Generic Name: Denosumab
Trade Name: Prolia®
How is this drug used? Prolia is used to treat men or postmenopausal women with osteoporosis and a high risk of fracture. Prolia is also used to increase bone mass in women with breast cancer that is being treated with an aromatase inhibitor, and men with nonmetastatic prostate cancer that is being treated with androgen deprivation therapy.
What is the mechanism of action? Prolia targets a protein known as the RANK ligand. This protein regulates the activity of osteoclasts (cells that break down bone).
How is Prolia given (administered)? Prolia is given as a subcutaneous (under-the-skin) injection every six months.
How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Prolia. Patients may undergo blood tests, physical examinations, scans or other measures to assess side effects and response to therapy.
What are the most common side effects among postmenopausal women with osteoporosis?
- Back pain
- Pain in arms or legs
- High blood cholesterol levels
- Muscle or joint pain
- Bladder infection
What are the most common side effects among men with osteoporosis?
- Back pain
- Joint pain
- Common cold (runny nose or sore throat)
What are the most common side effects among cancer patients being treated with hormonal therapy?
- Joint pain
- Back pain
- Pain in arms or legs
- Muscle pain
What are some of the potentially serious side effects of treatment with Prolia?
- Low levels of calcium in the blood
- Serious infections
- Skin problems
- Osteonecrosis of the jaw (ONJ; death of bone in the jaw)
- Unusual fractures of the thigh bone
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
- Pay careful attention to the physician’s instructions and inform the physician of any side effects.
- Practice proper mouth care and tell your dentist that you are being treated with Prolia. Tell your doctor in advance if you need to undergo dental surgery or tooth removal.
Are there any special precautions patients should be aware of before starting treatment?
- Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interact with treatment.
- Patients should inform their physician if they are taking Xgeva; it contains the same active ingredient as Prolia.
- Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future.
- Patients should inform their physician about all medical conditions, including low blood calcium levels, problems absorbing minerals, inability to take calcium or vitamin D, history of thyroid or parathyroid surgery, kidney problems, and kidney dialysis.
- Patients may be advised to undergo an oral examination and receive appropriate preventive dentistry prior to starting treatment with Prolia.
When should patients notify their physician?
Tell your doctor if you experience any side effects that bother you or don’t go away. Also notify your doctor if you experience symptoms of low calcium levels (such as muscle twitching, spasms, or cramps, or numbness or tingling in your fingers, toes, or near your mouth), symptoms of an infection (such as fever or chills; skin that is red, swollen, or tender; severe abdominal pain; or frequent or urgent urination or burning during urination), symptoms of a skin problem (such as redness, itching, rash, dry or leathery skin, oozing or crusty blisters, or skin peeling), symptoms of ONJ (such as pain, numbness, swelling, or slow healing of the jaw, mouth, or teeth), or symptoms of an unusual thigh bone fracture (such as new or unusual pain in the hip, groin, or thigh).
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
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