Xgeva 120mg (Denosumab)

Description of Xgeva 120mg (Denosumab 120mg)

Xgeva 120mg (Denosumab 120mg)  belongs to novel, fully human IgG2 monoclonal antibody especially to receptor activator of nuclear factor kappa-B ligand (RANKL), restrain bone resorption markers in patients with a difference of metastatic tumors and is being examined in multiple clinical trials for the inhibition and treatment of bone metastases. Chemically, it exists of 2 heavy and 2 light chains. Each light chain contains of 215 amino acids. Each heavy chain contains of 448 amino acids with 4 intramolecular disulfides.

Medical use /Indication of Xgeva 120mg (Denosumab 120mg)

Treatment for patients having postmenopausal women with osteoporosis at high risk for fracture. Treatment for patients with increase bone mass in men at more risk for fracture getting androgen deprivation therapy for non-metastatic prostate cancer. Treatment for patients having to increase bone mass in women at more risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

Mechanism of Action Xgeva 120mg (Denosumab 120mg)

Denosumab linked to RANKL, a protein which is specific for the formation, function and survival of osteoclasts, the cells necessary for bone resorption. Denosumab prohibits osteoclast formation, function and survival hence, reducing bone resorption and raising bone mass and strength of the bone.

ADME of Xgeva 120mg (Denosumab 120mg) 

Peak plasma concentration: 6.75mcg/mL

Tmax : 10days

Without aggregation in Xgeva 120mg (Denosumab 120mg) pharmacokinetics with duration was noticed upon multiple dosing of 60 mg SC administered once every 6 months. Pharmacokinetics of Xgeva 120mg (Denosumab 120mg) will not affected by the binding antibodies formation.
Half-life is 25.4 days.

Side effects of Xgeva 120mg (Denosumab 120mg)

Common side effects for the patient taking Xgeva 120mg (Denosumab 120mg) 60mg as follows : 

Fatigue, Muscle weakness, Phosphorus level reduced in blood, Nausea

Less common side effects for patients taking Xgeva 120mg (Denosumab 120mg):

Dyspnea, Hypocalcemia, Cough, Arthralgia, Limb pain, Eczema, Headache

Precautions of Xgeva 120mg (Denosumab 120mg)

• Before to start treatment with Xgeva 120mg (Denosumab 120mg), discuss with the doctor about any other regimens you are using (including over-the-counter medicines, vitamins, or herbal remedies). Do not take aspirin or products containing aspirin unless your doctor permits this.
• Xgeva 120mg (Denosumab 120mg) injection may improve the negative effects of immuno-suppressants. Especially the risk for serious infections may be increased. Inform your doctor of any immuno-suppressive medicines you early consume.
• Not to receive any type of vaccination without your doctor's consultation while admonishing denosumab.
• Use in pregnancy only if benefit to mother outweighs risk to fetus. Consult with doctor before the treatment
• During Xgeva 120mg (Denosumab 120mg) treatment do not breastfeed your infants.

Drug interaction of Xgeva 120mg (Denosumab 120mg)

No formal drug-drug interaction with denosumab during trials.
When interacting with some anticancer medicine, orthopedic medicine, vaccines will lead to risk of adverse effects can be increased

Contraindication of Xgeva 120mg (Denosumab 120mg)

Xgeva 120mg (Denosumab 120mg) is contraindicated in patients having Hypocalcemia, Pregnancy, Hypersensitivity

Pregnancy of Xgeva 120mg (Denosumab 120mg)

Pregnancy category C: There has no sufficient data in pregnant women to convey any medicine analog risk for adverse development outcomes. The medicine in pregnant women is contraindicated for use because it may cause serious risk to the fetus.

Lactation of Xgeva 120mg (Denosumab 120mg)

Xgeva 120mg (Denosumab 120mg) 60mg is excreted into human milk is not known. Since possible for severe side effects occurs in nursing infants from Xgeva 120mg (Denosumab 120mg) 60mg injection, a decision should be considered that to discontinue nursing or discontinue the medicine by giving preference of the importance of the medicine to the mother.

Dosage of Xgeva 120mg (Denosumab 120mg)

For adult :

Osteoporosis :

60mg SC (subcutaneously) once every 6 months

Injection of medicine  should be done in upper arm, upper thigh or abdomen

Giant Cell Tumor of bone :

120mg SC, every 4 weeks with additional 120mg doses on days 8 and 15 of the 1st month treatment

Injection of .medicine should be done in upper arm, upper thigh or abdomen

Osteolytic Bone Metastases of Solid Tumors :

120mg subcutaneously every 4 weeks

Injection of medicine should be done in upper arm, upper thigh or abdomen

Hypercalcemia :

Dose of 120mg Xgeva 120mg (Denosumab 120mg) tablet given SC, every 4 weeks with additional 120mg doses on days 8 and 15 of the 1st month treatment

Injection of medicine should be done in upper arm, upper thigh or abdomen

Dosage and administration in pediatric :

13 years and older and 45kg or more

Giant Cell Tumor of bone:

Dose of 120mg Xgeva 120mg (Denosumab 120mg) tablet given SC, every 4 weeks with additional 120mg doses on days 8 and 15 of the 1st month treatment

OVERDOSE:

Xgeva 120mg (Denosumab 120mg) overdose has no overdose. If occurs seek to emergency department and call poison control

Storage of Xgeva 120mg (Denosumab 120mg)

Store at 2℃ to 8℃ in the original container, avoid freeze

Before to administration keep at room temperature

Xgeva 120mg (Denosumab 120mg) protect from direct light and heat.

Missed dose of Xgeva 120mg (Denosumab 120mg)

Take the dose immediately before next dose duration, then left off the missed dose and continue regular schedule. Avoid taking double dose at same time.

Please consult the doctor for further information.