Drug Interaction:
No formal drug-drug interaction trials have been conducted with Xgeva.
Indication:
Proprietary Name- Prolia
Established Name - Denosunab To
Applicant- Amgen Inc
Indication-
Provide treatment for osteoporosis in post menopausal women
Approved by FDA on 1-6-2010 (Ref- FDA approved List- 2010)
Proprietary Name- Prolia
Established Name - Denosunab To
Applicant- Amgen Inc
Indication-
Provide treatment for osteoporosis in post menopausal women
Approved by FDA on 1-6-2010 (Ref- FDA approved List- 2010)
Proprietary Name- XGEVA INJECTION*
Established Name- Denosumab
Applicant- AMGEN INC.
Indication- For the treatment of adults and skeletally mature
adolescents with giant cell tumor of bone that is
unrecetable or whose surgical recection is
likely to severe morbidity
Approval Date- July 13,2013
Approved by U.S.FDA (Ref- FDA approved List- 2013)
Adverse Reaction:
Bone Metastasis from Solid Tumors:
Most common adverse reactions
(per-patient incidence greater than or equal to 25%) were fatigue/asthenia,
hypophosphatemia, and nausea
Giant Cell Tumor of Bone:
Most common adverse reactions (per-patient incidence greater than or equal to 10%) were
arthralgia, headache,nausea, back pain, fatigue, and pain in extremity (
Contra-Indications:
CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS
Hypocalcemia: Xgeva can cause severe symptomatic hypocalcemia, and fatal
cases have been reported.
Correct hypocalcemia prior to initiating Xgeva.
Monitor calcium levels and adequately supplement all patients with calcium
and vitamin D
Osteonecrosis of the jaw can occur in patients receiving Xgeva.
Perform an oral examination prior to starting Xgeva. Monitor for symptoms.
Avoid invasive dental procedures during treatment with Xgeva
Embryo-Fetal Toxicity: Can cause fetal harm.
Advise females of reproductive potential of potential risk to the fetus and to use highly
effective contraception
Dosages/ Overdosage Etc:
Indication-
Provide treatment for osteoporosis in post menopausal women
DOSAGE AND ADMINISTRATION
Bone Metastasis from Solid Tumors:
Administer 120 mg every 4 weeks as a subcutaneous injection in the upper arm,
upper thigh, or abdomen
Giant Cell Tumor of Bone:
Administer 120 mg every 4 weeks with additional 120 mg doses on Days 8 and 15
of the first month of therapy.
Administer subcutaneously in the upper arm, upper thigh, or abdomen
Administer calcium and vitamin D as necessary to treat or prevent
hypocalcemia
DOSAGE FORMS AND STRENGTHS
120 mg/1.7 mL (70 mg/mL) single-use vial
Patient Information:
PATIENT COUNSELING INFORMATION
Advise patients to contact a healthcare professional for any of the following:
1. Symptoms of hypocalcemia, including paresthesias or muscle stiffness, twitching,
spasms, or cramps
2. Symptoms of ONJ, including pain, numbness, swelling of or drainage from the jaw,
mouth, or teeth
3.Persistent pain or slow healing of the mouth or jaw after dental surgery
4. Pregnancy or nursing use only if required and as adviced by the physician
5.Advise patients of the need for:
- Proper oral hygiene and routine dental care
- Informing their dentist that they are receiving Xgeva
- Avoiding invasive dental procedures during treatment with Xgeva
- The use of highly effective contraception during and for at least 5 months after treatment
with Xgeva for females of reproductive potential.
6. Advise patients that denosumab is also marketed as Prolia®.
Patients should inform their healthcare provider if they are taking Prolia.
Pharmacology/ Pharmacokinetics:
1 Mechanism of Action
Xgeva binds to RANKL, a transmembrane or soluble protein essential for the formation,
function, and survival of osteoclasts, the cells responsible for bone resorption. Increased
osteoclast activity, stimulated by RANKL, is a mediator of bone pathology in solid tumors
with osseous metastases.
Xgeva prevents RANKL from activating its receptor, on the surface of osteoclasts,
their precursors, and osteoclast-like giant cells.
2.Pharmacokinetics
With multiple subcutaneous doses of 120 mg once every 4 weeks, up to
2.8-fold accumulation in serum denosumab concentrations was observed and
steady state was achieved by 6 months. A mean (± standard deviation)
serum steady-state trough concentration of 20.5 (± 13.5) mcg/mL was achieved
by 6 months
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1 Pregnancy
Pregnancy Category D
Risk Summary
Xgeva can cause fetal harm when administered to a pregnant woman based on findings
in animals. .
There are no adequate and well-controlled studies with Xgeva in pregnant women.
Women should be advised not to become pregnant when taking Xgeva.
If this drug is used during pregnancy, or if the patient becomes pregnant while
taking this drug, the patient should be apprised of the potential hazard to
the fetus.
2.Nursing Mothers
It is not known whether Xgeva is excreted into human milk.
Because many drugs are excreted in human milk and because of the potential
for serious adverse reactions in nursing infants from Xgeva, a decision should
be made whether to discontinue nursing or discontinue the drug, taking into account
the importance of the drug to the mother.
3.Pediatric Use
The safety and efficacy of Xgeva have not been established in pediatric patients except
in skeletally mature adolescents with giant cell tumor of bone. Xgeva is recommended only for treatment of skeletally mature adolescents with giant cell tumor of bone
Manufacturer Details