Denosumab (Prolia)


Denosumab (Prolia) is a biologic medication used to treat fragile bones, also known as osteoporosis, and prevent bone fractures. As a biologic drug, it is human-made and closely resembles naturally occurring antibodies in the body. In this case, it stops a molecule, called RANKL, which normally causes bone metabolism. By blocking RANKL, it helps to build and strengthen bones.

How to Take It

Denosumab is given as an injection just under the skin. It is given by your rheumatology provider or nursing staff. The usual dose is 60 mg every six months, and it should be taken with calcium (1,000–1,200 mg daily) and vitamin D (at least 400 IU) supplementation. The effect of denosumab is rapid - within three days of an injection, the effects can be detected in the blood; the drug also stays in the blood for several months after stopping the medicine.

Side Effects

The most common side effects that patients experience are muscle aches, back pain, pain in the hands and feet. The pain from denosumab can last a few days up to a few months after administration.

Denosumab can cause hypo calcium, or low calcium levels in the blood, with variable onset that is from 1–2 weeks or several months after treatment initiation.

Rarer side effects include an increased risk for atypical femur fractures (also known as stress or insufficiency fractures involving the hip joint), infections (especially if you are already taking medications that lower your immune system), loss of blood supply to the jawbone (called osteonecrosis of the jaw), severe allergic reactions, and vertebral fractures after discontinuation or interruption of therapy by more than 1 month beyond the next scheduled dose. It is, therefore, important to stay on schedule and follow closely with your rheumatology provider.

Tell Your Rheumatology Provider

Some symptoms may occur normally while taking denosumab, however, you should notify your rheumatology provider if you have these symptoms while taking this medication: tingling of the hands or around the mouth, new pain in the jaw, or fevers or other signs of infection.

Make sure to notify your other providers while you are taking this drug. If you are pregnant or considering pregnancy, let your provider know before starting this medication. Women should discuss birth control with their primary care providers or gynecologists. Breastfeeding should be avoided while taking denosumab because the drug can enter breast milk.

Updated March 2023 by Kristen Lee, MD, and reviewed by the American College of Rheumatology Communications and Marketing Committee.

This information provided for general education only. Individuals should consult a qualified health care provider for professional medical advice, diagnosis and treatment of a medical or health condition.

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