Romosozumab

Pronunciation: ro-mo-so-zu-mab
Generic name: romosozumab aqqg
Brand name: Evenity
Dosage form: pre-filled syringe for subcutaneous use (105 mg/1.17 mL)
Drug class: Miscellaneous bone resorption inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Mar 17, 2025.

What is romosozumab?

Romosozumab is used to treat osteoporosis in postmenopausal women at high risk of fractures. It is given once a month as an injection under the skin (subcutaneously) by a healthcare provider. The brand name is Evenity.

• Romosozumab injection should not be used for longer than 12 months.

Romosozumab gained FDA approval on April 9, 2019, under the brand Evenity. There is no generic or biosimilar.

How does romosozumab work?

Romosozumab works by blocking the action of sclerostin, a protein involved in bone metabolism. This increases the formation of new bone, and to a lesser extent, bone breakdown and resorption. This increases bone mass and improves bone structure and strength.

Romosozumab belongs to the drug class called sclerostin inhibitors. 

Romosozumab side effects

The most common side effects of romosozumab injection are:

• joint pain
• headache.

Serious side effects and warnings

Romosozumab injection carries a Boxed Warning for the potential risk of a heart attack, stroke, or cardiovascular death.

Increased risk of having a heart attack, stroke, or death from a cardiovascular (heart or blood vessel) problem. Before you receive romosozumab, tell your healthcare provider if you have had a heart attack or stroke, especially if it has happened in the past year. Call your healthcare provider or get emergency help right away if you have any of the symptoms listed below.

• Symptoms of heart attack such as chest pain or pressure, shortness of breath, feeling light-headed or dizzy
• Symptoms of stroke such as headache; numbness or weakness in the face, arm, or legs; difficulty talking; or changes in vision or loss of balance

Romosozumab may cause other serious side effects, including:

Serious allergic reactions. Call your healthcare provider or go to the nearest emergency room right away if you have any symptoms of a serious allergic reaction to romosozumab. Symptoms of a serious allergic reaction may include rash; hives; and swelling of the face, lips, mouth, tongue, or throat which may cause difficulty in swallowing or breathing.

Low calcium levels in your blood (hypocalcemia). Romosozumab may lower the calcium levels in your blood, and if you already have low blood calcium levels, they should be treated before you receive a dose. 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). These may happen when you take romosozumab. Your healthcare provider should examine your mouth before you start treatment and may tell you to see your dentist. Ask your healthcare provider or dentist about good mouth care, which you should practice while receiving romosozumab. 

Unusual thigh bone fractures. Symptoms of this type of fracture include new or unusual pain in your hip, groin, or thigh.

It is not known if romosozumab is safe and effective in children.

These are not all the possible side effects of romosozumab. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA1088.

Related/similar drugs

Before taking

Do not receive romosozumab if you:

• have been told by your healthcare provider that your blood calcium levels are too low.
• are allergic to romosozumab, Evenity, or any inactive ingredients in the injection.

Before receiving romosozumab injection, 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 if you are pregnant, plan to become pregnant, or are breastfeeding. Clinical trials have only investigated romosozumab in postmenopausal women, and it should not be used during pregnancy.

How is romosozumab administered?

Romosozumab is given subcutaneously (under the skin) by a healthcare provider.

• You will receive 1 dose (210 mg) every month, for 12 months.
• 1 dose equals 2 romosozumab injections.
• You can receive the injection in your abdomen (stomach) but not within 2 inches of your navel, outer thigh, or upper arm.
• The 2 doses will be injected one after the other.

You should take calcium and vitamin D while you are receiving this treatment.

• You should take good care of your teeth and gums while you receive romosozumab. You should tell your dentist that you are receiving this medicine before you have any dental work.

Dosing information

Recommended dose: Romosozumab 210 mg SC once a month.

• Do not exceed 12 monthly doses.

What happens if I miss a dose?

If you miss a dose of romosozumab, contact your healthcare provider as soon as possible to schedule your next dose. Your next dose should then be scheduled every month from the date of the last injection.

Romosozumab storage

If you need to pick up romosozumab from a pharmacy and store it at home:

• Keep it in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect it from light.
• Do not freeze or shake.

When you remove romosozumab from the refrigerator, it must be kept at room temperature up to 77°F (25°C) in the original carton and used within 30 days. Throw away if you have taken it out of the refrigerator and not used it within 30 days.

• Do not keep at temperatures above 77°F (25°C) because warm temperatures will affect how it works.

Keep out of reach of children.

Ingredients

Romosozumab is currently only available under the brand Evenity.

Evenity active ingredient: romosozumab aqqg

Evenity inactive ingredients: acetate, calcium, polysorbate 20, sodium hydroxide, sucrose, and water for injection.

Who makes romosozumab?

Amgen Inc. makes romosozumab under the brand name Evenity. Amgen is a biotechnology company based in Thousand Oaks, California, USA.

Romosozumab Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for romosozumab.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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