Trametinib
Generic name
Trametinib
Brand name
ATC Code
L01EE01
- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
The pharmacokinetic properties (absorption rate and clearance of the active substance) of trametinib in pediatric patients were comparable to those in adults. Weight had an influence on the oral clearance of trametinib, whereas age did not. The pharmacokinetic exposure to trametinib in pediatric patients receiving the recommended weight-based dose was within the range of exposure observed in adults.
[SmPC Spexotras]
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 safety profile in paediatric patients was largely consistent with the safety profile previously established in adult patients.
In clinical studies of paediatric patients treated with trametinib in combination with dabrafenib:
-most common adverse reactions (frequency ≥20%): pyrexia (65%), rash (47%), headache (40%), vomiting (38%), fatigue (35%), dry skin (34%), diarrhoea (31%), haemorrhage (30%), nausea (26%), dermatitis acneiform (26%), neutropenia (25%), abdominal pain (23%) and cough (22%).
-most frequently reported severe (Grade 3/4) adverse reactions: neutropenia (15%), pyrexia (9%), transaminases increased (6%) and weight increased (5%).
Long-term data on growth and skeletal maturation in paediatric patients are currently limited.
[SmPC Spexotras]
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 in children
Hemorrhagic events have been reported in pediatric patients receiving trametinib in combination with dabrafenib. A reduction in LVEF due to trametinib in combination with dabrafenib has been reported in pediatric patients. Fever has been reported in clinical studies of trametinib in pediatric patients. In addition, uveitis and iridocyclitis have been reported in clinical trials in pediatric patients treated with trametinib in combination with dabrafenib. Skin rash has been observed in 49% of pediatric patients in clinical trials with trametinib in combination with dabrafenib. Pancreatitis has been reported in pediatric patients treated with trametinib in combination with dabrafenib in clinical trials. Hepatic adverse reactions have been reported in clinical trials with trametinib in combination with dabrafenib in pediatric patients. Colitis and enterocolitis have been reported in pediatric patients receiving trametinib in combination with dabrafenib.
[SmPC Spexotras]
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 | ||
References
Changes
Therapeutic Drug Monitoring
Overdose
