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JUBBONTI is a brand name for Denosumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Indications have been granted on the basis of similarity between JUBBONTI and the reference biologic drug PROLIA®. JUBBONTI (denosumab injection) is indicated: • Postmenopausal Osteoporosis for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Jubbonti is intended for use under the guidance and supervision of physicians who have fully familiarized themselves with the efficacy/safety profile of Jubbonti. After an initial training in proper subcutaneous injection technique, patients may self -inject Jubbonti if a physician determines that is appropriate and with medical follow-up as necessary.
Patients should be informed that serious hypersensitivity reactions including anaphylaxis have been reported with denosumab injections. Pregnancy must be ruled out prior to administration of Jubbonti. Perform pregnancy testing in all women of reproductive potential prior to administration of Jubbonti.
Based on findings in animals, denosumab may cause fetal harm when administered to pregnant women (see 2 CONTRAINDICATIONS, 7 WARNINGS AND PRECAUTIONS and 16 NON-CLINICAL TOXICOLOGY, Animal Toxicology). Patients must be adequately supplemented with calcium and vitamin D at the recommended dosesa.
2 Recommended Dose and Dosage Adjustment Health Canada has not authorized an indication for pediatric use (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Pediatrics). The recommended dose of Jubbonti (denosumab) is a single SC injection of 60 mg, once every 6 months.
4 Administration Administration of Jubbonti should be performed by an individual who has been adequately trained in injection techniques. The prefilled syringe with safety guard is not made with natural rubber latex. Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit.
Jubbonti is a clear, colourless to slightly yellowish or slightly brownish solution. Do not use if the solution is cloudy or if the solution contains visible particles or foreign particulate matter. Prior to administration, Jubbonti may be allowed to reach room temperature (up to 25oC) in the original carton.
This generally takes 15 to 30 minutes. Administer Jubbonti via SC injection in the upper arm, the upper thigh, or the abdomen. 5 Missed Dose If a dose is missed, it should be given as soon as convenient. The next dose should be scheduled 6 months from the date of the previous injection.
, Postmarket Adverse Drug Reactions). • Hypocalcemia (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism, Hypocalcemia). • Female patients who are pregnant or who are trying to become pregnant. Jubbonti 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. In utero denosumab exposure in cynomolgus monkeys resulted in increased fetal loss, stillbirths, and postnatal mortality, along with evidence of absent lymph nodes, abnormal bone growth and decreased neonatal growth.
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women).
1 Dosing Considerations Jubbonti is intended for use under the guidance and supervision of physicians who have fully familiarized themselves with the efficacy/safety profile of Jubbonti. After an initial training in proper subcutaneous injection technique, patients may self -inject Jubbonti if a physician determines that is appropriate and with medical follow-up as necessary.
Patients should be informed that serious hypersensitivity reactions including anaphylaxis have been reported with denosumab injections. Pregnancy must be ruled out prior to administration of Jubbonti. Perform pregnancy testing in all women of reproductive potential prior to administration of Jubbonti.
Based on findings in animals, denosumab may cause fetal harm when administered to pregnant women (see 2 CONTRAINDICATIONS, 7 WARNINGS AND PRECAUTIONS and 16 NON-CLINICAL TOXICOLOGY, Animal Toxicology). Patients must be adequately supplemented with calcium and vitamin D at the recommended dosesa.
, Special Populations, Pediatrics). 2 Geriatrics Geriatrics (≥ 65 years of age): The majority of patients treated with denosumab in the postmenopausal osteoporosis (PMO) clinical trial were ≥ 65 years old (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Geriatrics).
• Of the patients in the osteoporosis study in men, 133 patients (55%) were ≥ 65 years old, while 39 patients (16%) were ≥ 75 years old. • In the clinical trial of men with bone loss associated with ADT for nonmetastatic prostate cancer, 1364 patients (93%) were ≥ 65 years old.
• In a clinical trial of women with bone loss associated with adjuvant AI therapy for breast cancer, 76 patients (30%) were ≥ 65 years old. 7%) were ≥ 65 years old. 2 CONTRAINDICATIONS • Jubbonti is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Anaphylactic reactions have been reported (see 7 WARNINGS AND PRECAUTIONS, Hypersensitivity and
• Jubbonti is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Anaphylactic reactions have been reported (see 7 WARNINGS AND PRECAUTIONS, Hypersensitivity and 8 ADVERSE REACTIONS, Postmarket Adverse Drug Reactions). • Hypocalcemia (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism, Hypocalcemia).
• Female patients who are pregnant or who are trying to become pregnant. Jubbonti 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.
In utero denosumab exposure in cynomolgus monkeys resulted in increased fetal loss, stillbirths, and postnatal mortality, along with evidence of absent lymph nodes, abnormal bone growth and decreased neonatal growth. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women).
JUBBONTI (denosumab injection) Page 6 of 82
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2 Recommended Dose and Dosage Adjustment Health Canada has not authorized an indication for pediatric use (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Pediatrics). The recommended dose of Jubbonti (denosumab) is a single SC injection of 60 mg, once every 6 months.
4 Administration Administration of Jubbonti should be performed by an individual who has been adequately trained in injection techniques. The prefilled syringe with safety guard is not made with natural rubber latex. Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit.
Jubbonti is a clear, colourless to slightly yellowish or slightly brownish solution. Do not use if the solution is cloudy or if the solution contains visible particles or foreign particulate matter. Prior to administration, Jubbonti may be allowed to reach room temperature (up to 25oC) in the original carton.
This generally takes 15 to 30 minutes. Administer Jubbonti via SC injection in the upper arm, the upper thigh, or the abdomen. 5 Missed Dose If a dose is missed, it should be given as soon as convenient. The next dose should be scheduled 6 months from the date of the previous injection.
5 OVERDOSAGE There is no experience with overdosage with denosumab. For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING To help ensure the traceability of biologic products, including biosimilars, health professionals should record both the brand name and the non-proprietary (active ingredient) name as well as other product-specific identifiers such as the Drug Identification Number (DIN) and the batch/lot number of the product supplied.
2. Jubbonti is supplied in a single use prefilled syringe with a 29 gauge ½ inch needle with a BD UltraSafe PlusTM** Passive Safety Guard. The prefilled syringe with safety guard is not made with natural rubber latex. 2. Jubbonti is supplied in a dispensing pack containing one prefilled syringe.
Description Jubbonti is a genetically engineered human IgG2 kappa type monoclonal antibody that targets the transmembrane or soluble receptor activator of nuclear factor kappa-B ligand (RANKL). The antibody is produced using recombinant DNA technology in a Chinese Hamster Ovary mammalian cell expression system.
Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Subcutaneous Solution for injection / 60 mg denosumab in 1 mL solution in a single use prefilled syringe (PFS) Acetic acid, hydrochloric acid, polysorbate 20, sodium hydroxide, sorbitol, water for injection JUBBONTI (denosumab injection) Page 8 of 82 7 WARNINGS AND PRECAUTIONS General Adequate intake of calcium and vitamin D is important in all patients.
Patients being treated with Jubbonti should not be treated concomitantly with other denosumab-containing medicinal products. Atypical Femoral Fractures Atypical femoral fractures have been reported in patients receiving denosumab. Atypical femoral fractures may occur with little or no trauma in the subtrochanteric and diaphyseal regions of the femur and may be bilateral.
Specific radiographic findings characterize these events. Atypical femoral fractures have also been reported in patients with certain comorbid conditions (eg, vitamin D deficiency, rheumatoid arthritis, hypophosphatasia) and with use of certain pharmaceutical agents (eg, bisphosphonates, glucocorticoids, proton […]