The recommended dose and schedule of denosumab for the treatment of giant cell tumour of bone is 120 mg administered subcutaneously every four weeks with additional 120 mg doses on days 8 and 15 of the first month. Full prescribing information is available at here Source: FDA
How effective is denosumab for the treatment of bone metastasis?
An important finding was that denosumab significantly increased bone metastasis free survival (defined as first occurrence of bone metastasis, symptomatic or asymptomatic, or death from any cause) by 4.2 months compared with placebo: 29.5 months with denosumab versus 25.2 months with placebo (P= 0.028).
How much denosumab will I receive?
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:
What is a subcutaneous injection of denosumab?
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.
Can I take other medicines with denosumab?
Some medicines, including those that you can buy in a shop or chemist, may be harmful to take while you’re having denosumab. Tell your doctor about any medicines you are taking, including over-the-counter drugs, complementary therapies and herbal drugs.
How much is a denosumab injection?
The list price for Prolia® is $1,434.14* ,† per treatment every six months. Most patients do not pay the list price. Your actual cost will vary. Talk to your insurance provider.
Whats is denosumab 60 mg?
Denosumab Uses. Denosumab is used in the treatment of osteoporosis. It is also used to treat bone loss in men with prostate cancer and in women with breast cancer who are receiving certain treatments that increase their risk for fractures.
How do you administer denosumab?
Denosumab is administered as a single subcutaneous injection once every six months into the thigh, abdomen or back of arm. It can be administered by an individual who is adequately trained in injection techniques so is appropriate for administration in primary care.
How long does it take for denosumab to start working?
6. Response and effectiveness. Maximal Prolia concentrations are reached within 10 days of an injection, and levels of Prolia declined over four to five months.
How often is denosumab given?
Denosumab injection (Prolia) is usually given once every 6 months. When denosumab injection (Xgeva) is used to reduce the risk of fractures from multiple myeloma, or cancer that has spread to the bones, it is usually given once every 4 weeks.
Is denosumab considered chemotherapy?
Denosumab | Chemotherapy Drug Information | Chemocare.
How long do you take denosumab?
Answer. Denosumab (brand name Prolia) is a medication used to treat severe osteoporosis. It works by turning off the natural process of breaking down and reabsorbing bones. It is administered through a shot twice per year for up to 10 years.
Can denosumab be self administered?
The current U.S. Prescribing Information states that Prolia® (denosumab) should be administered by a healthcare provider. At this time, self-administration of Prolia® is not approved in the United States. However, administration by healthcare providers may be a challenge in the context of the current COVID-19 pandemic.
Is denosumab an immunotherapy?
Immunotherapy with monoclonal antibodies, such as denosumab, pembrolizumab, and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Does denosumab cause hair loss?
Hair loss. During initial clinical trials of Prolia, hair loss wasn't reported as a side effect. However, hair loss was reported in postmarketing studies of the drug.
What does denosumab do to bones?
Denosumab works by targeting a protein called RANKL which controls the activity of osteoclasts. This stops bone cells being broken down and strengthens the bone.
Does denosumab cause weight gain?
Prolia (denosumab) has not been associated with weight gain in clinical studies. Prolia can cause peripheral edema (fluid retention) or swelling, and this may lead to weight gain in some people. Speak with your doctor if you have any side effect that bothers you or that does not go away.
Where is denosumab given?
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.
What is Denosumab used for?
What Denosumab Is Used For: Prolia. 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.
What is denosumab a monoclonal antibody?
Drug type: 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 is Xgeva treatment?
Xgeva. 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, ...
How to treat low calcium levels?
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.
What is chemocare.com?
Chemocare.com is designed to provide the latest information about chemotherapy to patients and their families, caregivers and friends. For information about the 4th Angel Mentoring Program visit www.4thangel.org
Can denosumab cause osteonecrosis?
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.
How often is denosumab given?
You have the injection in either the thigh, stomach or upper arm. Xgeva is usually given once every 4 weeks. Prolia is given once every 6 months. Your doctor or nurse will take a blood test before each treatment.
What is denosumab?
Denosumab is used to treat secondary bone cancer. It is also used for some types of cancer to help strengthen the bones. Denosumab helps to:
How to look after teeth after denosumab?
It is very important to look after your teeth during and after having denosumab. Brush them regularly and have regular dental check-ups. Let your dentist know that you are having denosumab.
What to do if you think you need dental treatment?
If you think you need dental treatment, talk to your cancer doctor or nurse. Always tell your dentist you are having cancer treatment.
What to do if you have cancer?
Medical and dental treatment. If you need medical treatment for any reason other than cancer, always tell the doctors and nurses you are having cancer treatment . Give them the contact details for your cancer doctor so they can ask for advice. If you think you need dental treatment, talk to your cancer doctor or nurse.
Can you get all the side effects of a cancer drug?
You may get some of the side effects we mention, but you are unlikely to get all of them. If you are also having treatment with other cancer drugs, you may have some side effects that we have not listed here. Always tell your doctor, nurse or pharmacist about any side effects you have.
Is Xgeva a blood cancer?
A solid tumour is a cancer that occurs in one of the body’s organs, such as the breast, kidney or lung. It is not a blood cancer, like myeloma or leukaemia. Prolia® is given to men with prostate cancer who have weakened bones from ...
What is the function of denosumab?
Introduction:Denosumab, a fully human monoclonal antibody, targets the receptor activator of nuclear factor-kappaB (RANK) ligand, a protein essential for osteoclast differentiation, activity and survival. Loss of osteoclasts from the bone surface reduces bone turnover and bone loss in malignant and benign diseases. In breast cancer, bone metastases are frequently observed; cancer treatment-induced bone loss (CTIBL) may result as a consequence of endocrine treatment or chemotherapy. Furthermore, preclinical studies suggest a direct role of the RANK/RANK-ligand pathway in breast tumorigenesis. This paper reviews preclinical and clinical data on denosumab in breast cancer.
What is bone loss in breast cancer?
Breast cancer is the most common malignant disease in women worldwide [American Cancer Society, 2009]. Bone loss and bone degradation are frequently observed in breast cancer patients and occur as a treatment side effect, that is, cancer treatment induced bone loss (CTIBL) [Amir et al. 2010] or directly due to bone metastases [Coleman, 2001]. Bone resorption requires osteoclasts, cells specialized in the degradation of bone tissue. Osteoclast activation is triggered by the receptor activator of nuclear factor-kappaB (RANK)/RANK-ligand pathway, rendering RANK-ligand an attractive target for the prevention of bone loss. Recent preclinical data suggest that this pathway may also play a role in breast tumorigenesis, opening the stage for new options of breast cancer prophylaxis and therapy [Beleut et al. 2010; Schramek et al. 2010].
Does denosumab cause ONJ?
In studies of denosumab in osteoporosis, no cases of ONJ were observed. Therefore, a lower incidence of ONJ was anticipated also in metastatic cancer patients. Results from three phase III clinical trials including 5677 patients with bone metastases, however, clearly indicated a risk of ONJ associated with denosumab treatment similar to that with bisphosphonates: 37 (1.3%) cases were recorded in patients treated with zoledronic acid compared with 52 (1.8%) cases in patients receiving denosumab [Brown et al. 2010]. Recently, Van den Wyngaert and colleagues reported pooled ONJ safety data from all three randomized phase III trials. A total of 89 ONJ cases were reported with 52 (1.83%; 95% CI 1.37–2.39) occurring in the denosumab group and 37 (1.30%; 95% CI 0.92–1.79) in the zoledronic acid group, respectively. Overall, there was no significant difference in the pooled risk ratio (RR) for ONJ (RR 1.40; 95% CI 0.92–2.13; p = 0.11). It is necessary to remember, however, that neither separately nor pooled, those trials had adequate statistical power (>80%) to detect an excess relative risk of ONJ [Van den Wyngaert et al. 2011]. Therefore, postmarketing risk-benefit studies focusing on incidence of ONJ appear warranted.
Does bisphosphonate reduce vertebral fractures?
As outlined, bisphosphonates are active in the prevention of CTIBL [Van Poznak et al. 2010; Gnant et al. 2007]. It is still not proven, however, whether this effect eventually translates into a reduction in fracture rates [Valachis et al. 2010]. Denosumab, on the other hand, was found to lower the rate of vertebral fractures significantly in patients on androgen-deprivation therapy for prostate cancer [Smith et al. 2009]. Further studies are currently ongoing: the Austrian Breast and Colorectal Cancer Study Group Study 18 (ABCSG-18) randomized postmenopausal patients treated with aromatase inhibitors as adjuvant therapy for hormone receptor-positive early breast cancer to denosumab or placebo. This study is among the first phase III trials evaluating denosumab in the prevention of CTIBL in breast cancer and also includes relevant oncological treatment goals as secondary endpoints [ClinicalTrials.gov identifier: {"type":"clinical-trial","attrs":{"text":"NCT00556374","term_id":"NCT00556374"}}NCT00556374].
Does denosumab help with CTIBL?
The role of denosumab for the prevention of CTIBL was evaluated in another phase II trial: 252 patients with early breast cancer and reduced bone mass who received aromatase inhibitors in the adjuvant setting were included and randomized to denosumab 60 mg or placebo every 6 months. In the denosumab group, bone mineral density increased significantly over time (5.5% and 7.6%, at 12 and 24 months, respectively; p < 0.0001 [both time points]). Again, treatment was generally well tolerated and adverse events were similar between the respective denosumab and placebo groups [Ellis et al. 2008].
Does bisphosphonate reduce bone mineral density?
Bisphosphonates, when given in conjunction with endocrine therapy, prevent CTIBL as evidenced by a decreased reduction of bone mineral density [Van Poznak et al. 2010; Gnant et al. 2007]. Other trials even observed an increase of bone mineral density in patients receiving bisphosphonates [Eidtmann et al. 2010; Brufsky et al. 2009]. However, this effect might not translate into a reduction in fracture rates [Valachis et al. 2010]. In this context, however, it is important to realize that the reason such a decrease in fracture rates was not observed may be related to the fact that bisphosphonates in most trials were only initiated when patients developed a T-score of less than -2.0. Furthermore, many of those studies were not adequately powered to detect such an effect. Denosumab on the other hand was found to reduce the incidence of new vertebral fractures in prostate cancer patients on androgen deprivation in a large, adequately powered phase III study [Smith et al. 2009]. Phase III clinical trials of denosumab for the prevention of CTIBL in breast cancer are currently ongoing [ClinicalTrials.gov identifier: NCT0056374; Bartsch and Steger 2009].
Is denosumab safe for breast cancer patients?
Conclusion:In conclusion, denosumab appears to be an effective and safe treatment option in patients with bone metastases from breast cancer with the potential of also preventing CTIBL.
When should bone modifying agents be started for prostate cancer?
For prostate cancer, 2017 clinical practice guidelines also recommended that bone-modifying agents be started at the time of diagnosis of bone metastases. Options include either:
What cancers can spread to bone?
Cancers Which May Spread to Bone. There are many cancers which can spread to bone the most common being breast cancer, lung cancer, prostate cancer, and multiple myeloma. Other cancers which may spread to bone include kidney cancer, stomach cancer, bladder cancer, uterine cancer, thyroid cancer, and colorectal cancers.
What percentage of women have bone metastases?
Bone metastases occur in roughly 70 percent of women with metastatic breast cancer (bones are the most common site of metastases), and bone metastases from breast cancer are a significant cause of pain and disability for these women (and men). For many of these people, bone metastases are the first sign that the cancer has recurred ...
What is bone metastasis?
Cancer that has spread to bones ( bone metastasis) is very common and can cause a great deal of pain and disability related to fractures and other complications. In recent years, medications called bone-modifying agents have been recommended for many cancers to treat bone metastases as soon as they are diagnosed.
Where do men with prostate cancer have metastases?
Four out of five men with metastatic prostate cancer will have metastases to bone. Common sites of metastases are the hips, spine, and pelvic bones. Bone metastases from multiple myeloma are also common. On an X-ray, the bones take on a moth-eaten appearance.
What bones do breast cancer spread to?
The most common bones to which breast cancer spreads are the spine, the ribs, the pelvis, and the bones of the upper legs and arms.
Where is multiple myeloma found?
Multiple myeloma is usually found in larger bones such as the spine, the skull, the pelvis, the ribs, and the larger bones of the legs.
