Search FDA labels and WHO health references

# Search FDA labels and WHO health references

Find FDA drug labels and WHO Global Health Observatory data.
Usage limits: Restricted to FDA-label and WHO sources, short responses, 1-10 results. Billed from total_deduction_dollars, not a flat per-call maximum. Reference search only.
Draft retail price: at cost from the upstream USD meter; no markup. Only the documented data sources are allowed.
Request contract: include all six declared body fields. Send search_type=proprietary, response_length=short, and the exact max_price and included_sources shown in the example; these are constrained source settings.
Documentation: https://openany.si/apis/c2912078-fd08-4188-8ce3-e7bd9dd4eece
Method: POST
Endpoint: https://api.openany.si/v1/agent-apis/treg/call/valyu.health.references.search
Price: $1 / 1 upstream_usd
Provider: treg
Contract revision: 2
Price source: selected implementation in the OpenAny public API catalog. Price update time: not supplied.

Use OPENANY_API_KEY from the environment. API Key calls use your shared balance.

## Prepared request
```bash
curl \
  'https://api.openany.si/v1/agent-apis/treg/call/valyu.health.references.search' \
  -X POST \
  -H "Authorization: Bearer $OPENANY_API_KEY" \
  -H 'Content-Type: application/json' \
  --data-raw '{
  "included_sources": [
    "valyu/valyu-drug-labels",
    "valyu/valyu-who-gho"
  ],
  "max_num_results": 1,
  "max_price": 3,
  "query": "Ozempic semaglutide FDA drug label",
  "response_length": "short",
  "search_type": "proprietary"
}'
```

## API contract
```json
{
  "resource_type": "api",
  "name": "Search FDA labels and WHO health references",
  "endpoint": "https://api.openany.si/v1/agent-apis/treg/call/valyu.health.references.search",
  "method": "POST",
  "content_type": "application/json",
  "execution_mode": "sync",
  "authentication": {
    "type": "bearer",
    "environment_variable": "OPENANY_API_KEY"
  },
  "inputs": [
    {
      "description": "Find FDA drug labels and WHO Global Health Observatory data.\nUsage limits: Restricted to FDA-label and WHO sources, short responses, 1-10 results. Billed from total_deduction_dollars, not a flat per-call maximum. Reference search only.\nDraft retail price: at cost from the upstream USD meter; no markup. Only the documented data sources are allowed.\nRequest contract: include all six declared body fields. Send search_type=proprietary, response_length=short, and the exact max_price and included_sources shown in the example; these are constrained source settings.",
      "json_schema": {
        "additionalProperties": false,
        "properties": {
          "included_sources": {
            "description": "Required TREG source constraint; send this exact value.",
            "enum": [
              [
                "valyu/valyu-drug-labels",
                "valyu/valyu-who-gho"
              ]
            ],
            "example": [
              "valyu/valyu-drug-labels",
              "valyu/valyu-who-gho"
            ],
            "items": {
              "type": "string"
            },
            "maxItems": 2,
            "minItems": 2,
            "type": "array"
          },
          "max_num_results": {
            "description": "",
            "example": 1,
            "maximum": 10,
            "minimum": 1,
            "type": "integer"
          },
          "max_price": {
            "description": "Required TREG source constraint; send this exact value.",
            "enum": [
              3
            ],
            "example": 3,
            "type": "number"
          },
          "query": {
            "description": "",
            "example": "Ozempic FDA drug label",
            "type": "string"
          },
          "response_length": {
            "description": "Required TREG source constraint; send this exact value.",
            "enum": [
              "short"
            ],
            "example": "short",
            "type": "string"
          },
          "search_type": {
            "description": "Required TREG source constraint; send this exact value.",
            "enum": [
              "proprietary"
            ],
            "example": "proprietary",
            "type": "string"
          }
        },
        "required": [
          "query",
          "max_num_results",
          "search_type",
          "max_price",
          "response_length",
          "included_sources"
        ],
        "type": "object"
      },
      "location": "body",
      "name": "body",
      "nullable": false,
      "pointer": "",
      "required": true,
      "type": "object"
    }
  ],
  "billing": {
    "currency": "USD",
    "mode": "usage",
    "priceMicroUsd": "1000000",
    "rounding": "ceil",
    "unit": "upstream_usd",
    "unitQuantity": "1"
  },
  "examples": [
    {
      "http_status": 200,
      "name": "Third-party reference · Testnet 2026-11-04: success",
      "request": {
        "body": {
          "included_sources": [
            "valyu/valyu-drug-labels",
            "valyu/valyu-who-gho"
          ],
          "max_num_results": 1,
          "max_price": 3,
          "query": "Ozempic semaglutide FDA drug label",
          "response_length": "short",
          "search_type": "proprietary"
        },
        "headers": {},
        "path": {},
        "query": {}
      },
      "response_body": {
        "error": "",
        "query": "Ozempic semaglutide FDA drug label",
        "results": [
          {
            "content": "# OZEMPIC (ORAL SEMAGLUTIDE) TABLET RYBELSUS (ORAL SEMAGLUTIDE) TABLET [NOVO NORDISK PHARMACEUTICAL INDUSTRIES, LP]\n**SetId:** 27f15fac-7d98-4114-a2ec-92494a91da98\n\n## WARNING: RISK OF THYROID C-CELL TUMORS\n- In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether RYBELSUS and OZEMPIC tablets cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ), Nonclinical Toxicology ( 13.1 )] .\n- RYBELSUS and OZEMPIC tablets are contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Contraindications ( 4 )] . Counsel patients regarding the potential risk for MTC with the use of RYBELSUS or OZEMPIC tablets and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with RYBELSUS or OZEMPIC tablets [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )].\n\n## 1 INDICATIONS AND USAGE\nRYBELSUS and OZEMPIC tablets are indicated:\n\n- as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.\n- to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events.\n\n## 2 DOSAGE AND ADMINISTRATION\nRecommended Starting, Escalation and Maintenance Dosage of RYBELSUS and OZEMPIC Tablets ( 2.2 )\n\nRYBELSUS ( 2.2 )\n\nOZEMPIC Tablets ( 2.2 )\n\n- RYBELSUS and OZEMPIC tablets are not substitutable on a mg-to-mg basis.\n- Take RYBELSUS or OZEMPIC tablets orally once daily on an empty stomach in the morning with water (up to 4 ounces of water); do not take with other liquids besides water. ( 2.1 )\n- Swallow tablets whole. Do not split, crush, chew or dissolve in any solution. ( 2.1 )\n- After taking RYBELSUS or OZEMPIC tablets, wait at least 30 minutes before eating food, drinking beverages or taking other oral medications. ( 2.1 )\n- See the Full Prescribing Information for instructions on switching between RYBELSUS and OZEMPIC tablets ( 2.3 ) and from OZEMPIC injections to RYBELSUS or OZEMPIC tablets. ( 2.4 )\n\n- Day 1 to 30: Recommended starting dosage is 3 mg orally once daily for 30 days (this dosage is not effective for glycemic control)\n- Days 31 to 60: Increase the dosage to 7 mg orally once daily.\n- On Day 61 or thereafter, if: ( 2.2 )\n- o No additional glycemic control is needed, maintain the dosage at 7 mg orally once daily.\n- o Additional glycemic control is needed, increase the dosage to 14 mg orally once daily.\n\n- Day 1 to 30: Recommended starting dosage is 1.5 mg orally once daily for 30 days (this dosage is not effective for glycemic control).\n- Days 31 to 60: Increase the dosage to 4 mg orally once daily.\n- On Day 61 or thereafter, if: ( 2.2 )\n- o No additional glycemic control is needed, maintain the dosage at 4 mg orally once daily.\n- o Additional glycemic control is needed, increase the dosage to 9 mg orally once daily.\n\n## 2.1 Important Administration Instructions\n- RYBELSUS and OZEMPIC tablets are not substitutable on a mg-to-mg basis.\n- Take one RYBELSUS or OZEMPIC tablet orally once daily on an empty stomach in the morning with water (up to 4 ounces of water). Do not take RYBELSUS or OZEMPIC tablets with other liquids besides water [see Clinical Pharmacology ( 12.3 )] .\n- Do not take more than one tablet per day.\n- Swallow tablets whole. Do not split, crush, chew or dissolve in any solution.\n- After taking RYBELSUS or OZEMPIC tablets, wait at least 30 minutes before eating food, drinking beverages or taking other oral medications [see Clinical Pharmacology ( 12.3 )] .\n- If a dose is missed, skip the missed dose and take the next dose the following day.\n\n## 3 DOSAGE FORMS AND STRENGTHS\nRYBELSUS (semaglutide) tablets are available as:\n\nOZEMPIC (semaglutide) tablets are available as:\n\n- 3 mg: white to light yellow, oval shaped debossed with “3” on one side and “novo” on the other side.\n- 7 mg: white to light yellow, oval shaped debossed with “7” on one side and “novo” on the other side.\n- 14 mg: white to light yellow, oval shaped debossed with “14” on one side and “novo” on the other side.\n\n- 1.5 mg: white to light yellow, round shaped debossed with “1.5” on one side and “novo” on the other side.\n- 4 mg: white to light yellow, round shaped debossed with “4” on one side and “novo” on the other side.\n- 9 mg: white to light yellow, round shaped debossed with “9” on one side and “novo” on the other side.\n\n## 4 CONTRAINDICATIONS\nRYBELSUS and OZEMPIC tablets are contraindicated in patients with:\n\n- A personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions ( 5.1 )] .\n- A prior serious hypersensitivity reaction to semaglutide or to any of the excipients in RYBELSUS or OZEMPIC tablets. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with semaglutide tablets [see Warnings and Precautions ( 5.7 )] .\n\n## 5 WARNINGS AND PRECAUTIONS\n- Acute Pancreatitis : Has been observed in patients treated with GLP-1 receptor agonists, including RYBELSUS or OZEMPIC tablets. Discontinue if pancreatitis is suspected. ( 5.2 )\n- Diabetic Retinopathy Complications : Has been reported in a cardiovascular outcomes trial with semaglutide injection. Patients with a history of diabetic retinopathy should be monitored. ( 5.3 )\n- Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin : May increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dosage of insulin secretagogue or insulin may be necessary. ( 5.4 )\n- Acute Kidney Injury Due to Volume Depletion : Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. ( 5.5 )\n- Severe Gastrointestinal Adverse Reactions : Use of RYBELSUS or OZEMPIC tablets has been associated with gastrointestinal adverse reactions, sometimes severe. RYBELSUS and OZEMPIC tablets are not recommended in patients with severe gastroparesis. ( 5.6 )\n- Hypersensitivity Reactions : Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue RYBELSUS or OZEMPIC tablets if hypersensitivity reactions occur and monitor until signs and symptoms resolve. ( 5.7 )\n- Acute Gallbladder Disease : If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated. ( 5.8 )\n- Pulmonary Aspiration During General Anesthesia or Deep Sedation : Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures. ( 5.9 )\n\n## 6 ADVERSE REACTIONS\nThe following serious adverse reactions are described below or elsewhere in the prescribing information:\n\n- Risk of Thyroid C-cell Tumors [see Warnings and Precautions ( 5.1 )]\n- Acute Pancreatitis [see Warnings and Precautions ( 5.2 )]\n- Diabetic Retinopathy Complications [see Warnings and Precautions ( 5.3 )]\n- Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin [see Warnings and Precautions ( 5.4 )]\n- Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.5 )]\n- Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.6 )]\n- Hypersensitivity Reactions [see Warnings and Precautions ( 5.7 )]\n- Acute Gallbladder Disease [see Warnings and Precautions ( 5.8 )]\n- Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.9 )]\n\n## 7 DRUG INTERACTIONS\nOther Oral Drugs : RYBELSUS and OZEMPIC tablets delay gastric emptying. Consider increased clinical or laboratory monitoring when co-administered with other oral medications that have a narrow therapeutic index or that require clinical monitoring. ( 7.2 )\n\n## 8 USE IN SPECIFIC POPULATIONS\n- Pregnancy : See Pregnancy subsection. ( 8.1 )\n- Lactation : Breastfeeding not recommended. ( 8.2 )\n- Females and Males of Reproductive Potential : Discontinue RYBELSUS or OZEMPIC tablets in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide. ( 8.3 )\n\n## 8.1 Pregnancy\nRisk Summary\n\nAvailable data with semaglutide use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy (see Clinical Considerations ). Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy. RYBELSUS or OZEMPIC tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.\n\nIn pregnant rats administered semaglutide during organogenesis, embryofetal mortality, structural abnormalities and alterations to growth occurred at maternal exposures below the maximum recommended human dose (MRHD) based on AUC. In rabbits and cynomolgus monkeys administered semaglutide during organogenesis, early pregnancy losses and structural abnormalities were observed at exposure below the MRHD (rabbit) and ≥10-fold the MRHD (monkey). These findings coincided with a marked maternal body weight loss in both animal species (see Data ).\n\nThe estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with an HbA 1c >7 and has been reported to be as high as 20% to 25% in women with an HbA 1c >10. 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.\n\nClinical Considerations\n\nDisease Associated Maternal and Fetal Risk : Poorly controlled diabetes during pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth and macrosomia related morbidity.\n\nData\n\nAnimal Data : In a combined fertility and embryofetal development study in rats, subcutaneous doses of 0.01, 0.03 and 0.09 mg/kg/day (0.2-, 0.7- and 2.1-fold the MRHD) were administered to males for 4 weeks prior to and throughout mating and to females for 2 weeks prior to mating, and throughout organogenesis to Gestation Day 17. In parental animals, pharmacologically mediated reductions in body weight gain and food consumption were observed at all dose levels. In the offspring, reduced growth and fetuses with visceral (heart blood vessels) and skeletal (cranial bones, vertebra, ribs) abnormalities were observed at the human exposure.\n\nIn an embryofetal development study in pregnant rabbits, subcutaneous doses of 0.0010, 0.0025 or 0.0075 mg/kg/day (0.06-, 0.6- and 4.4-fold the MRHD) were administered throughout organogenesis from Gestation Day 6 to 19. Pharmacologically mediated reductions in maternal body weight gain and food consumption were observed at all dose levels. Early pregnancy losses and increased incidences of minor visceral (kidney, liver) and skeletal (sternebra) fetal abnormalities were observed at ≥0.0025 mg/kg/day, at clinically relevant exposures.\n\nIn an embryofetal development study in pregnant cynomolgus monkeys, subcutaneous doses of 0.015, 0.075 and 0.15 mg/kg twice weekly (1.9-, 9.9- and 29-fold the MRHD) were administered throughout organogenesis, from Gestation Day 16 to 50. Pharmacologically mediated, marked initial maternal body weight loss and reductions in body weight gain and food consumption coincided with the occurrence of sporadic abnormalities (vertebra, sternebra, ribs) at ≥0.075 mg/kg twice weekly (≥9X human exposure).\n\nIn a pre- and postnatal development study in pregnant cynomolgus monkeys, subcutaneous doses of 0.015, 0.075 and 0.15 mg/kg twice weekly (1.3-, 6.4- and 14-fold the MRHD) were administered from Gestation Day 16 to 140. Pharmacologically mediated marked initial maternal body weight loss and reductions in body weight gain and food consumption coincided with an increase in early pregnancy losses and led to delivery of slightly smaller offspring at ≥0.075 mg/kg twice weekly (≥6X human exposure).\n\nSalcaprozate sodium (SNAC), an absorption enhancer in RYBELSUS and OZEMPIC tablets, crosses the placenta and reaches fetal tissues in rats. In a pre- and postnatal development study in pregnant Sprague Dawley rats, SNAC was administered orally at 1,000 mg/kg/day (exposure levels were not measured) on Gestation Day 7 through Lactation Day 20. An increase in gestation length, an increase in the number of stillbirths and a decrease in pup viability were observed.\n\n## 8.4 Pediatric Use\nThe safety and effectiveness of RYBELSUS and OZEMPIC tablets have not been established in pediatric patients.\n\n## 8.5 Geriatric Use\nIn the pool of glycemic control trials, 1,229 (30%) patients treated with semaglutide tablets were 65 years of age and over and 199 (5%) patients treated with semaglutide tablets were 75 years of age and over [see Clinical Studies ( 14 )] . In Trial 8, one of the CV outcomes trials, 891 (56%) patients treated with semaglutide tablets were 65 years of age and over and 200 (13%) patients treated with semaglutide tablets were 75 years of age and over.\n\nNo overall differences in safety or effectiveness for semaglutide tablets have been observed between patients 65 years of age and older and younger adult patients.\n\n## 10 OVERDOSAGE\nIn the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of semaglutide of approximately 1 week.\n\n## 11 DESCRIPTION\nRYBELSUS and OZEMPIC tablets, for oral use, contain semaglutide, a GLP-1 receptor agonist. The peptide backbone is produced by yeast fermentation. The main protraction mechanism of semaglutide is albumin binding, facilitated by modification of position 26 lysine with a hydrophilic spacer and a C18 fatty di-acid. Furthermore, semaglutide is modified in position 8 to provide stabilization against degradation by the enzyme dipeptidyl-peptidase 4 (DPP-4). A minor modification was made in position 34 to ensure the attachment of only one fatty di-acid. The molecular formula is C 187 H 291 N 45 O 59 and the molecular weight is 4113.58 g/mol.\n\nStructural formula:\n\nSemaglutide is a white to almost white hygroscopic powder.\n\nRYBELSUS tablets contain 3 mg, 7 mg or 14 mg of semaglutide and the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and salcaprozate sodium (SNAC).\n\nOZEMPIC tablets contain 1.5 mg, 4 mg or 9 mg of semaglutide and the following inactive ingredients: magnesium stearate and SNAC.\n\n## 12 CLINICAL PHARMACOLOGY\nSemaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1.\n\nGLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors.\n\nThe principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, semaglutide is stabilized against degradation by the DPP-4 enzyme.\n\nSemaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner. Thus, when blood glucose is high, insulin secretion is stimulated and glucagon secretion is inhibited. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase.\n\n## 12.1 Mechanism of Action\nSemaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1.\n\nGLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors.\n\nThe principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, semaglutide is stabilized against degradation by the DPP-4 enzyme.\n\nSemaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner. Thus, when blood glucose is high, insulin secretion is stimulated and glucagon secretion is inhibited. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase.\n\n## 12.2 Pharmacodynamics\nThe pharmacodynamic evaluations described below were in patients with type 2 diabetes mellitus who received once-weekly subcutaneous injections of placebo or semaglutide injection over 12 weeks (semaglutide injection-treated patients were started on lower dosages and then titrated up to 1 mg once weekly). RYBELSUS and OZEMPIC tablets are not approved for subcutaneous use.\n\nFasting and Postprandial Glucose\n\nSemaglutide reduces fasting and postprandial glucose concentrations. In patients with type 2 diabetes mellitus, treatment with semaglutide injection 1 mg resulted in reductions in glucose in terms of absolute change from baseline and relative reduction compared to placebo of 29 mg/dL (22%) for fasting glucose, 74 mg/dL (36%) for 2-hour postprandial glucose and 30 mg/dL (22%) for mean 24-hour glucose concentration.\n\nInsulin Secretion\n\nBoth first- and second-phase insulin secretion are increased in patients with type 2 diabetes mellitus treated with semaglutide compared with placebo.\n\nGlucagon Secretion\n\nSemaglutide lowers the fasting and postprandial glucagon concentrations.\n\nGlucose dependent insulin and glucagon secretion\n\nSemaglutide lowers high blood glucose concentrations by stimulating insulin secretion and lowering glucagon secretion in a glucose-dependent manner.\n\nDuring induced hypoglycemia, semaglutide did not alter the counter regulatory responses of increased glucagon compared to placebo and did not impair the decrease of C-peptide in patients with type 2 diabetes mellitus.\n\nGastric emptying\n\nSemaglutide causes a delay of early postprandial gastric emptying, thereby reducing the rate at which glucose appears in the circulation postprandially.\n\nCardiac Electrophysiology\n\nThe effect of subcutaneously administered semaglutide on cardiac repolarization was tested in a thorough QTc trial. At an average exposure level 4-fold higher than that of the maximum recommended dose of semaglutide tablets, semaglutide does not prolong QTc intervals to any clinically relevant extent.\n\n## 12.3 Pharmacokinetics\nSemaglutide estimated mean steady-state concentration was 6.7 nmol/L and 14.6 nmol/L following once daily oral administration of 7 mg and 14 mg of RYBELSUS, respectively, in patients with type 2 diabetes mellitus.\n\nSemaglutide exposures increased in a dose-proportional manner. Steady-state exposure was achieved following 4 to 5 weeks of semaglutide tablets oral administration.\n\nAbsorption\n\nRYBELSUS and OZEMPIC tablets are co-formulated with SNAC which facilitates the absorption of semaglutide after oral administration. The absorption of semaglutide predominantly occurs in the stomach.\n\nSemaglutide estimated absolute bioavailability was approximately:\n\nSemaglutide maximum concentration was reached approximately 1-hour after oral administration of semaglutide tablets.\n\nEffect of Semaglutide Tablet Formulations : There were no clinically significant differences observed in the mean steady state AUC 0-24h,SS and C max,SS between the 3 mg, 7 mg and 14 mg doses of RYBELSUS and the 1.5 mg, 4 mg and 9 mg doses of OZEMPIC tablets, respectively, in a clinical study conducted in healthy subjects.\n\nEffect of Volume and Timing of Water Consumption : Single oral doses of semaglutide tablets were administered with 50 mL or 240 mL of water after an 8-hour overnight fast and a continued fast of 4 hours post-dose in healthy subjects. Semaglutide absorption (i.e., area under the curve (AUC) and peak concentrations (C max ) were higher following dosing with 50 mL water compared to that of 240 mL water.\n\nFor 10 days, healthy subjects received semaglutide tablets once daily doses orally with 50 mL or 120 mL of water under fasting conditions with post-dose fasting period of 15, 30, 60 or 120 minutes. In this study, semaglutide absorption (i.e., AUC and C max ) was higher after a longer post-dose fasting period. There were no clinically significant differences in semaglutide absorption with administration of 50 mL or 120 mL of water.\n\nDistribution\n\nSemaglutide absolute volume of distribution is approximately 8 L in patients with type 2 diabetes. Semaglutide is >99% bound to plasma albumin.\n\nElimination\n\nSemaglutide elimination half-life is approximately one week with an absolute clearance of approximately 0.04 L/hour in patients with type 2 diabetes. Semaglutide is present in the circulation for about five weeks after the last semaglutide tablet dose.\n\nMetabolism : The primary route of elimination for semaglutide is metabolism following proteolytic cleavage of the peptide backbone and sequential beta-oxidation of the fatty acid side chain.\n\nExcretion : The primary excretion routes of semaglutide-related material are via the urine and feces. Approximately 3% of the absorbed dose is excreted in the urine as intact semaglutide.\n\nSpecific Populations\n\nNo clinically significant differences in semaglutide pharmacokinetics were observed based on age (≥18 years old), sex, race (White, Asian or Black or African American), ethnicity, body weight (40 to 188 kg), upper GI disease (i.e., chronic gastritis and/or gastroesophageal reflux disease), hepatic impairment (i.e., mild, moderate, severe based on the Child-Pugh system) and renal impairment (i.e., mild, moderate, severe, end staged renal disease).\n\nDrug Interaction Studies\n\nClinical Studies and Model-Informed Approaches : The delay of gastric emptying with semaglutide may influence the absorption of concomitantly administered oral drugs. Trials were conducted to study the potential effect of semaglutide on the absorption of oral drugs taken with semaglutide administered orally at steady-state exposure.\n\nIn Vitro Studies : Semaglutide has very low potential to inhibit or induce CYP enzymes, and to inhibit drug transporters.\n\n- 0.4% to 1% after oral administration of 3 mg, 7 mg and 14 mg of RYBELSUS.\n- 1% to 2% after oral administration of 1.5 mg, 4 mg and 9 mg of OZEMPIC tablets.\n\n- Levothyroxine : Total thyroxine (i.e., adjusted for endogenous levels) AUC was increased by 33% following administration of a single dose of levothyroxine 600 mcg concomitantly administered with semaglutide tablets. Maximum exposure (C max ) was unchanged.\n- Other Drugs : No clinically significant differences in semaglutide pharmacokinetics were observed when used concomitantly with omeprazole. No clinically significant differences in the pharmacokinetics of the following drugs were observed when used concomitantly with semaglutide: lisinopril, S-warfarin, R-warfarin, metformin, digoxin, ethinyl estradiol, levonorgestrel, furosemide or rosuvastatin.\n\n## 13 NONCLINICAL TOXICOLOGY\nIn a 2-year carcinogenicity study in CD-1 mice, subcutaneous doses of 0.3, 1 and 3 mg/kg/day [9-, 33- and 113- fold the maximum recommended human dose (MRHD) of semaglutide tablet 14 mg, based on AUC] were administered to the males, and 0.1, 0.3 and 1 mg/kg/day (3-, 9- and 33-fold MRHD) were administered to the females. A statistically significant increase in thyroid C-cell adenomas and a numerical increase in C-cell carcinomas were observed in males and females at all dose levels (>3 times human exposure).\n\nIn a 2-year carcinogenicity study in Sprague Dawley rats, subcutaneous doses of 0.0025, 0.01, 0.025 and 0.1 mg/kg/day were administered (below quantification, 0.8-, 1.8- and 11-fold the exposure at the MRHD). A statistically significant increase in thyroid C-cell adenomas was observed in males and females at all dose levels, and a statistically significant increase in thyroid C-cell carcin",
            "data_type": "unstructured",
            "id": "dailymed-27f15fac-7d98-4114-a2ec-92494a91da98",
            "length": 25000,
            "metadata": {},
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