伊曲莫德(Etrasimod)的用法用量:用药指南,特殊人群用药

Etrasimod is a sphingosine 1-phosphate (S1P) receptor modulator that exerts a therapeutic effect by reversibly isolating lymphocytes in lymphoid tissue and reducing the number of peripheral blood lymphocytes.

Itrimod (Etrasimod) usage and dosage

1. Assessment, medication and vaccination before taking Etrasimod for the first time

Before starting treatment, the following assessments are required:

(1) Complete blood count

Obtain a recent complete blood count, including lymphocyte count, (i.e. within the past 6 months or after stopping previous UC treatment).

(2). Cardiac evaluation

Obtain an electrocardiogram to determine whether there are pre-existing cardiac conduction abnormalities. Patients with certain pre-existing conditions should seek the advice of a cardiologist.

(3) Liver function test

Obtain recent (i.e., within the past 6 months) transaminase and bilirubin levels.

(4), Ophthalmic evaluation

At the beginning of itrimod treatment, obtain a baseline evaluation of the fundus, including the macula.

(5) Skin examination

Carry out a skin examination before starting or shortly after starting isramod treatment. If suspicious skin lesions are observed, prompt evaluation should be performed.

(6) Vaccination

For patients who do not have a history of chickenpox confirmed by medical professionals, or who have not completed the full course of varicella-zoster virus vaccination records, a VZV antibody test should be performed before starting itrimod treatment; it is recommended that patients with negative antibodies be vaccinated with VZV vaccine before starting itrimod treatment.

If a live attenuated vaccine is required, it should be given at least 4 weeks before starting treatment with istrimod.

Update vaccinations according to current immunization guidelines before initiating treatment with istrimod.

2. Recommended dose

The recommended dose is 2 mg, taken orally once a day.

3. How to take the medicine

Swallow the tablet whole, with or without food.

4. Treatment of missed doses

If you miss a dose, you should take the missed dose at the next scheduled time; do not double the next dose.

The pictures come from public channels (such as the official website of the FDA, the official website of the original drug manufacturer, etc.) and are for reference only.

Usage of Itramod (Etrasimod) for special groups

1. Pregnancy

According to findings from animal studies, pregnant women taking Etrasimod may cause harm to the fetus. Existing data from pregnancy reports in the itrimod clinical development program are insufficient to determine the risk of drug-related major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Increased disease activity of inflammatory bowel disease during pregnancy poses risks to mother and fetus.

2. Lactation period

There are no data on whether itrimod is present in human milk, its effects on breastfed infants, or its effects on milk production. When itrimod was administered orally to female rats during pregnancy and lactation, itrimod was detected in the plasma of the offspring, suggesting that itrimod is excreted in milk.

The developmental and health benefits of breastfeeding should be considered, taking into account the mother's clinical need for istrimod and any potential adverse effects of itrimod or the underlying maternal condition on the breastfed infant.

3. Women of childbearing potential

Before initiating treatment with istrimod, women of childbearing potential should be informed of the serious potential risks to the fetus and the need to use effective contraception during treatment with istrimod and for one week after the last dose.

4. Pediatric use

The safety and effectiveness of itrimod in pediatric patients have not been determined.

5. Medication for the elderly

Clinical studies of istrimod did not include sufficient numbers of subjects aged 65 and older to determine whether they responded differently than younger adult subjects. The pharmacokinetics of istrimod in subjects 65 years of age and older are similar to those in younger adult subjects.

6. Liver function impairment

The exposure of itrimod in subjects with mild and moderate hepatic impairment (Child-Pugh Class A and B) is similar to that in subjects with normal liver function. The exposure of itridimod in subjects with severe hepatic impairment (Child-Pugh Class C) is increased compared with subjects with normal liver function.

Itrimod is not recommended for use in patients with severe hepatic impairment, and no dose adjustment is required in patients with mild to moderate hepatic impairment.

7. Poor metabolizers of CYP2C9

For poor metabolizers of CYP2C9, concurrent use of moderate to strong inhibitors of CYP2C8 or CYP3A4 is expected to increase the exposure of itridimod. Concomitant use of istrimod is not recommended in these patients.