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OTEZLA (APREMILAST)
- Moderate to severe plaque psoriasis
- Oral ulcers associated with behcet's disease
- Psoriatic arthritis
30 mg tablet
- 1 tablet (30 mg) by oral route 2 times per day approximately 12 hours apart
Starter 10 mg (4)-20 mg (4)-30 mg(19) tablets in a dose pack
- Dosage information is not available
Starter 10 mg (4)-20 mg (4)-30 mg(47) tablets in a dose pack
- Dosage information is not available
Moderate to severe plaque psoriasis
- 1 tablet (30 mg) by oral route 2 times per day approximately 12 hours apart
Oral ulcers associated with behcet's disease
- 1 tablet (30 mg) by oral route 2 times per day approximately 12 hours apart
Psoriatic arthritis
- 1 tablet (30 mg) by oral route 2 times per day approximately 12 hours apart
- None
Contraindicated
- None
Severe
Moderate
- Belladonna-phenobarbital
- carbamazepine
- Carbatrol
- Cerebyx
- Dilantin
- Dilantin Extended
- Dilantin Infatabs
- Dilantin Kapseal
- Dilantin-125
- Donnatal
- enzalutamide
- Epitol
- Equetro
- fosphenytoin
- isoniazid-rifamp-pyrazinamide
- Luminal
- Mysoline
- phenobarb-hyoscy-atropine-scop
- phenobarbital
- phenobarbital sodium
- Phenytek
- phenytoin
- phenytoin sodium
- phenytoin sodium extended
- primidone
- Rifadin
- Rifamate
- rifampin
- rifampin-isoniazid
- Rifater
- Tegretol
- Tegretol Xr
- Xtandi
- None
Contraindicated
- Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
- Chronic kidney disease stage 5 (failure) GFr<15 ml/min
- Depression
Severe
Moderate
- Weight loss
OTEZLA (APREMILAST)
- Moderate to severe plaque psoriasis
- Oral ulcers associated with behcet's disease
- Psoriatic arthritis
- None
- Diarrhea
- Headache disorder
- Nausea
- Upper respiratory infection
- Weight loss
More Frequent
Severe
Less Severe
- Depression
- Arthralgias
- Back pain
- Pharyngitis
- Upper abdominal pain
- Vomiting
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Hypersensitivity drug reaction
- Suicidal
- Suicidal ideation
Less Severe
- Anorexia
- Cough
- Dyspepsia
- Gastroesophageal reflux disease
- Migraine
- Skin rash
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Apremilast
No safety and effectiveness established in pediatrics.
- 1 Day – 18 Years
- No safety and effectiveness established in pediatrics.
Apremilast
- Severity Level:
2
- Additional Notes: Insufficient human data available
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Apremilast
Insufficient human data; excreted in mice
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Insufficient human data; excreted in mice |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- None
| Moderate to severe plaque psoriasis | |
| L40.0 | Psoriasis vulgaris |
| L40.9 | Psoriasis, unspecified |
| Oral ulcers associated with behcet's disease | |
| M35.2 | Behcet's disease |
| Psoriatic arthritis | |
| L40.5 | Arthropathic psoriasis |
| L40.50 | Arthropathic psoriasis, unspecified |
| L40.51 | Distal interphalangeal psoriatic arthropathy |
| L40.52 | Psoriatic arthritis mutilans |
| L40.53 | Psoriatic spondylitis |
| L40.54 | Psoriatic juvenile arthropathy |
| L40.59 | Other psoriatic arthropathy |
| 0-9 | A-Z |
|---|---|
| L40.0 | Psoriasis vulgaris |
| L40.5 | Arthropathic psoriasis |
| L40.50 | Arthropathic psoriasis, unspecified |
| L40.51 | Distal interphalangeal psoriatic arthropathy |
| L40.52 | Psoriatic arthritis mutilans |
| L40.53 | Psoriatic spondylitis |
| L40.54 | Psoriatic juvenile arthropathy |
| L40.59 | Other psoriatic arthropathy |
| L40.9 | Psoriasis, unspecified |
| M35.2 | Behcet's disease |
Formulary Reference Tool