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Evenity romosozumab-aqqg 105 mg/1.17mL Injection, Solution, 2 syringes — NDC 55513-0509-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Evenity romosozumab-aqqg 105 mg/1.17mL Injection, Solution, 2 syringes — NDC 55513-509-02 (Billing 55513-0509-02)

by Amgen, Inc · 2 SYRINGE, GLASS in 1 CARTON / 1.17 mL in 1 SYRINGE, GLASS

This is a package of 2 syringes of Evenity romosozumab-aqqg 105 mg/1.17mL Injection, Solution from Amgen, Inc, marketed since Jan 2026 and currently FDA-listed. It is this product's only package size.

NDC 55513-0509-02
🏷️ FDA NDC (as labeled) 55513-509-02 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 13, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 55513-509-02 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
55513 labeler · 509 product · 02 package
Package marketed since
Jan 1, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5551350902 2
FDA record last changed
Aug 13, 2026
🚨
Active recall for this product.
Class II · Apr 21, 2025 — CGMP Deviations; potential temperature excursions due to transit delays (Mckesson Medical-Surgical Inc. Corporate Office) · FDA recall D-0539-2025
Lots / codes: Lot: 1178382, Expiration date: 3/31/2027 · reported Jul 30, 2025
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55513-509-02
Product NDC 55513-509
11-digit billing NDC 55513050902
RxCUI 2123184, 2123185, 2123190, 2123191
UNII 3VHF2ZD92J
Application # BLA761062
SPL Set ID 471baba2-7154-4488-9891-0db2f46791e7
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-01-01
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance ROMOSOZUMAB
Biologic (Purple Book) 351(a)
Quick answers
  • RxCUI (RxNorm): 2123184
Why two NDCs? The FDA registers this code as 55513-509-02 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 55513-0509-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Other drugs affecting bone structure and mineralization class.

Drug family (ATC) Other drugs affecting bone structure and mineralization
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Evenity treats osteoporosis in postmenopausal women who are at high risk of fracture. That includes women who have already broken a bone from osteoporosis, have multiple fracture r...
  • A healthcare provider gives it as two quick injections under your skin, once a month. Treatment lasts 12 monthly doses, because its bone-building effect fades after that. Your pres...
  • How is Evenity given, and how long will I be on it?
  • Call your provider to reschedule as soon as you can. Once you get the missed dose, your monthly schedule continues from that date.
📖 Read our full Romosozumab-aqqg Injection guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $1,140.76 $2,669.39 / 2.34 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
55513-0509-02 You're viewing this Main listing 2 SYRINGE, GLASS in 1 CARTON / 1.17 mL in 1 SYRINGE, GLASS 2026-01-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Evenity 105 mg/1.17mL 55513-0880-02 Amgen, 2 syringes — — FDA listed —
Evenity 105 mg/1.17mLthis 55513-0509-02 Amgen, 2 syringes — — FDA listed —
Evenity 105 mg/1.17mL 55513-0998-02 Amgen, 2 syringes — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2019
First FDA approval
Apr 2019
📍
2026
Currently FDA-listed
7 years listed
🛡️
2031
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Apr 2031. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 9, 2019 ⏳ ~4.5 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Evenityromosozumab-aqqg
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2019 2021 2023 2025 2027 2029 2031
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateApr 9, 2031
Common questions
Is there a biosimilar for this drug?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Romosozumab-aqqg Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 3.8 mg / 1.17 mL UNII 569DQM74SC
    Acetate ion is a salt form derived from acetic acid. It's commonly used in medicines as a buffer to help maintain the correct pH level and stabilize the product.
  • 0.61 mg / 1.17 mL UNII SY7Q814VUP
    Calcium is a mineral element used in medicines as a filler and binder. It helps give tablets and capsules their shape and structure while keeping ingredients mixed together.
  • 0.07 mg / 1.17 mL UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 70 mg / 1.17 mL UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAmgen, Inc
FDA applicationBLA761062 (BLA)
Labeler code55513
First marketedJan 2026
Product typeHuman Prescription Drug
Portfolio81 products on file

More NDCs from Amgen, Inc labeler code 55513

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 164 words ▾

WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH EVENITY may increase the risk of myocardial infarction, stroke, and cardiovascular death [see Warnings and Precautions (5.1) ] . EVENITY should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors.

If a patient experiences a myocardial infarction or stroke during therapy, EVENITY should be discontinued. WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH See full prescribing information for complete boxed warning. EVENITY may increase the risk of myocardial infarction, stroke and cardiovascular death.

( 5.1 ) EVENITY should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. ( 5.1 ) If a patient experiences a myocardial infarction or stroke during therapy, EVENITY should be discontinued.

( 5.1 )

🎯 Indications and Usage 188 words ▾

1 INDICATIONS AND USAGE EVENITY is a sclerostin inhibitor indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. ( 1 ) Limitations of Use: Limit duration of use to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered.

( 1.2 )

1.1Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture EVENITY is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

1.2Limitations of Use The anabolic effect of EVENITY wanes after 12 monthly doses of therapy. Therefore, the duration of EVENITY use should be limited to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered [see Dosage and Administration (2.2) and Clinical Studies (14.1) ] .

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Two separate subcutaneous injections are needed to administer the total dose of 210 mg. Inject two syringes, one after the other. ( 2.1 ) Should be administered by a healthcare provider. ( 2.1 ) Administer 210 mg subcutaneously once every month for 12 doses in the abdomen, thigh, or upper arm. ( 2.2 ) Adequately supplement calcium and vitamin D during treatment. ( 2.2 )

2.1Important Dosage and Administration Instructions Two separate syringes (and two separate subcutaneous injections) are needed to administer the total dose of 210 mg of EVENITY. Inject two 105 mg/1.17 mL prefilled syringes, one after the other. EVENITY should be administered by a healthcare provider.

2.2Recommended Dosage The recommended dose of EVENITY is 210 mg administered subcutaneously in the abdomen, thigh or upper arm. Administer EVENITY once every month. The treatment duration for EVENITY is 12 monthly doses.

Patients should be adequately supplemented with calcium and vitamin D during treatment with EVENITY [see Warnings and Precautions (5.3) and Clinical Studies (14.1) ] . If the EVENITY dose is missed, administer as soon as it can be rescheduled. Thereafter, EVENITY can be scheduled every month from the date of the last dose.

2.3Preparation and Administration Instructions Administration instructions: Prefilled syringe with automatic needle guard: Step 1: Prior to Administration: Remove two syringes from the carton. Visually inspect EVENITY for particles and discoloration prior to administration. EVENITY is a clear to opalescent, colorless to light yellow solution.

Do not use if the solution is cloudy or discolored or contains particles. Do not use the syringe if any part appears cracked or broken the gray needle cap is missing or not securely attached the expiration date printed on the label has passed the syringe has been dropped on a hard surface Always hold the syringe by the syringe body to remove the syringe from the tray. See Figure A .

Do not grasp the plunger rod. Do not grasp the gray needle cap. Do not remove the gray needle cap until you are ready to inject.

Allow EVENITY to sit at room temperature for at least 30 minutes before injecting. Do not warm in any other way [see How Supplied/Storage and Handling (16) ] . Figure A Step 2: Select the Injection Site and Prepare the Syringe Prepare and clean two injection sites, one for each of the two injections.

See Figure B . Figure B The recommended subcutaneous injection sites include: The thigh Abdomen, except for a two-inch area right around the navel Outer area of upper arm Clean the injection sites with alcohol wipes. Let the skin dry.

Choose a different site each time you give an injection. If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection. Do not inject into areas where the skin is tender, bruised, red, or hard.

Avoid injecting into areas with scars or stretch marks. Choose the first syringe. Pull the gray needle cap straight off and away from your body when you are ready to inject.

See Figure C . Figure C Do not put the gray needle cap back onto the syringe. Do not leave the cap off for more than 5 minutes as this can dry out the solution.

The prefilled syringe may contain air bubbles. Do not try to push air bubbles out as it is normal to see air bubbles. Step 3: Inject EVENITY Pinch the skin around the injection site before injecting.

Insert the needle into the pinched skin at or about a 45-degree angle. Slowly press the plunger head all the way down with your thumb until it is completely between the needle guard clips. Do not pull back on the plunger rod at any time.

Do not remove the syringe until all the medicine has been injected. Do not administer into muscle or blood vessel. See Figure D .

Figure D Slowly release pressure on the plunger head with your thumb and remove the syringe from the skin. Let go of the skin after the needle is removed. Releasing the plunger head… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 55 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 105 mg/1.17 mL clear to opalescent, colorless to light yellow solution in a single-use prefilled syringe. A full dose of EVENITY requires two single-use prefilled syringes. Injection: 105 mg/1.17 mL solution in a single-use prefilled syringe. A full dose of EVENITY requires two single-use prefilled syringes. ( 3 )

⛔ Contraindications 81 words ▾

4 CONTRAINDICATIONS EVENITY is contraindicated in patients with: Hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating therapy with EVENITY [see Warnings and Precautions (5.3) , Adverse Reactions (6.1) and Use in Specific Populations (8.7) ]. A history of systemic hypersensitivity to romosozumab-aqqg or to any component of the product formulation.

Reactions have included angioedema, erythema multiforme, and urticaria [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] . Hypocalcemia ( 4 ) Known hypersensitivity to EVENITY ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Major Adverse Cardiac Events (MACE): Monitor for symptoms of MI and stroke and seek prompt medical attention if symptoms occur. ( 5.1 ) Hypersensitivity: Hypersensitivity reactions, including angioedema, erythema multiforme, dermatitis, rash, and urticaria. Discontinue EVENITY if a clinically significant allergic reaction occurs.

( 5.2 ) Hypocalcemia: Adequately supplement calcium and vitamin D during treatment with EVENITY. ( 5.3 ) Osteonecrosis of the Jaw: Monitor for symptoms. Consider discontinuation of therapy based on benefit-risk assessment.

( 5.4 ) Atypical Femoral Fracture: Evaluate new or unusual thigh, hip, or groin pain to rule out an incomplete femur fracture. ( 5.5 )

5.1Major Adverse Cardiac Events (MACE) In a randomized controlled trial in postmenopausal women, there was a higher rate of major adverse cardiac events (MACE), a composite endpoint of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke, in patients treated with EVENITY compared to those treated with alendronate [see Boxed Warning and Adverse Reactions (6.1) ] . EVENITY should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors.

Monitor for signs and symptoms of myocardial infarction and stroke and instruct patients to seek prompt medical attention if symptoms occur. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY should be discontinued.

5.2Hypersensitivity Reactions Hypersensitivity reactions, including angioedema, erythema multiforme, dermatitis, rash, and urticaria have occurred in EVENITY-treated patients. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of EVENITY [see Contraindications (4) and Adverse Reactions (6.1) ].

5.3Hypocalcemia Hypocalcemia has occurred in patients receiving EVENITY. Correct hypocalcemia prior to initiating EVENITY [see Contraindications (4) , Adverse Reactions (6.1) and Use in Specific Populations (8.7) ] . Monitor patients for signs and symptoms of hypocalcemia.

Patients should be adequately supplemented with calcium and vitamin D while on EVENITY [see Dosage and Administration (2.2) and Clinical Studies (14.1) ] . Patients with severe renal impairment (estimated glomerular filtration rate [eGFR] 15 to 29 mL/min/1.73 m 2 ) or receiving dialysis are at greater risk of developing hypocalcemia. Monitor serum calcium and adequately supplement patients who have severe renal impairment or are receiving dialysis with calcium and vitamin D.

Instruct patients with severe renal impairment, including those receiving dialysis, about the symptoms of hypocalcemia and the importance of maintaining calcium levels with adequate calcium and vitamin D supplementation.

5.4Osteonecrosis of the Jaw Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients receiving EVENITY. A routine oral examination should be performed by the prescriber prior to initiation of EVENITY treatment. Concomitant administration of drugs associated with ONJ (chemotherapy, bisphosphonates, denosumab, angiogenesis inhibitors, and corticosteroids) may increase the risk of developing ONJ.

Other risk factors for ONJ include cancer, radiotherapy, poor oral hygiene, pre-existing dental disease or infection, anemia, and coagulopathy [see Adverse Reactions (6.1) ] . For patients requiring invasive dental procedures, clinical judgment of the treating physician and/or oral surgeon should guide the management plan of each patient based on benefit-risk assessment. Patients who are suspected of having or who develop ONJ while on EVENITY should receive care by a dentist or an oral surgeon.

In these patients, dental surgery to treat O… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: Major adverse cardiac events [see Boxed Warning and Warnings and Precautions (5.1) ] Hypersensitivity [see Contraindications (4) and Warnings and Precautions (5.2) ] Hypocalcemia [see Contraindications (4) and Warnings and Precautions (5.3) ] Osteonecrosis of the Jaw [see Warnings and Precautions (5.4) ] Atypical Subtrochanteric and Diaphyseal Femoral Fractures [see Warnings and Precautions (5.5) ] The most common adverse reactions (≥ 5%) reported with EVENITY in clinical trials were arthralgia and headache.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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 practice. The safety of EVENITY for the treatment of postmenopausal osteoporosis was evaluated in a multicenter, randomized, double-blind, placebo-controlled study (Study 1, NCT01575834) of 7180 postmenopausal women aged 55 to 90 years (mean age of 71 years).

A total of 3581 and 3576 women received at least one dose of EVENITY and placebo, respectively, administered once every month during the 12-month double-blind study period. Women received at least 500 mg calcium and 600 international units of vitamin D supplementation daily and 77% received a loading dose of 50,000 to 60,000 international units of vitamin D within one week of randomization (if serum 25-hydroxyvitamin D concentrations were 40 ng/mL or less). The safety of EVENITY for the treatment of postmenopausal osteoporosis in patients at high risk of fracture was evaluated in a multicenter, randomized, double-blind, alendronate-controlled study (Study 2, NCT01631214) of 4093 postmenopausal women aged 55 to 90 years (mean age of 74 years).

A total of 2040 and 2014 women received at least one dose of EVENITY and alendronate, respectively, during the 12-month double-blind study period. Women received at least 500 mg calcium and 600 international units vitamin D supplementation daily and 74% received a loading dose of 50,000 to 60,000 international units of vitamin D within one week of randomization (if serum 25-hydroxyvitamin D concentrations were 40 ng/mL or less). In Study 1, during the 12-month double-blind treatment period, the incidence of all-cause mortality was 0.7% (24/3576) in the placebo group and 0.8% (29/3581) in the EVENITY group.

The incidence of nonfatal serious adverse events was 8.3% in the placebo group and 9.1% in the EVENITY group. The percentage of patients who withdrew from the study due to adverse events was 1.1% in the placebo group and 1.1% in the EVENITY group. The most common adverse reactions reported with EVENITY (greater than or equal to 5% and at a higher incidence than placebo) were arthralgia and headache.

The most common adverse reaction leading to discontinuation of EVENITY was arthralgia (6 subjects [0.2%] in the placebo group and 5 subjects [0.1%] in the EVENITY group). In Study 2, during the 12-month double-blind treatment period, the incidence of all-cause mortality was 1.1% (22/2014) in the alendronate group and 1.5% (30/2040) in the EVENITY group. The incidence of nonfatal serious adverse events was 13.3% in the alendronate group and 11.9% in the EVENITY group.

The percentage of patients who withdrew from the study due to adverse events was 1.2% in the alendronate group and 1.2% in the EVENITY group. The most common adverse reactions reported with EVENITY (greater than or equal to 5%) were arthralgia and headache. Table 1 outlines the most common adverse reactions occurring in greater than or equal to 2% of EVENITY-treated women in at least one study.

Table 1. Adverse Reactions Occurri… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Renal Impairment: Patients with severe renal impairment or receiving dialysis are at greater risk of developing hypocalcemia. Monitor serum calcium and supplement with calcium and vitamin D. ( 5.3 , 8.7 )

8.1Pregnancy Risk Summary EVENITY is not indicated for use in women of reproductive potential. In animal reproduction studies, weekly administration of romosozumab-aqqg to pregnant rats during the period of organogenesis at exposures greater than 31 times the clinical exposure produced skeletal abnormalities in the offspring. Administration of romosozumab-aqqg to rats prior to mating and through to the end of lactation produced minimal to slight decreases in femoral bone mineral density and/or cortical circumferences in the offspring at 1.4 to 54 times the expected exposure in humans [see Data ] .

Data Animal Data Reproductive and developmental effects of romosozumab-aqqg were assessed in the rat in a preliminary and definitive embryo-fetal development study, a combined fertility and embryo-development study, and a pre and postnatal development study. Skeletal malformations including syndactyly and polydactyly occurred in 1 out of 75 litters across all rat reproductive toxicity studies, in the litter of a dam given weekly subcutaneous romosozumab-aqqg doses of 300 mg/kg (equivalent to at least 31 times the clinical exposure observed in humans following a monthly subcutaneous dose of 210 mg, based on area under the concentration-time curve [AUC] comparison).

In the offspring of female rats given weekly romosozumab-aqqg doses from 6 weeks before cohabitation through mating and lactation, femoral periosteal and endocortical circumferences were slightly decreased at 10, 60, and 300 mg/kg (equivalent to 1.4, 18, and 54 times the clinical exposure following a monthly subcutaneous dose of 210 mg, based on AUC comparison). Cortical thickness was increased at 300 mg/kg (equivalent to 54 times expected clinical exposure). Femoral metaphyseal bone mineral density was slightly decreased at 60 and 300 mg/kg (equivalent to 18 and 54 times expected clinical exposure).

8.2Lactation Risk Summary EVENITY is not indicated for use in women of reproductive potential. In animal studies where pregnant rats were given weekly doses of romosozumab-aqqg from 6 weeks before cohabitation through mating and lactation at 10, 60, or 300 mg/kg (equivalent to 1.4, 18 or 54 times the clinical exposure following a monthly subcutaneous dose of 210 mg, based on AUC comparison), romosozumab-aqqg was dose-dependently present in the serum of offspring on postnatal day 21 at 0.01 to 2.4 times maternal exposure due to gestational and/or lactational exposure.

8.4Pediatric Use Safety and effectiveness of EVENITY have not been established in pediatric patients.

8.5Geriatric Use Of the 6544 postmenopausal women with osteoporosis in the clinical studies of EVENITY, 5234 (80%) were age 65 years and over and 2390 (37%) were age 75 years and over. No overall differences in safety or efficacy were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

8.7Renal Impairment No dose adjustment is required in patients with renal impairment. Patients with severe renal impairment (estimated glomerular filtration rate [eGFR] 15 to 29 mL/min/1.73 m 2 by MDRD equation) or receiving dialysis are at greater risk of developing hypocalcemia [see Contraindications (4) , Warnings and Precautions (5.3) and Adverse Reactions (6.1) ] . Monitor calcium concentrations and adequately supplement calcium and vitamin D in patients who have severe renal impairment or are receiving dialysis.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary EVENITY is not indicated for use in women of reproductive potential. In animal reproduction studies, weekly administration of romosozumab-aqqg to pregnant rats during the period of organogenesis at exposures greater than 31 times the clinical exposure produced skeletal abnormalities in the offspring. Administration of romosozumab-aqqg to rats prior to mating and through to the end of lactation produced minimal to slight decreases in femoral bone mineral density and/or cortical circumferences in the offspring at 1.4 to 54 times the expected exposure in humans [see Data ] .

Data Animal Data Reproductive and developmental effects of romosozumab-aqqg were assessed in the rat in a preliminary and definitive embryo-fetal development study, a combined fertility and embryo-development study, and a pre and postnatal development study. Skeletal malformations including syndactyly and polydactyly occurred in 1 out of 75 litters across all rat reproductive toxicity studies, in the litter of a dam given weekly subcutaneous romosozumab-aqqg doses of 300 mg/kg (equivalent to at least 31 times the clinical exposure observed in humans following a monthly subcutaneous dose of 210 mg, based on area under the concentration-time curve [AUC] comparison).

In the offspring of female rats given weekly romosozumab-aqqg doses from 6 weeks before cohabitation through mating and lactation, femoral periosteal and endocortical circumferences were slightly decreased at 10, 60, and 300 mg/kg (equivalent to 1.4, 18, and 54 times the clinical exposure following a monthly subcutaneous dose of 210 mg, based on AUC comparison). Cortical thickness was increased at 300 mg/kg (equivalent to 54 times expected clinical exposure). Femoral metaphyseal bone mineral density was slightly decreased at 60 and 300 mg/kg (equivalent to 18 and 54 times expected clinical exposure).

🧒 Pediatric Use 15 words ▾

8.4Pediatric Use Safety and effectiveness of EVENITY have not been established in pediatric patients.

🧓 Geriatric Use 76 words ▾

8.5Geriatric Use Of the 6544 postmenopausal women with osteoporosis in the clinical studies of EVENITY, 5234 (80%) were age 65 years and over and 2390 (37%) were age 75 years and over. No overall differences in safety or efficacy were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action EVENITY inhibits the action of sclerostin, a regulatory factor in bone metabolism. EVENITY increases bone formation and, to a lesser extent, decreases bone resorption. Animal studies showed that romosozumab-aqqg stimulates new bone formation on trabecular and cortical bone surfaces by stimulating osteoblastic activity resulting in increases in trabecular and cortical bone mass and improvements in bone structure and strength [see Nonclinical Toxicology (13.2) and Clinical Studies (14.1) ] .

12.2Pharmacodynamics In postmenopausal women with osteoporosis, EVENITY increased the bone formation marker procollagen type 1 N-telopeptide (P1NP) with a peak increase from baseline of approximately 145% compared to placebo 2 weeks after initiating treatment, followed by a return to concentrations seen with placebo at month 9 and a decline from baseline to approximately 15% below the concentration change seen with placebo at month 12. EVENITY decreased the bone resorption marker type 1 collagen C-telopeptide (CTX) with a maximal reduction from baseline of approximately 55% compared to placebo 2 weeks after initiating treatment.

CTX remained below concentrations seen with placebo and was approximately 25% below the concentration change seen with placebo at month 12. After discontinuation of EVENITY, P1NP levels returned to baseline within 12 months; CTX increased above baseline levels within 3 months and returned toward baseline levels by month 12.

12.3Pharmacokinetics Administration of a single dose of 210 mg EVENITY in healthy volunteers resulted in a mean (standard deviation [SD]) maximum romosozumab-aqqg serum concentration (C max ) of 22.2 (5.8) mcg/mL and a mean (SD) AUC of 389 (127) mcg*day/mL. Steady-state concentrations were achieved by month 3 following the monthly administration of 210 mg to postmenopausal women. The mean trough serum romosozumab-aqqg concentrations at months 3, 6, 9, and 12 ranged from 8 to 13 mcg/mL.

Romosozumab-aqqg exhibited nonlinear pharmacokinetics with exposure increasing greater than dose proportionally (e.g., 550-fold increase in mean AUC inf for the 100-fold increase in subcutaneous doses ranging from 0.1 to 10 mg/kg 0.03 to 3.3 times the approved recommended dosage for a 70 kg woman). Absorption The median time to maximum romosozumab-aqqg concentration (T max ) is 5 days (range: 2 to 7 days). Distribution The estimated volume of distribution at steady-state is approximately

3.92L. Elimination Romosozumab-aqqg exhibited nonlinear pharmacokinetics with the clearance of romosozumab-aqqg decreasing as the dose increased. The estimated mean systemic clearance (CL/F) of romosozumab-aqqg was 0.38 mL/hr/kg, following a single subcutaneous administration of 3 mg/kg (the approved recommended dosage for a 70 kg woman).

The mean effective t 1/2 was 12.8 days after 3 doses of 3 mg/kg (the approved recommended dosage for a 70 kg woman) every 4 weeks. Metabolism The metabolic pathway of romosozumab-aqqg has not been characterized. As a humanized IgG2 monoclonal antibody, romosozumab-aqqg is expected to be degraded into small peptides and amino acids via catabolic pathways in a manner similar to endogenous IgG.

Specific Populations No clinically significant differences in the pharmacokinetics of romosozumab-aqqg were observed based on age (20-89 years), sex, race, disease state (low bone mass or osteoporosis), prior exposure to alendronate, or renal impairment including end-stage renal disease (ESRD) requiring dialysis. The effect of ESRD not requiring dialysis on the pharmacokinetics of romosozumab-aqqg is unknown. Body Weight The exposure of romosozumab-aqqg decreases with increasing body weight.

12.6Immunogenicity The observed incidence of anti-drug antibodies (ADA) is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of ADA in the studies described below with the incid… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 73 words ▾

12.1Mechanism of Action EVENITY inhibits the action of sclerostin, a regulatory factor in bone metabolism. EVENITY increases bone formation and, to a lesser extent, decreases bone resorption. Animal studies showed that romosozumab-aqqg stimulates new bone formation on trabecular and cortical bone surfaces by stimulating osteoblastic activity resulting in increases in trabecular and cortical bone mass and improvements in bone structure and strength [see Nonclinical Toxicology (13.2) and Clinical Studies (14.1) ] .

📦 How Supplied / Storage and Handling 192 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied EVENITY (romosozumab-aqqg) injection is a clear to opalescent, colorless to light yellow solution for subcutaneous injection supplied in a single-use prefilled syringe. Each single-use prefilled syringe contains 105 mg of EVENITY in a deliverable volume of 1.17 mL. To deliver a full dose, inject two 105 mg/1.17 mL EVENITY prefilled syringes, one after the other for a total dose of 210 mg.

NDC 55513-509-02: Carton of two 105 mg/1.17 mL single-use glass prefilled syringes with automatic needle guard. NDC 55513-998-02: Carton of two 105 mg/1.17 mL single-use glass prefilled syringes. NDC 55513-880-02: Carton of two 105 mg/1.17 mL single-use plastic prefilled syringes.

The single-use prefilled syringe is not made with natural rubber latex.

16.2Storage and Handling Refrigerate EVENITY at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake. If removed from the refrigerator, EVENITY can be kept at room temperature up to 25°C (77°F) in the original carton and must be used within 30 days. If not used within 30 days, discard EVENITY. Do not expose EVENITY to temperatures above 25°C (77°F).

📦 Storage and Handling 71 words ▾

16.2Storage and Handling Refrigerate EVENITY at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake. If removed from the refrigerator, EVENITY can be kept at room temperature up to 25°C (77°F) in the original carton and must be used within 30 days. If not used within 30 days, discard EVENITY. Do not expose EVENITY to temperatures above 25°C (77°F).

📋 Description 127 words ▾

11 DESCRIPTION Romosozumab-aqqg is a humanized monoclonal antibody (IgG2) produced in a mammalian cell line (Chinese Hamster Ovary) by recombinant DNA technology that binds to and inhibits sclerostin. Romosozumab-aqqg has an approximate molecular weight of 149 kDa. EVENITY (romosozumab-aqqg) injection is supplied as a sterile, preservative-free, clear to opalescent, colorless to light yellow solution for subcutaneous injection in a single-use prefilled syringe.

Two 105 mg/1.17 mL single-use prefilled syringes are required to administer the recommended 210 mg dose of EVENITY [see Dosage and Administration (2.1) ]. Each single-use prefilled syringe delivers 1.17 mL of solution containing 105 mg of romosozumab-aqqg, acetate (3.8 mg), calcium (0.61 mg), polysorbate 20 (0.07 mg) and sucrose (70 mg) in Water for Injection, USP, and sodium hydroxide to a pH of 5.2.

💬 Information for Patients 219 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Major Adverse Cardiac Events Advise patients to seek immediate medical attention if they experience signs or symptoms of a myocardial infarction or stroke [see Boxed Warning , Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . Hypersensitivity Reactions Advise patients to seek immediate medical attention if they experience signs or symptoms of a hypersensitivity reaction including angioedema, erythema multiforme, dermatitis, rash, and urticaria [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] .

Calcium and Vitamin D Supplements to Prevent Hypocalcemia Advise patients to take calcium and vitamin D supplements daily to reduce the risk of hypocalcemia . Advise patients to seek immediate medical attention for symptoms of hypocalcemia [see Dosage and Administration (2.1) , Warnings and Precautions (5.3) and Adverse Reactions (6.1) ]. Osteonecrosis of the Jaw Advise patients to practice good oral hygiene during treatment with EVENITY and tell their dentist that they are receiving EVENITY before having dental work. [see Warnings and Precautions (5.4) and Adverse Reactions (6.1) ] .

Atypical Femoral Fracture Advise patients to report signs and symptoms that could be consistent with impending atypical femoral fracture including new or unusual thigh, hip, or groin pain [see Warnings and Precautions (5.5) and Adverse Reactions (6.1) ] .

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE EVENITY ® (E-ven-i-tee) (romosozumab-aqqg) Injection, for subcutaneous use What is the most important information I should know about EVENITY ? EVENITY can cause serious side effects, including: increased risk of having a heart attack, stroke, or death from a cardiovascular (heart or blood vessel) problem . Call your healthcare provider or get emergency help right away if you have any of the symptoms listed below.

Symptoms of heart attack may include: chest pain or pressure shortness of breath feeling light-headed or dizzy Symptoms of stroke may include: headache numbness or weakness in face, arm, or legs difficulty talking changes in vision or loss of balance Before you receive EVENITY, tell your healthcare provider if you have had a heart attack or stroke, especially if it has happened in the past year. See “What are the possible side effects of EVENITY ?” below for other side effects of EVENITY. What is EVENITY?

EVENITY is a prescription medicine used to: treat osteoporosis (thinning and weakening of bone) in women after menopause (“change of life”) who: are at high risk of fracture (broken bone), or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well. It is not known if EVENITY is safe and effective in children. Do not receive EVENITY if you: have been told by your healthcare provider that your blood calcium level is too low. are allergic to romosozumab or any of the ingredients in EVENITY.

See the end of this Medication Guide for a complete list of ingredients in EVENITY. Before receiving EVENITY , tell your healthcare provider about all your medical conditions, including if you: have a history of other heart or blood vessel problems have low blood calcium cannot take daily calcium and vitamin D have kidney problems or are on kidney dialysis plan to have dental surgery or teeth removed Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive EVENITY ? EVENITY is an injection that will be given to you by your healthcare provider. EVENITY is injected under your skin (subcutaneous).

You will receive an EVENITY dose (2 injections) 1 time every month for 12 doses. You should take calcium and vitamin D while you receive EVENITY. If you miss a dose of EVENITY, contact your healthcare provider as soon as possible to schedule your next dose.

Your next dose of EVENITY should then be scheduled every month from the date of the last injection. You should take good care of your teeth and gums while you receive EVENITY. You should tell your dentist that you are receiving EVENITY before you have dental work.

What are the possible side effects of EVENITY ? EVENITY may cause serious side effects, including: See “What is the most important information I should know about EVENITY ?” Serious allergic reactions. Serious allergic reactions have happened in people who receive EVENITY.

Call your healthcare provider or go to the nearest emergency room right away if you have any symptoms of a serious allergic reaction. Symptoms of a serious allergic reaction may include: ○ rash ○ hives ○ swelling of the face, lips, mouth, tongue, or throat which may cause difficulty in swallowing or breathing Low calcium levels in your blood (hypocalcemia). EVENITY may lower the calcium levels in your blood.

Your low blood calcium should be treated before you receive EVENITY. Call your healthcare provider if you have symptoms of low blood calcium such as: ○ spasms, twitches, or cramps in your muscles ○ numbness or tingling in your fingers, toes or around your mouth Severe jaw bone problems (osteonecrosis). Severe jaw bone problems may happen when you take EVENITY.

Your healthcare provider should examine your mouth before you start EVENITY. ○ Your healthcare provider may tell you to see your dentist before you start EVENITY. Ask your healthcare provider or dentist about good mouth care. Unusual thi… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Administration of a single dose of 210 mg EVENITY in healthy volunteers resulted in a mean (standard deviation [SD]) maximum romosozumab-aqqg serum concentration (C max ) of 22.2 (5.8) mcg/mL and a mean (SD) AUC of 389 (127) mcg*day/mL. Steady-state concentrations were achieved by month 3 following the monthly administration of 210 mg to postmenopausal women. The mean trough serum romosozumab-aqqg concentrations at months 3, 6, 9, and 12 ranged from 8 to 13 mcg/mL.

Romosozumab-aqqg exhibited nonlinear pharmacokinetics with exposure increasing greater than dose proportionally (e.g., 550-fold increase in mean AUC inf for the 100-fold increase in subcutaneous doses ranging from 0.1 to 10 mg/kg 0.03 to 3.3 times the approved recommended dosage for a 70 kg woman). Absorption The median time to maximum romosozumab-aqqg concentration (T max ) is 5 days (range: 2 to 7 days). Distribution The estimated volume of distribution at steady-state is approximately

3.92L. Elimination Romosozumab-aqqg exhibited nonlinear pharmacokinetics with the clearance of romosozumab-aqqg decreasing as the dose increased. The estimated mean systemic clearance (CL/F) of romosozumab-aqqg was 0.38 mL/hr/kg, following a single subcutaneous administration of 3 mg/kg (the approved recommended dosage for a 70 kg woman).

The mean effective t 1/2 was 12.8 days after 3 doses of 3 mg/kg (the approved recommended dosage for a 70 kg woman) every 4 weeks. Metabolism The metabolic pathway of romosozumab-aqqg has not been characterized. As a humanized IgG2 monoclonal antibody, romosozumab-aqqg is expected to be degraded into small peptides and amino acids via catabolic pathways in a manner similar to endogenous IgG.

Specific Populations No clinically significant differences in the pharmacokinetics of romosozumab-aqqg were observed based on age (20-89 years), sex, race, disease state (low bone mass or osteoporosis), prior exposure to alendronate, or renal impairment including end-stage renal disease (ESRD) requiring dialysis. The effect of ESRD not requiring dialysis on the pharmacokinetics of romosozumab-aqqg is unknown. Body Weight The exposure of romosozumab-aqqg decreases with increasing body weight.

🧬 Pharmacodynamics 142 words ▾

12.2Pharmacodynamics In postmenopausal women with osteoporosis, EVENITY increased the bone formation marker procollagen type 1 N-telopeptide (P1NP) with a peak increase from baseline of approximately 145% compared to placebo 2 weeks after initiating treatment, followed by a return to concentrations seen with placebo at month 9 and a decline from baseline to approximately 15% below the concentration change seen with placebo at month 12. EVENITY decreased the bone resorption marker type 1 collagen C-telopeptide (CTX) with a maximal reduction from baseline of approximately 55% compared to placebo 2 weeks after initiating treatment.

CTX remained below concentrations seen with placebo and was approximately 25% below the concentration change seen with placebo at month 12. After discontinuation of EVENITY, P1NP levels returned to baseline within 12 months; CTX increased above baseline levels within 3 months and returned toward baseline levels by month 12.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Treatment of Osteoporosis in Postmenopausal Women Study 1 (NCT01575834) was a randomized, double-blind, placebo-controlled study of postmenopausal women aged 55 to 90 years (mean age of 71 years) with bone mineral density (BMD) T-score less than or equal to −2.5 at the total hip or femoral neck. Women were randomized to receive subcutaneous injections of either EVENITY (N = 3589) or placebo (N = 3591) for 12 months. At baseline, 18% of women had a vertebral fracture.

After the 12-month treatment period, women in both arms transitioned to open-label anti-resorptive therapy (denosumab) for 12 months while remaining blinded to their initial treatment. Women received 500 to 1000 mg calcium and 600 to 800 international units vitamin D supplementation daily. The coprimary efficacy endpoints were new vertebral fracture at month 12 and month 24.

Effect on Fractures EVENITY significantly reduced the incidence of new vertebral fractures through month 12 compared to placebo. In addition, the significant reduction in fracture risk persisted through the second year in women who received EVENITY during the first year and transitioned to denosumab compared to those who transitioned from placebo to denosumab (see Table 2 ). Table 2.

Effect of EVENITY on the Incidence and Risk of Fractures in Study 1 Proportion of Women with Fractures Absolute Risk Reduction (%) (95% CI) Absolute and relative risk reduction are based on the Mantel-Haenszel method adjusting for age and prevalent vertebral fracture strata. Relative Risk Reduction (%) (95% CI) p-value P-value is based on logistic regression model adjusting for age and prevalent vertebral fracture strata. At Month 12 Placebo (N = 3591) EVENITY (N = 3589) N = Number of subjects randomized New vertebral fracture 1.8% 0.5% 1.3 (0.8, 1.8) 73 (53, 84) < 0.001 At Month 24 Placebo Followed by Denosumab (N = 3591) EVENITY Followed by Denosumab (N = 3589) New vertebral fracture 2.5% 0.6% 1.9 (1.3, 2.5) 75 (60, 84) < 0.001 EVENITY significantly reduced the incidence of clinical fracture (a composite endpoint of symptomatic vertebral fracture and nonvertebral fracture) at 12 months.

However, 88% of these clinical fractures were nonvertebral fractures and the incidence of nonvertebral fractures was not statistically significantly different when comparing EVENITY-treated women to placebo-treated women at month 12 or month 24. Effect on Bone Mineral Density (BMD) EVENITY significantly increased BMD at the lumbar spine, total hip, and femoral neck compared with placebo at month 12. The treatment differences in BMD were 12.7% at the lumbar spine, 5.8% at the total hip, and 5.2% at the femoral neck.

Following the transition from EVENITY to denosumab at month 12, BMD continued to increase through month 24. In patients who transitioned from placebo to denosumab, BMD also increased with denosumab use. The differences in BMD achieved at month 12 between EVENITY and placebo patients were overall maintained at month 24, when comparing patients who transitioned from EVENITY to denosumab to those who transitioned from placebo to denosumab.

There was no evidence of differences in effects on BMD at the lumbar spine or total hip across subgroups defined by baseline age, baseline BMD, or geographic region. After EVENITY discontinuation, BMD returns to approximately baseline levels within 12 months in the absence of follow-on anti-resorptive therapy [see Indications and Usage (1.2) ]. Bone Histology and Histomorphometry A total of 154 transiliac crest bone biopsy specimens were obtained from 139 postmenopausal women with osteoporosis at month 2, month 12, and/or month 24.

All of these biopsies were adequate for qualitative histology and 138 (90%) were adequate for full quantitative histomorphometry assessment. Qualitative histology assessments from women treated with EVENITY showed normal bone architecture and quality at all time points. There was no evidence of woven bone, mineralization defects, or m… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity In a rat carcinogenicity study, once-weekly romosozumab-aqqg doses of 3, 10 or 50 mg/kg were administered by subcutaneous injection to Sprague-Dawley rats from 8 weeks up to 98 weeks of age, resulting in systemic exposures that were up to 19 times the systemic exposure observed in humans following a monthly subcutaneous dose of 210 mg EVENITY (based on AUC comparison). Romosozumab-aqqg caused a dose-dependent increase in bone mass with trabecular and cortical bone thickening at all doses.

There were no effects of romosozumab-aqqg on mortality and romosozumab-aqqg did not cause significant increases in tumor incidence in male or female rats. Mutagenicity Mutagenesis has not been evaluated, as monoclonal antibodies are not expected to alter DNA or chromosomes. Impairment of Fertility No effects on fertility were observed in male and female rats given subcutaneous romosozumab-aqqg doses up to 300 mg/kg (up to 54 times the systemic exposure observed in humans following a monthly subcutaneous dose of 210 mg EVENITY, based on AUC comparison).

No effects were noted in reproductive organs in rats and cynomolgus monkeys dosed subcutaneously for 6 months with weekly doses up to 100 mg/kg (exposures up to 37 and 90 times, respectively, the systemic exposure observed in humans administered monthly subcutaneous doses of 210 mg based on AUC comparison).

13.2Animal Toxicology and Pharmacology No adverse effects were noted in rats and monkeys after 26 once-weekly subcutaneous romosozumab-aqqg doses up to 100 mg/kg, equivalent to systemic exposures of 37 and 90 times, respectively, the systemic exposure observed in humans following a monthly subcutaneous dose of 210 mg EVENITY (based on AUC comparison). Bone safety studies of up to 12-month duration were conducted in ovariectomized rats and monkeys with once-weekly romosozumab-aqqg doses yielding exposures ranging from 1 to 21 times the systemic exposure in humans given monthly doses of 210 mg, based on AUC comparison.

Romosozumab-aqqg increased bone mass and improved cancellous bone microarchitecture and cortical bone geometry by increasing bone formation on periosteal, endocortical, and trabecular surfaces, and decreasing bone resorption on trabecular and endocortical surfaces. The increases in bone mass were significantly correlated with increases in bone strength. In rats and monkeys, bone quality was maintained at all skeletal sites at doses ranging from 1 to 21 times human exposure, and slightly improved in vertebrae at 19 to 21 times human exposure.

There was no evidence of mineralization defects, osteoid accumulation, or woven bone formation.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 218 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity In a rat carcinogenicity study, once-weekly romosozumab-aqqg doses of 3, 10 or 50 mg/kg were administered by subcutaneous injection to Sprague-Dawley rats from 8 weeks up to 98 weeks of age, resulting in systemic exposures that were up to 19 times the systemic exposure observed in humans following a monthly subcutaneous dose of 210 mg EVENITY (based on AUC comparison). Romosozumab-aqqg caused a dose-dependent increase in bone mass with trabecular and cortical bone thickening at all doses.

There were no effects of romosozumab-aqqg on mortality and romosozumab-aqqg did not cause significant increases in tumor incidence in male or female rats. Mutagenicity Mutagenesis has not been evaluated, as monoclonal antibodies are not expected to alter DNA or chromosomes. Impairment of Fertility No effects on fertility were observed in male and female rats given subcutaneous romosozumab-aqqg doses up to 300 mg/kg (up to 54 times the systemic exposure observed in humans following a monthly subcutaneous dose of 210 mg EVENITY, based on AUC comparison).

No effects were noted in reproductive organs in rats and cynomolgus monkeys dosed subcutaneously for 6 months with weekly doses up to 100 mg/kg (exposures up to 37 and 90 times, respectively, the systemic exposure observed in humans administered monthly subcutaneous doses of 210 mg based on AUC comparison).

📄 Recent Major Changes 7 words ▾

Dosage and Administration ( 2.3 ) 1/2026

📄 Package Label / Principal Display Panel ~2 min read ▾

PRINCIPAL DISPLAY PANEL 2 x 105 mg/1.17 mL Single-Use Prefilled Syringe NDC 55513-880-02 EVENITY ® (romosozumab-aqqg) injection For Healthcare Provider Use Only 105 mg/1.17 mL + 105 mg/1.17 mL = 1 Dose 210 mg/2.34 mL 2 x 105 mg/1.17 mL 105 mg/1.17 mL For Subcutaneous Use Only Sterile Solution – No Preservative Store Refrigerated at 2°C to 8°C (36°F to 46°F). Do not Freeze or Shake. Store in carton to protect from light.

Keep out of the sight and reach of children. ATTENTION: Provide the enclosed Medication Guide to each patient. For more copies see EVENITY.com or call 1-800-77AMGEN.

2 syringes must be administered for a full 210 mg/2.34 mL dose Rx Only AMGEN ® ucb 2 x 105 mg/1.17 mL Single-Use Prefilled Syringe NDC 55513-880-02 EVENITY® (romosozumab-aqqg) injection For Healthcare Provider Use Only 105 mg/1.17 mL + 105 mg/1.17 mL = 1 Dose 210 mg/2.34 mL 2 x 105 mg/1.17 mL 105 mg/1.17 mL For Subcutaneous Use Only Sterile Solution – No Preservative Store Refrigerated at 2°C to 8°C (36°F to 46°F). Do not Freeze or Shake. Store in carton to protect from light.

Keep out of the sight and reach of children. ATTENTION: Provide the enclosed Medication Guide to each patient. For more copies see EVENITY.com or call 1-800-77AMGEN.

2 syringes must be administered for a full 210 mg/2.34 mL dose Rx Only AMGEN® ucb

PRINCIPAL DISPLAY PANEL - 105 mg/1.17 mL Syringe Carton 2 x 105 mg/1.17 mL Single-Use Prefilled Syringe NDC 55513-998-02 EVENITY ® (romosozumab-aqqg) injection For Healthcare Provider Use Only 105 mg/ 1.17 mL + 105 mg/ 1.17 mL = 1 Dose 210 mg/ 2.34 mL 2 x 105 mg/1.17 mL 105 mg/1.17 mL For Subcutaneous Use Only Sterile Solution – No Preservative Store Refrigerated at 2°C to 8°C (36°F to 46°F). Do not Freeze or Shake. Store in carton to protect from light.

Keep out of the sight and reach of children. ATTENTION: Provide the enclosed Medication Guide to each patient. For more copies see EVENITY.com or call 1-800-77AMGEN.

2 syringes must be administered for a full 210 mg/2.34 mL dose Rx Only AMGEN ucb PRINCIPAL DISPLAY PANEL - 105 mg/1.17 mL Syringe Carton

PRINCIPAL DISPLAY PANEL - 105 mg/1.17 mL Syringe Carton 2 x 105 mg/1.17 mL Single-Use Prefilled Syringe NDC 55513-509-02 EVENITY ® (romosozumab-aqqg) injection For Healthcare Provider Use Only 105 mg/ 1.17 mL + 105 mg/ 1.17 mL = 1 Dose 210 mg/ 2.34 mL 105 mg/1.17 mL For Subcutaneous Use Only Sterile Solution – No Preservative Dispense in this sealed carton ATTENTION: Provide the enclosed Medication Guide to each patient. For more copies see EVENITY.com or call 1-800-77AMGEN. 2 syringes must be administered for a full 210 mg/2.34 mL dose Rx Only AMGEN ucb PRINCIPAL DISPLAY PANEL - 105 mg/1.17 mL Syringe Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Evenity — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Evenity. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$793.8K
Claims incl. refills
298
Beneficiaries
163
Spend / beneficiary
$4,869.73
Spend / claim
$2,663.65
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Evenity (this brand).

Top reported reactions

Fall795
Fracture661
Arthralgia624
Injection Site Pain567
Bone Density Abnormal462
Hospitalisation458
Headache457

Age at onset

Child3
Adolescent1
Adult1,469
Elderly6,224

Reporter sex

13,496 reports
Male · 7%
Female · 93%
Unknown · 0%

Serious outcomes

Hospitalization3,264
Death724
Life-threatening218
Disabling175
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,143 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Amgen, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Amgen, Inc is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 55513-0508-55 · Amgen, 55513-0512-60 · Amgen →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.