Prolia

Prolia Special Precautions

denosumab

Manufacturer:

Amgen

Distributor:

Zuellig
Full Prescribing Info
Special Precautions
Adequate intake of calcium and vitamin D is important in all patients receiving Denosumab (Prolia).
Hypocalcaemia must be corrected by adequate intake of calcium and vitamin D before initiating therapy. In patients predisposed to hypocalcaemia, monitoring of calcium levels is recommended during treatment, especially in the first few weeks (see Adverse Reactions).
Patients receiving Denosumab (Prolia) may develop skin infections (predominantly cellulitis) leading to hospitalization. These events were reported more frequently in the denosumab (0.4%) versus the placebo (0.1%) groups (see Adverse Reactions). 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 (eg, tooth extraction) were risk factors for ONJ in patients receiving PROLIA in clinical trials.
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.
Denosumab (Prolia) contains the same active ingredient found in Xgeva. Patients receiving Denosumab (Prolia) should not receive Xgeva.
Atypical femoral fractures have been reported in patients receiving Denosumab (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 Denosumab (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.
Effects on the Ability to Drive and Use Machines: No studies on the effect on the ability to drive or use heavy machinery have been performed in patients receiving Denosumab.
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