Heterozygous Familial Hypercholesterolemia (HeFH) Treatments
Find Heterozygous Familial Hypercholesterolemia (HeFH) Treatments
Brand Name
Repatha
Generic Name
Evolocumab
View Brand Information FDA approval date: October 09, 2018
Classification: PCSK9 Inhibitor
Form: Injection
What is Repatha (Evolocumab)?
REPATHA is indicated: To reduce the risk of major adverse cardiovascular events in adults at increased risk for these events. As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol in: adults with hypercholesterolemia. adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia . adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia . REPATHA is a PCSK9 inhibitor indicated: To reduce the risk of major adverse cardiovascular events in adults at increased risk for these events. As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol in: adults with hypercholesterolemia. adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia . adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia .
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Brand Information
REPATHA (Evolocumab)
1INDICATIONS AND USAGE
REPATHA is indicated:
- To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events.
- As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in:
- adults with hypercholesterolemia.
- adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
- adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).
2DOSAGE FORMS AND STRENGTHS
REPATHA injection is a clear to opalescent, colorless to pale yellow solution available as follows:
- 140 mg/mL solution in a prefilled single-dose pen
- 140 mg/mL solution in a prefilled single-dose SureClick
- 140 mg/mL solution in a prefilled single-dose syringe
3CONTRAINDICATIONS
REPATHA is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in REPATHA. Serious hypersensitivity reactions including angioedema have occurred in patients treated with REPATHA
4ADVERSE REACTIONS
The following adverse reactions are also discussed in other sections of the label:
- Hypersensitivity Reactions
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Adverse Reactions in Adults with Primary Hypercholesterolemia
The data described below reflect exposure to REPATHA in 8 placebo-controlled trials that included 2651 patients treated with REPATHA, including 557 exposed for 6 months and 515 exposed for 1 year (median treatment duration of 12 weeks). The mean age of the population was 57 years, 49% of the population were women, 85% White, 6% Black, 8% Asian, and 2% other races.
Adverse Reactions in a 52-Week Controlled Trial
In a 52-week, double-blind, randomized, placebo-controlled trial, 599 patients received 420 mg of REPATHA subcutaneously once monthly
Adverse Reactions in Seven Pooled 12-Week Controlled Trials
In seven pooled 12-week, double-blind, randomized, placebo-controlled trials, 993 patients received 140 mg of REPATHA subcutaneously every 2 weeks and 1059 patients received 420 mg of REPATHA subcutaneously monthly. The mean age was 57 years (range: 18 to 80 years), 29% were older than 65 years, 49% women, 85% White, 5% Black, 9% Asian; 5% identified as Hispanic ethnicity. Adverse reactions reported in at least 1% of REPATHA-treated patients, and more frequently than in placebo-treated patients, are shown in Table 2.
Adverse Reactions in Eight Pooled Controlled Trials (Seven 12-Week Trials and One 52-Week Trial)
The adverse reactions described below are from a pool of the 52-week trial and seven 12-week trials. The mean and median exposure durations of REPATHA in this pool of eight trials were 20 weeks and 12 weeks, respectively.
Local Injection Site Reactions
Injection site reactions occurred in 3.2% and 3.0% of REPATHA-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. The proportions of patients who discontinued treatment due to local injection site reactions in REPATHA-treated patients and placebo-treated patients were 0.1% and 0%, respectively.
Hypersensitivity Reactions
Hypersensitivity reactions occurred in 5.1% and 4.7% of REPATHA-treated and placebo-treated patients, respectively. The most common hypersensitivity reactions were rash (1.0% versus 0.5% for REPATHA and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).
Adverse Reactions in the CV Outcomes Trial
In a double-blind, randomized, placebo-controlled CV outcomes trial, 27,525 patients received at least one dose of REPATHA or placebo
The safety profile of REPATHA in this trial was generally consistent with the safety profile described above in the 12- and 52-week controlled trials involving patients with primary hypercholesterolemia. Common adverse reactions (> 5% of patients treated with REPATHA and occurring more frequently than placebo) included diabetes mellitus (8.8% REPATHA, 8.2% placebo), nasopharyngitis (7.8% REPATHA, 7.4% placebo), and upper respiratory tract infection (5.1% REPATHA, 4.8% placebo).
Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients treated with REPATHA compared with 7.7% in patients that received placebo.
Adverse Reactions in Pediatric Patients with HeFH
In a 24-week, randomized, placebo-controlled, double-blind trial of 157 pediatric patients with HeFH, 104 patients received 420 mg REPATHA subcutaneously once monthly
- Nasopharyngitis (12% versus 11%)
- Headache (11% versus 2%)
- Oropharyngeal pain (7% versus 0%)
- Influenza (6% versus 4%)
- Upper respiratory tract infection (6% versus 2%)
Adverse Reactions in Adults and Pediatric Patients with HoFH
In a 12-week, double-blind, randomized, placebo-controlled trial of 49 patients with HoFH, 33 patients received 420 mg of REPATHA subcutaneously once monthly
- Upper respiratory tract infection (9.1% versus 6.3%)
- Influenza (9.1% versus 0%)
- Gastroenteritis (6.1% versus 0%)
- Nasopharyngitis (6.1% versus 0%)
In a multicenter, open-label 5-year extension study, 106 patients with HoFH, including 14 pediatric patients, received 420 mg of REPATHA subcutaneously once monthly or every 2 weeks
4.2Postmarketing Experience
The following additional adverse reactions have been identified during post-approval use of REPATHA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Hypersensitivity reactions: Angioedema
- Influenza-like illness
5DESCRIPTION
Evolocumab is a human monoclonal immunoglobulin G2 (IgG2) directed against human proprotein convertase subtilisin kexin type 9 (PCSK9). Evolocumab has an approximate molecular weight (MW) of 144 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells.
REPATHA is a sterile, preservative-free, clear to opalescent, colorless to pale yellow solution for subcutaneous use. Each 1 mL prefilled single-dose pen, prefilled single-dose SureClick
6CLINICAL STUDIES
Adult Patients with Established Cardiovascular Disease
Study 1 (FOURIER, NCT01764633) was a double-blind, randomized, placebo-controlled, event-driven trial in 27,564 (13,784 REPATHA, 13,780 placebo) adult patients with established cardiovascular disease (CVD) and with LDL-C ≥ 70 mg/dL and/or non-HDL-C ≥ 100 mg/dL despite high- or moderate-intensity statin therapy. Patients were randomly assigned 1:1 to receive either subcutaneous injections of REPATHA (140 mg every 2 weeks or 420 mg once monthly) or placebo; 86% used the every-2-week regimen throughout the trial. The median follow-up duration was 26 months. Overall, 99.2% of patients were followed until the end of the trial or death.
The mean (SD) age at baseline was 63 (9) years, with 45% being at least 65 years old; 25% were women. The trial population was 85% White, 2% Black, and 10% Asian; 8% identified as Hispanic ethnicity. Regarding prior diagnoses of CVD, 81% had prior myocardial infarction, 19% prior non-hemorrhagic stroke, and 13% had symptomatic peripheral arterial disease. Selected additional baseline risk factors included hypertension (80%), diabetes mellitus (1% type 1; 36% type 2), current daily cigarette smoking (28%), New York Heart Association class I or II congestive heart failure (23%), and eGFR < 60 mL/min per 1.73 m
REPATHA significantly reduced the risk for the primary composite endpoint (time to first occurrence of CV death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization; p < 0.0001) and the key secondary composite endpoint (time to first occurrence of cardiovascular death, myocardial infarction, or stroke; p < 0.0001). The Kaplan-Meier estimates of the cumulative incidence of the primary and key secondary composite endpoints over time are shown in Figure 1 and Figure 2 below.
The results of primary and secondary efficacy endpoints are shown in Table 3 below.
The difference between REPATHA and placebo in mean percent change in LDL-C from baseline to Week 12 was −63% (95% CI: −63%, −62%) and from baseline to Week 72 was −57% (95% CI: −58%, −56%). At Week 48, the median [Q1, Q3] LDL-C was 26 [15, 46] mg/dL in the REPATHA group, with 47% of patients having LDL-C < 25 mg/dL.
In EBBINGHAUS (NCT02207634), a substudy of 1974 patients enrolled in the FOURIER trial, REPATHA was non-inferior to placebo on selected cognitive function domains as assessed with the use of neuropsychological function tests over a median follow-up of 19 months.
Primary Hypercholesterolemia
Study 2 (LAPLACE-2, NCT01763866) was a multicenter, double-blind, randomized controlled 12-week trial in which patients were initially randomized to an open-label specific statin regimen for a 4-week lipid stabilization period followed by random assignment to subcutaneous injections of REPATHA 140 mg every 2 weeks, REPATHA 420 mg once monthly, or placebo for 12 weeks. The trial included 1896 patients with hypercholesterolemia who received REPATHA, placebo, or ezetimibe as add-on therapy to daily doses of statins (atorvastatin, rosuvastatin, or simvastatin). Ezetimibe was also included as an active control only among those assigned to background atorvastatin. Overall, the mean age at baseline was 60 years (range: 20 to 80 years), 35% were ≥ 65 years old, 46% women, 94% White, 4% were Black, and 1% Asian; 5% identified as Hispanic or Latino ethnicity. After 4 weeks of background statin therapy, the mean baseline LDL-C ranged between 77 and 127 mg/dL across the five background therapy arms.
The difference between REPATHA and placebo in mean percent change in LDL-C from baseline to Week 12 was −71% (95% CI: −74%, −67%; p < 0.0001) and −63% (95% CI: −68%, −57%; p ˂ 0.0001) for the 140 mg every 2 weeks and 420 mg once monthly dosages, respectively. The difference between REPATHA and ezetimibe in mean percent change in LDL-C from baseline to Week 12 was −45% (95% CI: −52%, −39%; p < 0.0001) and −41% (95% CI: −47%, −35%; p ˂ 0.0001) for the 140 mg every 2 weeks and 420 mg once monthly dosages, respectively. For additional results, see
Study 3 (DESCARTES, NCT01516879) was a multicenter, double-blind, randomized, placebo-controlled, 52-week trial that included 901 patients with hypercholesterolemia who received protocol-determined background lipid-lowering therapy of a cholesterol-lowering diet either alone or in addition to atorvastatin (10 mg or 80 mg daily) or the combination of atorvastatin 80 mg daily with ezetimibe. After stabilization on background therapy, patients were randomly assigned to the addition of placebo or REPATHA 420 mg administered subcutaneously once monthly. Overall, the mean age at baseline was 56 years (range: 25 to 75 years), 23% were ≥ 65 years, 52% women, 80% White, 8% Black, and 6% Asian; 6% identified as Hispanic or Latino ethnicity. After stabilization on the assigned background therapy, the mean baseline LDL-C ranged between 90 and 117 mg/dL across the four background therapy groups.
In these patients with hypercholesterolemia on a protocol-determined background therapy, the difference between REPATHA 420 mg once monthly and placebo in mean percent change in LDL-C from baseline to Week 52 was −55% (95% CI: −60%, −50%; p ˂ 0.0001) (Table 5 and Figure 4). For additional results, see
Study 4 (MENDEL-2, NCT01763827) was a multicenter, double-blind, randomized, placebo- and active-controlled, 12-week trial that included 614 patients with hypercholesterolemia who were not taking lipid-lowering therapy at baseline. Patients were randomly assigned to receive subcutaneous injections of REPATHA 140 mg every 2 weeks, REPATHA 420 mg once monthly, or placebo for 12 weeks. Blinded administration of ezetimibe was also included as an active control. Overall, the mean age at baseline was 53 years (range: 20 to 80 years), 18% were ≥ 65 years old, 66% were women, 83% White, 7% Black, and 9% Asian; 11% identified as Hispanic or Latino ethnicity. The mean baseline LDL-C was 143 mg/dL.
The difference between REPATHA and placebo in mean percent change in LDL-C from baseline to Week 12 was −55% (95% CI: −60%, −50%; p < 0.0001) and −57% (95% CI: −61%, −52%; p ˂ 0.0001) for the 140 mg every 2 weeks and 420 mg once monthly dosages, respectively. The difference between REPATHA and ezetimibe in mean percent change in LDL-C from baseline to Week 12 was −37% (95% CI: −42%, −32%; p < 0.0001) and −38% (95% CI: −42%, −34%; p ˂ 0.0001) for the 140 mg every 2 weeks and 420 mg once monthly dosages, respectively. For additional results, see
Study 5 (RUTHERFORD-2, NCT01763918) was a multicenter, double-blind, randomized, placebo-controlled, 12-week trial in 329 patients with HeFH on statins with or without other lipid-lowering therapies. Patients were randomized to receive subcutaneous injections of REPATHA 140 mg every two weeks, 420 mg once monthly, or placebo. HeFH was diagnosed by the Simon Broome criteria (1991). In Study 5, 38% of patients had clinical atherosclerotic CVD. The mean age at baseline was 51 years (range: 19 to 79 years), 15% of the patients were ≥ 65 years old, 42% were women, 90% were White, 5% were Asian, and 1% were Black. The average LDL-C at baseline was 156 mg/dL with 76% of the patients on high-intensity statin therapy.
The differences between REPATHA and placebo in mean percent change in LDL-C from baseline to Week 12 was −61% (95% CI: −67%, −55%; p < 0.0001) and −60% (95% CI: −68%, −52%; p < 0.0001) for the 140 mg every 2 weeks and 420 mg once monthly dosages, respectively. For additional results, see
Pediatric Patients with HeFH
Study 6 (HAUSER-RCT, NCT02392559) was a randomized, multicenter, placebo-controlled, double-blind, 24-week trial in 157 pediatric patients aged 10 to 17 years with HeFH
The difference between REPATHA and placebo in mean percent change in LDL-C from baseline to Week 24 was −38% (95% CI: −45%, −31%; p < 0.0001). For additional results, see
Adults and Pediatric Patients with HoFH
Study 7 (TESLA, NCT01588496) was a multicenter, double-blind, randomized, placebo-controlled, 12-week trial in 49 patients (not on lipid-apheresis therapy) with HoFH. In this trial, 33 patients received subcutaneous injections of 420 mg of REPATHA once monthly and 16 patients received placebo as an adjunct to other lipid-lowering therapies (e.g., statins, ezetimibe). The mean age at baseline was 31 years, 49% were women, 90% White, 4% were Asian, and 6% other. The trial included 10 adolescents (ages 13 to 17 years), 7 of whom received REPATHA. The mean LDL-C at baseline was 349 mg/dL with all patients on statins (atorvastatin or rosuvastatin) and 92% on ezetimibe. The diagnosis of HoFH was made by genetic confirmation or a clinical diagnosis based on a history of an untreated LDL-C concentration > 500 mg/dL together with either xanthoma before 10 years of age or evidence of HeFH in both parents.
The difference between REPATHA and placebo in mean percent change in LDL-C from baseline to Week 12 was −31% (95% CI: −44%, −18%; p < 0.0001). For additional results, see
Patients known to have two LDL-receptor negative alleles (little to no residual function) did not respond to REPATHA.
Study 8 (TAUSSIG, NCT01624142) was a multicenter, open-label 5-year extension study with REPATHA in 106 patients with HoFH, who were treated with REPATHA as an adjunct to other lipid-lowering therapies. The study included 14 pediatric patients (ages 13 to 17 years). All patients in the study were initially treated with REPATHA 420 mg once monthly except for those receiving lipid apheresis at enrollment, who began with REPATHA 420 mg every 2 weeks. Dose frequency in non-apheresis patients could be titrated up to 420 mg once every 2 weeks based on LDL-C response and PCSK9 levels.
A total of 48 patients with HoFH received REPATHA 420 mg once monthly for at least 12 weeks in Study 8 followed by REPATHA 420 mg every 2 weeks for at least 12 weeks. Mean percent change from baseline in LDL-C were −20% at Week 12 of 420 mg once monthly treatment and −30% at Week 12 of 420 mg every 2 weeks treatment, based on available data.
Study 9 (HAUSER-OLE, NCT02624869) was an open-label, single-arm, multicenter, 80-week study to evaluate the safety, tolerability, and efficacy of REPATHA for LDL-C reduction in pediatric patients aged 10 to 17 years with HoFH
7HOW SUPPLIED/STORAGE AND HANDLING
REPATHA is a clear to opalescent, colorless to pale yellow solution supplied as follows:
8PATIENT COUNSELING INFORMATION
Advise the patient and/or caregiver to read the FDA-Approved Patient Labeling (Patient Information and Instructions for Use).
Hypersensitivity
Inform patients that serious hypersensitivity reactions (e.g., angioedema) have been reported in patients treated with REPATHA. Advise patients on the symptoms of hypersensitivity reactions and instruct them to discontinue REPATHA and seek medical attention promptly, if such symptoms occur.
Latex-Sensitivity
Instruct patients to inform their healthcare provider if they are sensitive to latex. Inform patients that REPATHA is available as prefilled single-dose SureClick
Pregnancy
Advise women who are exposed to REPATHA during pregnancy that there is a pregnancy safety study that monitors pregnancy outcomes. Encourage these patients to report their pregnancy to Amgen at 1-800-77-AMGEN (1-800-772-6436) or https://wwwext.amgen.com/products/global-patient-safety/adverse-event-reporting
Administration
Provide guidance to patients and caregivers on proper subcutaneous administration technique and how to use the prescribed REPATHA device correctly. Inform patients that it may take up to 15 seconds to administer REPATHA using the prefilled single-dose pen, prefilled single-dose SureClick
The prefilled single-dose pen is not made with natural rubber latex.
9INSTRUCTIONS FOR USE REPATHA®[ri-PAth-a] (evolocumab) injection, for subcutaneous use mg/mL prefilled single-dose SureClick®autoinjector (contains dry natural rubber)
This Instructions for Use contains information on how to inject REPATHA with a SureClick autoinjector.
If your healthcare provider decides that you or a caregiver may be able to give your injections of REPATHA at home, you should receive training on the right way to prepare and inject REPATHA. Do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse.
The medicine in the REPATHA autoinjector is for injection under the skin (subcutaneous injection). See the REPATHA
Additional information about your sharps disposal container
- made of a heavy-duty plastic,
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak-resistant, and
- properly labeled to warn of hazardous waste inside the container.
Disposing of sharps disposal containers:
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container.
There may be state or local laws about how you should throw away used needles and syringes.
For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.
Do not recycle your used sharps disposal container.
Keep the autoinjector and sharps disposal container out of the sight and reach of children.
For more information or help call 1-844-REPATHA (1-844-737-2842).
REPATHA (evolocumab)
Manufactured by:
© 2015-2022, 2024-2025 Amgen Inc.
10INSTRUCTIONS FOR USE REPATHA®[ri-PAth-a] (evolocumab) injection, for subcutaneous use mg/mL prefilled single-dose SureClick®autoinjector
This Instructions for Use contains information on how to inject REPATHA with a SureClick autoinjector.
If your healthcare provider decides that you or a caregiver may be able to give your injections of REPATHA at home, you should receive training on the right way to prepare and inject REPATHA. Do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider or nurse.
The medicine in the REPATHA autoinjector is for injection under the skin (subcutaneous injection). See the REPATHA
Additional information about your sharps disposal container
- made of a heavy-duty plastic,
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak-resistant, and
- properly labeled to warn of hazardous waste inside the container.
Disposing of sharps disposal containers:
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container.
There may be state or local laws about how you should throw away used needles and syringes.
For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.
Do not recycle your used sharps disposal container.
Keep the autoinjector and sharps disposal container out of the sight and reach of children.
For more information or help call 1-844-REPATHA (1-844-737-2842).
REPATHA (evolocumab)
Manufactured by:
© 2024-2025 Amgen Inc.
11Instructions For Use for Patients
Side B
This Instructions for Use contains information on how to inject Repatha with a prefilled pen.
- If your healthcare provider decides that Repatha injections may be given at home, you or your caregiver should receive training on the right way to prepare and inject Repatha. You should not inject until you or your caregiver have been shown the right way to give the injections by your healthcare provider or nurse.
- The medicine in the prefilled pen is for injection under the skin (subcutaneous injection). See the Repatha Patient Information for information about Repatha.
Important Information You Need to Know Before Injecting Repatha
- You should not give the injection until you have fully read and understood this Instructions for Use.
- Do not shake the prefilled pen.
- The prefilled pen is not made with natural rubber latex.
Dosing
- The prefilled pen contains a 140 mg dose of Repatha.
- If your prescribed dose is
- If your prescribed dose is
- Check the prefilled pen label and prescription to make sure you have the correct medicine, dose and number of prefilled pens.
Storage Information
- Keep the prefilled pen in the original carton to protect it from light and physical damage.
- Do not freeze the prefilled pen or store in extreme heat.
- You may keep the prefilled pen at room temperature between 68°F to 77°F (20°C to 25°C) for up to 30 days, if needed.
Getting to Know the Prefilled Pen
Side A
Pull to see instructions
Gather the above items for the injection on a clean, flat, and well-lit surface.
Where to get help
For more information or help using Repatha:
- Contact your healthcare provider
- Visit
- Call 1-844-REPATHA (1-844-737-2842).
- Remove the pens from the refrigerator. Wait at least 30 minutes for it to warm naturally to room temperature.
- Only remove the number of prefilled pens needed for a full dose of medicine.
- Do not heat the prefilled pen with hot water, a microwave, or direct sunlight.
- Put any unused prefilled pens back into the refrigerator.
- Inspect the medicine. It should be clear and colorless to slightly yellow. It is okay to see air bubbles.
- Check the expiration date (Exp.) and inspect the prefilled pen for damage.
- Select the thigh or stomach for the injection site.
- Only a caregiver or healthcare provider should inject in the back of the upper arm.
- Choose a different site for each injection.
- Wash your hands with soap and water. Clean the skin at the injection site with an alcohol wipe.
- Let the skin dry naturally.
- Do not blow on or touch the injection site again.
- Pull hard or twist the cap to remove it. Never put the cap back on as it may damage the needle.
- It is okay to see a few drops of medicine come out of the needle.
- Grasp the prefilled pen so you can see the window. Create a firm surface at the injection site.
- If needed, stretch or pinch the skin to create a firm surface at the injection site until the injection is finished.
- To start the injection, place the pen on your skin. Push down and hold firmly without releasing.
- The yellow safety guard will disappear, and you may hear a click.
Pull to see instructions
- Continue to hold the prefilled pen down. The injection is complete when the window turns fully yellow. You may hear a second click.
- Confirm all medicine was injected.
- A small drop of liquid on the injection site is okay.
- Call your healthcare provider if you have not received a full injection of medicine.
- Check the injection site.
- Do not rub the injection site.
- If there is blood, use a cotton ball and apply an adhesive bandage.
- Place the used prefilled pen and cap in a sharps disposal container.
- Do not throw away the prefilled pen in your household trash.
- Do not reuse the prefilled pen.
For more information or help call 1-844-REPATHA (1-844-737-2842).
If prescribed a 420 mg dose: Use 3 prefilled pens. Dispose of each used pen and cap, then inject with a new pen at a different injection site. Give all 3 injections within 30 minutes.
If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic,
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak-resistant, and
- properly labeled to warn of hazardous waste inside the container.
Throwing away (disposing of) sharps disposal containers:
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container.
There may be state or local laws about how you should throw away used needles and syringes.
For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at:
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.
Do not recycle your used sharps disposal container.
Keep the prefilled pen and sharps disposal container out of the sight and reach of children.
Manufactured by:
12PRINCIPAL DISPLAY PANEL - 2 x 140 mg/mL Autoinjector Carton - NDC 72511-760-02
AMGEN
2 x Prefilled Single-Dose Autoinjectors
Repatha
repathainjection.com
140 mg/mL
For Subcutaneous Use Only
Sterile Solution – No Preservative
140
CAUTION, See package insert
This Product Contains
Do not re-use
Refrigerate
Keep out of the sight
Rx Only
U.S. License No. 1080
NDC 72511-760-02
13PRINCIPAL DISPLAY PANEL - 1 x 140 mg/mL Autoinjector Carton - NDC 72511-760-91
AMGEN
1 x Prefilled Single-Dose Autoinjector
Repatha
Not for Sale
repathainjection.com
140 mg/mL
For Subcutaneous Use Only
Sterile Solution – No Preservative
140
CAUTION, See package insert
This Product Contains
Do not re-use
Refrigerate
Keep out of the sight
Rx Only
U.S. License No. 1080
NDC 72511-760-91
14PRINCIPAL DISPLAY PANEL - 140 mg/mL Syringe Carton
1 x 1 mL Prefilled Syringe
AMGEN
Repatha
140 mg/mL
For Subcutaneous Use Only
Store refigerated at 2°C to 8°C (36°F to 46°F). Do Not Freeze or Shake.
Sterile Solution – No Preservative
Do not re-use
CAUTION, See package insert for full prescribing
This Product Contains Dry Natural Rubber.
Keep out of the sight and reach of children
15PRINCIPAL DISPLAY PANEL - Kit Carton
1 x 3.5 mL Prefilled Cartridge
AMGEN
Repatha
420 mg/3.5 mL
For Subcutaneous Use Only
Single-Dose Only
Sterile Solution – No Preservative
Keep out of the sight and reach of children.
Refer to Instructions for Use
Do Not Use if Package is Damaged
On-Body Infusor Sterilized
420 mg/
MR Unsafe
Keep Dry
Do not re-use
Type BF Applied Part
Relative Humidity
Rx Only
16PRINCIPAL DISPLAY PANEL - 1 x 140 mg/mL Autoinjector Carton - NDC 72511-393-01
AMGEN
1 x Prefilled Single-Dose Autoinjector
Repatha
repathainjection.com
140 mg/mL
For Subcutaneous Use Only
Sterile Solution – No Preservative
140
Not made with
CAUTION, See package insert
Do not re-use
Refrigerate
Keep out of the sight
Rx Only
U.S. License No. 1080
NDC 72511-393-01
17PRINCIPAL DISPLAY PANEL - 2 x 140 mg/mL Autoinjector Carton - NDC 72511-393-02
AMGEN
2 x Prefilled Single-Dose Autoinjectors
Repatha
repathainjection.com
140 mg/mL
For Subcutaneous Use Only
Sterile Solution – No Preservative
140
Not made with
CAUTION, See package insert
Do not re-use
Refrigerate
Keep out of the sight
Rx Only
U.S. License No. 1080
NDC 72511-393-02
18PRINCIPAL DISPLAY PANEL - 1 x 140 mg/mL Autoinjector Carton - NDC 72511-393-96
AMGEN
1 x Prefilled Single-Dose Autoinjector
Repatha
Not for Sale
repathainjection.com
140 mg/mL
For Subcutaneous Use Only
Sterile Solution – No Preservative
140
Not made with
CAUTION, See package insert
Do not re-use
Refrigerate
Keep out of the sight
Rx Only
U.S. License No. 1080
NDC 72511-393-96
19PRINCIPAL DISPLAY PANEL - 140 mg/mL Syringe Carton - NDC 72511-501-01
1 x 1 mL Prefilled Syringe
AMGEN
140
Repatha
Not made
140 mg/mL
For Subcutaneous Use Only
Store refrigerated at 2°C to 8°C (36°F to 46°F). Do Not Freeze or Shake.
Sterile Solution – No Preservative
Rx Only
Do not re-use
CAUTION, See package insert for full prescribing
Keep out of the sight and reach of children
GTIN
20PRINCIPAL DISPLAY PANEL - 140 mg/mL Prefilled Pen Carton - NDC 72511-143-02
NDC 72511-143-02
AMGEN
140
Repatha
140 mg/mL
For Subcutaneous Use Only
ATTENTION: Enclosed Patient Information is required for each patient.
See back of carton for important storage information.
New Device
Read the Instructions for Use Before Using.
2 x Single-Dose Prefilled Pens
GTIN:
21PRINCIPAL DISPLAY PANEL - 140 mg/mL Prefilled Pen Carton - NDC 72511-143-01
NDC 72511-143-01
AMGEN
140
Repatha
140 mg/mL
For Subcutaneous Use Only
ATTENTION: Enclosed Patient Information is required for each patient.
See back of carton for important storage information.
New Device
Read the Instructions for Use Before Using.
1 x Single-Dose Prefilled Pen
GTIN:
