Indications & Uses
Denosis 60 is indicated for:
Pharmacology
Denosumab is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL. It binds to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. By binding RANKL, denosumab prevents it from activating its receptor, RANK, on the surface of osteoclasts and their precursors. This blocks the RANKL/RANK interaction, inhibiting osteoclast formation, function, and survival. As a result, bone resorption decreases while bone mass and strength increase in both cortical and trabecular bone.
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.
Pregnancy & Breastfeeding
Pregnant women and females of reproductive potential: Denosumab may cause fetal harm when given during pregnancy. Females of reproductive potential should be advised to use effective contraception during treatment and for at least 5 months after the last dose of Denosumab.
Lactation: Whether to breastfeed while using Denosumab should take into account the developmental and health benefits of breastfeeding, the mother's clinical need for Denosumab treatment, and any potential adverse effects on the breastfed child from Denosumab itself or from the underlying maternal condition.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Pediatric patients: Denosumab is not approved for use in pediatric patients. It is recommended only for treating skeletally mature adolescents with giant cell tumor of bone.
Geriatric patients: No overall differences in safety or efficacy were seen between these patients and younger patients.
Renal impairment: No dose adjustment is needed in patients with renal impairment. But patients with creatinine clearance below 30 mL/min, or those receiving dialysis, are at risk of hypocalcemia. Give calcium and vitamin D supplements, and consider monitoring serum calcium.
Hepatic impairment: No clinical studies have been done to look at the effect of hepatic impairment on the pharmacokinetics of Denosumab.
Storage
Keep Denosumab in a refrigerator at 2°C to 8°C, in its original carton. Don't freeze it. Once you take it out of the refrigerator, it must not be exposed to temperatures above 25°C or to direct light, and it must be used within 14 days. If it isn't used within those 14 days, throw it away. Protect Denosumab from direct light and heat, and avoid shaking it vigorously.
Drug Interactions
Common questions about Denosis 60 60 mg/ml
What is Denosis 60 60 mg/ml Injection?
Denosis 60 60 mg/ml Injection is a medicine that contains Denosumab. It is made by Incepta Pharmaceuticals Ltd. It belongs to the Inhibiting bone resorption group of medicines.
What is Denosis 60 used for?
Denosis 60 is used for: Osteoporosis, Cancer.
What are the side effects of Denosis 60?
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.
Can I take Denosis 60 during pregnancy or while breastfeeding?
Pregnant women and females of reproductive potential: Denosumab may cause fetal harm when given during pregnancy. Females of reproductive potential should be advised to use effective contraception during treatment and for at least 5 months after the last dose of Denosumab. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Denosis 60?
Keep Denosumab in a refrigerator at 2°C to 8°C, in its original carton. Don't freeze it.
Do I need a prescription for Denosis 60?
Denosis 60 is a prescription (Rx) medicine. Take it as your doctor advises.