Insulin

Yes; No (regular and NPH insulin)

Insulin is prescribed for the treatment of type 1 and type 2 diabetes mellitus.

• Insulin is the drug of choice for controlling diabetes during pregnancy, that is, it is preferred over oral drugs to reduce blood sugar. NPH, insulin aspart, insulin detemir, and insulin lispro also are used during pregnancy.
• Insulins are considered safe to use by nursing mothers.

Mechanism Of Action

HUMULIN 70/30 lowers blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis, and enhance protein synthesis.

Pharmacodynamics

HUMULIN 70/30 combines an intermediate-acting insulin with the more rapid onset of action of regular human insulin. In healthy males (n=18) given HUMULIN 70/30 (0.3 unit/kg) subcutaneously, the pharmacologic effect began at approximately 50 minutes (range: 30 to 90 minutes) (see Figure 1). The effect was maximal at approximately 3.5 hours (range: 1.5 to 6.5 hours) and the mean duration of action was relatively long (approximately 23 hours; range: 18-24 hours).

Figure 1 should be considered only as a representative example since the time course of action of insulin may vary in different individuals or within the same individual. The rate of insulin absorption and consequently the onset of activity is known to be affected by the site of injection, physical activity level, and other variables [see WARNINGS AND PRECAUTIONS].

Figure 1: Mean Insulin Activity Versus Time Profiles After Subcutaneous Injection of HUMULIN 70/30 or HUMULIN® R U-100 (0.3 unit/kg) in Healthy Subjects.

Pharmacokinetics

In healthy male subjects given HUMULIN 70/30 (0.3 unit/kg) subcutaneously, the mean peak serum concentration occurred at 2.2 hours (range: 1 to 5 hours) after dosing.

The uptake and degradation of insulin occurs predominantly in liver, kidney, muscle, and adipocytes, with the liver being the major organ involved in the clearance of insulin.

Because of the absorption-rate limited kinetics of insulin mixtures, a true half-life cannot be accurately estimated from the terminal slope of the concentration versus time curve.

The effects of age, gender, race, obesity, pregnancy, or smoking on the pharmacokinetics of HUMULIN 70/30 have not been studied. Careful glucose monitoring and dose adjustments of insulin, including HUMULIN 70/30, may be necessary in patients with renal or hepatic dysfunction [see Use In Specific Populations].

HUMULIN®
(HU-mu-lin) 70/30
(70% human insulin isophane) Suspension and (30% human insulin) Injection [rDNA origin]

What is HUMULIN 70/30?

• HUMULIN 70/30 is a man-made insulin that is used to control high blood sugar in adults with diabetes mellitus.

Who should not use HUMULIN 70/30?

Do not use HUMULIN 70/30 if you:

• are having an episode of low blood sugar (hypoglycemia).
• have an allergy to HUMULIN 70/30 or any of the ingredients in HUMULIN 70/30.

Before using HUMULIN 70/30, tell your healthcare provider about all your medical conditions including, if you:

• have liver or kidney problems.
• take any other medicines, especially ones commonly called TZDs (thiazolidinediones).
• have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with HUMULIN 70/30.
• are pregnant, planning to become pregnant, or are breastfeeding.
• are taking new prescription or over-the-counter medicines, vitamins, or herbal supplements.

Before you start using HUMULIN 70/30, talk to your healthcare provider about low blood sugar and how to manage it.

How should I use HUMULIN 70/30?

• Read the Instructions for Use that come with your HUMULIN 70/30.
• Use HUMULIN 70/30 exactly as your healthcare provider tells you to.
• Know the type and strength of insulin you use. Do not change the type of insulin you use unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you use different types of insulin.
• Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.

Your HUMULIN 70/30 dose may need to change because of:

• change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet.

What should I avoid while using HUMULIN 70/30?

While using HUMULIN 70/30 do not:

• Drive or operate heavy machinery, until you know how HUMULIN 70/30 affects you.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

What are the possible side effects of HUMULIN 70/30?

HUMULIN 70/30 may cause serious side effects that can lead to death, including:

• low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:
  • dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger.
• serious allergic reaction (whole body reaction). Get medical help right away, if you have any of these symptoms of an allergic reaction:
  • a rash over your whole body, trouble breathing, a fast heartbeat, or sweating.
• low potassium in your blood (hypokalemia).
• heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with HUMULIN 70/30 may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you use TZDs with HUMULIN 70/30. Your healthcare provider should monitor you closely while you are taking TZDs with HUMULIN 70/30. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:
  • shortness of breath, swelling of your ankles or feet, sudden weight gain Treatment with TZDs and HUMULIN 70/30 may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.

Get emergency medical help if you have:

• trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.

The most common side effects of HUMULIN 70/30 include:

• low blood sugar (hypoglycemia), allergic reactions including reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, weight gain, and swelling of your hands and feet. These are not all the possible side effects of HUMULIN 70/30. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of HUMULIN 70/30:

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about HUMULIN 70/30 that is written for health professionals. Do not use HUMULIN 70/30 for a condition for which it was not prescribed. Do not give HUMULIN 70/30 to other people, even if they have the same symptoms that you have. It may harm them.

What are the ingredients in HUMULIN 70/30?

Active Ingredient: insulin human (rDNA origin)

Inactive Ingredients: protamine sulfate, glycerin, dibasic sodium phosphate, metacresol, phenol, zinc oxide, water for injection, hydrochloric acid or sodium hydroxide For more information, call 1-800-545-5979 or go to www.humulin.com.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Instructions for Use

HUMULIN®
(HU-mu-lin) 70/30 (70% human insulin isophane suspension and 30% human insulin injection [rDNA origin]) vial (100 Units/mL, U-100)

Read the Instructions for Use before you start taking HUMULIN 70/30 and each time you get a new HUMULIN 70/30 vial. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Do not share your syringes or needles with anyone else. You may give an infection to them or get an infection from them.

Supplies needed to give your injection:

• a HUMULIN 70/30 vial
• a U-100 insulin syringe and needle
• 2 alcohol swabs
• 1 sharps container for throwing away used needles and syringes. See “Disposing of used needles and syringes” at the end of these instructions.

Preparing your HUMULIN 70/30 dose:

• Wash your hands with soap and water.
• Check the HUMULIN 70/30 label to make sure you are taking the right type of insulin. This is especially important if you use more than 1 type of insulin.
• Do not use HUMULIN 70/30 past the expiration date printed on the label or 31 days after you first use it.
• Always use a new needle for each injection to help ensure sterility and prevent blocked needles.

Step 1: Gently roll the vial between the palms of your hands at least 10 times.

Step 2: Invert the vial at least 10 times.

Do not shake.

Mixing is important to make sure you get the right dose. Humulin 70/30 should look white and cloudy after mixing. Do not use it if it looks clear or contains any lumps or particles.

Step 3: If you are using a new vial, pull off the plastic Protective Cap, but do not remove the Rubber Stopper.

Step 4: Wipe the Rubber Stopper with an alcohol swab.

Step 5: Hold the syringe with the needle pointing up. Pull down on the Plunger until the tip of the Plunger reaches the line for the number of units for your prescribed dose. (Example Dose: 20 units shown)

Step 6: Push the needle through the Rubber Stopper of the vial.

Step 7: Push the plunger all the way in. This puts air into the vial.

Step 8: Turn the vial and syringe upside down and slowly pull the Plunger down until the tip is a few units past the line for your prescribed dose. (Example Dose: 20 units Plunger is shown at 24 units)

 If there are air bubbles, tap the syringe gently a few times to let any air bubbles rise to the top.

 Step 9: Slowly push the Plunger up until the tip reaches the line for your prescribed dose.

Check the syringe to make sure that you have the right dose. (Example Dose: 20 units shown)

Step 10: Pull the syringe out of the vial's Rubber Stopper.

Giving your HUMULIN 70/30 injection:

• Inject your insulin exactly as your healthcare provider has shown you.
• Change (rotate) your injection site for each injection.

Step 11: Choose your injection site.

HUMULIN 70/30 is injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs or upper arms.

Wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose.

 Step 12: Insert the needle into your skin.

Step 13: Push down on the Plunger to inject your dose.

The needle should stay in your skin for at least 5 seconds to make sure you have injected all of your insulin dose.

Step 14: Pull the needle out of your skin.

• If you see blood after you take the needle out of your skin, press the injection site with a piece of gauze or an alcohol swab. Do not rub the area.
• Do not recap the needle. Recapping the needle can lead to a needle stick injury.

Disposing of used needles and syringes:

• Put your used needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.
• If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant, and
  • properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal
• Do not recycle the container.

How should I store HUMULIN 70/30?

All unopened HUMULIN 70/30 vials:

• Store all unopened vials in the refrigerator.
• Do not freeze. Do not use if it has been frozen.
• Keep away from heat and out of direct light.
• Unopened vials can be used until the expiration date on the carton and label, if they have been stored in the refrigerator.
• Unopened vials should be thrown away after 31 days, if they are stored at room temperature.

After HUMULIN 70/30 vials have been opened:

• Store opened vials in the refrigerator or at room temperature below 86°F (30°C) for up to 31 days.
• Keep away from heat and out of direct light.
• Throw away all opened vials after 31 days of use, even if there is still insulin left in the vial.

General information about the safe and effective use of HUMULIN 70/30.

Keep HUMULIN 70/30 vials, syringes, needles, and all medicines out of the reach of children.

If you have any questions or problems with your HUMULIN, contact Lilly at 1-800Lilly-Rx (1-800-545-5979) or call your healthcare provider for help. For moreinformation on HUMULIN and insulin, go to www.humulin.com.

Scan this code to launch the humulin.com website

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Instructions for Use

HUMULIN® 70/30 KwikPen™
(70% human insulin isophane suspension 30% human insulin injection [rDNA origin])

Read the Instructions for Use before you start taking HUMULIN 70/30 and each time you get another HUMULIN® 70/30 KwikPen™. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

HUMULIN 70/30 KwikPen (“Pen”) is a disposable pen containing 3 mL (300 units) of U-100 HUMULIN® 70/30 (70% human insulin isophane suspension and 30% human insulin injection [rDNA origin]) insulin. You can inject from 1 to 60 units in a single injection.

HUMULIN 70/30 KwikPen has a blue and brown Label with a matching brown Dose Knob (See the KwikPen Parts diagram below).

Do not share your HUMULIN 70/30 KwikPen or needles with another person. You may give an infection to them or get an infection from them.

This Pen is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of the product.

KwikPen Parts

Supplies you will need to give your HUMULIN 70/30 injection:

• HUMULIN 70/30 KwikPen
• KwikPen compatible Needle (Becton, Dickinson and Company Pen Needles recommended)
• alcohol swab

Preparing HUMULIN 70/30 KwikPen:

• Wash your hands with soap and water.
• Check the HUMULIN 70/30 KwikPen Label to make sure you are taking the right type of insulin. This is especially important if you use more than 1 type of insulin.
• Do not use HUMULIN 70/30 past the expiration date printed on the Label or 10 days after you start using the Pen.
• Always use a new needle for each injection to help ensure sterility and prevent blocked needles.

Step 1:

• Pull the Pen Cap straight off.
• Wipe the Rubber Seal with an alcohol swab.
  • Do not twist the cap.
  • Do not remove the HUMULIN 70/30 KwikPen Label.
  • Do not attach the Needle before mixing.

Step 2:

• Gently roll the Pen between your hands 10 times.

Step 3:

• Move the Pen up and down (invert) the Pen 10 times.

Mixing by rolling and inverting the Pen is important to make sure you get the right dose.

Step 4:

• Check the liquid in the Pen. HUMULIN 70/30 should look white and cloudy after mixing. Do not use if it looks clear or has any lumps or particles in it.

Step 5:

• Select a new Needle.
• Pull off the Paper Tab from the Outer Needle Shield.

Step 6:

• Push the capped Needle straight onto the Pen and twist the Needle on until it is tight.

Step 7:

• Pull off the Outer Needle Shield. Do not throw it away.
• Pull off the Inner Needle Shield and throw it away.

Priming the HUMULIN 70/30 KwikPen:

Prime the HUMULIN 70/30 KwikPen before each injection. Priming ensures the Pen is ready to dose and removes air that may collect in the cartridge during normal use. If you do not prime before each injection, you may get too much or too little insulin.

Step 8:

• Turn the Dose Knob to select 2 units.

Step 9:

• Hold the Pen with the Needle pointing up. Tap the Cartridge Holder gently to collect air bubbles at the top.

Step 10:

• Hold the Pen with Needle pointing up. Push the Dose Knob in until it stops, and “0” is seen in the Dose Window.
• Hold the Dose Knob in and count to 5 slowly.
  A stream of insulin should be seen from the needle.
  • If you do not see a stream of insulin, repeat steps 8 to 10, no more than 4 times.
  • If you still do not see a stream of insulin, change the needle and repeat steps 8 to 10.

Selecting your dose:

Step 11:

• Turn the Dose Knob to select the number of units you need to inject. The Dose Indicator should line up with your dose.
  The dose can be corrected by turning the Dose Knob in either direction until the correct dose lines up with the Dose Indicator.
  • The even numbers are printed on the dial. (Example: 10 units shown)

• The odd numbers, after the number 1, are shown as full lines (Example: 15 units shown)

• The HUMULIN 70/30 KwikPen will not let you dial more than the number of units left in the Pen.
• If your dose is more than the number of units left in the Pen, you may either:
  • inject the amount left in your Pen and then use a new Pen to give the rest of your dose, or
  • get a new Pen and inject the full dose.
• The Pen is designed to deliver a total of 300 units of insulin. The cartridge contains an additional small amount of insulin that cannot be delivered.

Giving your HUMULIN 70/30 injection:

• Inject your HUMULIN 70/30 exactly as your healthcare provider has shown you.
• Change (rotate) your injection site for each injection.
• Do not try to change your dose while injecting HUMULIN 70/30.

Step 12:

• Choose your injection site.
  HUMULIN 70/30 is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms.
• Wipe the skin with an alcohol swab, and let the injection site dry before you inject your dose.

Step 13:

• Insert the Needle into your skin.

Step 14:

• Put your thumb on the Dose Knob and push the Dose Knob in until it stops.

• Hold the Dose Knob in and slowly count to 5.

Step 15:

• Pull the Needle out of your skin.
  You should see “0” in the Dose Window. If you do not see “0” in the Dose Window, you did not receive your full dose.
  • If you see blood after you take the Needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab. Do not rub the area.
  • A drop of insulin at the needle tip is normal. It will not affect your dose.
  • If you do not think you received your full dose, do not take another dose. Call Lilly at 1-800-LillyRx (1-800-545-5979) or your healthcare provider for help.

Step 16:

• Carefully replace the Outer Needle Shield.

Step 17:

• Unscrew the capped Needle and throw it away.
• Do not store the Pen with the Needle attached to prevent leaking, blocking of the Needle, and air from entering the Pen.

Step 18:

• Replace the Pen Cap by lining up the Cap Clip with the Dose Indicator and pushing straight on.

After your injection:

• Put your used needles and pens in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and pens in your household trash.
• If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant, and
  • properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal

How should I store my HUMULIN 70/30 KwikPen?

• Store unused HUMULIN 70/30 KwikPens in the refrigerator at 36°F to 46°F (2°C to 8°C). The Pen you are currently using should be stored at room temperature, below 86°F (30°C).
• Do not freeze HUMULIN 70/30. Do not use HUMULIN 70/30 if it has been frozen.
• Unused Pens may be used until the expiration date printed on the Label, if kept in the refrigerator.
• The HUMULIN 70/30 Pen you are using should be thrown away after 10 days, even if it still has insulin left in it.
• Keep HUMULIN 70/30 away from heat and out of the light.

General information about the safe and effective use of HUMULIN 70/30 KwikPen.

• Keep HUMULIN 70/30 KwikPen and needles out of the reach of children.
• Do not use the Pen if any part looks broken or damaged.
• Always carry an extra Pen in case yours is lost or damaged.
• If you cannot remove the Pen Cap, gently twist the Pen Cap back and forth, and then pull the Pen Cap straight off.
• If it is hard to push the Dose Knob or the Pen is not working the right way:
  • Your Needle may be blocked. Put on a new Needle and prime the Pen.
  • You may have dust, food, or liquid inside the Pen. Throw the Pen away and get a new one.
  • It may help to push the Dose Knob more slowly during your injection.
• Use the space below to keep track of how long you should use each HUMULIN 70/30 KwikPen.
  • Write down the date you start using your HUMULIN 70/30 KwikPen. Count forward 10 days.
  • Write down the date you should throw it away.

Example:

First used on _______ + 10 days = Throw out on ______

Pen 1 -First used on _______ Throw out on _______

_________________Date_______________Date

Pen 2 -First used on _______ Throw out on _______

_________________Date_______________Date

Pen 3 -First used on _______ Throw out on _______

_________________Date_______________Date

Pen 4 -First used on _______ Throw out on _______

_________________Date_______________Date

Pen 5 -First used on _______ Throw out on _______

_________________Date_______________Date

If you have any questions or problems with your HUMULIN 70/30 KwikPen, contact Lilly at 1-800-LillyRx (1-800-545-5979) or call your healthcare provider for help. For more information on HUMULIN 70/30 KwikPen and insulin, go to www.lilly.com.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Excess insulin administration may cause hypoglycemia and hypokalemia [see WARNINGS AND PRECAUTIONS]. Mild episodes of hypoglycemia can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or physical activity level may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.

Humulin R (insulin (human recombinant)) U-100 is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 1 and type 2 diabetes mellitus.

Humulin R (insulin (human recombinant)) U-100 may be administered intravenously under proper medical supervision in a clinical setting for glycemic control (see DOSAGE AND ADMINISTRATION and Storage).

The following adverse reactions are discussed elsewhere in the labeling:

• Hypoglycemia [see WARNINGS AND PRECAUTIONS].
• Hypokalemia [see WARNINGS AND PRECAUTIONS].

The following additional adverse reactions have been identified during post-approval use of HUMULIN 70/30. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure.

Allergic Reactions

Some patients taking HUMULIN 70/30 have experienced erythema, local edema, and pruritus at the site of injection. These conditions were usually self-limiting. Severe cases of generalized allergy (anaphylaxis) have been reported [see WARNINGS AND PRECAUTIONS].

Peripheral Edema

Some patients taking HUMULIN 70/30 have experienced sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.

Lipodystrophy

Administration of insulin subcutaneously, including HUMULIN 70/30, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) [see DOSAGE AND ADMINISTRATION] in some patients.

Weight gain

Weight gain has occurred with some insulin therapies including HUMULIN 70/30 and has been attributed to the anabolic effects of insulin and the decrease in glycosuria.

Immunogenicity

Development of antibodies that react with human insulin have been observed with all insulin, including HUMULIN 70/30.

Read the entire FDA prescribing information for Humulin 70-30 (Insulin (Human Recombinant))

Since insulin isophane is used before meals or snacks, you may not be on a timed dosing schedule. Whenever you use insulin isophane, be sure to eat a meal or snack within 30 to 60 minutes. Do not use extra insulin isophane to make up a missed dose.

It is important to keep insulin isophane on hand at all times. Get your prescription refilled before you run out of medicine completely.

• Diabetes (Type 1 and Type 2)
• Diabetes and Eye Problems
• Diabetes and Kidney Disease
• Diabetes Insipidus
• Diabetes Prescription Insulin Medications
• Diabetes Prevention (Type 2)
• Diabetes Treatment (Type 1 and Type 2 Medications and Diet)
• Diabetes: Caring for Your Diabetes at Special Times
• Diabetic Neuropathy
• Tips for Managing Type 1 and 2 Diabetes at Home