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Romosozumab-aqqg Injection

Romosozumab-aqqg is a bone-building injection used to treat osteoporosis in postmenopausal women who are at high risk for fractures.

Brand name Evenity
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 6, 2026 🚨Recall on record
Romosozumab-aqqg Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Evenity, a specialist medicine on the market since about 2019, is a monthly bone-building injection for postmenopausal women with osteoporosis at high fracture risk; it blocks sclerostin, a protein that brakes bone growth, so it builds bone and, to a lesser degree, slows breakdown. Most people tolerate it fairly well, and joint pain and headache are what they notice most. The thing to watch is its boxed warning for heart attack, stroke and cardiovascular death, so it is not started within a year of either, and chest pain or sudden one-sided weakness means calling 911. It stops after 12 monthly doses because the bone-building effect fades, then another osteoporosis medicine usually follows.

Clinical pearls

  • Take calcium and vitamin D throughout treatment, and if you have severe kidney disease or dialysis, expect regular calcium checks.
  • Get a dental check-up before starting, and tell your dentist about Evenity before any extraction, implant or other invasive work.
  • Each monthly dose is two separate injections given one after the other by a healthcare provider.
  • Report new thigh, hip or groin pain promptly, since it can signal a rare stress fracture of the thigh bone.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Evenity may increase the risk of heart attack, stroke, and cardiovascular death. In a clinical trial, more patients taking Evenity had these serious events compared to patients taking alendronate, another osteoporosis medication. Because of this, Evenity should NOT be started if you have had a heart attack or stroke within the past 12 months. If you have other heart disease risk factors, your prescriber should carefully weigh the benefits against the risks before starting this medication. Watch for warning signs such as chest pain, sudden weakness on one side of the body, slurred speech, or severe headache — and seek emergency care immediately. If you do have a heart attack or stroke while on Evenity, the medication must be stopped.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asInjection
Earliest FDA record2019
Companies listing it with the FDA1
FDA label last updatedJul 16, 2026
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Romosozumab-aqqg Injection, written from its FDA label.

What Romosozumab-aqqg Injection is used for

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Romosozumab-aqqg is an injectable treatment for a specific group of patients with osteoporosis (weak, brittle bones). All approved uses below are for Evenity, the brand of romosozumab-aqqg injection:

  • Evenity treats osteoporosis in postmenopausal women who are at high risk for fracture — defined as having a history of a fracture caused by osteoporosis, or having multiple risk factors for fractures
  • Evenity is used for postmenopausal women who have tried other osteoporosis therapies but did not respond well or could not tolerate them
  • Evenity use is limited to 12 monthly doses; if further osteoporosis treatment is needed after that, a prescriber will recommend an anti-resorptive medication to continue protecting bone

How Romosozumab-aqqg Injection works

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Evenity targets and blocks a protein called sclerostin, which acts as a natural brake on bone formation. By inhibiting sclerostin, Evenity simultaneously stimulates osteoblasts (the cells that build new bone) and, to a lesser degree, reduces osteoclast activity (the cells that break bone down). This dual action — more bone being built, less being lost — leads to greater bone mass, improved bone structure, and stronger bones that are more resistant to fracturing.

Romosozumab-aqqg Injection dosage

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Evenity is given as a subcutaneous (under-the-skin) injection once every month by a healthcare provider. Each monthly dose requires two separate injections given back-to-back at the same visit — together they make up one full dose. Injections can be given in the abdomen, thigh, or outer upper arm, rotating sites each time. Treatment runs for exactly 12 monthly doses.

  • Take calcium and vitamin D supplements throughout treatment as directed by your prescriber
  • If you miss a scheduled dose, get the injection as soon as it can be rescheduled, then continue on a monthly schedule from that date

Dosing details from the FDA-approved label

From the Romosozumab-aqqg Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Recommended dosage (EVENITY, romosozumab-aqqg)
    • 210 mg administered subcutaneously in the abdomen, thigh or upper arm, once every month
    • The treatment duration is 12 monthly doses
    • Two separate subcutaneous injections (two 105 mg/1.17 mL prefilled syringes, one after the other) are needed to give the total dose of 210 mg
    • Should be administered by a healthcare provider. Patients should be adequately supplemented with calcium and vitamin D during treatment. If a dose is missed, administer as soon as it can be rescheduled, then schedule every month from the date of the last dose.
Read the label’s full dosing text

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 ) 2.1 Important 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. 2.2 Recommended 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. 2.3 Preparation 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) ] .

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Romosozumab-aqqg Injection side effects

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The most common side effects with Evenity include:

Common side effects

  • Joint pain (arthralgia)
  • Headache
  • Muscle spasms
  • Swelling in the legs or feet (peripheral edema)
  • Weakness or fatigue (asthenia)
  • Neck pain
  • Trouble sleeping (insomnia)
  • Tingling or numbness (paresthesia)
  • Injection site reactions such as pain or redness

When to get medical help

  • Call 911 immediately if you have chest pain, shortness of breath, or sudden numbness or weakness — these may be signs of a heart attack or stroke
  • Call your doctor right away if you have new or unusual thigh, hip, or groin pain — this could signal a rare type of thigh-bone fracture
  • Tell your doctor if you have jaw pain, swelling, or sores that won't heal — this could be osteonecrosis of the jaw (bone tissue death in the jaw)
  • Seek medical help if you have muscle cramps, numbness or tingling around the mouth, or muscle stiffness — these can be signs of low calcium (hypocalcemia)
  • Get medical attention right away for severe allergic reactions: swelling of the face or throat, hives, or a widespread rash

Serious reactions — including heart attack, stroke, severe allergic reactions, low calcium, jaw bone problems, and unusual thigh fractures — are less common but require immediate medical attention. See the warnings section for details.

Romosozumab-aqqg Injection warnings and precautions

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  • Heart attack, stroke, and cardiovascular death: Evenity carries the FDA's most serious (boxed) warning. In a clinical trial, it was linked to more heart attacks and strokes compared to another osteoporosis drug. It must not be started within one year of a heart attack or stroke, and must be stopped immediately if one occurs during treatment.
  • Low calcium (hypocalcemia): Evenity can lower calcium levels in the blood. Pre-existing low calcium must be corrected before starting. Patients with severe kidney disease or on dialysis are at the greatest risk and need regular calcium monitoring and supplementation.
  • Osteonecrosis of the jaw (ONJ): A rare but serious condition where jaw bone tissue breaks down. Risk is higher in patients who also take certain other drugs (like bisphosphonates or corticosteroids) or who have poor dental health. A dental exam is recommended before starting treatment.
  • Atypical femoral fractures: Unusual stress fractures in the thigh bone have been reported. Report any new or unexplained thigh, hip, or groin pain to your doctor right away.
  • Allergic reactions: Serious reactions including severe swelling (angioedema) and widespread rash have occurred. Stop Evenity and get medical help immediately if a serious allergic reaction develops.

Romosozumab-aqqg Injection interactions

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The FDA label identifies one main category of drug interaction to be aware of with Evenity:

  • Drugs associated with osteonecrosis of the jaw (ONJ) — including bisphosphonates (e.g., alendronate), denosumab, chemotherapy agents, angiogenesis inhibitors, and corticosteroids — may increase the risk of developing ONJ when used at the same time as Evenity. Tell your prescriber about all medications you take before starting treatment.

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Check Romosozumab-aqqg Injection against a supplement or herb →

Before taking Romosozumab-aqqg Injection

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  • Low blood calcium (hypocalcemia): Evenity is contraindicated if you have low calcium — it must be corrected before starting treatment
  • Recent heart attack or stroke: Do not start Evenity if you have had a heart attack or stroke within the past 12 months
  • Other cardiovascular risk factors: Tell your prescriber about any history of heart disease so the benefits and risks can be weighed carefully
  • Severe kidney disease or dialysis: You are at higher risk for low calcium; closer monitoring and supplementation are needed
  • Planned or recent dental procedures: Tell your dentist and prescriber — invasive dental work increases ONJ risk
  • Known allergy to romosozumab-aqqg or any ingredient in Evenity: Evenity is contraindicated if you have had a serious allergic reaction to it before
  • Pregnancy and breastfeeding: Evenity is not indicated for use in women who are pregnant or of reproductive potential; animal studies showed potential harm to offspring at high doses
  • Children: Safety and effectiveness have not been established in pediatric patients
  • Older adults: Most study participants were over 65; no overall differences in safety or effectiveness were found, though individual sensitivity can vary

What Romosozumab-aqqg Injection does in the body

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In postmenopausal women with osteoporosis, Evenity produced rapid effects on bone turnover markers. Bone formation markers rose sharply — peaking at about 145% above placebo levels within 2 weeks — then gradually returned toward baseline by month 12. At the same time, bone breakdown markers dropped by up to about 55% compared to placebo within the first 2 weeks and remained suppressed through the 12-month treatment period. After stopping Evenity, bone formation markers returned to baseline within about 12 months, while bone breakdown markers temporarily rebounded above baseline within 3 months before returning toward baseline by month 12.

How your body processes Romosozumab-aqqg Injection

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After a subcutaneous injection of Evenity, peak blood levels are typically reached within about 5 days. The drug has a mean effective half-life (the time it takes for the body to clear half of the drug) of approximately 12.8 days after multiple doses. Evenity is expected to be broken down into small peptides and amino acids through the body's normal protein-clearing pathways, similar to how the body handles its own antibodies. Steady-state drug levels in the blood are achieved by about 3 months of monthly dosing. Higher body weight is associated with somewhat lower drug exposure.

How to store Romosozumab-aqqg Injection

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Refrigerate EVENITY at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. 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.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Romosozumab-aqqg Injection: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Romosozumab-aqqg Injection — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly does Evenity do for my bones?

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Evenity works in a unique way — it actually helps your body build new bone, not just slow down bone loss. It does this by blocking a protein called sclerostin, which normally limits how much bone your body makes. By blocking sclerostin, Evenity turns up bone production while also reducing the natural breakdown of bone. The result is denser, stronger bone that is less likely to fracture. Most other osteoporosis medications only focus on slowing bone loss, so Evenity's bone-building effect is a real advantage — especially during the 12-month treatment window.

Why is the treatment only 12 months? Does it stop working?

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Yes — Evenity's bone-building effect is strongest in the first several months and gradually wanes over the 12-month course. After 12 doses, the anabolic (bone-building) benefit has largely run its course, so continuing beyond that doesn't provide the same value. The good news is that the bone you gained doesn't disappear overnight — but to protect it, your prescriber will likely recommend switching to a different osteoporosis medication after you finish Evenity.

I heard there's a heart risk with this medication. Should I be worried?

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This is a really important question, and I'm glad you're asking. Evenity does carry a serious FDA warning about a potential increased risk of heart attack, stroke, and cardiovascular death. In one clinical trial, more patients on Evenity had these events compared to patients taking alendronate (another osteoporosis drug). If you've had a heart attack or stroke in the past year, Evenity is not recommended for you. If you have other heart disease risk factors, your doctor will carefully weigh whether the fracture-prevention benefits outweigh the cardiovascular risks for your specific situation. This is a real conversation to have with your prescriber before starting.

Do I need to take any supplements while I'm on Evenity?

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Yes — calcium and vitamin D supplementation is required while you're taking Evenity. Evenity can lower calcium levels in the blood (a condition called hypocalcemia), and getting enough calcium and vitamin D helps prevent that. Your prescriber will tell you how much to take daily. If you have severe kidney disease or are on dialysis, you're at even higher risk for low calcium, so your doctor will monitor your calcium levels closely throughout treatment.

What should I watch out for and when should I call my doctor?

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Call 911 immediately for any signs of a heart attack — chest pain, trouble breathing — or stroke — sudden numbness on one side, slurred speech, or severe headache. Call your doctor right away if you notice new or unusual thigh, hip, or groin pain (which can signal a rare type of thigh-bone fracture), jaw pain or sores that won't heal, or signs of low calcium like muscle cramps or tingling around the mouth. A serious allergic reaction — swelling of the face or throat, hives — also needs immediate attention. The most common, day-to-day side effects are joint pain and headache, which are generally manageable but worth mentioning to your doctor if they bother you.

Do I give this injection to myself at home?

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No — Evenity is always administered by a healthcare provider, not self-injected at home. Each monthly visit involves two separate injections given one right after the other, usually in the abdomen, thigh, or upper arm, to deliver the full monthly dose. The prefilled syringes need to sit at room temperature for at least 30 minutes before use, so your care team will handle all the preparation. You'll just need to show up for your monthly appointment and make sure you keep up with your calcium and vitamin D supplements at home.

Is Romosozumab-aqqg Injection available over the counter?

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No. Romosozumab-aqqg Injection is a prescription medicine: every Romosozumab-aqqg Injection product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Romosozumab-aqqg Injection first available?

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The earliest FDA record we hold for Romosozumab-aqqg Injection is from 2019: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Romosozumab-aqqg Injection was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Romosozumab-aqqg Injection on HelloPharmacist

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Detailed data & references for Romosozumab-aqqg Injection Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Romosozumab-aqqg Injection forms and strengths (how it comes)

Romosozumab-aqqg Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Romosozumab-aqqg Injection inactive ingredients by manufacturer.

Injection

By injection · Under the skin
Brands Evenity
How this form is used
What it may be used for
  • Evenity is used to treat osteoporosis in postmenopausal women at high risk for fracture, including those with a prior osteoporotic fracture or multiple fracture risk factors
  • Evenity is used for postmenopausal women who have not responded to or cannot tolerate other osteoporosis treatments
Important instructions
  • Evenity is given as two separate subcutaneous (under-the-skin) injections once a month — both injections are needed to deliver the full dose
  • Evenity must be administered by a healthcare provider into the abdomen, thigh, or outer upper arm
  • Allow Evenity prefilled syringes to sit at room temperature for at least 30 minutes before injection; do not warm them any other way
  • Evenity treatment is limited to 12 monthly doses; take calcium and vitamin D supplements throughout the entire course of treatment
Available strengths 1 strength
105 mg/1.17 mL
8 FDA-listed product records ⓘ

Romosozumab-aqqg Injection on the U.S. market: products, makers and brands

How Romosozumab-aqqg Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1 company lists 3 Romosozumab-aqqg Injection product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 2019. Brand names on the directory include Evenity; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
3
FDA-listed product records ⓘ
2019
Earliest FDA record ⓘ

How widely Romosozumab-aqqg Injection is used (Medicaid data)

A general measure of how commonly Romosozumab-aqqg Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Romosozumab-aqqg Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

14,773
Medicaid prescriptions filled (Q1–Q4 2025)
$29.6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Romosozumab-aqqg Injection prescribed? Of the 1,601 medications we measure, Romosozumab-aqqg Injection ranks #856 by Medicaid prescriptions — more than 47% of them.

Where Romosozumab-aqqg Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #856 of 1,601
#851 Lenalidomide 15,430 Rx #852 Acetylcysteine Oral In... 15,323 Rx #853 Hydrochlorothiazide /... 15,067 Rx #854 Solriamfetol 15,014 Rx #855 Difluprednate Ophthalm... 14,855 Rx #856 Romosozumab-aqqg Injec... 14,773 Rx #857 Bismuth, Metronidazole... 14,740 Rx #858 Etoposide 14,672 Rx #859 Desmopressin Nasal 14,664 Rx #860 Hydrocortisone Injecti... 14,630 Rx #861 Abiraterone 14,531 Rx

Utilization by Romosozumab-aqqg Injection product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

Other Romosozumab-aqqg Injection products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

14,773 Medicaid prescriptions (Q1–Q4 2025) 100% of Romosozumab-aqqg Injection prescriptions shown $29.6M gross reimbursement (before rebates) ≈ $2,001 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Romosozumab-aqqg Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 4 listed Romosozumab-aqqg Injection NDCs with Medicaid activity.

Compare Romosozumab-aqqg Injection products

A representative set of FDA-listed product records for Romosozumab-aqqg Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Injection
105 mg/1.17 mL Subcutaneous Amgen, Inc × 3 listings BLA View NDC →

Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Romosozumab-aqqg Injection NDCs →

Romosozumab-aqqg Injection side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Romosozumab-aqqg Injection — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Romosozumab-aqqg Injection are fall, fracture, arthralgia; about 58% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

13,496
Reports mentioning it
58%
Reported as serious
12
Distinct effects shown
Most reported effects
Fall
795
Fracture
661
Arthralgia
624
Injection Site Pain
567
Bone Density Abnormal
462
Hospitalisation
458
Headache
457
Product Storage Error
355
Pain In Extremity
314
Death
310
Age groups
Elderly · 6,224Adult · 1,469Child · 3Adolescent · 1

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Romosozumab-aqqg Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Romosozumab-aqqg Injection FDA approval history

How Romosozumab-aqqg Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Romosozumab-aqqg Injection was first approved by the FDA in 2019 (Brand: EVENITY · Amgen Inc). It remains available in U.S. pharmacies today.

2019
Brand approved
Brand: EVENITY · Amgen Inc
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Romosozumab-aqqg Injection recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list one Romosozumab-aqqg recall since July 2021. It is still ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Apr 21, 2025 · Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations; potential temperature excursions due to transit delays
  • EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02. Lots: Lot: 1178382, Expiration date: 3/31/2027 FDA record D-0539-2025 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Romosozumab-aqqg Injection RxCUI 2123126 1 dose form · 1 strength

Look up RxCUI 2123126 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Romosozumab-aqqg Injection brand names

Romosozumab-aqqg Injection is sold under one brand name in the FDA directory — Evenity. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Evenity

Who makes Romosozumab-aqqg Injection: manufacturers and labelers

One company lists Romosozumab-aqqg Injection products with the FDA. By number of product records, the largest are Amgen, Inc. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Amgen, Inc 3

Romosozumab-aqqg Injection drug class (RxNorm)

Romosozumab-aqqg Injection belongs to the Other drugs affecting bone structure and mineralization class.

Drug family (ATC) Other drugs affecting bone structure and mineralization

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Romosozumab-aqqg Injection page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 16, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Romosozumab-aqqg Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Romosozumab-aqqg Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
3
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
Amgen Inc
Linked label effective
Jul 16, 2026
Composite sections available
22
Linked SPL Set ID
471baba2-7154-4488-9891-0db2f46791e7
Linked SPL Document ID
1b60403e-86c5-4694-8cb5-2fc19f46dc49
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Amgen Inc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →