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As the world’s first and only highly selective JAK1 inhibitor, golidocitinib demonstrates significant efficacy in relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) with a lower risk of off-target adverse reactions.
AuthenticGuaranteeFast DeliveryPrivacy Golidocitinib is the world’s first and only highly selective JAK1 inhibitor independently developed by Dizal (Jiangsu) Pharmaceutical Co., Ltd., and was granted conditional approval for marketing by the National Medical Products Administration (NMPA) of China on June 18, 2024.
This product is indicated as monotherapy for adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) who have received at least one prior line of systemic therapy.
The above indication was granted conditional approval based on the objective response rate (ORR) and duration of response (DOR) results from a single-arm clinical trial. The full approval of this indication is contingent upon the results of subsequent confirmatory randomized controlled trials.
This product shall be prescribed by physicians experienced in cancer treatment.
The recommended dose of this product is 150 mg once daily, taken orally until disease progression or unacceptable adverse reactions occur.
This product should be administered at approximately the same time each day, either on an empty stomach or with food. The capsule should be swallowed whole with water. Do not open, chew or dissolve the capsule contents.
If a dose is missed or not taken at the scheduled time, the missed dose should be taken within 12 hours of the scheduled administration time. If more than 12 hours have elapsed, the missed dose should not be taken.
1.Pregnancy and lactation.
2.Hypersensitivity to the active ingredient of this product or any of its excipients.
The most common adverse reactions (≥ 20%) are neutropenia, thrombocytopenia, leukopenia, anemia, lymphopenia, increased AST, and increased alanine aminotransferase (ALT).
Contraception
Patients of childbearing potential should avoid conception during treatment with this product and continue to use effective contraceptive measures for a certain period after completing treatment: at least 3 months for females and at least 6 months for males. Concomitant use of this product may increase the risk of decreased exposure to hormonal contraceptives; therefore, physical contraception is recommended as the preferred method.
Pregnancy
This product is contraindicated in pregnant women. The pregnancy status of women of childbearing potential should be confirmed prior to the initiation of treatment with this product. There are no available data on the use of this product in pregnant women, and the potential safety risks to the fetus are currently unknown. Animal studies have indicated that this product has reproductive toxicity (including impairment of female fertility, induction of maternal abortion, stillbirth, retardation of embryonic and fetal growth and development, and fetal malformations).
Fertility
There are no available data on the effects of this product on human fertility. Non-clinical studies have demonstrated adverse effects of this product on the fertility of female animals.
Lactation
There are currently no data regarding the excretion of golidocitinib and its metabolites in human milk, nor are there data on their potential effects on breastfed infants or milk production. Potential risks to breastfed infants or milk production cannot be excluded. Therefore, breastfeeding should be discontinued during treatment with this product.
The safety and efficacy of this product in patients under 18 years of age have not been established.
In the clinical trials of this product, patients aged ≥ 65 years accounted for 31.8% (87/274) of the total population, and 30.6% (26/85) of patients in the pivotal registration study were aged ≥ 65 years. Compared with patients under 65 years of age, no significant difference in efficacy was observed in geriatric patients aged ≥ 65 years. The incidence of grade 3 or higher thrombocytopenia and infectious pneumonia was slightly higher in geriatric patients, but the difference was not clinically meaningful. Close monitoring is recommended for geriatric patients taking this product.
For more detailed drug information, please consult the official package leaflet.
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Golidocitinib is an oral inhibitor of the JAK/STAT signaling pathway, primarily indicated for the treatment of hematologic malignancies such as relapsed or refractory peripheral T-cell lymphoma (PTCL).
Common adverse reactions of Golidocitinib include neutropenia, anemia, infections and the like. Regular monitoring of blood routine and liver function is required for patients taking this medication.
Each box is priced at approximately 2,215 US dollars, containing 30 capsules of the standard specification with a dosage of 0.15 g per capsule.
Golidocitinib capsules are available for postal delivery. We will provide compliant packaging and professional distribution services, and arrange the shipment for you in accordance with relevant requirements.
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