Summary of adverse reactions: Adverse reactions and frequencies observed in worldwide controlled clinical trials and extension studies, at the recommended doses, are listed as follows by system organ class. Frequencies are defined as: very common (≥1/10), common (≥1/100, to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) very rare (<1/10,000) and not known.
Blood and the lymphatic system disorders: Uncommon: Anaemia.
Metabolism and nutrition disorders: Uncommon: Anorexia.
Psychiatric disorders: Uncommon: Insomnia.
Nervous system disorders: Common: Headache. Uncommon: Dizziness, Dysgeusia, Somnolence.
Eye disorders: Rare: Visual acuity reduced.
Ear and labyrinth disorders: Uncommon: Tinnitus.
Gastrointestinal disorders: Common: Constipation, Diarrhoea, Dyspepsia, Nausea. Uncommon: Abdominal Pain, Dry Mouth, Vomiting. Rare: Glossodynia, pancreatitis acute.
Hepato-biliary disorders: Uncommon: Transaminases (aspartate aminotransferase, alanine aminotransferase) increased. Rare: Jaundice cholestatic.
Skin and subcutaneous tissue disorders: Uncommon: Pruritus, Rash, Rare: Urticaria, Erythema.
Musculoskeletal, connective tissue and bone disorders: Common: Myalgia, Arthralgia. Uncommon: Muscle spasms. Frequency unknown: Immune-mediated necrotising myopathy (see Precautions).
Renal and urinary disorders: Uncommon: Pollakiuria.
General disorders and administration site conditions: Uncommon: Asthenia, Malaise, Fatigue, Peripheral Oedema.
Elevated blood creatinine kinase of >3 times the upper limit of normal (ULN) occurred in 49 out of 2800 (1.8%) patients receiving LIVALO in the controlled clinical trials. Levels of ≥10 times ULN with concurrent muscle symptoms were rare and only observed in one patient out of 2406 treated with 4mg LIVALO (0.04%) in the clinical trial programme.
Paediatric population: The clinical safety database includes safety data for 142 paediatric patients who received pitavastatin among which 87 patients were in the age range of 6 to 11, and 55 patients were in the age range of 12 to 17. In total, 91 patients received pitavastatin for 1 year with 12 patients receiving pitavastatin for 2.5 years and 2 patients for 3 years. Less than 3% of pitavastatin treated patients were withdrawn due to adverse events. The most commonly reported pitavastatin related adverse reactions in the clinical programme were headache (4.9%), myalgia (2.1%) and abdominal pain (4.9%). Based on the data available, the frequency, type and severity of adverse reactions are expected to be similar in children and adolescents to adults.
Post Marketing Experience: A two year prospective post-marketing surveillance study was conducted in nearly 20,000 patients in Japan. The overwhelming majority of the 20,000 patients in the study were treated with 1mg or 2mg pitavastatin and not 4mg. 10.4% of patients reported adverse events for which a causal relationship to pitavastatin could not be ruled out and 7.4% of patients withdrew from therapy due to adverse events. The myalgia rate was 1.08%. The majority of adverse events were mild. Adverse event rates were higher over 2 years in patients with a history of drug allergy (20.4%), or hepatic or renal disease (13.5%).
Adverse reactions and frequencies observed in the prospective post-marketing surveillance study but not in worldwide controlled clinical trials, at the recommended doses are listed as follows.
Hepato-biliary disorders: Rare: Hepatic function abnormal, Liver disorder.
Musculoskeletal, connective tissue disorders: Rare: Myopathy, Rhabdomyolysis.
In the post-marketing surveillance study there were two reports of rhabdomyolysis requiring hospitalisation (0.01% of patients).
In addition, there are unsolicited post-marketing reports of skeletal muscle effects including myalgia and myopathy in LIVALO treated patients at all recommended doses. Reports of rhabdomyolysis, with and without acute renal failure, including fatal rhabdomyolysis have also been received. Unsolicited reports of the following events have also been received (the frequency is based on that observed in post-marketing studies): Nervous system disorders: Uncommon: Hypoaesthesia.
Gastrointestinal disorders: Rare: Abdominal discomfort.
Statin class effects: The following adverse events have been reported with some statins: Sleep disturbances, including nightmares; Cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion); Sexual dysfunction; Depression; Exceptional cases of interstitial lung disease, especially with long term therapy (see Precautions); Diabetes Mellitus: Frequency will depend on the presence or absence of risk factors (fasting blood glucose ≥5.6 mmol/L, BMI >30 kg/m2, raised triglycerides, history of hypertension); Hyperglycemia; Increase in HbA1c.
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