Nikita (pitavastatin)

Nikita (pitavastatin) 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).

Limitations Of Use

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

Pediatric use information is approved for Kowa Co Ltd’s LIVALO (pitavastatin) tablets. However, due to Kowa Co Ltd’s marketing exclusivity rights, this drug product is not labeled with that information.

Myopathy And Rhabdomyolysis

Advise patients that Nikita may cause myopathy and rhabdomyolysis. Inform patients that the risk is increased when taking certain types of medication and they should discuss all medication, both prescription and over the counter, with their healthcare provider. Instruct patientsto promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever.

Hepatic Dysfunction

Inform patients that Nikita may cause liver enzyme elevations and possibly liver failure. Advise patients to promptly report fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.

Increases In HbA1c And Fasting Serum Glucose Levels

Inform patients that increases in HbA1c and fasting serum glucose levels may occur with Nikita. Encourage patients to optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices.

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of one drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Adverse Reactions In Adults With Primary Hyperlipidemia And Mixed Dyslipidemia

In 10 controlled clinical studies and 4 subsequent open-label extension studies, 3,291 adult patients with primary hyperlipidemia or mixed dyslipidemia were administered pitavastatin 1 mg to 4 mg daily. The mean continuous exposure of pitavastatin (1 mg to 4 mg) was 36.7 weeks (median 51.1 weeks). The mean age of the patients was 60.9 years (range; 18 years to 89 years) and the gender distribution was 48% males and 52% females. Approximately 93% of the patients were Caucasian, 7% were Asian/Indian, 0.2% were African American and 0.3% were Hispanic and other.

In controlled clinical studies and their open-label extensions, 3.9% (1 mg), 3.3% (2 mg), and 3.7% (4 mg) of pitavastatin-treated patients were discontinued due to adverse reactions. The most common adverse reactions that led to treatment discontinuation were: elevated creatine phosphokinase (0.6% on 4 mg) and myalgia (0.5% on 4 mg).

Adverse reactions reported in ≥ 2% of patients in controlled clinical studies and at a rate greater than or equal to placebo are shown in Table 1. These studies had treatment duration of up to 12 weeks.

Table 1: Adverse Reactions (≥2% and ≥ placebo) in Adult Patients with Primary Hyperlipidemia and Mixed Dyslipidemia in Studies up to 12 Weeks

Other adverse reactions reported from clinical studies were arthralgia, headache, influenza, and nasopharyngitis.

Hypersensitivity reactions including rash, pruritus, and urticaria have been reported with pitavastatin.

The following laboratory abnormalities have been reported: elevated creatine phosphokinase, transaminases, alkaline phosphatase, bilirubin, and glucose.

Adverse Reactions In Adult HIV-Infected Patients With Dyslipidemia

In a double-blind, randomized, controlled, 52-week trial, 252 HIV-infected patients with dyslipidemia were treated with either pitavastatin 4 mg once daily (n=126) or another statin (n=126). All patients were taking antiretroviral therapy (excluding darunavir) and had HIV-1 RNA less than 200 copies/mL and CD4 count greater than 200 cell/μL for at least 3 months prior to randomization. The safety profile of pitavastatin was generally consistent with that observed in the clinical trials described above. One patient (0.8%) treated with pitavastatin had a peak creatine phosphokinase value exceeding 10 times the upper limit of normal (ULN), which resolved spontaneously. Four patients (3%) treated with pitavastatin had at least one ALT value exceeding 3 times but less than 5 times the ULN, none of which led to drug discontinuation. Virologic failure was reported for four patients (3%) treated with pitavastatin, defined as a confirmed measurement of HIV-1 RNA exceeding 200 copies/mL that was also more than a 2-fold increase from baseline.

General Dosage And Administration Information

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

Recommended Dosage For Adults

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

Recommended Dosage In Patients With Renal Impairment

• The recommended starting dose for adults with moderate and severe renal impairment (estimated glomerular filtration rate 30 to 59 mL/minute/1.73 m² and 15 to 29 mL/minute/1.73 m², respectively) and patients with end-stage renal disease receiving hemodialysis is Nikita 1 mg once daily.
• The maximum recommended dose for these patients is Nikita 2 mg once daily.

Nikita Dosage Adjustments Due To Drug Interactions

• In patients taking erythromycin, do not exceed Nikita 1 mg once daily.
• In patients taking rifampin, do not exceed Nikita 2 mg once daily.y.

Pediatric use information is approved for Kowa Co Ltd’s LIVALO (pitavastatin) tablets. However, due to Kowa Co Ltd’s marketing exclusivity rights, this drug product is not labeled with that information.

Drug Interactions That Increase The Risk Of Myopathy And Rhabdomyolysis With Nikita

Table 2 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when administered concomitantly with Nikita and instructions for preventing or managing drug interactions.

Table 2: Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Nikita

Advise females of reproductive potential of the potential risk to a fetus, to use effective contraception during treatment and to inform their healthcare professional of a known or suspected pregnancy.

Lactation

Advise women not to breastfeed during treatment with Nikita.