Xgeva

Xgeva 120mg injection is a trade name of denosumab and which belongs to type of monoclonal antibody. This drug is classified as a “bone-modifying agent”, it works as a RANK ligand (RANKL) inhibitor. Xgeva 120mg injection which attach and repairs only certain cells in the body and help to protect healthy cells from destroy.

Denosumab

Xgeva

120mg

Dr. Reddy’s




INDICATION

Xgeva 120mg injection is indicated for the treatment of Osteoporosis occur in men and women (menopause stage) (end of menopause/ change of life), whose have severe problem of fractures increased or who failed to other medication of osteoporosis.
Breast cancer in women whose taking certain treatment which make severe their risk of fractures and bone loss in men with prostate cancer.
In adults and some adolescents with giant cell tumor of bone which cannot cured with surgery / surgery is not possible is treated with Xgeva 120mg injection.

Mechanism of action

Denosumab is decided to target RANKL (RANK ligand), a protein which act as the main signal to help bone removal/resorption. Some of the bone loss conditions, RANKL overcome the body's natural defense against bone eradication. Denosumab prohibits RANKL from activating its receptor, RANK, which is on the surface of osteoclasts and their messengers. Prevention of the RANKL/RANK interplay prevents osteoclast formation, function, and survival, hence reducing bone resorption and raising bone mass and vitality in both cortical and trabecular bone.



Pharmacokinetic

Peak plasma concentration: 6.75mcg/mL

Tmax : 10days
Without aggregation in Xgevapharmacokinetics with duration was noticed upon multiple dosing of 60 mg SC administered once every 6 months.
Pharmacokinetics of Xgevawill not affected by the binding antibodies formation.
Half-life is 25.4 days.



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drug
Brand Xgeva
Ingredients Denosumab
Strength 120mg
Manufactured Dr. Reddy’s
Rating

For adult :
Hypercalcemia :
The recommended dose is of 120mg Xgevatablet given SC, every 4 weeks with additional 120mg doses on days 8 and 15 of the 1st month treatment
Injection of drug should be done in upper arm, upper thigh or abdomen.
Osteoporosis :
The recommended dose is 60mg SC (subcutaneously) once every 6 months
Injection of drug should be done in upper arm, upper thigh or abdomen.
Giant Cell Tumor of bone:
The recommended dose is 120mg SC, every 4 weeks with additional 120mg doses on days 8 and 15 of the 1st month treatment
Injection of drug should be done in upper arm, upper thigh or abdomen.
Osteolytic Bone Metastases of Solid Tumors.
The usual dose for the patient with Osteolytic Bone Metastases of Solid Tumors is 120mg subcutaneously every 4 weeks
Injection of drug should be done in upper arm, upper thigh or abdomen.
For pediatric :
The recommended dose is 13 years and older and 45kg or more for Giant Cell Tumor of bone: The recommended dose is of 120mg Xgeva tablet given SC, every 4 weeks with additional 120mg doses on days 8 and 15 of the 1-month treatment
OVERDOSE:
No experienced with Xgevaoverdose. If occurs seek to emergency department and call poison control.

Side effects

Common side effects :
• Fatigue
• Muscle weakness
• Phosphorus level reduced in blood.
• Nausea
Less common side effects :
• Dyspnea
• Hypocalcemia
• Cough
• Arthralgia
• Limb pain
• Eczema
• Headache

Precautions

Xgeva 120mg injection may improve the negative effects of immuno-suppressants. Especially the risk for severe infections may be raised. Inform your doctor of any immuno-suppressive drugs you early consume.
Not to receive any type of vaccination without your doctor's consultation while admonishing denosumab.
Prior to start treatment with denosumab, consult with your doctor about any other regimens you are using (including over-the-counter drugs, vitamins, or herbal remedies). Not to take aspirin or products containing aspirin unless your doctor permits this.
Any plan to become pregnant prior to starting this treatment, consult with doctor before the treatment because use in pregnancy only if benefit to mother outweighs risk to fetus).
Avoid breast feeding during Denosumab treatment.

DRUG – DRUG INTERACTION

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

Contraindications

Xgeva is contraindicated in :
Hypocalcemia
Pregnancy
Hypersensitivity .




The Xgeva 120mg belongs to category C which has no sufficient data in pregnant women to convey any drug analog risk for adverse development outcomes
The drug in pregnant women is contraindicated for use because it may cause serious risk to the fetus.

Xgeva 120mg is excreted into human milk is not known. Since possible for severe side effects occurs in nursing infants from Xgeva 120mg injection. Avoid breastfeeding during treatment of Denosumab.

Store at 2°C to 8°C in the original container.
Avoid freeze.
Before to administration keep at room temperature.
Xgeva protect from direct light and heat.

Take the dose immediately before next dose duration. Next dose time reaches then left off the missed dose and continue regular schedule. Avoid taking double dose at same time. Please consult the doctor for further information.


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