Loading…
VITRAKVI is a brand name for Larotrectinib, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: VITRAKVI (larotrectinib) is indicated for the treatment of adult and pediatric patients with solid tumours that: • have a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion without a known acquired resistance mutation, • are metastatic or where surgical resection is likely to result in severe morbidity, and •…
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics 08/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..........................................................................................
2 TABLE OF CONTENTS ..................................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................
4 1 INDICATIONS ............................................................................................................................ 1 Pediatrics .............................................................................................................................
2 Geriatrics ............................................................................................................................. 4 2 CONTRAINDICATIONS ............................................................................................................
4 4 DOSAGE AND ADMINISTRATION .......................................................................................... 1 Dosing Considerations ........................................................................................................
2 Recommended Dose and Dosage Adjustment ................................................................... 4 Administration ......................................................................................................................
5 Missed Dose ........................................................................................................................ 8 5 OVERDOSAGE .........................................................................................................................
8
1 Adverse Reaction Overview The safety of VITRAKVI was evaluated in 418 patients. Overall, 97% of patients experienced at least one TEAE. The most commonly reported TEAEs (≥ 20%), in order of decreasing frequency, were ALT increased, AST increased, vomiting, anemia, cough, constipation, fatigue, diarrhea, pyrexia, nausea, and dizziness.
The most common serious adverse events (≥ 2%) regardless of attribution included pneumonia, pyrexia, diarrhea, and dyspnea. Grade 3 or 4 TEAEs occurred in 50% of patients. Grade 4 events (n>2) included sepsis (n=5), neutrophil count decreased (n=7), lymphocyte count decreased (n=3), and ALT increased (n=3).
Other Grade 4 adverse reactions included blood alkaline phosphatase increased (n=2), leukocyte count decreased (n=2), AST increased (n=2), platelet count decreased (n=1) and muscular weakness (n=1). Grade 3 events (≥ 2%) included anemia (8%), weight increased (4%), hypophosphatemia (2%), fatigue (2%), ALT increased (4%), neutrophil count decreased (6%), dyspnea (2%), lymphocyte count decreased (3%), pneumonia (3%), hypokalemia (2%), AST increased (3%), diarrhea (3%), pyrexia (2%), hypertension (2%), hyponatremia (2%), and NOC/c VITRAKVI (larotrectinib) Product Monograph Page 12 of 40 hypoxia (2%).
Other Grade 3 adverse reactions included gait disturbance (1%), vomiting (<1%), dizziness (<1%), myalgia (<1%), paresthesia (<1%), nausea (<1%), and constipation (<1%). Dose modification (interruption or reduction) of VITRAKVI dosage due to a TEAE occurred in 44% of patients.
The most common TEAEs (≥ 3%) leading to dose modification were ALT increased (5%), AST increased (5%), neutrophil count decreased (5%), and pyrexia (3%). The majority of adverse events leading to dose modification occurred in the first three months of treatment.
Permanent discontinuation of VITRAKVI for treatment emergent adverse events occurred in 11% of patients. The TEAEs that led to discontinuation of VITRAKVI and occurred in more than one patient were dehydration, malignant neoplasm progression, increased ALT, increased AST, muscular weakness, neutrophil count decreased and vomiting.
4 Geriatrics 08/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..........................................................................................
2 TABLE OF CONTENTS ..................................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................
4 1 INDICATIONS ............................................................................................................................ 1 Pediatrics .............................................................................................................................
2 Geriatrics ............................................................................................................................. 4 2 CONTRAINDICATIONS ............................................................................................................
4 4 DOSAGE AND ADMINISTRATION .......................................................................................... 1 Dosing Considerations ........................................................................................................
2 Recommended Dose and Dosage Adjustment ................................................................... 4 Administration ......................................................................................................................
5 Missed Dose ........................................................................................................................ 8 5 OVERDOSAGE .........................................................................................................................
8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 8 7 WARNINGS AND PRECAUTIONS ........................................................................................... 1 Special Populations ...........................................................................................................
VITRAKVI is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. The safety of VITRAKVI was evaluated in 418 patients (overall safety population) who received at least one dose of VITRAKVI in one adult dose-finding trial [Study 1 (LOXO-TRK-14001) (n= 75)], one single arm trial [Study 2 (NAVIGATE) (n=200)], and one pediatric trial [Study 3 (SCOUT) (n=143)].
5 months). Two-hundred and fifty four (61%) patients were exposed to VITRAKVI for ≥ 6 months and 186 (44%) patients were exposed for ≥ 1 year. The majority of patients had an unresectable or metastatic solid tumour, including metastatic (68%) and locally advanced (19%) disease extent at enrollment.
1 year to 90 years) with 34% of patients being pediatric patients. Forty-eight percent of patients were males and 60% were white. The majority (90%) of adult patients (18 years and older) received 100 mg VITRAKVI taken twice daily as their starting dose.
Three pediatric dose levels were evaluated with 90% of pediatric patients having received a starting dose of 100 mg/m2 (with a maximum of 100 mg) taken twice daily. 6 mg/m2 twice daily to 120 mg/m2 twice daily in pediatric patients.
03. VITRAKVI (larotrectinib) Product Monograph Page 14 of 40 Additional Information in Selected Adverse Reactions Neurologic/Psychiatric events In the overall safety database (n=418), neurologic/psychiatric TEAEs of any grade were reported in 61% of patients.
Neurologic/psychiatric adverse events occurring in > 5% of patients included dizziness (22%), headache (16%), mood disorders (14%), cognitive impairment (11%), sleep disorders (11%), gait […]
1 Pregnant Women ........................................................................................................ 2 Breast-feeding.............................................................................................................
3 Pediatrics .................................................................................................................... 4 Geriatrics.....................................................................................................................
11 8 ADVERSE REACTIONS ......................................................................................................... 1 Adverse Reaction Overview ..............................................................................................
2 Clinical Trial Adverse Reactions ........................................................................................ 12 Additional Information in Selected Adverse Reactions ........................................................
14 Clinical Trial Adverse Reactions (Geriatrics) ....................................................................... 1 Clinical Trial Adverse Reactions (Pediatrics) .............................................................. 3.
Less Common Clinical Trial Adverse Reactions............................................................... 5 Post-Market Adverse Reactions ........................................................................................ 16 9 DRUG INTERACTIONS ..........................................................................................................
2 Drug Interactions Overview ............................................................................................... 4 Drug-Drug Interactions ......................................................................................................
17 Effects of Other Agents on Larotrectinib .............................................................................. 5 Drug-Food Interactions ......................................................................................................
6 Drug-Herb Interactions ...................................................................................................... 18 10 CLINICAL PHARMACOLOGY ..............................................................................................
1 Mechanism of Action ....................................................................................................... 2 Pharmacodynamics .........................................................................................................
3 Pharmacokinetics ............................................................................................................ 19 11 STORAGE, STABILITY AND DISPOSAL ............................................................................
21 PART II: SCIENTIFIC INFORMATION ....................................................................................... 22 13 PHARMACEUTICAL INFORMATION ...................................................................................
22 14 CLINICAL TRIALS ................................................................................................................ 1 Clinical Trials by Indication […]