Generic Name and Formulations:
Denosumab 120mg/vial (70mg/mL); soln for SC inj; preservative-free.
Company:
Amgen, Inc.
Indications for XGEVA:
Treatment of adults and skeletally-mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Adult:
Give by SC inj into upper arm, upper thigh, or abdomen. 120mg once every 4 weeks with additional 120mg doses on Days 8 and 15 of the 1st month of therapy.
Children:
Not established (interferes with bone growth and dentition).
Pharmacological Class:
Osteoclast inhibitor (RANKL inhibitor).
Contraindications:
Pre-existing hypocalcemia.
Warnings/Precautions:
Correct hypocalcemia before starting; ensure adequate daily calcium, magnesium, and Vit.D intake, esp. in renal impairment (CrCl <30mL/min). Monitor calcium, phosphorus, magnesium levels in susceptible patients (eg, severe renal impairment, receiving dialysis). Monitor for osteonecrosis of the jaw. Perform oral exam and preventive dentistry before and regularly during therapy. Maintain good oral hygiene. Avoid invasive dental procedures during treatment. eva luate for atypical fractures if thigh/groin pain develops; consider withholding therapy until risk/benefit assessment. Pregnancy (Cat.D); use highly effective contraception during therapy, and for at least 5 months after last dose. Nursing mothers: avoid (may impair mammary gland development/lactation).
Interactions:
Concomitant other denosumab-containing products (eg, Prolia): not recommended. Concomitant drugs that can lower calcium levels; monitor.
Adverse Reactions:
Fatigue, asthenia, hypophosphatemia, nausea, arthralgia, headache, back pain, pain in extremity, dyspnea, decreased appetite, peripheral edema, vomiting, anemia, constipation, diarrhea; osteonecrosis of jaw, severe hypocalcemia (may be fatal), anaphylactic reactions (discontinue if occurs).
REMS:
NO, but Prolia, another product containing denosumab, does.
Generic Availability:
NO
How Supplied:
Single-use vial (1.7mL)—1
Indications for XGEVA:
Prevention of skeletal-related events (SRE) in patients with bone metastases from solid tumors. Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
Limitations Of use:
Not for preventing SRE with multiple myeloma.
Adult:
Give by SC inj into upper arm, upper thigh, or abdomen. SRE: 120mg once every 4 weeks. Hypercalcemia: 120mg once every 4 weeks with additional 120mg doses on Days 8 and 15 of the 1st month of therapy.
Children:
Not established (interferes with bone growth and dentition).
Pharmacological Class:
Osteoclast inhibitor (RANKL inhibitor).
Contraindications:
Pre-existing hypocalcemia.
Warnings/Precautions:
Correct hypocalcemia before starting; ensure adequate daily calcium, magnesium, and Vit.D intake, esp. in renal impairment (CrCl <30mL/min). Monitor calcium, phosphorus, magnesium levels in susceptible patients (eg, severe renal impairment, receiving dialysis). Monitor for osteonecrosis of the jaw. Perform oral exam and preventive dentistry before and regularly during therapy. Maintain good oral hygiene. Avoid invasive dental procedures during treatment. eva luate for atypical fractures if thigh/groin pain develops; consider withholding therapy until risk/benefit assessment. Pregnancy (Cat.D); use highly effective contraception during therapy, and for at least 5 months after last dose. Nursing mothers: avoid (may impair mammary gland development/lactation).
Interactions:
Concomitant other denosumab-containing products (eg, Prolia): not recommended. Concomitant drugs that can lower calcium levels; monitor.
Adverse Reactions:
Fatigue, asthenia, hypophosphatemia, nausea, arthralgia, headache, back pain, pain in extremity, dyspnea, decreased appetite, peripheral edema, vomiting, anemia, constipation, diarrhea; osteonecrosis of jaw, severe hypocalcemia (may be fatal), anaphylactic reactions (discontinue if occurs).
REMS:
NO, but Prolia, another product containing denosumab, does.
Generic Availability:
NO
How Supplied:
Single-use vial (1.7mL)—1
