Quick answers
- What is Romosozumab-aqqg used for?
- The FDA-approved label (Evenity, Amgen, Inc, July 16, 2026) says: “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. Limitations of Use: Limit duration of use to 12 monthly doses. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Romosozumab-aqqg?
- The “Adverse Reactions” section of the FDA label (Evenity, Amgen, Inc, July 16, 2026) begins: “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.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Romosozumab-aqqg have a boxed warning?
- Yes. The FDA label for Evenity has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Romosozumab-aqqg?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Romosozumab-aqqg been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started April 21, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Romosozumab-aqqg?
- 1 company lists prescription products of Romosozumab-aqqg in the FDA NDC Directory, including Amgen, Inc.
What Romosozumab-aqqg is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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. Limitations of Use: Limit duration of use to 12 monthly doses. …
— FDA label: Evenity, Amgen, Inc, effective July 16, 2026. Read the full label on DailyMed →
Label quoted: the one for the most common form (injection, solution, subcutaneous), Evenity, Amgen, Inc; it covers 3 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
Romosozumab-aqqg boxed warning: what the label says
Quoted from the boxed warning of the FDA-approved label.
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.
Read more of this section
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)
— FDA label: Evenity, Amgen, Inc, effective July 16, 2026. Read the full label on DailyMed →
Romosozumab-aqqg side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
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.
Read more of this section
(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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in 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).
Table from the label
| Study 1 | Study 2 | |||
|---|---|---|---|---|
| Preferred Term | Placebo (N = 3576) n (%) | EVENITY (N = 3581) n (%) | Alendronate (N = 2014) n (%) | EVENITY (N = 2040) n (%) |
| Arthralgia | 434 (12.1) | 468 (13.1) | 194 (9.6) | 166 (8.1) |
| Headache | 208 (5.8) | 235 (6.6) | 110 (5.5) | 106 (5.2) |
| Muscle spasms | 140 (3.9) | 163 (4.6) | 81 (4.0) | 70 (3.4) |
| Edema peripheral | 67 (1.9) | 86 (2.4) | 38 (1.9) | 34 (1.7) |
| Asthenia | 79 (2.2) | 84 (2.3) | 53 (2.6) | 50 (2.5) |
| Neck pain | 54 (1.5) | 80 (2.2) | 42 (2.1) | 34 (1.7) |
| Insomnia | 68 (1.9) | 72 (2.0) | 36 (1.8) | 34 (1.7) |
| Paresthesia | 62 (1.7) | 72 (2.0) | 34 (1.7) | 29 (1.4) |
— FDA label: Evenity, Amgen, Inc, effective July 16, 2026. This is part of the section. Read the full label on DailyMed →
Romosozumab-aqqg dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
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.
Read more of this section
(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)]. 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.
— FDA label: Evenity, Amgen, Inc, effective July 16, 2026. This is part of the section. Read the full label on DailyMed →
Romosozumab-aqqg in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
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.
Read more of this section
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).
— FDA label: Evenity, Amgen, Inc, effective July 16, 2026. Read the full label on DailyMed →
When Romosozumab-aqqg should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
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.
Read more of this section
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)
— FDA label: Evenity, Amgen, Inc, effective July 16, 2026. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Evenity |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Amgen, Inc3 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 21, 2025 · Class II · Ongoing · D-0539-2025
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. — Mckesson Medical-Surgical Inc. Corporate Office
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 2123184, 2123185, 2123190, 2123191 |
|---|---|
| SPL set ID of the quoted label | 471baba2-7154-4488-9891-0db2f46791e7 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761062 |
| Active ingredients (FDA) | ROMOSOZUMAB |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- OsteoporosisCondition named on the label: hospitals that treat it
- Amgen, IncMaker or distributor
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Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Evenity, Amgen, Inc, effective July 16, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →