Imbruvica_ 140 mg & 420 mg FC tablets
PDF Leaflet Revision Date: 11 June 2025
Clinical Summary
Quick overview from the medicine insert
Indication
Treatment of MCL, CLL, and WM in adults.
Dosage (summary)
MCL: 560 mg once daily; CLL: 420 mg once daily; WM: 420 mg once daily.
Special Populations
- Renal impairment
- Hepatic impairment
Pregnancy & Breastfeeding
Contraindicated in pregnancy; breastfeeding should be discontinued during treatment.
Key Drug Interactions
- Strong CYP3A inhibitors
- St. John's Wort
Contraindications
- Hypersensitivity to ibrutinib
- Pregnancy
- Severe hepatic impairment
Common side effects
- Diarrhoea
- Neutropenia
- Rash
- Musculoskeletal pain
- Haemorrhage
Counselling Points
- Avoid grapefruit juice.
- Monitor for signs of bleeding.
- Use effective contraception during treatment.
Serious warnings
- Bleeding-related events
- Leukostasis
- Splenic rupture
- Infections
- Hepatic events
Important Disclaimer
The Imbruvica_ 140 mg & 420 mg FC tablets professional information leaflet below is the property of Janssen Pharmaceutica (Pty) Ltd 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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