Larotrectinib

Generic name
Larotrectinib
Brand name
ATC Code
L01EX12
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Larotrectinib

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Based on population pharmacokinetic analyses, exposure (Cmax and AUC) in paediatric patients at the
recommended dose of 100 mg/m2 with a maximum of 100 mg twice a day was higher than in adults
(≥ 18 years of age) given the dose of 100 mg twice a day. Data defining exposure in small children (1 month to < 2 years of age) at the recommended dose is limited (n=40). [SmPC Vitrakvi]

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

Solid tumors with neurotrophic tyrosine receptor kinase (NTRK) gene fusion
  • Oral
    • 1 month up to 18 years
      • (Larotrectinib) 200 mg/m²/day in 2 doses. Max: 200 mg/day.

      • In case of serious side effects: adjust the dose, interrupt or discontinue treatment  (see the official product information EMA for guidance

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

Infants and toddlers:
Very common (> 10%): Anemia, neutropenia, leukopenia. Nausea, vomiting, constipation. Fatigue. Weight gain. Increase ALAT, ASAT in blood.
Common (1-10%): Dizziness.

Children (2-12 years).
Very common (> 10%): Anemia, neutropenia, leukopenia. Nausea, vomiting, constipation. Fatigue. Weight gain. Increase ALAT, ASAT in blood.
Common (1-10%): Dizziness, gait disturbance, paresthesia. Dysgeusia. Myalgia, muscle weakness. Increase in alkaline phosphatase (AF) in blood.

Adolescents (12-18 years).
Very common (> 10%): Neutropenia, leukopenia. Dizziness. Nausea, vomiting, Fatigue. Weight gain. Increase ALAT, ASAT in blood.
Common (1-10%): Anemia. Paresthesia. Constipation. Myalgia, muscle weakness. Rise of alkaline phosphatase (AF) in blood.

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

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.

Anthracyclines and related substances
L01DB02
L01DB01
L01DB06
L01DB07
Other cytotoxic antibiotics
L01DC01
OTHER MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
L01FX06

Reference

  1. Bayer AG, SmPC Vitrakvi (EU/1/19/1385/004) Rev8, 05-04-2023, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose