SALKALLI- retatrutide lyophilized powder 2.5mg injection, powder, lyophilized, for solution

Salkalli by

Drug Labeling and Warnings

Salkalli by is a Prescription medication manufactured, distributed, or labeled by Guangzhou Yixin Cross-border E-commerce Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each kit)

Retatrutide 2.5 mg (lyophilized powder)

Sterile Water for Injection 0.25 mL

Purpose

Antidiabetic / Weight management agent

Diluent

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.

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

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)

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

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

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

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.

Not for use in children.

Inactive Ingredients:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SALKALLI 
retatrutide lyophilized powder 2.5mg injection, powder, lyophilized, for solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 84778-116
Route of Administration	SUBCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RETATRUTIDE (UNII: NOP2Y096GV) (RETATRUTIDE - UNII:NOP2Y096GV)	RETATRUTIDE	2.5 mg  in 0.25 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
MANNITOL (UNII: 3OWL53L36A)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84778-116-02	2 in 1 PACKAGE, COMBINATION	10/30/2025
1		4 in 1 CARTON
1		0.25 mL in 1 KIT; Type 1: Convenience Kit of Co-Package
2	NDC: 84778-116-01	4 in 1 CARTON	10/30/2025
2		0.25 mL in 1 KIT; Type 1: Convenience Kit of Co-Package
3	NDC: 84778-116-03	3 in 1 PACKAGE, COMBINATION	10/30/2025
3		4 in 1 CARTON
3		0.25 mL in 1 KIT; Type 1: Convenience Kit of Co-Package
4	NDC: 84778-116-04	4 in 1 PACKAGE, COMBINATION	10/30/2025
4		4 in 1 CARTON
4		0.25 mL in 1 KIT; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		10/30/2025

Labeler - Guangzhou Yixin Cross-border E-commerce Co., Ltd. (455800881)

Registrant - Guangzhou Yixin Cross-border E-commerce Co., Ltd. (455800881)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Yixin Cross-border E-commerce Co., Ltd.		455800881	label(84778-116) , manufacture(84778-116)