Denomab SC Injection 60 mg/ml

Uses

Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or bone surgery) in patients with bone metastases from solid tumours.

Denomab SC Injection 60 mg/ml is also used to associated treatment for these conditions: Bone Loss, Bone pain, Fracture Bone, Spinal Cord Compression, Bone destruction, Giant cell tumor of the bone, High risk of fracture Osteoporosis, Refractory Hypercalcemia of malignancy

How Denomab SC Injection 60 mg/ml works

Denomab SC Injection 60 mg/ml is designed to target RANKL (RANK ligand), a protein that acts as the primary signal to promote bone removal/resorption. In many bone loss conditions, RANKL overwhelms the body's natural defense against bone destruction. Denomab SC Injection 60 mg/ml prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone.

Dosage

Denomab SC Injection 60 mg/ml dosage

Subcutaneous Injection: 120 mg once every 4 wk into thigh, abdomen or upper arm. Ca & vitamin D supplements should be given whilst undergoing treatment.

Side Effects

Dyspnoea, Hypocalcaemia, hypophosphataemia, Osteonecrosis of the Jaw (ONJ).

Toxicity

In patients with postmenopausal osteoporosis, the 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. In male patients with osteoporosis, the most common adverse reactions (> 5% and more common than placebo) were: back pain, arthralgia, and nasopharyngitis. In patients experiencing bone loss due to hormone ablation for cancer, the 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

Precaution

Correct preexisting hypocalcaemia prior to therapy. Osteonecrosis of the jaw (ONJ). Perform oral & dental exam with preventive dentistry prior to treatment. Avoid invasive dental procedures & maintain good oral hygiene while on treatment. Atypical femoral fractures. Severe renal impairment (CrCl <30 ml/min) or in patients receiving dialysis. Concomitant use with other denosumab-containing prep. Pregnancy & lactation. Children.

Interaction

In subjects with postmenopausal osteoporosis, Denomab SC Injection 60 mg/ml (60 mg subcutaneous injection) did not affect the pharmacokinetics of midazolam, which is metabolized by cytochrome P450 3A4 (CYP3A4), indicating that it should not affect the pharmacokinetics of drugs metabolized by this enzyme in this population

Food Interaction

• Administer calcium supplement. Calcium supplements should be used as necessary to prevent hypocalcemia.
• Administer vitamin supplements. Vitamin D should be administered as necessary to complement calcium in preventing hypocalcemia.

Denomab SC Injection 60 mg/ml Drug Interaction

Unknown: zolpidem, aspirin, aspirin, aspirin, calcium / vitamin d, docusate, duloxetine, apixaban, omega-3 polyunsaturated fatty acids, atorvastatin, metoprolol, metoprolol, nitroglycerin, oxycodone, acetaminophen, levothyroxine, acetaminophen, cyanocobalamin, ascorbic acid, cholecalciferol

Denomab SC Injection 60 mg/ml Disease Interaction

Major: hypocalcemiaModerate: immunosuppression

Elimination Route

When 60 mg of denosumab was subcutaneously administered to healthy subjects after fasting for 12 hours, the pharmacokinetic parameters are as follows: Cmax = 6.75 mcg/mL; Tmax= 10 days (range of 3 to 21 days); AUC (0-16 weeks) = 316 mcg•day/mL. Denomab SC Injection 60 mg/ml does not accumulate following multiple doses once every 6 months. The pharmacokinetics of denosumab were not affected by the formation of antibodies.

Half Life

25.4 days

Pregnancy & Breastfeeding use

Pregnancy Category D. There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Contraindication

Hypersensitivity to denosumab or to any of the excipients.

Acute Overdose

There is no experience with overdose in clinical studies. Denomab SC Injection 60 mg/ml has been administered in clinical studies using doses up to 180 mg every 4 weeks (cumulative doses up to 1,080 mg over 6 months), and no additional adverse reactions were observed.

Storage Condition

Should be stored in cool and dry place.

Innovators Monograph

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