Tresiba 100 U/ml Flextouch 3 Ml

Here is a detailed product description for TRESIBA 100 U/ML FLEXTOUCH 3 ML:

Name

• Brand Name: Tresiba® FlexTouch® 100 units/mL
• Common Name: Insulin Degludec

Composition

• Active Ingredient: Each mL of solution contains 100 units of insulin degludec. Each pre-filled pen contains 300 units of insulin degludec in 3 mL solution.
• Other Ingredients: Glycerol, metacresol, phenol, zinc acetate, hydrochloric acid, sodium hydroxide (for pH adjustment), and water for injections.

Uses Tresiba is an ultra-long-acting basal insulin indicated to improve glycemic control in patients aged 1 year and older with diabetes mellitus (Type 1 and Type 2). It provides a steady level of insulin in the body for an extended period, helping to normalize blood sugar levels and reduce the risk of diabetes-related complications. It is not recommended for treating diabetic ketoacidosis.

Dosage and Administration Tresiba 100 units/mL FlexTouch is administered once daily via subcutaneous injection at any time of day for adults, preferably at the same time every day. For pediatric patients, it should be injected once daily at the same time every day. The dose, ranging from 1 to 80 units per injection in 1-unit steps, should be individualized based on metabolic needs and blood glucose monitoring. If a dose is missed, it can be taken upon discovery, ensuring at least 8 hours between consecutive injections. Injection sites should be rotated within the thigh, upper arm, or abdominal wall to minimize the risk of lipodystrophy. Do not use in insulin infusion pumps or dilute/mix with other insulins.

Side Effects

• Common: Hypoglycemia (low blood sugar), injection site reactions (redness, swelling, pain, itching), lipodystrophy (skin thickening or pitting), rash, pruritus, headache, nasopharyngitis, upper respiratory infections, edema, and weight gain.
• Serious: Severe hypoglycemia (which can be life-threatening), hypokalemia (low potassium in the blood), and heart failure when used in combination with thiazolidinediones (TZDs).

Precautions Never share a Tresiba FlexTouch pen, needle, or syringe between patients due to the risk of transmitting blood-borne pathogens. Changes in insulin regimen or accidental mix-ups between insulin products can lead to hyperglycemia or hypoglycemia, necessitating careful monitoring. Patients with renal or hepatic impairment may have a higher risk of hypoglycemia. Alcohol consumption can affect blood sugar levels and should be avoided or monitored closely.

Storage Unopened Tresiba FlexTouch pens should be stored in a refrigerator (2°C to 8°C or 36°F to 46°F) until the expiration date. It can also be stored at temperatures up to 30°C (86°F) for up to 56 days. Once in use (opened), the pen can be stored for up to 8 weeks (56 days) at room temperature (below 30°C or 86°F) or in the refrigerator, away from direct heat and light. Do not freeze Tresiba, and do not use it if it has been frozen. Always remove the needle after each injection to prevent contamination, infection, and leakage.

TRESIBA 100 U/ML FLEXTOUCH 3 ML is a pre-filled pen containing insulin degludec, an ultra-long-acting basal insulin. It is used to manage blood sugar levels in people with diabetes mellitus.

What is TRESIBA used for?

TRESIBA 100 U/ML FLEXTOUCH is used to improve glycemic control (blood sugar levels) in adults, adolescents, and children aged 1 year and above with type 1 or type 2 diabetes mellitus. It provides a steady level of insulin in the body for an extended period, helping to control blood sugar between meals and overnight.

How does TRESIBA work?

TRESIBA contains insulin degludec, an ultra-long-acting basal insulin analog. After subcutaneous injection, it forms multi-hexamers, creating a depot of insulin degludec in the subcutaneous tissue. Insulin degludec is then slowly absorbed into the bloodstream from this depot, providing a prolonged and steady glucose-lowering effect for up to 42 hours. Insulin works by stimulating glucose uptake in muscle and fat tissue and by decreasing the liver's production of glucose.

What is the usual dosage for TRESIBA?

TRESIBA is typically injected once daily under the skin (subcutaneously). For adults, it can be taken at any time of day, but children with type 1 diabetes should take it at approximately the same time each day. The dose is individualized based on the patient's needs, blood glucose measurements, and glycemic goals.

For insulin-naïve patients with type 1 diabetes, the initial dose is typically one-third to one-half of the total daily insulin requirement. For insulin-naïve patients with type 2 diabetes, the recommended starting dose is 10 units once daily. When switching from other insulin therapies, the starting dose for adults is usually the same total daily dose of the previous long or intermediate-acting insulin, while for pediatric patients, it's about 80% of the previous dose. The TRESIBA 100 U/ML FlexTouch pen can deliver 1–80 units in steps of 1 unit.

What are the possible side effects of TRESIBA?

The most common side effect of TRESIBA is low blood sugar (hypoglycemia). Symptoms of low blood sugar can include dizziness, light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, and hunger.

Other common side effects may include allergic reactions, reactions at the injection site (such as redness, swelling, itching, or pain), skin thickening or pits at the injection site (lipodystrophy), itching, rash, edema (swelling of hands and feet), and weight gain.

Serious side effects, though less common, can include severe allergic reactions, low potassium in the blood (hypokalemia), and heart failure if taken with certain diabetes medications called thiazolidinediones (TZDs).

Is TRESIBA safe during pregnancy or breastfeeding?

It's important to discuss the risks and benefits of using TRESIBA during pregnancy with your doctor, as poorly controlled diabetes can pose risks to both the mother and the fetus. While there are no adequate studies in pregnant women, animal studies have not shown differences between insulin degludec and human insulin regarding embryotoxicity and teratogenicity. Intensified blood glucose control and monitoring are recommended throughout pregnancy.

TRESIBA is generally considered safe to use during breastfeeding. Insulin passes into breast milk, but it's a protein that would be inactivated if consumed by the infant, so no metabolic effects are expected. However, your insulin dosage may need adjustments while breastfeeding.

Can TRESIBA be taken with other medications?

Yes, TRESIBA can interact with many other medications. Some medicines can increase the blood glucose-lowering effect of insulin, increasing the risk of hypoglycemia. These include other antidiabetic agents, ACE inhibitors, angiotensin II receptor blockers, certain antidepressants, and sulfonamide antibiotics.

Other medications can decrease the blood glucose-lowering effect of insulin, potentially requiring an increased insulin dose. These include oral contraceptives, corticosteroids, thyroid hormones, and certain diuretics.

Alcohol can either intensify or reduce the hypoglycemic effect of insulin. Beta-blockers may mask the symptoms of hypoglycemia, making it harder to recognize when blood sugar is low. Always tell your doctor or pharmacist about all prescription, over-the-counter, and herbal medications you are taking.

What precautions should be taken with TRESIBA?

• Never share your pen: TRESIBA FlexTouch pens, needles, or syringes should never be shared with another person, even if the needle is changed, to prevent the transmission of infections.
• Hypoglycemia: Do not use TRESIBA if you are experiencing an episode of low blood sugar. Be aware of the symptoms of hypoglycemia and how to treat it.
• Injection site rotation: Rotate injection sites within the chosen area (abdomen, thigh, or upper arm) to reduce the risk of skin changes like lipodystrophy.
• Kidney or liver problems: If you have kidney or liver problems, you may need to monitor your blood sugar more frequently and your doctor may adjust your dose.
• Alcohol consumption: Alcohol can affect blood sugar levels, so discuss alcohol intake with your doctor.
• Diabetic ketoacidosis: TRESIBA is not recommended for treating diabetic ketoacidosis.

What happens if a dose is missed?

If an adult misses or is delayed in taking a dose of TRESIBA, they should take it as soon as they remember and then continue with their regular dosing schedule. However, ensure there is a minimum of 8 hours between doses. For children, if a dose is missed, their healthcare provider should be contacted, and blood glucose levels should be monitored more frequently until the next scheduled dose. Do not inject two doses at once or take extra insulin to make up for a missed dose, as this can lead to severe low blood sugar.

How should TRESIBA be stored?

Unopened TRESIBA FlexTouch pens should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F) until the expiration date. Do not freeze.

After the first use, or if carried as a spare, the pen can be kept at room temperature (up to 30°C or 86°F) or in the refrigerator (2°C to 8°C) for a maximum of 8 weeks (56 days). Always keep the cap on the pen to protect it from light. Do not store TRESIBA with the needle attached.