Xgeva (Subcutaneous)

Xgeva (Subcutaneous) Uses, Dosage, Side Effects, Food Interaction and all others data.

Xgeva (Subcutaneous) binds to Receptor activator of nuclear factor kappa-B ligand (RANKL), a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. Xgeva (Subcutaneous) 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.

In clinical studies, treatment with 60 mg of Prolia resulted in reduction in the bone resorption marker serum type 1 C-telopeptide (CTX) by approximately 85% by 3 days. Consistent with the physiological coupling of bone formation and resorption in skeletal remodeling, subsequent reductions in bone formation markers (i.e. osteocalcin and procollagen type 1 N-terminal peptide [PlNP]) were observed starting 1 month after the first dose of Prolia.

Trade Name Xgeva (Subcutaneous)
Availability Prescription only
Generic Denosumab
Denosumab Other Names Denosumab
Related Drugs Prolia, prednisone, hydrochlorothiazide, dexamethasone, alendronate, calcitonin, Fosamax, Decadron, Reclast, Zometa
Type
Formula C6404H9912N1724O2004S50
Weight 144700.0 Da
Groups Approved
Therapeutic Class Other preparations: Inhibiting bone resorption
Manufacturer
Available Country USA
Last Updated: September 19, 2023 at 7:00 am
Xgeva (Subcutaneous)
Xgeva (Subcutaneous)

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.

Xgeva (Subcutaneous) 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 Xgeva (Subcutaneous) works

Xgeva (Subcutaneous) 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. Xgeva (Subcutaneous) 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

Xgeva (Subcutaneous) 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, Xgeva (Subcutaneous) (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.

Xgeva (Subcutaneous) 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. Xgeva (Subcutaneous) 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. Xgeva (Subcutaneous) 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

You find simplified version here Xgeva (Subcutaneous)

Xgeva (Subcutaneous) contains Denosumab see full prescribing information from innovator Xgeva (Subcutaneous) Monograph, Xgeva (Subcutaneous) MSDS, Xgeva (Subcutaneous) FDA label

*** Taking medicines without doctor's advice can cause long-term problems.
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