ˆ’ Personal or familial history of hereditary muscular disorders
A CK level should be measured before starting statin treatment in the following situations: Īvamax, like other HMG-CoA reductase inhibitors, may in rare occasions affect the skeletal muscle and cause myalgia, myositis, and myopathy that may progress to rhabdomyolysis, a potentially life-threatening condition characterised by markedly elevated creatine kinase (CK) levels (> 10 times ULN), myoglobinaemia and myoglobinuria which may lead to renal failure.Īvamax should be prescribed with caution in patients with pre-disposing factors for rhabdomyolysis. For patients with prior hemorrhagic stroke or lacunar infarct, the balance of risks and benefits of Avamax 80 mg is uncertain, and the potential risk of hemorrhagic stroke should be carefully considered before initiating treatment. The increased risk was particularly noted in patients with prior hemorrhagic stroke or lacunar infarct at study entry. In a post-hoc analysis of stroke subtypes in patients without coronary heart disease (CHD) who had a recent stroke or transient ischemic attack (TIA) there was a higher incidence of hemorrhagic stroke in patients initiated on Avamax 80 mg compared to placebo. Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) Should an increase in transaminases of greater than 3 times the upper limit of normal (ULN) persist, reduction of dose or withdrawal of Avamax is recommended.Īvamax should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease. Patients who develop increased transaminase levels should be monitored until the abnormality(ies) resolve. Patients who develop any signs or symptoms suggestive of liver injury should have liver function tests performed. Liver function tests should be performed before the initiation of treatment and periodically thereafter. Each daily dose of Avamax is given all at once and may be given at any time of day with or without food. Other pharmaceutical forms/strengths may be more appropriate for this population.Īvamax is for oral administration.
Avamax is not indicated in the treatment of patients below the age of 10 years. There is limited experience in children between 6-10 years of age. Safety information for paediatric patients treated with doses above 20 mg, corresponding to about 0.5 mg/kg, is limited.
Titration should be conducted according to the individual response and tolerability in paediatric patients. Paediatric use should only be carried out by physicians experienced in the treatment of paediatric hyperlipidaemia and patients should be re-evaluated on a regular basis to assess progress.įor patients aged 10 years and above, the recommended starting dose of Avamax is 10 mg per day with titration up to 20 mg per day. Avamax is contraindicated in patients with active liver disease.Įfficacy and safety in patients older than 70 using recommended doses are similar to those seen in the general population. Higher doses may be necessary in order to attain (LDL-) cholesterol levels according to current guidelines.Īvamax should be used with caution in patients with hepatic impairment. In the primary prevention trials the dose was 10 mg/day. LDL apheresis) in these patients or if such treatments are unavailable. Avamax should be used as an adjunct to other lipid-lowering treatments (e.g. The dose of Avamax in patients with homozygous familial hypercholesterolemia is 10 to 80 mg daily. Homozygous familial hypercholesterolaemia Thereafter, either the dose may be increased to a maximum of 80 mg daily or a bile acid sequestrant may be combined with 40 mg Avamax once daily. Doses should be individualised and adjusted every 4 weeks to 40 mg daily. Patients should be started with Avamax 10 mg daily. Heterozygous familial hypercholesterolaemia The response is maintained during chronic therapy. A therapeutic response is evident within 2 weeks, and the maximum therapeutic response is usually achieved within 4 weeks. The majority of patients are controlled with Avamax 10 mg once a day. Primary hypercholesterolaemia and combined (mixed) hyperlipidaemia Adjustment of dose should be made at intervals of 4 weeks or more. The usual starting dose is 10 mg once a day. The dose should be individualised according to baseline LDL-C levels, the goal of therapy, and patient response. The patient should be placed on a standard cholesterol-lowering diet before receiving Avamax and should continue on this diet during treatment with Avamax.
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