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Its core advantages are potent ROS1 inhibition, high intracranial activity, outstanding anti-resistance efficacy, superior safety profile, and high accessibility.
AuthenticGuaranteeFast DeliveryPrivacy Talectinib Adipate Capsules is a Class 1 innovative drug independently developed in China, and also the only domestically developed second-generation ROS1 tyrosine kinase inhibitor (TKI).
It was launched for the first time in China in December 2024, and has been granted breakthrough therapy designation and priority review approval in multiple countries.
Talectinib Adipate Capsules are indicated for adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
This indication was approved conditionally based on the results of a single-arm clinical trial. The full approval of this indication will depend on the clinical benefits demonstrated by subsequent confirmatory trials.
Only patients with confirmed ROS1-positive locally advanced or metastatic NSCLC using a validated detection method are eligible for treatment with this product. The ROS1-positive status should be determined prior to the initiation of treatment.
The recommended dosage for adults is 0.6g, administered orally once daily, until disease progression or intolerable toxicity occurs.
This product should be taken on an empty stomach (it is recommended that no food be consumed 2hours before or after administration).
Swallow the capsule whole with water. Do not break, chew, crush, or dissolve the capsule before taking. Do not take any damaged, broken, or defective capsules.
It is advisable to take the medication at approximately the same time each day. In case of a missed dose:
If more than 12 hours have passed since the scheduled time, the missed dose may be taken.
If less than 12 hours remain until the next scheduled dose, the missed dose should not be taken.
If vomiting occurs after taking this product, do not take an additional dose; resume the recommended dosage at the next scheduled time.
Patients with known hypersensitivity to this product or any of its excipients are prohibited from using this product.
Among 355 patients, the most common adverse reactions (≥20%) were elevated transaminases (elevated AST or elevated ALT), diarrhea, vomiting, nausea, and anemia. The most common serious adverse reaction was pulmonary infection (4.5%).
Use in Pregnant and Lactating Women
Females
Female patients of childbearing potential should undergo pregnancy testing prior to the initiation of treatment with this product.
Female patients of childbearing potential should be advised to avoid pregnancy during treatment with this product, and to use effective contraceptive measures during treatment and for at least 90 days after the last dose.
Males
Male patients with female partners of childbearing potential should use condoms during treatment with this product and for at least 90 days after the last dose.
There are no clinical data on the use of this product in pregnant women. Based on the results of animal studies and the mechanism of action of this product, administration of this product to pregnant women may cause fetal harm. Women of childbearing potential and pregnant women should be informed of the potential risks of this product to the fetus.
It is unknown whether this product or its metabolites are excreted in human milk. Lactating women are advised to discontinue breastfeeding during treatment with this product.
There are no clinical data on the effects of this product on fertility; therefore, the impact of this product on male and female fertility remains unknown.
The safety and efficacy of this product in patients under 18 years of age have not been established.
In the AB-106-C203 study involving 173patients, no differences in safety or efficacy were observed between patients aged ≥ 65 years and younger patients (accounting for 21.4% and 78.6% of the study population, respectively).
No dosage adjustment is required for patients aged ≥ 65 years.
For more detailed drug information, please consult the official package leaflet.
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Taletrectinib is a targeted therapeutic agent indicated for the treatment of non-small cell lung cancer (NSCLC) positive for ALK/ROS1 gene fusions. It halts the growth of cancer cells by inhibiting abnormal kinase activity.
The recommended adult dosage of Taletrectinib is generally one oral dose once daily. The specific dosage shall be adjusted based on the patient's body weight, type of gene mutation, and disease condition.
Taletrectinib can be taken either on an empty stomach or after meals, but it must be administered at a fixed time each day to maintain stable blood drug concentration. If a dose is missed, it should be made up for before the next scheduled dose, while double dosing should be avoided.
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