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Indication for Humalog Brand of Insulins

Humalog® is used to treat people with diabetes for the control of blood sugar. Humalog® Mix75/25 (75% insulin lispro protamine suspension and 25% insulin lispro injection) and Humalog® Mix50/50 (50% insulin lispro protamine suspension and 50% insulin lispro injection) are used to treat adults with diabetes for the control of high blood sugar.

Do not take Humalog if your blood sugar is too low (hypoglycemia) or if you are allergic to insulin lispro or any of the ingredients in Humalog.

Important Safety Information for Humalog Brand of Insulins

What is the most important information I should know about Humalog, Humalog 200 units/mL KwikPen, Humalog Mix75/25, and Humalog Mix50/50?

  • Do not share your Humalog, Humalog Mix75/25, or Humalog Mix50/50 KwikPen, cartridges, reusable pen compatible with Lilly 3 mL cartridges, 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.
  • Humalog 200 units/mL KwikPen contains 2 times as much insulin (200 units/mL) in 1 mL as standard insulin (100 units/mL).
  • The Humalog contained in the Humalog U-200 KwikPen should ONLY be injected with the Humalog U-200 KwikPen. Do NOT withdraw Humalog U-200 from the pen using a syringe. It could result in an overdose causing severe low blood sugar which may put your life in danger.
  • Do not change the insulin you use without talking to your healthcare provider. Changes may make you more likely to experience low or high blood sugar. Changes should be made cautiously under the supervision of your healthcare provider.
  • Test your blood sugar levels as your healthcare provider instructs.
  • Your insulin dose may need to change because of illness, stress, other medicines you take, change in diet, or change in physical activity or exercise.
  • When used in a pump, do not mix or dilute Humalog U-100 with any other insulin or liquid. Do NOT use Humalog U-200, Humalog Mix75/25 or Humalog Mix50/50 in a pump.

Who should not take Humalog, Humalog Mix75/25, or Humalog Mix50/50?

  • Do not take these insulins if your blood sugar is too low (hypoglycemia) or if you are allergic to insulin lispro or any of the ingredients in these insulins.

Before using Humalog, Humalog Mix75/25, or Humalog Mix50/50, what should I tell my healthcare providers?

  • About all of your medical conditions, including liver, kidney, or heart failure or other heart problems.
  • If you are pregnant, planning to become pregnant, or are breastfeeding.
  • About all the medicines you take, including prescription (especially ones commonly called TZDs [thiazolidinediones]) and nonprescription medicines, vitamins, and herbal supplements.

How should I use Humalog, Humalog Mix75/25, or Humalog Mix50/50?

  • These insulins start working faster than other insulins that contain regular human insulin. You should take Humalog within fifteen minutes before eating or right after eating a meal. You should take Humalog Mix75/25 and Humalog Mix50/50 within fifteen minutes before eating.
  • Always make sure that you receive the correct type of insulin from the pharmacy.
  • Do not use Humalog if it is cloudy, colored, or has solid particles or clumps in it.
  • Do not use Humalog Mix75/25 or Humalog Mix50/50 if they have solid particles or clumps in them. Humalog Mix75/25 and Humalog Mix50/50 should be mixed carefully before each use and should be cloudy or milky after mixing.
  • Do not mix Humalog U-100 with insulin other than NPH when using a syringe. Do not mix or dilute Humalog U-100 when used in a pump.
  • Never mix Humalog Mix75/25 or Humalog Mix50/50 in the same syringe with other insulin products. Never use Humalog U-200, Humalog Mix75/25 or Humalog Mix50/50 in a pump.
  • Inject your insulin under your skin (subcutaneously). Never inject into a vein or muscle. Change (rotate) your injection site with each dose. Make sure you inject the correct insulin and dose.
  • Do not re-use needles. Always use a new needle for each injection. Re-use of needles can cause you to receive the wrong dose of Humalog and result in infection.
  • Do not drive or operate heavy machinery until you know how Humalog affects you. Do not use alcohol while using Humalog.

What are the possible side effects of Humalog, Humalog Mix75/25, or Humalog Mix50/50?

  • Severe low blood sugar can cause unconsciousness (passing out), seizures, and death. Low blood sugar is the most common side effect. There are many causes of low blood sugar, including taking too much insulin. It is important to treat it quickly. You can treat mild to moderate low blood sugar by drinking or eating a quick source of sugar right away. Symptoms may be different for each person. Be sure to talk to your healthcare provider about low blood sugar symptoms and treatment.
  • Severe life-threatening allergic reactions (whole-body reactions) can happen. Get medical help right away if you develop a rash over your whole body, have trouble breathing, have a fast heartbeat, or are sweating.
  • Humalog, Humalog Mix75/25, and Humalog Mix50/50 can cause life-threatening low potassium in your blood (hypokalemia), which can cause severe breathing problems, irregular heartbeat, and death.
  • Serious side effects can include swelling of your hands and feet and heart failure when taking certain pills called thiazolidinediones or “TZDs” with Humalog, Humalog Mix75/25, or Humalog Mix50/50. This may occur in some people even if they have not had heart problems before. Tell your healthcare provider if you have shortness of breath, swelling of your ankles or feet, or sudden weight gain, which may be symptoms of heart failure. Your healthcare provider may need to adjust or stop your treatment with TZDs, Humalog, Humalog Mix75/25, or Humalog Mix50/50.
  • Failure of your insulin pump or infusion set or degradation of the insulin in the pump can cause hyperglycemia and ketoacidosis. Always carry an alternate form of insulin administration in case of pump failure.
  • The most common side effects of Humalog include low blood sugar, allergic reactions, including reactions at your injection site, skin thickening or pits at the injection site (lipodystrophy), itching, and rash. These are not all of the possible side effects. Ask your healthcare provider for more information or for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit fda.gov/medwatch or call 1-800-FDA-1088.

For additional information talk to your healthcare providers and please click to access Humalog Full Prescribing Information, Humalog U-100 Patient Prescribing Information, Humalog U-200 KwikPen Patient Prescribing Information, Humalog Mix75/25 Full Prescribing Information and Patient Prescribing Information, and Humalog Mix50/50 Full Prescribing Information and Patient Prescribing Information.

Please see Instructions for Use included with your pen.

HI U200 BOI CON ISI 26MAY2015

Humalog® and Humalog® KwikPen® are registered trademarks of Eli Lilly and Company, its subsidiaries, or affiliates, 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.

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Indication for Humalog Brand of Insulins

Humalog® is a rapid-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. Humalog® Mix75/25 (75% insulin lispro protamine suspension and 25% insulin lispro injection) and Humalog® Mix50/50 (50% insulin lispro protamine suspension and 50% insulin lispro injection) are indicated in the treatment of adults with diabetes mellitus for the control of hyperglycemia.

Important Safety Information for Humalog Brand of Insulins

Contraindications

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

Warnings and Precautions

  • Never Share a Humalog KwikPen, Humalog Mix75/25 KwikPen, or Humalog Mix50/50 KwikPen, Cartridge, Reusable Pen Compatible with Lilly 3 mL Cartridges, or Syringe Between Patients: Humalog, Humalog Mix75/25, and Humalog Mix50/50 KwikPens, cartridges, and reusable pens compatible with Lilly 3 mL cartridges must never be shared between patients, even if the needle is changed. Patients using Humalog, Humalog Mix75/25, or Humalog Mix50/50 vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
  • Changes in Insulin Regimen: Changes may affect glycemic control and predispose to hypoglycemia or hyperglycemia. These changes should be made cautiously under close medical supervision and the frequency of blood glucose monitoring should be increased.
  • Hypoglycemia: Severe hypoglycemia may be life threatening and can cause seizures or death. Hypoglycemia is the most common adverse reaction of Humalog, Humalog Mix75/25, and Humalog Mix50/50. The patient’s ability to concentrate and react may be impaired as a result of 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 in patients who experience recurrent hypoglycemia. These situations may result in severe hypoglycemia and possibly loss of consciousness prior to the patient’s awareness of hypoglycemia.
  • Timing of hypoglycemia usually reflects the time-action profile of administered insulins which may vary in different individuals or at different times in the same individual. Other factors such as changes in food intake, injection site, exercise, and concomitant medications may increase the risk of hypoglycemia.
  • Educate patients to recognize and manage hypoglycemia. In patients at higher risk for hypoglycemia and patients with reduced symptomatic awareness, increased frequency of blood glucose monitoring is recommended. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia.
  • Hypoglycemia Due to Medication Errors: Instruct patients to always check the insulin label before each injection to avoid medication errors.
  • Humalog U-200 should not be transferred from the Humalog KwikPen to a syringe as overdose and severe hypoglycemia can occur.
  • Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with Humalog, Humalog Mix75/25, and Humalog Mix50/50. If hypersensitivity reactions occur, discontinue the use of insulin and treat per standard of care until signs and symptoms resolve.
  • Hypokalemia: Hypokalemia may be life threatening. Insulins, including Humalog, Humalog Mix75/25, and Humalog Mix50/50, cause a shift in potassium from the extracellular to intracellular space possibly leading to hypokalemia, which, if untreated, may result in respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia (eg, patients using potassium-lowering medications or medications sensitive to serum potassium concentrations).
  • 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, and Humalog Mix50/50. This 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.
  • Hyperglycemia and Ketoacidosis Due to Insulin Pump Device Malfunction: Malfunction of the insulin pump device, infusion set, or insulin degradation can rapidly lead to hyperglycemia and ketoacidosis. Patients using subcutaneous insulin infusion pumps must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure.

Drug Interactions

  • Some medications may alter glucose metabolism, insulin requirements, and the risk for hypoglycemia or hyperglycemia. Signs of hypoglycemia may be reduced or absent in patients taking anti-adrenergic drugs. Particularly close monitoring may be required.

Adverse Reactions

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

Use in Specific Populations

  • 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.

Dosage and Administration

  • Humalog should be given within 15 minutes before or immediately after a meal.
  • Humalog Mix75/25 and Humalog Mix50/50 should be given within 15 minutes before a meal.
  • Humalog U-100 can be administered intravenously under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia. Do NOT administer Humalog Mix75/25, Humalog Mix50/50, or Humalog U-200 intravenously.
  • Humalog U-100 for subcutaneous injection should only be mixed with NPH insulin. If Humalog U-100 is mixed with NPH insulin, Humalog should be drawn into the syringe first. Injection should occur immediately after mixing. Do NOT mix Humalog Mix75/25, Humalog Mix50/50, or Humalog U-200 in a syringe with any other insulin.
  • Humalog U-100 should not be diluted or mixed when used in an external insulin pump. Change Humalog U-100 in the reservoir at least every 7 days. Change the infusion set and insertion site at least every 3 days. Do NOT use Humalog Mix75/25, Humalog Mix50/50, or Humalog U-200 in a subcutaneous insulin infusion pump.
  • Do NOT perform dose conversion when using either the Humalog U-100 or Humalog U-200 KwikPens. The dose window shows the number of insulin units to be delivered and no conversion is needed.

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

Please see Instructions for Use included with the pen.

HI BOI U200 HCP ISI 26MAY2015

Humalog® and Humalog® KwikPen® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates, 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.

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Pen

Humalog® U-200 KwikPen®

Humalog U-200 KwikPen holds twice the insulin, so it could last twice as long between pen changes.*

*As compared with U-100 mealtime insulin pens.

Once opened, Humalog U-200 KwikPen should be thrown away after 28 days, even if insulin remains.

Consider U-200 KwikPen for your patients with diabetes who:

  • Currently take an average of 15 units of mealtime insulin at each meal
  • Go through more than 4 mealtime insulin pens every month

Humalog U-200 KwikPen

  • Holds twice the insulin compared to a U-100 insulin pen
  • Could last twice as long between pen changes*†‡

*As compared with U-100 mealtime insulin pens.

Once opened, Humalog prefilled pens should be thrown away after 28 days, even if insulin remains.

As with other pens, patients should always carry an extra pen.

Humalog U-200 KwikPen is the first and only mealtime insulin pen that:

  • Is bioequivalent* to Humalog® U-100; therefore, you should expect similar efficacy as Humalog U-100
  • Contains 600 units of rapid-acting insulin compared with the 300 units in a U-100 pen
  • Contains concentrated 200 units/mL insulin
  • Delivers the same dose in half the liquid volume
  • Is the same size and familiar design as Humalog® U-100 KwikPen®‡

*As determined by area under the curve and maximum concentration.

As compared with U-100 mealtime insulin pens.

Based on overall dimensions of pen as measured with cap on and dial set to zero.1

Select Safety Information

  • Humalog®, Humalog® Mix75/25™, and Humalog® Mix50/50™ are contraindicated during episodes of hypoglycemia and in patients who are hypersensitive to Humalog or any of its excipients.

Humalog U-200 KwikPen holds twice the insulin, so it could last twice as long between pen changes*†‡

CALENDAR GRAPHIC:
CALENDAR GRAPHIC:

Because it lasts longer between pen changes, Humalog U-200 KwikPen may help patients worry less about running out of insulin when plans change unexpectedly.*†‡

*As compared with U-100 mealtime insulin pens.

Once opened, Humalog prefilled pens should be thrown away after 28 days, even if insulin remains.

As with other pens, patients should always carry an extra pen.

Delivers the same dose in half the liquid volume of Humalog U-100 KwikPen

Equal units of insulin

Humalog 200 units/mL is twice the concentration of Humalog U-100 insulin.

Select Safety Information

  • Never share a Humalog, Humalog Mix75/25, or Humalog Mix50/50 KwikPen, cartridge, reusable pen compatible with Lilly 3 mL cartridges, or syringe between patients as it poses a risk for transmission of blood-borne pathogens.

Humalog U-200 KwikPen is the same size as, and feels and operates like, a Humalog U-100 KwikPen

Equal units of insulin

Same size and familiar design*

  • No dose calculations or conversions are required
  • Dialing 1 unit delivers 1 unit of mealtime insulin
  • Both pens contain 3 mL of liquid

*As compared with U-100 mealtime insulin pens.

Based on overall dimensions of pen as measured with cap on and dial set to zero.1

Prescribing U-200 KwikPen

When using EMR to prescribe Humalog U-200 KwikPen, use this chart as a guide, based on the requirements of your EMR.*

Be sure to specify the full product name: Humalog 200 units/mL KwikPen.

chart

2 X 3 mL Prefilled Pens per Box.
Each pen contains 600 units.
NDC Code: 0002-7712-27

Equal units of insulin

Unit for unit, Humalog U-200 KwikPen costs the same as Humalog U-100 KwikPen and has similar coverage nationwide.2

*Assumes a 30-day month. Assumes product is dispensed in full packs.

Cost defined as List Price per insulin unit. AnalySource, Pricing as of September 2016.

Humalog U-200 KwikPen could cost patients less than Humalog U-100 KwikPen

With the Humalog U-200 KwikPen Savings Card, eligible commercially insured patients may pay less out of pocket—as little as $25 per month*—compared to Humalog U-100 KwikPen. *See full terms and conditions on savings card for eligibility.

Prescription card

STEP 1: Request savings card(s)

0

Download and print cards

OR

You will receive a separate email for each savings card requested. This will allow you to forward the savings card directly to a patient.

Pay as little as $25 per prescription*

*Applies to each of your first 24 prescriptions. Lilly pays up to $100 per month. Other terms and restrictions apply.

If you have questions, we’re here to help. Call The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979).

This offer is invalid for patients whose prescription claims are eligible to be reimbursed, in whole or in part, by any governmental program.

Be sure to activate your card by going to Humalog.com prior to taking it to the pharmacy.

RxBin: 601341 RxPCN: OHCP
RxGRP: OH6801051 RxID: [XXXXXXX] SUF: 01

Expiration Date: 12/31/2019

Pharmacist Instructions:

This card must be accompanied by a valid prescription for Humalog U-200 KwikPen. This offer is eligible for patients with commercial insurance who do not receive government reimbursement for their prescriptions. If the patient qualifies per the terms of the offer, submit as a secondary claim to OPUS Health using BIN: 601341 and using the Coordination of Benefits fields with coverage code type 08. One card per patient. By accepting this offer you certify that you understand and agree to comply with the offer terms set forth herein. If you are required to do so under the terms of your third-party payer contracts or as otherwise required by law, you should notify the affected third-party payer of your redemption of this offer. Please return card to patient after claim is processed. Pharmacists with questions, please call OPUS Health at 1-800-364-4767.

Eligibility Requirements:

By using the Humalog U-200 KwikPen savings card ("Card"), you attest that you meet the eligibility criteria and will comply with the Terms and Conditions described below. Offer void where prohibited by law. This offer is invalid for patients without commercial insurance coverage or those whose prescription claims for Humalog U-200 KwikPen are eligible to be reimbursed, in whole or in part, by any governmental program, including, without limitation, Medicaid, Medicare, Medicare Part D, Medigap, DOD, VA, TRICARE/CHAMPUS, or any State Patient or Pharmaceutical Assistance Program. If you live in Massachusetts, the Card expires on the earlier of: (i) the expiration date of this Card (December 31, 2019); (ii) the date an AB rated generic equivalent becomes available; or (iii) June 30, 2017, absent a change in Massachusetts state law. Available only in the US and Puerto Rico to residents of the US and Puerto Rico. By accepting this offer, you agree that if you are required to do so under the terms of your insurance coverage for this prescription or are otherwise required to do so by law, you should notify your insurance carrier of your redemption of this Card. This offer is not valid with any other program, discount, incentive, or similar offer involving Humalog U-200 KwikPen. It is prohibited for any person to sell, purchase or trade; or to offer to sell, purchase or trade, or to counterfeit this Card. This offer may be terminated, rescinded, revoked or amended by Lilly USA, LLC at any time without notice. This Card is not health insurance. This Card expires on 12/31/2019.

PP-HI-US-0807 11/2016 ©Lilly USA, LLC 2016. All rights reserved.

Humalog® and Humalog® KwikPen® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates, and are available by prescription only.

STEP 2: Patient support

We are committed to helping you help patients get started successfully

  • Please remind patients that the first step is activating their savings card

Learn more about Humalog U-200 KwikPen Savings Card support and eligibility for your patients >

Select Safety Information

  • Changes in insulin regimen may affect glycemic control and predispose patients to hypoglycemia and hyperglycemia. Changes should be made cautiously and the frequency of blood glucose monitoring should be increased.

The Lilly Answers Center

Questions? Ask your Lilly Diabetes Sales Professional or call 1-800-LillyRx (1-800-545-5979), Monday through Friday from 9 AM to 8 PM ET.

Humalog U-200 is bioequivalent* to Humalog U-100

Humalog U-200 was bioequivalent* to Humalog U-100 after subcutaneous administration of a single 20-unit dose in healthy subjects. Time to maximum concentration was also similar between formulations.

Simliar pharmacokinetic properties3

pharmacokinetic graph

Simliar pharmacodynamic properties1

pharmacodynamic graph

*As determined by area under the curve and maximum concentration.

References

  1. Data on file, Lilly Research Laboratories: HI20150526A.
  2. MMIT data compiled from Commercial and Medicare formulary data accurate as of 04/2016.
  3. Data on file, Lilly Research Laboratories: HI20150521A.

You clicked on a page that’s meant for healthcare providers.

This section includes technical information. If you’re a US healthcare provider, click “Continue.” Otherwise, click “Return” to keep reading the main site.

You are now leaving the Humalog.com website

The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Lilly USA, LLC, does not control, influence, or endorse this site, and the opinions, claims, or comments expressed on this site should not be attributed to Lilly USA, LLC. Lilly USA, LLC, is not responsible for the privacy policy of any third-party websites. We encourage you to read the privacy policy of every website you visit.

Click "Continue" to proceed or "Cancel" to return to Humalog.com