Prolia 60 mg Solution for subcutaneous injection.

Prolia 60 mg Solution for subcutaneous injection.

S4
PDF Leaflet Revision Date: 02 September 2024

API: Denosumab | Company: Amgen South Africa

Clinical Summary

Quick overview from the medicine insert

Indication

Treatment of osteoporosis and bone loss in specific populations.

Dosage (summary)

60 mg subcutaneously every 6 months; no adjustment for elderly or renal impairment.

Special Populations

  • Elderly
  • Renal impairment
  • Hepatic impairment

Pregnancy & Breastfeeding

Not recommended in pregnancy; potential risks in breastfeeding.

Key Drug Interactions

  • CYP3A4 substrates
  • Hormone replacement therapy

Contraindications

  • Hypersensitivity
  • Hypocalcaemia

Common side effects

  • Musculoskeletal pain
  • Cellulitis
  • Hypocalcaemia

Counselling Points

  • Ensure adequate calcium and vitamin D intake
  • Monitor for signs of hypocalcaemia
  • Report any unusual thigh or hip pain

Serious warnings

  • Severe hypocalcaemia
  • Osteonecrosis of the jaw
  • Atypical femoral fractures
Important Disclaimer

The Prolia 60 mg Solution for subcutaneous injection. professional information leaflet below is the property of Amgen South Africa and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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