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Adverse Reactions
The following serious adverse reactions are discussed in other sections of the labeling:
- Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1)]
- Immune-Mediated Necrotizing Myopathy [see Warning and Precautions (5.2)]
- Hepatic Dysfunction [see Warning and Precautions (5.3)]
- Increases in HbA1c and Fasting Serum Glucose Levels [see Warning and Precautions (5.4)].
- Constipation / diarrhea
- Other minor adverse effects possible
6.1 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 Livalo 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 – 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 LIVALO-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.
| Adverse Reactions | Placebo (n= 208) % | LIVALO 1 mg (n=309) % | LIVALO 2 mg (n=951) % | LIVALO 4 mg (n=1540) % |
| Back Pain | 2.9 | 3.9 | 1.8 | 1.4 |
| Constipation | 1.9 | 3.6 | 1.5 | 2.2 |
| Diarrhea | 1.9 | 2.6 | 1.5 | 1.9 |
| Myalgia | 1.4 | 1.9 | 2.8 | 3.1 |
| 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 LIVALO.
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 LIVALO 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 LIVALO was generally consistent with that observed in the clinical trials described above. One patient (0.8%) treated with LIVALO had a peak creatine phosphokinase value exceeding 10 times the upper limit of normal (ULN), which resolved spontaneously. Four patients (3%) treated with LIVALO 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 LIVALO, defined as a confirmed measurement of HIV-1 RNA exceeding 200 copies/mL that was also more than a 2-fold increase from baseline.
Adverse Reactions in Pediatric Patients Aged 8 Years and Older with HeFH
In a 12-week, double-blind, placebo-controlled trial of LIVALO 1 mg, 2 mg, and 4 mg once daily in 82 pediatric patients 8 years to 16 years of age with HeFH and a 52-week open-label trial in 85 pediatric patients with HeFH, the safety profile was similar to that observed in the adult population.
6.2 Postmarketing Experience
The following adverse reactions have been identified during postapproval use of LIVALO. 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: 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
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