NovoLOG Mix 70/30

Name: NovoLOG Mix 70/30

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.

NovoLog Mix 70/30 (insulin aspart and insulin aspart protamine) side effects

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.

Uses For Novolog Mix 70/30

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.

Before Using Novolog Mix 70/30

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

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

Dosage Forms and Strengths

Novolog Mix 70/30 is 100 units per mL (U-100), 70% insulin aspart protamine and 30% insulin aspart, is available as a white and cloudy injectable suspension:

• 10 mL vials • 3 mL Novolog Mix 70/30 FlexPen

Use in specific populations

Pregnancy

Pregnancy Category B.

All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. This background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. It is essential for patients with diabetes or history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. Insulin requirements may decrease during the first trimester, generally increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring of glucose control is essential in such patients.

An open-label, randomized study compared the safety and efficacy of NOVOLOG (the rapid-acting component of Novolog Mix 70/30) versus human insulin in the treatment of pregnant women with type 1 diabetes (322 exposed pregnancies (NOVOLOG: 157, human insulin: 165)). Two-thirds of the enrolled patients were already pregnant when they entered the study. Since only one-third of the patients enrolled before conception, the study was not large enough to evaluate the risk of congenital malformations. Mean HbA1c of ~ 6% was observed in both groups during pregnancy, and there was no significant difference in the incidence of maternal hypoglycemia.

Animal reproduction studies have not been conducted with Novolog Mix 70/30. However, subcutaneous reproduction and teratology studies have been performed with NOVOLOG (the rapid-acting component of Novolog Mix 70/30) and regular human insulin in rats and rabbits. In these studies, NOVOLOG was given to female rats before mating, during mating, and throughout pregnancy, and to rabbits during organogenesis. The effects of NOVOLOG did not differ from those observed with subcutaneous regular human insulin. NOVOLOG caused pre- and post-implantation losses and visceral/skeletal abnormalities in rats at a dose of 200 units/kg/day (approximately 32-times the human subcutaneous dose of 1.0 units/kg/day, based on units/body surface area), and in rabbits at a dose of 10 units/kg/day (approximately three times the human subcutaneous dose of 1.0 units/kg/day, based on units/body surface area). No significant effects were observed in rats at a dose of 50 units/kg/day and rabbits at a dose of 3 units/kg/day. These doses are approximately 8 times the human subcutaneous dose of 1.0 units/kg/day for rats and equal to the human subcutaneous dose of 1.0 units/kg/day for rabbits based on units/body surface area.

Female patients should be advised to discuss with their physician if they intend to, or if they become pregnant. There are no adequate and well-controlled studies of the use of Novolog Mix 70/30 in pregnant women.

Nursing Mothers

It is unknown whether insulin aspart is excreted in human milk as occurs with human insulin. There are no adequate and well-controlled studies of the use of Novolog Mix 70/30 in lactating women. Women with diabetes who are lactating may require adjustments of their insulin doses. 

Pediatric Use

Safety and effectiveness of Novolog Mix 70/30 have not been established in pediatric patients.

Geriatric Use

Clinical studies of Novolog Mix 70/30 did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients. In elderly patients with diabetes, the initial dosing, dose increments should be conservative to avoid hypoglycemic reactions. Hypoglycemia may be difficult to recognize in the elderly.

Renal Impairment

The effect of renal impairment on the pharmacokinetics of Novolog Mix 70/30 has not been studied. Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure. Patients with renal impairment may be at increased risk of hypoglycemia and may require more frequent Novolog Mix 70/30 dose adjustment and more frequent blood glucose monitoring [see Warnings and Precautions (5.3)].

Hepatic Impairment

The effect of hepatic impairment on the pharmacokinetics of Novolog Mix 70/30 has not been studied. Patients with hepatic impairment may be at increased risk of hypoglycemia and may require more frequent Novolog Mix 70/30 dose adjustment and more frequent blood glucose monitoring [see Warnings and Precautions (5.3)].

How Supplied/Storage and Handling

How Supplied

Novolog Mix 70/30 100 units per mL (U-100), 70% insulin aspart protamine and 30% insulin aspart, is available as a white and cloudy injectable suspension:

10 mL vials

NDC 0169-3685-12

3 mL Novolog Mix 70/30 FlexPen 

NDC 0169-3696-19

  Novolog Mix 70/30 vials and Novolog Mix 70/30 FlexPen are latex free. Novolog Mix 70/30 FlexPens must never be shared between patients, even if the needle is changed.

Recommended Storage

Unused Novolog Mix 70/30 should be stored in a refrigerator between 2°C and 8°C (36°F to 46°F). Do not freeze Novolog Mix 70/30 or use Novolog Mix 70/30 if it has been frozen. Do not expose NOVOLOG to excessive heat or light.

Always remove the needle after each injection and store Novolog Mix 70/30 FlexPen without a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.

The storage conditions are summarized in the following table:

Table 7:Storage conditions for Novolog Mix 70/30 vial and FlexPen

Not in-use (unopened)

Room Temperature

(below 30°C [86°F])

Not in-use (unopened)

Refrigerated

(2°C - 8°C [36°F - 46°F])

In-use (opened)

Room Temperature

(below 30°C [86°F])

10 mL vial

28 days

Until expiration date

28 days (refrigerated/room temperature)

3 mL Novolog Mix 70/30 FlexPen

14 days

Until expiration date

14 days (Do not refrigerate)

Principal display panel - flexpen 3ml

NDC 0169-3696-19

List 369619

NovoLog® Mix 70/30

FlexPen® Prefilled Syringe

insulin aspart protamine and

insulin aspart injectable suspension

For Single Patient Use Only

100 units/mL (U-100)

5x3 mL Prefilled insulin Syringes

Shake carefully before using.

See enclosed insert for proper technique.

Rx only

For use with NovoFine®,
NovoFine® Plus or NovoTwist®
disposable needles.

Keep in a cold place.
Avoid freezing.
Protect from light.

novo nordisk®

Novolog Mix 70/30 
insulin aspart injection, suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0169-3685
Route of Administration SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN ASPART (insulin aspart) INSULIN ASPART 100 [iU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 1.25 mg  in 1 mL
HYDROCHLORIC ACID  
GLYCERIN 16.0 mg  in 1 mL
METACRESOL 1.72 mg  in 1 mL
PHENOL 1.5 mg  in 1 mL
PROTAMINE SULFATE 0.32 mg  in 1 mL
SODIUM CHLORIDE 0.877 mg  in 1 mL
SODIUM HYDROXIDE  
ZINC 19.6 ug  in 1 mL
Packaging
# Item Code Package Description
1 NDC:0169-3685-12 1 VIAL, GLASS in 1 CARTON
1 10 mL in 1 VIAL, GLASS
2 NDC:0169-3685-92 1 VIAL, GLASS in 1 CARTON
2 10 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021172 11/01/2001
Novolog Mix 70/30 
insulin aspart injection, suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0169-3696
Route of Administration SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN ASPART (insulin aspart) INSULIN ASPART 100 [iU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 1.25 mg  in 1 mL
GLYCERIN 16 mg  in 1 mL
HYDROCHLORIC ACID  
METACRESOL 1.72 mg  in 1 mL
PHENOL 1.5 mg  in 1 mL
PROTAMINE SULFATE 0.32 mg  in 1 mL
SODIUM CHLORIDE 0.877 mg  in 1 mL
SODIUM HYDROXIDE  
ZINC 19.6 ug  in 1 mL
Packaging
# Item Code Package Description
1 NDC:0169-3696-19 5 SYRINGE, PLASTIC in 1 CARTON
1 3 mL in 1 SYRINGE, PLASTIC
2 NDC:0169-3696-97 1 SYRINGE, PLASTIC in 1 CARTON
2 3 mL in 1 SYRINGE, PLASTIC
3 NDC:0169-3696-98 1 SYRINGE, PLASTIC in 1 CARTON
3 3 mL in 1 SYRINGE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021172 09/11/2002
Labeler - Novo Nordisk (622920320)
Establishment
Name Address ID/FEI Operations
Novo Nordisk Pharmaceuticals Industries, Inc. 622920320 MANUFACTURE(0169-3685, 0169-3696)
Establishment
Name Address ID/FEI Operations
Novo Nordisk A/S 305156788 API MANUFACTURE(0169-3685, 0169-3696)
Establishment
Name Address ID/FEI Operations
Novo Nordisk A/S 305914798 MANUFACTURE(0169-3696)
Revised: 05/2017   Novo Nordisk

For the Consumer

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:

More common
  • 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
Incidence not known
  • 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:

Symptoms of overdose
  • 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:

Most common
  • 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

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