Care During Chemotherapy and Beyond
Trade names: Prolia ®, Xgeva
Denosumab is the generic name for the trade name drugs Prolia or Xgeva. In
some cases, health care professionals may use the trade names Prolia or Xgeva when
referring to the generic drug name denosumab. Prolia and Xgeva
are the same generic drug (denosumab). They were given distinct trade names
in order to differentiate between their unique dosing schedules and indications
for use. How they are used is different, but strictly speaking, the two are
the same drug.
Denosumab is a monoclonal antibody that works as a RANK ligand (RANKL) inhibitor.
This medications is classified as a "bone-modifying agent". (For more detail see
"How denosumab works" section below).
What Denosumab Is Used For:
- Treatment of postmenopausal women with osteoporosis at high risk for fracture.
- Treatment to increase bone mass in men at high risk for fracture receiving androgen
deprivation therapy for non-metastatic prostate cancer.
- Treatment to increase bone mass in women at high risk for fracture receiving adjuvant
aromatase inhibitor therapy for breast cancer.
- Prevention of skeletal-related events (need for radiation, fracture due to cancer
in the bone, surgery to the bone, or compression of the spinal cord) in patients
with multiple myeloma and bone metastases from solid tumors.
- Treatment of giant cell tumor of the bone.
Note: If a drug has been approved for one use, physicians sometimes
elect to use this same drug for other problems if they believe it might be helpful.
How Denosumab Is Given:
- As a subcutaneous injection in the upper arm, upper thigh, or abdomen. A subcutaneous
injection is a shot into the layer of skin directly below the outer skin layer.
- There is no pill form of denosumab.
- The amount of denosumab you will receive depends on many factors, including
your general health or other health problems, and the type of cancer or condition
you have. Your doctor will determine your dose and schedule.
Important things to remember about the side effects of denosumab:
- Most people will not experience all of the denosumab side effects listed.
- Denosumab side effects are often predictable in terms of their onset, duration and
- Denosumab side effects will likely improve after therapy is complete.
- Denosumab side effects may be quite manageable. There are many options
to minimize of prevent the side effects of denosumab.
The following are common (occurring in greater than 30%) side effects for
patients taking denosumab:
These are less common side effects (occurring in 10-29%) for patients receiving
Osteonecrosis of the jaw has been reported rarely in patients with cancer receiving
treatment regimens that include bone modifying agents. Many of the reported
cases were associated with dental procedures, such as removal of a tooth.
A dental examination with appropriate preventative dentistry should be considered
prior to treatment with denosumab, particularly in patients with additional risk
factors (ie cancer, chemotherapy, corticoseroids, poor oral hygiene).
Invasive dental procedures should be avoided during treatment.
Not all side effects are listed above, some that are rare (occurring in less than
10% of patients) are not listed here. However, you should always inform your
health care provider if you experience any unusual symptoms.
When to contact your doctor or health care provider:
Contact your health care provider immediately, day or night, if you should
experience the following:
- Difficulty breathing
- Chest pain
- Swelling of the face/throat
The following symptoms require medical attention, but are not an emergency.
Contact your health care provider within 24 hours after noticing any of
Muscle stiffness, twitching, spasms, or cramps (signs of low blood calcium)
Pain, numbness, swelling of or drainage from the jaw, mouth or teeth.
Any signs or symptoms of infection, especially involving the skin (redness, drainage,
Fever of 100.4° F (38° C)
Fatigue and extreme tiredness (unable to perform self-care activities)
Nausea that interferes with eating and is not relieved by medications prescribed
by your doctor.
Vomiting (more than 4-5 episodes within a 24-hour period).
Always inform your health care provider if you experience any unusual symptoms.
Do not use both Xgeva and Prolia at the same time. If you are receiving one,
you should not be receiving the other, too.
Before starting denosumab treatment, make sure you tell your doctor about any
other medications you are taking (including over-the-counter drugs, vitamins, or
herbal remedies). Do not take aspirin or products containing aspirin unless your
doctor permits this.
Denosumab may enhance the negative effects of immuno-suppressants. Specifically,
the risk for serious infections may be increased. Notify your doctor of any
immuno-suppressive medication you are taking.
Do not receive any kind of vaccination without your doctor's approval while taking
Inform your health care professional if you are pregnant or may be pregnant prior
to starting this treatment. Pregnancy category C (use in pregnancy only if
benefit to mother outweighs risk to fetus).
For both men and women: Do not conceive a child (get pregnant) while taking denosumab.
Barrier methods of contraception, such as condoms, are recommended.
It is not known whether denosumab is excreted into human milk. Because of
the potential for serious adverse reactions in nursing infants from denosumab, a
decision should be made whether to discontinue nursing or discontinue the drug taking
into account the importance of the drug to the mother.
- Take a calcium and vitamin D supplement as necessary to treat and/or prevent low
blood calcium levels. Go for blood tests as ordered by your provider.
- Perform proper, thorough oral hygiene and routine dental care. Inform your
dentist that you are being treated with denosumab.
- Avoid invasive dental procedures.
- Inform your physician or dentist if you experience persistent pain and/or slow
healing of the mouth or jaw following invasive dental procedures.
- Drink at least 2 to 3 quarts of fluid every 24 hours, unless you are instructed
otherwise, as it is important to avoid becoming dehydrated.
- Acetaminophen may help relieve discomfort from fever, headache and generalized aches
and pains, however talk with your provider prior to taking it.
- To reduce nausea, take anti-nausea medications as prescribed by your doctor, and
eat small, frequent meals.
- Eat foods that may help reduce diarrhea (see managing side effects -
diarrhea) and if necessary, follow the regimen of anti-diarrhea medication as
prescribed by your health care professional.
- Use mild, unscented soaps, laundry detergents, and lotions to avoid irritating your
skin. Use lotion liberally to keep skin moisturized and prevent cracking.
(see managing side effects -
- Get plenty of rest.
- Maintain good nutrition.
- If you experience symptoms or side effects, be sure to discuss them with your health
care team. They can prescribe medications and/or offer other suggestions that are
effective in managing such problems.
Monitoring and Testing:
You will be checked regularly by your doctor while you are taking denosumab, to
monitor side effects and check your response to therapy. Periodic blood work
will be obtained to monitor the function of your organs (such as your kidneys
and liver), as deemed necessary by your doctor.
How Denosumab Works:
Cancer cells that spread to the bone can secrete substances that can cause cells
in the bone called osteoclasts to dissolve or "eat away" a portion of the bone.
The process, during which osteoclasts break down bone and then release those minerals
such as calcium from bone fluid into the blood, is called "bone resorption".
These tumors or lesions in the bone weaken the bone and can lead to complications,
referred to as "skeletal related events". Some of the complications (skeletal
related events) that can result from this bone breakdown are bone pain, fractures,
and the need for additional procedures such as radiation therapy to reduce pain
or surgery to fix or stabilize an affected bone. Bone resorption also releases
growth factors that may cause growth of tumors.
Receptor activator of nuclear factor kappa-B ligand (RANKL) is a type of protein
that is important in bone metabolism. This natural and necessary protein is
found on oteoblasts (cells that are responsible for bone formation) and serves to
activate osteoclasts (cells involved in bone resorption - as described above). By
inhibiting RANKL we may be able to decrease bone resorption and therefore decrease
bone loss and hypercalcemia.
Denosumab binds to RANKL, a protein that is essential for the formation, function
and survival of osteoclasts, the cells responsible for bone resorption. Denosumab
inhibits osteoclast formation, function and survival thereby, decreasing bone resorption
and increasing bone mass and strength of the bone.
Note: We strongly encourage you to talk with your health care professional
about your specific medical condition and treatments. The information contained
in this website is meant to be helpful and educational, but is not a substitute
for medical advice.
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