Frequently Asked Questions

Prolia is used:

• for the treatment of 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 other osteoporosis medicines did not work well.
• to increase bone mass in men with osteoporosis at high risk for fracture.
• to increase bone mass and may reduce fractures that occur when medication to reduce testosterone levels are taken for the treatment of prostate cancer that has not spread to other parts of the body (nonmetastatic).
• to increase bone mass in women who are receiving certain treatments for breast cancer, which has not spread to other parts of the body (nonmetastatic) and at high risk of fracture.
• to increase bone mass to treat osteoporosis in both women and men at high risk for fracture related to the use of corticosteroid medicines, such as prednisone.
• to increase bone mass to prevent osteoporosis in both women and men at high risk for fracture related to starting corticosteroid medicines, such as prednisone.

Bones are constantly changing. Normally, there is a balance between the cells that remove old bone and those that create new bone. With osteoporosis, more bone is removed than is replaced, which causes thinning and weakening of the bones and makes them more likely to break.

Prolia works by blocking RANK ligand, a protein that activates cells that break down bone. Prolia strengthens bones by increasing bone mass. This lowers the chance of breaking bones of the hip, spine and non-spinal sites.

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

These are not all the possible symptoms or side effects you may experience; if you are concerned about any effects you experience you should contact your healthcare professional.

Possible side effects include:

• Pain, sometimes severe, in the muscles, joints, arms, legs or back.
• Low blood calcium levels. Tell your doctor right away if you experience symptoms that may include muscle spasms, twitches, cramps, numbness or tingling in fingers, toes or around the mouth. This was reported in less than 0.1% of patients taking Prolia.
• 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
• A skin condition with itching, redness and/or dryness (eczema). This was reported in 1% to 10% of patients taking Prolia. Injection site reactions were uncommon.
• Rash that may occur on the skin or sores in the mouth (lichenoid drug eruption)
• Hair loss (alopecia)
• Tell your doctor right away if you experience the symptoms of skin infection – 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 frequent or urgent need to urinate or burning feeling when you urinate (bladder infection), severe stomach pains (pancreatitis) or ear infection. Tell your doctor if you have any of the following skin problems that do not go away or get worse: redness; itching; rash; dry or leathery skin; open, crusted or peeling skin; blisters. Any dental symptoms, including pain or unusual feeling in your teeth or gums, or any dental infections (osteonecrosis of the jaw); or new or unusual pain in your hip, groin or thigh (fracture of the thigh bone).

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.

These are not all the possible symptoms or side effects that you may experience – it is important to contact your doctor or pharmacist if you are concerned about potential side effects you may be experiencing with your Prolia treatment.

It is important to receive your Prolia injection every 6 months and to follow your doctor’s instructions for calcium and vitamin D supplementation.

Prolia is taken as an injection just under the skin in your upper arm, upper thigh or abdomen. It can be given to you at any time of day by a healthcare professional or a trained injector and it can be given with or without food.

The ProVital Support Program will help you stay on track with your Prolia treatment. As a member of the program, you will receive ongoing communications to help you manage your osteoporosis and your Prolia appointments.

Services include:

• Next injection reminders
• Educational resources that help keep you on track with the Program
• Access to the ProVital Support Program via telephone or online for answers to any questions you may have about Prolia

You can also ask your doctor for the reminder card with calendar stickers that come inside the box of Prolia to help you remember your next appointment.

Sign the ProVital fax enrolment form in your doctor’s office and fax to 1-877-776-1022, or call 1-877-776-1002.

Prolia.ca is your online resource for answers to frequently asked questions about Prolia and postmenopausal osteoporosis.