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denosumab (Rx)Brand and Other Names:Prolia, Xgeva

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

subcutaneous injection

  • Prolia: 60mg/mL (1mL prefilled syringe or 1mL vial)
  • Xgeva: 70mg/mL (120mg/1.7mL vial)
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Osteoporosis

Treatment of men and postmenopausal women with osteoporosis who are at high risk for fracture; treatment to increase bone mass in men at high risk for fracture who are receiving androgen deprivation therapy for nonmetastatic prostate cancer; treatment to increase bone mass in women at high risk for fracture who are receiving adjuvant aromatase inhibitor therapy for breast cancer

Prolia: 60 mg SC every 6 months

Supplement with calcium 1000 mg/day and vitamin D 400 IU/day

Aromatase Inhibitor Induced Bone Loss

Women with breast cancer: 60 mg (Prolia) SC every 6 months

Androgen Deprivation Induced Bone Loss

Men with prostate cancer: 60 mg (Prolia) SC every 6 months

Skeletal-Related Events

Prevention of skeletal-related events (SREs; eg, bone fractures and pain) in patients with bone metastases from solid tumors

Xgeva: 120 mg (1.7 mL) SC every 4 weeks

Giant Cell Tumor

Treatment of adults and skeletally mature adolescents with giant cell tumor of bone in whom surgical resection is impossible or is likely to result in severe morbidity

Xgeva: 120 mg SC every 4 weeks with additional 120 mg on days 8 and 15 during first month of therapy

Hypercalcemia of Malignancy

Indicated for treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy

Xgeva: 120 mg SC q4wk

Give 2 additional 120 mg doses during the first month of therapy on Days 8 and 15

Administration

Must be administered by healthcare professional

Administer SC in upper arm, upper thigh, or abdomen; do NOT administer intradermally, IM, or IV

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

Avoid vigorous shaking of vial/syringe

Storage

  • Store refrigerated at 2-8°C (36-46°F)
  • Once removed from refrigerator, preparation must be used within 14 days

Dosage Forms & Strengths

subcutaneous injection

  • Xgeva: 70mg/mL (120mg/1.7mL vial)
more...

Giant Cell Tumor

Treatment of skeletally mature adolescents with giant cell tumor of bone in whom surgical resection is impossible or is likely to result in severe morbidity

Xgeva: 120 mg SC every 4 weeks, with additional 120 mg on days 8 and 15 during first month of therapy

Administration

Must be administered by healthcare professional

Administer SC in upper arm, upper thigh, or abdomen; do NOT administer intradermally, IM, or IV

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

Avoid vigorous shaking of vial/syringe

Storage

  • Store refrigerated at 2-8°C (36-46°F)
  • Once removed from refrigerator, preparation must be used within 14 days
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Interactions

Interaction Checker

denosumab and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Back pain (34.7%)

            Extremity pain (11.7%)

            1-10%

            Musculoskeletal pain (7.6%)

            Hypercholesterolemia (7.2%)

            Cystitis (5.9%)

            Upper respiratory tract infection (4.9%)

            New malignancies (4.8%, compared with 4.3% in placebo group)

            Sciatica (4.6%)

            Nonfatal serious infection (4%)

            Bone pain (3.7%)

            Anemia (3.3%)

            Upper abdominal pain (3.3%)

            Rash (2.5%)

            Flatulence (2.2%)

            Osteonecrosis of jaw (2.2%)

            Pruritus (2.2%)

            Hypocalcemia (1.7%)

            <1%

            Serious infection of abdomen resulting in hospitalization (0.9%)

            Serious infection of urinary tract resulting in hospitalization (0.7%)

            Serious infection resulting in death (0.2%)

            Pancreatitis (0.2%)

            Serious infection of ear resulting in hospitalization (0.1%)

            Postmarketing Reports

            Hypocalcemia

            Marked elevation in PTH in patients with severe renal impairment or receiving dialysis

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            Warnings

            Contraindications

            History of systemic hypersensitivity, including anaphylaxis, facial swelling, and urticaria

            Preexisting hypocalcemia

            Cautions

            Denosumab is available as 2 distinct brands (Prolia and Xgeva) that have different dosage strengths for their respective indications; do not use concurrently

            Hypocalcemia may occur; monitor calcium levels during therapy, especially in the first weeks of initiating therapy, and adequately supplement all patients with calcium and vitamin D

            Severe symptomatic hypocalcemia has been reported; hypocalcemia may worsen, especially in patients who have CrCl <30 mL/min or are on hemodialysis

            Serious infections (including cellulitis) and dermatologic reactions (eg, dermatitis, rashes, eczema) have been reported

            Hypersensitivity (including anaphylaxis) has been reported

            Bone turnover suppression may increase risk for osteonecrosis of jaw; perform an oral examination prior to initiating therapy; osteonecrosis of the jaw, can occur spontaneously and is generally associated with tooth extraction and/or local infection with delayed healing; known risk factors include invasive dental procedures (e.g., tooth extraction, dental implants, boney surgery), diagnosis of cancer, concomitant therapies (e.g., chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders; risk of osteonecrosis of the jaw may increase with duration of therapy

            Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported

            Monitor patients for signs and symptoms of hypercalcemia and treat appropriately

            Atypical femoral fracture has been reported; evaluate patients with thigh or groin pain to rule out a femoral fracture

            Pancreatitis reported in clinical trials

            Pediatric use is not recommended; drug may impair bone growth in children with open growth plates and may inhibit eruption of dentition

            Latex allergy: If sensitive to latex, do not handle gray needle cap on single-use prefilled syringe, which contains dry natural rubber (a derivative of latex)

            Pregnancy; females of reproductive potential should be advised to use highly effective contraception during therapy and for at least 5 months after last dose (Prolia)

            Not indicated for the prevention of skeletal-related events in patients with multiple myeloma

            Use caution in patients with renal impairment <30 mL/min) or patients on dialysis; risk of hypocalcemia increased; dose adjustment not necessary when administered at 60 mg every 6 months; once monthly dosing not evaluated in patients with renal impairment

            Not for intravenous, intradermal, or intramuscular administration

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            Pregnancy & Lactation

            Pregnancy category: X; on basis of animal studies, may cause fetal harm when administered pregnant women; in utero, results in increased fetal loss, stillbirths, and postnatal mortality, including absent lymph nodes, abnormal bone growth, and decreased neonatal growth

            Women with reproductive potential must use highly effective contraception during therapy and for ≥5 months after last dose

            On basis of animal studies in pregnant mice lacking RANK/RANK ligand (RANKL) signaling pathway that have shown altered maturation of the maternal mammary gland, leading to impaired lactation post partum, maternal exposure during pregnancy may impair mammary gland development and lactation

            Lactation: Unknown whether drug is distributed in breast milk; caution is advised

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            Monoclonal antibody that specifically targets RANKL; binds to RANKL and inhibits its binding to RANK receptor, thereby preventing osteoclast formation; this results in decreased bone resorption and increases bone mass in osteoporosis; in solid tumors with bony metastases, RANKL inhibition decreases tumor-induced bone destruction and SREs

            Absorption

            Peak serum time: 10 days

            Peak plasma concentration: 6.75 mcg/mL

            AUC: 316 mcg•day/mL

            Elimination

            Duration: Markers of bone resorption return to baseline within 12 months of discontinuing therapy

            Half-life: 25.4 days (Prolia); 28 days (Xgeva)

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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