repatha
Pharmaranks rates Repatha 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Repatha (Evolocumab) is a medication used to treat Hypercholesterolemia, Atherosclerosis.
Evolocumab · by Amgen Inc
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Evolocumab
- Form
- Injectable
- Strength
- Evolocumab 140MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- hypercholesterolemia, atherosclerosis
- Manufacturer
- Amgen Inc
- FDA application
- BLA125522
What is Repatha?
From the FDA label: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 ® autoinjector and prefilled single-dose syringe contains 140 mg evolocumab, acetate (1.2 mg), polysorbate 80 (0.1 mg), proline (25 mg) in Water for Injection, USP. Sodium hydroxide may be used to adjust to a pH of 5.0.
How to use
In adults at increased risk for CV events or with hypercholesterolemia : The recommended dosage of REPATHA is either 140 mg every 2 weeks OR 420 mg once monthly administered subcutaneously. ( 2.1 ) If switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of the prior regimen. ( 2.1 ) In adults and pediatric patients aged 10 years and older with HeFH : The recommended dosage of REPATHA is either 140 mg every 2 weeks OR 420 mg once monthly administered subcutaneously. ( 2.1 ) If switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of the prior regimen. ( 2.1 ) In adults and pediatric patients aged 10 years and older with HoFH : The initial recommended dosage of REPATHA is 420 mg once monthly administered subcutaneously. ( 2.1 ) The dosage can be increased to 420 mg every 2 weeks if a clinically meaningful response is not achieved in 12 weeks. ( 2.1 ) Patients on lipid apheresis may initiate treatment with 420 mg every 2 weeks to correspond with their apheresis schedule. Administer REPATHA after the apheresis session is complete. ( 2.1 ) Assess LDL-C when clinically appropriate. The LDL-lowering effect of REPATHA may be measured as early as 4 weeks after initiation. ( 2.1 ) REPATHA is available as prefilled single-dose SureClick ® autoinjectors, and prefilled single-dose syringes that…
Side effects
The following adverse reactions are also discussed in other sections of the label: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Common (> 5% of patients treated with REPATHA and more frequently than placebo) adverse reactions in adults with: Primary hypercholesterolemia: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions. ( 6 ) Established CV Disease: diabetes mellitus, nasopharyngitis and upper respiratory tract infection. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical 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.…
Warnings
Important safety information
Hypersensitivity Reactions : Angioedema has occurred. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with REPATHA, treat according to the standard of care, and monitor until signs and symptoms resolve. ( 5.1 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including angioedema, have been reported in patients treated with REPATHA. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with REPATHA, treat according to the standard of care, and monitor until signs and symptoms resolve. REPATHA is contraindicated in patients with a history of serious hypersensitivity reactions to evolocumab or any excipient in REPATHA [see Contraindications (4) ] . The prefilled single-dose SureClick ® autoinjector and prefilled single-dose syringe presentations of REPATHA that contain dry natural rubber (a derivative of latex) in the needle cover may cause an allergic reaction in individuals sensitive to latex. Instruct patients to inform their healthcare provider if they are sensitive to latex. Consider prescribing a presentation of REPATHA that does not contain dry natural rubber for individuals that are sensitive to latex [see How Supplied/Storage and Handling (16) ] .
Who should not take Repatha
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 [see Warnings and Precautions (5.1) ] . Patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in REPATHA. ( 4 )
Storing Repatha, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “If not used within the 30 days, discard REPATHA.”
May treat (source: NIH RxClass)
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Repatha treat?
- Repatha (Evolocumab) may be used to treat hypercholesterolemia, atherosclerosis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Repatha rated?
- pharmaranks gives Repatha a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Repatha?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Repatha. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Repatha?
- Repatha is marketed by Amgen Inc. You can see Amgen Inc's full profile, rating, and other products on pharmaranks.
- Is Repatha a brand-name or generic drug?
- Repatha is a brand-name product with the active ingredient Evolocumab.
- Is Repatha available over the counter?
- No. Repatha is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Repatha come in?
- Repatha is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Repatha FDA-registered?
- Repatha is on record with the U.S. FDA under application number BLA125522. You can verify this on its official FDA label.
- Has Repatha been recalled by the FDA?
- Repatha has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Repatha safe?
- There's no single safe-or-not verdict. pharmaranks gives Repatha a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Repatha?
- Repatha's side effects are taken directly from its FDA label. From the label: The following adverse reactions are also discussed in other sections of the label: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Common (> 5% of patients treated with REPATHA and more frequently than placebo) adverse reactions in adults with: Primary hypercholesterolemia: nasophar… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
Reviews
No reviews yet. Be the first to write one.
People also viewed
crestor
Rosuvastatin Calcium
gemfibrozil
Gemfibrozil
juxtapid
Lomitapide Mesylate
leqvio
Inclisiran Sodium
praluent
Alirocumab
zetia
Ezetimibe
Compare Repatha head-to-head
Browse medications A–Z
Research products from A to Z, compare independent ratings, and find alternatives.
repatha
72/100