Laronib (Larotrectinib) 100 mg – 30 CAPSULES

Description

Product Features

Laronib (Larotrectinib) is an oral selective tropomyosin receptor kinase (TRK) inhibitor for the treatment solid tumors harboring NTRK-fusion proteins.

• Research suggests that the NTRK genes can become abnormally fuse to other genes, producing a TRK fusion protein that can lead to the development of solid tumors across various sites of the body.
• Examples of tumor types with an NTRK fusion that responded to medicine include soft tissue sarcoma, salivary gland cancer, infantile fibrosarcoma, thyroid cancer and lung cancer.
• The efficacy of drug was studied in three clinical trials that included 55 pediatric and adult patients with solid tumors that had an identified NTRK gene fusion. It demonstrate a 75 percent overall response rate across different types of solid tumors. These responses were durable, with 73 percent of responses lasting at least six months, and 39 percent lasting a year or more.
• This Capsules is taken orally twice daily.
• Common side effects (≥ 20%) reported by patients receiving in clinical trials include fatigue, nausea, cough, constipation, diarrhea, dizziness, vomiting, and increased AST and ALT enzyme blood levels in the liver.
• This tablets receive an accelerated approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need using clinical trial data. That is thought to predict a clinical benefit to patients.

Product details Larotrectinib

Product name: Larotrectinib Laronib 100mg (Everest) 100mg Capsules.

Dosage specification: 100mg/capsule, 30 capsules/bottle.

Manufacturer: Everest, Bangladesh.

Indications Larotrectinib

Suitable for the treatment of adult patients with solid tumors:

• With neurotrophic receptor tyrosine kinase (NTRK) gene fusion, no known acquired resistance mutations,
• Metastasis or surgical resection may cause severe morbidity, and
• There is no satisfactory alternative treatment or post-treatment progression.

The indication is approved under accelerated approval based on the overall response rate and response duration. Continued approval of this indication may depend on the verification and description of the clinical benefit in the validation trial.

Dosage and Usage Larotrectinib

Patient selection

According to the presence of NTRK gene fusion in tumor specimens, Larotrectinib was selected to treat patients. There is currently no FDA-approved test method for detecting NTRK gene fusion.

Recommended dosage

Recommended dose for adult patients is 100 mg orally per day, with or without food, until the disease progresses or until unacceptable toxicity.

Dose adjustment of adverse reactions

For grade 3 or 4 adverse reactions: Stop using larotinib until the adverse reaction subsides or improves to baseline or grade 1. If it subsides within 4 weeks, it will restore at the next dose modification. The adverse reaction does not subside within 4 weeks, the drug permanently discontinue.

Dosage adjustment for co-administration with strong CYP3A4 inhibitors

Avoid co-administration of strong CYP3A4 inhibitors with Larotrectinib. While the co-administration of strong CYP3A4 inhibitors cannot avoid, reduce the dose by 50%. After stopping the inhibitor 3 to 5 times to eliminate the half-life, resume the dose taken before starting the CYP3A4 inhibitor.

Dose adjustment for co-administration with strong CYP3A4 inducers

Avoid co-administration of strong CYP3A4 inducers with Larotrectinib. However this co-administration of strong CYP3A4 inducers cannot avoid, double the dose. After the inducer stop for 3 to 5 elimination half-lives, resume the dose taken before the CYP3A4 inducer start.

Dose adjustment for patients with liver damage

The initial dose for patients with moderate (Child-Pugh B) to severe (Child-Pugh C) liver damage reduce by 50%.

Management

Do not make up for the missed dose within 6 hours of the next scheduled dose. If vomiting occurs after taking one dose, take the next dose at the scheduled time.

Capsule

Swallow the capsules with water. Do not chew or crush the capsules.

Larotrectinib Pregnancy Warnings

Animal studies reveal evidence of malformations in the fetus. When this drug administer to pregnant animals during organogenesis. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phase out.

Manufacturing product is a product of Bangladesh: direct mail from Bangladesh will take 10-20 days to arrive in your hands. For special areas, please contact customer service. Regarding whether it can clear, it depends on the customs situation of each country. The customs can clear in the country, you need to consult the local customs. Our company is only responsible for customs clearance at the place of origin. The received package deduct, it can generally return and the return can reissue. The postage is not refundable, please be aware.

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