Semglee Pen (Subcutaneous)

Insulin glargine-yfgn injection is a long-acting insulin that works slowly, over about 24 hours. Insulin is one of several hormones that help the body convert food into energy. It does this by using the glucose (sugar) in the blood for quick energy. Insulin also helps us store energy for later use. When you have diabetes mellitus, your body cannot produce enough insulin or does not use insulin properly. This leads to too much sugar in your blood. Like other insulins, insulin glargine-yfgn helps keep your blood sugar level close to normal. You may need to use insulin glargine-yfgn along with another type of insulin or an oral diabetes medicine to manage your blood sugar.

This medicine is available only with your doctor's prescription.

Never share insulin pens or cartridges with anyone for any reason. It is not safe for one pen to be used by more than one person. Sharing needles or pens can lead to the spread of hepatitis viruses, HIV, or other infections that can be transmitted through blood.

Your doctor will want to monitor your progress during regular visits, especially in the first few weeks you use this medicine. Blood tests may be necessary to check for side effects.

It is very important to carefully follow any instructions from your health care team regarding:

• Alcohol—Drinking alcohol may lead to severe low blood sugar. Talk about this with your health care team.
• Other medicines—Do not take any other medicines while using insulin glargine-yfgn unless your doctor has discussed them with you. This includes over-the-counter medicines like aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus issues.
• Counseling—Other family members should learn how to prevent or help with side effects if they happen. Also, patients with diabetes may need special counseling about changes in medicine dosing due to lifestyle changes, like changes in exercise and diet. Additionally, counseling on contraception and pregnancy may be necessary due to potential issues for patients with diabetes during pregnancy.
• Travel—Keep a recent prescription and your medical history with you. Be ready for emergencies as you normally would. Adjust for different time zones and try to keep your meal times as close as possible to your usual schedule.

In case of emergency—There may be times when you need emergency assistance for a diabetes-related issue. Be prepared for these situations. It is a good idea to:

• Wear a medical identification (ID) bracelet or necklace at all times. Also, carry an ID card in your wallet or purse that states you have diabetes and lists all of your medicines.
• Keep an extra supply of insulin glargine-yfgn and syringes or injection devices on hand in case of high blood sugar.
• Have quick-acting sugar available to treat low blood sugar.
• Have a glucagon kit and a syringe and needle ready in case of severe low blood sugar. Regularly check and replace any expired kits.

Too much insulin glargine-yfgn can cause hypoglycemia (low blood sugar). Low blood sugar can also happen if you use insulin glargine-yfgn with another diabetes medicine, change your insulin regimen (e.g., insulin strength, type of insulin, injection site), delay or skip a meal or snack, exercise more than usual, or drink alcohol. Symptoms of low blood sugar should be treated before they lead to unconsciousness (passing out). Different people may experience different symptoms of low blood sugar. It is important to recognize which symptoms you usually have so you can treat it quickly.

Symptoms of low blood sugar include anxiety, behavior changes similar to intoxication, blurred vision, cold sweats, confusion, difficulty thinking, dizziness or lightheadedness, drowsiness, excessive hunger, fast heartbeat, headache, irritability or unusual behavior, nervousness, nightmares, restless sleep, shakiness, slurred speech, and tingling in the hands, feet, lips, or tongue.

If you experience symptoms of low blood sugar, consume glucose tablets or gel, corn syrup, honey, or sugar cubes, or drink fruit juice, regular soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. If symptoms do not improve, seek medical help immediately. Someone should call for emergency assistance if severe symptoms like convulsions (seizures) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Other members of your household should also know how to use it.

This medicine may cause dizziness or drowsiness. Do not drive or perform any activities that could be dangerous until you know how this medicine affects you.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your diabetes medicine, change your insulin regimen, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed dry skin, a fruity odor on your breath, increased urination, ketones in the urine, loss of appetite, stomachache, nausea, or vomiting, tiredness, rapid and deep breathing, unconsciousness, and unusual thirst.

If you notice symptoms of high blood sugar, check your blood sugar level and then call your doctor for instructions.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Contact your doctor immediately if you experience a rash, itching, difficulty breathing, trouble swallowing, or any swelling of your hands, face, or mouth while using this medicine.

This medicine may lower the potassium levels in your blood. Do not use medicines, supplements, or salt substitutes that contain potassium unless you have discussed this with your doctor.

Using this medicine along with other diabetes medications (e.g., thiazolidinedione [TZD] medicine) may lead to serious heart problems or edema (fluid retention). Contact your doctor right away if you experience rapid weight gain, chest pain or discomfort, extreme tiredness or weakness, difficulty breathing, an irregular heartbeat, or significant swelling of the hands, wrists, ankles, or feet.

In deciding to use a medicine, you and your doctor will consider the risks of taking the medicine against the benefits it may provide. For this medicine, please consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, inform your healthcare professional if you have other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not shown any pediatric-specific problems that would limit the use of Semglee® to treat type 1 diabetes in children aged 6 years and older. However, the safety and effectiveness of Semglee® have not been established in children younger than 6 years with type 1 diabetes or in children with type 2 diabetes.

Geriatric

Studies have not shown any geriatric-specific problems that would limit the use of Semglee® in elderly patients. However, older adults are more likely to experience unwanted effects (e.g., heart problems, low blood sugar), which may require caution when using this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be used together despite possible interactions. In these cases, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the following medicines while using this medicine. The interactions listed below are based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Acarbose
• Alogliptin
• Bromocriptine
• Canagliflozin
• Chlorpropamide
• Dapagliflozin
• Empagliflozin
• Ertugliflozin
• Glimepiride
• Glipizide
• Glyburide
• Lanreotide
• Linagliptin
• Liraglutide
• Metformin
• Metoclopramide
• Metreleptin
• Miglitol
• Nateglinide
• Octreotide
• Pasireotide
• Pioglitazone
• Pramlintide
• Repaglinide
• Rosiglitazone
• Sitagliptin
• Thioctic Acid
• Tolazamide
• Tolbutamide
• Vildagliptin

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Acebutolol
• Albiglutide
• Atenolol
• Betaxolol
• Bisoprolol
• Carteolol
• Carvedilol
• Celiprolol
• Dulaglutide
• Esmolol
• Exenatide
• Isocarboxazid
• Labetalol
• Levobunolol
• Linezolid
• Lixisenatide
• Methylene Blue
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Ozanimod
• Penbutolol
• Phenelzine
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Rasagiline
• Safinamide
• Selegiline
• Sotalol
• Timolol
• Tranylcypromine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating certain foods, as interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss the use of your medicine with food, alcohol, or tobacco with your healthcare professional.

Other Medical Problems

Other medical problems may affect the use of this medicine. Make sure to inform your doctor if you have any other medical conditions, especially:

• Diabetic ketoacidosis—Use is not recommended for patients with this condition.

• Heart failure or
• Hypokalemia (low potassium in the blood)—Use with caution. It may worsen these conditions and increase the risk of serious side effects.

• Hypoglycemia (low blood sugar)—Should not be used during episodes of hypoglycemia. If you have low blood sugar and take insulin, your blood sugar may drop to dangerously low levels.

• Illness or
• Stress—These conditions could change blood sugar levels and may affect the amount of insulin you need.

• Kidney disease or
• Liver disease—Use with caution. The effects may be stronger due to slower removal of the medicine from the body.

Along with its intended effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor right away if you notice any of the following side effects:

More common

• Blindness
• blurred vision
• cough or hoarseness
• decreased vision
• diarrhea
• dizziness
• fever or chills
• general feeling of discomfort or illness
• headache
• joint pain
• lower back or side pain
• loss of appetite
• muscle aches and pains
• nausea
• nervousness
• painful or difficult urination
• pounding in the ears
• runny nose
• shivering
• slow or fast heartbeat
• sore throat
• sweating
• swelling of the hands, ankles, feet, or lower legs
• trouble sleeping
• unusual tiredness or weakness
• vomiting

Incidence not known

• Anxiety
• chest tightness
• cold sweats
• coma
• confusion
• cool, pale skin
• decreased urine
• depression
• depression or thickening of the skin at the injection site
• difficulty swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• fast heartbeat
• hives, itching, skin rash
• increased hunger
• increased thirst
• itching, pain, redness, or swelling at the injection site
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• mood changes
• muscle cramps
• nightmares
• numbness or tingling in the hands, feet, or lips
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• shakiness
• slurred speech
• trouble breathing
• weight gain

Some side effects may happen that usually do not need medical attention. These side effects may go away as your body adjusts to the medicine. Your health care professional may also be able to tell you how to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Body aches or pain
• diarrhea
• difficulty in moving
• discouragement
• ear congestion
• feeling sad or empty
• irritability
• lack of appetite
• loss of interest or pleasure
• loss of voice
• muscle pain or stiffness
• pain in the arms or legs
• pain in the joints
• pain or tenderness around the eyes and cheekbones
• sneezing
• stuffy or runny nose
• tender, swollen glands in the neck
• trouble concentrating
• voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Semglee
• Semglee Pen

In Canada

• Lantus

Available Dosage Forms:

• Solution

Therapeutic Class: Antidiabetic

Pharmacologic Class: Insulin Glargine, Recombinant

Find detailed information on biosimilars for this medication.

A nurse or other trained health professional may give you this medicine. You may also be taught how to give your medicine at home. This medicine is given as a shot under the skin of your stomach, thigh, or upper arm.

Always check the label before use, to make sure you have the correct type of insulin. Do not change the brand, type, or concentration unless your doctor tells you to. If you use a pump or other device, make sure the insulin is made for that device.

Always double-check both the concentration (strength) of your insulin and your dose. Concentration and dose are not the same. The dose is how many units of insulin you will use. The concentration tells how many units of insulin are in each milliliter (mL), such as 100 units/mL (U-100), but this does not mean you will use 100 units at a time.

Each package of Semglee® contains a patient information sheet. Read this sheet carefully and make sure you understand:

• How to prepare the medicine.
• How to inject the medicine.
• How to dispose of syringes, needles, and injection devices.

If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not use the exact same spot for each injection. This will help prevent skin problems from the injections.

Since this medicine lowers the blood glucose over 24 hours, it should be injected once daily at bedtime. It is best to use it at about the same time every day.

This medicine should be clear and colorless before you use it. Do not use it if it looks cloudy colored, or has particles in it. Do not shake the vial. Do not mix this medicine with any other insulin or with water.

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (solution): For type 1 diabetes mellitus: Adults and children 6 years of age and older—Dose is based on your blood sugar and must be determined by your doctor. Children younger than 6 years of age—Use and dose must be determined by your doctor. For type 2 diabetes mellitus: Adults—Dose is based on your blood sugar and must be determined by your doctor. Children—Use and dose must be determined by your doctor.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Unopened medicine: Store the vials and pens in the refrigerator. You may store the medicine at room temperature for 28 days. Protect from light. Do not freeze.

Opened vials: Store in the refrigerator or at room temperature in a cool place, away from sunlight and heat. Use within 28 days.

Opened prefilled pens: Store at room temperature, away from direct heat and light. Do not refrigerate. Throw away any opened pen after 28 days.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

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