Tresibapenfill 100 Iu 3 Ml Cartridge

TRESIBAPENFILL 100 IU 3 ML CARTRIDGE (Tresiba Penfill)

This detailed product description is for healthcare professionals and consumers.

Name

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

Composition

Tresiba Penfill 100 units/mL solution for injection contains insulin degludec as the active ingredient. Each 3 mL cartridge contains 300 units of insulin degludec, with 1 mL solution containing 100 units of insulin degludec.

Uses

Tresiba Penfill is an ultra-long-acting basal insulin analog prescribed for the treatment of diabetes mellitus in adults, adolescents, and children from the age of 1 year. It helps to control blood sugar levels by providing a steady release of insulin over an extended period, preventing complications associated with diabetes. It can be used for both Type 1 and Type 2 diabetes.

Dosage and Administration

Tresiba Penfill is for once-daily subcutaneous administration at any time of the day, preferably at the same time each day. If a dose is missed, it can be taken upon discovery, ensuring a minimum of 8 hours between injections. The injection should be administered into the thigh, upper arm, or abdominal wall, with rotation of injection sites within the chosen area to reduce the risk of skin changes. Do not inject intravenously or intramuscularly.

Side Effects

• Common Side Effects: Hypoglycemia (low blood sugar) is very common and can be serious. Other common side effects include injection site reactions (pain, redness, swelling, itching), weight gain, headache, diarrhea, and lipodystrophy (skin thickening or pitting).
• Serious Side Effects: Severe hypoglycemia, low potassium in the blood (hypokalemia), and serious allergic reactions (including anaphylaxis) are possible. Heart failure has been reported in some patients when Tresiba is used in combination with thiazolidinediones (TZDs).

Precautions

• Close blood glucose monitoring is recommended, especially when initiating treatment or changing doses.
• Inform your doctor if you have kidney, liver, or heart problems.
• Avoid excessive alcohol consumption as it can interfere with insulin's action and increase the risk of hypoglycemia.
• Do not share insulin delivery devices to prevent the transmission of blood-borne pathogens.
• Do not mix Tresiba with any other insulin product.
• If you experience signs of heart failure (unusual shortness of breath, rapid weight gain, localized swelling) while taking Tresiba with pioglitazone, inform your doctor immediately.
• Fast improvements in blood sugar control can temporarily worsen diabetic eye disorder.

Storage

Before first use, unopened Tresiba Penfill cartridges should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F) and protected from light. Do not freeze. Once in use, the cartridge can be stored at room temperature (not above 30°C or 86°F) or refrigerated for up to 8 weeks. Keep it in the outer carton to protect from light. Discard after 8 weeks, even if it still contains insulin.

Frequently Asked Questions about TRESIBAPENFILL 100 IU 3 ML CARTRIDGE (Insulin Degludec)

TRESIBAPENFILL 100 IU 3 ML CARTRIDGE contains insulin degludec, an ultra-long-acting insulin, and is manufactured by Novo Nordisk (with Abbott India Limited potentially as a distributor).

What is TRESIBAPENFILL used for?

TRESIBAPENFILL is an ultra-long-acting insulin used to treat both type 1 and type 2 diabetes mellitus in adults, adolescents, and children aged 1 year and above. It helps to control high blood sugar levels and prevent diabetes-related complications by providing a steady level of insulin in the body for over 24 hours.

How does TRESIBAPENFILL work?

This medicine, containing insulin degludec, works like the natural insulin produced by your body. Upon subcutaneous injection, it forms soluble multi-hexamers that act as an insulin depot. Insulin monomers slowly separate from these multi-hexamers, providing a slow, continuous release of insulin into the bloodstream. This process facilitates the uptake of sugar from the blood into muscle and fat cells and suppresses glucose production by the liver, thereby lowering blood sugar levels consistently over an extended period.

What is the usual dosage of TRESIBAPENFILL?

TRESIBAPENFILL is administered once daily via subcutaneous injection, preferably at the same time each day. However, if a regular dosing time is not possible, it can be taken at a different time of day, ensuring there is a minimum of 8 hours between doses. Your doctor will determine the appropriate dose based on your individual needs and blood glucose monitoring. For type 1 diabetes, it must be used in combination with mealtime insulin, and for type 2 diabetes, it can be used alone or with other antidiabetic medications.

What are the possible side effects of TRESIBAPENFILL?

The most common and serious side effect is low blood sugar (hypoglycemia), which can manifest as dizziness, sweating, confusion, fast heartbeat, headache, blurred vision, shakiness, or anxiety. Other common side effects include:

• Reactions at the injection site such as pain, redness, swelling, itching, or the formation of lumps (lipodystrophy or cutaneous amyloidosis).
• Headache, nasopharyngitis, and upper respiratory tract infections.
• Weight gain and peripheral edema (swelling of hands and feet).
• Low potassium levels in the blood (hypokalemia). Rarely, severe allergic reactions, including anaphylaxis, can occur.

Is TRESIBAPENFILL safe during pregnancy or breastfeeding?

• Pregnancy: TRESIBAPENFILL is generally considered safe for use during pregnancy if prescribed by a doctor. While human studies are limited, animal studies indicate no harmful effects to the developing baby. Close monitoring of blood sugar levels and potential dose adjustments are recommended throughout pregnancy.
• Breastfeeding: It is likely safe to use during breastfeeding. Insulin is not absorbed from the gut, so any insulin present in breast milk is unlikely to affect a nursing child.

Can TRESIBAPENFILL be taken with other medications?

Yes, TRESIBAPENFILL can be used in combination with other diabetes medications, including oral antidiabetic agents, GLP-1 receptor agonists, and bolus insulins. However, certain medications can interact with insulin degludec, requiring careful monitoring and potential dose adjustments. For instance, taking thiazolidinediones (TZDs) with insulin can increase the risk of heart failure. Alcohol can also intensify or reduce the blood sugar-lowering effect of insulin. Always inform your doctor about all medications and supplements you are taking.

What precautions should be taken when using TRESIBAPENFILL?

• Always visually check the insulin label before each injection to avoid medication errors.
• Rotate injection sites within the same chosen area (e.g., abdomen, thigh, upper arm) to prevent skin changes like thickening or lumps. Do not inject into affected areas.
• Do not inject intravenously or intramuscularly, and do not use in insulin infusion pumps.
• Do not dilute or mix TRESIBAPENFILL with any other insulin product, and never share needles or pens to prevent transmission of blood-borne pathogens.
• Regularly monitor your blood glucose levels, especially when switching insulin types, during illness, or stress.
• Always carry a fast-acting source of sugar (like glucose tablets or fruit juice) to treat potential low blood sugar episodes.
• If you have kidney or liver problems, your doctor may need to adjust your dose.

What happens if a dose of TRESIBAPENFILL is missed?

If you are an adult and miss a dose, inject it as soon as you remember, but ensure there is a minimum of 8 hours between consecutive doses. Then, resume your usual once-daily dosing schedule. Do not take a double dose to make up for the missed one. For pediatric patients, contact a healthcare provider for guidance on monitoring blood sugar levels until the next scheduled dose.

How should TRESIBAPENFILL be stored?

• Unopened cartridges: Store in a refrigerator between 2°C and 8°C (36°F to 46°F) in their original carton to protect them from light. Do not freeze the medicine.
• Opened or in-use cartridges: Can be stored at room temperature (up to 30°C or 86°F) or refrigerated for up to 8 weeks (56 days). Protect from direct heat and light. After 8 weeks, dispose of the cartridge even if there is insulin remaining. Always remove and safely dispose of the needle after each injection and store the cartridge without a needle attached.