Missed a Prolia Injection? What the FDA Label Says
[Missed dose · Prolia]

I missed my Prolia injection. What should I do?

denosumab injection · One injection every 6 months, given by a healthcare provider · Label checked

Short answer: The Prolia label says that if a dose is missed, give the injection as soon as the patient is available, then schedule the next ones every 6 months from the date of that last injection. The label also warns that stopping, skipping or delaying Prolia raises the risk of broken bones in the spine.

What does the Prolia label say about missed doses?

From the FDA label on DailyMed. Numbers in brackets are label section numbers.
SituationWhat the label says
Schedule60 mg every 6 months, given by a healthcare provider (2.3)
Missed a doseGive it as soon as possible (2.3)
Next dose after a late oneEvery 6 months from the date of the late injection (2.3)
Risk of a delayMore spine fractures after stopping or delaying (5.6, Medication Guide)
Half-lifeAbout 25.4 days (12.3)

What does the Prolia label say about a missed injection?

Section 2.3 says that if a dose of Prolia is missed, give the injection as soon as the patient is available, then schedule injections every 6 months from the date of the last injection.

Example: your Prolia was due March 1 and you get it on April 15. Under the label your next injection would be due around October 15, 6 months after April 15, not September 1.

Why does a Prolia delay matter?

Section 5.6 warns about multiple spine fractures after Prolia is stopped. The Medication Guide says the risk of broken bones, including in the spine, goes up after stopping, skipping or delaying a dose. That is why the label says to get a missed injection as soon as possible rather than waiting.

Denosumab levels fall over 4 to 5 months, with a mean half-life of about 25.4 days (section 12.3).

How do I keep track of a 6-month schedule?

Six months is long enough to forget. Note the exact date of each injection, because after a late dose the next due date moves with it.

This page summarizes FDA labeling. It is not personalized medical advice; confirm what to do with your prescriber or pharmacist.

Missed-dose rules for other medicines

Frequently asked questions

How late can a Prolia shot be?+
The label gives no grace period. It says to give a missed dose as soon as possible.
After a late Prolia shot, when is the next one due?+
6 months from the date of the late injection, according to section 2.3.
Is it risky to delay Prolia?+
The label warns that stopping, skipping or delaying Prolia raises the risk of broken bones, especially in the spine.