Apremilast is an oral medication prescribed for adults with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. It is also approved for pediatric patients aged 6 years and older, weighing at least 20 kg, with moderate to severe plaque psoriasis.
Below are the dosages of Apremilast, marketed as Otezla and Aprezo, as per the FDA’s recommendations (source: OTEZLA (apremilast) Label – accessdata.fda.gov):
Adult Dosing Schedule
Apremilast treatment begins with a 5-day titration period to minimize gastrointestinal side effects. The dosing schedule is as follows:
| Day | Dosage |
|---|---|
| Day 1 | 10 mg in the morning |
| Day 2 | 10 mg in the morning and 10 mg in the evening |
| Day 3 | 10 mg in the morning and 20 mg in the evening |
| Day 4 | 20 mg in the morning and 20 mg in the evening |
| Day 5 | 20 mg in the morning and 30 mg in the evening |
| Day 6 and onward | 30 mg in the morning and 30 mg in the evening (total of 60 mg per day) |
This titration schedule helps reduce the risk of gastrointestinal symptoms associated with the initiation of therapy.
Pediatric Dosing Schedule
For pediatric patients aged 6 years and older with moderate to severe plaque psoriasis, dosing is based on body weight:
Children weighing 50 kg or more
| Day | Dosage |
|---|---|
| Day 1 | 10 mg in the morning |
| Day 2 | 10 mg in the morning and 10 mg in the evening |
| Day 3 | 10 mg in the morning and 20 mg in the evening |
| Day 4 | 20 mg in the morning and 20 mg in the evening |
| Day 5 | 20 mg in the morning and 30 mg in the evening |
| Day 6 and onward | 30 mg in the morning and 30 mg in the evening |
Children weighing 20 kg to less than 50 kg:
| Day | Dosage |
|---|---|
| Day 1 | 10 mg in the morning |
| Day 2 | 10 mg in the morning and 10 mg in the evening |
| Day 3 | 10 mg in the morning and 20 mg in the evening |
| Day 4 | 20 mg in the morning and 20 mg in the evening |
| Day 5 | 20 mg in the morning and 20 mg in the evening |
| Day 6 and onward | 20 mg in the morning and 20 mg in the evening |
This dosing regimen is designed to reduce gastrointestinal symptoms during the initiation of therapy.
Dose Adjustments for Severe Renal Impairment
In adult patients with severe renal impairment (creatinine clearance less than 30 mL/min), the dosing schedule is modified:
- Initial titration: Use only the morning doses as per the standard titration schedule, skipping the evening doses.
- Maintenance dose: 30 mg once daily in the morning.
For pediatric patients with severe renal impairment:
Children weighing 50 kg or more
- Initial titration: Use only the morning doses as per the standard titration schedule, skipping the evening doses.
- Maintenance dose: 30 mg once daily in the morning.
Children weighing 20 kg to less than 50 kg
- Initial titration: Use only the morning doses as per the standard titration schedule, skipping the evening doses.
- Maintenance dose: 20 mg once daily in the morning.
These adjustments are necessary due to reduced drug clearance in patients with severe renal impairment.
Administration Guidelines
- Apremilast tablets should be swallowed whole and not crushed, split, or chewed.
- The medication can be taken with or without food.
- Consistency in taking the medication at the same times each day is recommended.
Following the prescribed dosing schedule and administration guidelines is important for the effectiveness of apremilast in managing plaque psoriasis.
Where to buy Oral Apremilast
Here are the most reliable and trusted sites where you can purchase Oral Apremilast (Aprezo):