{"components":["Active ingredient (in each 3 mL pen) Retatrutide — 40 mg"],"do_not_use":["Directions for Use • For subcutaneous injection only. • Inject once weekly on the same day each week, any time of day, with or without meals. • Recommended injection sites: abdomen, thigh, or upper arm. • Clean the injection site with alcohol before injection. • Rotate injection sites each week. • Use a new needle for each injection. Do not share your pen."],"dosage_and_administration":["Titration schedule: Weeks 1–4 0.19 mL (2.5 mg) once weekly Weeks 5–8 0.37 mL (5 mg) once weekly Weeks 9–12 0.56 mL (7.5 mg) once weekly Week 13 and beyond 0.75 mL (10 mg) once weekly"],"effective_time":"20251107","id":"42ff036a-fd92-4f60-e063-6294a90a49c8","inactive_ingredient":["Inactive ingredients Sterile Water for Injection"],"indications_and_usage":["Uses To improve blood glucose control in adults with type 2 diabetes. For long-term weight management and reduction of visceral fat in adults who are overweight or obese, with or without diabetes."],"keep_out_of_reach_of_children":["Keep out of reach of children. Keep out of reach of children"],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL 01 02 03 04"],"purpose":["Purpose Antidiabetic / Weight management agent"],"set_id":"42fefef4-22d3-19ba-e063-6394a90af86e","spl_product_data_elements":["Salkalli RETATRUTIDE Pen 40mg RETATRUTIDE RETATRUTIDE AQUA"],"stop_use":["stop use Pancreatitis: Acute pancreatitis has been reported with GLP-1 receptor agonists. If severe or persistent abdominal pain occurs (with or without vomiting), stop using RETATRUTIDE and contact your healthcare provider immediately. Allergic reactions: Serious hypersensitivity reactions (including anaphylaxis) have been reported. Stop use and seek medical attention if you develop rash, swelling, or difficulty breathing. Severe gastrointestinal disease: RETATRUTIDE has not been studied in patients with severe GI disorders; use is not recommended. Gallbladder disease: Acute gallbladder events, including cholelithiasis, have occurred. Evaluate promptly if gallbladder disease is suspected. Hypoglycemia warning: Do not use RETATRUTIDE if you have a history of recurrent or severe hypoglycemia. RETATRUTIDE may further lower blood glucose levels. Use is contraindicated in individuals with baseline hypoglycemia or conditions predisposing to hypoglycemia. Pregnancy and breastfeeding: Do not use if pregnant or breastfeeding. Pediatric use: Not for use in children. Drug Interactions / Precautions Other antidiabetic medications: Retatrutide lowers blood glucose. Using it with insulin or sulfonylureas may increase the risk of hypoglycemia. Blood glucose should be closely monitored; doses of other antidiabetic drugs may need adjustment. Drugs affecting gastrointestinal motility: Retatrutide may delay gastric emptying. Co-administration with prokinetic agents (e.g., domperidone) or antacids may alter absorption or worsen GI discomfort. Cardiovascular medications: Caution with statins, digoxin, or warfarin. Statins: absorption may be affected; monitor lipid levels. Warfarin: changes in metabolism may alter anticoagulant effects; monitor INR levels. General precautions: Retatrutide should be used only under medical supervision. Inform your healthcare provider about all medications, including prescription, over-the-counter, and herbal products. Possible side effects Common: nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, abdominal pain. Stop use and contact a doctor if symptoms become severe or persistent. When to stop and call your doctor Stop using the pen and contact your physician if you experience: • Severe or persistent abdominal pain or vomiting • Symptoms of an allergic reaction • Signs of pancreatitis • Any other unexpected or severe reaction"],"version":"1","warnings":["Warnings Pancreatitis: Acute pancreatitis has been reported with GLP-1 receptor agonists. If severe or persistent abdominal pain occurs (with or without vomiting), stop using RETATRUTIDE and contact your healthcare provider immediately. Allergic reactions: Serious hypersensitivity reactions (including anaphylaxis) have been reported. Stop use and seek medical attention if you develop rash, swelling, or difficulty breathing. Severe gastrointestinal disease: RETATRUTIDE has not been studied in patients with severe GI disorders; use is not recommended. Gallbladder disease: Acute gallbladder events, including cholelithiasis, have occurred. Evaluate promptly if gallbladder disease is suspected. Hypoglycemia warning: Do not use RETATRUTIDE if you have a history of recurrent or severe hypoglycemia. RETATRUTIDE may further lower blood glucose levels. Use is contraindicated in individuals with baseline hypoglycemia or conditions predisposing to hypoglycemia. Pregnancy and breastfeeding: Do not use if pregnant or breastfeeding. Pediatric use: Not for use in children. Drug Interactions / Precautions Other antidiabetic medications: Retatrutide lowers blood glucose. Using it with insulin or sulfonylureas may increase the risk of hypoglycemia. Blood glucose should be closely monitored; doses of other antidiabetic drugs may need adjustment. Drugs affecting gastrointestinal motility: Retatrutide may delay gastric emptying. Co-administration with prokinetic agents (e.g., domperidone) or antacids may alter absorption or worsen GI discomfort. Cardiovascular medications: Caution with statins, digoxin, or warfarin. Statins: absorption may be affected; monitor lipid levels. Warfarin: changes in metabolism may alter anticoagulant effects; monitor INR levels. General precautions: Retatrutide should be used only under medical supervision. Inform your healthcare provider about all medications, including prescription, over-the-counter, and herbal products. Possible side effects Common: nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, abdominal pain. Stop use and contact a doctor if symptoms become severe or persistent. When to stop and call your doctor Stop using the pen and contact your physician if you experience: • Severe or persistent abdominal pain or vomiting • Symptoms of an allergic reaction • Signs of pancreatitis • Any other unexpected or severe reaction"],"when_using":["Uses • To improve blood glucose control in adults with type 2 diabetes. • For long-term weight management and reduction of visceral fat in adults who are overweight or obese, with or without diabetes. Warnings Pancreatitis: Acute pancreatitis has been reported with GLP-1 receptor agonists. If severe or persistent abdominal pain occurs (with or without vomiting), stop using RETATRUTIDE and contact your healthcare provider immediately. Allergic reactions: Serious hypersensitivity reactions (including anaphylaxis) have been reported. Stop use and seek medical attention if you develop rash, swelling, or difficulty breathing. Severe gastrointestinal disease: RETATRUTIDE has not been studied in patients with severe GI disorders; use is not recommended. Gallbladder disease: Acute gallbladder events, including cholelithiasis, have occurred. Evaluate promptly if gallbladder disease is suspected. Hypoglycemia warning: Do not use RETATRUTIDE if you have a history of recurrent or severe hypoglycemia. RETATRUTIDE may further lower blood glucose levels. Use is contraindicated in individuals with baseline hypoglycemia or conditions predisposing to hypoglycemia. Pregnancy and breastfeeding: Do not use if pregnant or breastfeeding. Pediatric use: Not for use in children. Drug Interactions / Precautions Other antidiabetic medications: Retatrutide lowers blood glucose. Using it with insulin or sulfonylureas may increase the risk of hypoglycemia. Blood glucose should be closely monitored; doses of other antidiabetic drugs may need adjustment. Drugs affecting gastrointestinal motility: Retatrutide may delay gastric emptying. Co-administration with prokinetic agents (e.g., domperidone) or antacids may alter absorption or worsen GI discomfort. Cardiovascular medications: Caution with statins, digoxin, or warfarin. Statins: absorption may be affected; monitor lipid levels. Warfarin: changes in metabolism may alter anticoagulant effects; monitor INR levels. General precautions: Retatrutide should be used only under medical supervision. Inform your healthcare provider about all medications, including prescription, over-the-counter, and herbal products. Possible side effects Common: nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, abdominal pain. Stop use and contact a doctor if symptoms become severe or persistent. When to stop and call your doctor Stop using the pen and contact your physician if you experience: • Severe or persistent abdominal pain or vomiting • Symptoms of an allergic reaction • Signs of pancreatitis • Any other unexpected or severe reaction"]}