Humulin 70 / 30

Included as part of the PRECAUTIONS section.

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.

• Eli Lilly and Company

If you take too much insulin (human), call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• It is used to lower blood sugar in patients with high blood sugar (diabetes).

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
• Very bad irritation where the shot was given.
• Change in eyesight.
• Chills.
• Very bad dizziness or passing out.
• Mood changes.
• Seizures.
• Slurred speech.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Change in skin to thick or thin where the shot was given.
• Low blood sugar may occur. Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call the doctor right away if any of these signs occur. Follow what you have been told to do if low blood sugar occurs. This may include taking glucose tablets, liquid glucose, or some fruit juices.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

HUMULIN 70/30 is contraindicated:

• During episodes of hypoglycemia [see Warnings and Precautions (5.3)], and
• In patients who have had hypersensitivity reactions to HUMULIN 70/30 or any of its excipients [see Warnings and Precautions (5.4)].

How Supplied

HUMULIN 70/30 100 units per mL (U-100) is available as:

Each prefilled Humulin 70/30 pen and Humulin 70/30 KwikPen is for use by a single patient. Humulin 70/30 pens and Humulin 70/30 KwikPens must never be shared between patients, even if the needle is changed. Patients using Humulin 70/30 vials must never share needles or syringes with another person.

Storage and Handling

Protect from heat and light. Do not freeze. Do not use after the expiration date.

Not In-Use (Unopened) HUMULIN 70/30 Vials

Refrigerated

Store in a refrigerator (36° to 46°F [2° to 8°C]), but not in the freezer. Do not use if it has been frozen.

Room Temperature

If stored at room temperature, below 86°F (30°C) the vial must be discarded after 31days.

In-Use (Opened) HUMULIN 70/30 Vials

Refrigerated

Store in a refrigerator (36° to 46°F [2° to 8°C]), but not in the freezer. Do not use if it has been frozen. Vials must be used within 31 days or be discarded, even if they still contain HUMULIN 70/30.

Room Temperature

If stored at room temperature, below 86°F (30°C) the vial must be discarded after 31 days, even if the vial still contains HUMULIN 70/30.

Not In-Use (Unopened) HUMULIN 70/30 Pen and KwikPen

Refrigerated

Store in a refrigerator (36° to 46°F [2° to 8°C]), but not in the freezer. Do not use if it has been frozen.

Room Temperature

If stored at room temperature, below 86°F (30°C) the pen must be discarded after 10 days.

In-Use (Opened) HUMULIN 70/30 Pen and KwikPen

Refrigerated

Do NOT store in a refrigerator.

Room Temperature

Store at room temperature, below 86°F (30°C) and the pen must be discarded after 10 days, even if the pen still contains HUMULIN 70/30. See storage table below:

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Never Share a Humulin 70/30 Pen, Humulin 70/30 KwikPen, or Syringe Between Patients

Advise patients that they must never share a Humulin 70/30 pen or Humulin 70/30 KwikPen with another person, even if the needle is changed. Advise patients using Humulin 70/30 vials not to share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.

Hypoglycemia

Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia especially at initiation of HUMULIN 70/30 therapy. Instruct patients on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals. Instruct patients on the management of hypoglycemia.

Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery [see Warnings and Precautions (5.3)].

Inform patients that accidental mix-ups between HUMULIN 70/30 and other insulins have been reported. Instruct patients to always carefully check that they are administering the correct insulin (e.g., by checking the insulin label before each injection) to avoid medication errors between HUMULIN 70/30 and other insulins.

Hypersensitivity Reactions

Advise patients that hypersensitivity reactions have occurred with HUMULIN 70/30. Inform patients on the symptoms of hypersensitivity reactions [see Warnings and Precautions (5.4)].

Females with Reproductive Potential

Advise females of reproductive potential with diabetes to inform their doctor if they are pregnant or are contemplating pregnancy [see Use in Specific Populations (8.1)].

Visual Inspection Prior to Use

Instruct patients to visually inspect HUMULIN 70/30 before use and to use HUMULIN 70/30 only if it contains no particulate matter and appears uniformly cloudy after mixing [see Dosage and Administration (2.1)].

Expiration Date

Instruct patients not to use HUMULIN 70/30 after the printed expiration date.

____________

HUMULIN® and HUMULIN® 70/30 KwikPen® are trademarks of Eli Lilly and Company.

Literature revised February 25, 2015

Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA
Copyright © 1992, 2015, Eli Lilly and Company. All rights reserved.

LIN7030-0001-USPI-20150225

PATIENT INFORMATION
HUMULIN® (HU-mu-lin) 70/30
(70% human insulin isophane suspension and
30% human insulin injection [rDNA origin])

Do not share your Humulin 70/30 Pen, Humulin 70/30 KwikPen, or syringes with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

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.
• Do not share your Humulin 70/30 Pen, Humulin 70/30 KwikPen, or syringes with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

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 take 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.

Patient Information revised February 25, 2015

Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA
Copyright © 1992, 2015, Eli Lilly and Company. All rights reserved.

LIN7030-0001-PPI-20150225

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.

Do not share your Humulin 70/30 KwikPen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

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).

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.

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. Do not reuse or share needles with other people. You may give other people a serious infection or get a serious infection from them.

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.

Selecting your dose:

• 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.

After your injection:

• Put your used needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles 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 dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
• The used Pen may be discarded in your household trash after you have removed the needle.

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.
• Always use a new needle for each injection.
• Do not share your Pen or needles with other people. You may give other people a serious infection or get a serious infection from them.
• 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 ______

                          Date                                                Date

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.

HUMULIN® and HUMULIN® KwikPen® are trademarks of Eli Lilly and Company.

Revised: March 12, 2015

Marketed by: Lilly USA, LLC
Indianapolis, IN 46285, USA

Copyright © 2013, 2015, Eli Lilly and Company. All rights reserved.

LIN7030KP-0002-IFU-20150312

Since Humulin 70/30 is used with a meal, you may not be on a timed dosing schedule. Whenever you use this insulin, be sure to eat a meal within 45 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.

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.