Class: Supportive Care
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?
What are the most common side effects among men with osteoporosis?
What are the most common side effects among cancer patients being treated with hormonal therapy?
What are some of the potentially serious side effects of treatment with Prolia?
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?
Are there any special precautions patients should be aware of before starting treatment?
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.
Copyright © 2012 CancerConnect Last updated 10/12.
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