apremilast (Rx)

Brand and Other Names:Otezla
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 10mg
  • 20mg
  • 30mg

Psoriatic Arthritis

Indicated for active psoriatic arthritis

Day 1: 10 mg PO in AM

Day 2: 10 mg PO AM and PM

Day 3: 10 mg PO AM and 20 PO mg PM

Day 4: 20 mg PO AM and PM

Day 5: 20 mg PO AM and 30 PO mg PM

Day 6 and thereafter: 30 PO mg BID

Plaque Psoriasis

Indicated for any severity of plaque psoriasis in adults who are candidates for phototherapy or systemic therapy

Day 1: 10 mg PO in AM

Day 2: 10 mg PO AM and PM

Day 3: 10 mg PO AM and 20 PO mg PM

Day 4: 20 mg PO AM and PM

Day 5: 20 mg PO AM and 30 mg PO PM

Day 6 and thereafter: 30 mg PO BID

Oral Ulcers associated with Behςet Disease

Indicated for oral ulcers associated with Behςet disease

Day 1: 10 mg PO in AM

Day 2: 10 mg PO AM and PM

Day 3: 10 mg PO AM and 20 mg PO PM

Day 4: 20 mg PO AM and PM

Day 5: 20 mg PO AM and 30 mg PO PM

Day 6 and thereafter: 30 mg PO BID

Dosage Modifications

Hepatic impairment: No dosage adjustment required

Renal impairment

  • Mild-to-moderate (CrCl ≥30): No dosage adjustment required
  • Severe (CrCl <30 mL/min)
    • Reduce dose to 30 mg PO qDay
    • For initial dosage titration, titrate using only the AM schedule listed above and skip the PM doses

Safety and efficacy not established

Ulcerative Colitis (Orphan)

Orphan designation for treatment of pediatric patients with ulcerative colitis

Sponsor

  • Celgene Corporation; 86 Morris Avenue Summit, New Jersey 07901
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Interactions

Interaction Checker

and apremilast

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            Contraindicated (0)

              Serious - Use Alternative (29)

              • abametapir

                abametapir will increase the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.

              • apalutamide

                apalutamide will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.

              • bosentan

                bosentan will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong CYP inducers results in a significant decrease of systemic exposure of apremilast, which may result in loss of efficacy

              • carbamazepine

                carbamazepine will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong CYP inducers results in a significant decrease of systemic exposure of apremilast, which may result in loss of efficacy

              • dabrafenib

                dabrafenib will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong CYP inducers results in a significant decrease of systemic exposure of apremilast, which may result in loss of efficacy

              • dexamethasone

                dexamethasone will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong CYP inducers results in a significant decrease of systemic exposure of apremilast, which may result in loss of efficacy

              • efavirenz

                efavirenz will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong CYP inducers results in a significant decrease of systemic exposure of apremilast, which may result in loss of efficacy

              • enzalutamide

                enzalutamide will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong CYP inducers results in a significant decrease of systemic exposure of apremilast, which may result in loss of efficacy

              • eslicarbazepine acetate

                eslicarbazepine acetate will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong CYP inducers results in a significant decrease of systemic exposure of apremilast, which may result in loss of efficacy

              • etravirine

                etravirine will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong CYP inducers results in a significant decrease of systemic exposure of apremilast, which may result in loss of efficacy

              • fexinidazole

                fexinidazole will increase the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.

              • fosphenytoin

                fosphenytoin will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong CYP inducers results in a significant decrease of systemic exposure of apremilast, which may result in loss of efficacy

              • idelalisib

                idelalisib will increase the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates

              • ivosidenib

                ivosidenib will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternate therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.

              • lonafarnib

                lonafarnib will increase the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration with sensitive CYP3A substrates. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling.

              • lopinavir

                lopinavir will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.

              • mitotane

                mitotane will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong CYP inducers results in a significant decrease of systemic exposure of apremilast, which may result in loss of efficacy

              • nafcillin

                nafcillin will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong CYP inducers results in a significant decrease of systemic exposure of apremilast, which may result in loss of efficacy

              • nevirapine

                nevirapine will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong CYP inducers results in a significant decrease of systemic exposure of apremilast, which may result in loss of efficacy

              • oxcarbazepine

                oxcarbazepine will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong CYP inducers results in a significant decrease of systemic exposure of apremilast, which may result in loss of efficacy

              • pentobarbital

                pentobarbital will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong CYP inducers results in a significant decrease of systemic exposure of apremilast, which may result in loss of efficacy

              • phenobarbital

                phenobarbital will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong CYP inducers results in a significant decrease of systemic exposure of apremilast, which may result in loss of efficacy

              • phenytoin

                phenytoin will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong CYP inducers results in a significant decrease of systemic exposure of apremilast, which may result in loss of efficacy

              • primidone

                primidone will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong CYP inducers results in a significant decrease of systemic exposure of apremilast, which may result in loss of efficacy

              • rifabutin

                rifabutin will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong CYP inducers results in a significant decrease of systemic exposure of apremilast, which may result in loss of efficacy

              • rifampin

                rifampin will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong CYP inducers results in a significant decrease of systemic exposure of apremilast, which may result in loss of efficacy

              • rifapentine

                rifapentine will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration with strong CYP inducers results in a significant decrease of systemic exposure of apremilast, which may result in loss of efficacy

              • secobarbital

                secobarbital will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • voxelotor

                voxelotor will increase the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.

              Monitor Closely (13)

              • amobarbital

                amobarbital will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • belzutifan

                belzutifan will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. If unable to avoid coadministration of belzutifan with sensitive CYP3A4 substrates, consider increasing the sensitive CYP3A4 substrate dose in accordance with its prescribing information.

              • cenobamate

                cenobamate will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.

              • elagolix

                elagolix will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.

              • encorafenib

                encorafenib, apremilast. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents.

              • fedratinib

                fedratinib will increase the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.

              • istradefylline

                istradefylline will increase the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.

              • lenacapavir

                lenacapavir will increase the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lencapavir may increase CYP3A4 substrates initiated within 9 months after last SC dose of lenacapavir, which may increase potential risk of adverse reactions of CYP3A4 substrates.

              • lorlatinib

                lorlatinib will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • rucaparib

                rucaparib will increase the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.

              • stiripentol

                stiripentol, apremilast. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.

              • tazemetostat

                tazemetostat will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • tecovirimat

                tecovirimat will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.

              Minor (6)

              • acetazolamide

                acetazolamide will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • anastrozole

                anastrozole will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • cyclophosphamide

                cyclophosphamide will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • larotrectinib

                larotrectinib will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • levoketoconazole

                levoketoconazole will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • ribociclib

                ribociclib will decrease the level or effect of apremilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

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              Adverse Effects

              >10% (Psoriasis and Psoriatic Arthritis)

              Diarrhea (7.7-17%)

              Nausea (7.4-17%)

              >10% (Behςet Disease)

              Diarrhea (41.3%)

              Nausea (19.2%)

              Headache (14.4%)

              Upper respiratory tract infection (11.5%)

              1-10% (Behςet Disease)

              Upper abdominal pain (8.7%)

              Vomiting (8.7%)

              Back pain (7.7%)

              Viral upper respiratory tract infection (6.7%)

              Arthralgia (5.8%)

              1-10% (Psoriasis and Psoriatic Arthritis)

              Upper respiratory tract infection (0.6-9%)

              Tension headache (8%)

              Headache (4.8-6%)

              Vomiting (0.8-4%)

              Fatigue (3%)

              Dyspepsia (3%)

              Decreased appetite (3%)

              Insomnia (2%)

              Back pain (2%)

              Migraine (2%)

              Frequent bowel movements (2%)

              Depression (1%)

              Bronchitis (1%)

              Tooth abscess (1%)

              Folliculitis (1%)

              Frequency Not Defined (Psoriasis and Psoriatic Arthritis)

              Immune system disorders: Hypersensitivity

              Investigations: Weight decrease

              Gastrointestinal disorders: Frequent bowel movement, gastroesophageal reflux disease, dyspepsia

              Metabolism and nutrition disorders: Decreased appetite

              Nervous system disorders: Migraine

              Respiratory, thoracic, and mediastinal disorders: Cough

              Skin and SC tissue disorders: Rash

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              Warnings

              Contraindications

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

              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 yr 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
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              Pregnancy & Lactation

              Pregnancy

              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 pregnancyRegistry information can be obtained by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/otezla

              Animal data

              • In a pre- and postnatal study in mice, apremilast was administered to pregnant female mice at doses of 10, 80, or 300 mg/kg/day from Day 6 of gestation through Day 20 of lactation, with weaning on Day 21
              • Dystocia, reduced viability, and reduced birth weights occurred at doses corresponding to ≥4-times the MRHD (on an AUC basis at doses ≥80 mg/kg/day)
              • No adverse effects occurred at a dose 1.3- times the MRHD (10 mg/kg/day)No evidence for functional impairment of physical development, behavior, learning ability, immune competence, or fertility in the offspring at doses up to 7.5-times the MRHD (on an AUC basis at a dose of 300 mg/kg/day)
              • Apremilast distributed across the placenta into the fetal compartment in mice and monkeys
              • Advise pregnant women of the potential risk of fetal lossConsider pregnancy planning and prevention for females of reproductive potential

              Lactation

              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

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Oral small molecule inhibitor of phosphodiesterase-4 specific for cAMP, resulting in increased intracellular cAMP levels

              The specific mechanism by which apremilast exerts it therapeutic action in psoriatic arthritis is not well defined

              Absorption

              Absolute bioavailability: 73%

              Peak plasma time: 2.5 hr

              Coadministration with food does not alter absorption

              Distribution

              Protein bound: 68%

              Vd: 87 L

              Metabolism

              Apremilast is a major circulating component (45%) followed by inactive metabolite M12 (39%), a glucuronide conjugate of O-demethylated apremilast

              Metabolized by both CYP oxidative metabolism with subsequent glucuronidation and non-CYP mediated hydrolysis

              In vitro CYP metabolism primarily by CYP3A4, with minor contribution from CYP1A2 and CYP2A6

              Elimination

              Half-life: 6-9 hr

              Clearance: 10 L/hr

              Excretion: 58% urine; 39% feces

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              Administration

              Oral Administration

              To reduce risk of GI symptoms associated with initial therapy, titrate to recommended dose (30 mg PO BID) according to the dosage schedules listed above

              Can be administered without regard to meals

              Swallow tablet whole; do not crush, split, or chew

              Storage

              Store below 30ºC (86ºF)

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Otezla Starter oral
              -
              10 mg (4)-20 mg (4)-30 mg(19) tablet
              Otezla Starter oral
              -
              10 mg (4)-20 mg (4)-30 mg (47) tablet
              Otezla Starter oral
              -
              10 mg (4)-20 mg (4)-30 mg (47) tablet
              Otezla oral
              -
              30 mg tablet

              Copyright © 2010 First DataBank, Inc.

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              Formulary

              FormularyPatient Discounts

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              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.