Praluent Injection

Alirocumab
75mg/ml
Sanofi Aventis Groupe
Pack size 2 Pre-filled Pen
Dispensing mode POM
Source FRANCE
AgentCITY MEDICAL STORE
Retail Price 2254.00 AED

Available as:

Indications

Praluent Injection is used for: Hypercholesterolemia, Indicated as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-cholesterol (LDL-C)

Adult Dose

Hypercholesterolemia Indicated as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-cholesterol (LDL-C) Every 2 week schedule Recommended starting dose: 75 mg SC q2Weeks Measure CLC-C levels within 4-8 week of initiating; if inadequate response, may increase to 150 mg SC q2Weeks; reassess LDL-C within 4-8 weeks Not to exceed 150 mg SC q2Weeks Every 4 week schedule Recommended starting dose: 300 mg SC q4Weeks (ie, two 150-mg injections consecutively at 2 different injection sites) Measure LDL-C just prior to the next scheduled dose; if inadequate response, may adjust dose to 150 mg q2Weeks, starting the new dose on the next scheduled dosing date; reassess LDL-C within 4-8 weeks Hepatic impairment Mild or moderate: No dose adjustment required Severe: Not studied

Child Dose

Renal Dose

Renal impairment Mild or moderate: No dose adjustment required Severe: Not studied

Administration

SC Preparation Provide proper training to patients and/or caregivers on preparation and administration prior to use Allow prefilled syringe or pen to warm to room temperature for 30-40 minutes prior injection; administer as soon as possible after it has warmed up Do not use if it has been at room temperature [77°F (25°C)] for ?24 hr Visually inspect for particulate matter and discoloration before administration; discard if the solution is discolored or contains visible particulate matter Follow aseptic injection technique for every administration time SC Administration Administer by SC injection into the thigh, abdomen, or upper arm using a single-dose prefilled pen or syringe Rotate the injection site with each injection Do not inject into areas of active skin disease or injury (eg, sunburns, rashes, inflammation, infections) Do not coadminister with other injectable drugs at the same injection site

Contra Indications

History of serious hypersensitivity reaction to alirocumab; reactions have included hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization

Precautions

Discontinue if symptoms of allergic reactions occur. Exclude secondary causes of hyperlipidaemia or mixed dyslipidaemia (eg, nephrotic syndrome, hypothyroidism) prior to initiating therapy. Severe renal & hepatic impairment. Pregnancy & lactation. Childn & adolescents <18 yr. Lactation Unknown if distributed in human breast milk The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant Human IgG is present in human milk, but published data suggest that breastmilk IgG antibodies do not enter the neonatal and infant circulation in substantial amounts

Pregnancy-Lactation

Pregnancy No available data on use in pregnant women; Lactation Unknown if distributed in human breast milk The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant Human IgG is present in human milk, but published data suggest that breastmilk IgG antibodies do not enter the neonatal and infant circulation in substantial amounts

Interactions

Increased target-mediated clearance & reduced systemic exposure w/ statins & other lipid-modifying therapy.

Adverse Effects

Side effects of Alirocumab : 1-10% Allergic reactions (8.6%) Injection site reactions (7.2%) Influenza (5.7%) Antidrug antibodies (4.8%) Myalgia (4.2%) Muscle spasms (3.1%) Contusion (2.1%) Musculoskeletal pain (2.1%)

Mechanism of Action

Monoclonal antibody that binds to PCSK9 (proprotein convertase subtilisin/kexin type 9) LDL-C is cleared from the circulation preferentially through the LDL receptor (LDLR) pathway PCSK9 is a serine protease that destroys LDLR in the liver, resulting in decreased LDL-C clearance and increased plasma LDL-C PCSK9 inhibitors decrease LDLR degradation by PCSK9, and thereby improve LDL-C clearance and lower plasma LDL-C

Note

Praluent 75mg/ml Injection manufactured by Sanofi Aventis Groupe. Its generic name is Alirocumab. Praluent is availble in United Arab Emirates. Farmaco UAE drug index information on Praluent Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

Some other brands of Alirocumab :