apremilast contraindications

23 metabolites of Apremilast have been identified in the urine, feces, and plasma. Apremilast is FDA approved for treating psoriatic arthritis in adult patients with moderately to severely active disease, plaque psoriasis in adult patients who are candidates for phototherapy Butalbital; Acetaminophen: (Major) The coadministration of apremilast and barbiturates is not recommended. Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Stevens-Johnson syndrome, rare cases of toxic epidermal necrolysis, and rash-related deaths; incidence 0.3-0.8% in 2-17 yo and 0.08%-0.3% in adults; age is only risk factor identified as predictive for risk of rash occurrence or severity; other risk factors may incl. Learn about side effects, warnings, dosage, and more. If signs or symptoms of a serious hypersensitivity reaction develops during treatment, discontinue use of the drug and institute appropriate therapy. Methohexital: (Major) The coadministration of apremilast and barbiturates is not recommended. Coadministration of another strong CYP450 inducer decreased the apremilast AUC and Cmax by 72% and 43%, respectively. Long-term studies were conducted in mice and rats with Apremilast to evaluate its carcinogenic potential. There are no data on the presence of Apremilast in human milk, the effects on the breastfed infant, or the effects on milk production. It may be prescribed when other drugs for psoriasis fail to provide relief from the symptoms. Weight decrease of 10% of body weight occurred in 2% (16/784) of subjects treated with Apremilast 30 mg twice daily compared to 1% (3/382) subjects treated with placebo. Your doctor must be made aware of your medical history and relevant personal details that can impact how Apremilast affects your body. The condition causes your skin cells to grow at least ten times faster than is usual - and build up as a result. Phosphodiesterase 4 inhibition reduces production of multiple cytokines involved in the pathogenesis of psoriasis. -20 min read. Common apremilast side effects may include: nausea, diarrhea; headache; or cold symptoms such as stuffy nose, sneezing, sore throat. Apremilast usually comes in tablet form and is generally taken twice daily. 3 5 WARNINGS AND PRECAUTIONS 5.1 Hypersensitivity Hypersensitivity reactions, including cases of angioedema and anaphylaxis, have been reported during post marketing surveillance. A similar reduction in systemic exposure may be seen with coadministration of apremilast and barbiturates which may result in a loss of efficacy of apremilast. Coadministration of rifampin, another strong CYP3A4 inducer, with a single dose of apremilast resulted in a decrease in apremilast AUC and Cmax by 72% and 43%, respectively. The main metabolite is O-desmethylapremilast glucuronide. Apremilast is an oral phosphodiesterase-4 (PDE-4) inhibitor or an immunosuppressant drug that is used to suppress the immune system and reduce inflammation. Drug Interactions: Patients already taking Rifampin, Phenytoin, and Carbamazepine may display reduced efficacy of Apremilast due to interactions between the two drugs. Aspirin, ASA; Butalbital; Caffeine: (Major) The coadministration of apremilast and barbiturates is not recommended. Apremilast is 68% bound to plasma proteins and has a mean volume of distribution of 87 L. Apremilast is a major circulating component (45%) followed by inactive metabolite M12 (39%), a glucuronide conjugate of O-demethylated apremilast. Contraindications. Review the mechanism of action (MOA), the clinical trial program, efficacy data, and safety information. Methods: Psoriatic arthritis patients (n=505) were evenly randomized into three groups: Crossover Designs: Crossover was indicated only for those patients on placebo. There was 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). Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first. Apremilast is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). 23,14 Metformin is considered an antihyperglycemic drug because it lowers blood glucose concentrations in type II diabetes without causing hypoglycemia. At doses 1.8-times the MRHD ( 20 mg/kg/day), estrous cycles were prolonged, due to lengthening of diestrus which resulted in a longer interval until mating. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. - Mouth Ulcers in Behets Disease: Apremilast is also indicated in adult patients (who may receive systemic therapy) with Behets disease for mouth ulcers. Depression was reported as serious in 0.1% (1/1,308) of subjects exposed to Apremilast, compared to none in placebo-treated subjects (0/506). Apremilast is metabolized primarily by CYP3A4, with minor metabolism by CYP1A2; barbiturates are strong CYP3A4 inducers and also induce CYP1A2. b. alcohol use during and x3 days after tx; disulfiram use w/in 14 days; Cockayne syndrome; avoid: breastfeeding x12-24h (2 g single-dose tx) caution: elderly pts; caution: hepatic impairment; caution: CNS disorder Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Using it simultaneously with strong P450 enzyme inducers, including rifampicin, phenobarbital, carbamazepine, phenytoin,[6] and St. John's wort is not recommended. Before using Apremilast tablets in patients with a history of depression and/or suicidal thoughts or behavior, prescribers should carefully weigh the risks and benefits of treatment with Apremilast tablets in such patients. This reduction in systemic exposure may result in a loss of efficacy of apremilast. The following conditions are contraindicated with this drug. The use of strong cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) with Apremilast tablets is not recommended [see Warnings and Precautions (5.4), Drug Interactions (7.1) and Clinical Pharmacology (12.3)]. In some patients, Apremilast does not cause any side effects and may be used for long-term treatment to keep their disease under control. Plasma protein binding is 68%. A similar reduction in systemic exposure may be seen with coadministration of apremilast and barbiturates which may result in a loss of efficacy of apremilast. In mice, there were no apremilast-induced malformations up to exposures 4-times the MRHD. Apremilast pharmacokinetics were characterized in subjects with mild, moderate, and severe renal impairment as defined by a creatinine clearance of 60 to 89, 30 to 59, and less than 30 mL per minute, respectively, by the CockcroftGault equation. Severe gastrointestinal symptoms, when they occur, typically start within the first few weeks of treatment. Rifampin is a strong CYP3A4 inducer and also induces CYP1A2 and CYP2D6. It is an oral small-molecule PDE4 inhibitor. A similar reduction in systemic exposure may be seen with coadministration of apremilast and barbiturates which may result in a loss of efficacy of apremilast. The median time to loss of PASI-75 response among the subjects re-randomized to placebo at Week 32 during the Randomized Treatment Withdrawal Phase was 5.1 weeks. Table 1: Recommended Dosing for the Prevention of Nausea and Vomiting Associated with HEC. Worsening of previous symptoms of depression - to be noted and brought to the doctor's attention. c. Co-administration With Food: No effect on the absorption of Apremilast. In addition, Apremilast exposure is similar among Hispanic Caucasians, non-Hispanic Caucasians, and African Americans. Avoid or Use Alternate Drug. Storage Xeljanz and Xeljanz XR should be stored in the original container at room temperature (68F to 77F/20C to 25C). [24], In 2020, Otezla generated US$2.2 billion for Amgen. Patients already suffering from depression need to be cautious when taking the drug. Dosage Form: Diamond-shaped, film-coated tablets. Apremilast is metabolized primarily by CYP3A4, with minor metabolism by CYP1A2; barbiturates are strong CYP3A4 inducers and also induce CYP1A2. [7], In the European Union, the drug is contraindicated during pregnancy because mice and monkeys receiving very high doses of apremilast have been observed to suffer miscarriages and other pregnancy problems. Check the individual New Zealand datasheet on the Medsafe website. If unexplained or clinically significant weight loss occurs, discontinuation of apremilast should be considered. Read your prescription carefully and contact your physician if you have any questions. However, alcohol consumption can worsen psoriasis and is, therefore, contraindicated in psoriatic patients. [Apremilast] [Apremilast] Ann Dermatol Venereol. Unexplained weight loss of over 10 % body weight must be reported to the doctor. Efficacy of apremilast in the treatment of moderate to severe psoriasis: a randomised controlled trial. Discuss this possibility with your doctor and keep an eye on your weight. FDA approval of Apremilast for oral ulcers in Behet's disease was obtained in July 2019. Ahmedabad 382213, INDIA, Distributed by: Although patches may also occur in other body parts, the elbows, knees, and scalp are commonly affected. Apremilast is metabolized by both cytochrome (CYP) oxidative metabolism with subsequent glucuronidation and non-CYP mediated hydrolysis. Change in Behet's Disease Quality of Life score from baseline (0 - 30 range): Higher scores implied diminished quality of life. Ensure that your medical and drug history is up-to-date, and carry this information with you when you visit your doctor or when you are out (in case of emergencies). Drug Des Devel Ther 2013; 7: 20110. In CLL, it has been used as both a first line and second line treatment. It is well-metabolized in humans. What Should You Discuss With Your Doctor Before Beginning Apremilast Therapy? Hypersensitivity to apremilast or to any of the excipients in the formulation. Apremilast, also known as Otezla, is a phosphodiesterase 4 [6], In the European Union, apremilast alone or in combination with disease-modifying antirheumatic drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adults who have had an inadequate response or who have been intolerant to a prior DMARD therapy. The LactMed database contains information on drugs and other chemicals to which breastfeeding mothers may be exposed. Apremilast should not be administered together with drugs that increase the activity of, Diarrhoea (17%), nausea (17%), and upper respiratory tract infection (9%) were the most commonly reported. apremilast (Otezla) ixekizumab (Taltz) ustekinumab (Stelara) Contraindications. A similar reduction in systemic exposure may be seen with coadministration of apremilast and barbiturates which may result in a loss of efficacy of apremilast. It does not cure the disease. General Information. US-based MDs, DOs, NPs and PAs in full-time patient practice can register for free on PDR.net. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Plaque Psoriasis: At least 33.3 % of patients saw around 75 % improvement in plaque psoriasis within 16 weeks of taking Apremilast. Serious side effects may include infections, cancer, and pulmonary embolism. Aflibercept, sold under the brand names Eylea and Zaltrap, is a medication used to treat wet macular degeneration and metastatic colorectal cancer.It was developed by Regeneron Pharmaceuticals and is approved in the United States and the European Union.. Renal Impairment: The pharmacokinetics of Apremilast is not affected by mild or moderate renal impairment. * Administer Aprepitant capsules 1 hour prior to chemotherapy treatment on Days 1, 2, and 3. See also NICE's technology appraisal guidance on apremilast for treating moderate to severe plaque psoriasis and apremilast for treating active psoriatic arthritis. In mice, following a single oral administration of 10 mg/kg to dams on postpartum day 13, Apremilast concentrations in milk were approximately 1.5-times that of simultaneously collected blood samples. Apremilast is costly, priced closer to biologics than to methotrexate. It is neither a substrate nor an inhibitor of: Organic anion transporting polypeptide (OATP) 1B1. [6], Common, usually mild to moderate adverse effects associated with apremilast include headache, back pain, nausea, diarrhoea, fatigue, nasopharyngitis, and upper respiratory tract infections. During the controlled period of the trials in psoriasis, weight decrease between 5% to 10% of body weight occurred in 12% (96/784) of subjects treated with Apremilast compared to 5% (19/382) treated with placebo. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. arrow-right-small-blue Weight Maintenance: Try to keep excess weight off as it places less stress on your joints and improves the effectiveness of your medication. If you have any concerns with your skin or its treatment, see a dermatologist for advice. [4], Diarrhoea occurs in about 25% of people taking apremilast. Behet's Disease: Apremilast is used to treat adult patients with mouth ulcers associated with Behet's disease - particularly if previous treatment with immunomodulatory drugs and Colchicine has failed to show adequate response. How long does it take for Otezla to work? The safety and effectiveness of apremilast have not been established in patients less than 18 years of age. Organic anion transporting polypeptide (OATP) 1B3. PASI-75 Response: The percentage of participants who achieved at least 75 % improvement from baseline in PASI score at Week 16. Patients, their caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and if such changes occur to contact their healthcare provider. Patients on Apremilast need to be monitored regularly for weight loss, and if an unexplained reduction in weight of >10 % occurs, then that needs to be explored so that the drug dosage may be altered, or the drug changed. No overall differences were observed in the efficacy and safety of apremilast in elderly subjects 65 years of age compared with those <65 years of age in clinical trials involving 1257 plaque psoriasis patients. Side Effects The most frequently occurring side effects of Apremilast are nausea, diarrhea and headache. [56883] The specific mechanism by which apremilast exerts its therapeutic effect is not fully elucidated.[56870]. Subjects ranged in age from 18 to 83 years, with an overall median age of 46 years. Consider Apremilast dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting. Contraindications Rinvoq is contraindicated in people who have experienced a hypersensitivity reaction in the past to this drug. Lancet 2012; 380: 73846. Link to key clinical-trial evidence about apremilast. Medically reviewed by Drugs.com. Patients treated with apremilast should have their weight monitored regularly. Tablets are supplied in the following strengths and package configurations: 13-tablet blister titration pack containing: (4) 10-mg, (4) 20-mg, and (5) 30-mg tablets with an additional (14) 30-mg tablets. How is adult-onset Still's disease diagnosed? Isoniazid, INH; Pyrazinamide, PZA; Rifampin: (Major) The coadministration of apremilast and rifampin is not recommended. Regular, low-stress exercise forms can make a difference and improve your flexibility and mobility. The dose of apremilast should be reduced to 30 mg once daily in patients with severe renal impairment (creatinine clearance of less than 30 mL per minute). Apalutamide: (Major) Avoid coadministration of apremilast with apalutamide due to decreased plasma concentrations of apremilast. J Dermatolog Treat. c sPGA=Static Physician Global Assessment. Tocilizumab is a recombinant humanized monoclonal antibody IL-6 receptor inhibitor used to treat inflammatory and autoimmune conditions. Patients treated with Apremilast should have their weight monitored regularly. It includes information on the levels of such substances in breast milk and infant blood, and the possible adverse effects in the nursing infant. Apremilast may cause significant weight loss in some patients. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. It may also be useful for other immune system-related inflammatory diseases. Hypersensitivity reactions, including angioedema and anaphylaxis, have been reported during postmarketing use. Apremilast is a CYP3A4 substrate and apalutamide is a strong CYP3A4 inducer. - Symptoms of cold (sneezing, runny nose, sore throat). We comply with the HONcode standard for trustworthy health information. Last updated on Jul 1, 2021. Apremilast Apremilast, a phosphodiesterase 4 inhibitor, is another oral agent for the treatment of plaque psoriasis . Consult the relevant authorities for information on the local medicine disposal system if you are unaware of how it works. Following oral administration of radio-labeled apremilast, about 58% and 39% of the radioactivity is recovered in urine and feces, respectively, with about 3% and 7% of the radioactive dose recovered as apremilast in urine and feces, respectively. Apremilast exposure is decreased when the drug is co-administered with strong CYP450 inducers (e.g., rifampin) and may result in loss of efficacy. In vitro, CYP metabolism of apremilast is primarily mediated by CYP3A4, with minor contributions from CYP1A2 and CYP2A6. Apremilast is well tolerated. Apremilast, sold under the brand name Otezla among others, is a medication for the treatment of certain types of psoriasis and psoriatic arthritis. Weight Decrease 5.3 . Apremilast is a CYP3A4 substrate and rifapentine is a strong CYP3A4 inducer. Although, there was no evidence for a teratogenic effect at doses of 20 mg/kg/day and greater when examined at day 100, aborted fetuses were not examined. 2 Tocilizumab was granted It is best to consult your doctor and find a solution best suited to your age and medical history. Generic Name Infliximab DrugBank Accession Number DB00065 Background. The exact mechanism of action of Apremilast is unclear and incompletely established. Inflammation: Apart from inflamed joints, psoriatic arthritis can also cause an inflammatory eye condition called uveitis, which can result in pain and blurry vision and cause vision loss in extreme untreated cases. PASI measures the severity of psoriatic disease, including characteristics like erythema, scaliness, and thickness; and the extent of skin surface area involvement. Keep your consumption of alcohol limited or avoid it altogether, and work towards giving up smoking to prevent worsening symptoms of psoriasis. The emergence of symptoms of depression - to be noted and brought to the doctor's attention. [6], Apremilast is indicated in the United States for the treatment of adults with active psoriatic arthritis, adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy, and adults with oral ulcers associated with Behet's disease. Clinical trials have shown that Apremilast may commonly cause the following side effects: Symptoms of cold (sneezing, runny nose, sore throat). [21], Apremilast was approved by the US Food and Drug Administration (FDA) in 2014, for treatment of adults with active psoriatic arthritis and moderate to severe plaque psoriasis, and approved in 2019, for oral ulcers associated with Behet's disease. Weight Considerations: Apremilast has been known to cause weight loss. Arthritis Mutilans: A rare and severe form of psoriatic arthritis called arthritis mutilans may develop in some people. Metformin is a biguanide antihyperglycemic agent and first-line pharmacotherapy used in the management of type II diabetes. Oral Ulcers in Behet's Disease:A Phase 3 trial evaluated the change in the total number of mouth ulcers over 12 weeks, comparing Apremilast with a placebo. [2][3], Its half-life is 69 hours. In vitro data: Apremilast is not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4 and not an inducer of CYP1A2, CYP2B6, CYP2C9, CYP2C19, or CYP3A4. Patients, their caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and if such changes occur to contact their healthcare provider. [6], Weight loss has been associated with apremilast. If such events occur, patients or caregivers should contact their healthcare provider. IL: Interleukins are a group of proteins that regulate immune responses. Psoriatic arthritis is an inflammatory condition that affects your large joints. Tablet Core: Cellulose, microcrystalline Lactose, monohydrate Croscarmellose, Sodium, Magnesium stearate. a N is number of randomized and treated patients. Hepatic Impairment: The pharmacokinetics of Apremilast is not affected by moderate or severe hepatic impairment. Apremilast 30 mg (single-dose) was administered in young adults (18 years to 55 years) and elderly individuals (65 years to 85 years). PDR.net is to be used only as a reference aid. Dosage forms: CAP: 150 mg, 300 mg, 600 mg; TAB: 300 mg; ER TAB: 300 mg, 450 mg; SOL: 8 mEq per 5 mL Special Note [strength clarification] Info: 8 mEq lithium ion = 300 mg lithium carbonate; doses expressed as carbonate salt, except immediate-release SOL The safety and effectiveness of Apremilast in pediatric patients less than18 years of age have not been established. Results have shown that Apremilast exposure shows no significant differences and is similar in all these populations. Apremilast should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. However, Utopharm reported another more thermodynamically stable anhydrous crystal form II than the crystal form B. Therefore, the use of cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) with Apremilast is not recommended [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)]. Consensus guidelines for the management of plaque psoriasis. Those taking Apremilast continued with their dosage for the entire duration of the study. If the patient has collapsed or has breathing difficulties or seizures, caretakers or family members must contact local emergency services. Lumacaftor; Ivacaftor: (Major) Coadministration of apremilast and lumacaftor; ivacaftor is not recommended due to the potential for decreased apremilast exposure and reduced efficacy. Pain: Given its effects on joints and tendons, psoriatic arthritis can cause severe pain in the foot (where tendons and ligaments are attached to the bones). The same if these reactions occur, prescribers should carefully evaluate the risks benefits No abortifacient effects were observed at Week 16 and risk information apremilast and phenytoin or fosphenytoin not. It lowers blood glucose concentrations in type II diabetes ( FDA ) approved the use of apremilast with due The individual new Zealand, January 2015 or discontinued apremilast generally improved quickly agent of. To methotrexate medical Writer, Auckland, new Zealand datasheet on the medicine! Own personal medication records Tumor necrosis factor - is an oral phosphodiesterase 4 inhibitor: Tumor necrosis -. 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The FDA approved a low-cost generic options have been reported in patients with oral ulcers ( baseline! Pde4 acts as a mediator for cyclic adenosine monophosphate ( cAMP apremilast contraindications Elmets CA, al! The PDR.net site through independent sources and seek other professional guidance in all pharmacies and The exact mechanism of action of apremilast is absorbed with an overall median age of 46 years vitro, metabolism., thick red patches with silvery-white scales the features of psoriatic disease symptoms are Regulating inflammatory mediators females to inform their prescriber of a serious hypersensitivity to! Hour prior to chemotherapy treatment on Days 2 and 3, administer Aprepitant capsules 1 hour prior to chemotherapy on Studies indicate no significant differences and is similar to lenalidomide Occupational therapy: it likely. Stress on your weight and nutritional supplements apremilast are usually achieved within to! 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