Prolia® - Denosumab
Pronounce: den-OH-sue-mab
Classification: Monoclonal Antibody
About Prolia® - Denosumab
This medication is a type of monoclonal antibody. Monoclonal antibodies target a specific protein or cell – in this case, the target is a protein called RANKL, which helps the formation, function, and survival of osteoclasts that help with bone resorption. By targeting RANKL, bone resorption is decreased, and bone mass and strength are increased.
Denosumab (Prolia®) is used to treat osteoporosis or to increase bone mass in some people, including those with glucocorticoid-induced osteoporosis. It is also used in people receiving androgen deprivation therapy (ADT) for prostate cancer and in those taking aromatase inhibitor therapy. This medication is different from Denosumab (Xgeva®), which treats bone metastasis. They are used to treat different issues, are not interchangeable, and should not be taken at the same time.
How to Take This Medication
Denosumab (Prolia®) is usually given every 6 months by subcutaneous injection (SQ, given under the skin) in the upper arm, upper thigh, or abdomen (belly). You may need to take calcium and vitamin D supplements to help with your bone health and prevent your blood calcium levels from getting too low. If you miss a dose, take your missed dose as soon as possible.
Possible Side Effects
These are some of the most common or most serious side effects of this medication. Talk with your provider about the side effects you are having and how they can be managed.
Low Blood Calcium (Hypocalcemia)
This medication can cause your blood calcium levels to drop below normal. Calcium and vitamin D supplements can be taken to prevent the levels from getting too low. Signs that calcium levels are low include numbness or tingling around the lips, muscle stiffness, twitching, spasms, or cramps. Be sure to call your provider if you have any of these symptoms. Tell your provider if you have chronic kidney disease before starting treatment with denosumab.
Pain
Patients taking this medication may have pain in their back and other parts of their body. Talk to your provider about how you can manage this pain.
Reproductive Concerns
There is a higher risk of health problems for your baby if you are pregnant, become pregnant, or get someone pregnant while on this medication. To lower the risk of birth defects, you should use birth control (contraception) to avoid pregnancy. Talk with your provider about what kind of birth control is safest for you and your partner.
If you can become pregnant, you will need to use effective birth control during treatment and for 5 months after the last dose of this medication, even if your menstrual cycle has stopped or changed.
If you can get someone pregnant, you will need to use effective birth control during treatment and for 5 months after the last dose of this medication, even if you believe you are not producing sperm.
Talk with your provider about breastfeeding while taking this medication.
Important but Less Common Side Effects
Allergic Reactions
Some people may have an allergic reaction to this medication. Signs of an allergic reaction are:
- Shortness of breath or trouble breathing.
- Chest pain.
- Rash.
- Itching.
- Flushing (reddening of the skin, often on the face, neck, or chest).
- A drop in blood pressure (you may feel lightheaded, dizzy, or weak).
If you have any of these signs while you are getting an infusion, tell your provider right away. The infusion will be slowed down or stopped. Depending on your reaction, you may still be able to get the medication if you are given medicine to prevent a reaction or if the medication is given at a slower rate.
Osteonecrosis of the Jaw
Osteonecrosis of the jaw (ONJ) is a rare side effect. It happens when there is a loss of blood supply to the jawbone. This can cause the bone to become exposed (can be seen) through the gums. Symptoms of ONJ may be:
- Pain.
- Swelling.
- Infection of the gums.
- Loosening of the teeth.
- Exposed bone (often where a tooth was removed).
- Numbness or tingling in the jaw.
- A "heavy" feeling in the jaw.
Most cases of ONJ are related to a dental issue, and if these are avoided, ONJ may be as well. You should stop taking this medication at least 3 weeks before any dental work.
Some things you can do to lower your risk of ONJ are:
Before starting therapy, you should have a dental exam and cleaning. Any teeth in poor health should be removed.
- If you wear dentures, make sure they fit well.
- Brush your teeth after meals and at bedtime with a soft brush. Ask your provider if you can floss, and, if so, floss gently once a day.
- Check your teeth and gums in a mirror every day for sores, swelling, loose teeth, pain, or numbness. Tell your dentist or provider right away if you notice any changes.
Call your provider right away if you are having any symptoms of ONJ or dental issues.
Bone Fractures
This medication can increase your risk of bone fractures, especially of the femur (thigh) and spine. If you have any new or unusual thigh, hip, groin, or back pain, contact your provider right away.
Vertebral Fracture (broken bones in the spine)
You may be at higher risk for fractures in the spine when this medicine is stopped, especially if you have a history of osteoporosis or other fractures. Report any new or worsening back pain to your provider. Do not stop the medication without talking to your provider.
Infection
This medication can cause infections of the skin, abdomen, bladder, and ear. This medication can also lower your ability to fight infections. If you have a fever, chills, skin that is red, swollen, hot, or tender to the touch, shortness of breath, or a cough that won’t go away, belly pain, or frequency and urgency with urinating, you should contact your provider right away.
Skin Reactions
This medication can cause skin reactions like rashes, dermatitis, and eczema. If you have new redness, itching, small bumps or patches, skin is drier than normal or becomes leathery, blisters that crust or ooze, or your skin is peeling, contact your provider right away.