- 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]
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
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Available formulations
No information is present at this moment.
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Dosages
| Solid tumors with neurotrophic tyrosine receptor kinase (NTRK) gene fusion |
|---|
|
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Renal impaiment in children > 3 months
No information available on dose adjustment in renal impairment.
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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.
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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.
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| Anthracyclines and related substances | ||
|---|---|---|
| L01DB02 | ||
| L01DB01 | ||
| L01DB06 | ||
| L01DB07 | ||
| Other cytotoxic antibiotics | ||
|---|---|---|
| L01DC01 | ||
| OTHER MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES | ||
|---|---|---|
| L01FX06 | ||
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Reference
- Bayer AG, SmPC Vitrakvi (EU/1/19/1385/004) Rev8, 05-04-2023, www.ema.europa.eu
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Changes
Changes
