Apremilast

Apremilast is a prescription medication used to treat Psoriatic Arthritis, Plaque Psoriasis, and Oral Ulcers associated with Behςet Disease

• Apremilast is available under the following different brand names: Otezla

Adult dosage

Tablet

• 10 mg
• 20 mg
• 30 mg

Psoriatic Arthritis 

Adult dosage

• Day 1: 10 mg orally in the morning
• Day 2: 10 mg orally in the morning and in the evening
• Day 3: 10 mg orally in the morning and 20 mg orally in the evening
• Day 4: 20 mg orally in the morning and in the evening
• Day 5: 20 mg orally in the morning and 30 mg orally in the evening
• Day 6 and thereafter: 30 mg orally twice daily

Plaque Psoriasis

Adult dosage

• Day 1: 10 mg orally in the morning
• Day 2: 10 mg orally in the morning and in the evening
• Day 3: 10 mg orally in the morning and 20 mg orally in the evening
• Day 4: 20 mg orally in the morning and in the evening
• Day 5: 20 mg orally in the morning and 30 mg orally in the evening
• Day 6 and thereafter: 30 mg orally twice daily

Oral Ulcers associated with Behςet Disease

Adult dosage

• Day 1: 10 mg orally in the morning
• Day 2: 10 mg orally in the morning and in the evening
• Day 3: 10 mg orally in the morning and 20 mg orally in the evening
• Day 4: 20 mg orally in the morning and in the evening
• Day 5: 20 mg orally in the morning and 30 mg orally in the evening
• Day 6 and thereafter: 30 mg orally twice daily

Dosage Considerations – Should be Given as Follows: 

• See "Dosages."

Common side effects of Apremilast include:

• nausea, 
• diarrhea, 
• headache, 
• stuffy nose, 
• sneezing, and,
• sore throat 

Serious side effects of Apremilast include:

• hives, 
• difficult breathing, 
• swelling in the face or throat, 
• severe diarrhea, 
• nausea, 
• vomiting, 
• unexplained weight loss, 
• mood changes, 
• new or worsening depression, and
• thoughts of self-harm

Rare side effects of Apremilast include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Apremilast has severe interactions with no other drugs.
• Apremilast has serious interactions with at least 30 other drugs. 
• Apremilast has moderate interactions with at least 11 other drugs.
• Apremilast has minor interactions with the following drug:
  • ribociclib 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• Hypersensitivity to apremilast or to any of the excipients in the formulation

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Apremilast?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Apremilast?”

Cautions

• Hypersensitivity reactions, including angioedema and anaphylaxis, reported; with known hypersensitivity to apremilast; if signs or symptoms of serious hypersensitivity reactions develop during treatment, discontinue and institute appropriate therapy
• Associated with an increase in adverse reactions of depression; before using, evaluate patient for history of depression and/or suicidal thoughts or behavior
• Weight decrease of 5-10% of body weight reported in 10-12% of patients
• Because patients 65 years of age or older may be at a higher risk of complications such as volume depletion or hypotension from severe diarrhea, nausea, or vomiting, monitor geriatric patients closely for such complications
• Severe GI adverse effects
  • Severe diarrhea, nausea, and vomiting reported; mostly occurred within the first few weeks of treatment
  • In some cases, patients were hospitalized
  • Patients aged 65 years of age and older and patients taking medications that cause volume depletion or hypotension may be at a higher risk of these complications; monitor those who are more susceptible to complications of diarrhea or vomiting
  • Quick improvement observed with dosage reduction or discontinuation; consider dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting
• Drug interaction overview
  • Coadministration with strong CYP inducers (eg, rifampin, carbamazepine, phenobarbital phenytoin) may occur and result in a loss of efficacy of apremilast; therefore, coadministration is not recommended

Pregnancy and Lactation

• Available pharmacovigilance data use in pregnant women have not established a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes, but data are extremely limited
• Based on findings from animal reproduction studies, may increase the risk for fetal loss
• Pregnancy exposure registry
  • Registry monitors pregnancy outcomes in women exposed to apremilast during pregnancy Registry information can be obtained by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/otezla
• There are no data on the presence of apremilast in human milk, the effects on the breastfed infant, or the effects on milk production
• Detected in the milk of lactating mice
• Consider developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed infant or from the underlying maternal condition