Apremilast
Apremilast is an oral immunosuppressant medication that works by inhibiting phosphodiesterase 4 (PDE4), an enzyme that breaks down cyclic adenosine monophosphate (cAMP). By increasing cAMP levels inside immune cells, it helps reduce inflammation and is used to treat certain autoimmune conditions.
Apremilast is an oral PDE4 inhibitor used to treat autoimmune inflammatory conditions like psoriasis and psoriatic arthritis by modulating immune response.
Key facts at a glance
- ATC
- L04AA32
- RxNorm
- 1492727
- Generic
- Apremilast
- Class
- atc-l04
- Brands
- Otezla
- Availability
- rx
- Lactation
- unknown
- Routes
- oral
- Forms
- tablet
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 30mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- not indicated for patients under 18 years
- Maximum
- consult physician
- Frequency
- not applicable
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 30mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
7 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second third trimesteravoid
discontinue therapy if pregnancy occurs
fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingnot recommended
do not breastfeed during treatment and for at least 5 days after last dose
monitor infant for adverse effects
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
under 18 yearsnot established
not recommended for patients under 18 years due to lack of safety data
not applicable
geriatric
elderly 65 years and olderno specific adjustment required
use with caution due to increased sensitivity monitor for adverse effects
regular monitoring of renal function and weight
Use with caution and monitor for adverse effects.
renal_impairment
severe renal impairmentreduce dose to 30mg once daily
use reduced dose in severe renal impairment and monitor closely
monitor renal function regularly
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate severe hepatic impairmentno specific adjustment
use with caution in moderate to severe hepatic impairment
monitor liver function tests
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Apremilast is a selective PDE4 inhibitor that works by increasing cyclic adenosine monophosphate (cAMP) levels
FDA approval year
Apremilast (Otezla) was approved by the FDA in March 2014
Primary indications
Approved for treatment of plaque psoriasis and psoriatic arthritis in adults
Common therapeutic use
Used for moderate to severe plaque psoriasis and active psoriatic arthritis
Apremilast is approved for the treatment of moderate to severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, and oral ulcers associated with Behçet's disease.
Apremilast selectively inhibits PDE4, an enzyme that normally breaks down cAMP. This inhibition leads to increased intracellular cAMP levels in immune cells, which modulates the production of pro-inflammatory and anti-inflammatory mediators, ultimately reducing inflammatory responses.
As an immunosuppressant, apremilast may increase the risk of infections. Common side effects include diarrhea, nausea, and headache, particularly during the first few weeks of treatment. Regular monitoring and dose titration are typically recommended when starting therapy.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy