Apremilast tablets detailed instructions and usage and dosage

1. Common name: Apremilast, Apremilast

Product name: OTEZLA, OTEZLA

2. Indications:

1. Psoriatic arthritis (PSA): Apremilast is suitable for the treatment of adult patients with active psoriatic arthritis.

2. Plaque psoriasis: It is suitable for the treatment of adult patients with plaque psoriasis who receive phototherapy or systemic treatment; and pediatric patients aged 6 and above, weighing at least 20 kg, with moderate to severe plaque psoriasis, who are suitable for treatment of phototherapy or systemic treatment.

3. Oral ulcers associated withBehçet's disease: Applicable to the treatment of adult patients with oral ulcers associated withBehçet's disease.

3. Usage and dosage:

1. Recommended dosage:

To reduce gastrointestinal symptoms, the recommended dose of apremilast is 30 milligrams (mg) twice daily. During initial administration, the dosage can be gradually increased, such as 10 mg in the morning on the first day, 10 mg in the morning and 10 mg in the evening on the second day, 10 mg in the morning and 20 mg in the evening on the third day, 20 mg in the morning and 20 mg in the evening on the fourth day, 20 mg in the morning and 30 mg in the evening on the fifth day, and 30 mg in the morning and 30 mg in the evening on the sixth day and beyond. In patients with severe hepatic impairment, the dose should be reduced to 30 mg once daily.

2. Medication management: Take Apremilast tablets with or without food. Swallow slices whole. Do not crush, split or chew.

4. Adverse reactions:

In clinical studies, apremilast tablets were studied to treat psoriasis or psoriatic arthritis, including diarrhea, nausea, upper respiratory tract infections (nose and throat infections), and headaches. Among adults with Behçet's disease, the most common side effects include diarrhea, nausea, headache, upper respiratory tract infection, upper abdominal pain, vomiting, and back pain.

5. Supply and storage:

Apremilast tablets may be stored below 30°C (86°F).

6. Taboo:

Apremilast tablets are contraindicated in patients with known allergiesto Apremilast or any excipients in the formula.xa0

7. Mechanism of action:

Apremilast is an oral small molecule inhibitor of phosphodiesterase4 (PDE4), specific for cyclic adenosine monophosphate (cAMP) . PDE4 inhibition leads to an increase in intracellular cAMP levels. The specific mechanism by which apremilast exerts its therapeutic effects is unclear.

8. Listing situation:

Original drug:

United States: 2014-09-23, approved for marketing (trade name: Otezla)

EU:2015-01-15, approved for marketing (trade name: Otezla)

China: 2021-08-12, approved for listing (trade name: Otelac)

9. Price information:

Apremilast is already on the market in China and is covered by medical insurance, and can be purchased at local hospital pharmacies. Overseas, the original drug Apremilast has a European version, and the latest price is more than 10,000 yuan. There are officially launched generic versions of Apremilast in India and Laos. The latest price is about one to two hundred yuan (the price may fluctuate due to exchange rates), and the drug ingredients are basically the same as those of the original research.

Reference materials:https://go.drugbank.com/drugs/DB05676