Indications & Uses
Denosis is indicated for:
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Denosumab must be given by a healthcare professional. It is meant for subcutaneous injection only and should never be given by the intravenous, intramuscular, or intradermal route. For Osteoporosis and Bone Loss: give 60 mg every 6 months as a subcutaneous injection into the upper arm, upper thigh, or abdomen. Patients should also take 1000 mg of calcium daily and at least 400 IU of vitamin D daily. If a dose is missed, give the injection as soon as the patient is available, then resume the 6 month schedule counting from the date of that injection. For Multiple Myeloma and Bone Metastasis from Solid Tumors: give 120 mg every 4 weeks as a subcutaneous injection into the upper arm, upper thigh, or abdomen. For Giant Cell Tumor of Bone: give 120 mg every 4 weeks, with extra 120 mg doses on Days 8 and 15 of the first month of treatment. Give subcutaneously into the upper arm, upper thigh, or abdomen, and provide calcium and vitamin D as needed to treat or prevent low blood calcium. For Hypercalcemia of Malignancy: give 120 mg every 4 weeks, with extra 120 mg doses on Days 8 and 15 of the first month of treatment, injected subcutaneously into the upper arm, upper thigh, or abdomen.
Side Effects
Postmenopausal osteoporosis: the most common side effects (over 5%) were back pain, pain in the extremity, high cholesterol, musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical trials. Male osteoporosis: the most common side effects (over 5%) were back pain, joint pain, and nasopharyngitis. Glucocorticoid-induced osteoporosis: the most common side effects (over 3%) were back pain, high blood pressure, bronchitis, and headache. Bone loss from hormone ablation therapy for cancer: the most common side effects (over 10%) were joint pain and back pain. Pain in the extremity and musculoskeletal pain have also been reported in clinical trials. Bone metastasis from solid tumors: the most common side effects (over 25%) were fatigue/weakness, low blood phosphate, and nausea. Multiple myeloma: the most common side effects (over 10%) were diarrhea, nausea, anemia, back pain, low platelet count, swelling of the limbs, low blood calcium, upper respiratory tract infection, rash, and headache. Giant cell tumor of bone: the most common side effects (over 10%) were joint pain, headache, nausea, back pain, fatigue, and pain in the extremity. Hypercalcemia of malignancy: the most common side effects (over 20%) were nausea, breathlessness, reduced appetite, headache, swelling of the limbs, vomiting, anemia, constipation, and diarrhea.
Cautions & Contraindications
Warnings & Precautions
Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, can occur with Denosis. If a clinically significant reaction develops, stop the medicine permanently. Hypocalcemia: Denosis can cause severe, symptomatic low blood calcium, and deaths have been reported. Any existing hypocalcemia must be corrected before starting Denosis, and the risk is greater in patients with kidney impairment. Calcium levels should be monitored during treatment, particularly in the first few weeks, and all patients should receive adequate calcium and vitamin D supplementation. Osteonecrosis of the jaw: This has been reported with Denosis. An oral examination should be carried out before treatment begins, patients should be monitored for symptoms, and invasive dental procedures should be avoided while on Denosis. Atypical femoral fractures: These have been reported. Patients who develop new thigh or groin pain should be assessed to rule out a femoral fracture. Multiple vertebral fractures (MVF) after stopping treatment: When Denosis is discontinued, the patient's individual risk of vertebral fractures should be evaluated, and patients should be switched to another antiresorptive agent if Denosis is stopped. Serious infections, including skin infections: These may occur and can lead to hospitalization. Patients should be told to seek prompt medical care if signs or symptoms of infection, such as cellulitis, appear. Dermatologic reactions: Dermatitis, rash, and eczema have been reported. Stopping Denosis should be considered if severe dermatologic symptoms occur. Severe pain: Severe bone, joint, or muscle pain may occur. Denosis should be discontinued if symptoms become severe. Suppression of bone turnover: Denosis has been shown to significantly suppress bone turnover, so patients should be monitored for consequences of over suppression. Hypercalcemia after stopping treatment in patients with giant cell tumor of bone and in patients with growing skeletons: These patients should be monitored for signs and symptoms of hypercalcemia and managed accordingly. Embryo fetal toxicity: Denosis can cause harm to the developing fetus. Women of reproductive potential should be informed of this risk to the embryo and fetus and advised to use effective contraception.
Contraindications
Hypocalcemia: Any existing hypocalcemia should be corrected before starting Denosumab. Pregnancy: Denosumab can harm the fetus if given to a pregnant woman. Women of reproductive potential should have a pregnancy test before starting treatment. Hypersensitivity: Denosumab should not be used in patients with a history of systemic hypersensitivity to any of its components, as reactions can include anaphylaxis, facial swelling, and urticaria.