February 24, 2011


By Anonymous User

Class: Supportive Care

Generic Name: Denosumab

Trade Name: XGEVA®

For which conditions is this drug approved? XGEVA is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors.

What is the mechanism of action? XGEVA targets a protein known as the RANK ligand. This protein regulates the activity of osteoclasts (cells that break down bone). In patients with bone metastases, increased RANK ligand production can cause destruction of bone.

How is XGEVA typically given (administered)? XGEVA is given as a subcutaneous (under-the-skin) injection once every four weeks.

How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with XGEVA. Patients may undergo blood tests, physical examinations, scans or other measures to assess side effects and response to therapy. XGEVA can cause extremely low levels of calcium in the blood, a condition known as severe hypocalcemia. To reduce risk of hypocalcemia, physicians are advised to treat pre-existing hypocalcemia prior to XGEVA treatment and then monitor calcium levels and administer calcium, magnesium, and vitamin D as necessary. Patients receiving XGEVA are also at risk of osteonecrosis of the jaw (ONJ), a condition where parts of the jawbones die. Physicians are advised to perform an oral examination before starting XGEVA and monitor for symptoms during treatment.

What are the common (occur in 30% or more of patients) side effects of treatment with XGEVA?

  • Fatigue and asthenia (lack or loss of strength)
  • Hypophosphatemia (deficiency of phosphates in the blood)
  • Nausea

What are the less common (occur in 10% to 29% of patients) side effects of treatment with XGEVA?

  • Dyspnea (difficult or labored respiration)
  • Headache
  • Cough
  • Diarrhea
  • Hypocalcemia

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?

Patients receiving XGEVA are encouraged to maintain proper oral hygiene and receive routine dental care. Tell your dentist that you’re receiving XGEVA and avoid invasive dental procedures during treatment.

Are there any special precautions patients should be aware of before starting treatment?

Be aware that denosumab is also marketed as Prolia®. Patients should not take Prolia and XGEVA together. XGEVA is not considered safe for women who are pregnant or may become pregnant. To prevent fetal harm, women of reproductive age are advised to use highly effective contraception during treatment with XGEVA and for at least five months after 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 hypocalcemia, such as muscle twitching, spasms, or cramps, or numbness or tingling in your fingers, toes, or near your mouth). Tell your doctor if you have 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.

Tags: Supportive, X

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