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REPATHA is a brand name for Evolocumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Prevention of Cardiovascular Events Repatha® (evolocumab injection) is indicated as an adjunct to diet and standard of care therapy (including moderate- to high-intensity statin therapy alone or in combination with other lipid- lowering therapy), to reduce the risk of myocardial infarction, stroke, and coronary…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • REPATHA is administered subcutaneously. g. parent) after proper training by a healthcare professional. Administration should be performed by an individual who has been trained to administer the product. • In pediatric patients, REPATHA use should be initiated and supervised by healthcare professionals who treat children with dyslipidemias.
2 Recommended Dose and Dosage Adjustment Prevention of Cardiovascular Events and Primary Hyperlipidemia in Adult Patients (including HeFH and ASCVD) and HeFH in Pediatric Patients (aged 10 years and older) The recommended dose for REPATHA is either 140 mg every 2 weeks or 420 mg once monthly; both doses are clinically equivalent.
When switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of the prior regimen. One prefilled syringe* (PFS) or prefilled autoinjector (AI) delivers the 140 mg every 2 week dose. 5 mL prefilled cartridge delivers the 420 mg once monthly dose.
Alternatively, 3 prefilled syringes* or 3 prefilled AIs administered consecutively within 30 minutes delivers the 420 mg once monthly dose. Homozygous Familial Hypercholesterolemia Adult and Pediatric Patients (aged 10 years and older): The initial recommended dose is 420 mg once monthly.
After 12 weeks of treatment, dose frequency can be up-titrated to 420 mg once every 2 weeks if a clinically meaningful response is not achieved. Patients on apheresis may initiate treatment with 420 mg every two weeks to correspond with their apheresis schedule.
One AMD with prefilled cartridge delivers the 420 mg once monthly dose. Alternatively, three prefilled syringes* or 3 prefilled AIs administered consecutively within 30 minutes deliver the 420 mg once monthly or 420 mg every 2 weeks dose.
*Pre-filled syringes are not available in Canada REPATHA (evolocumab injection) Page 6 of 82 Patients with Renal Impairment There is limited experience in patients with severe or end-stage renal disease (ESRD) receiving hemodialysis.
No dosage adjustment may be required in these patient populations. However, REPATHA should be used with caution in patients with severe renal impairment (see 10 CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency).
). Hepatic/Biliary/Pancreatic The safety and efficacy of REPATHA in patients with severe hepatic impairment has not been studied. REPATHA should be used with caution in patients with severe hepatic impairment (Childs-Pugh, Class C). The effects of REPATHA in patients with or at risk of hepatitis C virus (HCV) infection remain uncertain.
Renal No dose adjustment is necessary in patients with mild to moderate renal impairment. There is limited experience with REPATHA in patients with severe renal impairment (see 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions, Renal Insufficiency).
Reproductive Health:
Female and Male Potential Fertility: No data are available on the effect of REPATHA on human fertility. For further fertility information regarding animal studies, see 16 NON-CLINICAL TOXICOLOGY. 1 Pregnant Women No studies have been conducted with REPATHA in pregnant women and relevant data from clinical use are very limited.
Studies in monkeys showed that evolocumab crosses the placental barrier. The serum concentrations in infant monkeys at birth were comparable to the maternal serum. For further information regarding animal studies, see 16 NON-CLINICAL TOXICOLOGY.
Animal studies are not always predictive of human response. Therefore, it is not known whether REPATHA can cause fetal harm when administered to a pregnant woman. For patients being treated for primary hyperlipidemia, REPATHA can be used alone or in comb ination with other lipid-lowering therapies.
Statin product monographs recommend discontinuation when a patient becomes pregnant, therefore REPATHA should also be discontinued (see the Special Populations section of the product monograph of the statins). For patients being treated for *Prefilled syringes are not available in Canada REPATHA (evolocumab injection) Page 9 of 82 homozygous familial hypercholesterolemia REPATHA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
, General 10/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .....................................................................................
2 TABLE OF CONTENTS .......................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION............................................................... 4 1 INDICATIONS..............................................................................................................
1 Pediatrics ........................................................................................................... 2 Geriatrics............................................................................................................
4 2 CONTRAINDICATIONS............................................................................................... 5 4 DOSAGE AND ADMINISTRATION.............................................................................. 1 Dosing Considerations........................................................................................
2 Recommended Dose and Dosage Adjustment .................................................... 3 Reconstitution..................................................................................................... 4 Administration.....................................................................................................
5 Missed Dose....................................................................................................... 6 5 OVERDOSAGE ...........................................................................................................
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ........................ 7 7 WARNINGS AND PRECAUTIONS .............................................................................. 1 Special Populations ............................................................................................
• REPATHA 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 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• For the lipid-lowering therapies such as statin or other lipid-lowering therapies used in combination with REPATHA, see the 2 CONTRAINDICATIONS section of the product monographs for those medications.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Patients with Hepatic Impairment No dosage adjustment is necessary in patients with mild to moderate hepatic impairment. Geriatric Patients No dosage adjustment is necessary in geriatric patients. 4 Administration Prior to subcutaneous administration, allow REPATHA to sit at room temperature up to 25°C for at least 30 minutes for the prefilled syringe* or autoinjector and at least 45 minutes for the automated mini-doser with prefilled cartridge.
Do not warm in any other way. Avoid vigorous shaking of the product. Visually inspect the solution for particles and discolouration. Do not use if the solution is discoloured, cloudy, or if flakes or particles are present. Doses may be administered in the upper arm, thigh, or abdomen.
Injection sites should be rotated and injections should not be given into areas where the skin is tender, bruised, red, or hard. Comprehensive instructions for the administration of REPATHA are provided in the Patient Medication Information.
5 Missed Dose If an every 2 week or once monthly dose is missed, instruct the patient to: • Administer REPATHA as soon as possible if there are more than 7 days until the next scheduled dose, or, • Omit the missed dose and administer the next dose according to the original schedule.
Women who become pregnant during REPATHA treatment, or their healthcare provider, are encouraged to call Amgen at 1-866-502-6436 to report the pregnancy. 2 Breast-feeding There is no information regarding the presence of evolocumab in human milk, the effects on the breastfed infant, or the effects on milk production.
A risk to breastfed newborns and infants cannot be excluded. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for REPATHA and any potential adverse effects on the breastfed infant from REPATHA or from the underlying maternal condition.
3 Pediatrics The efficacy and safety of REPATHA have been established in pediatric patients ≥ 10 years of age with HeFH and HoFH. A clinical study to evaluate the effects of REPATHA treatment was conducted in 157 pediatric patients aged 10 to 17 years old with HeFH and who received at least one dose of REPATHA or placebo.
No new safety concerns were identified and the safety data in this pediatric population were generally consistent with the known safety profile of the product in adults with HeFH. Twenty-six pediatric patients aged 11 to 17 years with HoFH have been treated with REPATHA in clinical studies.
The efficacy and safety data were generally consistent between pediatric and adult patients with HoFH. Data on efficacy and safety in HoFH patients aged 10-11 years are limited (see 14 CLINICAL TRIALS, Homozygous Familial Hypercholesterolemia (HoFH), Trial Design and Study Demographics).
REPATHA has not been studied in pediatric patients < 10 years of age with HeFH, HoFH or in pediatric patients with other types of dyslipidemia (see 14 CLINICAL TRIALS). 1%) were ≥ 75 years of age. No overall differences in safety or efficacy were observed between these patients and younger patients.
1 Adverse Reaction Overview The safety of REPATHA was evaluated in approximately 37,756 patients; 20,238 patients received REPATHA, representing 30,387 patient-years of exposure of REPATHA. The most common adverse reactions with REPATHA reported in > 2% of patients and greater than control were nasopharyngitis, upper respiratory tract infection, influenza and injection site reactions (pain, erythema, bruising, swelling and hemorrhage).
Rash, urticaria, back pain, arthralgia and nausea have also been reported. The safety profile in the pediatric population was generally consistent with the safety profile of REPATHA in the adult population. 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 for identifying and approximating rates of drug reactions in real - world use.
Adverse Reactions in the Cardiovascular Outcomes Trial In a double-blind, randomized, placebo controlled cardiovascular outcomes trial, 13,769 patients received at least one dose of REPATHA and 13,756 received placebo (see 14 CLINICAL TRIALS, Prevention of Cardiovascular Events).
5 years (range: 40 to 86 years), and 45% were 65 years of age and older. Twenty -five percent (25%) were women, 85% were White, 2% were Black, 10% were Asian, 8% identified as Hispanic. 1 months; 91% of patients were exposed for ≥ 12 months, 54% were exposed for ≥ 24 months, and 5% were exposed for ≥ 36 months.
In general, the safety profile of REPATHA in these patients was consistent with the known safety profile of REPATHA in patients with primary hyperlipidemia […]
1 Pregnant Women .......................................................................................... 2 Breast-feeding............................................................................................... 3 Pediatrics......................................................................................................
4 Geriatrics ...................................................................................................... 9 8 ADVERSE REACTIONS ..............................................................................................
1 Adverse Reaction Overview................................................................................ 2 Clinical Trial Adverse Reactions ........................................................................ 1 Clinical Trial Adverse Reactions – Pediatrics ...............................................
3 Less Common Clinical Trial Adverse Reactions................................................. 1 Less Common Clinical Trial Adverse Reactions – Pediatrics ........................ 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data .......................................................................................................
5 Post-Market Adverse Reactions ........................................................................ 14 REPATHA (evolocumab injection) Page 3 of 82 9 DRUG INTERACTIONS .............................................................................................
1 Serious Drug Interactions.................................................................................. 2 Drug Interactions Overview............................................................................... 3 Drug-Behavioural Interactions...........................................................................
4 Drug-Drug Interactions...................................................................................... 5 Drug-Food Interactions ..................................................................................... 6 Drug-Herb Interactions......................................................................................
7 Drug-Laboratory Test Interactions ..................................................................... 15 10 CLINICAL PHARMACOLOGY................................................................................... 1 Mechanism of Action ...................................................................................
2 Pharmacodynamics..................................................................................... 3 Pharmacokinetics........................................................................................ 16 11 STORAGE, STABILITY AND DISPOSAL ..................................................................
17 12 SPECIAL HANDLING INSTRUCTIONS ..................................................................... 17 PART II: SCIENTIFIC INFORMATION .................................................................................. 18 13 PHARMACEUTICAL INFORMATION ........................................................................
18 14 CLINICAL TRIALS .................................................................................................... 1 Clinical Trials by Indication .......................................................................... 2 Comparative Bioavailability Studies .............................................................
3 Immunogenicity........................................................................................... 35 15 MICROBIOLOGY....................................................................................................... 36 16 NON-CLINICAL TOXICOLOGY […]