Protyga 250 mg Uncoated tablets.
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
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