{
  "schemaVersion": "peptidescanner-official-label-context/v1",
  "boundary": "Product-specific U.S. label accounts. Labeling hosted by NLM is not an NLM-authored efficacy opinion. No treatment or dosing instructions.",
  "contexts": [
    {
      "peptideSlug": "bremelanotide",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "dailymed-bremelanotide-f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf-v1",
      "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?type=zip&setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf&version=1",
      "sourceRole": "U.S. product labeling hosted by the National Library of Medicine",
      "zipSha256": "deb36c45aeecfb5e78f4b9ff837af0dfa1d12acf404c2d0424a6c279343cc780",
      "xmlSha256": "40f565dabb4834a5e8ae91adc6836df37b62102e1b94a57aa2bfc74969fa09be",
      "product": "Vyleesi",
      "findings": [
        {
          "heading": "Which population and use does the label cover?",
          "text": "The cited U.S. label covers acquired, generalized hypoactive sexual desire disorder in premenopausal women, with specified exclusions. It does not cover men, postmenopausal women or enhancement of sexual performance.",
          "sections": [
            "1"
          ]
        },
        {
          "heading": "Which safety limits matter?",
          "text": "The label lists uncontrolled hypertension or known cardiovascular disease as contraindications. It describes transient blood-pressure increases, heart-rate reduction, focal hyperpigmentation and nausea.",
          "sections": [
            "1",
            "4",
            "5"
          ]
        }
      ],
      "documentKind": "dailymed-spl",
      "jurisdiction": "United States",
      "sourceTitle": "VYLEESI (bremelanotide) injection · SPL version 1 · published 2025-11-18",
      "versionPath": "/peptides/bremelanotide/labels/versions/1/"
    },
    {
      "peptideSlug": "lanreotide",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "dailymed-lanreotide-2892b4c3-0329-4d29-97ff-3b45283bbab1-v3",
      "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?type=zip&setid=2892b4c3-0329-4d29-97ff-3b45283bbab1&version=3",
      "sourceRole": "U.S. product labeling hosted by the National Library of Medicine",
      "zipSha256": "549b28079c4ff34c485706fc6353164f8e1903e90a1ec7f10f97482b441b0bfe",
      "xmlSha256": "c8c3f515d19dbbec43ebb5353991467b8f96123d3e513e3e183fd915087f874b",
      "product": "Lanreotide acetate injection",
      "findings": [
        {
          "heading": "Which population and use does the label cover?",
          "text": "The cited label covers specified acromegaly, gastroenteropancreatic neuroendocrine tumor and carcinoid-syndrome settings. Indications and outcomes differ across those populations.",
          "sections": [
            "1"
          ]
        },
        {
          "heading": "Which safety limits matter?",
          "text": "Warnings include gallstones and complications, altered glucose control, reduced heart rate, thyroid abnormalities, and fat malabsorption or steatorrhea. These label risks are distinct from event rates in an individual trial.",
          "sections": [
            "1",
            "5"
          ]
        }
      ],
      "documentKind": "dailymed-spl",
      "jurisdiction": "United States",
      "sourceTitle": "Lanreotide acetate injection · SPL version 3 · published 2025-06-02",
      "versionPath": "/peptides/lanreotide/labels/versions/1/"
    },
    {
      "peptideSlug": "linaclotide",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "dailymed-linaclotide-09beda19-56d6-4a56-afdc-9a77b70b2ef3-v39",
      "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?type=zip&setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3&version=39",
      "sourceRole": "U.S. product labeling hosted by the National Library of Medicine",
      "zipSha256": "77c54fc2bf053002e1fd77970d745d4088919827b5a4a74d5d139cf8df320a54",
      "xmlSha256": "0e36407b126e3d4b3c616c030ed28362be4484ad305e337e12c319145523082a",
      "product": "Linzess",
      "findings": [
        {
          "heading": "Which population and use does the label cover?",
          "text": "The June 2026 label distinguishes IBS with constipation in adults and children aged seven years and older, chronic idiopathic constipation in adults, and functional constipation in children aged two years and older.",
          "sections": [
            "1"
          ]
        },
        {
          "heading": "Which safety limits matter?",
          "text": "The boxed warning concerns serious dehydration in children younger than two, for whom the product is contraindicated. The label also lists known or suspected mechanical gastrointestinal obstruction as a contraindication and describes potentially severe diarrhea.",
          "sections": [
            "1",
            "4",
            "5",
            "boxed warning"
          ]
        }
      ],
      "documentKind": "dailymed-spl",
      "jurisdiction": "United States",
      "sourceTitle": "LINZESS (linaclotide) capsule · SPL version 39 · published 2026-06-01",
      "versionPath": "/peptides/linaclotide/labels/versions/1/"
    },
    {
      "peptideSlug": "plecanatide",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "dailymed-plecanatide-fe2895bf-71a6-493a-b0ca-e06b2dfefc82-v15",
      "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?type=zip&setid=fe2895bf-71a6-493a-b0ca-e06b2dfefc82&version=15",
      "sourceRole": "U.S. product labeling hosted by the National Library of Medicine",
      "zipSha256": "0d42da0dc89f9dad302f67bcff3df820d6dffe4743c9999083d93df18c88c534",
      "xmlSha256": "3ff2626593747b7b8c7e3c379036fec8f8a4f83a19229be9997b73801ed43470",
      "product": "Trulance",
      "findings": [
        {
          "heading": "Which population and use does the label cover?",
          "text": "The cited label covers chronic idiopathic constipation and IBS with constipation in adults. Pediatric effectiveness and safety have not been established.",
          "sections": [
            "1",
            "8.4"
          ]
        },
        {
          "heading": "Which safety limits matter?",
          "text": "The boxed warning concerns serious dehydration in pediatric patients. The product is contraindicated below age six and the label advises avoiding use at ages six through seventeen. Known or suspected mechanical gastrointestinal obstruction is also contraindicated; severe diarrhea can occur.",
          "sections": [
            "1",
            "4",
            "5",
            "8.4",
            "boxed warning"
          ]
        }
      ],
      "documentKind": "dailymed-spl",
      "jurisdiction": "United States",
      "sourceTitle": "TRULANCE (plecanatide) tablet · SPL version 15 · published 2024-04-05",
      "versionPath": "/peptides/plecanatide/labels/versions/1/"
    },
    {
      "peptideSlug": "pramlintide",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "dailymed-pramlintide-4aea30ff-eb0d-45c1-b114-3127966328ff-v18",
      "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?type=zip&setid=4aea30ff-eb0d-45c1-b114-3127966328ff&version=18",
      "sourceRole": "U.S. product labeling hosted by the National Library of Medicine",
      "zipSha256": "41e40e12d2e7bbf400a8bcd1a8032e423aa305f795982acb1264301692a93a15",
      "xmlSha256": "e223f4cb25daee6d6785fc4e0d427c65dbbe94d27da19f34b5fafb7ba6a1842a",
      "product": "Symlin",
      "findings": [
        {
          "heading": "Which population and use does the label cover?",
          "text": "The cited label describes adjunctive use with mealtime insulin in type 1 or type 2 diabetes when desired glucose control has not been achieved despite optimal insulin therapy. Pediatric safety and effectiveness have not been established.",
          "sections": [
            "1",
            "8.4"
          ]
        },
        {
          "heading": "Which safety limits matter?",
          "text": "The boxed warning concerns severe hypoglycemia when used with insulin, particularly in type 1 diabetes. Contraindications include hypoglycemia unawareness, confirmed gastroparesis and serious hypersensitivity. A study reporting no overall increase in severe events does not cancel the label warning.",
          "sections": [
            "1",
            "4",
            "5",
            "8.4",
            "boxed warning"
          ]
        }
      ],
      "documentKind": "dailymed-spl",
      "jurisdiction": "United States",
      "sourceTitle": "SYMLINPEN (pramlintide acetate) injection · SPL version 18 · published 2024-08-20",
      "versionPath": "/peptides/pramlintide/labels/versions/1/"
    },
    {
      "peptideSlug": "ziconotide",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "dailymed-ziconotide-b025d8ed-937d-4597-9ad1-0b2f6e0ee5b1-v6",
      "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?type=zip&setid=b025d8ed-937d-4597-9ad1-0b2f6e0ee5b1&version=6",
      "sourceRole": "U.S. product labeling hosted by the National Library of Medicine",
      "zipSha256": "a0b31d16771b167c912140ba2b59337f79cfddd632109f3ed8c1556065e8b9e5",
      "xmlSha256": "101aad729a27b6c532f9e28f511dcac5a723e305274e0a2703ecc1119c76a748",
      "product": "Prialt",
      "findings": [
        {
          "heading": "Which population and use does the label cover?",
          "text": "The cited label concerns intrathecal management of severe chronic pain in adults for whom intrathecal therapy is warranted and who are intolerant of or refractory to other treatment. This is a specialized route and population.",
          "sections": [
            "1"
          ]
        },
        {
          "heading": "Which safety limits matter?",
          "text": "The boxed warning addresses severe psychiatric and neurological effects; pre-existing psychosis is a contraindication. Other intrathecal contraindications include relevant infection, uncontrolled bleeding problems and obstruction impairing cerebrospinal-fluid circulation. Pediatric safety and effectiveness have not been established.",
          "sections": [
            "1",
            "4",
            "5",
            "8.4",
            "boxed warning"
          ]
        }
      ],
      "documentKind": "dailymed-spl",
      "jurisdiction": "United States",
      "sourceTitle": "PRIALT (ziconotide acetate) injection, solution · SPL version 6 · published 2025-07-14",
      "versionPath": "/peptides/ziconotide/labels/versions/1/"
    },
    {
      "peptideSlug": "vosoritide",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "dailymed-vosoritide-228e8560-04a4-4bb1-a81f-29531a9e4d27-v16",
      "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?type=zip&setid=228e8560-04a4-4bb1-a81f-29531a9e4d27&version=16",
      "sourceRole": "U.S. product labeling hosted by the National Library of Medicine",
      "zipSha256": "01bd93709f678ebf940f87c036fa3fe74fef3e457891d243c5c4e759d0253924",
      "xmlSha256": "3faeddb93511f0bc64c4bd0e70f367ced4dcb0b45a2b9864ad5ad67026080e89",
      "product": "Voxzogo",
      "findings": [
        {
          "heading": "Which population and use does the label cover?",
          "text": "The cited U.S. label covers increased linear growth in pediatric patients with achondroplasia and open growth plates. Accelerated approval is based on annualized growth velocity; continued approval depends on confirmation of clinical benefit.",
          "sections": [
            "1"
          ]
        },
        {
          "heading": "What clinical outcome supported the label?",
          "text": "The label describes a 52-week randomized placebo-controlled study in 121 children with achondroplasia. The adjusted difference in annualized growth velocity was 1.57 cm per year in favor of vosoritide. This growth-rate endpoint does not establish final adult height or every functional outcome; extension participants overlap the original trial.",
          "sections": [
            "14"
          ]
        },
        {
          "heading": "Which safety limits matter?",
          "text": "The label describes transient decreases in blood pressure. Its growth-velocity finding is not itself proof of improved adult height or all functional outcomes.",
          "sections": [
            "1",
            "5",
            "14"
          ]
        }
      ],
      "documentKind": "dailymed-spl",
      "jurisdiction": "United States",
      "sourceTitle": "VOXZOGO (vosoritide) kit · SPL version 16 · published 2025-11-26",
      "versionPath": "/peptides/vosoritide/labels/versions/1/"
    },
    {
      "peptideSlug": "insulin-glargine-aldy",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "dailymed-insulin-glargine-aldy-5328761e-59d3-ca7a-e063-6394a90ae810-v5",
      "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?type=zip&setid=5328761e-59d3-ca7a-e063-6394a90ae810&version=5",
      "sourceRole": "U.S. product labeling hosted by the National Library of Medicine",
      "zipSha256": "c393585bbdb741f3ff47b5db3b45ed1dfc84a10d2d03e83796d8aae94d3ad187",
      "xmlSha256": "a785c2958a54aeb8984fecab009a9c899d5b73479104b4d2ae4982ac6f32f770",
      "product": "Langlara",
      "findings": [
        {
          "heading": "Which population and use does the label cover?",
          "text": "The cited Langlara label covers glycemic control in adults and children with diabetes mellitus. It does not cover treatment of diabetic ketoacidosis.",
          "sections": [
            "1"
          ]
        },
        {
          "heading": "What clinical studies does the label describe?",
          "text": "Section 14 summarizes open-label randomized comparisons of insulin glargine with NPH insulin involving 2,327 adults and 349 children with type 1 diabetes and 1,563 adults with type 2 diabetes. HbA1c reductions were generally similar. These are the label’s insulin-glargine clinical studies, not a count of trials conducted specifically with insulin glargine-aldy.",
          "sections": [
            "14.1",
            "14.2",
            "14.3"
          ]
        },
        {
          "heading": "Which safety limits matter?",
          "text": "The label describes potentially life-threatening hypoglycemia, severe hypersensitivity, low potassium, medication errors and fluid retention or heart failure with thiazolidinediones. Hypoglycemia episodes and relevant hypersensitivity are contraindications.",
          "sections": [
            "4",
            "5"
          ]
        }
      ],
      "documentKind": "dailymed-spl",
      "jurisdiction": "United States",
      "sourceTitle": "LANGLARA (insulin glargine-aldy) injection, solution · SPL version 5 · published 2026-07-08",
      "versionPath": "/peptides/insulin-glargine-aldy/labels/versions/1/"
    },
    {
      "peptideSlug": "abaloparatide",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "dailymed-abaloparatide-712143d9-e21e-4013-bb3b-3426a21060a8-v19",
      "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?type=zip&setid=712143d9-e21e-4013-bb3b-3426a21060a8&version=19",
      "sourceRole": "U.S. product labeling hosted by the National Library of Medicine",
      "documentKind": "dailymed-spl",
      "jurisdiction": "United States",
      "zipSha256": "0972d261dcba3ae48d54920e976a32e45e2f7b9f8c2f3458dd827ca900db9c44",
      "xmlSha256": "4ac5a2ba440d0e916a9741978deee40d0ba4d42f291d6e40d1d113dae70b533f",
      "product": "Tymlos",
      "findings": [
        {
          "heading": "Which population and use does the label cover?",
          "text": "The cited label covers postmenopausal women with osteoporosis at high fracture risk or failure or intolerance of other available osteoporosis therapies. For men in the corresponding osteoporosis population, its indication is to increase bone density; that wording differs from the fracture-reduction account for women.",
          "sections": [
            "1"
          ]
        },
        {
          "heading": "Which safety limits matter?",
          "text": "The label contraindicates severe hypersensitivity, including reported anaphylaxis and angioedema. Warnings also address osteosarcoma risk, orthostatic hypotension, high blood calcium and urinary calcium or stones. The rodent osteosarcoma finding does not establish that Tymlos causes osteosarcoma in humans.",
          "sections": [
            "4",
            "5"
          ]
        }
      ],
      "sourceTitle": "TYMLOS (abaloparatide) injection, solution · SPL version 19 · published 2026-08-17",
      "versionPath": "/peptides/abaloparatide/labels/versions/1/"
    },
    {
      "peptideSlug": "dulaglutide",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "dailymed-dulaglutide-463050bd-2b1c-40f5-b3c3-0a04bb433309-v62",
      "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?type=zip&setid=463050bd-2b1c-40f5-b3c3-0a04bb433309&version=62",
      "sourceRole": "U.S. product labeling hosted by the National Library of Medicine",
      "documentKind": "dailymed-spl",
      "jurisdiction": "United States",
      "zipSha256": "0be61134741cd12e32e7ea35d42b7ad3d11a0a333b31e08005cf499692d46779",
      "xmlSha256": "2a790740cae6415ba5160d0c578d599e26decb426a6f5c59d99803bb53b227d5",
      "product": "Trulicity",
      "findings": [
        {
          "heading": "Which population and use does the label cover?",
          "text": "The label covers glycemic control with diet and exercise in adults and children aged ten years and older with type 2 diabetes. Its cardiovascular indication concerns adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors.",
          "sections": [
            "1"
          ]
        },
        {
          "heading": "Which safety limits matter?",
          "text": "The boxed warning reports thyroid C-cell tumors in rats, with uncertain human relevance. Contraindications include a personal or family history of medullary thyroid carcinoma, MEN 2 and serious hypersensitivity. Other warnings include pancreatitis, hypoglycemia with insulin or insulin secretagogues, kidney injury from volume depletion, severe gastrointestinal reactions, retinopathy complications, gallbladder disease and aspiration during anesthesia or deep sedation.",
          "sections": [
            "boxed warning",
            "4",
            "5"
          ]
        }
      ],
      "sourceTitle": "TRULICITY (dulaglutide) injection, solution · SPL version 62 · published 2026-08-10",
      "versionPath": "/peptides/dulaglutide/labels/versions/1/"
    },
    {
      "peptideSlug": "tesamorelin",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "dailymed-tesamorelin-3d783378-b02d-4f19-99dd-0fc91a042224-v9",
      "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?type=zip&setid=3d783378-b02d-4f19-99dd-0fc91a042224&version=9",
      "sourceRole": "U.S. product labeling hosted by the National Library of Medicine",
      "documentKind": "dailymed-spl",
      "jurisdiction": "United States",
      "zipSha256": "2208a57e39a937407fe40c3d00ff1f8547a7a33e87685d40205cfaba9137cc6c",
      "xmlSha256": "280dc13506741337de1fe23ec2d53b3c65241abd9501425611ff106932ca714d",
      "product": "Egrifta SV",
      "findings": [
        {
          "heading": "Which population and use does the label cover?",
          "text": "The label covers reduction of excess abdominal fat in adults with HIV and lipodystrophy. It explicitly excludes weight-loss management and says long-term cardiovascular safety has not been established.",
          "sections": [
            "1"
          ]
        },
        {
          "heading": "Which safety limits matter?",
          "text": "Contraindications include disruption of the hypothalamic-pituitary axis, active malignancy, hypersensitivity and pregnancy. Warnings address neoplasms, elevated IGF-1, fluid retention, glucose intolerance or diabetes, hypersensitivity and acute critical illness. The label says effects of prolonged IGF-1 elevation are unknown.",
          "sections": [
            "4",
            "5"
          ]
        }
      ],
      "sourceTitle": "EGRIFTA SV (tesamorelin) kit · SPL version 9 · published 2026-07-31",
      "versionPath": "/peptides/tesamorelin/labels/versions/1/"
    },
    {
      "peptideSlug": "tirzepatide",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "dailymed-tirzepatide-487cd7e7-434c-4925-99fa-aa80b1cc776b-v40",
      "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?type=zip&setid=487cd7e7-434c-4925-99fa-aa80b1cc776b&version=40",
      "sourceRole": "U.S. product labeling hosted by the National Library of Medicine",
      "documentKind": "dailymed-spl",
      "jurisdiction": "United States",
      "zipSha256": "4fe25d4173ba662adc2b4ac0653c09643bc7a9e883557286abe2c5d36f19d87e",
      "xmlSha256": "7c40611952c42e85d4688669dae2a5529cd563e0e857fdb23e411a8f7d8b0f14",
      "product": "Zepbound",
      "findings": [
        {
          "heading": "Which population and use does the label cover?",
          "text": "The cited Zepbound label covers long-term weight reduction in adults with obesity, or overweight with a weight-related condition, and moderate to severe obstructive sleep apnea in adults with obesity. Both indications are described alongside diet and physical activity. This is a product-specific account, separate from Mounjaro labeling.",
          "sections": [
            "1"
          ]
        },
        {
          "heading": "Which safety limits matter?",
          "text": "The boxed warning reports thyroid C-cell tumors in rats, with uncertain human relevance. Contraindications include a personal or family history of medullary thyroid carcinoma, MEN 2 and serious hypersensitivity. Warnings address severe gastrointestinal reactions, kidney injury from volume depletion, gallbladder disease, pancreatitis, hypoglycemia, diabetic retinopathy complications and aspiration during anesthesia or deep sedation.",
          "sections": [
            "boxed warning",
            "4",
            "5"
          ]
        }
      ],
      "sourceTitle": "ZEPBOUND (tirzepatide) injection · SPL version 40 · published 2026-09-02",
      "versionPath": "/peptides/tirzepatide/labels/versions/1/"
    },
    {
      "peptideSlug": "afamelanotide",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "dailymed-afamelanotide-94f53286-11dd-7fbb-e053-2a95a90a7c48-v11",
      "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?type=zip&setid=94f53286-11dd-7fbb-e053-2a95a90a7c48&version=11",
      "sourceRole": "U.S. product labeling hosted by the National Library of Medicine",
      "documentKind": "dailymed-spl",
      "jurisdiction": "United States",
      "zipSha256": "2524c0069e687a8d327718fa17678071dd3c817a42624f569870344888f34e29",
      "xmlSha256": "d58fc4df343aa1a49a633ed2fbfb46eb5cc94ec6d9e059a4e1d86d4dd1f43397",
      "product": "Scenesse",
      "findings": [
        {
          "heading": "Which population and use does the label cover?",
          "text": "The cited implant label covers increased pain-free light exposure in adults with erythropoietic protoporphyria and a history of phototoxic reactions. This is not a general tanning or cosmetic indication.",
          "sections": [
            "indications and usage"
          ]
        },
        {
          "heading": "Which safety limits matter?",
          "text": "The label contraindicates severe hypersensitivity and reports postmarketing anaphylaxis. It also describes increased pigmentation and darkening of existing skin lesions, with skin monitoring addressed in the warnings.",
          "sections": [
            "contraindications",
            "warnings and precautions"
          ]
        }
      ],
      "sourceTitle": "SCENESSE (afamelanotide) implant · SPL version 11 · published 2026-05-13",
      "versionPath": "/peptides/afamelanotide/labels/versions/1/"
    },
    {
      "peptideSlug": "exenatide",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "dailymed-exenatide-e6cb5c8f-e97f-4a6a-95a4-939fd2393949-v17",
      "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?type=zip&setid=e6cb5c8f-e97f-4a6a-95a4-939fd2393949&version=17",
      "sourceRole": "U.S. product labeling hosted by the National Library of Medicine",
      "documentKind": "dailymed-spl",
      "jurisdiction": "United States",
      "zipSha256": "3a938f95f72fa59782922c490dc415fef7aa62df9872a1da096e4bff95b65abb",
      "xmlSha256": "18efb84e3d03a7719a6efd35e086f73cfc27232395a36db93da5fe7334894977",
      "product": "Exenatide injection",
      "findings": [
        {
          "heading": "Which population and use does the label cover?",
          "text": "This injection label covers glycemic control alongside diet and exercise in adults with type 2 diabetes. Its formulation-specific account does not substitute for extended-release exenatide labeling.",
          "sections": [
            "1"
          ]
        },
        {
          "heading": "Which safety limits matter?",
          "text": "Contraindications include severe hypersensitivity and prior exenatide-induced immune-mediated thrombocytopenia. Warnings address pancreatitis, hypoglycemia with insulin or insulin secretagogues, kidney injury from volume depletion, severe gastrointestinal reactions, antibodies, potentially fatal bleeding from immune-mediated thrombocytopenia, gallbladder disease and aspiration during anesthesia or deep sedation.",
          "sections": [
            "4",
            "5"
          ]
        }
      ],
      "sourceTitle": "Exenatide injection · SPL version 17 · published 2026-06-30",
      "versionPath": "/peptides/exenatide/labels/versions/1/"
    },
    {
      "peptideSlug": "leuprolide",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "dailymed-leuprolide-4838c674-044e-46b2-81e7-c691b99d8fa5-v10",
      "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?type=zip&setid=4838c674-044e-46b2-81e7-c691b99d8fa5&version=10",
      "sourceRole": "U.S. product labeling hosted by the National Library of Medicine",
      "documentKind": "dailymed-spl",
      "jurisdiction": "United States",
      "zipSha256": "86f3963f5e8c460c7214ef2ac8e45182d3919a279b0fa097bf03eb2c5632471d",
      "xmlSha256": "62478327ea5fa12911efbec7eef842d246d0987362191dbd644223838558fcdb",
      "product": "Leuprolide acetate injection",
      "findings": [
        {
          "heading": "Which population and use does the label cover?",
          "text": "The cited injection label covers palliative treatment of advanced prostate cancer. Other leuprolide formulations and gynecologic or pediatric indications require their own product records.",
          "sections": [
            "indications and usage"
          ]
        },
        {
          "heading": "Which safety limits matter?",
          "text": "The label describes initial testosterone increases and possible worsening of cancer symptoms, including urinary obstruction or spinal cord compression. It also addresses severe skin reactions, hypersensitivity, hyperglycemia or diabetes, cardiovascular events reported with GnRH agonists, QT prolongation and potential fetal harm.",
          "sections": [
            "contraindications",
            "warnings",
            "precautions"
          ]
        }
      ],
      "sourceTitle": "Leuprolide acetate kit · SPL version 10 · published 2026-07-06",
      "versionPath": "/peptides/leuprolide/labels/versions/1/"
    },
    {
      "peptideSlug": "liraglutide",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "dailymed-liraglutide-22c86976-9657-4dd0-8fff-0c3f3f08357c-v6",
      "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?type=zip&setid=22c86976-9657-4dd0-8fff-0c3f3f08357c&version=6",
      "sourceRole": "U.S. product labeling hosted by the National Library of Medicine",
      "documentKind": "dailymed-spl",
      "jurisdiction": "United States",
      "zipSha256": "48d493b4dc6af7d7574aedf0a2f7ab6235a9ed62875baffe6c484b5433647541",
      "xmlSha256": "26e94f7191fa24c8a25945ac1cd23ef4a95e897a8c9e84520043a4d7ff6edbef",
      "product": "Liraglutide injection for weight management",
      "findings": [
        {
          "heading": "Which population and use does the label cover?",
          "text": "The cited generic injection label covers long-term weight reduction alongside diet and activity in adults with obesity or overweight with a weight-related condition, and children aged twelve years and older with obesity and body weight above 60 kg. It does not establish the scope of every liraglutide product.",
          "sections": [
            "1"
          ]
        },
        {
          "heading": "Which safety limits matter?",
          "text": "The boxed warning reports thyroid C-cell tumors in rodents, with uncertain human relevance. Contraindications include personal or family medullary thyroid carcinoma, MEN 2 and hypersensitivity. Other warnings address pancreatitis, gallbladder disease, hypoglycemia, increased heart rate, kidney injury from volume depletion, severe gastrointestinal reactions and aspiration during anesthesia or deep sedation.",
          "sections": [
            "boxed warning",
            "4",
            "5"
          ]
        }
      ],
      "sourceTitle": "Liraglutide injection, solution · SPL version 6 · published 2026-07-14",
      "versionPath": "/peptides/liraglutide/labels/versions/1/"
    },
    {
      "peptideSlug": "octreotide",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "dailymed-octreotide-387d7f8d-9762-4f6b-99e1-bdc50b8a1633-v2",
      "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?type=zip&setid=387d7f8d-9762-4f6b-99e1-bdc50b8a1633&version=2",
      "sourceRole": "U.S. product labeling hosted by the National Library of Medicine",
      "documentKind": "dailymed-spl",
      "jurisdiction": "United States",
      "zipSha256": "ef983a96082e22365e0421c84727fd1f1c4edba8f562651f80efe7222ff70491",
      "xmlSha256": "14384962a14328e523de4f1f393ab757985c463cef9f2e690b3b8491076f76d7",
      "product": "Octreotide acetate injection",
      "findings": [
        {
          "heading": "Which population and use does the label cover?",
          "text": "The label covers reduction of growth hormone and IGF-1 in specified acromegaly settings, diarrhea and flushing with metastatic carcinoid tumors, and diarrhea with VIP-secreting tumors. It says the cited injection trials did not establish reduction in tumor size or growth; this is separate from evidence for other formulations.",
          "sections": [
            "1"
          ]
        },
        {
          "heading": "Which safety limits matter?",
          "text": "The label contraindicates hypersensitivity and warns about cardiac conduction abnormalities, gallstones and complications, altered glucose control, hypothyroidism, and impaired fat absorption. Intravenous administration has a distinct warning about higher-degree heart block.",
          "sections": [
            "4",
            "5"
          ]
        }
      ],
      "sourceTitle": "Octreotide acetate injection, solution · SPL version 2 · published 2026-02-02",
      "versionPath": "/peptides/octreotide/labels/versions/1/"
    },
    {
      "peptideSlug": "semaglutide",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "dailymed-semaglutide-ee06186f-2aa3-4990-a760-757579d8f77b-v19",
      "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?type=zip&setid=ee06186f-2aa3-4990-a760-757579d8f77b&version=19",
      "sourceRole": "U.S. product labeling hosted by the National Library of Medicine",
      "documentKind": "dailymed-spl",
      "jurisdiction": "United States",
      "zipSha256": "a8c57f3e8cf2c89501ac3b6077dd7480fb4bf72bb0b42135078f0d3a1f20f8f8",
      "xmlSha256": "2f2c51a1fdf57a3a2459f340abfbe1e0283e5c8849d3a844db8c28ede302f6b3",
      "product": "Wegovy injection and tablets",
      "findings": [
        {
          "heading": "Which population and use does the label cover?",
          "text": "For adults with established cardiovascular disease and obesity or overweight, the label covers cardiovascular-risk reduction with injection or tablets. Both formulations cover weight management in adults with obesity, or overweight with a weight-related condition. Injection additionally covers weight management in children aged twelve years and older with obesity, and noncirrhotic MASH with F2–F3 fibrosis in adults. The MASH indication has accelerated approval requiring confirmation of clinical benefit; it does not apply to the tablets.",
          "sections": [
            "1"
          ]
        },
        {
          "heading": "Which safety limits matter?",
          "text": "The boxed warning reports thyroid C-cell tumors in rodents, with uncertain human relevance. Contraindications include personal or family medullary thyroid carcinoma, MEN 2 and hypersensitivity. Warnings address pancreatitis, gallbladder disease, hypoglycemia with insulin or insulin secretagogues, kidney injury from volume depletion, severe gastrointestinal reactions, retinopathy complications, increased heart rate and aspiration during anesthesia or deep sedation.",
          "sections": [
            "boxed warning",
            "4",
            "5"
          ]
        }
      ],
      "sourceTitle": "WEGOVY (semaglutide) injection and tablet · SPL version 19 · published 2026-06-30",
      "versionPath": "/peptides/semaglutide/labels/versions/1/"
    },
    {
      "peptideSlug": "setmelanotide",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "dailymed-setmelanotide-70c3ccf7-4df0-4c75-ba07-fede9970c8d9-v14",
      "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?type=zip&setid=70c3ccf7-4df0-4c75-ba07-fede9970c8d9&version=14",
      "sourceRole": "U.S. product labeling hosted by the National Library of Medicine",
      "documentKind": "dailymed-spl",
      "jurisdiction": "United States",
      "zipSha256": "3a9024abc434e828923d30e4f860e834f3887ceece2a7a47cdc1c8828105e6f1",
      "xmlSha256": "b144f343fa74b6d436776a8f7fcb548db348e1c7ffcc8e567930b96cd3b1b812",
      "product": "Imcivree",
      "findings": [
        {
          "heading": "Which population and use does the label cover?",
          "text": "The label covers acquired hypothalamic obesity from age four, and Bardet-Biedl syndrome or specified genetically confirmed POMC, PCSK1 or LEPR deficiency from age two. It explicitly excludes general polygenic obesity and specified benign genetic variants.",
          "sections": [
            "1"
          ]
        },
        {
          "heading": "Which safety limits matter?",
          "text": "Warnings address sexual-arousal effects, depression or suicidal ideation, serious hypersensitivity, pigmentary changes and new or darkened nevi. For acquired hypothalamic obesity, the label adds acute adrenal insufficiency and, with central diabetes insipidus, sodium imbalance.",
          "sections": [
            "4",
            "5"
          ]
        }
      ],
      "sourceTitle": "IMCIVREE (setmelanotide) solution · SPL version 14 · published 2026-04-02",
      "versionPath": "/peptides/setmelanotide/labels/versions/1/"
    },
    {
      "peptideSlug": "teriparatide",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "dailymed-teriparatide-d77d40db-7f38-88eb-fd5d-4282f0642028-v9",
      "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?type=zip&setid=d77d40db-7f38-88eb-fd5d-4282f0642028&version=9",
      "sourceRole": "U.S. product labeling hosted by the National Library of Medicine",
      "documentKind": "dailymed-spl",
      "jurisdiction": "United States",
      "zipSha256": "3d44d13e5c26a6d99016811b324c701e16b0d18d7390d19dd9e3ee5833bb6cb8",
      "xmlSha256": "a86aaababbba9a8a6ddf6737fbd40d6ecf891c291bb211b5722997e127bf509b",
      "product": "Teriparatide injection",
      "findings": [
        {
          "heading": "Which population and use does the label cover?",
          "text": "The label covers specified high-fracture-risk osteoporosis settings in postmenopausal women, men with primary or hypogonadal osteoporosis, and men or women with glucocorticoid-associated osteoporosis. The male indication refers to increasing bone mass; the postmenopausal account includes fracture-risk reduction.",
          "sections": [
            "1"
          ]
        },
        {
          "heading": "Which safety limits matter?",
          "text": "The label contraindicates hypersensitivity and addresses osteosarcoma risk, hypercalcemia, cutaneous calcification including calciphylaxis, urinary stones and orthostatic hypotension. It distinguishes the rat osteosarcoma finding from observational human studies in which an increased risk was not observed.",
          "sections": [
            "4",
            "5"
          ]
        }
      ],
      "sourceTitle": "Teriparatide injection, solution · SPL version 9 · published 2026-06-30",
      "versionPath": "/peptides/teriparatide/labels/versions/1/"
    },
    {
      "peptideSlug": "glucagon",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "dailymed-glucagon-359982a8-ec5c-4927-8c0f-89771e0f942b-v2",
      "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?type=zip&setid=359982a8-ec5c-4927-8c0f-89771e0f942b&version=2",
      "sourceRole": "U.S. product labeling hosted by the National Library of Medicine",
      "documentKind": "dailymed-spl",
      "jurisdiction": "United States",
      "zipSha256": "8a7eea4413fc92f6e205eb71e1c76b56e2ae78d9fe5eb31679c7319800c12d49",
      "xmlSha256": "aaa5ae4cd4355c3558a0223bcca2f00eabc45db6667177ac9561b0b4db5c95ba",
      "product": "Gvoke and Gvoke VialDx",
      "findings": [
        {
          "heading": "Which population and use does the label cover?",
          "text": "The shared label separates Gvoke for severe hypoglycemia in adults and children aged two years and older with diabetes from Gvoke VialDx as a diagnostic aid during gastrointestinal radiologic examinations in adults. These are different product uses; the diagnostic vial is not the severe-hypoglycemia presentation.",
          "sections": [
            "1.1",
            "1.2"
          ]
        },
        {
          "heading": "Which safety limits matter?",
          "text": "Contraindications include pheochromocytoma, insulinoma and prior hypersensitivity; diagnostic use also contraindicates glucagonoma. Warnings address serious allergic reactions, blood-pressure increases, hypoglycemia in specific tumor settings, reduced efficacy when liver glycogen is depleted, and a skin reaction reported with continuous infusion. Diagnostic use has additional warnings about hyperglycemia and increased cardiac demand, blood pressure and heart rate.",
          "sections": [
            "4",
            "5"
          ]
        }
      ],
      "sourceTitle": "GVOKE VIALDX (glucagon) injection, solution · SPL version 2 · published 2026-07-09",
      "versionPath": "/peptides/glucagon/labels/versions/1/"
    },
    {
      "peptideSlug": "elamipretide",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "fda-forzinity-label-2025",
      "sourceUrl": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215244s000lbl.pdf",
      "sourceRole": "FDA-hosted U.S. prescribing information",
      "documentKind": "fda-label-pdf",
      "jurisdiction": "United States",
      "pdfSha256": "1a32a3b7452b7c33c4a60b7f9175f80fcce499775feb39b4c14743293e6bf618",
      "product": "FORZINITY, revised September 2025",
      "findings": [
        {
          "heading": "Which population and use does the label cover?",
          "text": "The label covers improved muscle strength in adults and children with Barth syndrome weighing at least 30 kg. Accelerated approval rests on an intermediate clinical endpoint and requires confirmation of clinical benefit.",
          "sections": [
            "1"
          ]
        },
        {
          "heading": "Which safety limits matter?",
          "text": "The label contraindicates serious hypersensitivity and warns about hypersensitivity reactions and benzyl-alcohol toxicity in neonates. Injection-site reactions were the most common adverse reactions.",
          "sections": [
            "4",
            "5",
            "6"
          ]
        }
      ],
      "sourceTitle": "FORZINITY, revised September 2025: U.S. prescribing information",
      "versionPath": "/peptides/elamipretide/labels/versions/1/"
    },
    {
      "peptideSlug": "lixisenatide",
      "version": 1,
      "publishedAt": "2026-09-15",
      "reviewedAt": "2026-09-15",
      "sourceId": "fda-adlyxin-label-2024",
      "sourceUrl": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208471s009lbl.pdf",
      "sourceRole": "FDA-hosted U.S. prescribing information",
      "documentKind": "fda-label-pdf",
      "jurisdiction": "United States",
      "pdfSha256": "62efbf5418ef53b5e665d679c1184fa7bc006960fb487a68aa04bf1e2a04d597",
      "product": "ADLYXIN, revised November 2024",
      "findings": [
        {
          "heading": "Which population and use does the label cover?",
          "text": "This single-ingredient label covers glycemic control alongside diet and exercise in adults with type 2 diabetes. It is separate from the insulin glargine/lixisenatide combination label cited by the profile, and does not establish current commercial availability.",
          "sections": [
            "1"
          ]
        },
        {
          "heading": "Which safety limits matter?",
          "text": "The label contraindicates severe hypersensitivity and addresses anaphylaxis, pancreatitis, hypoglycemia with insulin or insulin secretagogues, acute kidney injury, immunogenicity, gallbladder disease and aspiration during anesthesia or deep sedation. It does not recommend use in gastroparesis.",
          "sections": [
            "4",
            "5",
            "6"
          ]
        }
      ],
      "sourceTitle": "ADLYXIN, revised November 2024: U.S. prescribing information",
      "versionPath": "/peptides/lixisenatide/labels/versions/1/"
    }
  ]
}