NovoLOG Mix 70/30 FlexPen

Name: NovoLOG Mix 70/30 FlexPen

Descriptions

Insulin aspart protamine and insulin aspart is a combination of a fast-acting insulin and an intermediate-acting type of human insulin. Insulin is used by people with diabetes to help keep blood sugar levels under control. If you have diabetes mellitus, your body cannot make enough or does not use insulin properly. So, you must take additional insulin to regulate your blood sugar and keep your body healthy. This is very important as too much sugar in your blood can be harmful to your health.

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

This product is available in the following dosage forms:

  • Suspension

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of 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 required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Balofloxacin
  • Besifloxacin
  • Ciprofloxacin
  • Enoxacin
  • Fleroxacin
  • Flumequine
  • Gatifloxacin
  • Gemifloxacin
  • Lanreotide
  • Levofloxacin
  • Liraglutide
  • Lomefloxacin
  • Metreleptin
  • Moxifloxacin
  • Nadifloxacin
  • Norfloxacin
  • Octreotide
  • Ofloxacin
  • Pasireotide
  • Pazufloxacin
  • Pefloxacin
  • Pioglitazone
  • Pramlintide
  • Prulifloxacin
  • Rosiglitazone
  • Rufloxacin
  • Sparfloxacin
  • Thioctic Acid
  • Tosufloxacin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acebutolol
  • Albiglutide
  • Atenolol
  • Betaxolol
  • Bisoprolol
  • Bitter Melon
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Dulaglutide
  • Esmolol
  • Exenatide
  • Fenugreek
  • Furazolidone
  • Glucomannan
  • Guar Gum
  • Iproniazid
  • Isocarboxazid
  • Labetalol
  • Levobunolol
  • Linezolid
  • Lixisenatide
  • Methylene Blue
  • Metipranolol
  • Metoprolol
  • Moclobemide
  • Nadolol
  • Nebivolol
  • Nialamide
  • Oxprenolol
  • Penbutolol
  • Phenelzine
  • Pindolol
  • Practolol
  • Procarbazine
  • Propranolol
  • Psyllium
  • Rasagiline
  • Safinamide
  • Selegiline
  • Sotalol
  • Timolol
  • Tranylcypromine

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:
    • For diabetes mellitus:
      • Adults—The dose is based on your blood sugar and must be determined by your doctor.
      • Children—Use and dose must be determined by your doctor.

What is NovoLog Mix 70/30 FlexPen (insulin aspart and insulin aspart protamine)?

Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin aspart is a fast-acting insulin. Insulin aspart protamine is an intermediate-acting insulin. This combination insulin starts to work within 10 to 20 minutes after injection, peaks in 2 hours, and keeps working for up to 24 hours.

Insulin aspart and insulin aspart protamine is a combination medicine used to improve blood sugar control in adults with diabetes mellitus (type 1 or type 2).

Insulin aspart and insulin aspart protamine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about this medicine?

Never share an injection pen or syringe with another person, even if the needle has been changed.

What should I discuss with my healthcare provider before using this medicine?

You should not use this medicine if you are allergic to insulin aspart, or if you are having an episode of hypoglycemia (low blood sugar).

Insulin aspart and insulin aspart protamine is not approved for use by anyone younger than 18 years old.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

  • liver or kidney disease; or

  • low levels of potassium in your blood (hypokalemia).

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Follow your doctor's instructions about using insulin if you are pregnant or breast-feeding a baby. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy. Your dose needs may also be different while you are breast-feeding.

How should I use this medicine?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Insulin is injected under the skin. You will be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.

Insulin aspart and insulin aspart protamine must not be given with an insulin pump, or mixed with other insulins. Do not inject this medicine into a vein or a muscle.

Your care provider will show you the best places on your body to inject insulin aspart and insulin aspart protamine. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

It is important to time your insulin use with meals.

  • If you have type 1 diabetes: Use this medicine within 15 minutes before the start of a meal.

  • If you have type 2 diabetes: Use this medicine within 15 minutes before or after the start of a meal.

If you use an injection pen, use only the injection pen that comes with this medicine. Attach a new needle before each use.

Never share an injection pen or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

Use a disposable needle or syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your insulin dose or schedule.

This medicine is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Keep this medicine in its original container protected from heat and light. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing this medicine unopened (not in use):

  • Refrigerate and use until expiration date; or

  • Store at room temperature, and use the vial within 28 days or use the injection pen within 14 days.

Storing this medicine opened (in use):

  • Store vial in a refrigerator or at room temperature and use within 28 days.

  • Store the injection pen at room temperature (do not refrigerate) and use within 14 days. Do not store the injection pen with a needle attached.

This medicine should look white and cloudy. Do not use the medicine if it looks clear or has particles in it. Call your pharmacist for new medicine.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Wear a diabetes medical alert tag in case of emergency. Any medical care provider who treats you should know that you have diabetes.

Uses For NovoLOG Mix 70/30 FlexPen

Insulin aspart protamine and insulin aspart is a combination of a fast-acting insulin and an intermediate-acting type of human insulin. Insulin is used by people with diabetes to help keep blood sugar levels under control. When you have diabetes mellitus, your body cannot make enough or does not use insulin properly. So, you must take additional insulin to regulate your blood sugar and keep your body healthy. This is very important as too much sugar in your blood can be harmful to your health.

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

For Healthcare Professionals

Applies to insulin aspart / insulin aspart protamine: subcutaneous suspension

General

The most common adverse reactions observed with insulin therapy include hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus.[Ref]

Metabolic

Hypoglycemia is the most frequently reported adverse reaction with insulin therapy. It occurs if the dose of the insulin is too high in relation to the insulin requirement. In clinical trials, the frequency of hypoglycemia varied with patient population, dose regimens, and level of glycemic control. Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria.[Ref]

Very common (10% or more): Hypoglycemia (69%)
Frequency not reported: Weight gain[Ref]

Hypersensitivity

Very rare (less than 0.01%): Anaphylactic reactions
Frequency not reported: Allergic reactions[Ref]

Local

Frequency not reported: Injection site reactions[Ref]

Injection site reactions including pain, redness, hives, inflammation, bruising, swelling, and itching, may occur. These reactions are usually transitory.[Ref]

Ocular

Frequency not reported: Transient, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy[Ref]

Rapid improvement or intensification of in glucose control has been associated with transitory, reversible ophthalmologic refraction disorder; however, long-term glycemic control decreases the risk of diabetic retinopathy.[Ref]

Cardiovascular

Insulin may cause sodium retention and edema, especially if previously poor metabolic control is improved by intensified insulin therapy.[Ref]

Frequency not reported: Peripheral edema[Ref]

Dermatologic

Frequency not reported: Lipodystrophy, rash, pruritus[Ref]

Gastrointestinal

Common (1% to 10%): Dyspepsia, diarrhea, abdominal pain[Ref]

Immunologic

Common (1% to 10%): Influenza-like symptoms
Frequency not reported: Anti-insulin antibodies[Ref]

In a 3-month, open-label study, anti-insulin antibodies and cross-reacting anti-insulin antibodies were monitored in patients using this insulin compared with an insulin mix of 70% NPH (human insulin isophane suspension) and 30% regular (human insulin injection). Changes in cross-reactive antibodies were more common after this mix but these changes did not correlate with a change in HbA1c or increase in insulin dose. The clinical significance of these antibodies has not been established. Antibodies did not increase further after long-term exposure (greater than 6 months).[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, skeletal pain[Ref]

Nervous system

Rapid improvement or intensification of in glucose control has been associated with acute and painful peripheral neuropathy; however, long-term glycemic control decreases the risk of neuropathy.[Ref]

Very common (10% or more): Headache (19%)
Common (1% to 10%): Neuropathy[Ref]

Other

Postmarketing reports: Medication errors in which other insulins have been accidentally substituted[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, rhinitis , upper respiratory tract infection[Ref]

Some side effects of NovoLog Mix 70 / 30 FlexPen may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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