Toujeo SoloStar Pens

Toujeo (insulin glargine injection) is a man-made long-acting insulin analogue that is used to control glycemic levels in adults and children (over the age of 6) with type diabetes mellitus. It is still not known whether Toujeo is safe for children under the age of 6.

It is indicated as a once-daily injection subcutaneously (under the skin).

Patients using Toujeo require a basal (long-acting) insulin.

How to take Toujeo?

Toujeo should be taken each day at the same time. Blood sugar levels should be tested daily when usin insulin. Unless instructed by your doctor, do not modify your dosage.

Before every injection, check the label to verify you have the correct medication.

Never use a syringe to remove insulin from the pen.

It is not necessary to rotate or shake this medication prior to use and should not be mixed with other types of insulin.

Several factors may affect dosage such as body weight, existing medical conditions and medication currently being taken.

It is important to follow your doctor instructions on how to take this medication. Timing is important with respect to meal time in order to keep blood glucose levels under control. If you miss a dose and become hyperglycemic, follow your doctors instructions on how to treat episodes of hyperglycemia.

Blood Glucose Monitoring

It is important that patients taking insulin should monitor their blood glucose levels regularly or as recommended by their doctor. This is especially important when travelling across different time zones, under stress, are ill, have modified dosage or drastic change in diet. If blood sugar levels are showing consistently as very low or high, contact your doctor.

Rotate injection site

The fatty tissue underneath the skin may thicken or shrink if you inject frequently into the same site. To avoid this, rotate injection sites. If you notice any skin thickening or pitting, inform your doctor. Inform your doctor od diabetes educator if you notice any skin thickening or pitting at the site of injection.

Storing Toujeo

• Store unopened Toujeo insulin pens in the refrigerator until needed.
• Open pens in use may be store at room temperature for up to 42 days after first use.
• Do not expose to extreme heat, sunlight or freeze.
• Use medication until the expiry date on the label or carton.
• Keep insulin away from children and pets.
• Do not dispose insulin pens down wastewater (i.e. toilet or sink) or place inside household trash. Speak to your pharmacist about how to properly dispose of medication that is expired or no longer required.

Side Effects

Common side effects include:

• allergic reactions
• body fat redistribution (lipodystrophy)
• cold symptoms
• injection site reactions
• itching
• low blood sugar levels (hypoglycemia)
• rash
• swell of extremities
• weight gain

Toujeo side effects in detail:

Allergic Reactions

Stop using this medication if you notice any signs of allergic reaction such as difficulty breathing, wheezing, swelling of the face or throat, itch skin or rash.

Hypoglycemia (low blood sugar)

Hypoglycemia is the most common side effect with most insulin medications, including Toujeo. This can result is patient uses too much insulin, skips meals or if they exercise more than usual.

Mild to moderate hypoglycemia symptoms can include:

• cold sweat
• confusion
• fast heartbeat
• headache
• hunger
• lightheadedness
• nervousness or shakiness
• numbness or tingling (lips, tongue or fingers)
• weakness

Mild to moderate hypoglycemia can be treated by consuming a glucose tablet, sugary snack or beverage such as hard candies, raisins, fruit juice or soda drinks (non-diet), sugar packets or jelly beans.

It is advised that diabetics should always carry a quick source of sugar to avoid episodes of hypoglycemia.

In serious cases of hypoglycemia where patients experiences severe low blood glucose levels, they may experience seizures or lose consciousness may require an injection of glucagon or receive glucose intravenously (into the vein) since they cannot (and should not) consume sugar orally.

Family & friends should be educated about the signs and symptoms of hypoglycemia, be aware where the glucagon emergency kit is store and how to properly administer it in case of severe hypoglycemia and loss of consciousness.

Hyperglycemia (high blood sugar)

If you miss a dose or your insulin dose is too low, this may lead to hyperglycemia. Symptoms of hyperglycemia may include:

• acetone or fruity odor on breath
• anxiety
• difficulty concentrating
• drowsiness
• dry mouth
• flushed dry skin
• headache
• hunger
• increased need to urinate
• increased thirst
• increased heart beat
• loss of appetite
• nausea
• nervousness
• numbness or tingling of the lips, fingers, or tongue
• signs of dehydration
• sweating
• swelling around the ankles or calves (fluid build-up in the body)
• tiredness
• trembling
• vision changes
• vomiting
• weight loss

Hyperglycemia is not experienced immediately but can be over hours throughout the day. Contact your doctor if you are experiencing symptoms of hyperglycemia.

If hyperglycemia persists, its can lead to diabetic ketoacidosis where the body begins to use fat as fuel and can result in a high concentration of acid in the blood stream. In extreme cases, this can lead to unconsciousness coma or even death. Your doctor may need to modify your treatment if you experience hyperglycemia.

Kidney Function

Your dosage may be modified if you have any reduced kidney function or kidney disease. You should discuss the following with your doctor: if any special monitoring is required, how this medication will affect your medical condition and how your condition may affect dosage and the effectiveness of the medication. Your doctor may choose to perform regular blood and kidney function tests while taking Toujeo.

Liver Function

Reduced liver function or liver disease may reduce the amount of insulin required by the body. Speak to your doctor about how this medication may affect your condition, how this medication will affect your condition may effect dosing and if any liver function monitoring is required.

Peripheral Edema

Toujeo (insulin glargine) may cause sodium retention and edema. Especially if the patient has poor metabolic control.

Lipodystrophy

Lipodystrophy, lipoatrophy (depression in the skin) or lipohypertrophy (thickening or enlargement of tissue) may result from prolonged use of insulin.

Weight Gain

With some insulin therapies, weight gain may occur. This is usually a result of a decrease of glucosaria and the anabolic effects of insulin.

Warnings & Precautions

Prior to using Toujeo, inform your doctor of any significant facts about your health including:

• existing medical conditions
• allergies or medications you are currently taking
• if you are pregnant or planning on pregnancy
• breast feeding or planning to breast feed
• any changes to your insulin dosage or treatment
• changes in blood glucose readings

These factors may affect how you should use and how your body responds to this medication.

Seek medical attention and stop taking this medication immediately if you notice signs of serious allergic reactions (i.e. difficulty breathing, wheezing, itchy skin, swelling of face or throat).

Patients should wear diabetes identification in the form of a card or bracelet/necklace that lets others know they have diabetes and are taking insulin.

Toujeo is not to be used for treating diabetic ketoacidosis.

Do not share your pen with others even if the needle has been changed as it can spread infection.

Rotate injection sites to avoid developing skin complications such as lipodystrophy (thickened or pitted skin) or localized cutaneous amyloidosis (lumpy skin) at site of injection. Do not inject into areas of the skin that appear tender, scaly, hard, bruised, thickened, lumpy, pitted, scarred or damaged.

Before starting treatment, inform your doctor of any major medial conditions such as problems with the liver or kidney, breast feeding or planning to breast feed or if you are pregnant or planning pregnancy,

Patients taking TZD’s (thiazolidinediones) or other medication along with insulin are at a higher risk of heart failure, even for those who have no history of heart problems. If you are currently taking Toujeo with TZD’s, your heart problems may worsen. Your doctor may choose to modify your treatment if you are experiencing heart complications. Speak to your doctor if you are experiencing any of the following symptoms:

• Difficulty breathing
• Swelling of ankles and feet
• Sudden weight gain

Inform your doctor if you are taking any other drugs including over-the-counter medications, herbal supplements or vitamins.

Any modifications to your treatment such as change in dosage should be made under medical supervision.

Do not mix or dilute Toujeo with other solutions such as insulin as this may impact the efficacy and glycemic control.

Only use Toujeo if solution appears clear and colorless. Do not use this medication if it appears cloudy, discolored, looks clumpy or contains particles.

Do not drive or operate heavy machinery unless you understand how your body reacts when taking it.

Try to avoid consuming alcoholic beverages or medications that contain alcohol as it may impact your blood sugar levels.

As with taking any insulin, hypoglycemia (low blood sugar) is a common side effect that can have serious side effects including diabetic coma or death. Common symptoms related to hypoglycemia include: shaking, increased heartbeat, sweating and blurred vision.

During pregnancy, it is important to maintain blood sugar levels. Insulin requirements typically decrease during the first trimester and increase during the second and third trimesters. Inform your doctor if you are pregnant or thinking about getting pregnant.

It is unknown how insulin glargine affects breast milk however it is possible that it may affect your body. That being said, you should still inform your doctor if you are breast feeding, planning to breast feed and whether you should continue breast feeding. Mothers who are breast feeding may require modifications to their dosage or diet.

The effectiveness and safety of this medication has not been established for children under the age of six with type 1 diabetes and children under the age of 18 with type 2 diabetes.

Drug Interactions

The following substances may interact with Toujeo:

• alcohol
• androgens (i.e. methyltestosterone, nandrolone, testosterone)
• atypical antipsychotics (i.e. clozapine, olanzapine, quetiapine, risperidone)
• beta-blockers (i.e. atenolol, metoprolol, pindolol, propranolol, sotalol)
• birth control pills
• canagliflozin
• clarithromycin
• corticosteroids (i.e. prednisone, prednisolone)
• danazol
• dapagliflozin
• decongestants (i.e. pseudoephedrine)
• hepatitis C antivirals (i.e. daclatasvir, ledipasvir, paritaprevir, sofosbuvir)
• disopyramide
• certain diuretics (i.e. furosemide, hydrochlorothiazide)
• epinephrine
• estrogens (i.e. conjugated estrogen, estradiol, ethinyl estradiol)
• exenatide
• “gliptin” diabetes medications (i.e. alogliptin, linagliptin, saxagliptin)
• glucagon
• growth hormone
• other insulins
• certain kinase inhibitors (i.e. dabrafenib, nilotinib, sunitinib)
• lanreotide
• liraglutide
• metformin
• monoamine oxidase inhibitors (MAOIs; i.e. moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
• niacin
• octreotide
• pasireotide
• pegvisomant
• pioglitazone
• progestins (i.e. dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
• protease inhibitors (i.e. atazanavir, ritonavir, saquinavir)
• quinine
• quinolone antibiotics (i.e. ciprofloxacin, norfloxacin, ofloxacin)
• repaglinide
• rosiglitazone
• salicylates (i.e. ASA)
• selective serotonin reuptake inhibitors (SSRIs; i.e. citalopram, fluoxetine, paroxetine, sertraline)
• sulfa antibiotics (i.e. sulfamethoxazole, sulfadiazine)
• sulfonylurea diabetes medications (i.e. chlorpropamide, gliclazide glyburide)
• sunitinib
• tacrolimus
• thyroid replacement therapy (if beginning or changing dose)
• vorinostat