Celebrating Ten Years of Reduced Bone Fracture Risk with Prolia?

This month marks the tenth anniversary of the U.S. approval of Prolia? (denosumab), an innovative Amgen medicine that reduces the risk of bone fractures in postmenopausal women with osteoporosis. Although the world is understandably focused on COVID-19 at the moment, it would be a mistake to ignore other pressing, preventable health threats – and osteoporosis is certainly one of them. This is a disease that affects 200 million people worldwide, mostly women, and results in debilitating bone fractures every three seconds. To make matters worse, we know that after suffering a first fracture, a woman is five times more likely to experience another one within just a year.

I’ve written before about the need to shift from a healthcare system that spends on the things that are broken to one focused on predicting and preventing the breaks in the first place. With osteoporosis, we already know who is at highest risk of fracturing: postmenopausal women. We know how to measure that risk: through a simple bone density test. And we know how to significantly reduce that risk: by promoting healthy behaviors and utilizing innovative medicines like Prolia to strengthen weak bones.  Wouldn’t it make sense to direct at least some of the estimated $57 billion a year we spend in the U.S. on treating osteoporotic fractures toward reducing the risk of fractures?

To improve our ability to predict and prevent secondary osteoporotic fractures, Amgen partnered recently with the International Osteoporosis Foundation, the University of Oxford, and UCB on the Capture the Fracture? Partnership, a global program that seeks to identify, screen, diagnose, and appropriately treat patients who have experienced an osteoporotic fracture in order to reduce their risk of future breaks.

On this tenth anniversary of Prolia’s first regulatory approval, Amgen remains more committed than ever to the fight against osteoporosis. I want to congratulate and thank all of my colleagues who have had a hand in this important medicine over the years. It has made a huge difference.

#mycompany

INDICATIONS

Prolia? is a prescription medicine used to treat osteoporosis in women after menopause who are at high risk for fracture or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well.

Prolia? is a prescription medicine used to increase bone mass in men with osteoporosis who are at high risk for fracture.

Prolia? is a prescription medicine used to treat osteoporosis in men and women who will be taking corticosteroid medicines (such as prednisone) for at least six months and are at high risk for fracture.

Prolia? is a prescription medicine used to treat bone loss in men who are at high risk for fracture receiving certain treatments for prostate cancer that has not spread to other parts of the body.

Prolia? is a prescription medicine used to treat bone loss in women who are at high risk for fracture receiving certain treatments for breast cancer that has not spread to other parts of the body.

Important Safety Information About Prolia?

Do not take Prolia? if you: have low blood calcium; or are pregnant or plan to become pregnant, as Prolia? may harm your unborn baby; or are allergic to denosumab or any ingredients in Prolia?.

What is the most important information I should know about Prolia??

If you receive Prolia?, you should not receive XGEVA?. Prolia? contains the same medicine as XGEVA? (denosumab).

Prolia? can cause serious side effects:

Serious allergic reactions have happened in people who take Prolia?. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction, including low blood pressure (hypotension); trouble breathing; throat tightness; swelling of your face, lips, or tongue; rash; itching; or hives.

Low blood calcium (hypocalcemia). Prolia? may lower the calcium levels in your blood. If you have low blood calcium, it may get worse during treatment. Your low blood calcium must be treated before you receive Prolia?.

Take calcium and vitamin D as your doctor tells you to help prevent low blood calcium.

Severe jaw bone problems (osteonecrosis) may occur. Your doctor should examine your mouth before you start Prolia? and may tell you to see your dentist. It is important for you to practice good mouth care during treatment with Prolia?.

Unusual thigh bone fractures. Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh.

Increased risk of broken bones, including broken bones in the spine, after stopping, skipping or delaying Prolia?. Talk with your doctor before starting Prolia? treatment. After your treatment with Prolia? is stopped, or if you skip or delay taking a dose, your risk for breaking bones, including bones in your spine, is increased. Your risk for having more than 1 broken bone in your spine is increased if you have already had a broken bone in your spine. Do not stop, skip or delay taking Prolia? without first talking with your doctor. If your Prolia? treatment is stopped, talk to your doctor about other medicine that you can take.

Serious infections in your skin, lower stomach area (abdomen), bladder, or ear may happen. Inflammation of the inner lining of the heart (endocarditis) due to an infection may also happen more often in people who take Prolia?. You may need to go to the hospital for treatment.

Prolia? is a medicine that may affect the ability of your body to fight infections. People who have weakened immune systems or take medicines that affect the immune system may have an increased risk for developing serious infections.

Skin problems such as inflammation of your skin (dermatitis), rash, and eczema have been reported.

Bone, joint, or muscle pain. Some people who take Prolia? develop severe bone, joint, or muscle pain.

Before taking Prolia?, tell your doctor about all of your medical conditions, including if you:

·      Take the medicine XGEVA? (denosumab)

·      Have low blood calcium

·      Cannot take daily calcium and vitamin D

·      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

·      Are taking medicine that can lower your blood calcium levels

·      Plan to have dental surgery or teeth removed

·      Are pregnant or plan to become pregnant

Females who are able to become pregnant:

o  Your healthcare provider should do a pregnancy test before you start treatment with Prolia?.

o  You should use an effective method of birth control (contraception) during treatment with Prolia? and for at least 5 months after your last dose of Prolia?.

o  Tell your doctor right away if you become pregnant while taking Prolia?.

·      Are breast-feeding or plan to breast-feed

What are the possible side effects of Prolia??

It is not known if the use of Prolia? over a long period of time may cause slow healing of broken bones. The most common side effects of Prolia? in women being treated for osteoporosis after menopause are back pain, pain in your arms and legs, high cholesterol, muscle pain, and bladder infection.

The most common side effects of Prolia? in men with osteoporosis are back pain, joint pain, and common cold (runny nose or sore throat).

The most common side effects of Prolia? in patients with corticosteroid-induced osteoporosis are back pain, high blood pressure, lung infection (bronchitis), and headache.

The most common side effects of Prolia? in patients receiving certain treatments for prostate or breast cancer are joint pain, back pain, pain in your arms and legs, and muscle pain. Additionally, in Prolia?-treated men with nonmetastatic prostate cancer receiving ADT, a greater incidence of cataracts was observed.

These are not all the possible side effects of Prolia?. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. 

Please see Prolia? full Prescribing Information and Medication Guide.