Medical Editor: John P. Cunha, DO, FACOEP
What Is Nikita?
Nikita (pitavastatin) tablet is a HMG-CoA reductase inhibitor indicated for patients with primary hyperlipidemia or mixed dyslipidemia as an adjunctive therapy to diet 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).
What Are Side Effects of Nikita?
Common side effects of Nikita include:
- muscle pain,
- back pain,
- pain in extremities,
- joint pain,
- influenza, and
- runny or stuffy nose.
The dose range for Nikita is 1 mg to 4 mg once daily. Nikita may interact with erythromycin, rifampin, cyclosporine, gemfibrozil, niacin, colchicine, warfarin, and other lipid-lowering therapies. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Nikita; it may harm a fetus. Women are advised to use effective contraception during treatment with Nikita. It is unknown if Nikita passes into breast milk. Other drugs in this class pass into breast milk. Because of the potential for adverse reactions in nursing infants, Nikita is not recommended for use while breastfeeding.
Our Nikita (pitavastatin) Tablet Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
The following serious adverse reactions are discussed in other sections of the labeling:
- Myopathy and Rhabdomyolysis [see WARNINGS AND PRECAUTIONS]
- Immune-Mediated Necrotizing Myopathy [see WARNING AND PRECAUTIONS]
- Hepatic Dysfunction [see WARNING AND PRECAUTIONS]
- Increases in HbA1c and Fasting Serum Glucose Levels [see WARNING AND PRECAUTIONS].
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
(n= 208 )
|Pain in extremity||1.9||2.3||0.6||0.9|
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.
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.
The following adverse reactions have been identified during postapproval use of pitavastatin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal disorders: abdominal discomfort, abdominal pain, dyspepsia, nausea
General disorders:asthenia, fatigue, malaise, dizziness
Hepatobiliary disorders: hepatitis, jaundice, fatal and non-fatal hepatic failure
Immune system disorders: angioedema, immune-mediated necrotizing myopathy associated with statin use.
Metabolism and nutrition disorders: increases in HbA1c, fasting serum glucose levels
Musculoskeletal and connective tissue disorders: muscle spasms, myopathy, rhabdomyolysis
Nervous system disorders: hypoesthesia, peripheral neuropathy
Psychiatric disorders: insomnia, depression. Rare reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. Cognitive impairment was generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
Reproductive system and breast disorders: erectile dysfunction
Respiratory, thoracic and mediastinal disorders: interstitial lung disease
Read the entire FDA prescribing information for Nikita (Pitavastatin)
© Nikita Patient Information is supplied by Cerner Multum, Inc. and Nikita Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.