Pharmacokinetics in children

No information is present at this moment.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

The side effect profile in children is generally similar to the side effect profile in adults.

Adverse reactions that occurred more frequently in children compared to adults: ≥ 5% were neutropenia (19.8%), weight gain(18.7%), fractures (11%), lung infection (11%) and anemia (8.8%).

There were no differences in adverse events between children of different ages3 (infants, children up to 2 years of age, older children and adolescents).

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

• ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
• ANTINEOPLASTIC AGENTS

CYTOTOXIC ANTIBIOTICS AND RELATED SUBSTANCES

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Reference

1. Roche Registration G, SmPC Rozlytrek (EU/1/20/1460/001) Rev 9; 3-7-2024, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring

Overdose