Protyga 250 mg Uncoated tablets.

Protyga 250 mg Uncoated tablets.

S4
PDF Leaflet Revision Date: 21 July 2023


Clinical Summary

Quick overview from the medicine insert

Indication

Treatment of high-risk metastatic prostate cancer and metastatic castration-resistant prostate cancer.

Dosage (summary)

1 g (four 250 mg tablets) daily with 5 mg prednisone for mHNPC/mHSPC or 10 mg for mCRPC.

Special Populations

  • Hepatic impairment
  • Renal impairment

Pregnancy & Breastfeeding

Contraindicated in pregnancy and lactation; handle with gloves.

Key Drug Interactions

  • Avoid strong CYP3A4 inducers
  • Caution with CYP2D6 substrates

Contraindications

  • Hypersensitivity to abiraterone
  • Moderate to severe hepatic impairment
  • Pregnancy
  • Concomitant use with rifampicin

Common side effects

  • Hypertension
  • Hypokalaemia
  • Hepatotoxicity
  • Diarrhoea
  • Rash

Counselling Points

  • Take on an empty stomach
  • Monitor blood pressure and liver function
  • Use effective contraception during treatment

Serious warnings

  • Hepatotoxicity
  • Cardiac failure risk
  • QT prolongation
Important Disclaimer

The Protyga 250 mg Uncoated tablets. professional information leaflet below is the property of Forrester Pharma 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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