CYP inducers (eg, rifampin, carbamazepine, phenobarbital phenytoin) may occur and result in a loss of efficacy of apremilast; therefore, coadministration is not recommended 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 conditionPregnancy 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. 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 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) BRAND FORM. UNIT PRICE PILL IMAGE Otezla oral- 30 mg tabletOtezla Starter oral- 10 mg (4)-20 mg (4)-30 mg (47) tabletOtezla Starter oral- 10 mg (4)-20 mg (4)-30 mg (47) tabletOtezla Starter oral- 10 mg (4)-20 mg (4)-30 mg(19) tabletCopyright © 2010 First DataBank, Inc.Print Patient Educationapremilast oral APREMILAST - ORAL (a-PRE-mi-last) COMMON BRAND NAME(S): Otezla USES: This medication is used to treat a certain type of arthritis (psoriatic arthritis). Apremilast is also used to treat a certain type of skin condition (moderate to severe plaque psoriasis). Apremilast belongs to a class of drugs known as phosphodiesterase 4 (PDE4) inhibitors. For the treatment of psoriatic arthritis, it decreases pain and swelling, and may help improve flexibility in the affected joints. For the treatment of plaque psoriasis, it may help to reduce the redness, thickening, and scaling of the skin that occurs with this condition.Apremilast is also used to treat mouth sores in people who have Behcet's disease. It helps to reduce the pain and improve the healing of these mouth sores. HOW TO USE: Take this medication by mouth with or without food as directed by your doctor, usually twice daily. The manufacturer directs not to crush, split, or chew the tablet before taking it. However, many similar drugs (immediate-release tablets) can be crushed, split, or chewed. Follow your doctor's directions on how to take this medication.The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.Tell your doctor if your condition does not improve or if it worsens. SIDE EFFECTS: Diarrhea, nausea/vomiting, loss of appetite, headache, or weight loss may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: severe nausea/vomiting/diarrhea.Rarely, people who take this medication may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. PRECAUTIONS: Before taking apremilast, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, mental/mood disorders (such as depression).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding. DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Other medications can affect the removal of apremilast from your body, which may affect how apremilast works. Examples include certain drugs used to treat seizures (such as carbamazepine, phenobarbital, phenytoin, primidone), rifamycins (such as rifampin, rifabutin), among others. OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. NOTES: Do not share this medication with others.Since this medication can cause weight loss, check your weight regularly while taking this drug. Tell your doctor of any unusual weight loss. MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. Information last revised March 2022. Copyright(c) 2023 First Databank, Inc. IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. 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. View explanations for tiers and restrictions 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 Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. QL Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered. ST Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription. OR Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription. 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