VITRAKVI▼ (larotrectinib): low rate of adverse events in adult and paediatric patients, with 2% permanent discontinuation1
The safety of VITRAKVI was evaluated in 248 patients in three clinical studies. Due to the rarity of TRK fusion positive cancer, patients were studied across multiple tumour types.1
The majority of adverse events were Grade 1 or 2 in severity1
-
Grade 3 AEs: anaemia, weight increased, fatigue, dizziness, paraesthesia, muscular weakness, nausea, myalgia, gait disturbance and vomiting (all affecting <5% of patients, except anaemia [7%])
-
Grade 4 AEs reported were neutrophil count decreased (2%) and ALT increased (1%), AST increased, leucocyte count decreased, and blood alkaline phosphatase increased (each in <1%)
Please refer to the Summary of Product Characteristics (SmPC) for full details on adverse events.
Most common (>1%) adverse drug reactions (safety population; n=248).1
|
System organ class |
All |
|---|---|
|
Blood and lymphatic system disorders |
Anaemia, neutrophil count decreased (Neutropenia), leukocyte count decreased (Leukopenia) |
|
Nervous system disorders |
Dizziness |
|
Gastrointestinal disorders |
Nausea, constipation, vomiting |
|
Musculoskeletal and connective tissue disorders |
Myalgia |
|
General disorders and |
Fatigue |
|
Investigations |
Alanine aminotransferase (ALT) increased, Aspartate aminotransferase (AST) increased, weight increased (Abnormal weight gain) |
Adapted from VITRAKVI Summary of Product Characteristics.
|
Most common (≥20%) TEAEs:1 |
Grade 3 and 4 TEAEs:1 |
|---|---|
|
Increased ALT and/or AST |
Increased ALT (Grade 3: 2%) |
|
Decreased neutrophil and/or leukocyte counts |
Decreased neutrophil count (Grade 3: 4%; Grade 4: 2%) |
|
Vomiting |
Nausea (Grade 3: 2%) |
|
Diarrhoea |
|
|
Cough |
|
|
Constipation (in patients aged ≤11 years) |
|
|
Pyrexia |
|
|
Nausea |
|
|
Fatigue |
|
|
Anaemia |
|
|
Headache |
|
|
Nasal congestion |
|
|
Pain in extremities |
Paediatric safety population (n=37); data cut-off: 30 July 2018
Adverse events were primarily grade 1 and 2 and the pattern and frequency were similar across adult and paediatric age groups2
AEs that occurred at any grade in at least 15% of patients, or at grade 3 or worse in ≥3% of patients, regardless of attribution2
|
|
All AEs |
TEAEs |
||||
|---|---|---|---|---|---|---|
|
AE |
Grade 1-2 |
Grade 3 |
Grade 4 |
Grade 3 |
Grade 4 |
|
|
Fatigue |
79 (30%) |
6 (2%) |
- |
1 (<1%) |
- |
|
|
ALT increased |
64 (25%) |
7 (3%) |
2 (<1%) |
7 (3%) |
1 (<1%) |
|
|
Cough |
71 (27%) |
1 (<1%) |
- |
- |
- |
|
|
Constipation |
69 (27%) |
1 (<1%) |
- |
- |
- |
|
|
Anaemia |
44 (17%) |
25 (10%) |
- |
6 (2%) |
- |
|
|
AST increased |
62 (24%) |
6 (2%) |
1 (<1%) |
2 (<1%) |
- |
|
|
Dizziness |
64 (25%) |
2 (<1%) |
- |
1 (<1%) |
- |
|
|
Nausea |
62 (24%) |
2 (<1%) |
- |
2 (<1%) |
- |
|
|
Vomiting |
62 (24%) |
2 (<1%) |
- |
- |
- |
|
|
Diarrhoea |
59 (23%) |
3 (1%) |
- |
- |
- |
|
|
Pyrexia |
50 (19%) |
2 (<1%) |
1 (<1%) |
- |
- |
|
|
Dyspnoea |
35 (13%) |
6 (2%) |
- |
- |
- |
|
|
Myalgia |
38 (15%) |
3 (1%) |
- |
2 (<1%) |
- |
|
|
Peripheral oedema |
40 (15%) |
1 (<1%) |
- |
- |
- |
|
|
Headache |
38 (15%) |
1 (<1%) |
- |
1 (<1%) |
- |
|
|
Neutrophil count decreased |
18 (7%) |
12 (5%) |
2 (<1%) |
4 (2%) |
1 (<1%) |
|
|
Lymphocyte count decreased |
22 (8%) |
7 (3%) |
2 (<1%) |
2 (<1%) |
- |
|
|
Hypokalaemia |
12 (5%) |
8 (3%) |
1 (<1%) |
- |
- |
|
|
Hypophosphataemia |
5 (2%) |
9 (3%) |
- |
- |
- |
|
Adapted from Hong et al. 2020.
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Reporting adverse events and quality complaints
Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigiliance. Reports can also be sent directly to Bayer via this link. Both side effects or quality complaints can be reported to Bayer by email to adr-ireland@bayerhealthcare.com
