XGEVA Rx

Select the drug indication to add to your list

XGEVA

Bone and connective tissue cancer
Cytoprotective and supportive care agents
Only 4 drugs may be compared at once

Generic Name and Formulations:

Denosumab 120mg/vial (70mg/mL); soln for SC inj; preservative-free.

Company:

Amgen, Inc.

Select therapeutic use:

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).

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 (esp. 1st weeks of initiating), phosphorus, magnesium levels and Vit.D intake in susceptible patients (eg, severe renal impairment, receiving dialysis). Risk of osteonecrosis of the jaw (ONJ) in diabetes, gingival infections. Perform oral exam and preventive dentistry before and regularly during therapy. Maintain good oral hygiene. Avoid invasive dental procedures during treatment; consider temporary discontinuation if procedure is necessary. Evaluate for atypical fractures if thigh/groin pain develops; consider withholding therapy until risk/benefit assessment. Monitor for hypercalcemia after treatment discontinuation in patients with growing skeletons. Embryo-fetal toxicity. Pregnancy; exclude status prior to initiation. Use highly effective contraception during therapy and for at least 5 months after last dose. Nursing mothers: not recommended (may impair mammary gland development/lactation).

Interactions:

Concomitant other denosumab-containing products (eg, Prolia): not recommended. Concomitant drugs that can lower calcium levels; monitor. Increased risk of ONJ with concomitant corticosteroids, chemotherapy, angiogenesis inhibitors or duration of denosumab exposure.

Pharmacological Class:

Osteoclast inhibitor (RANKL inhibitor).

Adverse Reactions:

Fatigue, asthenia, hypophosphatemia, nausea, arthralgia, headache, back pain, pain in extremity, dyspnea, decreased appetite, peripheral edema, vomiting, anemia, constipation, diarrhea; ONJ, hypocalcemia (may be fatal), hypersensitivity reactions (discontinue if occur).

REMS:

NO, but Prolia, another product containing denosumab, does.

Generic Availability:

NO

How Supplied:

Single-use vial (1.7mL)—1

XGEVA 1.7ml of 120mg/1.7ml vials (Qty:1)

appx. price $2066.00

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).

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 (esp. 1st weeks of initiating), phosphorus, magnesium levels and Vit.D intake in susceptible patients (eg, severe renal impairment, receiving dialysis). Risk of osteonecrosis of the jaw (ONJ) in diabetes, gingival infections. Perform oral exam and preventive dentistry before and regularly during therapy. Maintain good oral hygiene. Avoid invasive dental procedures during treatment; consider temporary discontinuation if procedure is necessary. Evaluate for atypical fractures if thigh/groin pain develops; consider withholding therapy until risk/benefit assessment. Monitor for hypercalcemia after treatment discontinuation in patients with growing skeletons. Embryo-fetal toxicity. Pregnancy; exclude status prior to initiation. Use highly effective contraception during therapy and for at least 5 months after last dose. Nursing mothers: not recommended (may impair mammary gland development/lactation).

Interactions:

Concomitant other denosumab-containing products (eg, Prolia): not recommended. Concomitant drugs that can lower calcium levels; monitor. Increased risk of ONJ with concomitant corticosteroids, chemotherapy, angiogenesis inhibitors or duration of denosumab exposure.

Pharmacological Class:

Osteoclast inhibitor (RANKL inhibitor).

Adverse Reactions:

Fatigue, asthenia, hypophosphatemia, nausea, arthralgia, headache, back pain, pain in extremity, dyspnea, decreased appetite, peripheral edema, vomiting, anemia, constipation, diarrhea; ONJ, hypocalcemia (may be fatal), hypersensitivity reactions (discontinue if occur).

REMS:

NO, but Prolia, another product containing denosumab, does.

Generic Availability:

NO

How Supplied:

Single-use vial (1.7mL)—1

XGEVA 1.7ml of 120mg/1.7ml vials (Qty:1)

appx. price $2066.00