Praluent 75, 150 mg

/ Sanofi Israel Ltd

Prior to initiating Praluent secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g., nephrotic syndrome, hypothyroidism) should be excluded.
The usual starting dose is 75 mg administered subcutaneously once every 2 weeks. Patients requiring larger LDL-C reduction (>60%) may be started on 150 mg once every 2 weeks, or 300 mg once every 4 weeks (monthly), administered subcutaneously.
The dose of alirocumab can be individualized based on patient characteristics such as baseline LDL-C level, goal of therapy and response. Lipid levels can be assessed 4 to 8 weeks after treatment initiation or titration, and dose adjusted accordingly (up-titration or down-titration). If additional LDL-C reduction is needed in patients treated with 75 mg once every 2 weeks or 300 mg once every 4 weeks (monthly), the dosage may be adjusted to the maximum dosage of 150 mg once every 2 weeks.
If a dose is missed, the patient should administer the injection as soon as possible and thereafter resume treatment on the original schedule.
Method of administration
Alirocumab is injected as a subcutaneous injection into the thigh, abdomen or upper arm.
To administer the 300 mg dose, give two 150 mg injections consecutively at two different injection sites.
It is recommended to rotate the injection site with each injection.
Praluent should not be injected into areas of active skin disease or injury such as sunburns, skin rashes, inflammation, or skin infections.
Praluent must not be co-administered with other injectable medicinal products at the same injection site.
The patient may either self-inject Praluent, or a caregiver may administer Alirocumab, after guidance has been provided by a healthcare professional on proper subcutaneous injection technique.
Precautions to be taken before handling: The solution should be allowed to warm to room temperature prior to use.
See prescribing information for full details.

Primary hypercholesterolaemia and mixed dyslipidaemia
Praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and nonfamilial) or mixed dyslipidaemia, and in paediatric patients 8 years of age and older with heterozygous familial hypercholesterolaemia (HeFH) as an adjunct to diet:
– in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,
– alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
Established atherosclerotic cardiovascular disease
Praluent is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
– in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,
– alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Hypersensitivity to the active substance or to any of the excipients.

Allergic reactions: General allergic reactions, including pruritus, as well as rare and sometimes serious allergic reactions such as hypersensitivity, nummular eczema, urticaria, and hypersensitivity vasculitis have been reported in clinical studies. If signs or symptoms of serious allergic reactions occur, treatment with Praluent must be discontinued and appropriate symptomatic treatment initiated.
Renal impairment: In clinical studies, there was limited representation of patients with severe renal impairment (defined as eGFR<30 mL/min/1.73 m²). Praluent should be used with caution in patients with severe renal impairment.
Hepatic impairment: Patients with severe hepatic impairment (Child-Pugh C) have not been studied. Praluent should be used with caution in patients with severe hepatic impairment.

Common: Upper respiratory tract signs and symptoms, pruritus, injection site reactions.
See prescribing information for full details.

Effects of alirocumab on other medicinal products: Since alirocumab is a biological medicinal product, no pharmacokinetic effects of alirocumab on other medicinal products and no effect on cytochrome P450 enzymes are anticipated.
Effects of other medicinal products on alirocumab: Statins and other lipid-modifying therapy are known to increase production of PCSK9, the protein targeted by alirocumab. This leads to the increased target-mediated clearance and reduced systemic exposure of alirocumab. Compared to alirocumab monotherapy, the exposure to alirocumab is about 40%, 15%, and 35% lower when used concomitantly with statins, ezetimibe and fenofibrate, respectively. However, reduction of LDL-C is maintained during the dosing interval when alirocumab is administered every two weeks.

Pregnancy: There are no data from the use in pregnant women. Alirocumab is a recombinant IgG1 antibody, therefore it is expected to cross the placental barrier.
The use of Alirocumab is not recommended during pregnancy unless the clinical condition of the woman requires treatment with alirocumab.
Lactation: It is not known whether alirocumab is excreted in human milk. Human immunoglobulin G (IgG) is excreted in human milk, in particular in colostrum; the use of Alirocumab is not recommended in breastfeeding women during this period. For the remaining duration of breast-feeding, exposure is expected to be low. Since the effects of alirocumab on the breast-fed infant are unknown, a decision should be made whether to discontinue nursing or to discontinue Alirocumab during this period.
See prescribing information for full details.

In controlled clinical studies, no safety issues were identified with more frequent dosing than the recommended every 2 week dosing dosing schedule. There is no specific treatment for Praluent overdose. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required.

Storage: Store in a refrigerator (2°C – to 8°C). Do not freeze.
Praluent can be stored outside the refrigerator (below 25 °C) protected from light for a single period not exceeding 30 days. After removal from the refrigerator, the medicinal product must be used within 30 days or discarded.