"Miriam E. Tucker
Medscape Medical News
The U.S. Food and Drug Administration (FDA) will now require a "for single patient use only" warning on all multidose pen devices used for injectable diabetes medications.
Humalog Mix 50-50
Humalog® (HU-ma-log) Mix50/50™
50% insulin lispro protamine Suspension and
50% insulin lispro Injection (rDNA origin)
Know your insulin. Do not change the type of insulin you use unless told to do so by your healthcare provider. Your insulin dose and the time you take your dose can change with different types of insulin.
Make sure you have the right type and strength of insulin prescribed for you.
Read the Patient Information that comes with Humalog Mix50/50 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. Make sure that you know how to manage your diabetes. Ask your healthcare provider if you have questions about managing your diabetes.
What is Humalog Mix50/50?
Humalog Mix50/50 is a mixture of fast-acting and longer-acting man-made insulins. Humalog Mix50/50 is used to control high blood sugar (glucose) in people with diabetes.
Humalog Mix50/50 comes in:
- 10 mL vials (bottles) for use with a syringe
- Prefilled pens
Who should not take Humalog Mix50/50?
Do not take Humalog Mix50/50 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 Mix50/50.
- you are allergic to anything in Humalog Mix50/50. See the end of this leaflet for a complete list of ingredients in Humalog Mix50/50.
What should I tell my healthcare provider before taking Humalog Mix50/50?
Before you use Humalog Mix50/50, tell your healthcare provider if you:
- have liver or kidney problems or any other medical conditions. Medical conditions can affect your insulin needs and your dose of Humalog Mix50/50.
- 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 Mix50/50.
- 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 Mix50/50 has not been studied in pregnant or nursing women.
- take other medicines, including prescription and non-prescription medicines, vitamins and herbal supplements. Many medicines can affect your blood sugar levels and insulin needs. Your Humalog Mix50/50 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 to all of your healthcare providers.
How should I use Humalog Mix50/50?
Talk to your healthcare provider if you have any questions. Your healthcare provider will tell you the right syringes to use with Humalog Mix50/50 vials. Your healthcare provider should show you how to inject Humalog Mix50/50 before you start using it. Read the User Manual that comes with your Humalog Mix50/50 prefilled pen.
- Use Humalog Mix50/50 exactly as prescribed by your healthcare provider.
- Humalog Mix50/50 starts working faster than other insulins that contain regular human insulin. Inject Humalog Mix50/50 fifteen minutes or less before a meal. If you do not plan to eat within 15 minutes, delay the injection until the correct time (15 minutes before eating).
- Check your blood sugar levels as told by your healthcare provider.
- Mix Humalog Mix50/50 well before each use. For Humalog Mix50/50 in a vial, carefully shake or rotate the vial until completely mixed. For prefilled pens, carefully follow the User Manual for instructions on mixing the pen. Humalog Mix50/50 should be cloudy or milky after mixing well.
- Look at your Humalog Mix50/50 before each injection. If it is not evenly mixed or has solid particles or clumps in it, do not use. Return it to your pharmacy for new Humalog Mix50/50.
- Inject your dose of Humalog Mix50/50 under the skin of your stomach area, upper arm, upper leg, or buttocks. Never inject Humalog Mix50/50 into a muscle or vein.
- Change (rotate) your injection site with each dose.
- Your insulin needs may change because of:
- other medicines you take
- changes in eating
- physical activity changes
Follow your healthcare provider's instructions to make changes in your insulin dose.
- Never mix Humalog Mix50/50 in the same syringe with other insulin products.
- Never use Humalog Mix50/50 in an insulin pump.
- Always carry a quick source of sugar to treat low blood sugar, such as glucose tablets, hard candy, or juice.
What are the possible side effects of Humalog Mix50/50?
Low Blood Sugar (Hypoglycemia). Symptoms of low blood sugar include:
- feeling shaky or shakiness
- fast heartbeat
Low blood sugar symptoms can happen suddenly. Symptoms of low blood sugar may be different for each person and may change from time to time. Severe low blood sugar can cause 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. Low blood sugar can be treated by drinking juice or regular soda or eating glucose tablets, sugar, or hard candy. 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 reactions (whole body allergic reaction). Severe, life-threatening allergic reactions can happen with insulin. Get medical help right away if you develop a rash over your whole body, have trouble breathing, wheezing, 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 injection site reactions or they are serious, you need to call your healthcare provider. Do not inject insulin into a skin area that is red, swollen, or itchy.
- Skin thickens or pits at the injection site (lipodystrophy). This can happen if you don't change (rotate) your injection sites enough.
Humalog Mix50/50 may cause serious side effects, including
- swelling of your hands and feet
- heart failure. Taking certain diabetes pills
called thiazolidinediones or “TZDs” with Humalog Mix50/50 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 Mix50/50. Your healthcare provider
should monitor you closely while you are taking TZDs with Humalog Mix50/50.
Tell your healthcare provider if you have any new or worse symptoms of heart
- shortness of breath
- swelling of your ankles or feet
- sudden weight gain
Treatment with TZDs and Humalog Mix50/50 may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.These are not all the side effects from Humalog Mix50/50. Ask your healthcare provider or pharmacist for more information.
How should I store Humalog Mix50/50?
Store all unopened (unused) Humalog Mix50/50 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 Mix50/50 that has been frozen.
- Do not use after the expiration date printed on the carton and label.
- Protect Humalog Mix50/50 from extreme heat, cold or light.
After starting use (open):
- Vials: Keep in the refrigerator or at room temperature below 86°F (30°C) for up to 28 days. Keep open vials away from direct heat or light. Throw away an opened vial 28 days after first use, even if there is insulin left in the vial.
- Prefilled Pens: Do not store a prefilled pen that you are using in the refrigerator. Keep at room temperature below 86°F (30°C) for up to 10 days. Throw away a prefilled pen 10days after first use, even if there is insulin left in the pen.
General information about Humalog Mix50/50
Use Humalog Mix50/50 only to treat your diabetes. Do not share it with anyone else, even if they also have diabetes. It may harm them.
This leaflet summarized the most important information about Humalog Mix50/50. If you would like more information about Humalog Mix50/50 or diabetes, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Humalog Mix50/50 that is written for healthcare providers.
For questions you may call 1-800-LillyRx (1-800-545-5979) or visit www.humalog.com.
What are the ingredients in Humalog Mix50/50?
Active ingredients: insulin lispro protamine suspension and insulin lispro.
Instructions for Use
HUMALOG® Mix50/50™ KwikPen™
50% insulin lispro protamine suspension and 50% insulin lispro injection (rDNA origin)
Read the Instructions for Use before you start taking HUMALOG Mix50/50 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® Mix50/50™ KwikPen™ (“Pen”) is a disposable pen containing 3 mL (300 units) of U-100 HUMALOG® Mix50/50™ [50% insulin lispro protamine suspension and 50% insulin lispro injection (rDNA origin)] insulin. You can inject from 1 to 60 units in a single injection.
Do not share your HUMALOG Mix50/50 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 Mix50/50 injection:
- HUMALOG Mix50/50 KwikPen
- HUMALOG Mix50/50 KwikPen compatible needle (Becton, Dickinson and Company Pen Needles recommended)
- Alcohol swab
Preparing HUMALOG Mix50/50 KwikPen:
- Wash your hands with soap and water.
- Check the HUMALOG Mix50/50 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 Mix50/50 past the expiration date printed on the Label.
- 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 KwikPen Label.
Step2: Gently roll the Pen ten times.
Invert the Pen ten times.
HUMALOG Mix50/50 should look white and cloudy after mixing. Do not use if it looks clear or contains any lumps or particles.
Step 3: Pull off the Paper Tab from Outer Needle Shield.
Step 4: Push the capped Needle straight onto the Pen and turn the Needle forward until it is tight.
Step 5: Pull off the Outer Needle Shield. Do not throw it away.
Pull off the Inner Needle Shield and throw it away.
Priming your HUMALOG Mix50/50 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.
Step 6 : Turn the Dose Knob to select 2 units.
Step 7: Hold your Pen with the Needle pointing up. Tap the Cartridge Holder gently to collect air bubbles at the top.
Step 8: 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 6 to 8, no more than 4 times.
- If you still do not see a stream of insulin, change the needle and repeat steps 6 to 8.
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 Mix50/50 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 can't be delivered.
Giving your HUMALOG Mix50/50 injection:
- Inject your HUMALOG Mix50/50 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 Mix50/50.
Choose your injection site.
HUMALOG Mix50/50 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 Mix50/50 KwikPen?
- Store unused HUMALOG Mix50/50 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 Mix50/50. Do not use HUMALOG Mix50/50 if it has been frozen.
- Unused HUMALOG Mix50/50 Pens may be used until the expiration date printed on the Label, if kept in the refrigerator.
- The HUMALOG Mix50/50 Pen you are using should be thrown away after 10 days, even if it still has insulin left in it.
- Keep HUMALOG Mix50/50 away from heat and out of the light.
General information about the safe and effective use of HUMALOG Mix50/50 KwikPen
- Keep HUMALOG Mix50/50 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 Mix50/50 KwikPen.
- Write down the date you start using your HUMALOG Mix50/50 KwikPen. Count forward 10 days.
- Write down the date you should throw it away.
Pen 1 - First used on [Date] _______ + 10 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 Mix50/50 KwikPen, contact Lilly at 1-800-Lilly-Rx (1-800-545-5979) or call your healthcare provider for help. For more information on HUMALOG Mix50/50 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.
Additional Humalog Mix 50-50 Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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