贝舒地尔服用时需要注意什么?

Attention should be paid when taking Besudil:

1. Follow the doctor's instructions: Be sure to take the medication according to the doctor's guidance, and do not increase or decrease the dosage or change the medication method on your own. The doctor will develop a personalized medication plan for you based on your illness and physical condition.

2. Pay attention to the medication time: According to the doctor's advice, there should be a certain period of time between each dose of Besudil to ensure that the concentration of the drug in the body is stable. It should not be taken on an empty stomach. It is recommended to take it after a meal to reduce stomach discomfort.

3. Take the medicine with warm water: It is recommended to use warm water to take the medicine. Avoid using overheated or cold water to avoid affecting the dissolution and absorption of the medicine.

4. Avoid using it at the same time with other drugs: Besudil may interact with other drugs, especially analgesics, antipyretics, cold medicines, tranquilizers, etc. Therefore, while taking besudil, you should tell your doctor about other medications you are taking to avoid potential drug conflicts.

5. Pay attention to driving and mechanical operation: After taking Besudil, you may experience adverse reactions such as dizziness and fatigue, which may affect your ability to drive and operate machinery. Therefore, during medication, you should try to avoid driving or operating machinery to avoid accidents.

6. Avoid drinking alcohol: You should avoid drinking alcohol while taking Besudil. Alcohol may aggravate the side effects of medications and affect treatment effectiveness.

7. Pay attention to adverse reactions: If you experience nausea, diarrhea, headache, palpitations and other uncomfortable symptoms after taking Besudil, you should seek medical treatment in time and inform the doctor of your medication status so that the doctor can adjust the treatment plan in a timely manner.

In addition, special groups of people need to be paid attention to when taking Besudil.

1. Allergy

If you have any abnormal or allergic reaction to this medicine or any other medicine, please tell your doctor. Also tell your doctor if you have any other types of allergies, such as to foods, dyes, preservatives, or animals.

2. Pediatrics

Appropriate studies have not been conducted on the relationship between age and the efficacy of berusudil in children under 12 years of age. Safety and effectiveness have not been established.

3. Elderly people

Appropriate studies conducted to date have not demonstrated geriatric-specific issues that would limit use in the elderly.

4. Breastfeeding

There are insufficient studies in women to determine the risk to the infant when this medication is used during breastfeeding. Before taking this medication while breastfeeding, weigh the potential benefits against the potential risks.

5. Renal impairment

Besudil treatment has not been studied in patients with existing severe renal impairment.

6. Hepatic impairment

Avoid use in patients with moderate hepatic impairment (Child-Pugh B) or severe hepatic impairment (Child-Pugh C) and no hepatic GVHD.

Marketing of Besudil

In October 2017, Besudil was granted orphan drug status by the U.S. Food and Drug Administration (FDA) for the treatment of cGVHD.

In October 2018, the FDA granted Besudil Breakthrough Therapy Designation (BTD) for the treatment of patients with cGVHD after failure of two or more systemic therapies.

In November 2020, the US FDA accepted the new drug application and granted priority review.

On July 16, 2021, besudil received its first approval in the United States for the treatment of cGVHD in adult and pediatric patients aged ≥12 years after failure of at least two prior systemic therapies.

The recommended dose of besudil is 200 mg once daily (with food) until cGVHD progresses and new systemic therapy is required. In patients receiving concomitant strong CYP3A4 inducers or proton pump inhibitors, the besudil dose should be increased to 200 mg twice daily. It is recommended that patients take medication under the guidance of a doctor and receive symptomatic treatment.

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