo® tablets and Nikita™ tablets.

Breast Feeding

Studies in breastfeeding women have shown harmful effects on infants. An alternative to this medication should be given, or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if there is a chance of interaction. In these situations, your doctor may want to adjust the dose, or take other precautions. It is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine 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
• Letermovir

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Atazanavir
• Bezafibrate
• Ciprofibrate
• Clofibrate
• Cobicistat
• Colchicine
• Daptomycin
• Darolutamide
• Darunavir
• Elexacaftor
• Enasidenib
• Encorafenib
• Erythromycin
• Fenofibrate
• Fenofibric Acid
• Gemfibrozil
• Leflunomide
• Leniolisib
• Midostaurin
• Niacin
• Rifampin
• Teriflunomide
• Trofinetide

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best option for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Eltrombopag
• Fostemsavir

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or specific types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Alcohol abuse, or history of or
• Diabetes or
• Liver disease, history of—Use with caution. May worsen side effects.

• Seizures, not well-controlled or
• Severe dehydration or
• Severe electrolyte disorders or
• Severe endocrine disorders or
• Low blood pressure or
• Underactive thyroid, not adequately treated or
• Severe kidney disease or
• Recent major surgery or
• Recent major trauma (injury) or
• Severe metabolic disorders or
• Severe infection in the blood—Patients with these conditions may be at higher risk for muscle and kidney problems.

• Moderate to severe kidney disease (e.g., end-stage kidney disease)—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

• Active liver disease or
• Unexplained persistently high liver enzymes—Should not be used in patients with these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Back pain
• difficulty with moving
• joint pain
• muscle ache, cramp, pain, or stiffness
• pain in the arms and legs
• swollen joints

Incidence not known

• Chills
• clay-colored stools
• cough
• dark urine
• diarrhea
• difficulty breathing
• dizziness
• fever
• general feeling of discomfort or illness
• headache
• hives or welts, itching skin, or rash
• loss of appetite
• muscle spasm
• nausea
• runny nose
• shivering
• sore throat
• stomach pain
• sweating
• trouble sleeping
• unusual tiredness or weakness
• vomiting
• vomiting of blood
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Difficulty having a bowel movement

Incidence not known

• Burning, numbness, tingling, or painful sensations
• decreased interest in sexual intercourse
• discouragement
• feeling sad or empty
• inability to have or keep an erection
• irritability
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss in sexual ability, desire, drive, or performance
• loss of interest or pleasure
• loss of memory
• problems with memory
• redness of the skin
• trouble concentrating
• unsteadiness or awkwardness
• weakness in the arms, hands, legs, or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Livalo
• Nikita
• Zypitamag

Available Dosage Forms:

• Tablet

Therapeutic Class: Antihyperlipidemic

Pharmacologic Class: HMG-COA Reductase Inhibitor

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

In addition to this medicine, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor's orders about any special diet.

You may take this medicine at any time of the day with or without food.

Do not drink large amounts of alcohol while using pitavastatin. This could cause unwanted side effects on the liver.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For high cholesterol: Livalo®: Adults and children 8 years of age and older—At first, 2 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 4 mg per day. Children younger than 8 years of age—Use and dose must be determined by your doctor. Nikita™ and Zypitamag™: Adults—At first, 2 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 4 mg per day. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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