• Prolia is a brand (trade) name for denosumab which may be used to treat osteoporosis.
• Prolia (denosumab) works by binding to a protein called RANKL on osteoclasts (the cells that break down bone), inhibiting their formation, function, and survival. This decreases bone breakdown and increases bone density and strength both in the outer layer of bone and the inner spongy layer.
• Prolia belongs to the class of drugs known as miscellaneous bone resorption inhibitors. It may also be called a monoclonal antibody.

• Prolia may be used to treat postmenopausal women with osteoporosis at high risk of fracture.
• May also be used to increase bone density in men with osteoporosis.
• Prolia may be used to increase bone mass in men who have undergone androgen deprivation therapy for prostate cancer and in women receiving aromatase inhibitor therapy for breast cancer.
• Prolia is administered by injection under the skin of the upper thigh, abdomen, or upper arm, once every six months.
• The dosage of Prolia does not need to be reduced in people with kidney disease.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Back pain, constipation, muscle pain, pain in the hands or feet, high cholesterol levels, nasal congestion, and bladder infections (in women) are the most common side effects reported with Prolia.
• Prolia may exacerbate low calcium levels and has been associated with low energy or low trauma fractures of the femoral shaft. The risk of serious infections may also be increased.
• Skin reactions occur frequently in people receiving Prolia, and there have been reports of severe incapacitating bone, joint, or muscle pain associated with Prolia use. Prolia may suppress bone remodeling.
• People undergoing Prolia therapy need to receive calcium 1000mg daily and at least 400 IU of vitamin D daily.
• Prolia has been associated with osteonecrosis of the jaw. The risk of osteonecrosis of the jaw is greater in those who have received chemotherapy, radiation, or steroids. A routine oral examination should be completed by a dentist before Prolia is started.
• Severe allergic reactions have been reported with Prolia and symptoms have included low blood pressure, shortness of breath, facial and throat tightness, and rash.
• Prolia may not be suitable for some people including those with low calcium levels (must be corrected before administration), who are pregnant, or with allergic reactions to Prolia or its components.
• Prolia is only available as an injection; however, people can be taught how to self-administer Prolia.
• The grey needle cap that fits onto the end of a pre-filled syringe of Prolia should not be handled by people with latex allergies because it may cause a reaction.
• Prolia must be stored in the refrigerator until needed for use.
• The risk of fracture, including multiple vertebral fractures, increases when Prolia is discontinued, and new vertebral fractures have been reported in as little as 7 months following discontinuation. The risk decreases to pretreatment values within 24 months. Bone density returns to pretreatment values within 18 months of the last injection of Prolia. Evaluate the benefits/risks for each patient before starting Prolia. When discontinuing Prolia, consider transitioning to another osteoporosis treatment agent.
• Avoid during pregnancy because Prolia may cause fetal harm. Potential placental transfer of Prolia is dependent upon the IgG subclass and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis. Prolia should only be used by postmenopausal women. If a female is inadvertently exposed to denosumab during pregnancy enroll her in the Amgen Pregnancy Surveillance Program (1-800-772-6436).
• There is no generic of Prolia. There is another brand of denosumab called Xgeva.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• If you have been shown how to self-inject Prolia, administer yourself a dose once every six months, otherwise see your healthcare provider for a dose every six months. If you forget a dose, schedule it as soon as you can, then continue getting your future injections six months from that date.
• Immediately before administration, take Prolia out of the refrigerator and leave it in its original container to warm up to room temperature for around 15 to 30 minutes. Do not warm in any other way. Once at room temperature, remove the grey needle cap and insert the needle under the skin of the upper thigh, abdomen, or upper arm. Push the plunger to inject the dose of Prolia under the skin. When finished, click the green safety guard into place (there is no need to replace the grey needle cap). Dispose of the used needle immediately in an approved sharps container.
• Keep Prolia in the refrigerator. Once taken out of the refrigerator, use it within 14 days. Do not shake Prolia vigorously.
• Prolia usually needs to be taken alongside calcium and vitamin D supplements. Make sure you take your supplements as directed and talk to your doctor or pharmacist if you are unsure about what supplements to take.
• Make sure you have a dental check-up before you start Prolia. Talk to both your dentist and doctor if you require dental surgery or tooth extraction and you have been administered Prolia. Keep good oral hygiene and get regular dental check-ups while you are being given Prolia. Report any oral symptoms such as tooth pain, jaw pain, and tooth loosening, mouth ulcers to your doctor while you are being administered Prolia.
• Talk to your doctor or seek urgent medical attention (if severe) if you experience symptoms such as dizziness on standing or fainting, shortness of breath, facial and throat tightness, or rash. Report any signs of infection immediately to your doctor.
• Tell your doctor if you experience any thigh or groin pain, muscle cramps or twitches, severe or debilitating muscle pain, or any other adverse effects of concern while you are being administered Prolia.
• Prolia should not be administered to women who are pregnant but if you inadvertently become pregnant while being administered Prolia, tell your doctor immediately.
• Talk to your doctor or pharmacist before taking any other medicines with Prolia. Prolia should not be taken at the same time as Xgeva.

• Maximal Prolia concentrations are reached within 10 days of an injection, and levels of Prolia decline over four to five months.
• Prolia reduced the risk of vertebral fractures by 4.8%, hip fractures by 0.3%, and nonvertebral fractures by 1.5%.
• Bone mineral density was increased by 8.8% in the spine, 6.4% in the hip, and 5.2% in the neck after three years of treatment with Prolia.

Medicines that interact with Prolia may either decrease its effect, affect how long it works for, increase side effects, or have less of an effect when taken with Prolia. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Prolia include:

• calcimimetic agents such as cinacalcet
• chemotherapy agents, such as cyclophosphamide, methotrexate, or bleomycin
• corticosteroids (such as prednisone or dexamethasone)
• immunosuppressants (such as azathioprine, cyclosporine, or tacrolimus).

Note that this list is not all-inclusive and includes only common medications that may interact with Prolia. You should refer to the prescribing information for Prolia for a complete list of interactions.