Salkalli

Manufacturer
Guangzhou Yixin Cross-border E-commerce Co., Ltd.
Effective date
2025-11-07
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:04:33

Label at a glance#

ProductSalkalli
Active ingredientRETATRUTIDE
Label structure11 sections

Indications and uses

Helps control blood sugar in adults with type 2 diabetes (when prescribed). Intended to assist adults with weight loss as directed by a healthcare provider.

Dosage and administration

Concentration after reconstitution (calculation): 10 mg ÷ 1 mL = 10 mg/mL. Therefore: 0.25 mL = 2.5 mg; 0.5 mL = 5 mg; 0.75 mL = 7.5 mg; 1 mL = 10 mg. Typical weekly dosing schedule (example shown — follow your prescriber): Weeks 1–4: 0.25 mL (2.5 mg) once weekly (subcutaneous) Weeks 5–8: 0.5 mL (5 mg) once weekly Weeks 9–12: 0.75 mL (7.5 mg) once weekly Week 13 and onward: 1 mL (10 mg) once weekly One carton (4 k...

Label contents#

Full prescribing information#

Active ingredients (in each kit)

COMPONENTS

Retatrutide 10 mg (lyophilized powder)

Sterile Water for Injection 1 mL

Purpose

OTC - PURPOSE SECTION

Antidiabetic / Weight management agent

Diluent

Uses

INDICATIONS & USAGE SECTION

Helps control blood sugar in adults with type 2 diabetes (when prescribed).
Intended to assist adults with weight loss as directed by a healthcare provider.

Warnings — Read carefully and tell your doctor if any apply to you.

WARNINGS SECTION

Pancreatitis: Cases of pancreatitis have been reported. If you have severe abdominal pain (that may spread to the back), persistent vomiting, or signs of pancreatitis — stop using and contact your healthcare provider immediately.
Allergic reaction: Serious allergic reactions have been reported. Stop use and seek emergency care if you have hives, swelling of face/lips/tongue/throat, or trouble breathing.
Serious gastrointestinal disease: May cause GI adverse reactions. Not recommended for patients with severe GI disease (not studied).
Acute gallbladder disease: Cases (e.g., gallstones) have been reported. If you experience severe right-upper-abdominal pain or jaundice, seek medical evaluation.
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 or breastfeeding: Do not use.
Children: Do not use.

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

Nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia (indigestion), abdominal pain. If side effects are severe or persistent, contact your healthcare provider.

When to stop and call your doctor

If you develop severe abdominal pain (possible pancreatitis), severe allergic reaction, jaundice, or other serious symptoms.

Directions — Preparation & Dosing (basic patient summary)

DOSAGE & ADMINISTRATION SECTION

Concentration after reconstitution (calculation):

10 mg ÷ 1 mL = 10 mg/mL.
Therefore: 0.25 mL = 2.5 mg; 0.5 mL = 5 mg; 0.75 mL = 7.5 mg; 1 mL = 10 mg.

Typical weekly dosing schedule (example shown — follow your prescriber):

Weeks 1–4: 0.25 mL (2.5 mg) once weekly (subcutaneous)
Weeks 5–8: 0.5 mL (5 mg) once weekly
Weeks 9–12: 0.75 mL (7.5 mg) once weekly
Week 13 and onward: 1 mL (10 mg) once weekly

One carton (4 kits) provides 4 weekly doses.

How to prepare and inject (patient summary):

Wash hands with soap and water. Inspect vials for damage.
Using aseptic technique, withdraw the prescribed volume (in mL) of Sterile Water for Injection into a sterile syringe. Inject the diluent into the vial containing the lyophilized powder.
Gently swirl the vial until the powder fully dissolves. Do not shake vigorously. Solution should be clear; do not use if cloudy or particulate present.
Withdraw the prescribed volume (e.g., 0.25, 0.5, 0.75 or 1 mL) into a sterile syringe and inject subcutaneously in the abdomen, thigh, or upper arm after cleaning the site with alcohol. Rotate injection sites.
Dispose of syringe/needle in an appropriate sharps container.

Do not use

OTC - DO NOT USE SECTION

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.

When using section

OTC - WHEN USING SECTION

Pancreatitis: Cases of pancreatitis have been reported. If you have severe abdominal pain (that may spread to the back), persistent vomiting, or signs of pancreatitis — stop using and contact your healthcare provider immediately.
Allergic reaction: Serious allergic reactions have been reported. Stop use and seek emergency care if you have hives, swelling of face/lips/tongue/throat, or trouble breathing.
Serious gastrointestinal disease: May cause GI adverse reactions. Not recommended for patients with severe GI disease (not studied).
Acute gallbladder disease: Cases (e.g., gallstones) have been reported. If you experience severe right-upper-abdominal pain or jaundice, seek medical evaluation.
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 or breastfeeding: Do not use.
Children: Do not use.

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

Nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia (indigestion), abdominal pain. If side effects are severe or persistent, contact your healthcare provider.

When to stop and call your doctor

If you develop severe abdominal pain (possible pancreatitis), severe allergic reaction, jaundice, or other serious symptoms.

stop use

OTC - STOP USE SECTION

Pancreatitis: Cases of pancreatitis have been reported. If you have severe abdominal pain (that may spread to the back), persistent vomiting, or signs of pancreatitis — stop using and contact your healthcare provider immediately.
Allergic reaction: Serious allergic reactions have been reported. Stop use and seek emergency care if you have hives, swelling of face/lips/tongue/throat, or trouble breathing.
Serious gastrointestinal disease: May cause GI adverse reactions. Not recommended for patients with severe GI disease (not studied).
Acute gallbladder disease: Cases (e.g., gallstones) have been reported. If you experience severe right-upper-abdominal pain or jaundice, seek medical evaluation.
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 or breastfeeding: Do not use.
Children: Do not use.

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

Nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia (indigestion), abdominal pain. If side effects are severe or persistent, contact your healthcare provider.

When to stop and call your doctor

If you develop severe abdominal pain (possible pancreatitis), severe allergic reaction, jaundice, or other serious symptoms.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Not for use in children.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Mannitol, Disodium Hydrogen Phosphate, Sodium Dihydrogen Phosphate, Sodium Chloride, Sodium Bicarbonate.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0101020203030404

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84778-115-01Salkalli4 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,41
84778-115-01Salkalli1 mL in 1 KITINJECTION, POWDER, LYOPHILIZED,11
84778-115-02Salkalli4 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,41
84778-115-02Salkalli2 in 1 PACKAGE, COMBINATIONINJECTION, POWDER, LYOPHILIZED,21
84778-115-03Salkalli4 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,41
84778-115-03Salkalli3 in 1 PACKAGE, COMBINATIONINJECTION, POWDER, LYOPHILIZED,31
84778-115-04Salkalli4 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,41
84778-115-04Salkalli4 in 1 PACKAGE, COMBINATIONINJECTION, POWDER, LYOPHILIZED,41

Products#

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DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84778-11584778-115-02, 84778-115-01, 84778-115-03, 84778-115-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4301e8bb-0ba8-c1d6-e063-6394a90a3c3b4302eb14-2065-d22b-e063-6394a90a9dcf2025-11-07WarningsExact identifier
spl id: 4301e8bb-0ba8-c1d6-e063-6394a90a3c3b
spl set id: 4302eb14-2065-d22b-e063-6394a90a9dcf

Reported adverse events (FAERS/openFDA)#

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