NovoLOG FlexPen

Name: NovoLOG FlexPen

Commonly used brand name(s)

In the U.S.

  • NovoLOG
  • NovoLOG FlexPen
  • NovoLOG PenFill

Available Dosage Forms:

  • Solution

Therapeutic Class: Antidiabetic

Pharmacologic Class: Insulin, Ultra Rapid Acting

Before Using Novolog FlexPen

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of insulin aspart in children. However, safety and efficacy of insulin aspart mix 50/50 and 70/30 in the pediatric population have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of insulin aspart have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of insulin aspart in the elderly. However, elderly patients are more likely to have age-related heart, liver, or kidney problems which may require an adjustment in the dose for patients receiving insulin aspart.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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 you need.
  • Kidney disease or
  • Liver disease—Use with caution. The effects of insulin aspart may be increased because of slower removal of the medicine from the body.

Precautions While Using Novolog FlexPen

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 you take this medicine. Blood 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 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 taking insulin aspart 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 aspart 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.

Insulin aspart 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, swelling of the face, tongue, and throat, trouble breathing or swallowing, or chest pain 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 insulin aspart 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 problem 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 can cause hypoglycemia (low blood sugar). Low blood sugar also can occur if you use insulin aspart with another antidiabetic medicine, 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.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your medicine, 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.

Novolog FlexPen 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
  • Anxious feeling
  • behavior change similar to being drunk
  • blurred vision
  • cold sweats
  • confusion
  • convulsions (seizures)
  • depression
  • difficulty with thinking
  • dizziness or lightheadedness
  • drowsiness
  • excessive hunger
  • fast heartbeat
  • headache
  • irritability or abnormal behavior
  • nightmares
  • restless sleep
  • shakiness
  • slurred speech
  • tingling in the hands, feet, lips, or tongue
Less common or rare
  • Depression of the skin at the place of injection
  • dryness of the mouth
  • fast or weak pulse
  • feeling of pressure, itching, redness, soreness, stinging, swelling, or tingling at the place of injection
  • increased thirst
  • irregular heartbeat
  • loss of appetite
  • mood or mental changes
  • muscle cramps or pain
  • nausea or vomiting
  • skin rash or itching over the whole body
  • sweating
  • thickening of the skin at the place of injection
  • trouble breathing
  • unusual tiredness or weakness

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.

What is the most important information I should know about NovoLog FlexPen (insulin aspart)?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

What should I avoid while using NovoLog FlexPen (insulin aspart)?

Insulin can cause low blood sugar. 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.

What other drugs will affect NovoLog FlexPen (insulin aspart)?

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of insulin. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

For Healthcare Professionals

Applies to insulin aspart: subcutaneous solution

General

Adverse reactions observed have included hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus.[Ref]

Hypersensitivity

Hypersensitivity side effects have included both local and systemic reactions. Anaphylaxis has been reported. Local reactions have presented as erythema, local edema, and pruritus at the injection site. Most minor reactions to insulin at the injection site resolve in a few days to a few weeks.

Generalized allergy to insulin may present as a whole body rash, dyspnea, wheezing, hypotension, tachycardia, or diaphoresis. In clinical trials, allergic reactions were reported in 0.7% (10/1394) patients receiving insulin aspart (the active ingredient contained in NovoLog FlexPen) [Ref]

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

Metabolic

Weight gain has been reported with insulin therapy and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.[Ref]

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

Cardiovascular

Common (1% to 10%): Chest pain
Uncommon (0.1% to 1%): Peripheral edema[Ref]

Insulin may cause sodium retention and edema, especially as metabolic control is improving.[Ref]

Dermatologic

Long-term use of insulin may cause lipodystrophy at the site of repeated injection. Lipodystrophy includes lipohypertrophy, a thickening of adipose tissue, and lipoatrophy, thinning of adipose tissue.[Ref]

Common (1% to 10%): Skin disorder
Uncommon (0.1% to 1%): Urticaria, rash
Frequency not reported: Lipodystrophy including lipohypertrophy and lipoatrophy[Ref]

Immunologic

Common (1% to 10%): Onychomycosis
Frequency not reported: Anti-insulin antibody titers[Ref]

The clinical significance of the development of these antibody titers is unknown.[Ref]

Ocular

Rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder and worsening of diabetic retinopathy. However, long-term glycemic control decreases the risk of diabetic retinopathy.[Ref]

Uncommon (0.1% to 1%): Refraction disorder, worsening of diabetic retinopathy[Ref]

Nervous system

Rapid improvement in glucose control has been associated with a transitory, reversible acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk.[Ref]

Very common (10% or more): Headache (up to 12%)
Common (1% to 10%): Hyporeflexia, sensory disturbance
Rare (less than 0.1%): Painful peripheral neuropathy[Ref]

Gastrointestinal

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

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Some side effects of NovoLog 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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