Prolia

(Denosumab)

The active ingredient in Prolia is denosumab. It works as a monoclonal antibody and works differently than bisphosphonates such as risedronate, which are commonly prescribed for osteoporosis.

Prolia is a subcutaneous injection (injection under the skin) that blocks a specific molecule called RANKL, which in turn stops bone cells called osteoclasts from breaking down in the body. This then helps your body increase your bone mass and strengthen your bones.

In addition to treating osteoporosis in women who have gone through menopause, Prolia is used to prevent bone loss in breast cancer in women who are receiving aromatase inhibitor therapy.

In addition to treating men with osteoporosis, it helps prevent bone loss due to prostate cancer medications. Prolia is also used to treat glucocorticoid-induced osteoporosis caused by specific corticosteroid medications such as prednisone in both men and women.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Prolia. However, the following is a synopsis of the general guidelines for the use of Prolia:

Prolia is a subcutaneous injection, usually given in your upper arm by a healthcare provider. You will receive an injection once every six months. Prolia has an increased risk of hypocalcemia (low calcium levels); your doctor will probably advise that you take calcium and Vitamin D supplements while taking Prolia and receive bone density, calcium level, and other tests during treatment.

You should also tell your dentist that you are receiving Prolia before you undergo any dental procedures. Make sure to take good care of your teeth while taking Prolia. Brush and floss your teeth regularly.

Make sure to receive your injection as soon as you can if you miss a dose.

The most common side effects of Prolia seen in clinical trials include:

• Back pain
• Joint pain
• Nerve pain
• High cholesterol
• Common cold symptoms
• Swelling
• Dizziness
• Headache
• Pain in your arms and legs
• Muscle pain
• Bladder infection or painful urination

Some individuals may experience serious side effects while using Prolia. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Allergic reaction
• Tell your doctor if you have any allergy to an ingredient within Prolia.
• Receive medical help immediately if you experience any of the symptoms of an allergic reaction, such as hives, swelling in the face, tongue, or throat, or trouble breathing.
• Severely low blood calcium levels (hypocalcemia)
• Osteonecrosis of the jaw (ONJ, or severe jaw bone problems)
• This usually occurs after a dental procedure such as a tooth extraction.
• Unusual thigh bone fractures
• Skin reactions such as blisters, dryness, and itching
• Increased risk of broken bones, including those of the spine after stopping, skipping, or delaying Prolia.
• Postmenopausal women have a decreased risk of hip fractures and vertebral fractures when using Prolia.
• Serious infections
• If you have a weakened immune system, you may struggle with infections more. Talk to your doctor about the best course of action for you.

These are not all of the possible side effects of Prolia. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Prolia, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• A condition where you take Xgeva (denosumab) as it contains the same ingredients as Prolia.
• Cannot take daily vitamin D or calcium.
• Low blood calcium.
• Have kidney problems or are on dialysis.
• Had thyroid or parathyroid surgery.
• Malabsorption syndrome or you have been told you have difficulty absorbing minerals in your intestines and/or stomach.
• Plan to have dental surgery or any teeth removed soon. The use of Prolia affects your teeth.
• Are pregnant, plan to become pregnant, or you are breastfeeding.
• You should not take Prolia if this applies to you. Talk to your doctor about the best course of action for you.
• You most likely will take a pregnancy test before starting Prolia.
• You should use an effective form of birth control during treatment and for at least 5 months after your last dose of Prolia.

Boxed Warning

Prolia carries a boxed warning. Patients with advanced chronic kidney disease are at greater risk of severe hypocalcemia after a Prolia administration.

There is a possibility of severe hypocalcemia that could result in hospitalization. There have been reports of life-threatening events and fatal cases.

The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) increases the risk of hypocalcemia.

Before starting Prolia in patients with advanced chronic kidney disease, these patients should be evaluated for the presence of CKD-MBD. If treatment happens with Prolia, these patients should be supervised by a healthcare provider who is an expert in the diagnosis and management of CKD-MBD.

Low calcium levels

Known hypersensitivity to Prolia

Pregnancy

Prolia begins working shortly after administration, but its effects on bone density may take several months to become noticeable. Most patients see improvements in bone strength and a reduction in fracture risk within the first year of treatment. Regular follow-up with your healthcare provider will help monitor progress and ensure the treatment is effective.

When Prolia is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Corticosteroids
• Bisphosphonates (used for osteoporosis)
• Immunosuppressants
• Meds that lower calcium levels

Prolia comes in a single-dose prefilled syringe that contains 60 mg in a 1 mL solution.

Keep Prolia in a refrigerator in its normal container, but do not freeze. After it’s been removed from the refrigerator, it must be used within 14 days. Do not keep at temperatures above 77°F (25°C) as it will affect how Prolia works. Protect from light and do not shake Prolia.

It is manufactured by Amgen.

Currently, there is no generic available for the brand name Prolia in the United States.

To stop taking Prolia, consult your healthcare provider, as discontinuing the medication can lead to rapid bone loss and an increased risk of fractures. Your doctor may recommend transitioning to another osteoporosis treatment to maintain bone density and reduce fracture risk. Always follow your provider’s guidance for a safe and effective plan.

If you are pregnant, you should not take Prolia as it can harm your unborn baby. Let your healthcare provider know immediately if you become pregnant while taking this medication. Be sure to use a reliable form of birth control while taking Prolia and for at least 5 months after you stop it.

It is not known if Prolia passes into your breast milk. You and your healthcare provider should decide if you will take Prolia or breastfeed. You should not do both.