Prolia Special Precautions

Adequate intake of calcium and vitamin D is important in all patients.
Hypocalcaemia must be corrected prior to initiating therapy with denosumab. In patients predisposed to hypocalcaemia, clinical monitoring of calcium levels is recommended during treatment, especially in the first few weeks of initiating therapy (see Adverse Reactions).
In clinical trials in women with postmenopausal osteoporosis, skin infections leading to hospitalisation were reported more frequently in the denosumab (0.4%) versus the placebo (0.1%) groups (see Adverse Reactions). These cases were predominantly cellulitis. The overall incidence of skin infections was similar between the placebo and denosumab groups. Patients should be advised to seek prompt medical attention if they develop signs or symptoms of cellulitis.
Cases of osteonecrosis of the jaw (ONJ) were reported predominantly in patients with advanced cancer receiving 120 mg every 4 weeks. ONJ was reported rarely in patients with osteoporosis receiving 60 mg every 6 months (see Adverse Reactions).
Poor oral hygiene and invasive dental procedures (e.g. tooth extraction) were risk factors for ONJ in patients receiving PROLIA in clinical trials. The risk of ONJ may increase with duration of exposure to PROLIA.
It is important to evaluate patients for risk factors for ONJ before starting treatment. If risk factors are identified, a dental examination with appropriate preventive dentistry is recommended prior to treatment with PROLIA. Good oral hygiene practices should be maintained during treatment with PROLIA.
Avoid invasive dental procedures during treatment with PROLIA. For patients in whom invasive dental procedures cannot be avoided, the clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
Patients who are suspected of having or who develop ONJ while on PROLIA should receive care by a dentist or an oral surgeon. In patients who develop ONJ during treatment with PROLIA, a temporary interruption of treatment should be considered based on individual risk/benefit assessment until the condition resolves.
Atypical femoral fractures have been reported in patients receiving PROLIA. 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 characterise these events. Atypical femoral fractures have also been reported in patients with certain comorbid conditions (e.g. vitamin D deficiency, rheumatoid arthritis, hypophosphatasia) and with use of certain pharmaceutical agents (e.g. bisphosphonates, glucocorticoids, proton pump inhibitors). These events have also occurred without antiresorptive therapy. During PROLIA treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Patients presenting with such symptoms should be evaluated for an incomplete femoral fracture and the contralateral femur should also be examined.
PROLIA contains the same active ingredient (denosumab) found in XGEVA. Patients receiving PROLIA should not receive XGEVA.
Multiple vertebral fractures (MVF) may occur following discontinuation of treatment with PROLIA, particularly in patients with a history of vertebral fracture.
Advise patients not to interrupt PROLIA therapy without their physician's advice. Evaluate the individual benefit/risk before discontinuing treatment with PROLIA.
If PROLIA treatment is discontinued, consider transitioning to an alternative antiresorptive therapy.
Effects on ability to drive and use machine: No studies on the effect on the ability to drive or use heavy machinery have been performed in patients receiving denosumab.
Use in Children: Hypercalcemia in Pediatric Patients with Osteogenesis Imperfecta: Prolia is not indicated for use in pediatric patients. In clinical trials, hypercalcemia has been reported in pediatric patients with osteogenesis imperfecta treated with denosumab. Some cases required hospitalization.
Denosumab is not indicated for use in pediatric patients.
In clinical trials, hypercalcemia has been reported very commonly in pediatric patients with osteogenesis imperfecta treated with denosumab. Some cases required hospitalization and were complicated by acute renal injury.