Romosozumab: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: April 17, 2026🚩 Report this page

Romosozumab

Other Drugs Affecting Bone Structure and Mineralization

Sold as Evenity

GB MHRAEU EMACA Health Canada

Drug class: Other Drugs Affecting Bone Structure and Mineralization
Availability: See label
Routes: Subcutaneous
Markets covered: 3
Products on record: 5

M05BXOther Drugs Affecting Bone Structure and Mineralization

Overview

Romosozumab is an active pharmaceutical ingredient in the Other Drugs Affecting Bone Structure and Mineralization group (M05BX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	3	April 17, 2026
EU European Union	EMA	1	May 7, 2025
CA Canada	Health Canada	1	March 22, 2025

GBUnited Kingdom· MHRA

3 products

Uses

GBOfficial regulatory label· revised April 17, 2026[1]

1).

How to take

GBOfficial regulatory label· revised April 17, 2026

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised May 7, 2025[2]

1).

How to take

EUOfficial regulatory label· revised May 7, 2025

CACanada· Health Canada

1 product

Uses

CAOfficial regulatory label· revised March 22, 2025[3]

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. 1 Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
5%) were ≥ 75 years old.

How to take

Drug interactions

Known interactions involving Romosozumab. Select one for details. This list is informational and not a complete interaction checker.

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]MHRA (UK) · PLGB000390793 · revised April 17, 2026
[2]European Medicines Agency · EMEA/H/C/004465 · revised May 7, 2025
[3]Health Canada (DPD) · 02489597 · revised March 22, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised April 17, 2026[1]

4%). 7% of patients treated with romosozumab. 4% of patients treated with romosozumab). 4 and information below). Tabulated list of adverse reactions The following convention has been used for the classification of the adverse reactions: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000).
Within each frequency grouping and system organ class, adverse reactions are presented in order of decreasing seriousness. MedDRA System Organ Class Adverse reaction Frequency category Nasopharyngitis Very common Infections and infestations Sinusitis Common Immune system disorders Hypersensitivitya Rash Dermatitis Urticaria Angioedema Erythema multiforme Common Common Common Uncommon Rare Rare Metabolism and nutrition disorders Hypocalcaemiab Uncommon Headache Common Nervous system disorders Strokec Uncommon Eye disorders Cataract Uncommon Cardiac disorders Myocardial infarctionc Uncommon Arthralgia Very common Neck pain Common Musculoskeletal and connective tissue disorders Muscle spasms Common General disorders and administration site conditions Injection site reactionsd Common a.
4. b. Defined as albumin adjusted serum calcium that was below the lower limit of normal. 4. c. See section “Myocardial infarction and stroke” below. d. Most frequent injection site reactions were pain and erythema. 9% (58 of 6244) for neutralizing antibodies.
The earliest onset of anti-romosozumab antibodies was 3 months after first dosing. The majority of antibody responses were transient. The presence of anti-romosozumab binding antibodies decreased romosozumab exposure by up to 25%. No impact on the efficacy of romosozumab was observed in the presence of antiromosozumab antibodies.
Limited safety data show that the incidence of injection site reactions was numerically higher in female patients with neutralizing antibodies. 3%) in the alendronate arm. These events occurred in patients with and without a history of myocardial infarction or stroke.
6%) women in the alendronate group. 14]) for romosozumab compared to alendronate. 1%) women in the alendronate group. 8%) in the placebo group. 7%) women in the placebo group. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised April 17, 2026[1]

8). 3). g. established cardiovascular disease, hypertension, hyperlipidaemia, diabetes mellitus, smoking, severe renal impairment, age). Romosozumab should only be used if the prescriber and patient agree that the benefit outweighs the risk.
If a patient experiences a myocardial infarction or stroke during therapy, treatment with romosozumab should be discontinued. Hypocalcaemia Transient hypocalcaemia has been observed in patients receiving romosozumab. Hypocalcaemia should be corrected prior to initiating therapy with romosozumab and patients should be monitored for signs and symptoms of hypocalcaemia.
8), calcium levels should be measured. 8). 73 m2) or receiving dialysis are at greater risk of developing hypocalcaemia and the safety data for these patients is limited. Calcium levels should be monitored in these patients. Hypersensitivity Clinically significant hypersensitivity reactions, including angioedema, erythema multiforme, and urticaria occurred in the romosozumab group in clinical trials.
8). Osteonecrosis of the jaw Osteonecrosis of the jaw (ONJ), has been reported rarely in patients receiving romosozumab. The following risk factors should be considered when evaluating a patient’s risk of developing ONJ: - potency of the medicinal product that inhibits bone resorption (the risk increases with the antiresorptive potency of the compound), and cumulative dose of antiresorptive therapy.
g. anaemia, coagulopathies, infection), smoking. - concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck. g. tooth extractions. All patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling or non-healing of sores or discharge during treatment with romosozumab.
Patients who are suspected of having or who develop ONJ while on romosozumab should receive care by a dentist or an oral surgeon with expertise in ONJ. Discontinuation of romosozumab therapy should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Atypical femoral fractures Atypical low-energy or low trauma fracture of the femoral shaft, which can occur spontaneously, has been reported rarely in patients receiving romosozumab. Any patient who presents with new or unusual thigh, hip, or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture.

This is not medical advice. Consult a qualified healthcare professional.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised May 7, 2025[2]

4%). 7% of patients treated with romosozumab. 4% of patients treated with romosozumab). 4 and information below). Tabulated list of adverse reactions The following convention has been used for the classification of the adverse reactions: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000).
Within each frequency grouping and system organ class, adverse reactions are presented in order of decreasing seriousness. Draft 6 MedDRA System Organ Class Adverse reaction Frequency category Infections and infestations Nasopharyngitis Very common Sinusitis Common Immune system disorders Hypersensitivitya Rash Dermatitis Urticaria Angioedema Erythema multiforme Common Common Common Uncommon Rare Rare Metabolism and nutrition disorders Hypocalcaemiab Uncommon Nervous system disorders Headache Common Strokec Uncommon Eye disorders Cataract Uncommon Cardiac disorders Myocardial infarctionc Uncommon Musculoskeletal and connective tissue disorders Arthralgia Very common Neck pain Common Muscle spasms Common General disorders and administration site conditions Injection site reactionsd Common a.
4. b. Defined as albumin adjusted serum calcium that was below the lower limit of normal. 4. c. See section “Myocardial infarction and stroke” below. d. Most frequent injection site reactions were pain and erythema. 9% (58 of 6244) for neutralizing antibodies.
The earliest onset of anti-romosozumab antibodies was 3 months after first dosing. The majority of antibody responses were transient. The presence of anti-romosozumab binding antibodies decreased romosozumab exposure by up to 25%. No impact on the efficacy of romosozumab was observed in the presence of antiromosozumab antibodies.
Limited safety data show that the incidence of injection site reactions was numerically higher in female patients with neutralizing antibodies. 3%) in the alendronate arm. These events occurred in patients with and without a history of myocardial infarction or stroke.
6%) women in the alendronate group. 14]) for romosozumab compared to alendronate. 1%) women in the alendronate group. 8%) in the placebo group. 7%) women in the placebo group. Draft 7 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

EUOfficial regulatory label· Warnings and precautions· revised May 7, 2025[2]

8). 3). g. established cardiovascular disease, hypertension, hyperlipidaemia, diabetes mellitus, smoking, severe renal impairment, age). Romosozumab should only be used if the prescriber and patient agree that the benefit outweighs the risk.
If a patient experiences a myocardial infarction or stroke during therapy, treatment with romosozumab should be discontinued. Draft 4 Hypocalcaemia Transient hypocalcaemia has been observed in patients receiving romosozumab. Hypocalcaemia should be corrected prior to initiating therapy with romosozumab and patients should be monitored for signs and symptoms of hypocalcaemia.
8), calcium levels should be measured. 8). 73 m2) or receiving dialysis are at greater risk of developing hypocalcaemia and the safety data for these patients is limited. Calcium levels should be monitored in these patients. Hypersensitivity Clinically significant hypersensitivity reactions, including angioedema, erythema multiforme, and urticaria occurred in the romosozumab group in clinical trials.
8). Osteonecrosis of the jaw Osteonecrosis of the jaw (ONJ), has been reported rarely in patients receiving romosozumab. The following risk factors should be considered when evaluating a patient’s risk of developing ONJ: - potency of the medicinal product that inhibits bone resorption (the risk increases with the antiresorptive potency of the compound), and cumulative dose of antiresorptive therapy.
g. anaemia, coagulopathies, infection), smoking. - concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck. g. tooth extractions. All patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling or non-healing of sores or discharge during treatment with romosozumab.
Patients who are suspected of having or who develop ONJ while on romosozumab should receive care by a dentist or an oral surgeon with expertise in ONJ. Discontinuation of romosozumab therapy should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Atypical femoral fractures Atypical low-energy or low trauma fracture of the femoral shaft, which can occur spontaneously, has been reported rarely in patients receiving romosozumab. Any patient who presents with new or unusual thigh, hip, or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture.

This is not medical advice. Consult a qualified healthcare professional.

1 Dosing Considerations EVENITY is administered subcutaneously. EVENITY should be administered by a health care professional or an individual trained by a health care professional. EVENITY Product Monograph Page 5 of 38 After initial training in proper subcutaneous injection technique, an individual may self-inject EVENITY if a physician determines that is appropriate and with medical follow-up as necessary.
2 Recommended Dose and Dosage Adjustment The recommended dose of EVENITY is 210 mg administered once every month as two consecutive subcutaneous injections of 105 mg each using the single-dose prefilled syringes for 12 doses. Patients should be adequately supplemented with calcium and vitamin D (see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and CLINICAL TRIALS).
Limit duration of use to 12 monthly doses. When a patient has completed the 12 months of EVENITY therapy, and osteoporosis therapy remains warranted, continued therapy with an anti- resorptive agent should be considered (see ACTION AND CLINICAL PHARMACOLOGY and CLINICAL TRIALS).
In the absence of a follow on anti-resorptive therapy, bone mineral density (BMD) gains trend toward pre-treatment levels following cessation of EVENITY. Health Canada has not authorized an indication for pediatric use. 73 m2) or end-stage renal disease (ESRD) requiring hemodialysis; however, EVENITY should be used with caution (see WARNINGS AND PRECAUTIONS, Renal Impairment).
3 Administration To administer the recommended dose of 210 mg, give two consecutive subcutaneous injections of 105 mg each. Visually inspect EVENITY for particles and discolouration prior to administration. EVENITY is a clear to opalescent, colourless to light yellow solution.
Do not use if the solution is cloudy or discoloured or contains particles. Administer EVENITY in the abdomen, thigh, or upper arm subcutaneously. 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. Comprehensive instructions for the administration of EVENITY are provided in the Patient Medication Information – How to take EVENITY section. 4 Missed Dose If an 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.

Side effects & warnings

CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[3]

8% (29/3581) in the EVENITY group. 1% in the EVENITY group. 1% in the EVENITY group. 6%). 1%) in the EVENITY group). 5% (30/2040) in the EVENITY group. 9% in the EVENITY group. 2% in the EVENITY group. 2%). 2 Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Treatment of Postmenopausal Osteoporosis in Women at High Risk of Fracture Study 1 (FRAME) (placebo-controlled) The safety of EVENITY in the treatment of postmenopausal osteoporosis in women at high risk of fracture was demonstrated in a multicenter, randomized, double-blind, placebo-controlled study of 7180 postmenopausal women aged 55 to 90 years (mean age of 71 years).
EVENITY Product Monograph Page 10 of 38 A total of 3581 and 3576 patients received at least 1 dose of EVENITY and placebo, respectively, administered once every month during the 12-month double-blind study period. Patients received at least 500 mg calcium and 600 international units (IU) vitamin D supplementation daily.
Most patients (77%) received a loading dose of 50,000 to 60,000 IU of vitamin D within one week of randomization if their serum 25-hydroxyvitamin D concentrations were 40 ng/mL or less. Study 2 (ARCH) (alendronate-controlled) The safety of EVENITY in the treatment of postmenopausal osteoporosis in women at high risk of fracture was demonstrated in a multicenter, randomized, double-blind, alendronate-controlled study of 4093 postmenopausal women aged 55 to 90 years (mean age of 74 years).
A total of 2040 and 2014 patients received at least 1 dose of EVENITY and alendronate, respectively, with EVENITY administered once every month during the 12-month double-blind study period. A total of 3462 patients received at least 1 dose of alendronate in the open-label period.
Patients received at least 500 mg calcium and 600 IU vitamin D supplementation daily. Most patients (74%) received a loading dose of 50,000 to 60,000 IU of vitamin D within one week of randomization if their serum 25-hydroxyvitamin D concentrations were 40 ng/mL or less.
Table 2 below summarizes the adverse events reported during the first 12 months of Study 1 (FRAME) and Study 2 (ARCH). EVENITY Product Monograph Page 11 of 38 Table 2. 2%) placebo-treated patients. 3%) placebo-treated patients. 4%) placebo-treated patients.
These events were reported in patients with and without a history of myocardial infarction or stroke. 8%) […]

CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[3]

Please see the Serious Warnings and Precautions Box at the beginning of Part I:
Health Professional Information. General Patients should be adequately supplemented with calcium and vitamin D during EVENITY treatment (see CONTRAINDICATIONS, and WARNINGS AND PRECAUTIONS, Endocrine and Metabolism -- Hypocalcemia).
Bone Osteonecrosis 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 occurred in EVENITY- treated patients in clinical trials (see Clinical Trial Adverse Reactions).
Evaluate patients for risk factors for ONJ before starting treatment. A dental examination with appropriate preventative dentistry is recommended prior to treatment with EVENITY in patients with risk factors for ONJ. g. g. g. periodontal and/or other pre-existing dental disease, ill- fitting dentures, anemia, coagulopathy, and infection).
Patients should maintain good oral hygiene practices during treatment with EVENITY. Patients should receive routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling during treatment with EVENITY.
For patients in whom invasive dental procedures cannot be avoided, the clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit-risk assessment. Patients who are suspected of having or who develop ONJ during treatment with EVENITY should receive care by a dentist or an oral surgeon.
Consider discontinuation of EVENITY treatment based on an individual benefit-risk assessment. Atypical Femoral Fractures Atypical low-energy or low-trauma fractures of the femoral shaft, which can occur spontaneously, have been reported in patients treated with EVENITY (see Clinical Trial Adverse Reactions).
Any patient who presents with new or unusual thigh, hip or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Assess patients presenting with an atypical femur fracture for symptoms and signs of fracture in the contralateral limb.

This is not medical advice. Consult a qualified healthcare professional.