denosumab (Rx)

Brand and Other Names:Prolia, Xgeva
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

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

Osteoporosis

Prolia only

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

Indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture

60 mg SC q6months

Aromatase Inhibitor Induced Bone Loss

Prolia only

Indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer

60 mg SC q6months

Androgen Deprivation Induced Bone Loss

Prolia only

Indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer

60 mg SC q6months

Glucocorticoid Induced Osteoporosis

Prolia only

Indicated for glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing 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 q6months

Skeletal-Related Events

Xgeva only

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

120 mg SC q4Weeks

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

Giant Cell Tumor

Xgeva only

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

120 mg SC q4Weeks

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

Hypercalcemia of Malignancy

Xgeva only

Indicated for treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy

120 mg SC q4Weeks

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

Dosage Modifications

Hepatic impairment: Safety and efficacy not evaluated

Renal impairment

  • Mild-to-severe: No dosage adjustment necessary
  • Severe (CrCl < 30 mL/min) or receiving dialysis: In clinical trial, patients were at greater risk of developing hypocalcemia (see Cautions)

Dosing Considerations

Prolia

  • Patients receiving Prolia should not receive Xgeva (see Cautions)
  • All patients should receive calcium 1000 mg/day and at least 400 IU vitamin D daily

Dosage Forms & Strengths

solution for injection

  • Xgeva: 70mg/mL (120mg/1.7mL vial)

Giant Cell Tumor

Xgeva only

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

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

<13 years or <45kg: Safety and efficacy not established

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

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Interactions

Interaction Checker

and denosumab

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    Interactions Found

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      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (0)

              Serious - Use Alternative (3)

              • influenza virus vaccine quadrivalent, adjuvanted

                denosumab decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • influenza virus vaccine trivalent, adjuvanted

                denosumab decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • palifermin

                palifermin increases toxicity of denosumab by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

              Monitor Closely (108)

              • abatacept

                abatacept, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • adalimumab

                adalimumab, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • alefacept

                alefacept, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems.

              • alemtuzumab

                alemtuzumab, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • anakinra

                anakinra, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • azacitidine

                azacitidine, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • azathioprine

                azathioprine, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • basiliximab

                basiliximab, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • beclomethasone, inhaled

                denosumab increases toxicity of beclomethasone, inhaled by immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • belatacept

                belatacept and denosumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • belimumab

                belimumab, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • betamethasone

                betamethasone, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • budesonide

                budesonide, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • busulfan

                busulfan, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • cabazitaxel

                cabazitaxel, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • canakinumab

                canakinumab, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • capecitabine

                capecitabine, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • carboplatin

                carboplatin, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • carmustine

                carmustine, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • certolizumab pegol

                certolizumab pegol, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • chlorambucil

                chlorambucil, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • cholera vaccine

                denosumab decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

              • cisplatin

                cisplatin, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • cladribine

                cladribine, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • cortisone

                cortisone, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • cyclophosphamide

                cyclophosphamide, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • cyclosporine

                cyclosporine, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • cytarabine

                cytarabine, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • dacarbazine

                dacarbazine, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • dactinomycin

                dactinomycin, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • daunorubicin

                daunorubicin, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • dengue vaccine

                denosumab decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

              • dexamethasone

                dexamethasone, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • docetaxel

                docetaxel, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • doxorubicin

                doxorubicin, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • doxorubicin liposomal

                doxorubicin liposomal, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • epirubicin

                epirubicin, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • etanercept

                etanercept, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • etoposide

                etoposide, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • everolimus

                everolimus, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • fingolimod

                fingolimod, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • floxuridine

                floxuridine, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • fludarabine

                fludarabine, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • fludrocortisone

                fludrocortisone, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • fluorouracil

                fluorouracil, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • gemcitabine

                gemcitabine, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • glatiramer

                glatiramer, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • golimumab

                golimumab, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • hydrocortisone

                hydrocortisone, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • hydroxychloroquine sulfate

                hydroxychloroquine sulfate, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • hydroxyurea

                hydroxyurea, denosumab. Other (see comment). Use Caution/Monitor. Comment: Combination therapy may lead to increased risk of infection.

              • ibritumomab tiuxetan

                ibritumomab tiuxetan, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • idarubicin

                idarubicin, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • ifosfamide

                ifosfamide, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

                ifosfamide, denosumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • imatinib

                imatinib, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • infliximab

                infliximab, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • irinotecan

                irinotecan, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • irinotecan liposomal

                irinotecan liposomal, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • leflunomide

                leflunomide, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • lenalidomide

                lenalidomide, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • lomustine

                lomustine, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • mechlorethamine

                mechlorethamine, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

                mechlorethamine, denosumab. immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • melphalan

                melphalan, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

                melphalan, denosumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • meningococcal group B vaccine

                denosumab decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.

              • mercaptopurine

                mercaptopurine, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • methotrexate

                methotrexate, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • methylprednisolone

                methylprednisolone, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • mitomycin

                mitomycin, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • mitoxantrone

                mitoxantrone, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • muromonab CD3

                muromonab CD3, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • mycophenolate

                mycophenolate, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • natalizumab

                natalizumab, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • nelarabine

                nelarabine, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • ofatumumab

                ofatumumab, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • ofatumumab SC

                ofatumumab SC, denosumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

              • olaparib

                denosumab and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.

              • oxaliplatin

                oxaliplatin, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • paclitaxel

                paclitaxel, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • paclitaxel protein bound

                paclitaxel protein bound, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • pazopanib

                pazopanib, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • pemetrexed

                pemetrexed, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • pentostatin

                pentostatin, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • ponesimod

                ponesimod and denosumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • pralatrexate

                pralatrexate, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • prednisolone

                prednisolone, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • prednisone

                prednisone, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • procarbazine

                procarbazine, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

                procarbazine, denosumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • rilonacept

                rilonacept, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • rituximab

                rituximab, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • rituximab-hyaluronidase

                rituximab-hyaluronidase, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • siponimod

                siponimod and denosumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • sirolimus

                sirolimus, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • sorafenib

                sorafenib, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • sunitinib

                sunitinib, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • tacrolimus

                tacrolimus, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • temozolomide

                temozolomide, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • temsirolimus

                temsirolimus, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • teniposide

                teniposide, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • thiotepa

                thiotepa, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • tocilizumab

                tocilizumab, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • topotecan

                topotecan, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • trastuzumab deruxtecan

                trastuzumab deruxtecan, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • triamcinolone acetonide injectable suspension

                triamcinolone acetonide injectable suspension, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • ustekinumab

                ustekinumab, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • vinblastine

                vinblastine, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • vincristine

                vincristine, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • vincristine liposomal

                vincristine liposomal, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • vinorelbine

                vinorelbine, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              Minor (0)

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                Adverse Effects

                >10% (Prolia)

                Back pain (34.7%)

                Extremity pain (11.7%)

                >10% (Xgeva)

                Fatigue/asthenia (45%)

                Hypophosphatemia (32%)

                Nausea (31%)

                Dyspnea (21%)

                Diarrhea (20%)

                Hypocalcemia (18%)

                Cough (15%)

                Headache (13%)

                1-10% (Prolia)

                Musculoskeletal pain (7.6%)

                Cystitis (5.9%)

                Vertigo (5%)

                Upper respiratory tract infection (4.9%)

                Peripheral edema (4.9%)

                Sciatica (4.6%)

                Pneumonia (3.9%)

                Bone pain (3.7%)

                Upper abdominal pain (3.3%)

                Anemia (3.3%)

                Insomnia (3.2%)

                Myalgia (2.9%)

                Angina pectoris (2.6%)

                Rash (2.5%)

                Pharyngitis (2.3%)

                Asthenia (2.3%)

                Flatulence (2.2%)

                Pruritus (2.2%)

                Spinal osteoarthritis (2.1%)

                Gastroesophageal reflux disease (2.1%)

                Atrial fibrillation (2%)

                Herpes zoster (2%)

                <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

                Prolia

                • Drug-related hypersensitivity reactions: Anaphylaxis, rash, urticaria, facial swelling, and erythema
                • Severe symptomatic hypocalcemia
                • Musculoskeletal pain, including severe cases
                • Parathyroid Hormone (PTH): Marked elevation in serum PTH in patients with severe renal impairment (CrCl <30 mL/min) or receiving dialysis
                • Multiple vertebral fractures following discontinuation of Prolia
                • Alopecia
                • Vasculitis (eg, ANCA positive vasculitis, leukocytoclastic vasculitis)
                • Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome

                Xgeva

                • Hypocalcemia: Severe symptomatic hypocalcemia, including fatal cases
                • Hypercalcemia following treatment discontinuation in patients with giant cell tumor of bone and in patients with growing skeletons
                • Hypersensitivity, including anaphylactic reactions
                • Musculoskeletal pain, including severe musculoskeletal pain
                • Positive rechallenge has been reported
                • Lichenoid drug eruptions (e.g., lichen planus-like reactions)
                • Atypical subtrochanteric and diaphyseal fracture
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                Warnings

                Contraindications

                Hypersensitivity

                Hypocalcemia

                Pregnancy (Prolia only)

                Cautions

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

                Serious infections (including cellulitis) and dermatologic reactions (eg, dermatitis, rashes, eczema) have been reported; advise patients to seek prompt medical attention if they develop signs or symptoms of infection, including cellulitis; consider discontinuing therapy if severe symptoms develop

                Hypersensitivity (including anaphylaxis) has been reported; symptoms have included hypotension, dyspnea, throat tightness, facial and upper airway edema, pruritus, and urticaria

                Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported; discontinue use if severe symptoms develop

                Atypical femoral fracture reported; risk increased with longer duration of treatment; events have occurred during and after treatment discontinued; evaluate patients with thigh or groin pain to rule out a femoral fracture

                Following discontinuation of denosumab, fracture risk increases, including risk of multiple vertebral fractures

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

                Thearpy results in significant suppression of bone turnover; cessation of therapy results in increased bone turnover above pretreatment values 9 months after last dose; bone turnover then returns to pretreatment values 24 months after last dose

                Significant suppression of bone remodeling as evidenced by markers of bone turnover and bone histomorphometry; long-term consequences of the degree of suppression of bone remodeling observed may contribute to adverse outcomes such as osteonecrosis of the jaw, atypical fractures, and delayed fracture healing

                Osteonecrosis of the Jaw

                • Bone turnover suppression may increase risk for osteonecrosis of jaw; perform an oral examination prior to initiating therapy; osteonecrosis of the jaw (ONJ), can occur spontaneously and is generally associated with tooth extraction and/or local infection with delayed healing; known risk factors include invasive dental procedures (eg, tooth extraction, dental implants, bone surgery), diagnosis of cancer, concomitant therapies (eg, chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and comorbid disorders; risk of ONJ may increase with duration of therapy
                • Good oral hygiene practices should be maintained during treatment; concomitant administration of drugs associated with ONJ may increase risk of developing ONJ; risk of ONJ may increase with duration of exposure to treatment; for patients requiring invasive dental procedures, clinical judgment of treating physician and/or oral surgeon should guide management plan of each patient based on individual benefit-risk assessment
                • Patients who are suspected of having or who develop ONJ while on therapy should receive care by a dentist or an oral surgeon; in these patients, extensive dental surgery to treat ONJ may exacerbate condition; consider discontinuing therapy based on individual benefit-risk assessment

                Xgeva only

                • Clinically significant hypercalcemia requiring hospitalization and complicated by acute renal injury reported in patients with giant cell tumor of bone and patients with growing skeletons; hypercalcemia reported within first year after treatment discontinuation; after treatment is discontinued, monitor for signs and symptoms of hypercalcemia, assess serum calcium periodically, reevaluate patient’s calcium and vitamin D supplementation requirements and manage patients as clinically appropriate
                • Based on data from animal studies and its mechanism of action, Xgeva can cause fetal harm when administered to a pregnant woman (see Pregnancy)

                Prolia only

                • Patients on concomitant immunosuppressant agents or with impaired immune systems may be at increased risk for serious infections; consider benefit-risk profile in such patients before treating with Prolia; in patients who develop serious infections while on therapy, prescribers should assess need for continued therapy
                • Atypical low energy or low trauma fractures of the shaft reported in patients receiving therapy; these fractures can occur anywhere in femoral shaft from just below lesser trochanter to above supracondylar flare and are transverse or short oblique in orientation without evidence of comminution; causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with antiresorptive agents
                • In postmarketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported; time to onset of symptoms varied from one day to several months after starting Prolia; consider discontinuing use if severe symptoms develop
                • In a large clinical trial which included women with postmenopausal osteoporosis, epidermal and dermal adverse events (eg, dermatitis, eczema, and rashes); most of these events were not specific to the injection

                Hypocalcemia

                • 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
                • Hypocalcemia may be exacerbated by therapy with Prolia; correct pre-existing hypocalcemia prior to initiating therapy; in patients predisposed to hypocalcemia and disturbances of mineral metabolism (e.g. history of hypoparathyroidism, thyroid surgery, parathyroid surgery, malabsorption syndromes, excision of small intestine, severe renal impairment [CrCl <30 mL/min] or receiving dialysis), clinical monitor calcium and mineral levels (phosphorus and magnesium) within 14 days of injection; in some postmarketing cases, hypocalcemia persisted for weeks or months and required frequent monitoring and IV and/or oral calcium replacement, with or without vitamin D
                • Hypocalcemia is a significant risk in patients with severe renal impairment [CrCl <30 mL/min] or receiving dialysis; dose adjustment not necessary when administered at 60 mg every 6 months; once monthly dosing not evaluated in patients with renal impairment; these patients may also develop marked elevations of serum parathyroid hormone (PTH)
                • Concomitant use of calcimimetic drugs may worsen hypocalcemia risk and serum calcium should be closely monitored; Instruct all patients with severe renal impairment, including those receiving dialysis, about symptoms of hypocalcemia and importance of maintaining calcium levels with adequate calcium and vitamin D supplementation
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                Pregnancy & Lactation

                Pregnancy

                Prolia: Contraindicated

                Xgeva

                • Based on findings in animals and its mechanism of action, denosumab can cause fetal harm when administered to a pregnant woman
                • In utero exposure in cynomolgus monkeys dosed monthly with denosumab throughout pregnancy at a dose 50-fold higher than the recommended human dose based on body weight resulted in increased fetal loss, stillbirths, and postnatal mortality, and absent lymph nodes, abnormal bone growth, and decreased neonatal growth
                • Present at low concentrations (~2% of serum exposure) in seminal fluid of male subjects receiving therapy; following vaginal intercourse, maximum amount of denosumab delivered to a female partner would result in exposures ~11,000 times lower than the prescribed 60 mg subcutaneous dose; male condom use not necessary as it is unlikely that a female partner or fetus would be exposed to pharmacologically relevant concentrations of denosumab via seminal fluid

                Pregnancy testing

                • Prolia and Xgeva
                • Verify pregnancy status of females of reproductive potential prior to initiating treatment

                Contraception

                • Prolia and Xgeva
                • Females: Advise females of reproductive potential to use effective contraception during therapy, and for at least 5 months after the last dose of denosumab
                • Males: Denosumab was present at low concentrations (~2% of serum exposure) in the seminal fluid of male subjects; condom use would not be necessary as it is unlikely that a female partner or fetus would be exposed to pharmacologically relevant concentrations of denosumab via seminal fluid

                Lactation

                There is no information regarding presence of denosumab in human milk, effects on breastfed infant, or effects on milk production;

                Detected in maternal milk of cynomolgus monkeys up to 1 month after last dose (≤0.5% milk: serum ratio) and maternal mammary gland development was normal, with no impaired lactation; however, pregnant RANKL knockout mice showed altered maturation of maternal mammary gland, leading to impaired lactation

                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.

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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

                Prolia

                • Peak serum time: 10 days
                • Peak plasma concentration: 6.75 mcg/mL
                • AUC: 316 mcg•day/mL

                Xgeva

                • Bioavailability: 62%
                • Steady was achieved by 6 months with multiple SC doses of 120 mg q4Weeks

                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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                Administration

                SC Preparation

                Visually inspect for particulate matter and discoloration prior to administration

                Solution should appear clear, colorless-to-pale yellow solution that may contain trace amounts of translucent to white proteinaceous particles

                Do not use if discolored or cloudy, or if the solution contains many particles or foreign particulate matter

                Prior to administration, remove from refrigerator bring 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 sensitive to latex should not handle the grey needle cap on the single-use prefilled syringe, which contains dry natural rubber (a derivative of latex)

                SC Administration

                SC administration only

                Must be administered by healthcare professional

                Use a 27-gauge needle to withdraw and inject the entire contents of the vial; do not reenter the vial

                Do not administer intradermally, IM, or IV

                Administer SC in upper arm, upper thigh, or abdomen

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

                Avoid vigorous shaking of vial/syringe

                Discard vial after single-dose or entry

                Storage

                Xgeva and Prolia

                • Refrigerate at 2-8°C (36-46°F); do not freeze
                • Once removed from refrigerator, preparation must be used within 14 days and not exposed to temperatures above 25°C (77°F)
                • Protect from direct light and heat
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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Xgeva subcutaneous
                -
                120 mg/1.7 mL (70 mg/mL) vial
                Prolia subcutaneous
                -
                60 mg/mL solution

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                denosumab subcutaneous

                DENOSUMAB - INJECTION

                (den-OH-sue-mab)

                COMMON BRAND NAME(S): Prolia

                USES: Denosumab is used to treat bone loss (osteoporosis) in people who have a high risk of getting fractures. Osteoporosis causes bones to become thinner and break more easily. Your chance of developing osteoporosis increases after menopause (in women), as you age, if someone in your family has osteoporosis, or if you take certain medications (such as prednisone) for long periods.This medication works by slowing bone loss to help maintain strong bones and reduce the risk of broken bones (fractures). Denosumab belongs to a class of drugs called monoclonal antibodies. It prevents certain cells in the body (osteoclasts) from breaking down bone.

                HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using denosumab and before each injection. If you have any questions, ask your doctor or pharmacist.Your healthcare provider will inject this medication under your skin in the upper arm, upper thigh, or abdomen as directed by your doctor, usually every 6 months.Take calcium and vitamin D as directed by your doctor, usually 1000 milligrams of calcium and at least 400 IU of vitamin D daily.Use this medication regularly in order to get the most benefit from it. Keep receiving this medication even if you feel well. Most people with osteoporosis do not have symptoms. Remember to receive it every 6 months. It may help to mark your calendar with a reminder.Continue to take other medications for your condition as directed by your doctor.

                SIDE EFFECTS: See also Precautions section.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Denosumab may cause low calcium levels, especially if you have kidney problems. Take calcium and vitamin D as directed by your doctor. (See also How to Use section.) Your doctor will order calcium blood tests before your first injection and during treatment. Tell your doctor right away if you have any symptoms of low calcium such as: muscle spasms/cramps, mental/mood changes (such as irritability or confusion), numbness/tingling (especially around lips/mouth or in fingers/toes), fast/irregular heartbeat, severe dizziness/fainting, seizures.Denosumab can affect your immune system. You may be more likely to get a serious infection, such as a skin, ear, stomach/gut, or bladder infection. Tell your doctor right away if you develop any signs of infection, such as: fever/chills, red/swollen/tender/warm skin (with or without pus), severe abdominal pain, ear pain/discharge, trouble hearing, frequent/painful/burning urination, pink/bloody urine.Tell your doctor right away if you have any serious side effects, including: jaw pain, new or unusual thigh/hip/groin pain, bone/joint/muscle pain.After your treatment with denosumab is stopped, you may be at increased risk for bone fracture, including bones in your spine. Do not stop using this medication without first talking with your doctor. If your treatment is stopped, talk with your doctor about other medicines you can take.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.Denosumab can cause skin problems such as dryness, peeling, redness, itching, small bumps/patches, or blisters. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Get medical help right away if you develop any rash or if any of these symptoms persist or worsen.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                PRECAUTIONS: Before using denosumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood calcium levels (hypocalcemia), thyroid/parathyroid problems/surgery, stomach/intestinal problems (such as malabsorption, surgery), kidney problems, recent or planned dental surgery/tooth removal.Some people using denosumab may have serious jawbone problems. Your doctor should check your mouth before you start this medication. Tell your dentist that you are using this medication before you have any dental work done. To help prevent jawbone problems, have regular dental exams and learn how to keep your teeth and gums healthy. If you have jaw pain, tell your doctor and dentist right away.Before having any surgery (especially dental procedures), tell your doctor and dentist about this medication and all other products you use (including prescription drugs, nonprescription drugs, and herbal products).Denosumab is not recommended for use in children. It may slow down a child's growth and affect tooth development.This medication must not be used during pregnancy. It may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. It is important to prevent pregnancy while using this medication and for at least 5 months after treatment. Females must use reliable forms of birth control during treatment and for at least 5 months after treatment. If you become pregnant or think you may be pregnant, tell your doctor right away.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

                OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                NOTES: Do not share this medication with others.Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. Since you may also need to take calcium and vitamin D supplements and make other lifestyle changes, consult your doctor for specific advice.Laboratory and/or medical tests (such as bone density tests, calcium/phosphorus/magnesium levels, kidney function) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.Do not take this medication with any other product that contains denosumab.

                MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

                STORAGE: This medication is given in a hospital or clinic or doctor's office and usually will not be stored at home.If you are picking up this medication at the pharmacy to bring to your medical appointment, store in the refrigerator between 36-46 degrees F (2-8 degrees C) until the day of your appointment. Keep all medications away from children and pets.If you have any questions about storage, ask your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your medication.

                Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                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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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.