Prolia is an injection given every 6 months to treat osteoporosis in men, postmenopausal women, and people who take corticosteroid medicines who are at high risk for fractures. It is also used to increase bone mass and reduce fracture risk in people taking certain medicines for breast and prostate cancer. According to studies, people who took Prolia increased their bone mineral density (BMD) and decreased their risk of broken bones.
How Does It Work?
Prolia is a monoclonal antibody that binds to a specific protein on osteoclasts and decreases their activity. Osteoclasts are responsible for dissolving and breaking down old or damaged bone cells. By reducing the activity of osteoclasts, Prolia increases bone mass and makes the bones stronger.
How Was It Studied?
Breast cancer
The change in BMD was studied in women over 18 years of age who had hormone-receptive breast cancer and were taking an aromatase inhibitor medicine. The women in these studies had low BMD, and the average age was 59. People were given either Prolia or a placebo for four doses. They also received calcium and vitamin D.
Prostate cancer
The change in BMD was studied in men with prostate cancer who are taking androgen deprivation therapy. The study included men between the ages of 48 and 97. The average age was 75. They received either a placebo or Prolia every 6 months. They also received calcium and vitamin D.
Corticosteroid
The change in BMD was studied by comparing Prolia treatment to bisphosphonate treatment. People in these studies were between the ages of 20 and 94 with an average age of 63. Seventy percent were women. They were also taking a corticosteroid medicine and had a history of osteoporosis fracture, a low BMD score, or both. People received either Prolia every 6 months or risedronate 5 milligrams daily for 1 year. They also received calcium and vitamin D.
Postmenopausal women
The risk of new fractures in postmenopausal women was studied. People in these studies were between the ages of 60 and 90, with an average age of 72. They had low BMD scores, and 23% had a vertebral fracture. They received either Prolia or placebo plus calcium and vitamin D.
Men
The change in BMD of the spine was studied in men with osteoporosis. People in these studies were between the ages of 31 and 84, with an average age of 65. They had either a low BMD, a history of fragility fractures, or both. They received either Prolia or a placebo every 6 months and took calcium and vitamin D daily.
What Were the Main Benefits Seen in the Studies?
Breast cancer
- Increased BMD. At 24 months of treatment, BMD was increased by 7.6% in the spine. BMD also increased at other body sites.
- Quick results. Changes in BMD were seen as early as 1 month and continued throughout treatment.
Prostate cancer
- Increased BMD. People taking a placebo had their BMD decrease, while Prolia increased BMD at all sites including the spine, hip, and arm. After 3 years, the difference in BMD at the spine was 7.9% between placebo and Prolia.
- Less new fractures. At 3 years of treatment, Prolia reduced the risk of new spine fractures by 62%.
- Quick results. BMD started to improve in as early as 1 month and continued throughout treatment.
Corticosteroids
When compared to risedronate, Prolia showed greater increases in BMD at 1 year in people taking corticosteroids. Differences in BMD of the spine were seen at 6 months and continued through 1 year of treatment. Increases in BMD were seen at the spine, hip, and femoral neck locations.
Postmenopausal women
- Reduced spine fracture risk. After 3 years of use, Prolia reduced the risk of new spine fractures by 68% compared to placebo. Fractures occurred in 2.3% of people taking Prolia and 7.2% of people taking placebo.
- Increased BMD. After 3 years, Prolia increased BMD at the spine by 9.2% and at the hip by 6%.
- Reduced risk of hip and non-spine fractures. Prolia reduced the risk of getting a hip fracture by 40% and any non-spine fracture by 20%.
Long-term studies show that BMD continues to increase with treatment and the risk of broken bones remains low.
Men
Results showed that after 1 year, Prolia increased BMD in men with osteoporosis. Compared to placebo, Prolia increased BMD at the lumbar spine by 4.8%. BMD was also increased more than with placebo at the hip and femoral neck (where the thigh bone connects to the hip).
Your results may be different than what was seen in studies.
How Long Does It Take to Work?
Studies have shown that Prolia can increase BMD in as little as 1 month. Long-term studies have shown that BMD continues to increase throughout treatment and does not plateau.
If Prolia is stopped, fracture risk increases. Within 12 months, BMD will return to pretreatment levels. Talk with your health care provider if you plan on stopping Prolia.
How Can I Prevent and Manage Side Effects?
The most common side effect of Prolia is pain, including back, muscle, joint, and arm and leg pain. Other common side effects are high cholesterol, high blood pressure, headache, and bladder infection.
Mild pain can be relieved by applying ice or heat to the affected area. Staying active with regular exercise and stretching can also help. Your health care provider may recommend an over-the-counter (OTC) pain reliever such as acetaminophen or ibuprofen. If your pain becomes severe or bothersome, talk to your health care provider.
Increases in blood pressure and cholesterol can occur with Prolia. Your health care provider will monitor your blood pressure at visits and regularly check your cholesterol levels with blood work. If necessary, your provider may recommend lifestyle modifications to lower your blood pressure or cholesterol. These include getting regular exercise, eating a healthy diet, limiting salt, losing weight, and quitting smoking. In some cases, your provider may recommend a prescription medicine.
To limit headaches, make sure you are eating a healthy diet, staying hydrated, and getting enough sleep. Cool compresses, meditation, and resting in a cool, dark room may also help.
If you experience burning when you pee or need to use the restroom with urgency and frequency, you may have a bladder infection. If you develop these symptoms call your health care provider right away. You may need an antibiotic. Your health care provider may also recommend an OTC medicine for the burning pain such as AZO, or acetaminophen or ibuprofen for fever.
This is not a complete list of side effects of Prolia. Talk to your health care provider if side effects don’t go away or become bothersome. You can report side effects to the FDA at 800-FDA-1088.
What Kind of Drug Interactions Can Happen?
Prolia can increase your risk of infection, so you should avoid other medications that increase this risk. Tell your health care provider about all medicines you take including corticosteroids such as prednisone and immunosuppressants like cyclosporine.
Calcimimetics are medicines used to treat hyperparathyroidism and hypercalcemia. They also lower the calcium levels in the blood. This can be dangerous since Prolia can also lower calcium levels. Tell your health care provider if you are taking a medicine called cinacalcet.
How Do I Use It?
Prolia will be given by your health care provider every 6 months. It is a subcutaneous injection (given under the skin) that is administered in the upper arm, upper thigh, or abdomen.
Your health care provider may recommend that you also take 1,000 milligrams of calcium and at least 400 IU of vitamin D daily.
Is It Right for Me?
Prolia may be right for you if you have osteoporosis and are at high risk for broken bones or if you are taking corticosteroids or certain medicines for cancer.
Prolia can lower the level of calcium in your blood. Low levels of calcium must be corrected before starting Prolia. Your risk of low blood calcium is increased if you have advanced chronic kidney disease. Speak with your health care provider for more information.
Prolia may increase your risk of developing serious infections. Your risk is increased if you have a weakened immune system or are taking certain medications.
Prolia should not be used if you are pregnant or planning on becoming pregnant.
How Long Does It Stay in Your System?
Prolia takes about 4 to 5 months to leave your system.
If you could become pregnant while on Prolia, you must use birth control during treatment and for 5 months after the last dose of Prolia.
Keep in mind once you stop Prolia, your risk for bone fractures increases. Speak with your health care provider for more information.
What Do I Need to Do to Get It?
Prolia requires a prescription from a health care provider. Your health care provider will give you the injection. Depending on your insurance, either your health care provider will order it for you or you will get it from a retail or specialty pharmacy. For more information, speak with your health care provider or pharmacist.
Is There Any Cost Assistance Available?
Eligibility depends on your current prescription and medical insurance coverage.
There is a savings program that can help with out-of-pocket costs for commercially insured people or those without insurance. You may pay as little as $25 for each dose. Visit www.amgensupportplus.com/copay or call 866-264-2778 for more information.
If you have questions about cost, insurance coverage, or any other questions about Prolia, you can contact the manufacturer at 877-477-6542.
