Denosumab is a RANK ligand (RANKL) inhibitor indicated 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 nonmetastatic prostate cancer
Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer
Denosumab should be administered by a healthcare professional.
Administer 60 mg every 6 months as a subcutaneous injection in the upper arm, upper thigh, or abdomen.
Instruct patients to take calcium 1000 mg daily and at least 400 IU vitamin D daily.
Postmenopausal osteoporosis: Most common adverse reactions (> 5% and more common than placebo) were: back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical trials.
Bone loss due to hormone ablation for cancer: Most common adverse reactions (≥ 10% and more common than placebo) were: arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials.
Same Active Ingredient: Patients should not be given medicine with the same active ingredient as Denosumab.
Hypocalcemia: Must be corrected before initiating Denosumab. May worsen, especially in patients with renal impairment. Adequately supplement patients with calcium and vitamin D.
Serious infections including skin infections: May occur, including those leading to hospitalization. Advise patients to seek prompt medical attention if they develop signs or symptoms of infection, including cellulitis.
Dermatologic reactions: Dermatitis, rashes, and eczema have been reported. Consider discontinuing Denosumab if severe symptoms develop.
Osteonecrosis of the jaw: Has been reported with Denosumab. Monitor for symptoms.
Suppression of bone turnover: Significant suppression has been demonstrated. Monitor for consequences of bone oversuppression.
Is denosumab approved by the FDA for prostate cancer?
Yes, the FDA approved the medicine Denosumab for treatment of:
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 nonmetastatic prostate cancer.
Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
What are the FDA indications for denosumab?
Denosumab is a RANK ligand (RANKL) inhibitor indicated 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 nonmetastatic prostate cancer.
Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
Who should not take denosumab?
Healthcare professionals do not recommend Denosumab for women of child-bearing age. It’s recommended that it should not be used by women who are pregnant, planning to become pregnant or breastfeeding.
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