Loading…
PRALUENT is a brand name for Alirocumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: , 1.1 Pediatrics 01/2022 4 DOSAGE AND ADMINISTRATION 05/2024 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACAKGING 05/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES…
Verbatim from this product's HC label. Tap a section to expand.
). , angioedema, hypersensitivity reactions requiring hospitalization, nummular eczema, hypersensitivity vasculitis) have been reported with Praluent treatment (see 8 ADVERSE REACTIONS). If signs or symptoms of serious allergic reactions occur, discontinue treatment with Praluent and initiate appropriate treatment according to standard of care, and monitor until signs and symptoms resolve (see 2 CONTRAINDICATIONS).
Renal Renal Impairment:
The safety and efficacy of Praluent in patients with severe renal impairment, including end-stage renal disease, have not been studied.
Reproductive Health:
Female and Male Potential • Fertility No data are available on the effect of Praluent on human fertility. Animal studies did not show any effects on fertility endpoints (see 16 NON-CLINICAL TOXICOLOGY). 1 Pregnant Women No studies have been conducted with Praluent in pregnant women and data from clinical use are very limited.
Studies in monkeys showed that alirocumab crosses the placental barrier and is pharmacologically active in infants exposed during organogenesis through parturition. A suppression of the humoral immune response to keyhole limpet hemocyanin (KLH) antigen was observed in offspring of exposed animals.
Animal studies did not demonstrate any additional effects on pregnancy or neonatal/infant development (see 16 NON-CLINICAL TOXICOLOGY). Animal studies are not always predictive of human response. Therefore, it is not known whether Praluent can cause fetal harm when administered to a pregnant woman.
Praluent is used in combination with maximally tolerated statin. Statin Product Monographs recommend discontinuation when a patient becomes pregnant, therefore Praluent should also be discontinued (see the Special Populations section of the relevant statin Product Monograph).
2 Breast-feeding There is no information regarding the presence of Praluent in human breast milk, the effects on the breastfed infant, or the effects on milk production. A risk to breastfed newborns and infants cannot be excluded. Because many drugs and immunoglobulins are excreted in human milk, the use of Praluent is not recommended in breastfeeding women.
1 Pediatrics); therefore, Health Canada has not authorized an indication for pediatric use. Clinical trial experience in the pediatric population is limited to 8 patients aged 9-11 (<12) years and 10 patients aged 12-17 (≥12-<18) years with homozygous familial hypercholesterolemia (HoFH), treated with 75mg (BW<50kg) or 150mg (BW>50kg) of PRALUENT Q2W for up to 48 weeks.
4 Geriatrics). 2 CONTRAINDICATIONS • Praluent is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the product monograph.
2 Recommended Dose and Dosage Adjustment The recommended starting dose of Praluent is 75 mg once every 2 weeks (Q2W) administered subcutaneously, since the majority of patients achieve sufficient LDL-C reduction with this dosage. Alternatively, 300 mg once every 4 weeks (monthly) may be administered subcutaneously for patients who prefer less frequent dosing.
Product Monograph - Praluent Page 5 of 66 Measure LDL-C levels within 4 to 8 weeks of initiating Praluent to assess response and adjust the dose, if needed. For patients receiving Praluent 300 mg every 4 weeks, measure LDL-C just prior to the next scheduled dose of initiating Praluent, since LDL-C levels in some patients can vary considerably between doses with this regimen (see 14 CLINICAL TRIALS, CHOICE I study).
If the LDL-C response is inadequate, the dosage may be adjusted to the maximum dosage of 150 mg administered every 2 weeks. 1 Pediatrics) Elderly patients No dose adjustment is needed for elderly patients. Hepatic impairment No dose adjustment is needed for patients with mild or moderately impaired hepatic function.
No data are available in patients with severe hepatic impairment (see 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions). Renal impairment No dose adjustment is needed for patients with mild or moderately impaired renal function.
No data are available in patients with severe renal impairment (see 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions – Renal Insufficiency). Body weight No dose adjustment is needed in patients based on weight (see 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions – Obesity).
• Praluent is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the product monograph.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
No data are available in patients younger than 9 years of age. 2 %) treated with Praluent were ≥ 75 years of age. No overall differences in safety or efficacy were observed between age classes but data are limited in patients over 75 years of age.
5 patient-years of exposure), the majority with high or very high cardiovascular risk, treated with Praluent at a dose of 75 or 150 mg, administered subcutaneously once every 2 weeks (Q2W), for a treatment duration of up to 18 months (including 1999 patients exposed to Praluent for at least 52 weeks, and 639 patients Product Monograph - Praluent Page 9 of 66 exposed to Praluent for at least 76 weeks).
The safety data are based on pooled results from nine placebo-controlled studies (four phase 2 and five phase 3 studies, all in patients on background statin). 3% of patients in the placebo group. In ten phase 3 controlled trials, involving patients with primary hypercholesterolemia, the most common adverse reactions were local injection site reactions (including erythema/redness, itching, swelling, pain/tenderness), upper respiratory tract signs and symptoms and pruritus (itch).
1% of patients in the placebo group. 4% for Praluent and placebo, respectively). The safety profile of Praluent derived from the cardiovascular outcomes study (ODYSSEY OUTCOMES) was consistent with the overall safety profile described in the phase 3 controlled trials.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 3% Product Monograph - Praluent Page 10 […]
4 Administration Praluent is administered as a subcutaneous injection into the thigh, abdomen, or upper arm, using a single-use pre-filled pen. To allow the solution to come to room temperature, remove the 75 mg or 150 mg pen from the refrigerator approximately 30 to 40 min before the injection, or the 300 mg pen approximately 45 minutes before the injection.
The patient may either self-inject alirocumab, or a caregiver may administer alirocumab, after guidance has been provided by a healthcare professional on proper subcutaneous injection technique. To administer the 300 mg dose, give either one 300 mg Praluent injection or two 150 mg Praluent injections consecutively at two different injection sites.
The 300 mg dose may be self-administered in thigh or abdomen. Only upper arm administrations require the help of a caregiver. Product Monograph - Praluent Page 6 of 66 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. Do not co-administer Praluent with other injectable drugs at the same injection site. 5 Missed Dose If an every 2-week dose is missed, the patient should administer the injection as soon as possible (within 7 days from the missed dose), and thereafter resume treatment two weeks from the day of the missed dose, keeping the patient’s original schedule.
If the missed dose is not administered within 7 days, instruct the patient to wait until the next dose on the original schedule. If an every 4-week dose is missed, instruct the patient to administer the injection within 7 days of the missed dose and then resume the patient’s original schedule.
If the missed dose is not administered within 7 days, instruct the patient to administer the dose, starting a new schedule based on this date. 5 OVERDOSAGE In controlled clinical studies, no safety issues were identified with more frequent Praluent dosing than the recommended Q2W dosing schedule.
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING To help ensure the traceability of biologic products, including biosimilars, health professionals should recognise the importance of recording both the brand name and the non-proprietary (active ingredient) name as well as other product-specific identifiers such as the Drug Identification Number (DIN) and the batch/lot number of the product supplied.
0. Praluent is supplied as a sterile, preservative-free solution for injection, in a single-use pre-filled pen (PFP). Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Subcutaneous injection Solution in Pre-filled Pen (PFP) 75 mg/mL 150 mg/mL 300 mg/2 mL Histidine, polysorbate 20, sucrose, water for injection Product Monograph - Praluent Page 7 of 66 • 75 mg/mL PFP: The syringe components are assembled into a single-use pre-filled pen with a blue cap and a light green activation button.
• 150 mg/mL PFP: The syringe components are assembled into a single-use pre-filled pen with a blue cap and a dark grey activation button. • 300 mg/2 mL PFP: The syringe components are assembled into a single-use pre-filled pen with a blue cap and no activation button.
Each 1 mL PFP contains 75 mg or 150 mg alirocumab. Each 2 mL PFP contains 300 mg alirocumab. 0. Praluent 75 mg/mL or 150 mg/mL solution for injection in single-use PFP is supplied in a siliconized 1 mL or 2 mL […]