NovoLOG Mix 70/30 FlexPen

Since this medicine is used with meals, you may not be on a timed dosing schedule. Whenever you use this insulin, be sure to eat a meal within 15 minutes. Do not use extra medicine to make up a missed dose.

Keep insulin on hand at all times. Get your prescription refilled before you run out of medicine completely.

Avoid driving or operating machinery until you know how this medicine will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol. It can cause low blood sugar and may interfere with your diabetes treatment.

Get emergency medical help if you have signs of insulin allergy: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, wheezing, rapid pulse, sweating, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• fluid retention--weight gain, swelling in your hands or feet, feeling short of breath; or

• low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

• low blood sugar;

• itching, mild skin rash; or

• thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In the U.S.

• NovoLOG Mix 70/30
• NovoLOG Mix 70/30 FlexPen

Available Dosage Forms:

• Suspension

Therapeutic Class: Antidiabetic

Pharmacologic Class: Insulin Aspart, Recombinant

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of insulin aspart protamine and insulin aspart combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of insulin aspart protamine and insulin aspart combination in the elderly. However, elderly patients are more likely to have age-related heart, liver, or kidney problems which may require caution and an adjustment in the dose for patients receiving this medicine. Recommended doses should not be exceeded, and the patient should be carefully monitored for symptoms of hypoglycemia during treatment with this medicine.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

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
• Saxagliptin
• Selegiline
• Sotalol
• Timolol
• Tranylcypromine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Hypoglycemia (low blood sugar)—Should not be used in patients with this condition. If you have low blood sugar and take insulin, your blood sugar may reach dangerously low levels.

• Hypokalemia (low potassium in the blood)—May make this condition worse and increase your chance of having serious side effects.

• Infection or any illness or
• Stress (eg, physical or emotional)—These conditions increase blood sugar and may increase the amount of insulin aspart protamine and insulin aspart combination you need.

• Kidney disease or
• Liver disease—Effects of insulin aspart protamine and insulin aspart combination may be increased because of the slower removal of the medicine from the body.

Applies to insulin aspart / insulin aspart protamine: subcutaneous suspension

Along with its needed effects, insulin aspart / insulin aspart protamine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking insulin aspart / insulin aspart protamine:

• Anxiety
• blurred vision
• burning, tingling, numbness or pain in the hands, arms, feet, or legs
• chills
• cold sweats
• confusion
• cool, pale skin
• depression
• dizziness
• fast heartbeat
• headache
• increased hunger
• loss of consciousness
• nausea
• nervousness
• nightmares
• seizures
• sensation of pins and needles
• shakiness
• slurred speech
• stabbing pain
• unusual tiredness or weakness

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• change in vision
• chest tightness
• cough
• difficulty swallowing
• hives, itching, skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• rapid weight gain
• redistribution or accumulation of body fat
• thickening of the skin injection site
• unusual weight gain or loss

Get emergency help immediately if any of the following symptoms of overdose occur while taking insulin aspart / insulin aspart protamine:

• Decreased amount of urine
• dry mouth
• increased thirst
• irregular heartbeat
• loss of appetite
• mood changes
• muscle pain or cramps

Some side effects of insulin aspart / insulin aspart protamine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back pain
• belching
• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• body aches or pain
• bone pain
• diarrhea
• difficulty in breathing
• dryness or soreness of throat
• ear congestion
• general feeling of discomfort or illness
• heartburn
• hoarseness
• indigestion
• joint pain
• loss of voice
• nasal congestion
• runny nose
• shivering
• sneezing
• stomach discomfort, upset, or pain
• stuffy nose
• tender, swollen glands in the neck
• trouble sleeping
• voice changes
• vomiting