Prolia Solution For Injection 60Mg Drug Medication Dosage Information
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Prolia: Solution for injection (60mg)

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Prolia 60mg/mL Soln for Inj

What is this Medicine?

DENOSUMAB (den oh sue mab) slows bone breakdown. Prolia is used to treat osteoporosis in women after menopause and in men. Xgeva is used to prevent bone fractures and other bone problems caused by cancer bone metastases. Xgeva is also used to treat giant cell tumor of the bone.

Similar Brand Name Drugs : XGEVA: Solution for injection (70mg)
CVS Pharmacy Patient Statistics for Prolia: Solution for injection(60mg)
Generic vs. Brand Name Usage*
*Brand contains same active ingredient but may not represent FDA-approved generic equivalent
Usage By Strength
In-Depth Information
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Prolia 60mg/mL Solution for Injection

NDC: 555130710
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Giant Cell Tumor Of Bone, Osteoporosis Prophylaxis, Osteoporosis, Bone Metastases, Hypercalcemia

Storage Information
Refrigerate (between 36 and 46 degrees F)
Product must be used within 14 days after removal from refrigeration to room temperature (77 degrees F)
Protect from light
Store in original container
Discard product if it contains particulate matter, is cloudy, or discolored
Do not freeze
Avoid direct heat and sunlight
Prolia 60mg/mL Solution for Injection

Reported Side Effects for Prolia 60mg/mL Solution for Injection

Low Phosphate Level Incidence:
<15.4%*
Severity: SEVERE
Onset: DELAYED
Low Magnesium Levels Incidence:
<3.0%*
Severity: SEVERE
Onset: DELAYED
Low Calcium Levels Incidence:
<3.1%*
Severity: SEVERE
Onset: DELAYED
Tired Incidence:
<3.0%*
Severity: SEVERE
Onset: EARLY
Fluid Retention Incidence:
<24.0%*
Severity: MODERATE
Onset: DELAYED
Dead Bone Incidence:
0.7-7.1%*
Severity: SEVERE
Onset: DELAYED
Heartburn Incidence:
2.1%*
Severity: MILD
Onset: DELAYED
Itching Incidence:
2.2%*
Severity: MILD
Onset: RAPID
Gas Incidence:
2.2%*
Severity: MILD
Onset: EARLY
Weakness Incidence:
2.3-45.0%*
Severity: MILD
Onset: DELAYED
Skin Rash Incidence:
2.5%*
Severity: MILD
Onset: EARLY
Muscle Pain Incidence:
>3.0%*
Severity: MILD
Onset: EARLY
Stomach Pain Incidence:
3.3%*
Severity: MILD
Onset: EARLY
Bone Pain Incidence:
4.0-19.0%*
Severity: MODERATE
Onset: DELAYED
Anemia Incidence:
4.0-21.0%*
Severity: MODERATE
Onset: DELAYED
Muscle And/Or Bone Pain Incidence:
>8.0%*
Severity: MILD
Onset: EARLY
Low White Blood Cells Incidence:
>9.0%*
Severity: MODERATE
Onset: DELAYED
Back Pain Incidence:
10.0-34.7%*
Severity: MILD
Onset: DELAYED
Headache Incidence:
10.0-24.0%*
Severity: MILD
Onset: EARLY
Joint Pain Incidence:
>10.0%*
Severity: MILD
Onset: DELAYED
Upset Stomach Incidence:
10.0-31.0%*
Severity: MILD
Onset: EARLY
Chills Incidence:
>11.0%*
Severity: MILD
Onset: RAPID
Fever Incidence:
>11.0%*
Severity: MILD
Onset: EARLY
Cough Incidence:
>15.0%*
Severity: MILD
Onset: DELAYED
Loose Stools Incidence:
20.0%*
Severity: MILD
Onset: EARLY
Shortness Of Breath Incidence:
21.0-27.0%*
Severity: MODERATE
Onset: EARLY
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Pregnancy & Lactation Information
FIRST Trimester

Class X - Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant.

SECOND Trimester

Class X - Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant.

THIRD Trimester

Class X - Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant.

Lactation

Avoid - This drug is known to cause harm to infants when taken by nursing mothers.


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