"Nov. 21, 2012 -- The number of children and teens with type 1 and type 2 diabetes is expected to spike dramatically in the next 40 years, creating what one expert calls a potential catastrophe for the nation's health care system.
HUMALOG® insulin lispro injection, USP
Read the “Patient Information” that comes with HUMALOG (HU-ma-log) before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your diabetes or treatment. If you have questions about HUMALOG or diabetes, talk with your healthcare provider.
What is the most important information I should know about HUMALOG?
- Do not change the insulin you use without talking to your healthcare provider. Anychange in insulin strength, manufacturer, type (regular, NPH, analog) may need a change in the dose you are using. This dose change may be needed right away or later on. Sometimes this dose change may happen during the first several weeks or months on the new insulin. Doses of oral anti-diabetic medicines may also need to change if your insulin is changed.
- You must test your blood sugar levels while using an insulin such as HUMALOG. Your healthcare provider will tell you how often you should test your blood sugar level, and what to do if it is high or low.
- When used in a pump do not mix HUMALOG with any other insulin or liquid.
What is HUMALOG?
HUMALOG (insulin lispro injection, USP [rDNA origin]) is an injectable rapid-acting man-made insulin. HUMALOG is used to treat people with diabetes for the control of high blood sugar.
- HUMALOG is a clear, colorless, sterile solution for injection under the skin (subcutaneously).
- You need a prescription to get HUMALOG. Always be sure you receive the right insulin from the pharmacy.
HUMALOG comes in:
- 10 mL vials (bottles) for use with a syringe or external insulin pump
- 3 mL prefilled pens
- 3 mL Humalog® KwikPen™
- 3 mL cartridges for use with a reusable pen or external insulin pump
Who should not take HUMALOG?
Do not take HUMALOG if:
- your blood sugar is too low (hypoglycemia). After treating your low blood sugar, follow your healthcare provider's instructions on the use of HUMALOG.
- you are allergic to insulin lispro or any of the ingredients in HUMALOG. See the end of this leaflet for a complete list of ingredients in HUMALOG. Check with your healthcare provider if you are not sure.
What should I tell my healthcare provider before taking HUMALOG?
Before you use HUMALOG, tell your healthcare provider if you:
- have liver or kidney problems or any other medical conditions. Your dose may need to be adjusted.
- 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 HUMALOG.
- are pregnant or breastfeeding. You and your healthcare provider should talk about the best way to manage your diabetes while you are pregnant or breastfeeding. HUMALOG has not been studied in pregnant or nursing women.
- take other medicines, including prescription and non-prescription medicines, vitamins and herbal supplements. Your HUMALOG dose may need to change if you take other medicines.
Know the medicines you take. Keep a list of your medicines with you to show your healthcare providers when you get a new medicine.
How should I use HUMALOG?
HUMALOG can be used with a syringe, prefilled pen, reusable pen or external insulin pump. Talk to your healthcare provider if you have any questions.
- Read the instructions for use that comes with your HUMALOG product. Talk to your healthcare provider if you have any questions. Your healthcare provider should show you how to inject HUMALOG before you start taking it.
- HUMALOG is a rapid-acting insulin. You should take HUMALOG within fifteen minutes before eating or right after eating a meal.
- Only use HUMALOG that is clear and colorless. If your HUMALOG is cloudy, colored, or has solid particles or clumps in it, return it to your pharmacy for a replacement.
- Do not mix HUMALOG:
- with any type of insulin other than NPH when used with injections by syringe.
- with any other insulin or liquid when used in a pump.
- If your doctor recommends diluting HUMALOG, follow your
doctor's instructions exactly so that you know:
- How to make HUMALOG more dilute (that is, a smaller number of units of HUMALOG for a given amount of liquid) and
- How to use this more dilute form of HUMALOG. Do not use dilute insulin in a pump.
- Inject HUMALOG under your skin (subcutaneously) in your upper arm, abdomen (stomach area), thigh (upper leg), or buttocks. Never inject it into a vein or muscle.
- Change (rotate) your injection site with each dose.
- If you have type 1 diabetes, you need to take a longer-acting insulin in addition to HUMALOG (except when using an external insulin pump).
- If you have type 2 diabetes, you may be taking oral anti-diabetic medicines and/or a longer-acting insulin in addition to HUMALOG.
- Follow the instructions given by your healthcare provider about the type or types of insulin you are using. Do not make any changes with your insulin unless you have talked to your healthcare provider. Always make sure that you received the correct type of HUMALOG from the pharmacy. Check to make sure you are injecting the correct insulin and dose, especially if you use other insulin with HUMALOG.
- If you take too much HUMALOG, your blood sugar may fall low (hypoglycemia).You can treat mild low blood sugar by drinking or eating something sugary right away (fruit juice, sugar candies, or glucose tablets). It is important to treat low blood sugar right away because it could get worse and you could pass out (become unconscious). If you pass out, you will need help from another person or emergency medical services right away, and will need treatment with glucagon injection or treatment at a hospital. See “What are the possible side effects of HUMALOG?” for more information on low blood sugar.
- If you forget to take your dose of HUMALOG, your blood
sugar may go too high (hyperglycemia). If high blood sugar is not treated
it can lead to serious problems like loss of consciousness (passing out), coma
or even death. Follow your healthcare provider's instructions for treating high
blood sugar. Know your symptoms of high blood sugar which may include:
- increased thirst
- frequent urination
- loss of appetite
- a hard time breathing
- fruity smell on the breath
- high amounts of sugar and ketones in your urine
- nausea, vomiting (throwing up) or stomach pain
- Your insulin dosage may need to change because of:
- other medicines you take
- change in diet
- change in physical activity or exercise
What are the possible side effects of HUMALOG?
- low blood sugar (hypoglycemia). Symptoms of low
blood sugar may include:
- dizziness or lightheadedness
- fast heart beat
- tingling of lips and tongue
- trouble concentrating or confusion
- blurred vision
- slurred speech
- anxiety, irritability or mood changes
- Severe low blood sugar can cause unconsciousness (passing out), seizures, and death. Low blood sugar may affect your ability to drive a car or use mechanical equipment, risking injury to yourself or others. Know your symptoms of low blood sugar. Follow your healthcare provider's instructions for treating low blood sugar. Talk to your healthcare provider if low blood sugar is a problem for you.
- Serious allergic reaction (whole body reaction). Get medical help right away, if you develop a rash over your whole body, have trouble breathing, a fast heartbeat, or sweating.
- Reactions at the injection site (local allergic reaction). You may get redness, swelling, and itching at the injection site. If you keep having skin reactions or they are serious, talk to your healthcare provider. You may need to stop using HUMALOG and use a different insulin. Do not inject insulin to skin that is red, swollen or itchy.
- Skin thickens or pits at the injection site (lipodystrophy). Change (rotate) when youinject your insulin to help to prevent these skin changes from happening. Do not inject insulin into this type of skin.
- Low potassium in your blood (hypokalemia)
- Weight gain
HUMALOG may cause serious side effects, including:
- swelling of your hands and feet
- heart failure. Taking certain diabetes pills
called thiazolidinediones or “TZDs” with HUMALOG 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 HUMALOG. Your healthcare provider should monitor you closely
while you are taking TZDs with HUMALOG. 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 HUMALOG may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.
These are not all of the possible side effects from HUMALOG. Ask your healthcare provider or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.
How should I store HUMALOG?
- Store all unopened (unused) HUMALOG in the original carton in a refrigerator at 36°F to 46°F (2°C to 8°C).
- Do not freeze. Do not use HUMALOG if it has been frozen.
- Keep unopened HUMALOG in the carton to protect from light.
After starting use (open)
- Keep in the refrigerator or at room temperature below 86°F (30°C) for up to 28 days.
- Keep vials away from direct heat or light.
- Throw away an opened vial after 28 days of use, even if there is insulin left in the vial.
- Unopened vials can be used until the expiration date on the HUMALOG carton and label, if the medicine has been stored in a refrigerator.
Cartridge and Prefilled Pens:
- Keep at room temperature below 86°F (30°C) for up to 28 days.
- Do not store a cartridge or prefilled pen that you are using in the refrigerator.
- Keep cartridges and prefilled pens away from direct heat or light.
- A cartridge used in the D-Tron1 or D-Tronplus1 pump may be used for up to 7 days.
- Throw away a used cartridge or prefilled pen after 28 days, even if there is insulin left in the cartridge or the pen.
General Information about HUMALOG
- HUMALOG in the pump reservoir and the complete
external pump infusion set:
- When HUMALOG is used in pumps, use only pumps that are recommended byyour healthcare provider.
- The infusion set and infusion site should be changed at least every 3 days.
- The insulin in the reservoir should be changed at least every 7 days even if you havenot used all of the insulin.
- Change the infusion set and infusion site more often than every 3 days if you have high blood sugar (hyperglycemia), the pump alarms sounds, or the insulin flow is blocked (occlusion).
- Do not use HUMALOG for a condition for which it was not prescribed. Do not give orshare HUMALOG with another person, even if they also have diabetes. It may harmthem.
- This leaflet summarizes the most important information about HUMALOG. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider for information about HUMALOG that is written for healthcare providers. For more information about HUMALOG, call 1-800-LillyRx (1-800-545-5979) or visit www.humalog.com.
What are the ingredients in HUMALOG?
Helpful information for people with diabetes is published by the American Diabetes Association,1660 Duke Street, Alexandria, VA 22314 and on www.diabetes.org.
Instructions for Use
HUMALOG® KwikPen™ insulin lispro
Read the Instructions for Use before you start taking HUMALOG and each time you get a refill. 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.
HUMALOG® KwikPen™ (“Pen”) is a disposable pen containing 3 mL (300 units) of U100 HUMALOG® [insulin lispro injection (rDNA origin)] insulin. You can inject from 1 to 60 units in a single injection.
Do not share your HUMALOG KwikPen or needles with anyone else. 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.
Supplies you will need to give your HUMALOG injection:
- HUMALOG KwikPen
- HUMALOG KwikPen compatible needle (Becton, Dickinson and Company Pen Needles recommended)
- Alcohol swab
Preparing HUMALOG KwikPen:
- Wash your hands with soap and water.
- Check the HUMALOG 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 HUMALOG past the expiration date printed on the Label.
- Always use a new needle for each injection to help ensure sterility and prevent blocked needles.
Pull the Pen Cap straight off. Wipe the Rubber Seal with an alcohol swab.
- Do not twist the cap.
- Do not remove the KwikPen Label.
HUMALOG should look clear and colorless. Do not use HUMALOG if it is thick, cloudy, colored, has solid particles or clumps in it.
Pull off the Paper Tab from Outer Needle Shield.
Push the capped Needle straight onto the Pen and turn the Needle forward until it is tight.
Pull off the Outer Needle Shield. Do not throw it away.
Pull off the Inner Needle Shield and throw it away.
Priming your HUMALOG KwikPen:
Prime 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.
Turn the Dose Knob to select 2 units.
Hold your Pen with the Needle pointing up. Tap the Cartridge Holder gently to collect air bubbles at the top.
Step 7: Hold your 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 5 to 7, no more than 4 times.
- If you still do not see a stream of insulin, change the needle and repeat steps 5 to 7.
Selecting your dose:
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. The odd numbers, after the number 1, are shown as full lines.
- The HUMALOG 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
- 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 can't be delivered.
Giving your HUMALOG injection:
- Inject your HUMALOG as your healthcare provider has shown you.
- Change (rotate) your injection site for each injection.
- Do not try to change your dose while injecting HUMALOG.
Choose your injection site.
HUMALOG 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.
Insert the Needle into your skin.
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.
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 or your healthcare provider for assistance.
Carefully replace the Outer Needle Shield.
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.
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
- 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 pens. 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 HUMALOG KwikPen?
- Store unused HUMALOG Pens in the refrigerator at 36°F to 46°F (2°C to 8°C). The Pen you are currently using can be stored out of the refrigerator below 86°F (30°C).
- Do not freeze HUMALOG. Do not use HUMALOG if it has been frozen.
- Unused HUMALOG Pens may be used until the expiration date printed on the Label, if kept in the refrigerator.
- The HUMALOG Pen you are using should be thrown away after 28 days, even if it still has insulin left in it.
- Keep HUMALOG away from heat and out of the light.
General information about the safe and effective use of HUMALOG KwikPen
- Keep HUMALOG KwikPen and needles out of the reach of children.
- Do not use your Pen if any part looks broken or damaged.
- Always carry an extra Pen in case yours is lost or damaged.
- If you can not 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 HUMALOG KwikPen.
- Write down the date you start using your HUMALOG KwikPen. Count forward 28 days.
- Write down the date you should throw it away.
Pen 1 - First used on [Date] _______ + 28 days = Throw out on [Date]______
Pen 1 - First used on [Date] _______ Throw out on [Date]_______
Pen 2 - First used on [Date] _______ Throw out on [Date]_______
Pen 3 - First used on [Date]_______ Throw out on [Date]_______
Pen 4 - First used on [Date]_______ Throw out on [Date]_______
Pen 5 - First used on [Date]_______ Throw out on [Date]_______
If you have any questions or problems with your HUMALOG KwikPen, contact Lilly at 1-800-Lilly-Rx (1-800-545-5979) or call your healthcare provider for help. For more information on HUMALOG KwikPen and insulin, go to www.humalog.com.
These Instructions for Use have been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 3/26/2013
This monograph has been modified to include the generic and brand name in many instances.
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