Columvi 2,5 Mg/2,5 Ml & 10 Mg/10 Ml 2,5 & 10 mg Concentrate for solution for infusion
PDF Leaflet Revision Date: 04 February 2025
Clinical Summary
Quick overview from the medicine insert
Indication
Treatment of adult patients with relapsed or refractory DLBCL and PMBCL after two or more lines of systemic therapy.
Dosage (summary)
Step-up dosing: 2.5 mg on Day 8, 10 mg on Day 15, then 30 mg on Day 1 of Cycle 2 and thereafter every 21 days.
Special Populations
- Geriatric use
- Renal impairment
- Hepatic impairment
Pregnancy & Breastfeeding
Avoid pregnancy during treatment; potential harm to fetus; unknown if excreted in breast milk.
Key Drug Interactions
- Monitor for toxicity with CYP450 substrates
Contraindications
- Hypersensitivity to COLUMVI or excipients
Common side effects
- Cytokine release syndrome
- Neutropenia
- Anemia
- Thrombocytopenia
- Pyrexia
Counselling Points
- Premedicate to reduce CRS risk
- Monitor for CRS symptoms
- Seek immediate medical attention for CRS signs
Serious warnings
- Risk of serious infections
- Cytokine release syndrome can be life-threatening
Important Disclaimer
The Columvi 2,5 Mg/2,5 Ml & 10 Mg/10 Ml 2,5 & 10 mg Concentrate for solution for infusion professional information leaflet below is the property of Roche Products 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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