Salkalli

Manufacturer
Guangzhou Yixin Cross-border E-commerce Co., Ltd.
Effective date
2025-11-05
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:04:32

Label at a glance#

ProductSalkalli
Active ingredientRETATRUTIDE
Label structure11 sections

Indications and 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.

Dosage and administration

• 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.

Label contents#

Full prescribing information#

Active ingredient (in each 2.25 mL pen)

COMPONENTS

Retatrutide — 30 mg

Purpose

OTC - PURPOSE SECTION

Antidiabetic / Weight management agent

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

Titration schedule:

DOSAGE & ADMINISTRATION SECTION

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

Directions for Use

OTC - DO NOT USE SECTION

• 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.

Uses

OTC - WHEN USING SECTION

• 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

stop use

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sterile Water for Injection

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0101020203030404

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84778-108-01Salkalli1 in 1 CARTONINJECTION, SOLUTION11
84778-108-01Salkalli2.25 mL in 1 SYRINGEINJECTION, SOLUTION2.251
84778-108-02Salkalli1 in 1 CARTONINJECTION, SOLUTION11
84778-108-02Salkalli2 in 1 PACKAGE, COMBINATIONINJECTION, SOLUTION21
84778-108-03Salkalli3 in 1 PACKAGE, COMBINATIONINJECTION, SOLUTION31
84778-108-03Salkalli1 in 1 CARTONINJECTION, SOLUTION11
84778-108-04Salkalli1 in 1 CARTONINJECTION, SOLUTION11
84778-108-04Salkalli4 in 1 PACKAGE, COMBINATIONINJECTION, SOLUTION41

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84778-10884778-108-01, 84778-108-02, 84778-108-03, 84778-108-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
RETATRUTIDENOP2Y096GVACTIB
AQUA059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
42d6ebab-cbda-8dd1-e063-6394a90a849042d6e93c-7d91-e8ec-e063-6294a90a567f2025-11-05WarningsExact identifier
spl id: 42d6ebab-cbda-8dd1-e063-6394a90a8490
spl set id: 42d6e93c-7d91-e8ec-e063-6294a90a567f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.