Tretinoin is an all trans retinoic acid oral capsule preparation, belonging to the class of vitamin A compounds. It exerts therapeutic effects by inducing differentiation and inhibiting proliferation of acute promyelocytic leukemia (APL) cells, and is suitable for APL patients with specific genetic characteristics.

1、 Drug name

Retinoic acid capsules, trade name VESANOID

2、 Indications

Used to induce remission of acute promyelocytic leukemia (APL) in adults and children aged 1 year and above, suitable for patients with t (15; 17) translocation or PML/RAR α gene expression characteristics, who are resistant or recurrent to anthracycline chemotherapy, or contraindicated to anthracycline chemotherapy.

3、 Specifications and characteristics

20mg capsules.

4、 Main components

Active ingredient: Retinoic acid (all trans retinoic acid)

5、 Usage and dosage

1. Recommended dosage: 22.5mg/m2 orally, twice daily, until complete remission.

2. Discontinuation time: 30 days after achieving complete remission or 90 days after treatment, whichever comes first.

6、 Dose adjustment

1. When moderate to severe differentiation syndrome occurs, consider suspending medication until symptoms improve.

2. Consider interrupting, reducing, or discontinuing medication when intracranial hypertension occurs.

3. When the liver function test results increase to more than 5 times the upper limit of normal, consider suspending medication until recovery.

7、 Medication precautions

1. Take with meals.

2. Swallow the whole capsule, do not chew, dissolve or open the capsule.

3. Omission treatment: If there is less than 10 hours left before the next medication, it should not be taken again.

4. Vomiting treatment: After vomiting, there is no need to take the next dose according to the original plan.

8、 Medication for special populations

1. Pregnant women: There is a risk of embryo fetal toxicity, and it is contraindicated.

2. Breastfeeding period: It is not recommended to breastfeed during the treatment period and within one week after the last dose.

3. Women of childbearing age: A pregnancy test should be conducted before starting treatment, and two effective contraceptive measures should be taken during the treatment period and one month after the last dose.

4. Men: Effective contraceptive measures should be taken during the treatment period and one week after the last dose.

5. Children: The safety and effectiveness of children aged 1 year and above have been established.

9、 Adverse reactions

The most common adverse reactions (≥ 30%) include: headache, fever, dry skin/mucous membranes, bone pain, discomfort, chills, upper respiratory tract diseases, difficulty breathing, bleeding, infection, nausea/vomiting, rash, peripheral edema, leukocytosis, pain, gastrointestinal bleeding, chest discomfort, and abdominal pain.

10、 Contraindications

It is contraindicated for individuals allergic to retinoic acid, any of its components, or other retinoic acid drugs.

11、 Drug interactions

1. Avoid co administration with strong CYP3A inhibitors and inducers.

2. Avoid using with other products that can cause intracranial hypertension.

3. Avoid co administration with vitamin A.

4. Avoid using with anti fibrinolytic agents.

12、 Storage method

1. Stored at 20 ° C to 25 ° C, allowing fluctuations within the range of 15 ° C to 30 ° C.

2. Store in the dark and keep the bottle cap tightly closed.

Tretinoininformation