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Otezla
apremilast
Adult Dosing .
Dosage forms: TAB: 30 mg; 28-day convenience pack
Dosage Form Details
- [28-day (30 mg bid dose) convenience pack components]
- Info: 28-day starter pack contains 10 mg tab x4 and 20 mg tab x4 and 30 mg tab x47
psoriatic arthritis
- [30 mg PO bid]
- Start: 10 mg PO qam x1 day, then 10 mg PO bid x1 day, then 10 mg PO qam and 20 mg PO qpm x1 day, then 20 mg PO bid x1 day, then 20 mg PO qam and 30 mg PO qpm x1 day, then 30 mg PO bid; Info: do not cut/crush/chew tab
psoriasis, plaque
- [30 mg PO bid]
- Start: 10 mg PO qam x1 day, then 10 mg PO bid x1 day, then 10 mg PO qam and 20 mg PO qpm x1 day, then 20 mg PO bid x1 day, then 20 mg PO qam and 30 mg PO qpm x1 day, then 30 mg PO bid; Info: do not cut/crush/chew tab
oral ulcers, Behcet dz-assoc.
- [30 mg PO bid]
- Start: 10 mg PO qam x1 day, then 10 mg PO bid x1 day, then 10 mg PO qam and 20 mg PO qpm x1 day, then 20 mg PO bid x1 day, then 20 mg PO qam and 30 mg PO qpm x1 day, then 30 mg PO bid; Info: do not cut/crush/chew tab
renal dosing
- [adjust dose frequency]
- CrCl <30: start 10 mg qam x3 days, then 20 mg qam x2 days, then 30 mg qd
- HD/PD: not defined
hepatic dosing
- [no adjustment]
Peds Dosing .
- Dosage forms: TAB: 20 mg, 30 mg; 28-day convenience packs
Dosage Form Details
- [28-day (20 mg bid dose) convenience pack components]
- Info: 28-day starter pack contains 10 mg tab x4 and 20 mg tab x51
- [28-day (30 mg bid dose) convenience pack components]
- Info: 28-day starter pack contains 10 mg tab x4 and 20 mg tab x4 and 30 mg tab x47
psoriatic arthritis
- [6 yo and older, 20-49.9 kg]
- Dose: 20 mg PO bid; Start: 10 mg PO qam x1 day, then 10 mg PO bid x1 day, then 10 mg PO qam and 20 mg PO qpm x1 day, then 20 mg PO bid; Info: do not cut/crush/chew tab
- [6 yo and older, >50 kg]
- Dose: 30 mg PO bid; Start: 10 mg PO qam x1 day, then 10 mg PO bid x1 day, then 10 mg PO qam and 20 mg PO qpm x1 day, then 20 mg PO bid x1 day, then 20 mg PO qam and 30 mg PO qpm x1 day, then 30 mg PO bid; Info: do not cut/crush/chew tab
psoriasis, mod-severe plaque
- [6 yo and older, 20-49.9 kg]
- Dose: 20 mg PO bid; Start: 10 mg PO qam x1 day, then 10 mg PO bid x1 day, then 10 mg PO qam and 20 mg PO qpm x1 day, then 20 mg PO bid; Info: do not cut/crush/chew tab
- [6 yo and older, >50 kg]
- Dose: 30 mg PO bid; Start: 10 mg PO qam x1 day, then 10 mg PO bid x1 day, then 10 mg PO qam and 20 mg PO qpm x1 day, then 20 mg PO bid x1 day, then 20 mg PO qam and 30 mg PO qpm x1 day, then 30 mg PO bid; Info: do not cut/crush/chew tab
renal dosing
- [20-49.9 kg]
- CrCl <30: start 10 mg qam x3 days, then 20 mg qd
- HD/PD: not defined
- [>50 kg]
- CrCl <30: start 10 mg qam x3 days, then 20 mg qam x2 days, then 30 mg qd
- HD/PD: not defined
hepatic dosing
- [no adjustment]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- caution: patients 65 yo and older
- caution: patients of childbearing potential
- caution: CrCl <30
- caution: volume depletion
- caution: hypotension
- caution: depression history
- caution: suicidality history
Drug Interactions .
Overview
apremilast
PDE4 inhibitor
- CYP3A4 substrate
Avoid/Use Alternative
- apalutamide
- butalbital
- carbamazepine
- encorafenib
- enzalutamide
- fosphenytoin
- ivosidenib
- lumacaftor/ivacaftor
- mitotane
- pentobarbital
- phenobarbital
- phenytoin
- primidone
- rifabutin
- rifampin
- St. John's wort
Caution Advised
- bosentan
- cenobamate
- dabrafenib
- efavirenz
- etravirine
- fexinidazole
- lopinavir/ritonavir
- lorlatinib
- mavacamten
- mitapivat
- modafinil
- nafcillin
- pacritinib
- pexidartinib
- repotrectinib
- rifapentine
- sotorasib
Adverse Reactions .
Serious Reactions
- hypersensitivity rxn
- anaphylaxis
- angioedema
- diarrhea, severe
- vomiting, severe
- depression
- suicidal ideation
Common Reactions
- diarrhea
- nausea
- headache
- weight loss
- URI
- vomiting
- abdominal pain
- back pain
- arthralgia
- fatigue
- dyspepsia
- appetite decr.
- nasopharyngitis
- insomnia
- migraine
- bowel movement incr.
Safety/Monitoring .
Monitoring Parameters
Cr at baseline; weight; height (peds); s/sx depression, behavior changes, suicidality
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; inadequate human data available; risk of embryo-fetal death based on animal data at 2.1x MRHD and risk of skeletal variations, incl. incomplete ossification at 2.3x MRHD
Pregnancy Registry
encourage patients to enroll in MotherToBaby Pregnancy Studies at 1-877-311-8972 or www.mothertobaby.org/ongoing-study/otezla/
Individuals of Reproductive Potential
weigh risk/benefit in patients of childbearing potential; consider using effective contraception during tx
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm, though possible drug excretion into milk based on drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: oxidation, glucuronidation, hydrolysis; CYP450: 1A2, 2A6, 3A4 (primary) substrate
Excretion: urine 58% (3% unchanged), feces 39% (7% unchanged); Half-life: 6-9h
Subclass: Phosphodiesterase 4 (PDE4) Inhibitors, Dermatologic ; Phosphodiesterase 4 (PDE4) Inhibitors, Rheumatologic ; Psoriasis, Systemic Agents ; Spondyloarthropathies
Mechanism of Action
exact mechanism of action unknown; selectively inhibits phosphodiesterase type 4 (PDE4), leading to increased intracellular cAMP levels
Formulary .
No Formulary Selected
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