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XGEVA (DENOSUMAB)
- Giant cell tumor of bone
- Humoral hypercalcemia of malignancy
- Prevention of skeletal related events in bone metastases
- Prevention of skeletal related event in multiple myeloma
120 mg/1.7 mL (70 mg/mL) subcutaneous solution
- Inject 1.7 milliliters (120 mg) by subcutaneous route every 4 weeks
Giant cell tumor of bone
- Inject 1.7 milliliters (120 mg) by subcutaneous route every 4 weeks
- Inject 1.7 milliliters (120 mg) by subcutaneous route every 4 weeks and on days 8 and 15 of the first month of therapy
Humoral hypercalcemia of malignancy
- Inject 1.7 milliliters (120 mg) by subcutaneous route every 4 weeks
- Inject 1.7 milliliters (120 mg) by subcutaneous route every 4 weeks and on days 8 and 15 of the first month of therapy
Prevention of skeletal related event in multiple myeloma
- Inject 1.7 milliliters (120 mg) by subcutaneous route every 4 weeks
Prevention of skeletal related events in bone metastases
- Inject 1.7 milliliters (120 mg) by subcutaneous route every 4 weeks
- None
Contraindicated
- None
Severe
Moderate
- None
- None
Contraindicated
- Aseptic necrosis of jaw bone
- Atypical femoral fracture
- Congenital long QT syndrome
- Hypocalcemia
- Pregnancy
- Severe infection
Severe
Moderate
- Diabetes mellitus
- Hypercholesterolemia
- Hypoparathyroidism
- Invasive dental procedure
- Pancreatitis
- Periodontitis
- Thyroid surgery
XGEVA (DENOSUMAB)
- Giant cell tumor of bone
- Humoral hypercalcemia of malignancy
- Prevention of skeletal related events in bone metastases
- Prevention of skeletal related event in multiple myeloma
- Dyspnea
- Back pain
- Fatigue
- General weakness
- Hypophosphatemia
- Musculoskeletal pain
- Nausea
More Frequent
Severe
Less Severe
- Hypertension
- Hypokalemia
- Hypomagnesemia
- Allergic dermatitis
- Anemia
- Anorexia
- Arthralgias
- Bone pain
- Bronchitis
- Constipation
- Cystitis
- Diarrhea
- Dizziness
- Dyspepsia
- Eczema
- Flatulence
- Gastroesophageal reflux disease
- Headache disorder
- Hypercholesterolemia
- Infection of ear
- Limb pain
- Peripheral edema
- Pharyngitis
- Pruritus of skin
- Sciatica
- Skin inflammation
- Skin rash
- Spinal osteoarthritis
- Upper abdominal pain
- Upper respiratory infection
- Urinary tract infection
- Vertigo
- Vomiting
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Anaphylaxis
- Angina
- Aseptic necrosis of jaw bone
- Atypical femoral fracture
- Cataracts
- Cellulitis
- Cholesteatoma of external ear
- Dental abscess
- Endocarditis
- Erysipelas
- Hyperparathyroidism
- Hypersensitivity drug reaction
- Hypocalcemia
- Hypotension
- Infection
- Malignancy
- Pancreatitis
- Severe infection
- Throat constriction
Less Severe
- Alopecia
- Ear itching
- Earache
- Erythema
- Facial edema
- Hearing loss
- Herpes zoster
- Impacted cerumen
- Insomnia
- Lichenoid dermatitis drug eruption
- Tinnitus
- Urticaria
Contraindicated
None
Severe Precaution
Denosumab
Not recommended age < 4 years due to risk of impaired bone growth and tooth development. Limited use for giant cell tumor of bone in skeletally mature adolescents.
Potential risk of impaired bone growth and tooth development. Limited use for giant cell tumor of bone in skeletally mature adolescents.
- 1 Day – 4 Years
- Not recommended age < 4 years due to risk of impaired bone growth and tooth development. Limited use for giant cell tumor of bone in skeletally mature adolescents.
- Potential risk of impaired bone growth and tooth development. Limited use for giant cell tumor of bone in skeletally mature adolescents.
- 4 Years – 18 Years
- Not recommended age < 4 years due to risk of impaired bone growth and tooth development. Limited use for giant cell tumor of bone in skeletally mature adolescents.
- Potential risk of impaired bone growth and tooth development. Limited use for giant cell tumor of bone in skeletally mature adolescents.
Management or Monitoring Precaution
None
Denosumab
- Severity Level:
D
- Additional Notes: Based on drug pharmacology developmental toxicity is possible.
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Denosumab
Insufficient human data available
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Insufficient human data available |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
Denosumab
General-Monitor serum calcium closely. Increased risk of hypocalcemia with creatinine clearance less than 30 mL/min or on dialysis. Supplement calcium and vitamin D as needed. Musculoskeletal-Reports of atypical, pathologic subtrochanteric or proximal diaphyseal fractures can occur with little or no trauma. Caution with drug discontinuation in patients with osteoporosis or prior fractures; may be at risk for multiple vertebral fractures.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | Y | N | N | N | N | N |
BEERS: N HEDIS: N STOPP: N
No Known Risk
None
- None
| Giant cell tumor of bone | |
| C40 | Malignant neoplasm of bone and articular cartilage of limbs |
| C40.0 | Malignant neoplasm of scapula and long bones of upper limb |
| C40.00 | Malignant neoplasm of scapula and long bones of unspecified upper limb |
| C40.01 | Malignant neoplasm of scapula and long bones of right upper limb |
| C40.02 | Malignant neoplasm of scapula and long bones of left upper limb |
| C40.1 | Malignant neoplasm of short bones of upper limb |
| C40.10 | Malignant neoplasm of short bones of unspecified upper limb |
| C40.11 | Malignant neoplasm of short bones of right upper limb |
| C40.12 | Malignant neoplasm of short bones of left upper limb |
| C40.2 | Malignant neoplasm of long bones of lower limb |
| C40.20 | Malignant neoplasm of long bones of unspecified lower limb |
| C40.21 | Malignant neoplasm of long bones of right lower limb |
| C40.22 | Malignant neoplasm of long bones of left lower limb |
| C40.3 | Malignant neoplasm of short bones of lower limb |
| C40.30 | Malignant neoplasm of short bones of unspecified lower limb |
| C40.31 | Malignant neoplasm of short bones of right lower limb |
| C40.32 | Malignant neoplasm of short bones of left lower limb |
| C40.8 | Malignant neoplasm of overlapping sites of bone and articular cartilage of limb |
| C40.80 | Malignant neoplasm of overlapping sites of bone and articular cartilage of unspecified limb |
| C40.81 | Malignant neoplasm of overlapping sites of bone and articular cartilage of right limb |
| C40.82 | Malignant neoplasm of overlapping sites of bone and articular cartilage of left limb |
| C40.9 | Malignant neoplasm of unspecified bones and articular cartilage of limb |
| C40.90 | Malignant neoplasm of unspecified bones and articular cartilage of unspecified limb |
| C40.91 | Malignant neoplasm of unspecified bones and articular cartilage of right limb |
| C40.92 | Malignant neoplasm of unspecified bones and articular cartilage of left limb |
| C41 | Malignant neoplasm of bone and articular cartilage of other and unspecified sites |
| C41.0 | Malignant neoplasm of bones of skull and face |
| C41.1 | Malignant neoplasm of mandible |
| C41.2 | Malignant neoplasm of vertebral column |
| C41.3 | Malignant neoplasm of ribs, sternum and clavicle |
| C41.4 | Malignant neoplasm of pelvic bones, sacrum and coccyx |
| C41.9 | Malignant neoplasm of bone and articular cartilage, unspecified |
| D48.0 | Neoplasm of uncertain behavior of bone and articular cartilage |
| Humoral hypercalcemia of malignancy | |
| E83.52 | Hypercalcemia |
| Prevention of skeletal related event in multiple myeloma | |
| C90.0 | Multiple myeloma |
| C90.00 | Multiple myeloma not having achieved remission |
| C90.02 | Multiple myeloma in relapse |
| Prevention of skeletal related events in bone metastases | |
| C79.51 | Secondary malignant neoplasm of bone |
| 0-9 | A-Z |
|---|---|
| C40 | Malignant neoplasm of bone and articular cartilage of limbs |
| C40.0 | Malignant neoplasm of scapula and long bones of upper limb |
| C40.00 | Malignant neoplasm of scapula and long bones of unspecified upper limb |
| C40.01 | Malignant neoplasm of scapula and long bones of right upper limb |
| C40.02 | Malignant neoplasm of scapula and long bones of left upper limb |
| C40.1 | Malignant neoplasm of short bones of upper limb |
| C40.10 | Malignant neoplasm of short bones of unspecified upper limb |
| C40.11 | Malignant neoplasm of short bones of right upper limb |
| C40.12 | Malignant neoplasm of short bones of left upper limb |
| C40.2 | Malignant neoplasm of long bones of lower limb |
| C40.20 | Malignant neoplasm of long bones of unspecified lower limb |
| C40.21 | Malignant neoplasm of long bones of right lower limb |
| C40.22 | Malignant neoplasm of long bones of left lower limb |
| C40.3 | Malignant neoplasm of short bones of lower limb |
| C40.30 | Malignant neoplasm of short bones of unspecified lower limb |
| C40.31 | Malignant neoplasm of short bones of right lower limb |
| C40.32 | Malignant neoplasm of short bones of left lower limb |
| C40.8 | Malignant neoplasm of overlapping sites of bone and articular cartilage of limb |
| C40.80 | Malignant neoplasm of overlapping sites of bone and articular cartilage of unspecified limb |
| C40.81 | Malignant neoplasm of overlapping sites of bone and articular cartilage of right limb |
| C40.82 | Malignant neoplasm of overlapping sites of bone and articular cartilage of left limb |
| C40.9 | Malignant neoplasm of unspecified bones and articular cartilage of limb |
| C40.90 | Malignant neoplasm of unspecified bones and articular cartilage of unspecified limb |
| C40.91 | Malignant neoplasm of unspecified bones and articular cartilage of right limb |
| C40.92 | Malignant neoplasm of unspecified bones and articular cartilage of left limb |
| C41 | Malignant neoplasm of bone and articular cartilage of other and unspecified sites |
| C41.0 | Malignant neoplasm of bones of skull and face |
| C41.1 | Malignant neoplasm of mandible |
| C41.2 | Malignant neoplasm of vertebral column |
| C41.3 | Malignant neoplasm of ribs, sternum and clavicle |
| C41.4 | Malignant neoplasm of pelvic bones, sacrum and coccyx |
| C41.9 | Malignant neoplasm of bone and articular cartilage, unspecified |
| C79.51 | Secondary malignant neoplasm of bone |
| C90.0 | Multiple myeloma |
| C90.00 | Multiple myeloma not having achieved remission |
| C90.02 | Multiple myeloma in relapse |
| D48.0 | Neoplasm of uncertain behavior of bone and articular cartilage |
| E83.52 | Hypercalcemia |
Formulary Reference Tool