Semglee (insulin glargine-yfgn) U-100 Injectable, 10 mL Multi-Dose Vial

Long-Acting Insulin Glargine Biosimilar for Diabetes Control in Dogs and Cats

Product Description

Semglee (insulin glargine-yfgn) U-100 is a long-acting, FDA-approved biosimilar insulin used in the veterinary management of diabetes mellitus in dogs and cats. It is FDA-approved as interchangeable with Lantus (insulin glargine), delivering the same proven therapeutic effect at a lower cost. Administered as a once-daily subcutaneous injection, Semglee works by providing a steady, prolonged release of insulin over 12 to 24 hours, helping to maintain stable blood glucose levels and prevent dangerous fluctuations. It is particularly recommended as a first-choice insulin for newly diagnosed diabetic cats, where it has shown potential to support diabetic remission.

Benefits

• FDA-Approved Interchangeable Biosimilar: Semglee is FDA-approved as fully interchangeable with Lantus (insulin glargine), the most widely used long-acting insulin for diabetic pets, offering the same efficacy and safety profile.
• Long-Acting Blood Sugar Control: Semglee provides stable, prolonged glycemic control lasting 12 to 16 hours in pets, reducing the frequency of blood sugar spikes and drops compared to shorter-acting insulins.
• Supports Diabetic Remission in Cats: Glargine insulin is particularly beneficial for newly diagnosed diabetic cats, as some cats managed on it are able to achieve a diabetic remission with proper glucose control.
• Suitable for Both Dogs and Cats: While especially recommended for cats, Semglee is also a veterinary option for dogs in cases where other insulins do not provide adequate duration of activity.
• Convenient Multi-Dose Vial: The 10 mL multi-dose vial provides an economical and practical format for at-home use, containing 1,000 units of insulin glargine to support extended treatment.

Ingredients

Composition Table

Other Ingredients:

Water for Injection, USP. HCl acid and/or sodium hydroxide may be added to adjust pH to approximately 4.

How to Use

Dosage and Administration Instructions

• Prescription Required: Semglee is a prescription-only medication; it must be used only under the direction of a licensed veterinarian who has evaluated and diagnosed your pet with diabetes mellitus.
• Use U-100 Syringes Only: Semglee U-100 must only be administered using U-100 insulin syringes; using any other syringe type will result in incorrect dosing that can be harmful to your pet.
• Administer Subcutaneously Only: Inject Semglee under the skin only; never inject it into a vein or muscle, as this can cause serious and rapid changes in blood glucose levels.
• Follow Veterinarian's Dosing Instructions: Dosing must be individualized by your veterinarian based on your pet's blood glucose monitoring, body weight, and clinical response; never adjust doses on your own.
• Inspect Vial Before Each Use: Visually inspect the solution before every injection; only use if it appears clear and colorless with no particles. Discard immediately if it looks cloudy, discolored, or contains visible particles.
• Double-Check the Dose Before Injecting: Always verify the dose drawn into the syringe before administration to avoid over- or under-dosing your pet.
• Do Not Skip Meals Before Giving Insulin: Never administer insulin if your pet has not eaten, as this significantly increases the risk of dangerous low blood sugar (hypoglycemia).
• Do Not Mix with Other Insulins: Semglee must not be mixed with any other insulin or injectable solution, as this can alter its pH and change its duration and onset of action.

Disclaimer: This dosage information is provided by the manufacturer. Always consult your veterinarian before administering or adjusting any insulin dose for your pet.

Additional Information

Precautions

• Do Not Use in Hypersensitive Animals: Do not use Semglee in animals that are known to be allergic to insulin glargine or any other ingredients present in this formula.
• Not for Treating Diabetic Ketoacidosis: Semglee is not appropriate for managing episodes of diabetic ketoacidosis (DKA); this is a medical emergency requiring different, faster-acting treatment.
• Monitor Blood Glucose Regularly: Close and regular blood glucose monitoring is required throughout treatment to adjust the dose appropriately and detect hypoglycemia or hyperglycemia early.
• Use with Caution in Concurrent Illnesses: Illness, stress, surgery, and changes in diet or activity can all affect insulin requirements; always consult your veterinarian during any health changes.
• Do Not Share Needles or Syringes: Never reuse or share needles or syringes between animals, as this poses a serious risk of transmitting blood-borne pathogens.
• Rotate Injection Sites: Rotate the subcutaneous injection site within the same general area from one dose to the next to prevent localized skin changes at injection sites.
• Keep Out of Reach: Store all insulin and syringes in a location completely inaccessible to children and other pets to prevent accidental exposure.

Possible Side Effects

• Hypoglycemia (Low Blood Sugar): The most significant risk with insulin use; signs in pets include weakness, lethargy, stumbling, muscle tremors, seizures, and unresponsiveness — this is a potentially fatal emergency requiring immediate veterinary care.
• Allergic Reactions: Allergic reactions may show up as irregular breathing, rash, fever, or swelling around the face. Since sensitivities to medication can develop at any point, keep a close eye on your pet throughout the entire course of treatment.
• Injection Site Reactions: Rare localized reactions such as redness, swelling, or skin changes at the injection site may occur; rotating injection sites helps reduce this risk.
• Hypokalemia (Low Potassium): Excess insulin administration can cause low blood potassium levels; this can affect heart and muscle function and requires veterinary management if detected.

Storage Information

• Refrigerate Unopened Vials: Store unopened Semglee vials in the original carton in the refrigerator at 2°C to 8°C (36°F to 46°F) until the first use.
• After Opening, Use Within 28 Days: Once opened, store the vial either in the fridge or at room temperature (under 30°C / 86°F), but dispose of it 28 days after first opening, even if there is still product remaining.
• Never Freeze: Do not freeze Semglee under any circumstances; discard the vial immediately if it has been accidentally frozen, as freezing destroys the insulin's effectiveness.
• Protect from Direct Light and Heat: Keep the vial away from direct sunlight and excessive heat sources at all times to maintain the potency and sterility of the insulin.
• Discard Discolored or Cloudy Insulin: Never use insulin that appears discolored, cloudy, or contains visible particles; clear and colorless is the only acceptable appearance for Semglee before use.

Frequently Asked Questions

Q1: What is Semglee and how does it compare to Lantus for treating diabetes in dogs and cats?

Ans: Semglee (insulin glargine-yfgn) is an FDA-approved interchangeable biosimilar to Lantus (insulin glargine), meaning it delivers the same active ingredient and therapeutic effect. Veterinarians prescribed by the same dose can switch between the two. Semglee is often more cost-effective while providing the same long-acting blood glucose control.

Q2: How long does Semglee insulin last in a diabetic cat or dog?

Ans: Semglee is a long-acting insulin that stays active for roughly 12 to 16 hours in pets. Most diabetic cats can be managed with one injection per day, though cats with poor blood sugar control may need two daily doses as advised by their vet.

Q3: Can Semglee help my newly diagnosed diabetic cat go into remission?

Ans: Glargine insulin like Semglee is particularly beneficial for newly diagnosed diabetic cats, as tight early glucose control with this insulin has been associated with diabetic remission in some cats. However, remission is not guaranteed and depends on regular monitoring, diet management, and veterinary guidance.

Q4: What should I do if my pet shows signs of low blood sugar after a Semglee injection?

Ans: Signs of hypoglycemia such as weakness, tremors, or stumbling should be treated immediately by offering food or applying a small amount of a sugar source like corn syrup to the gums. Seek emergency veterinary care right away, as prolonged hypoglycemia from a long-acting insulin like Semglee can be fatal.

Q5: How long can I keep a Semglee vial after first opening it?

Ans: Once a Semglee vial has been opened, it must be used within 28 days and then discarded, regardless of how much insulin remains. After first use, it may be stored either refrigerated or at room temperature below 30°C (86°F), but never frozen or exposed to direct sunlight or heat.

Clinical Research:

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761201Orig1s000lbl.pdf

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=3ac85ebb-5594-59c8-77fd-df254329d151&type=display