VITRAKVI 25mg Hard Capsules: SmPC Summary
Quick summary VITRAKVI 25mg hard capsules contain larotrectinib sulfate and are used for certain NTRK gene fusion-positive solid tumours. This article summarises the product characteristics, including indications, monitoring, side effects and special-population considerations. Medical...
This content is for educational purposes only and does not replace medical advice, diagnosis or treatment from a qualified healthcare professional.
Quick summary
VITRAKVI 25mg hard capsules contain larotrectinib sulfate and are used for certain NTRK gene fusion-positive solid tumours. This article summarises the product characteristics, including indications, monitoring, side effects and special-population considerations.
Medical disclaimer
This page is for general information only and does not replace the official SmPC, patient leaflet, or advice from an oncology specialist, pharmacist or other qualified healthcare professional. It is not a diagnosis or treatment recommendation.
What VITRAKVI 25mg hard capsules are
VITRAKVI 25mg hard capsules are a prescription medicine containing larotrectinib sulfate. They are designed as a targeted treatment for certain solid tumours with NTRK gene fusion.
Because this medicine targets a specific genetic change, genetic testing is an important part of confirming whether it is appropriate for a patient.
Indications
The content provided describes VITRAKVI as being used for solid tumours with NTRK gene fusion, including cancers such as:
- Soft tissue sarcoma
- Thyroid cancer
- Non-small cell lung cancer
- Neuroblastoma
Use is generally considered after prior therapies have not worked well enough, and confirmation of the NTRK fusion is important before treatment decisions are made.
How it works
Larotrectinib works by inhibiting proteins produced by the NTRK gene. In tumours with NTRK fusion, this can block signals that support tumour growth.
This is a form of precision medicine, meaning the treatment is selected based on a tumour’s genetic profile rather than only its location in the body.
Dosage information
The source content states the following general dosing approach:
- Adults: 100 mg taken orally twice daily.
- Pediatric patients: Dose based on body surface area, with a maximum of 100 mg per administration.
If a dose is missed, the content advises not to take a double dose. Patients should return to the usual schedule. Any dose changes should be guided by the treating healthcare team.
Side effects reported in the source content
As with other cancer medicines, side effects may occur. The content highlights the following reported reactions:
- Increased liver enzymes
- Anemia
- Musculoskeletal pain
- Fatigue
- Gastrointestinal symptoms
Serious adverse events mentioned in the source include pneumonia and pyrexia, and some patients required treatment interruption. The article also notes that grade 3 or 4 reactions were reported in a substantial proportion of patients in the cited data.
Special populations
The source content notes that extra care may be needed in:
- Older adults
- Patients with hepatic impairment
- Patients with renal impairment
These groups may need closer monitoring, and treatment decisions should be individualised by the healthcare team.
Clinical trial findings mentioned in the source
The provided content refers to clinical trial data involving 279 participants, with a median age of 46 years and 33% under 18 years of age.
The most frequent adverse reactions in that dataset were elevated liver enzymes, anemia and fatigue. The content also notes that more than 20% of patients needed close observation for laboratory abnormalities.
Monitoring during treatment
Regular monitoring is an important part of treatment with VITRAKVI 25mg hard capsules. The source content highlights the following checks:
- Liver function tests to monitor enzyme levels
- Complete blood counts to check for anemia
- Assessment of musculoskeletal symptoms
Close observation is especially important early in treatment, when serious adverse events may be more likely to appear.
Key points for pharmacists and clinicians
| Topic | Summary from the source content |
|---|---|
| Active ingredient | Larotrectinib sulfate |
| Main use | Solid tumours with NTRK gene fusion |
| Monitoring focus | Liver tests, blood counts, symptom review |
| Special considerations | Older adults and patients with liver or kidney impairment |
Frequently asked questions
▸ What are the ingredients in VITRAKVI?
The source content identifies larotrectinib sulfate as the active ingredient. The capsule also contains inactive ingredients, which support the formulation but are not responsible for the main therapeutic effect.
▸ What does VITRAKVI do?
It targets proteins produced by the NTRK gene and helps block signals involved in tumour growth in cancers with NTRK fusion.
▸ How is VITRAKVI selected for treatment?
The content indicates that genetic testing is used to confirm the presence of an NTRK fusion before treatment is considered.
▸ What monitoring is mentioned for VITRAKVI?
The source highlights liver function tests, complete blood counts and review of musculoskeletal symptoms.
▸ What side effects are listed in the source content?
The listed reactions include increased liver enzymes, anemia, musculoskeletal pain, fatigue and gastrointestinal symptoms.
▸ Does this page replace the official SmPC?
No. This is a summary article. The official SmPC and patient leaflet should be checked for complete prescribing information.
Safety reminder: Cancer medicines require specialist oversight. Always verify the official product information, local guidance and the patient’s individual treatment plan before making clinical decisions.
Medical disclaimer
This content is for educational purposes only. It should not be used as a substitute for professional medical advice, diagnosis or treatment. Always ask a doctor, pharmacist or qualified healthcare professional before starting, stopping or changing any medicine.
Sources and verification
The following sources or official references are listed to support verification of the medicine information discussed in this article.
Medicine information can change and may vary depending on country, product formulation, patient history and professional guidance. Always check official medicine information and ask a healthcare professional for personal medical questions.