Denosumab-Bbdz is a medicine sold in the U.S. under 2 brand and generic names, for postmenopausal osteoporosis and osteoporotic fractures. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Jubbonti (application BLA761362). Other denosumab-bbdz products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Pregnancy must be ruled out prior to administration of Jubbonti. ( 2.1 ) • Before initiating Jubbonti in patients with advanced chronic kidney disease, including dialysis patients, evaluate for the presence of chronic kidney disease mineral and bone disorder with intact parathyroid hormone, serum calcium, 25(OH) vitamin D, and 1,25 (OH) 2 vitamin D. ( 2.2 , 5.1 , 8.6 ) • Jubbonti should be administered by a healthcare provider. ( 2.3 ) • Administer 60 mg every 6 months as a subcutaneous injection in the upper arm, upper thigh, or abdomen. ( 2.3 ) • Instruct patients to take calcium 1000 mg daily and at least 400 IU vitamin D daily. ( 2.3 ) 2.1 Pregnancy Testing Prior to Initiation of Jubbonti Pregnancy must be ruled out prior to administration of Jubbonti. Perform pregnancy testing in all females of reproductive potential prior to administration of Jubbonti. Based on findings in animals, denosumab products can cause fetal harm when administered to pregnant women [see Use in Specific Populations ( 8.1, 8.3) ] . 2.2 Laboratory Testing in Patients with Advanced Chronic Kidney Disease Prior to Initiation of Jubbonti In patients with advanced chronic kidney disease [i.e., estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m 2 ], including dialysis-dependent patients, evaluate for the presence of chronic kidney disease mineral and bone…
The following serious adverse reactions are discussed below and also elsewhere in the labeling: • Severe Hypocalcemia and Mineral Metabolism Changes [see Warnings and Precautions ( 5.1 )] • Hypersensitivity [see Warnings and Precautions ( 5.3 )] • Osteonecrosis of the Jaw [see Warnings and Precautions ( 5.4 )] • Atypical Subtrochanteric and Diaphyseal Femoral Fractures [see Warnings and Precautions ( 5.5 )] • Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation [see Warnings and Precautions ( 5.6 )] • Serious Infections [see Warnings and Precautions ( 5.7 )] • Dermatologic Adverse Reactions [see Warnings and Precautions ( 5.8 )] The most common adverse reactions reported with denosumab products in patients with postmenopausal osteoporosis are back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis. The most common adverse reactions reported with denosumab products in men with osteoporosis are back pain, arthralgia, and nasopharyngitis. The most common adverse reactions reported with denosumab products in patients with glucocorticoid-induced osteoporosis are back pain, hypertension, bronchitis, and headache. The most common (per patient incidence ≥ 10%) adverse reactions reported with denosumab products in patients with bone loss receiving androgen deprivation therapy for prostate cancer or adjuvant aromatase inhibitor therapy…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
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| 1 | 64/100 | Prescription | Injectable | — | — | View → | |
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Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Jubbonti is contraindicated in: • Patients with hypocalcemia: Pre-existing hypocalcemia must be corrected prior to initiating therapy with Jubbonti [see Warnings and Precautions ( 5.1 )] . • Pregnant women: Denosumab products may cause fetal harm when administered to a pregnant woman. In women of reproductive potential, pregnancy testing should be performed prior to initiating treatment with Jubbonti [see Use in Specific Populations ( 8.1 )] . • Patients with hypersensitivity to denosumab products: Jubbonti is contraindicated in patients with a history of systemic hypersensitivity to any component of the product. Reactions have included anaphylaxis, facial swelling, and urticaria [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.2 )] . • Hypocalcemia. ( 4 , 5.1 ) • Pregnancy. ( 4 , 8.1 ) • Known hypersensitivity to denosumab products. ( 4 , 5.3 )
| 64/100 |
| Prescription |
| Injectable |
| — |
| — |
| View → |