From the Guidelines
Prolia (denosumab) can cause several side effects, including jaw bone problems, unusual thigh bone fractures, and low calcium levels, and patients should be aware of these potential risks and take steps to mitigate them, such as maintaining good dental hygiene and ensuring adequate calcium and vitamin D intake 1.
Common Side Effects
- Back pain
- Arm and leg pain
- High cholesterol
- Musculoskeletal pain
- Bladder infections
Serious Side Effects
- Jaw bone problems (osteonecrosis)
- Unusual thigh bone fractures
- Serious infections
- Skin problems
- Severe bone/joint/muscle pain
- Low calcium levels
Allergic Reactions
- Rash
- Itching
- Swelling
Mechanism and Prevention
Prolia works by blocking a protein called RANKL, which helps prevent bone breakdown, but this mechanism can also lead to these side effects. Patients should maintain good dental hygiene while on Prolia due to the risk of jaw problems, ensure adequate calcium and vitamin D intake to prevent hypocalcemia, and report any thigh or groin pain promptly. It's essential to discuss all potential side effects with your doctor before starting Prolia and report any concerning symptoms during treatment 1.
Monitoring and Treatment
Monitoring of creatinine clearance is required to guide dosing of zoledronic acid, and denosumab may be administered to patients with impaired renal function or even patients on hemodialysis, but with caution and close monitoring for severe hypocalcemia and hypophosphatemia 1.
Recommendations
The NCCN Guidelines for MM recommend bisphosphonates (category 1) or denosumab for all patients receiving therapy for symptomatic MM regardless of documented bone disease, and denosumab is preferred in patients with renal disease 1.
From the FDA Drug Label
Prolia may cause serious side effects including: Increased risk of severe low calcium levels in your blood (hypocalcemia). Serious allergic reactions. Severe jaw bone problems (osteonecrosis). Unusual thigh bone fractures. Increased risk of broken bones, including broken bones in the spine, after stopping, skipping or delaying Prolia. Serious infections. Dermatologic Adverse Reactions Musculoskeletal Pain
The possible side effects of Prolia include:
- Hypocalcemia: increased risk of severe low calcium levels in the blood
- Allergic reactions: serious allergic reactions, including anaphylaxis, rash, urticaria, facial swelling, and erythema
- Osteonecrosis: severe jaw bone problems
- Atypical fractures: unusual thigh bone fractures
- Infections: serious infections, including cellulitis and endocarditis
- Dermatologic reactions: dermatitis, eczema, and rashes
- Musculoskeletal pain: severe bone, joint, and/or muscle pain
- Common side effects:
From the Research
Prolia Side Effects
Prolia, also known as denosumab, is a medication used to treat osteoporosis and various malignancies. The following are some of the known side effects of Prolia:
- Hypocalcemia (low calcium levels in the blood) 3, 4, 5, 6, 7
- Hypophosphatemia (low phosphate levels in the blood) 3, 5
- Electrolyte abnormalities 3
Risk Factors for Hypocalcemia
Several studies have identified risk factors for hypocalcemia in patients taking Prolia, including:
- Age ≥65 years 4
- Grade 1 or higher serum alkaline phosphatase elevation 4
- Adjusted serum calcium level of less than 9.3 mg/dL at baseline 4
- Co-administration of cytotoxic agents 4
- Pretreatment serum calcium and creatinine levels 7
- Decreased estimated glomerular filtration rate (eGFR) 6, 7
Management of Hypocalcemia
The management of hypocalcemia in patients taking Prolia typically involves: