{
 "query": "apremilast",
 "ingredient": "apremilast",
 "slug": "apremilast",
 "rxcui": "1492727",
 "brands": [
  "Otezla"
 ],
 "names": [
  "apremilast"
 ],
 "classes": [
  {
   "id": "L04AA",
   "name": "Selective immunosuppressants"
  }
 ],
 "alternatives": [
  "abatacept",
  "abetimus",
  "alefacept",
  "belatacept",
  "belumosudil",
  "cladribine",
  "efgartigimod alfa",
  "lymphocyte immune globulin, anti-thymocyte globulin, equine",
  "mycophenolic acid",
  "nerandomilast",
  "rabbit anti-human t-lymphocyte globulin",
  "remibrutinib"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "XR, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of: Adult patients with: Active psoriatic arthritis ( 1.1 ) Plaque psoriasis who are candidates for phototherapy or systemic therapy ( 1.2 ) Oral ulcers associated with Beh\u00e7et's Disease ( 1.3 ) Pediatric patients 6 years of age and older with: Active psoriatic arthritis ( 1.1 ) Moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy ( 1.2 ) In the pediatric population, OTEZLA is indicated for patients weighing at least 20 kg, and OTEZLA XR is indicated for patients weighing at least 50 kg. 1.1 Psoriatic Arthritis OTEZLA is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 20 kg with active psoriatic arthritis. OTEZLA XR is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 50 kg with active psoriatic arthritis. 1.2 Plaque Psoriasis OTEZLA/OTEZLA XR is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy. OTEZLA is indicated for the treatment of pediatric patients 6 years...",
  "contraindications": "is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation [see Warnings and Precautions (5.1) , see Adverse Reactions (6.1) ] . Known hypersensitivity to apremilast or to any of the excipients in the formulation ( 4 )",
  "warnings_and_cautions": "Hypersensitivity : Cases of angioedema and anaphylaxis have been reported during post marketing surveillance. Avoid the use of OTEZLA/OTEZLA XR in patients with known hypersensitivity to apremilast or to any of the excipients in the formulation. If signs or symptoms of serious hypersensitivity reactions develop during treatment, discontinue OTEZLA/OTEZLA XR and institute appropriate therapy ( 5.1 ) Diarrhea, Nausea, and Vomiting : Consider OTEZLA/OTEZLA XR dosage reduction or suspension if patients develop severe diarrhea, nausea, or vomiting ( 5.2 ) Depression : Advise patients, their caregivers, and families 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. Carefully weigh risks and benefits of treatment with OTEZLA/OTEZLA XR in patients with a history of depression and/or suicidal thoughts or behavior ( 5.3 ) Weight Decrease : Monitor weight regularly. If unexplained or clinically significant weight loss occurs, evaluate weight loss and consider discontinuation of OTEZLA/OTEZLA XR ( 5.4 ) Drug Interactions : Use with strong cytochrome P450 enzyme inducers (e.g., rifamp...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Diarrhea, Nausea, and Vomiting [see Warnings and Precautions (5.2) ] Depression [see Warnings and Precautions (5.3) ] Weight Decrease [see Warnings and Precautions (5.4) ] Drug Interactions [see Warnings and Precautions (5.5) ] Psoriatic Arthritis : The most common adverse reactions (\u2265 5%) are diarrhea, nausea, and headache ( 6.1 ) Plaque Psoriasis : The most common adverse reactions (\u2265 5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache ( 6.1 ) Beh\u00e7et's Disease : The most common adverse reactions (\u2265 10%) are diarrhea, nausea, headache, and upper respiratory tract infection ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clini...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Administration Instructions Instruct patients to take OTEZLA/OTEZLA XR only as prescribed [see Dosage and Administration (2.1 and 2.3) ] . Advise patients to take OTEZLA/OTEZLA XR with or without food. Instruct patients to swallow tablets whole and not to crush, split, or chew prior to swallowing [see Dosage and Administration (2.4) ] . Hypersensitivity Inform patients that hypersensitivity reactions can occur following administration of OTEZLA/OTEZLA XR. Instruct patients to contact their healthcare provider if they experience symptoms of an allergic reaction [see Warnings and Precautions (5.1) ] . Diarrhea, Nausea, and Vomiting Advise patients of the potential complications of severe diarrhea, nausea, or vomiting and instruct them to contact their healthcare provider if they experience these adverse reactions, especially if the patient is 65 years of age or older [see Warnings and Precautions (5.2) ] . Depression Inform patients that treatment with OTEZLA/OTEZLA XR is associated with an increased incidence of depression. Advise patients, their caregivers, and families of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, an...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Adult Psoriatic Arthritis The safety and efficacy of OTEZLA was evaluated in three multicenter, randomized, double-blind, placebo-controlled trials (PsA-1 [NCT01172938], PsA-2 [NCT01212757], and PsA-3 [NCT01212770]) of similar design. A total of 1493 adult subjects with active PsA (\u2265 3 swollen joints and \u2265 3 tender joints) despite prior or current treatment with disease-modifying antirheumatic drug (DMARD) therapy were randomized. Subjects enrolled in these trials had a diagnosis of PsA for at least 6 months. One qualifying psoriatic skin lesion of at least 2 cm in diameter was required in Trial PsA-3. Previous treatment with a biologic, including TNF blockers was allowed (up to 10% could be TNF blocker therapeutic failures). Across the three trials, subjects were randomly assigned to placebo (n = 496), OTEZLA 20 mg (n = 500), or OTEZLA 30 mg (n = 497) given orally twice daily. Titration was used over the first 5 days [see Dosage and Administration (2.1) ] . Subjects were allowed to receive stable doses of concomitant methotrexate [MTX (\u2264 25 mg/week)], sulfasalazine [SSZ (\u2264 2 g/day)], leflunomide [LEF (\u2264 20 mg/day)], low dose oral corticosteroids (equivalent to \u2264 10 mg of pred...",
  "brand_name": "Otezla",
  "manufacturer": "Amgen, Inc",
  "application_number": "NDA205437",
  "pharm_class_epc": [
   "Phosphodiesterase 4 Inhibitor [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260902",
  "set_id": "f6b1f516-4972-4d82-bced-113e47b41cc5",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 145544,
  "serious": 34415,
  "death": 5957,
  "hospitalization": 11565,
  "primary_suspect": 145531,
  "top_reactions": [
   [
    "Diarrhoea",
    24620
   ],
   [
    "Nausea",
    22171
   ],
   [
    "Psoriasis",
    20583
   ],
   [
    "Headache",
    17910
   ],
   [
    "Drug Ineffective",
    15564
   ],
   [
    "Abdominal Discomfort",
    8232
   ],
   [
    "Psoriatic Arthropathy",
    8173
   ],
   [
    "Pain",
    6926
   ],
   [
    "Rash",
    6776
   ],
   [
    "Vomiting",
    6555
   ],
   [
    "Arthralgia",
    6434
   ],
   [
    "Fatigue",
    6222
   ],
   [
    "Depression",
    5573
   ],
   [
    "Off Label Use",
    5291
   ],
   [
    "Weight Decreased",
    5044
   ]
  ],
  "by_year": {
   "2019": 22855,
   "2020": 19784,
   "2021": 10556,
   "2022": 7338,
   "2023": 5926,
   "2024": 6017,
   "2025": 4934,
   "2026": 2221
  },
  "by_year_primary": {
   "2019": 22855,
   "2020": 19784,
   "2021": 10556,
   "2022": 7334,
   "2023": 5922,
   "2024": 6016,
   "2025": 4932,
   "2026": 2219
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 17,
  "nda": 3,
  "anda": 13,
  "first_approval": "20140321",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 3,
  "labeling_recent": 1,
  "sponsors": [
   "ALKEM LABS LTD",
   "AMGEN INC",
   "AMNEAL",
   "ANNORA",
   "AUROBINDO PHARMA LTD",
   "CELGENE CORP",
   "DR REDDYS",
   "GLENMARK PHARMS LTD"
  ],
  "unapproved": false,
  "first_approval_fmt": "03/21/2014"
 },
 "trials": {
  "total": 173,
  "completed": 116,
  "terminated": 14,
  "with_results": 72,
  "industry": 125,
  "phase3": 40,
  "results_share": 0.6206896551724138,
  "terminated_share": 0.08092485549132948
 },
 "pubmed": {
  "rct": 80,
  "meta": 14,
  "recent_rct": 37,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 8386399.05,
  "records": 157251,
  "by_name": [
   [
    "Otezla",
    8386399.05
   ]
  ],
  "names_checked": [
   "apremilast",
   "Otezla"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 213396,
  "beneficiaries": 31045,
  "spend": 1045029750.9,
  "by_brand": [
   {
    "brand": "Otezla",
    "claims": 213396,
    "per_claim": 4897.1384231,
    "is_generic": false
   }
  ],
  "per_claim": 4897.138422932014
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 13167,
  "fills": 213396,
  "per_million": 61702.187482427034,
  "ratio": 22.28360677110964,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 85,
   "letter": "B",
   "why": [
    "61,702 FDA reports naming it as the suspect drug per million Medicare fills, 22.3x the median drug on this site (-15)",
    "Death share in reports is near or below the FAERS average (0.4x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 56,
   "letter": "D",
   "why": [
    "80 randomized trials and 14 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 100,
   "letter": "A",
   "why": [
    "No recalls on record since 2016"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 70,
   "letter": "C",
   "why": [
    "Pharma paid doctors $8,386,399 tied to this drug last year (-30)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (13 applications)",
    "12 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 79,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are diarrhoea, nausea, psoriasis, headache. How would we recognize and handle those?",
  "Why this one over abatacept, abetimus, alefacept? What would make you pick one of those instead?",
  "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}