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Vitrakvi

Brand: 德国拜耳
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Larotinib (LOXO101) Instructions

Common name: Larotinib

Trade name: Laronib

All names: Larotinib, Vitrakvi , larotrectinib, LOXO101, Laronib


Indications:

This product is suitable for the treatment of the following patients:

Adult and pediatric patients with solid tumors who require NTRK gene fusion (NTRK1, NTRK2 or NTRK3 gene fusion).

Larotinib is a broad-spectrum anticancer drug that is effective against many different tumors. Types that can be effectively treated: 17 types of tumors including lung cancer, thyroid cancer, melanoma, gastrointestinal cancer, colon cancer, soft tissue sarcoma, salivary gland, infantile fibrosarcoma, appendiceal cancer, breast cancer, bile duct cancer, and pancreatic cancer.


Usage and Dosage

This product should be used under the guidance of an experienced doctor. A well-validated test should be used to determine the presence of NTRK gene fusion before starting treatment.

TRK fusion tumors can be diagnosed through specific testing methods, including the use of next-generation sequencing (NGS) and fluorescence in situ hybridization (FISH) to identify NTRK gene fusions. Patients whose tumors harbor NTRK gene fusions are eligible for treatment with larotrectinib.


Recommended dosage

Adult dosage:

Vitrakvi is usually 100 mg taken orally twice a day.

Swallow Vitrakvi capsules whole. Do not chew or crush capsules.

Take with or without food.

If you vomit after taking one dose of Vitrakvi, take the next dose at the scheduled time.

Long-term use until disease progression or unacceptable toxicity occurs.


Dosage for children:

Pediatric patients take 100 mg/m2 orally, 2 times a day (the maximum dose per time is 100 mg).

For pediatric patients with a body surface area less than 1.0 meters, the recommended dose of Vitrakvi is 100mg/m2, taken orally twice a day.

Take with or without food.

It is not known whether Vitrakvi is safe and effective in children under 1 month old.


Adjust dosage due to adverse reactions

If a grade 3 or 4 adverse reaction occurs, reduce the dosage until improvement or the adverse reaction is grade 1. If the adverse reaction improves within 4 weeks, resume at the next dose. If adverse reactions do not resolve within 4 weeks, permanently discontinue Vitrakvi.


Side Effects and Adverse Reactions

The most common side effects of Vitrakvi include: fatigue, nausea, cough, constipation, diarrhea, dizziness, vomiting and increased blood levels of AST and ALT enzymes in the liver.

The majority of patients (93%) experienced grade 1 or 2 adverse reactions (AEs). There were no treatment-related Grade 4 AEs, and the most common treatment-related Grade 3 AEs included: increased ALT or AST (5%), anemia (2%), decreased neutrophil count (2%), nausea (2%), and dizziness (2%).


FAQ

1. Nervous system problems; If you experience any adverse reactions, difficulty speaking, dizziness, coordination problems, tingling, numbness, or burning sensation in your hands or feet, please inform your healthcare provider. Your doctor may temporarily stop treatment, reduce your dose, or permanently discontinue Vitrakvi.

2. Liver problems; Your healthcare provider will perform blood tests to check liver function during treatment. If you have liver problems including: loss of appetite, nausea or vomiting, or pain in the upper right side of your stomach. Temporarily stop treatment, reduce the dose, or permanently discontinue. 3. If you are pregnant or planning to become pregnant, Vitrakvi may harm the unborn baby, and you should not become pregnant during treatment. Women should use effective contraception (contraception) during treatment and for at least one week after the final dose. Talk to your doctor about birth control methods that may be right for you.

4. Breastfeeding. It is not known whether Vitrakvi passes into your breast milk. Do not breastfeed during treatment and for one week after the last dose.

5. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain other drugs may affect how Vitrakvi works.


Storage:

Store capsules at room temperature (20˚C to 25˚C)

Store oral solution refrigerated (2°C to 8°C). Do not freeze. Pot life is 90 days. Use within 90 days of first opening the bottle.


Treatment effect:

According to data released by the FDA, 73% of patients responded for more than 6 months, 63% of patients responded for more than 9 months, and 39% of patients responded for more than 12 months.

U.S. FDA: "Precise anti-cancer, effective rate as high as 75%"!

In February 2018, the New England Journal of Medicine (NEJM), one of the world's four most authoritative medical journals, published the results of three clinical studies on the safety and effectiveness of the anti-cancer drug Vitrakvi (also known as larotrectinib). The results showed that for patients aged 4 months to 76 years old, the overall effective rate for 17 different cancer treatments was 75%. This result was later confirmed by the FDA.

Following this, at the European Society for Medical Oncology (ESMO2018) meeting in October 2018, clinical data on the anti-cancer drug Vitrakvi in ​​the treatment of adult and pediatric patients with TRK fusion cancer covering 24 unique tumor types showed: overall response rate: 80%, partial response rate: 62%, and complete response rate: 18%.