Matching articles for "Xgeva"
In Brief: Severe Hypocalcemia with Denosumab (Prolia) in Chronic Kidney Disease
The Medical Letter on Drugs and Therapeutics • March 4, 2024; (Issue 1697)
The FDA is requiring a boxed warning in the label
of denosumab (Prolia – Amgen), a monoclonal
antibody that inhibits osteoclasts, about an
increased risk of severe hypocalcemia in patients
with advanced...
The FDA is requiring a boxed warning in the label
of denosumab (Prolia – Amgen), a monoclonal
antibody that inhibits osteoclasts, about an
increased risk of severe hypocalcemia in patients
with advanced chronic kidney disease (CKD;
eGFR <30 mL/min/1.73 m2), particularly those on
dialysis. FDA-approved indications for Prolia are
listed in Table 1.
Radium-223 (Xofigo) for Prostate Cancer
The Medical Letter on Drugs and Therapeutics • September 30, 2013; (Issue 1426)
Radium Ra 223 dichloride (Xofigo – Bayer), a radiotherapeutic
drug, has been approved by the FDA for
intravenous treatment of castration-resistant prostate
cancer with symptomatic bone metastases and...
Radium Ra 223 dichloride (Xofigo – Bayer), a radiotherapeutic
drug, has been approved by the FDA for
intravenous treatment of castration-resistant prostate
cancer with symptomatic bone metastases and no
known visceral metastatic disease.
In Brief: Denosumab for Bone Metastases
The Medical Letter on Drugs and Therapeutics • January 24, 2011; (Issue 1356)
The FDA, which recently approved subcutaneous (SC) administration of denosumab (Prolia – Amgen) for treatment of postmenopausal osteoporosis,1 has now approved the same drug with a different brand name (Xgeva...
The FDA, which recently approved subcutaneous (SC) administration of denosumab (Prolia – Amgen) for treatment of postmenopausal osteoporosis,1 has now approved the same drug with a different brand name (Xgeva – Amgen) and dosage for prevention of skeletal-related events (such as pathologic fracture, spinal cord compression or radiation to bone) in patients with bone metastases from solid tumors. Denosumab is a fully human anti-RANK ligand antibody that inhibits the formation, activation and survival of osteoclasts.2
A prospective, randomized, double-blind trial in 1901 patients with bone metastases from castration-resistant prostate cancer found that denosumab 120 mg injected SC every 4 weeks, compared to the bisphosphonate zoledronic acid (Zometa) 4 mg IV, delayed the time to a first skeletal event by 3.6 months (20.7 vs. 17.1 months).3 In 1776 patients with bone metastases from solid tumors or multiple myeloma, the mean time to a first skeletal event was 20.6 months with SC denosumab and 16.3 months with IV zoledronic acid.4
Denosumab can lower serum calcium concentrations, especially in patients with impaired renal function. Fatigue is the most commonly reported adverse effect. Other adverse effects of both denosumab and zoledronic acid in clinical trials have included nausea, dyspnea and diarrhea. Acute-phase reactions and renal toxicity have been less frequent with denosumab than with zoledronic acid. Osteonecrosis of the jaw, which can occur with bisphosphonates, has also been reported with denosumab.
1. Denosumab (Prolia) for postmenopausal osteoporosis. Med Lett Drugs Ther 2010; 52: 81.
2. A Lipton and C Goessl. Clinical development of anti-RANKL therapies for treatment and prevention of bone metastasis. Bone 2011; 48:96.
3. K Fizazi et al. A randomized phase III trial of denosumab versus zoledronic acid in patients with bone metastases from castration-resistant prostate cancer. J Clin Oncol 2010; 28:18s (abstr LBA4507).
4. D Henry et al. A double-blind, randomized study of denosumab versus zoledronic acid for the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. Eur J Cancer Suppl 2009; 7:11 (abstr 20LBA).
Download U.S. English
A prospective, randomized, double-blind trial in 1901 patients with bone metastases from castration-resistant prostate cancer found that denosumab 120 mg injected SC every 4 weeks, compared to the bisphosphonate zoledronic acid (Zometa) 4 mg IV, delayed the time to a first skeletal event by 3.6 months (20.7 vs. 17.1 months).3 In 1776 patients with bone metastases from solid tumors or multiple myeloma, the mean time to a first skeletal event was 20.6 months with SC denosumab and 16.3 months with IV zoledronic acid.4
Denosumab can lower serum calcium concentrations, especially in patients with impaired renal function. Fatigue is the most commonly reported adverse effect. Other adverse effects of both denosumab and zoledronic acid in clinical trials have included nausea, dyspnea and diarrhea. Acute-phase reactions and renal toxicity have been less frequent with denosumab than with zoledronic acid. Osteonecrosis of the jaw, which can occur with bisphosphonates, has also been reported with denosumab.
1. Denosumab (Prolia) for postmenopausal osteoporosis. Med Lett Drugs Ther 2010; 52: 81.
2. A Lipton and C Goessl. Clinical development of anti-RANKL therapies for treatment and prevention of bone metastasis. Bone 2011; 48:96.
3. K Fizazi et al. A randomized phase III trial of denosumab versus zoledronic acid in patients with bone metastases from castration-resistant prostate cancer. J Clin Oncol 2010; 28:18s (abstr LBA4507).
4. D Henry et al. A double-blind, randomized study of denosumab versus zoledronic acid for the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. Eur J Cancer Suppl 2009; 7:11 (abstr 20LBA).
Download U.S. English