Insulin aspart protamine and insulin aspart (subcutaneous route)

Brand Name

US Brand Name

NovoLOG Mix 70/30

NovoLOG Mix 70/30 FlexPen

Description

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.

This product is available in the following dosage forms:

Suspension

Before Using

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.

Breastfeeding

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.

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.

Abiraterone Acetate
Abiraterone Acetate, Micronized
Acarbose
Alogliptin
Bexagliflozin
Bromocriptine
Canagliflozin
Chloroquine
Chlorothiazide
Chlorpropamide
Chlorthalidone
Ciprofloxacin
Dapagliflozin
Delafloxacin
Empagliflozin
Enoxacin
Ertugliflozin
Furosemide
Gatifloxacin
Gemifloxacin
Glimepiride
Glipizide
Glyburide
Grepafloxacin
Hydrochlorothiazide
Hydroflumethiazide
Hydroxychloroquine
Indapamide
Lanreotide Acetate
Levofloxacin
Linagliptin
Liraglutide
Lomefloxacin
Macimorelin
Metformin
Metoclopramide
Metolazone
Metreleptin
Miglitol
Moxifloxacin

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
Glecaprevir
Glucomannan
Guar Gum
Isocarboxazid
Labetalol
Levobunolol
Linezolid
Lixisenatide
Methylene Blue
Metipranolol
Metoprolol
Nadolol
Nebivolol
Oxprenolol
Ozanimod
Penbutolol
Phenelzine
Pibrentasvir
Pindolol
Practolol
Procarbazine
Propranolol
Psyllium
Rasagiline
Safinamide
Saxagliptin
Selegiline

Other Interactions

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

Proper Use

A nurse or other trained health professional may give you this medicine. You may also be taught how to give your medicine at home. This medicine is given as a shot under your skin.

Always double-check both the concentration (strength) of your insulin and your dose. Concentration and dose are not the same. The dose is how many units of insulin you will use. The concentration tells how many units of insulin are in each milliliter (mL), such as 100 units/mL (U-100), but this does not mean you will use 100 units at a time.

Each package of insulin aspart protamine and insulin aspart combination contains a patient information sheet. Read this sheet carefully before beginning your treatment and each time you refill the medicine for any new information, and make sure you understand:

How to prepare the medicine.
How to inject the medicine.
How to use a disposable insulin delivery device.
How to dispose of syringes, needles, and injection devices.

It is best to use a different place on the body for each injection (eg, under the skin of your abdomen or stomach, thigh, buttocks, or upper arm). Do not use the exact same spot for each injection. If you have questions about this, contact a member of your health care team.

When used as a mealtime insulin, this insulin combination should be taken within 15 minutes before a meal. If you have type 2 diabetes, you can use this medicine after meals.

Use a new needle for the FlexPen® each time you give yourself an injection. Always remove and throw the needle after each injection from the pen. Store it without a needle attached.

Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your condition and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

You should never mix insulin aspart protamine and insulin aspart combination with other insulin injections without checking first with your doctor. These injections are usually done separately. Also, this medicine should not be used in an insulin infusion pump. If you have questions about this, ask your doctor or pharmacist.

Do not change the brand, type, or dose of your insulin unless your doctor tells you to. When you receive a new supply of insulin, check the label to be sure if it is the correct type of insulin.

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.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store insulin containers that have not been opened in the refrigerator in the original carton until the expiration date. Do not freeze. Do not use the insulin if it has been frozen. You may also store the unopened cartridge or FlexPen® at room temperature for up to 14 days, or the unopened vials at room temperature for up to 28 days.

Store the opened vial of insulin in the refrigerator. Do not freeze. If you cannot keep your vial of insulin in the refrigerator, you may store it at room temperature in a cool place, away from direct heat and light, for only 28 days.

The cartridge and pen you are currently using should not be refrigerated. You should store the cartridge or pen at room temperature in a cool place away from direct heat and light, for only 14 days.

Precautions

Never share insulin pens or cartridges with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of hepatitis viruses, HIV, or other bloodborne illnesses.

Your doctor will want to check your progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for unwanted effects.

It is very important to follow carefully any instructions from your health care team about:

Alcohol—Drinking alcohol (including beer and wine) may cause severe low blood sugar. Discuss this with your health care team.
Other medicines—Do not take other medicines during the time you are using this medicine unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency: There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:

Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.
Keep an extra supply of insulin and syringes with needles or injection devices on hand in case high blood sugar occurs.
Keep some kind of quick-acting sugar handy to treat low blood sugar.
Have a glucagon kit and a syringe and needle available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after you get the injection.

You may have some skin redness, rash, itching, or swelling at the injection site. If this irritation is severe or does not go away, call your doctor. Do not inject this medicine into a skin area that is red, swollen, or itchy.

Using this medicine together with other diabetes medicine (eg, pioglitazone, rosiglitazone, Actos®, Actoplus Met®, Avandia®) may cause serious heart problems or edema (fluid retention). Check with your doctor immediately if you are rapidly gaining weight, having shortness of breath, chest pain or discomfort, extreme tiredness or weakness, trouble breathing, uneven heartbeat, or excessive swelling of the hands, wrist, ankles, or feet.

Too much insulin aspart protamine and insulin aspart combination can cause hypoglycemia (low blood sugar). Low blood sugar also can occur if you use insulin aspart with another antidiabetic medicine, changes in insulin regimen (eg, insulin strength, type of insulin, injection site), delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting or have diarrhea. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Talk to your doctor about the best way to treat low blood sugar.

If symptoms of low blood sugar occur, eat glucose tablets or gel to relieve the symptoms. Also, check your blood for low blood sugar. Go to a doctor or a hospital right away if the symptoms do not improve. Someone should call for emergency help immediately if severe symptoms such as convulsions (seizures) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your household also should know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your medicine, changes in insulin regimen, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual. High blood sugar can be very serious and must be treated right away. It is important that you learn which symptoms you have in order to treat it quickly. Talk to your doctor about the best way to treat high blood sugar.

Symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed, dry skin, fruit-like breath odor, increased urination, ketones in the urine, loss of appetite, stomachache, nausea, or vomiting, tiredness, troubled breathing (rapid and deep), unconsciousness, or unusual thirst. If these symptoms occur, check your blood sugar level and call your doctor for instructions.

Side Effects

Along with its needed effects, a medicine 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:

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
difficulty with breathing
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 at the injection site
unusual weight gain or loss

Get emergency help immediately if any of the following symptoms of overdose occur:

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 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
dryness or soreness of the throat
ear congestion
general feeling of discomfort or illness
heartburn
hoarseness
indigestion
joint pain
loss of voice
runny or stuffy nose
shivering
sneezing
stomach discomfort, upset, or pain
stuffy nose
tender, swollen glands in the neck
trouble sleeping
voice changes
vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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