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KwikPen
Questions and Answers

Below is information that may help you address some of the questions your patients with type 2 diabetes may have about using Humalog® KwikPen, Humalog® Mix75/25 KwikPen, and Humalog® Mix50/50 KwikPen.

Preparation

How do I prepare my Humalog Mix75/25 KwikPen or Humalog Mix50/50 KwikPen?
Advise patients that a pen containing premixed insulin should be cloudy. The pen must be gently rolled 10 times and inverted 10 times to completely mix the insulin. The insulin should then look evenly mixed.
Can I use the same needle more than once?
No. Let patients know they should use a new needle for each injection. This will help ensure sterility. If needles are reused, patients may get the wrong amount of insulin, a clogged needle, or a jammed pen.
What kind of pen needle can be used with KwikPen?
Becton, Dickinson and Company’s insulin pen needles are recommended for use with KwikPen. There are a variety of pen needles available. Work with each patient to determine the type and size of pen needle appropriate for them.
What should I do if I am not sure how much insulin remains in my cartridge?
Patients should be instructed to hold the pen with the needle end pointing down. The scale on the clear Cartridge Holder shows an estimate of the number of units remaining. These numbers should NOT be used for measuring an insulin dose.

Priming

Why should I prime my KwikPen to a stream before each dose?
Inform patients about the importance of priming:
  1. If patients do not prime, they may get too much or too little insulin
  2. It ensures that the pen is ready to dose
  3. It confirms that a stream of insulin comes out of the tip of the needle when the Dose Knob is pushed in
  4. It removes air that may collect in the needle or insulin cartridge during normal use
What should I do if I cannot completely push in the Dose Knob when priming my KwikPen?
If a patient cannot completely push in the Dose Knob, they should be instructed to:
  1. Attach a new needle
  2. Prime the pen
What should I do if I see an air bubble in the cartridge?
Patients will need to be advised to prime the pen. Remind patients that they should not store the pen with the needle attached, as this may cause air bubbles to collect in the insulin cartridge. A small air bubble will not affect their dose and they can continue to take their dose as usual.

Injecting

Why is it difficult to push the Dose Knob when I try to inject?
Let patients know this could be caused by the following:
  1. Their needle may be clogged. Have them try attaching a new needle. When they do this they may see insulin come out of the needle. Then they should prime the pen
  2. Pressing the Dose Knob quickly may make the Dose Knob harder to push. Pressing the Dose Knob more slowly may make it easier

Using a larger diameter needle will make it easier to push the Dose Knob during their injection. Patients should consult with you to determine which needle size is best for them. If the Dose Knob continues to be difficult to push after following the steps above, refer to the steps below under "What should I do if my KwikPen is jammed?"

What should I do if my KwikPen is jammed?
A pen may be jammed if it is difficult to inject a dose or dial a dose. To help patients clear the jam:
  1. Have them attach a new needle. When they do this they may see insulin come out of the needle. Then they should prime the pen
  2. After priming, patients should dial their dose and inject
  3. If the Dose Knob is still difficult to push, instruct patients to contact The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979)
What does it mean if insulin is leaking from the needle after I finished injecting my dose?
Let patients know they may have removed the needle from the skin too quickly.
  1. Make sure patients see a "0" in the Dose Window to confirm they received the complete dose
  2. For the next dose, instruct them to push and hold the Dose Knob in and count to 5 slowly before removing the needle
What should I do if my dose is dialed and the Dose Knob is accidentally pushed in without a needle attached?
Instruct patients to do the following:
  1. Dial back to 0
  2. Attach a new needle. When they do this they may see insulin come out of the needle
  3. Prime the pen
  4. Dial their dose and inject
What should I do if I dial a wrong dose (too high or too low)?
Have patients turn the Dose Knob backward or forward to correct the dose before injecting.
What should I do if I see insulin leaking from the pen needle while dialing the dose or correcting the dose?
Tell patients not to inject the dose because they may not get their complete dose. Instruct them to dial the pen down to 0 and prime the pen again. They should then dial their dose and inject.
What should I do if my full dose cannot be dialed?
The pen will not allow patients to dial a dose greater than the number of insulin units remaining in the cartridge.

Tell patients not to attempt dialing past the number of units remaining in the cartridge. They may either:
  1. Inject the partial dose and then inject the remaining dose using a new pen
    or
  2. Inject the full dose with a new pen
Why can’t I dial the dose to use the small amount of insulin that remains in my cartridge?
Inform patients that the pen is designed to deliver at least 300 units of insulin. The pen design prevents the cartridge from being completely emptied because the small amount of insulin that remains in the cartridge cannot be delivered.

Storage and disposal

What is important storage information I should know about KwikPen?
Advise patients of the following:
  • Pens that have not been opened should be stored in a refrigerator but not in a freezer. Do not use a pen if it has been frozen
  • Do not store the pen with the needle attached. If the needle remains attached, insulin may leak from the pen, insulin may dry inside the needle causing the needle to clog, or air bubbles may form inside the cartridge
  • The pen they are currently using should be kept at room temperature and away from heat and light
  • Keep the pen out of the reach of children
How long will my KwikPen last?
Tell patients that a Humalog KwikPen that has been opened should be discarded after 28 days, even if it still contains insulin. Humalog Mix75/25 KwikPen or Humalog Mix50/50 KwikPen should be discarded after 10 days, even if it still contains insulin. Unopened, refrigerated pens can be kept until the printed expiration date. Do not use after the expiration date.
What should I do with used needles?
Patients should be instructed to dispose of used needles in a puncture-resistant container or according to your instruction.
What should I do with used pens?
Patients should be advised to dispose of used pens according to your instruction and without needles attached.

Pens and needles are for single-patient use only and should not be shared, even in healthcare facilities, as infection or disease can be spread from one person to another.

Do not withdraw insulin from the pen using a syringe.

Indication for Humalog, Humalog Mix75/25, and Humalog Mix50/50

Humalog® (insulin lispro injection, USP [rDNA origin]) is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. Humalog® Mix75/25 (75% insulin lispro protamine suspension, 25% insulin lispro injection [rDNA origin]) and Humalog® Mix50/50 (50% insulin lispro protamine suspension, 50% insulin lispro injection [rDNA origin]) are indicated in the treatment of adults with diabetes mellitus for the control of hyperglycemia. Humalog, Humalog Mix75/25, and Humalog Mix50/50 contain 100 units/mL.

Important Safety Information for Humalog, Humalog Mix75/25, and Humalog Mix50/50

Contraindications

  • Humalog, Humalog Mix75/25, and Humalog Mix50/50 are contraindicated during episodes of hypoglycemia and in patients who are hypersensitive to insulin lispro or any excipients contained in the formulation.

Warnings and Precautions

  • Dose Adjustment, Monitoring, and Considerations: Closely monitor blood glucose in all patients treated with insulin. Change insulin regimens cautiously. Concomitant oral antidiabetic treatment may need to be adjusted. The time course of action for Humalog, Humalog Mix75/25, and Humalog Mix50/50 may vary in different individuals or at different times in the same individual and is dependent on many conditions, including the delivery site, local blood supply, or local temperature. Patients who change their level of physical activity or meal plan, or experience illness, emotional disturbances, or other stress may require insulin dose adjustment. Humalog differs from regular human insulin by its rapid onset of action and shorter duration of activity. Humalog should be given within 15 minutes before or immediately after a meal. Humalog Mix75/25 and Humalog Mix50/50 are intended only for subcutaneous administration and should be given within 15 minutes before a meal.
  • Hypoglycemia: Hypoglycemia is the most common adverse effect of Humalog, Humalog Mix75/25, and Humalog Mix50/50. The risk of hypoglycemia increases with tighter glycemic control. Educate patients to recognize and manage hypoglycemia. Hypoglycemia can happen suddenly and symptoms may vary for each person and may change over time. Early warning symptoms of hypoglycemia may be different or less pronounced under conditions such as long-standing diabetes, diabetic nerve disease, use of medications such as beta-blockers, or intensified diabetes control. These situations may result in severe hypoglycemia and possibly loss of consciousness prior to the patient’s awareness of hypoglycemia. Severe hypoglycemia may be life threatening and can cause seizures or death. Use caution in patients with hypoglycemia unawareness and who may be predisposed to hypoglycemia. The patient’s ability to concentrate and react may be impaired as a result of hypoglycemia. Rapid changes in serum glucose levels may induce symptoms similar to hypoglycemia in persons with diabetes, regardless of the glucose value. The timing of hypoglycemia usually reflects the time-action profile of the administered insulins. Other factors such as changes in food intake, injection site, exercise, and concomitant medications may also alter the risk of hypoglycemia.
  • Allergic Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with Humalog, Humalog Mix75/25, and Humalog Mix50/50.
  • Hypokalemia: Humalog, Humalog Mix75/25, and Humalog Mix50/50 can cause hypokalemia, which, if untreated, may result in respiratory paralysis, ventricular arrhythmia, and death. Use caution in patients who may be at risk for hypokalemia (eg, patients using potassium-lowering medications or medications sensitive to serum potassium concentrations).
  • Renal or Hepatic Impairment: Frequent glucose monitoring and insulin dose reduction may be required in patients with renal or hepatic impairment.
  • Mixing of Insulins: Patients should be advised NOT to mix Humalog Mix75/25 or Humalog Mix50/50 with any other insulin. Humalog for subcutaneous injection should not be mixed with insulins other than NPH insulin. If Humalog is mixed with NPH insulin, Humalog should be drawn into the syringe first. Injection should occur immediately after mixing.
  • Humalog Use in a Subcutaneous Insulin Infusion Pump: Humalog should not be diluted or mixed when used in an external insulin pump. Change Humalog in the reservoir at least every 7 days. Change the infusion set and insertion site at least every 3 days. Malfunction of the insulin pump or infusion set or insulin degradation can rapidly lead to hyperglycemia and ketosis. Prompt correction of the cause of hyperglycemia or ketosis is necessary. Interim subcutaneous injections with Humalog may be required. Train patients using an insulin pump to administer insulin by injection and to have alternate insulin therapy available in case of pump failure.
  • Humalog Mix75/25 and Humalog Mix50/50 should never be used in a pump.
  • Drug Interactions: Some medications may alter glucose metabolism, insulin requirements, and the risk for hypoglycemia or hyperglycemia. The signs of hypoglycemia may be reduced or absent in patients taking anti-adrenergic drugs. Particularly close monitoring may be required.
  • Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists: Thiazolidinediones (TZDs), which are PPAR-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin, including Humalog, Humalog Mix75/25, or Humalog Mix50/50. Fluid retention may lead to or exacerbate heart failure. Observe patients for signs and symptoms of heart failure and consider discontinuation or dose reduction of the PPAR-gamma agonist.

Adverse Reactions

  • Adverse reactions associated with Humalog, Humalog Mix75/25, and Humalog Mix50/50 include hypoglycemia, hypokalemia, allergic reactions, injection-site reactions, lipodystrophy, pruritus, rash, weight gain, and peripheral edema.

Use in Specific Populations

  • Pediatrics: Humalog has not been studied in children with type 1 diabetes less than 3 years of age or in children with type 2 diabetes. Safety and effectiveness of Humalog Mix75/25 and Humalog Mix50/50 in patients less than 18 years of age have not been established.

Please click to access Full Prescribing Information for Humalog, Humalog Mix75/25, and Humalog Mix50/50.

Please see Instructions for Use that accompanies the pen.

HI BOI HCP ISI 29MAR2013

Important Safety Information for Glucagon

Contraindications

  • Glucagon is contraindicated in patients with known hypersensitivity to it or in patients with known pheochromocytoma.

Warnings

  • Glucagon should be administered cautiously to patients with a history suggestive of insulinoma, pheochromocytoma, or both. In patients with insulinoma, intravenous administration of Glucagon may produce an initial increase in blood glucose; however, because of Glucagon’s hyperglycemic effect the insulinoma may release insulin and cause subsequent hypoglycemia. A patient developing symptoms of hypoglycemia after a dose of Glucagon should be given glucose orally, intravenously, or by gavage, whichever is most appropriate.
  • Exogenous Glucagon also stimulates the release of catecholamines. In the presence of pheochromocytoma, Glucagon can cause the tumor to release catecholamines, which may result in a sudden and marked increase in blood pressure.
  • Generalized allergic reactions, including urticaria, respiratory distress, and hypotension, have been reported in patients who received Glucagon by injection.

Precautions

  • Glucagon is effective in treating hypoglycemia only if sufficient liver glycogen is present. Therefore, hypoglycemia associated with states of starvation, adrenal insufficiency, or chronic hypoglycemia should be treated with glucose.
  • Patients and family members should become familiar with the technique of preparing Glucagon before a severe hypoglycemic emergency arises.
  • To prevent severe hypoglycemia, patients and family members should be informed of the symptoms of mild hypoglycemia and how to treat it appropriately. Blood glucose determinations should be obtained to monitor the patient with hypoglycemia until patient is asymptomatic, and patients should be advised to inform their physician when hypoglycemic reactions occur.
  • One-half the adult dose should be used in pediatric patients weighing less than 44 lbs (20 kg). Any unused portion should be discarded.
  • Pregnancy Category B: There are no adequate and well-controlled clinical studies of the use of Glucagon in pregnant or nursing women.

Adverse Reactions

  • Severe adverse reactions are very rare, although nausea and vomiting may occur occasionally.

For more safety information, please click to access Information for the User and Information for the Physician.

HI GLUC HCP ISI 1NOV2013

Humalog® is a registered trademark of Eli Lilly and Company and is available by prescription only.

Humalog® and Humalog® KwikPen are registered trademarks of Eli Lilly and Company and are available by prescription only.

Humalog® Mix75/25, Humalog® Mix50/50, Humalog® Mix75/25 KwikPen, and Humalog® Mix50/50 KwikPen are trademarks of Eli Lilly and Company and are available by prescription only.

Humalog® Mix75/25, Humalog® Mix50/50, Humalog® Mix75/25 KwikPen, and Humalog® Mix50/50 KwikPen are trademarks of Eli Lilly and Company and are available by prescription only.

Humalog® Mix75/25, Humalog® Mix50/50, Humalog® Mix75/25 KwikPen, and Humalog® Mix50/50 KwikPen are trademarks of Eli Lilly and Company and are available by prescription only.

Humalog® Mix75/25, Humalog® Mix50/50, Humalog® Mix75/25 KwikPen, and Humalog® Mix50/50 KwikPen are trademarks of Eli Lilly and Company and are available by prescription only.

HumaPen® LUXURA is a registered trademark of Eli Lilly and Company. HumaPen® LUXURA HD is available by prescription only.

The Glucagon design is a trademark of Eli Lilly and Company. Glucagon is available by prescription only.

Managing Your Diabetes® is a registered trademark of Eli Lilly and Company.

BD, BD AutoShield, and BD Ultra-Fine are trademarks of Becton, Dickinson and Company.

BD and BD AutoShield are trademarks of Becton, Dickinson and Company.

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