{
 "query": "cabotegravir",
 "ingredient": "cabotegravir",
 "slug": "cabotegravir",
 "rxcui": "2475077",
 "brands": [
  "Apretude",
  "Vocabria"
 ],
 "names": [
  "cabotegravir",
  "cabotegravir sodium"
 ],
 "classes": [
  {
   "id": "J05AJ",
   "name": "Integrase inhibitors"
  }
 ],
 "alternatives": [
  "dolutegravir",
  "elvitegravir",
  "raltegravir"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "HIV-1 Treatment: VOCABRIA is an HIV-1 integrase strand transfer inhibitor (INSTI) indicated in combination with EDURANT (rilpivirine) for short-term treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. ( 1.1 ) HIV-1 Pre-Exposure Prophylaxis: VOCABRIA is indicated for short-term pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating VOCABRIA for HIV-1 PrEP. ( 1.2 ) VOCABRIA may be used as: \u2022 oral lead-in to assess the tolerability of cabotegravir prior to administration of CABENUVA (cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension) for HIV-1 treatment or APRETUDE (cabotegravir extended-release injectable suspension) for HIV-1 PrEP. ( 1.1 , 1.2 ) \u2022 oral therapy for patients who will m...",
  "contraindications": "Treatment of HIV-1 Infection VOCABRIA is contraindicated in patients: \u2022 with previous hypersensitivity reaction to cabotegravir [see Warnings and Precautions ( 5.2 )] . \u2022 receiving the following coadministered drugs for which significant decreases in cabotegravir plasma concentrations may occur due to uridine diphosphate glucuronosyltransferase (UGT)1A1 enzyme induction, which may result in loss of virologic response [see Drug Interactions ( 7.2 , 7.3 ), Clinical Pharmacology ( 12.3 )] : o Anticonvulsants: Carbamazepine, oxcarbazepine, phenobarbital, phenytoin o Antimycobacterials: Rifampin, rifapentine Prior to initiation of VOCABRIA, note that use of CABENUVA (cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension) with rifabutin is contraindicated. Since VOCABRIA is taken in combination with EDURANT tablets, the prescribing information for EDURANT should be consulted for additional contraindications. HIV-1 Pre-Exposure Prophylaxis VOCABRIA is contraindicated in individuals: \u2022 with unknown or positive HIV-1 status [see Warnings and Precautions ( 5.1 )] . \u2022 with previous hypersensitivity reaction to cabotegravir [see Warnings and Pr...",
  "warnings_and_cautions": "\u2022 HIV-1 PrEP: Comprehensive management to reduce the risk of HIV-1 acquisition. ( 5.1 ) \u2022 Serious or severe hypersensitivity reactions have been reported with cabotegravir and include Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN). Discontinue VOCABRIA immediately if signs or symptoms of hypersensitivity reactions develop. ( 5.2 ) \u2022 Hepatotoxicity has been reported in patients receiving cabotegravir. Monitoring of liver chemistries is recommended when VOCABRIA is used for HIV-1 treatment. Clinical and laboratory monitoring should be considered when VOCABRIA is used for HIV-1 PrEP. Discontinue VOCABRIA if hepatotoxicity is suspected. ( 5.3 ) \u2022 Depressive disorders have been reported with VOCABRIA when used with EDURANT for HIV-1 treatment. Prompt evaluation is recommended for depressive symptoms. ( 5.4 ) \u2022 Risks Associated with Combination Treatment: Review the prescribing information for EDURANT for information on rilpivirine prior to initiation of VOCABRIA in combination with EDURANT. ( 5.6 ) 5.1 Comprehensive Management to Reduce the Risk of HIV-1 Infection When VOCABRIA is Used for HIV-1 Pre-Exposure Prophylaxis Use of VOCABRIA for HIV-1 PrEP should be part of a...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are described below and in other sections of the labeling: \u2022 Hypersensitivity reactions [see Warnings and Precautions ( 5.2 )] \u2022 Hepatotoxicity [see Warnings and Precautions ( 5.3 )] \u2022 Depressive disorders [see Warnings and Precautions ( 5.4 )] \u2022 In patients with HIV-1, the most common adverse reactions observed in at least 3 participants receiving VOCABRIA were fatigue, headache, diarrhea, nausea, dizziness, abnormal dreams, anxiety, insomnia, abdominal discomfort, abdominal distension, and asthenia. ( 6.1 ) \u2022 In individuals without HIV-1 receiving VOCABRIA, the most common adverse reactions reported in \u22651% were headache, diarrhea, nausea, dizziness, upper respiratory tract infection, somnolence, fatigue, abnormal dreams, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at 1-877-844-8872 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 with rates in the clinical trials of another drug and may not reflect rates obse...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions, Hypersensitivity Reactions ( 5.2 ) 4/2025",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information). Important Information for Individuals without HIV-1 Taking VOCABRIA for HIV-1 PrEP Advise individuals without HIV-1 about the following [see Warnings and Precautions ( 5.1 )] : \u2022 VOCABRIA should be used for PrEP as part of an overall HIV-1 infection prevention strategy, including adherence to the dosing schedule and safer sex practices, including condoms, to reduce the risk of STIs. \u2022 VOCABRIA is not always effective in preventing HIV-1 acquisition [see Clinical Studies ( 14.2 )] . The time from initiation of VOCABRIA for HIV-1 PrEP to maximal protection against HIV-1 infection is unknown. \u2022 Counsel individuals on the use of other prevention measures (e.g., knowledge of partner HIV-1 status, testing for STIs condom use). Inform individuals about and support their efforts in reducing sexual risk behavior. \u2022 VOCABRIA should be used to reduce the risk of acquiring HIV-1 only in individuals confirmed to be HIV-1 negative [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )] . HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection who are taking only VOCABRIA,...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Clinical Trials in Adults for Treatment of HIV-1 Infection The use of VOCABRIA in combination with EDURANT as an oral lead-in and in patients who miss planned injections with CABENUVA was evaluated in 3 Phase 3 randomized, multicenter, active-controlled, parallel-arm, open-label, non-inferiority trials (Trial 201584: FLAIR [NCT02938520], Trial 201585: ATLAS [NCT02951052], and Trial 207966: ATLAS\u20112M [NCT03299049]) in participants who were virologically suppressed (HIV-1 RNA <50 copies/mL). Please refer to the CABENUVA prescribing information for additional information. In the FLAIR study during the Extension Phase (Week 100 to Week 124), the efficacy of CABENUVA was evaluated in participants who switched (at Week 100) from their current antiretroviral regimen to CABENUVA, with and without an oral lead-in phase. A total of 121 participants chose to start the treatment with oral lead-in and 111 participants chose direct to injection. Participants were not randomized during the Extension Phase. At Week 124, the proportion of participants with HIV-1 RNA \u226550 copies/mL was 0.8% and 0.9% for the oral lead-in and direct to injection groups, respectively. The rates of virologic suppress...",
  "brand_name": "Vocabria",
  "manufacturer": "ViiV Healthcare Company",
  "application_number": "NDA212887",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250411",
  "set_id": "66d450fb-cca4-476c-b0c7-c0730e3e4cf3",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 9413,
  "serious": 2602,
  "death": 185,
  "hospitalization": 529,
  "primary_suspect": 9389,
  "top_reactions": [
   [
    "Product Dose Omission Issue",
    1164
   ],
   [
    "Off Label Use",
    1101
   ],
   [
    "Injection Site Pain",
    1016
   ],
   [
    "Viral Load Increased",
    508
   ],
   [
    "Pain",
    447
   ],
   [
    "Virologic Failure",
    319
   ],
   [
    "Pathogen Resistance",
    300
   ],
   [
    "Pyrexia",
    295
   ],
   [
    "Product Use In Unapproved Therapeutic Environment",
    283
   ],
   [
    "Inappropriate Schedule Of Product Administration",
    274
   ],
   [
    "Fatigue",
    235
   ],
   [
    "Product Complaint",
    234
   ],
   [
    "Drug Ineffective",
    231
   ],
   [
    "Headache",
    204
   ],
   [
    "Injection Site Nodule",
    199
   ]
  ],
  "by_year": {
   "2019": 29,
   "2020": 47,
   "2021": 330,
   "2022": 1255,
   "2023": 2238,
   "2024": 2939,
   "2025": 2078,
   "2026": 465
  },
  "by_year_primary": {
   "2019": 29,
   "2020": 47,
   "2021": 330,
   "2022": 1252,
   "2023": 2236,
   "2024": 2931,
   "2025": 2072,
   "2026": 462
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 2,
  "nda": 2,
  "anda": 0,
  "first_approval": "20210121",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 6,
  "labeling_recent": 6,
  "sponsors": [
   "VIIV HLTHCARE"
  ],
  "unapproved": false,
  "first_approval_fmt": "01/21/2021"
 },
 "trials": {
  "total": 140,
  "completed": 58,
  "terminated": 10,
  "with_results": 34,
  "industry": 90,
  "phase3": 26,
  "results_share": 0.5862068965517241,
  "terminated_share": 0.07142857142857142
 },
 "pubmed": {
  "rct": 48,
  "meta": 15,
  "recent_rct": 33,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 2405706.23,
  "records": 18986,
  "by_name": [
   [
    "Apretude",
    2405706.23
   ]
  ],
  "names_checked": [
   "cabotegravir",
   "Apretude",
   "Vocabria"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 3358,
  "beneficiaries": 996,
  "spend": 12823731.96,
  "by_brand": [
   {
    "brand": "Apretude",
    "claims": 3358,
    "per_claim": 3818.8600238,
    "is_generic": false
   }
  ],
  "per_claim": 3818.860023823705
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "Death share in reports is near or below the FAERS average (0.2x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 52,
   "letter": "D",
   "why": [
    "48 randomized trials and 15 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 77,
   "letter": "B",
   "why": [
    "No recalls on record since 2016",
    "6 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)",
    "Approved within the last 5 years: long-term safety is not yet known (-10)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 70,
   "letter": "C",
   "why": [
    "Pharma paid doctors $2,405,706 tied to this drug last year (-30)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "3 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 75,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are product dose omission issue, injection site pain, viral load increased. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over dolutegravir, elvitegravir, raltegravir? What would make you pick one of those instead?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "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.)"
 ]
}