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Effective November 29, 2022, Viatris completed the sale of substantially all of its biosimilars portfolio (including related product trademarks) to Biocon Biologics Limited and its subsidiaries (“Biocon”) and the relevant marketing authorizations are in process of being transferred. Viatris Inc. and its subsidiaries (“Viatris”) are not affiliates of Biocon but are providing certain transition services to Biocon following the transaction completion date, such as operating websites (including this site) relating to the biosimilars portfolio on Biocon’s behalf.

Insulin Prefilled Pen

SEMGLEE® and Insulin Glargine (insulin glargine-yfgn) injection are delivered through a prefilled injector pen1

  • Prefilled with 3 ml solution containing 100 U/ml insulin glargine.
  • Designed to be used for multiple subcutaneous injections with disposable needles.
  • Give patients dosing flexibility, allowing up to 80 insulin units with a single injection.

Detailed Product Pen Image and Pen Needle Image

How to use SEMGLEE prefilled syringe2   
Click here for Instructions for Use

Step 1. Check the insulin

  1. Check the label on your SEMGLEE to make sure you have the correct insulin. SEMGLEE is blue with a purple injection button.
  2. Take off the pen cap.
  3. Check the appearance of your insulin. SEMGLEE is a clear insulin. Do not use this SEMGLEE if the insulin is cloudy, colored or has particles.

Step 2. Attach the needle

Do not re-use needles. Always use a new sterile needle for each injection. This helps prevent contamination and potential needle blocks.

  1. Wipe the rubber seal with alcohol.
  2. Remove the protective seal from a new needle.
  3. Line up the needle with the pen, and keep it straight as you screw it on (See Figure below).

    Hand Lining Up Needle to Pen

  • If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or break the needle (See Figure below).
    Hand Misaligning Needle to Pen

Step 3. Perform a Safety test
Always perform the safety test before each injection.
Performing the safety test ensures that you get an accurate dose by:

  •  ensuring that pen and needle work properly
  •  removing air bubbles
  1. Select a dose of 2 units by turning the white dose knob (See Figure below).
    Hand Turning Dial Clockwise by 2 Units
  2. Take off the outer needle cap and keep it to remove the used needle after injection. Take off the inner needle cap and discard it (See Figure below).
    Removal of Cap Leaving Needle Attached to Pen
  3. Hold the pen with the needle pointing upwards.
  4. Tap the cartridge so that any air bubbles rise up towards the needle.
  5. Press the purple injection button all the way in. Check if insulin comes out of the needle tip (See Figure below).
    Pen with Insulin Droplets

You may have to perform the safety test several times before insulin is seen.

  • If no insulin comes out, check for air bubbles and repeat the safety test two more times to remove them.
  • If still no insulin comes out, the needle may be blocked. Change the needle and try again.
  • If no insulin comes out after changing the needle, your SEMGLEE may be damaged. Do not use this SEMGLEE.

Step 4. Select the dose

You can set the dose in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units. If you need a dose greater than 80 units, you should give it as two or more injections.

  1. Check that the dose window shows “0” following the safety test.
  2. Select your required dose (in the example below, the selected dose is 30 units, see Figure below). If you turn past your dose, you can turn back down.
    Hand Turning Dial Clockwise by 2 Units
  • Do not push the purple injection button while turning, as insulin will come out.
  • You cannot turn the white dose knob past the number of units left in the pen. Do not force the dosage selector to turn. In this case, either you can inject what is remaining in the pen and complete your dose with a new SEMGLEE or use a new SEMGLEE for your full dose.

Step 5. Inject the dose

  1. Use the injection method as instructed by your healthcare professional.
  2. Insert the needle into the skin (See Figure below).
    Pen Being Inserted into Skin
  3. Deliver the dose by pressing the purple injection button in all the way. The number in the dose window will return to “0” as you inject. The white dose knob will turn, and you will hear “clicks” as you press down (See Figure below).
    Thumb Holding Purple Injection Button for 10 Seconds
  4. Keep the purple injection button pressed all the way in. Slowly count to 10 before you withdraw the needle from the skin. This ensures that the full dose will be delivered.

Step 6. Remove and discard the needle

Always remove the needle after each injection and store SEMGLEE without a needle attached.
This helps prevent:

  • Contamination and/or infection
  • Entry of air into the insulin cartridge and leakage of insulin, which can cause inaccurate dosing.
  1. Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen. To reduce the risk of accidental needle injury, never replace the inner needle cap.
    • If your injection is given by another person, special caution must be taken by this person when removing and disposing the needle. Follow recommended safety measures for removal and disposal of needles (e.g., a one-handed capping technique) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.
  2. Dispose of the needle safely. Used needles should be placed in sharps containers (such as red biohazard containers), hard plastic containers (such as detergent bottles), or metal containers (such as an empty coffee can). Such containers should be sealed and disposed of properly. If you are giving an injection to another person, you should remove the needle in an approved manner to avoid needle-stick injuries.
  3. Always put the pen cap back on the pen, then store the pen until your next injection.
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References:

  • SEMGLEE® (insulin glargine-yfgn) injection. Prescribing Information. 2021. Mylan Pharmaceuticals Inc. Morgantown, WV.  
  • SEMGLEE® (insulin glargine-yfgn) injection. Instructions for use. Mylan Pharmaceuticals Inc. Morgantown, WV.  

Adverse Events Reporting

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare providers are asked to report any suspected adverse reactions. Reporting forms and information can be found at http://www.mhra.gov.uk/yellowcard. In order to support effective tracking and traceability of biologics including biosimilars, it is recommended that the brand name and batch number are recorded and used when reporting adverse events. You can also report adverse events direct to the marketing authorisation holder at ukpharmacovigilance@mylan.com.

Semglee® (Insulin glargine) 100 units/ml solution for injection in pre-filled pen

Prescribing information

Please refer to Summary of Product Characteristics (SmPC) before prescribing.

Indication: Semglee® is indicated in the treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above. Presentation: Each ml contains 100 units insulin glargine* (equivalent to 3.64 mg). Each pen contains 3 ml of solution for injection, equivalent to 300 units. Dosage and administration: Semglee® (insulin glargine) has a prolonged duration of action. It should be administered once daily at any time but at the same time each day. The pre filled pen delivers insulin in increments of 1 unit up to a maximum single dose of 80 units. The dose regimen (dose and timing) should be individually adjusted. In patients with type 2 diabetes mellitus, Semglee® can also be given together with orally active antidiabetic medicinal products. The potency of Semglee® is stated in units and these units are exclusive to Semglee®. Special population: Elderly population (≤ 65 years old): progressive deterioration of renal function may lead to a steady decrease in insulin requirements. Renal impairment: insulin requirements may be diminished due to reduced insulin metabolism. Hepatic impairment: insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism. Paediatric population: For adolescents and children aged 2 years and older patients, the dose regimen (dose and timing) should be individually adjusted. For children below 2 years of age the safety and efficacy of Semglee® have not been established. No data are available. Switch from other insulins to Semglee® When switching from a treatment regimen with an intermediate or long acting insulin to a regimen with Semglee®, a change of the dose of the basal insulin may be required and the concomitant antidiabetic treatment may need to be adjusted (dose and timing of additional regular insulins or fast acting insulin analogues or the dose of oral antidiabetic medicinal products). Switch from twice daily NPH insulin to Semglee®: To reduce the risk of nocturnal and early morning hypoglycaemia, daily dose of once daily basal insulin should be reduced by 20-30% during the first weeks of treatment. Switch from insulin glargine 300 units/ml to Semglee®: Semglee® and insulin glargine 300 units/ml are not bioequivalent and are not directly interchangeable. To reduce the risk of hypoglycemia in this group, Semglee® dose should be reduced by approximately 20%. During the first weeks increase mealtime insulin, after this period the regimen should be adjusted individually. Close metabolic monitoring is recommended during the switch and in the initial weeks thereafter. A further adjustment in dose regimen may become necessary with improved metabolic control, change of timing of insulin, patient weight or life style changes. Patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with Semglee®. Method of administration Semglee® is administered subcutaneously only. Injection sites must be rotated within a given injection area from one injection to the next. Semglee® must not be mixed with any other insulin or diluted. Before using the pre filled pen, the instructions for use included in the package leaflet must be read carefully (see section 6.6). Contraindications: Known hypersensitivity to the active substances or to any of the excipients. Warnings and precautions: Warnings: Semglee® is not the insulin of choice for the treatment of diabetic ketoacidosis. In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered. Changes in insulin strength, manufacturer, type, origin, method of manufacture and/or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment. Hypoglycaemia Due to more sustained basal insulin supply with Semglee®, less nocturnal but more early morning hypoglycaemia can be expected. Intercurrent illness In many cases urine tests for ketones are indicated, and often it is necessary to adjust the insulin dose. The insulin requirement is often increased. Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates on a regular basis, even if they are able to eat only little or no food or are vomiting etc. and they must never omit insulin entirely. Insulin antibodies Rare chance of antibodies formation, may require insulin dose adjustment to avoid hyper- or hypoglycaemia. Handling of the pen Before using Semglee® pen, the instructions for use included in the package leaflet must be read carefully. Semglee® pen has to be used as recommended in the instructions for use. Medication errors Insulin label must always be checked before each injection to avoid medication errors between insulin glargine and other insulins. Interaction with other medicinal products: Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs when used with Semglee®. Substances that may enhance the blood glucose lowering effect include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics. Substances that may reduce the blood glucose lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens, phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, atypical antipsychotic medicinal products (e.g. clozapine and olanzapine) and protease inhibitors. Beta blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood glucose lowering effect of insulin. Pentamidine may cause hypoglycaemia, which may sometimes be followed by hyperglycaemia. Pregnancy and lactation: Pregnancy For insulin glargine no clinical data on exposed pregnancies from controlled clinical studies are available. A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicate no specific adverse effects of insulin glargine on pregnancy and no specific malformative nor feto/neonatal toxicity of insulin glargine. Animal data do not indicate reproductive toxicity. The use of Semglee® may be considered during pregnancy, if clinically needed. The use of Semglee® may be considered during pregnancy, if clinically needed. Careful monitoring of glucose control is essential. Breast feeding It is unknown whether insulin glargine is excreted in human milk. Women may require adjustments in insulin dose and diet. Effects on ability to drive and use machines: The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment. Undesirable effects: Very common: Hypoglycaemia. Common: Lipohypertrophy, Injection site reactions Uncommon: Lipoatrophy. For rare and very rare undesirable effects, please refer to SmPC. Name and Address of Marketing Authorisation Holder: Mylan S.A.S., 117 allée des Parcs, 69800 Saint Priest, France. Marketing Authorisation Number: EU/1/18/1270/003 Basic NHS price: 3ml x 5 pens=£29.99 Legal Category: POM Date of Last Revision: October 2018

Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu. and from Mylan Medical Information, Building 4, Trident Place, Hatfield Business Park, Mosquito Way, Hatfield, Hertfordshire, AL10 9BW, phone no. 01707 853000, Email: info@mylan.co.uk

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare providers are asked to report any suspected adverse reactions. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. In order to support effective tracking and traceability of biologics including biosimilars, it is recommended that the brand name and batch number are recorded and used when reporting adverse events. Adverse events should be reported to Pharmacovigilance, Mylan, Building 4, Trident Place, Hatfield Business Park, Mosquito Way, Hatfield, Hertfordshire, AL10 9UL, on phone no. 0800 121 8267, Email: ukpharmacovigilance@mylan.com

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Prescribing Information

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Instructions For Use

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SEMGLEE and the Semglee Logo are registered trademarks of Mylan Pharmaceuticals Inc., a Viatris Company.
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© 2023 Viatris Inc. All Rights Reserved.

SEMI-2021-0010 V4

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IMPORTANT SAFETY INFORMATION

(This information also applies to Insulin Glargine (insulin glargine-yfgn) injection)


SEMGLEE (insulin glargine-yfgn) injection 100 Units/mL is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus (T1D) and in adults with type 2 diabetes mellitus (T2D).

 

Limitations of Use

SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.

 

It is not known if SEMGLEE is safe and effective in children less than 6 years of age with type 1 diabetes.

 

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

SEMGLEE is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin glargine or one of its excipients.

WARNINGS AND PRECAUTIONS

Insulin pens, needles, or syringes must never be shared between patients. Do NOT reuse needles.

Monitor blood glucose in all patients treated with insulin. Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring.

Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia. Advise patients to rotate the injection site to unaffected areas and closely monitor for hypoglycemia.

Hypoglycemia is the most common adverse reaction associated with insulins, including insulin glargine products. Severe hypoglycemia can cause seizures, may be life threatening, or cause death. Hypoglycemia can impair concentration and reaction time.

Medication errors, such as accidental mix-ups between long-acting insulin products and other insulins, particularly rapid-acting insulins, have been reported. To avoid medication errors between SEMGLEE and other insulins, instruct patients to always check the insulin label before each injection.

Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue SEMGLEE, treat and monitor until symptoms and signs resolve.

All insulin products, including SEMGLEE, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia, if indicated.

Fluid retention, which may lead to or exacerbate heart failure can occur with concomitant use of thiazolidinediones (TZDs) with insulin. These patients should be observed for signs and symptoms of heart failure. If heart failure develops, dosage reduction or discontinuation of the TZD must be considered.

Do not dilute or mix SEMGLEE with any other insulin or solution.  If mixed or diluted, the solution may become cloudy, and the onset of action/time to peak effect may be altered in an unpredictable manner. Do not administer SEMGLEE via an insulin pump or intravenously because hypoglycemia can occur.

A reduction in the SEMGLEE dose may be required in patients with renal or hepatic impairment.

ADVERSE REACTIONS

Adverse reactions commonly associated with SEMGLEE include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritis, rash, edema and weight gain.

DRUG INTERACTIONS

Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose.  The signs of hypoglycemia may be reduced in patients taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine).