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Drug overview for OTEZLA XR (apremilast):
Generic name: APREMILAST (a-PRE-mi-last)
Drug class: Antipsoriatics
Therapeutic class: Analgesic, Anti-inflammatory or Antipyretic
Apremilast, a selective phosphodiesterase type 4 (PDE4) inhibitor, is a disease-modifying antirheumatic drug (DMARD).
No enhanced Uses information available for this drug.
Generic name: APREMILAST (a-PRE-mi-last)
Drug class: Antipsoriatics
Therapeutic class: Analgesic, Anti-inflammatory or Antipyretic
Apremilast, a selective phosphodiesterase type 4 (PDE4) inhibitor, is a disease-modifying antirheumatic drug (DMARD).
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for OTEZLA XR (apremilast) have been approved by the FDA:
Indications:
Moderate to severe plaque psoriasis
Oral ulcers associated with Behcet's disease
Psoriatic arthritis
Professional Synonyms:
Psoriasis arthropica
Psoriatic arthropathy
Indications:
Moderate to severe plaque psoriasis
Oral ulcers associated with Behcet's disease
Psoriatic arthritis
Professional Synonyms:
Psoriasis arthropica
Psoriatic arthropathy
The following dosing information is available for OTEZLA XR (apremilast):
No enhanced Dosing information available for this drug.
Administer apremilast orally without regard to meals. Do not crush, split, or chew tablets.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| OTEZLA XR 75 MG TABLET | Maintenance | Adults take 1 tablet (75 mg) by oral route once daily |
No generic dosing information available.
The following drug interaction information is available for OTEZLA XR (apremilast):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Apremilast; Roflumilast/Strong CYP3A4 Inducers SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: CYP3A4 inducers may induce the metabolism of apremilast(1) and roflumilast(2,3) by CYP3A4. CLINICAL EFFECTS: Concurrent or recent use of strong CYP3A4 inducers may reduce the clinical effectiveness of apremilast(1) and roflumilast.(2,3) PREDISPOSING FACTORS: Induction effects may be more likely with regular use of the inducer for longer than 1-2 weeks. PATIENT MANAGEMENT: Monitor patients receiving concurrent CYP3A4 inducers for decreased apremilast(1) and roflumilast(2,3) efficacy. Concurrent use is not recommended.(1,2) The dosage of roflumilast may need to be adjusted or additional COPD therapy may need to be adjusted during and for up to two weeks after therapy with a CYP3A4 inducer has been completed. DISCUSSION: Pretreatment with rifampin (600 mg daily for 15 days) decreased the maximum concentration (Cmax) and area-under-curve (AUC) of a single dose of apremilast by 43% and 72%, respectively.(1) In an open-label study in 16 healthy males, rifampin (600 mg daily) decreased AUC and Cmax of a single dose of roflumilast (500 mcg) by 80% and 68%, respectively. The AUC and Cmax of roflumilast N-oxide decreased by 56% and 30%, respectively.(2) The total PDE4 inhibitory activity of roflumilast decreased by 60%.(2-4) Strong CYP3A4 inducers linked to this monograph include: apalutamide, barbiturates, carbamazepine, encorafenib, enzalutamide, fosphenytoin, ivosidenib, lumacaftor, mitotane, natisedine, phenobarbital, phenytoin, primidone, rifampin, rifapentine and St. John's wort. |
ASA-BUTALB-CAFFEINE-CODEINE, ASCOMP WITH CODEINE, BRAFTOVI, BUTALB-ACETAMINOPH-CAFF-CODEIN, BUTALBITAL, BUTALBITAL-ACETAMINOPHEN, BUTALBITAL-ACETAMINOPHEN-CAFFE, BUTALBITAL-ASPIRIN-CAFFEINE, CARBAMAZEPINE, CARBAMAZEPINE ER, CARBATROL, CEREBYX, DILANTIN, DILANTIN-125, DONNATAL, EQUETRO, ERLEADA, FIORICET, FOSPHENYTOIN SODIUM, LYSODREN, MITOTANE, MYSOLINE, ORKAMBI, PENTOBARBITAL SODIUM, PHENOBARBITAL, PHENOBARBITAL SODIUM, PHENOBARBITAL-BELLADONNA, PHENOBARBITAL-HYOSC-ATROP-SCOP, PHENOHYTRO, PHENYTEK, PHENYTOIN, PHENYTOIN SODIUM, PHENYTOIN SODIUM EXTENDED, PRIFTIN, PRIMIDONE, RIFADIN, RIFAMPIN, SEZABY, TEGRETOL, TEGRETOL XR, TENCON, TIBSOVO, XTANDI |
There are 0 moderate interactions.
The following contraindication information is available for OTEZLA XR (apremilast):
Drug contraindication overview.
*Known hypersensitivity to apremilast or any ingredient in the formulation.
*Known hypersensitivity to apremilast or any ingredient in the formulation.
There are 0 contraindications.
There are 3 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
| Depression |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Weight loss |
The following adverse reaction information is available for OTEZLA XR (apremilast):
Adverse reaction overview.
Adverse effects reported in >=5% of patients receiving apremilast for active psoriatic arthritis include diarrhea, nausea, and headache. Adverse effects reported in >=5% of patients receiving apremilast for plaque psoriasis include diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache. Adverse effects reported in >=10% of patients receiving apremilast for Behcet disease include diarrhea, nausea, headache, and upper respiratory tract infection.
Adverse effects reported in >=5% of patients receiving apremilast for active psoriatic arthritis include diarrhea, nausea, and headache. Adverse effects reported in >=5% of patients receiving apremilast for plaque psoriasis include diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache. Adverse effects reported in >=10% of patients receiving apremilast for Behcet disease include diarrhea, nausea, headache, and upper respiratory tract infection.
There are 5 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Anaphylaxis Angioedema Hypersensitivity drug reaction Suicidal Suicidal ideation |
There are 22 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Diarrhea Headache disorder Nausea Upper respiratory infection Weight loss |
Arthralgia Back pain Depression Fatigue Insomnia Pharyngitis Upper abdominal pain Vomiting |
| Rare/Very Rare |
|---|
|
Anorexia Bronchitis Cough Dental abscess Dyspepsia Folliculitis Gastroesophageal reflux disease Migraine Skin rash |
The following precautions are available for OTEZLA XR (apremilast):
The efficacy and safety of apremilast have been established in pediatric patients >=6 years of age weighing >=20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. This indication for use is supported by results from a 52-week, well-controlled trial involving 245 pediatric patients (6-17 years of age). Safety and efficacy of apremilast have not been established in pediatric patients <6 years of age or weighing <20 kg with moderate to severe plaque psoriasis.
Safety and efficacy of apremilast have not been established in pediatric patients with psoriatic arthritis or oral ulcers associated with Behcet disease. Growth (height and weight) should be closely monitored in pediatric patients receiving apremilast. Treatment may need to be interrupted if pediatric patients are not growing or gaining weight as expected.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Safety and efficacy of apremilast have not been established in pediatric patients with psoriatic arthritis or oral ulcers associated with Behcet disease. Growth (height and weight) should be closely monitored in pediatric patients receiving apremilast. Treatment may need to be interrupted if pediatric patients are not growing or gaining weight as expected.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
In animal reproduction studies, administration of apremilast to cynomolgus monkeys during organogenesis resulted in dose-related increases in spontaneous abortion and embryofetal death at doses equivalent to 2.1 times the maximum recommended human dose. To monitor pregnancy outcomes in women who have been exposed to apremilast, a pregnancy registry has been established.
Information about the registry can be obtained by calling 877-311-8972 or visiting https://mothertobaby.org/ongoing-study/otezla/.
Information about the registry can be obtained by calling 877-311-8972 or visiting https://mothertobaby.org/ongoing-study/otezla/.
Apremilast is distributed into milk in mice; it is not known whether the drug is distributed into human milk. Consider the benefits of breast-feeding and the importance of apremilast to the patient along with potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.
In controlled clinical trials evaluating apremilast for the management of psoriatic arthritis, about 10% of patients were >=65 years of age, and about 1% were >=75 years of age. No overall differences in safety were observed between geriatric and younger adults. Similarly, no overall differences in efficacy and safety were observed between geriatric and younger adults in two placebo-controlled plaque psoriasis trials.
Following oral administration of a single 30-mg dose of apremilast, AUC and peak plasma concentrations of the drug were approximately 13 and 6% higher, respectively, in patients 65-85 years of age compared with those 18-55 years of age. Patients >=65 years of age should be monitored closely for volume depletion or hypotension resulting from treatment-related severe diarrhea, nausea, or vomiting.
Following oral administration of a single 30-mg dose of apremilast, AUC and peak plasma concentrations of the drug were approximately 13 and 6% higher, respectively, in patients 65-85 years of age compared with those 18-55 years of age. Patients >=65 years of age should be monitored closely for volume depletion or hypotension resulting from treatment-related severe diarrhea, nausea, or vomiting.
The following prioritized warning is available for OTEZLA XR (apremilast):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for OTEZLA XR (apremilast)'s list of indications:
| Moderate to severe plaque psoriasis | |
| L40.0 | Psoriasis vulgaris |
| L40.8 | Other psoriasis |
| 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 |
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