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ALIPZA is a brand name for Pitavastatin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Alipza is indicated for the reduction of elevated total cholesterol (TC) and LDL-C, in adults, adolescents and children aged 6 years or older with primary hypercholesterolaemia, including heterozygous familial hypercholesterolaemia, and combined (mixed) dyslipidaemia, when response to diet and other non-…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Patients should be on a cholesterol lowering diet before treatment. It is important that all patients continue dietary control during treatment. The usual starting dose is 1mg once daily. Adjustment of dose should be made at intervals of 4 weeks or more.
Doses should be individualized according to LDL-C levels, the goal of therapy and patient response. The maximum daily dose is 4mg. 2).
Paediatric population Children and adolescents aged 6 years and over:
Alipza use in children should only be carried out by physicians experienced in the treatment of hyperlipidaemia and progress should be regularly reviewed. In children and adolescents with heterozygous familial hypercholesterolaemia the usual starting dose is 1mg once daily.
Adjustment of dose should be made at intervals of 4 weeks or more. Doses should be individualized according to LDL-C levels, the goal of therapy and patient response. In children 6 to 9 years of age the maximum daily dose is 2mg. 2).
Children younger than 6 years of age:
The safety and efficacy of Alipza in children aged below 6 years has not been established. No data are available. Patients with impaired renal function No dosage adjustment is required in mild renal impairment but pitavastatin should be used with caution.
Data with 4mg dose are limited in all grades of impaired renal function. Therefore 4mg dose should ONLY be used with close monitoring after graded dose titration. 2). Patients with mild to moderate impaired hepatic function The 4mg dose is not recommended in patients with mild to moderate impaired hepatic function.
2). Method of administration For oral use only and should be swallowed whole. Alipza can be taken at any time of the day with or without food. It is desirable that the patient takes the tablet at the same time each day. Statin therapy is generally more effective in the evening due to the circadian rhythm of lipid metabolism.
If a child or adolescent is unable to swallow the tablet, where necessary, the tablet may be dispersed in a glass of water and taken immediately. To ensure accurate dosage a second volume of water should be used to rinse the glass and swallowed immediately.
Summary of the safety profile In controlled clinical trials, at the recommended doses, less than 4% of Alipza treated patients were withdrawn due to adverse events. The most commonly reported pitavastatin related adverse reaction in controlled clinical trials was myalgia.
Summary of adverse reactions Adverse reactions and frequencies observed in worldwide controlled clinical trials and extension studies, at the recommended doses, are listed below 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 (cannot be estimated from the available data).
8%) patients receiving Alipza in the controlled clinical trials. 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.
5 years and 2 patients for 3 years. Less than 3% of pitavastatin treated patients were withdrawn due to adverse events. 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.
4% of patients withdrew from therapy due to adverse events. 08%. The majority of adverse events were mild. 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 below.
Muscle effects In common with other HMG-CoA reductase inhibitors (statins), there is the potential for myalgia, myopathy and, rarely, rhabdomyolysis to develop. Patients should be asked to report any muscle symptoms. Creatine kinase (CK) levels should be measured in any patient reporting muscle pain, muscle tenderness or weakness especially if accompanied by malaise or fever.
Creatine kinase should not be measured following strenuous exercise or in the presence of any other plausible cause of CK increase which may confound interpretation of the result. When elevated CK concentrations (>5x ULN) are noted, a confirmatory test should be performed within 5 to 7 days.
There have been very rare reports of an immune-mediated necrotizing myopathy (IMNM) during or after treatment with some statins. IMNM is clinically characterized by persistent proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment.
Alipza must not be co-administered with systemic formulations of fusidic acid or within 7 days of stopping fusidic acid treatment. In patients where the use of systemic fusidic acid is considered essential, statin treatment should be discontinued throughout the duration of fusidic acid treatment.
5). The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness. Statin therapy may be re-introduced seven days after the last dose of fusidic acid. , for the treatment of severe infections, the need for co-administration of Alipza and fusidic acid should only be considered on a case by case basis and under close medical supervision.
Before treatment In common with other statins, Alipza should be prescribed with caution in patients with pre- disposing factors for rhabdomyolysis. A creatinine kinase level should be measured, to establish a reference baseline, in the following situations: • renal impairment, • hypothyroidism, • personal or family history of hereditary muscular disorders, • previous history of muscular toxicity with a fibrate or another statin, • history of liver disease or alcohol abuse, • elderly patients (over 70 years) with other predisposing risk factors for rhabdomyolysis, In such situations, clinical monitoring is recommended and the risk of treatment should be considered in relation to the possible benefit.
1) or other statins • in patients with severe hepatic impairment, active liver disease or unexplained persistent elevations in serum transaminases (exceeding 3 times the upper limit of normal [ULN]) • in patients with myopathy • in patients receiving concomitant ciclosporin • during pregnancy, while breast feeding and in women of child bearing potential not taking appropriate contraceptive precautions
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Tablets must not be dispersed in either acidic fruit juices or milk.
01% of patients). In addition there are unsolicited post-marketing reports of skeletal muscle effects including myalgia and myopathy in Alipza treated patients at all recommended doses. Reports of rhabdomyolysis, with and without acute renal failure, including fatal rhabdomyolysis have also been received.
6 mmol/L, BMI >30 kg/m2, raised triglycerides, history of hypertension) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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Treatment with Alipza should not be started if CK values are >5x ULN. During treatment Patients must be encouraged to report muscle pain, weakness or cramps immediately. Creatine kinase levels should be measured and treatment stopped if CK levels are elevated (>5x ULN).
Stopping treatment should be considered if muscular symptoms are severe even if CK levels are ≤5x ULN. If symptoms resolve and CK levels return to normal, then re- introduction of Alipza may be considered at a dose of 1mg and with close monitoring.
Liver effects In common with other statins, Alipza should be used with caution in patients with a history of liver disease or who regularly consume excessive quantities of alcohol. Liver function tests should be performed prior to initiating treatment with Alipza and then periodically during treatment.
Alipza treatment should be discontinued in patients who have a persistent increase in serum transaminases (ALT and AST) exceeding 3x ULN. Renal effects Alipza should be used with caution in patients with moderate or severe renal impairment.
Dose increments should be instituted only with close monitoring. 2). Diabetes mellitus Some evidence suggests that statins as a class raise blood glucose and in some patients, at high risk of future diabetes, may produce a level of hyperglycaemia where formal diabetes care is appropriate.
This risk, however, is outweighed by the reduction in vascular risk with statins and therefore should not be a reason for stopping statin treatment. 9 mmol/L, BMI>30 kg/m2, raised triglycerides, hypertension), should be monitored both clinically and biochemically according to national guidelines.
1). 8). Presenting features can include dyspnoea, non- productive cough and deterioration in general health (fatigue, weight loss and fever). If it is suspected a patient has developed interstitial lung disease, statin therapy should be discontinued.
Paediatric population There is limited data on the long term effect on growth and sexual maturation in paediatric patients 6 years of age or older taking Alipza. 6). 5). g. 5). The tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
8). Alipza should be discontinued in case of aggravation of symptoms. […]