About Prolia^®

Prolia (denosumab injection) is used to treat osteoporosis (thinning and weakening of the bone) in women after menopause, who have an increased risk for fractures or cannot use other osteoporosis medicines, or for whom other osteoporosis medicines did not work well.

Prolia (denosumab injection) is also used to increase bone mass in men with osteoporosis at high risk for fracture.

As with all prescription medications, it’s important that you take Prolia as directed by your doctor – and that you continue to take it as prescribed by your doctor.

Prolia works differently than other osteoporosis medications. Prolia works by blocking RANK ligand, a protein that activates the cells that break down bone. By doing this, Prolia helps increase bone mass – making your bones stronger and lowering your chance of breaking your hip, spine and nonspinal sites.

Prolia is administered by a healthcare professional or trained injector. You will receive an injection given just under the skin.

Please click here for Prolia^® Patient Self-Injection Instructions for Patients, and watch the Self-Injection Video below.

Prolia is administered as a single injection under the skin every 6 months. The injection can be in your upper arm, upper thigh or abdomen. It can be given by a health professional or trained injector at any time of day, with or without food. Use the reminder card in the carton to track your upcoming Prolia injection appointment.

If you miss a dose you should receive your next dose as soon as convenient. Schedule your next dose 6 months from the date of your last injection.

ProVital is a reminder and education program that will help you start and stay on track with your Prolia treatment. As a member of the program, you will receive ongoing communications to help you learn about osteoporosis and manage your Prolia appointments. Services include: You can also ask your doctor to give you a Prolia appointment card or ask for the reminder card with calendar stickers that come inside the box of Prolia, so you can write down the date of your next appointment.

You should take Prolia as directed by your doctor. Your doctor may recommend you include Prolia along with calcium and vitamin D supplements. Always follow your doctor’s instructions regarding how long you may need to take Prolia.

You should not use Prolia: if you are allergic to denosumab or any other ingredient of Prolia; have low calcium levels in your blood (hypocalcemia); are less than 18 years of age; are pregnant or breast-feeding; are a woman before menopause (unless you have been diagnosed with breast cancer or are taking Prolia for the treatment or prevention of osteoporosis related to the use of corticosteroid medicines); are currently taking denosumab under the brand name XGEVA^®; do not have access to a healthcare professional or trained injector.

Prolia may interfere with normal bone and tooth development in fetuses, nursing babies and children under 18 years of age. Women who are pregnant or could become pregnant should not take Prolia. Your healthcare provider should do a pregnancy test before you start treatment with Prolia. You should use an effective method of birth control (contraception) during treatment and for at least 5 months after your last dose. If you become pregnant while taking Prolia, stop taking Prolia and tell your doctor right away. Nursing mothers should not take Prolia; it may interfere with breast-feeding.

The prefilled syringe is not made with natural rubber latex.

There’s a lot you can do.

Be nutrition-wise – calcium and vitamin D are essential to bone health.

LEARN MORE ABOUT healthy eating choices

Keep moving – strength exercises can be beneficial to your bones.

LEARN MORE ABOUT exercise programs that are right for you
The more you know about your condition, the better equipped you’ll be to make healthy lifestyle changes. Be proactive in making healthy lifestyle changes to help manage your osteoporosis.

Before you use Prolia, talk to your doctor or pharmacist if you: have low blood calcium; cannot take daily calcium and vitamin D; have had parathyroid or thyroid surgery (glands located in your neck); have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome); have kidney problems or are on kidney dialysis; have ever had an allergic reaction to Prolia; plan to have dental surgery or teeth removed; have a history of cancer; are pregnant or could become pregnant.
Tell your doctor or pharmacist about all the medicines you take, including prescription and nonprescription drugs, vitamins and herbal supplements, and keep an up-to-date list of all of them.

Like all medications, Prolia can cause side effects, although not everybody gets them. Possible side effects include:

• Pain, sometimes severe, in the muscles, joints, arms, legs or back
• Low blood calcium levels (hypocalcemia); symptoms may include muscle spasms, twitches, cramps, numbness or tingling in fingers, toes or around the mouth
• Allergic reactions (e.g., rash, hives, or in rare cases, swelling of the face, lips, tongue, throat or trouble breathing)
• Allergic reaction that can damage blood vessels mainly in the skin (e.g., purple or brownish-red spots, hives or skin sores)
• Severe allergic reaction (drug reaction with eosinophilia and systemic symptoms [DRESS] syndrome) with skin rash/blisters, fever and/or increase in a type of white blood cell (eosinophils) with possible organ damage, such as liver, kidney, or lung
• Skin condition with itching, redness and/or dryness (eczema). Injection-site reactions were uncommon.
• Rash that may occur on the skin or sores in the mouth (lichenoid drug eruption)
• Hair loss (alopecia)
• Skin infection with swollen, red area of skin that feels hot and tender and may be accompanied by fever (cellulitis)
• Common cold (runny nose or sore throat)
• Broken bones in the spine after stopping Prolia (multiple vertebral fractures)

Tell your doctor right away if you have:

Alert your doctor if you have: These are not all the possible symptoms or side effects that you may experience. It’s important to contact your doctor or pharmacist if you’re concerned about potential side effects you may be experiencing with your Prolia treatment.

After your treatment with Prolia is stopped, it is possible that broken bones in your spine may occur especially if you have a history of broken bones in the spine. Do not stop taking Prolia without first talking with your doctor. If your Prolia treatment is stopped, discuss other available treatment options with your doctor.

After you start Prolia:

• Take good care of your teeth and gums, and see your dentist regularly. If you have a history of dental problems (such as poorly fitting dentures or gum disease), see your dentist before starting Prolia. Tell your dentist that you are taking Prolia, especially if you are having dental work done.
• A dental condition called osteonecrosis of the jaw (ONJ), which can cause tooth and jawbone loss, has been reported in patients treated with Prolia (less than 0.1%). The risk of ONJ may increase with length of time on Prolia. Tell your doctor and dentist immediately about any dental symptoms, including pain or unusual feeling in your teeth or gums, or any dental infections.
• Some people have developed unusual fractures in their thigh bone. Contact your doctor if you experience new or unusual pain in your hip, groin or thigh.

If you experience side effects or if you have any concerns about side effects, contact your doctor.

When prescribed Prolia, you will likely need to fill your prescription at a pharmacy and store Prolia in your fridge (at 2 to 8°C) in the original carton, until your injection appointment with your health professional or trained injector. Do not freeze Prolia. If removed from the refrigerator, Prolia should be kept at room temperature (up to 25°C) in the original carton and must be used within 30 days.

Protect Prolia from direct light and do not expose to temperatures above 25°C. Keep Prolia out of reach and sight of children. Do not use Prolia after the expiry date printed on the carton and label. The expiry date refers to the last day of a month.