What is Nikita (pitavastatin), and how does it work?

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.

What are the side effects of Nikita?

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

Adverse ReactionsPlacebo
(n= 208 )
%
Pitavastatin
1 mg
(n=309 )
%
Pitavastatin
2 mg
(n=951 )
%
Pitavastatin
4 mg
(n=1540 )
%
Back Pain2.93.91.81.4
Constipation1.93.61.52.2
Diarrhea1.92.61.51.9
Myalgia1.41.92.83.1
Pain in extremity1.92.30.60.9

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.

What is the dosage for Nikita?

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.

What drugs interact with Nikita?

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

Cyclosporine
Clinical Impact:Cyclosporine significantly increases pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis.
Intervention: Concomitant use of cyclosporine with Nikita is contraindicated.
Gemfibrozil
Clinical Impact:Gemfibrozil may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of gemfibrozil with statins, including Nikita.
Intervention:Avoid concomitant use of gemfibrozil with Nikita.
Erythromycin
Clinical Impact:Erythromycin significantly increases pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis.
Intervention:In patients taking erythromycin, do not exceed Nikita 1 mg once daily.
Rifampin
Clinical Impact:Rifampin significantly increases peak pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis.
Intervention: In patients taking rifampin, do not exceed Nikita 2 mg once daily.
Fibrates
Clinical Impact:Fibrates may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with statins, including Nikita.
Intervention:Consider if the benefit of using fibrates concomitantly with Nikita outweighs the increased risk of myopathy and rhabdomyolysis.
Niacin
Clinical Impact:The risk of myopathy and rhabdomyolysis may be increased with concomitant use of lipid modifying doses (≥1 g/day) of niacin with Nikita.
Intervention:Consider if the benefit of using lipid-modifying doses (≥1 g/day) of niacin concomitantly with Nikita outweighs the increased risk of myopathy and rhabdomyolysis.
Colchicine
Clinical Impact:Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with statins, including Nikita.
Intervention:Consider the risk/benefit of concomitant use of colchicine with Nikita.

SLIDESHOW

How to Lower Your Cholesterol & Save Your Heart See Slideshow

Is Nikita safe to use while pregnant or breastfeeding?

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.

Summary

Nikita (pitavastatin) is indicated as an adjunctive therapy to diet in adult patients with primary hyperlipidemia or mixed dyslipidemia (high cholesterol) 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). This lowers cardiovascular risk.

Treatment & Diagnosis

Medications & Supplements

Prevention & Wellness

QUESTION

What is cholesterol? See Answer

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Medically Reviewed on 10/14/2020
References
All sections courtesy of the U.S. Food and Drug Administration