Novomix Penfill Cartridge

Use of Novomix Penfill Cartridge

Insulin Novomix cartridges filled with NovoLog Mix 70/30, which is a mixture of 70% insulin aspart protamine and 30% soluble insulin aspart. Insulin aspart is a fast-acting mealtime insulin analog that is nearly identical to naturally occurring human insulin. Insulin aspart protamine is an intermediate-acting insulin analog that has small proteins called protamines added to slow down insulin aspart’s onset and to extend its duration of action.

NovoMix 30 penfill cartridges (pre-mixed) are for use with your insulin pen in the treatment of patients with diabetes. It has a rapid onset and an intermediate duration of action which means it can be used to control your blood sugar levels during meals and also between meals and at nighttime.

NovoMix 30 is a blood sugar-lowering mixture of man-made insulins that has a rapid onset and an intermediate duration of action. Its primary action is the regulation of sugar breakdown from the food you eat. All types of insulin including NovoMix 30 work by activating mechanisms in your body that lower blood sugar. They increase the absorption of sugar from the blood and into fat and skeletal muscle while also blocking the production and release of sugar from the liver into the blood.

The rapid absorption of insulin aspart itself is maintained by NovoMix 30. The insulin aspart component (30%) of the mixture is absorbed more rapidly from than naturally occurring human insulin and begins to work within 15 minutes. The remaining 70% of the mixture is insulin aspart protamine which has a long absorption profile lasting up to 24 hours. The peak activity of NovoLog Mix 70/30 is between one to four hours after subcutaneous (under the skin) injection.

Warnings and Precautions

Never share your insulin pen with anyone, even if you have changed the needle. Sharing poses a risk for transmission of infections to others and from them to yourself.

Do not take it if you:

• Have low blood sugar (hypoglycemia)
• Have allergies to any of the ingredients

Tell your doctor if you are:

• Pregnant, plan to become pregnant or are currently breast-feeding
• Taking a new prescription or over-the-counter drug or supplement

Do not drive or operate machinery until you know how it affects you. Do not drink alcohol or use any drugs that contain alcohol.

Dosage

Before use inspect your cartridge, its should be uniformly cloudy and white. If it is clear or contains solid particles, do not use it. Insulin Novomix 30/70 Penfill Cartridge must be re-suspended immediately before use. Re-suspension is easier when the insulin has reached room temperature.

This drug is for subcutaneous (under the skin) injection into the buttocks, abdominal region, upper arm or thigh. You should remember to rotate your injection sites from one injection to the next to reduce the chance of getting lipodystrophy. Do not administer it intravenously or use it in insulin infusion pumps.

NovoLog Mix 70/30 helps you control your mealtime blood sugar levels and also helps you control your blood sugar levels between meals too. It is usually taken twice-daily, with each dose intended to cover two meals or a meal plus a snack. You should administer your dose within 15 minutes before your meal starts. For treatment of type 2 diabetes the dose may be given after the start your meal.

Individual dosing schedules will vary among patients and should be determined by your doctor who is familiar with your eating habits, metabolic needs and other lifestyle variables. With all insulin therapies the action of the insulin can change according to the injection site, dose, temperature, blood flow and your level of physical activity.

Your individualized dosage schedule is based on your metabolic needs, blood glucose monitoring results, blood sugar level control goals. Dosage adjustments may be needed if you are switching from another type of insulin, or with any changes in physical activity, meal pattern, kidney or liver function or during sickness.

Side Effects

Common side effects:

• Hypoglycemia

The most common side effect of insulin is hypoglycemia (low blood sugar).

Some signs and symptoms of hypoglycemia include

• irritability
• anxiety
• sweating
• mood changes
• confusion
• headache
• dizziness

Less common side effects:

• Injection site reactions
• Lipodystrophy
• Hypokalemia
• Edema

With all treatments that include injections there is a potential for injection site reactions. Some common reactions include pain, swelling, redness, itching, inflammation, bruising and hives. If you consistently rotate your injection sites you can reduce you risk of developing any of these kind of skin site reactions. These reactions usually go away within a few days to weeks. Repeated subcutaneous injections can also result in a group of localized skin reactions called lipodystrophy. This can look like skin thickening (lipohypertrophy) or pits (lipoatrophy) at the injection site. A change in your subcutaneous injection technique may help to reduce the risk of getting these reactions.

Hypokalemia is the occurrence of excessively low potassium (K+) levels in your blood. All insulin therapies tend to cause a shift in potassium levels which can potentially lead to hypokalemia. If your blood potassium levels are left untreated it may lead to respiratory paralysis, ventricular arrhythmia and even death.

Edema is fluid retention which causes swelling which can occur during insulin therapy. It can occur in any part of your body, though its most observable in the legs and arms, including the feet, ankles and hands.

Taking antidiabetic medications called thiazolidinediones (TZDs) together with NovoMix 30 causes a risk of heart failure even if you never have had heart issues before. Let your doctor know if you have any signs or symptoms of heart failure which may include:

• Swelling in your feet or ankles
• Sudden weight gain
• Shortness of breath