Romosozumab

Pronunciation: ro-mo-so-zu-mab
Generic name: romosozumab
Brand name: Evenity
Dosage form: injection for subcutaneous use
Drug class: Miscellaneous bone resorption inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Jul 10, 2024.

What is romosozumab?

Romosozumab (brand name Evenity) is a sclerostin inhibitor that may be used to treat osteoporosis in women after menopause who are at high risk of fractures (broken bones), or who cannot use another osteoporosis medicine or other osteoporosis medicines did not work well.

• Romosozumab should not be used for more than 12 doses (12 months).

Romosozumab blocks the action of sclerostin which is a regulating protein in bone metabolism and is produced by osteoclasts (these are cells that dissolve and break down old or damaged bone). Romosozumab increases bone formation and to a lesser extent, decreases bone resorption, and animal studies have also shown improvements in bone structure and strength.

Romosozumab was FDA-approved on April 9, 2019, under the brand name Evenity. There is no Evenity generic available. The full biologic name for romosozumab is romosozumab-aqqg.

Romosozumab side effects

The most common side effects of romosozumab include:

• joint pain
• headache.

Serious side effects and warnings

Romosozumab 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 face, arm, or legs; difficulty talking; 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 level is too low.
• are allergic to romosozumab, Evenity, or any of the inactive ingredients in the injection.

Before receiving romosozumab, 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. Romosozumab is only for use in postmenopausal women and should not be used during pregnancy.

How is romosozumab administered?

Romosozumab is an injection that is administered subcutaneously (under the skin) by your healthcare provider.

• You will receive a romosozumab dose (2 injections) 1 time every month for 12 doses.
• You should take calcium and vitamin D while you receive romosozumab.
• You should take good care of your teeth and gums while you receive romosozumab. You should tell your dentist that you are receiving romosozumab before you have dental work.

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 of romosozumab 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 romosozumab 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 must be used within 30 days. Romosozumab should be thrown away if taken out of the refrigerator and not used within 30 days.

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

Keep out of the reach of children.

Romosozumab ingredients

Romosozumab is currently only available as 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 Evenity which is the only available brand of romosozumab.

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

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