Drug Action
Alirocumab binds to a pro-protein involved in the regulation of LDL receptors on liver cells; receptor numbers are increased, which results in increased uptake of LDL-cholesterol from the blood.
PDF page 241
Loading InternPractice…
Drug reference
Alirocumab binds to a pro-protein involved in the regulation of LDL receptors on liver cells; receptor numbers are increased, which results in increased uptake of LDL-cholesterol from the blood.
PDF page 241
Primary hypercholesterolaemia or mixed dyslipidaemia in patients who have not responded adequately to other appropriate measures [in combination with a statin, or with a statin and other lipid-lowering therapies, or with other lipid-lowering therapies or alone if a statin contra- indicated or not tolerated] | Established atherosclerotic cardiovascular disease [in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies, or with other lipid- lowering therapies or alone if a statin contra-indicated or not tolerated] ▶BY SUBCUTANEOUS INJECTION ▶Adult: Initially 75 mg every 2 weeks; increased if necessary to 150 mg every 2 weeks, alternatively 300 mg every 4 weeks, patients requiring an LDL-C reduction of greater than 60% may be initiated on 150 mg every 2 weeks or 300 mg every 4 weeks, dose adjustments should be made at 4 to 8 weekly intervals
PDF page 241
NICE decisions ▶Alirocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia (June 2016) NICE TA393 Alirocumab (Praluent ®) is recommended as an option for treating primary hypercholesterolaemia or mixed dyslipidaemia, only if : . low-density lipoprotein cholesterol (LDL-C) concentrations are persistently above the thresholds specified in the NICE documentation, and . the manufacturer provides alirocumab with the discount agreed in the patient access scheme. Patients whose treatment was started before this guidance was published should continue treatment until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta393 Scottish Medicines Consortium (SMC) decisions SMC No. 1147/16 The Scottish Medicines Consortium has advised (August 2016) that alirocumab (Praluent ®) is accepted for restricted use within NHS Scotland for treatment of primary hypercholesterolaemia or mixed dyslipidaemia (alone or in combination with other lipid lowering therapies, as specified within it’s licence), for specialist use only and only in patients at high cardiovascular risk as follows: . patients with heterozygous familial hypercholesterolaemia (HeFH) and LDL-C 5.0mmol/L, for primary prevention of cardiovascular events, or . patients with HeFH and LDL-C 3.5mmol/L, for Cardiovascular system secondary prevention of cardiovascular events, or . patients at high risk due to previous cardiovascular events and LDL-C 4.0mmol/L, or . patients with recurrent/polyvascular disease and LDL-C 3.5mmol/L This advice is contingent upon the continuing availability of the Patient Access Scheme (PAS) in NHS Scotland or a list price that is equivalent or lower.
PDF page 241
▶Common or very common Nasal complaints. oropharyngeal pain. pulmonary reaction. skin reactions ▶Rare or very rare Hypersensitivity. hypersensitivity vasculitis
PDF page 241
Manufacturer advises avoid unless clinical condition requires treatment—maternal toxicity in animal studies.
PDF page 241
Manufacturer advises avoid—no information available.
PDF page 241
Manufacturer advises use with caution in severe impairment—no information available.
PDF page 241
Manufacturer advises use with caution in severe impairment—no information available. l HANDLING AND STORAGE Manufacturer advises store in a refrigerator (2–8 °C)—consult product literature for further information regarding storage outside refrigerator.
PDF page 241
There can be variation in the licensing of different medicines containing the same drug. Solution for injection EXCIPIENTS: May contain Polysorbates ▶Praluent (Sanofi) A Alirocumab 75 mg per 1 ml Praluent 75mg/1ml solution for injection pre-filled pens | 1 pre-filled disposable injection P £168.00 | 2 pre-filled disposable injection P £336.00 DT = £336.00 Alirocumab 150 mg per 1 ml Praluent 150mg/1ml solution for injection pre-filled pens | 1 pre-filled disposable injection P £168.00 | 2 pre-filled disposable injection P £336.00 DT = £336.00
PDF page 241
Initially 75 mg every 2 weeks; increased if
First-line fragment. Read the complete Indications and Dose section above.
PDF page 241