地诺单抗的用法用量

(Denosumab), developed by Amgen, is the world's first RANKL monoclonal antibody approved for marketing. Its approved indications include bone-related events in patients with solid tumors/multiple myeloma bone metastases, giant cell tumor of bone, osteoporosis and prevention. How should patients with different indications use denosumab?

Medication management

Subcutaneous Injection (SC) Preparation

Visually inspect for particulate matter and discoloration before dosing

The solution should appear as a clear, colorless to pale yellow solution that may contain trace amounts of translucent to white protein particles.

Do not use if it is discolored or cloudy, or if the solution contains many particles or foreign particles

Before dosing, remove from refrigerator to room temperature (up to 25°C/77°F); generally takes 15-30 minutes; do not warm in any other way

latex allergy

Prolia only

People with latex sensitivities should not use the gray needle cap on disposable prefilled syringes, which contain dry natural rubber (a derivative of latex)

Subcutaneous injection (SC) administration

Only SC management

Must be administered by a healthcare professional

Remove and inject the entire contents of the vial using a 27-gauge needle; do not reenter the vial

Do not inject intradermally, IM or IV

Apply SC on upper arms, upper thighs, or abdomen

Give calcium and vitamin D as needed to treat or prevent hypocalcemia

Avoid vigorous shaking of vial/syringe

Single dose or discard vial after entry

adult

Dosage form

injection

Prolia: 60mg/mL (1mL prefilled syringe or vial)

Xgeva: 70mg/mL (120mg/1.7mL vial)

1. Osteoporosis

Prolia only

Indicated for postmenopausal women with osteoporosis who are at increased risk of fracture (defined as a history of osteoporotic fracture, or multiple fracture risk factors; or patients who have failed or are intolerant to other osteoporosis treatments)

A treatment indicated to increase bone mass in patients with osteoporosis who are at high risk of fractures

60 mg SC q6 months

2. Aromatase inhibitors induce bone loss

Prolia only

Shown as a treatment to increase bone mass in patients with fractures receiving adjuvant aromatase inhibitors for breast cancer

60 mg SC q6 months

3. Androgen deprivation leads to bone loss

Prolia only

Indicated as a treatment to increase bone mass in men at high risk for non-metastatic prostate cancer undergoing androgen deprivation therapy

60 mg SC q6 months

4. Glucocorticoid-induced osteoporosis

Prolia only

Represents patients with glucocorticoid-induced osteoporosis in whom men and women at risk for hypertension initiate or continue systemic glucocorticoids equivalent to ≥7.5 mg/day of prednisone and are expected to remain on glucocorticoids for at least 6 months

60 mg SC q6 months

5. Skeleton-related events

Only Xgeva

Prevention of skeletal-related events (SREs, such as fractures and pain) in patients with multiple myeloma and bone metastases from solid tumors

120 mg SC q4Weeks

Give calcium and vitamin D when necessary to treat or prevent hypocalcemia

6. Giant cell tumor

Only Xgeva

Treatment of giant cell tumor of bone in adults and skeletally mature adolescents for whom surgical resection is not possible or may result in significant morbidity

120 mg SC q4Weeks

Give 2 additional 120 mg doses during the first month of treatment on days 8 and 15

7. Malignant hypercalcemia

Only Xgeva

Indicated for the treatment of hypercalcemia in malignancies refractory to bisphosphonate therapy

120 mg SC q4Weeks

Give 2 additional 120 mg doses during the first month of treatment on days 8 and 15

Dosage modification

Hepatic Impairment: Safety and effectiveness have not been evaluated

renal insufficiency

Mild to severe: No dose adjustment required

Severe (CrCl <30 mL/min) or receiving dialysis: In clinical trials, patients were at higher risk for developing hypocalcemia

Dosage Precautions

Patients receiving Prolia should not receive Xgeva

All patients should receive 1000 mg of calcium and at least 400 IU of vitamin D daily

Pediatrics

Dosage form

injection

Xgeva: 70mg/mL (120mg/1.7mL vial)

giant cell tumor

Only Xgeva

Treatment of skeletally mature adolescents with giant cell tumor of bone in whom surgical resection is not possible or may result in significant morbidity

Skeletal maturity is defined by at least 1 mature long bone (e.g., closed epiphyseal growth plate of the humerus)

<13 years or <45kg: Safety and effectiveness have not been established

13-17 years (≥45kg): 120 mg SC q4Weeks; give 2 additional 120 mg doses during the first month of treatment on Days 8 and 15