denosumab

Treatment of osteoporosis in postmenopausal women who are at high risk for fracture or those who have failed/are intolerant of conventional osteoporosis therapy.
To increase bone mass in men with osteoporosis who are at high risk for fracture or those who have failed/are intolerant of conventional osteoporosis therapy.
Treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture who are initiating or continuing systemic glucocorticoids at a daily dosage of ≥7.5 mg of prednisone and are expected to remain on glucocorticoids for ≥6 mo.
To increase bone mass in men receiving androgen deprivation therapy for nonmetastatic prostate cancer who are at high risk for fracture.
To increase bone mass in women receiving adjuvant aromatase inhibitor therapy for breast cancer who are at high risk for fracture.

Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
Giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

REMS

Connexence, Jubbonti, Ospomyv, Prolia, or StobocloBomyntra, Osenvelt, Xbryk, Xgeva, or Wyost

Hypercalcemia of malignancy that is refractory to bisphosphonate therapy.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Hypocalcemia (correct before administration);
OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

Hypoparathyroidism, previous thyroid/parathyroid surgery, malabsorption syndromes, history of small intestinal excision, concurrent use of calcium-lowering medications, or severe renal impairment/hemodialysis (↑ risk of hypocalcemia; patients with severe renal impairment, including those on dialysis or with mineral bone disorder, at ↑ risk of severe hypocalcemia);
Invasive dental procedures; cancer; receiving chemotherapy, corticosteroids, or angiogenesis inhibitors; poor oral hygiene; diabetes; gingival infections; periodontal disease; dental disease; anemia; coagulopathy; infection; or poorly fitting dentures (↑ risk of jaw osteonecrosis);
History of osteoporosis or prior fractures (↑ risk of multiple vertebral fractures upon drug discontinuation);
Concurrent use of immunosuppressants or diseases resulting in immunosuppression (↑ risk of infection);
Rep: Women of reproductive potential;
Pedi: Safety and effectiveness not established in children;
Geri: Older adults may be more sensitive to drug effects.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: dermatitis, eczema, rash

F and E: hypocalcemia, hypophosphatemia, hypercalcemia

GI: diarrhea, nausea, PANCREATITIS

GU: cystitis

Metab: hypercholesterolemia

MS: back pain, musculoskeletal pain, atypical femoral fracture, osteonecrosis of the jaw, suppression of bone turnover

Neuro: headache

Resp: dyspnea, cough

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), infection

Interactions ⬆ ⬇

Drug-drug:

Immunosuppressants may ↑ risk of infection.
Calcimimetic drugs may ↑ risk of hypocalcemia.

Availability ⬆ ⬇

(Generic available)

Solution for injection (Conexxence, Jubbonti, Ospomyv, Prolia, or Stoboclo) (prefilled syringe): 60 mg/mL
Solution for injection (Bomyntra, Osenvelt, Xbryk, Xgeva, or Wyost): 120 mg/1.7 mL

Route/Dosage ⬆ ⬇

Conexxence, Jubbonti, Ospomyv, Prolia, or Stoboclo

SUBQ (Adults ): 60 mg every 6 mo.

Bomyntra, Osenvelt, Xbryk, Xgeva, or Wyost

SUBQ (Adults ): Multiple myeloma or bone metastasis from solid tumors: 120 mg every 4 wk; Giant cell tumor of bone: 120 mg every 4 wk, with additional doses of 120 mg given on Days 8 and 15 of first month of therapy; Hypercalcemia of malignancy: 120 mg every 4 wk, with additional doses of 120 mg given on Days 8 and 15 of first month of therapy.

US Brand Names ⬆ ⬇

Bomyntra, Conexxence, Jubbonti, Osenvelt, Ospomyv, Prolia, Stoboclo, Wyost, Xbryk, Xgeva

Action ⬆ ⬇

A monoclonal antibody that binds specifically to the human receptor activator of nuclear factor kappa-B-ligand (RANKL), which is required for formation, function, and survival of osteoclasts. Binding inhibits osteoclast formation, function, and survival.

Therapeutic effects:

↓bone resorption with ↓ occurrence of fractures (vertebral, nonvertebral, hip) or other skeletal-related events (e.g., radiation therapy to bone, surgery to bone, spinal cord compression).
↑bone mass.

Classifications ⬆ ⬇

Therapeutic Classification: bone resorption inhibitors

Pharmacologic Classification: monoclonal antibodies

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed following SUBQ administration.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 25.4 days.

Time/Action Profile ⬆ ⬇

( effects on bone resorption)

ROUTE		ONSET		PEAK		DURATION
SUBQ		1 mo		unknown‡		12 mo‡

‡Maximum ↓ in serum calcium occurs at 10 days.

‡Following discontinuation.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Do not stop receiving drug without consulting health care provider. If an appointment is missed, contact health care provider as soon as possible to reschedule. Advise patient to read Patient Information before starting therapy.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care provider before taking other medications.
Advise patient once treatment is stopped, there may be an ↑ risk of having broken bones in the spine, especially in patients who have had a fracture or who have had osteoporosis. Advise patients not to interrupt therapy without advice from a health care provider. If denosumab is discontinued, consider another bone resorption inhibitor.
Advise patient to eat a balanced diet and consult health care provider about the need for supplemental calcium and vitamin D (see Food Sources for Specific Nutrients).
Advise patient to notify health care provider immediately if signs of hypersensitivity, hypocalcemia (spasms, twitches, or cramps in muscles; numbness or tingling in fingers, toes, or around mouth), infection (fever; chills; skin that is red, swollen, hot, or tender to touch; severe abdominal pain; frequent or urgent need to urinate or burning during urination), skin reactions (redness, itching, rash, dry or leathery feeling, blisters that ooze or become crusty, peeling), or osteonecrosis of the jaw (pain; numbness; swelling of or drainage from the jaw, mouth, or teeth) occur.
Encourage patient to participate in regular exercise and to modify behaviors that ↑ the risk of osteoporosis (stop smoking, reduce alcohol consumption).
Advise patient to perform oral hygiene of teeth and gums (brush and floss regularly) and to inform health care provider of therapy before dental surgery.
Rep: Advise women of reproductive potential to use highly effective contraception during and for >5 mo after therapy is completed. Advise patient to notify health care provider if pregnancy is planned or suspected or if breastfeeding.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

0078- Novartis Pharmaceuticals Corporation
- 0078-1350-
  - 0078-1350-09- 2 kg in 1 BOTTLE (0078-1350-09)

43835- Catalent Belgium SA
- 43835-0053-
  - 43835-0053-1- 9 CONTAINER in 1 BOX (43835-0053-1) / 160 SYRINGE in 1 CONTAINER / 1 mL in 1 SYRINGE

55513- Amgen, Inc
- 55513-710- Prolia
  - 55513-710-01- 1 SYRINGE in 1 CARTON (55513-710-01) / 1 mL in 1 SYRINGE

55513- Amgen, Inc
- 55513-710- Prolia
  - 55513-710-21- 1 SYRINGE in 1 CARTON (55513-710-21) / 1 mL in 1 SYRINGE

55513- Amgen, Inc
- 55513-730- XGEVA
  - 55513-730-01- 1 VIAL, SINGLE-USE in 1 CARTON (55513-730-01) / 1.7 mL in 1 VIAL, SINGLE-USE

55513- Amgen, Inc
- 55513-730- XGEVA
  - 55513-730-21- 1 VIAL, SINGLE-USE in 1 CARTON (55513-730-21) / 1.7 mL in 1 VIAL, SINGLE-USE

61314- Sandoz Inc
- 61314-228- WYOST
  - 61314-228-94- 1 VIAL, SINGLE-DOSE in 1 CARTON (61314-228-94) / 1.7 mL in 1 VIAL, SINGLE-DOSE

61314- Sandoz Inc
- 61314-240- JUBBONTI
  - 61314-240-63- 1 SYRINGE in 1 CARTON (61314-240-63) / 1 mL in 1 SYRINGE

65219- Fresenius Kabi USA, LLC
- 65219-668- CONEXXENCE
  - 65219-668-01- 1 SYRINGE, PLASTIC in 1 CARTON (65219-668-01) / 1 mL in 1 SYRINGE, PLASTIC

65219- Fresenius Kabi USA, LLC
- 65219-670- BOMYNTRA
  - 65219-670-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-670-01) / 1.7 mL in 1 VIAL, SINGLE-DOSE

65219- Fresenius Kabi USA, LLC
- 65219-672- BOMYNTRA
  - 65219-672-01- 1 SYRINGE, PLASTIC in 1 CARTON (65219-672-01) / 1.7 mL in 1 SYRINGE, PLASTIC

71124- Samsung BioLogics Co. LTD
- 71124-0035-
  - 71124-0035-0- 1.7 mL in 1 VIAL, GLASS (71124-0035-0)

78206- Organon LLC
- 78206-193- BILDYOS
  78206-193-01- 1 SYRINGE, GLASS in 1 CARTON (78206-193-01) / 1 mL in 1 SYRINGE, GLASS

78206- Organon LLC
- 78206-195- Bilprevda
  - 78206-195-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (78206-195-01) / 1.7 mL in 1 VIAL, SINGLE-DOSE

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Indications ⬇