PROLIA™

What form is Prolia™ currently available?

Prolia™ is available in 2 forms: sterile, pre-filled syringe and vial form.

Each syringe or vial is designed for single-dose use only and contains 60 mg dose of the active medicine in 1 mL of solution.

What are some potential side effects of Prolia™?

Prolia™ is generally well tolerated. Possible side effects include, but are not limited to, back, muscle or joint pains, pains in leg or arm. Women taking Prolia™ may also experience bladder infection and high cholesterol.

If you are experiencing any unwanted side effect(s) or have any specific questions or concerns regarding a side effect, contact your doctor or pharmacist. You may also report the side effect(s) to the FDA at www.fda.gov/medwatch, or call 1-800-FDA-1088.

Who should NOT use Prolia™?

Prolia™ should be avoided in those with a history of allergy and/or hypersensitivity to denosumab or any other component of the product. Do not take Prolia™ if you are also on Xgeva® (denosumab), which has the same active drug.

Do not use Prolia™ if you are pregnant or as the drug may increase fetal loss and may be hazardous to a fetus.

How do you administer Prolia™?

Prolia™ needs to be injected subcutaneously in order for the medication to work. The medication should be administered by a health professional.

Each Prolia™ syringe is pre-fitted with needle. Prolia™ single-dose vial require the use of needle and syringe for injection. For detailed injection instructions, please refer to medication guide (PDF: prolia medication guide 09_2012).

Prolia™ should be taken with vitamin D and calcium supplements. Your doctor should check your calcium and vitamin D level to assure they are normal before giving Prolia™. Low levels must be corrected before starting Prolia™.

How do you store Prolia™?

Prolia™ should be stored in the refrigerator (36 – 46° Fahrenheit) prior to use. Once out of the refrigerator, Prolia™ is stable in room temperature (up to 77°F) for 14 days. Keep Prolia™ in its original carton, and store away from direct light.

How long does Prolia™ last?

Before opening, the Prolia™ is stable until the indicated expiration date listed on the packaging, while stored in the refrigerator. Prolia™ is stable up to 14 days in room temperature. Each Prolia™ vial or syringe is for single dose only. Discard the vial or syringe immediately after use.

Commonly Asked Questions

Q: What is the most important thing I should know about Prolia™?
A: Prolia™ and Xgeva® contain the same active ingredient, denosumab. Do not take both medications.

Q: Are there any preservatives in Prolia™?
A: No, Prolia™ does not contain any preservatives.

Q: How often do I take Prolia™?
A: You should take Prolia™ exactly as prescribed by your doctor. In general, Prolia™ is given as a single-dose      injection every 6 months.

Manufacturer Website

http://www.prolia.com/

Information on this site is provided for informational purposes and is not meant to substitute for the advice provided by your own physician or other medical professional.  You should not use the information contained herein for diagnosing or treating a health problem or disease, or prescribing any medication.  You should read carefully all product packaging.  If you have or suspect that you have a medical problem, promptly contact your health care provider.