SEMGLEETM Insulin Injector Pen

SEMGLEE is delivered through a pre-filled injector pen1

  • The SEMGLEE pen is pre-filled with 3 ml solution containing 100 U/ml insulin glargine.
  • It is designed to be used for multiple subcutaneous injections with disposable needles.
  • The SEMGLEE pre-filled pen gives patients dosing flexibility, allowing up to 80 insulin units with a single injection.

How to use SEMGLEE

The following instructions are provided to patients for use. Click here for Instructions for Use.

Required Supplies
• SEMGLEE single-patient-use prefilled pen
• Needle compatible with this pen
• Alcohol wipes
• A sharps container to throw away used needles. See “Step 8 Needle disposal” at the end of this Instructions for Use.

Step 1. Prepare your pen: Inspect the pen. Check the purple and white label on the pen to make sure:
• It is the correct insulin type.
• The expiration date has not passed.

Hold the pen body with 1 hand. With the other hand pull off the pen cap. Put the pen cap off to the side to be used later (See Figure a).

Check the insulin through the cartridge holder to make sure:
• The insulin looks clear and colorless
• There are no cracks, breaks or leaks around the cartridge holder.

Wipe the rubber seal (at the front of the cartridge) with a new alcohol wipe (See Figure b).

Semglee pen

Step 2. Attach a new needle: Take a new sterile disposable needle and peel off the protective tab (See Figure c). Do not use the needle if the protective tab is damaged or missing, as the needle may not be sterile.

While holding the pen body facing upwards, attach the outer needle cap straight on to the cartridge holder as shown. Do not attach the outer needle cap sideways as this may cause the needle to bend or become damaged (See Figure d).

Turn the outer needle cap in a clockwise (right) direction until it feels tightly fixed on the pen (See Figure e).

Carefully pull off the outer needle cap and put it off to the side (See Figure f). Do not throw it away. You will need the outer needle cap later.

Carefully pull off the inner needle cap and throw it away in the sharps container (See Figure g).

Semglee pen

Step 3. Prime your pen needle: Always prime a new pen needle before each injection.
Turn the white dose knob to 2 dose units (See Figure h). You will hear a “click” for each unit turned. If you accidentally turn past 2 units, turn back the dose knob in the opposite direction to the correct number of units.

Hold the pen body facing upwards with 1 hand.

Tap the cartridge gently with your finger to help any large air bubbles to move to the top of the cartridge (See Figure i). Small bubbles may still be visible. This is normal.

With the pen needle facing upwards, press the injection button until it stops moving and the dose window shows “0”.

Repeat these steps up to 4 times until you see drops of insulin at the tip of the needle. Priming is complete when you can see drops of insulin (See Figure j).

If you do not see any insulin at the needle tip after trying to prime the needle 4 times, the needle may be clogged. If this occurs:
• Go to Step 7 for instructions on safely removing the needle.
• Restart the process at step 2A to attach and prime a new needle.

Semglee pen

Step 4. Select your dose Check that the dose window shows “0”.
Turn the white dose knob until the yellow dose pointer lines up with your required dose.

The pen dials 1 unit at a time.
• The white dose knob clicks as you turn it and the white plunger will extend.
Do not push the purple injection button while you are turning the white dose knob.
Do not dial your dose by counting the clicks because you may dial the wrong dose.
• The even numbers are printed on the dial (See Figure k). The odd numbers are shown as lines in between
  the even numbers (See Figure l).
Do not force the white dose knob to turn beyond 80 units. If you need a dose greater than 80 units you should give it as two or more injections.
• The pen will not let you dial a dose more than the number of units left in the pen. If your dose is more than
  the number of units left in the pen you can either:
- Inject the amount left in your pen and use a new pen to give the rest of your dose or
- Get a new pen and inject the full dose.

Do not push the purple injection button when turning the white dose knob.

Semglee pen

Step 5. Select and clean the injection site:
Select the injection site as explained to you by your healthcare provider. SEMGLEE is injected under the skin (subcutaneously) of your stomach area (abdominal area), thigh, buttocks or upper arms. You should change (rotate) your injection site for each injection. Clean with a new alcohol wipe and let your skin dry before you inject your dose.

Inject your insulin exactly as your healthcare provider has shown you.

Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.

Do not inject where the skin has pits, is thickened or has lumps.
Do not inject where the skin is tender, bruised, scaly or hard or into scars or damaged skin.

Step 6. Inject your dose: Some injection sites may need to be pinched during your injection. Ask your healthcare provider if you are not sure if your skin needs to be pinched during the injection. If instructed by your healthcare provider you can pinch the cleaned skin between your fingers.

Push the needle straight into the skin as shown by your healthcare provider (See Figure m). Do not inject with the needle at an angle.
Press the purple injection button all the way in (See Figure n). The white dose knob will turn and you will hear “clicks” as you press down.

After the dose window shows “0”, continue to hold the purple injection button down and slowly count to 10 to make sure that the full dose of insulin is injected. If you do not keep the injection button pressed down for 10 seconds after “0” is displayed you may get the wrong dose of medicine (See Figure o).

Do not push the injection button sideways or block the white dose knob with your fingers as this will stop you from injecting the medicine.
Pull the needle out of your skin. A drop of insulin at the needle tip is normal. It will not affect your dose.

Semglee pen

Step 7. After your injection: Take the outer needle cap that you had saved in step 2D, hold it at the widest part and carefully cover the needle without touching it (See Figure p).

Squeeze the wide part of the outer needle cap and unscrew the needle in a counter-clockwise (left) direction (See Figure q ). Keep twisting the needle until it comes off the pen. It may take several twists to release the needle.

Put the needle in a sharps disposal container (See Step 8 Needle Disposal at the end of this Instructions for Use) (See Figure r).

Replace the pen cap over the cartridge (See Figure s).

If there is still medicine left in your pen, store the pen at room temperature (up to 86°F or 30°C). Do not store the pen with a used needle attached.

Semglee pen

Step 8. Needle Disposal: Put your used needle in an FDA-cleared sharps disposal container right away after use.

Do not throw away (dispose of) loose needles in your household trash.
If you do not have an FDA-cleared sharps container, you may use a household container that is:
• Made of heavy duty plastic,
• Can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
• Upright and stable during use,
• Leak-resistant, and
• Properly labeled to warn of hazardous waste inside the container.

When your sharps disposable container is almost full you will need to follow your community guidelines for the right way to dispose of your sharps container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA website at: www.fda.gov/safesharpsdisposal

Do not dispose of a used sharps disposal container in your household trash unless guidelines permit this. Do not recycle your used sharps disposal container.

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References:

  • SEMGLEE (insulin glargine injection). Prescribing Information. 2020. Mylan Pharmaceuticals Inc. Morgantown, WV. 
  • SEMGLEE (insulin glargine injection). Instructions for use. Mylan Pharmaceuticals Inc.

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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INDICATIONS AND USAGE

Semglee 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.

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

WARNINGS AND PRECAUTIONS
Never Share a Semglee Prefilled Pen, Syringe or Needle Between Patients

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 insulin, including SEMGLEE and may be life-threatening.

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 patents 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.

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

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