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HUMULIN R U-500
(insulin) Human Injection, for Subcutaneous Use
HUMULIN R U-500 (insulin human injection, USP) is a human insulin solution used to lower blood glucose. Human insulin is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. HUMULIN R has the empirical formula C257H383N65O77S6 with a molecular weight of 5808.
HUMULIN R U-500 is a sterile, aqueous, and colorless solution. HUMULIN R U-500 contains 500 units of insulin in each milliliter. Each milliliter of HUMULIN R U-500 also contains glycerin 16 mg, metacresol 2.5 mg, zinc oxide to supplement the endogenous zinc to obtain a total zinc content of 0.017 mg/100 units, and Water for Injection. Sodium hydroxide and hydrochloric acid may be added during manufacture to adjust the pH.
HUMULIN R U-500 is a concentrated human insulin indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus requiring more than 200 units of insulin per day.
The safety and efficacy of HUMULIN R U-500 used in combination with other insulins has not been determined.
The safety and efficacy of HUMULIN R U-500 delivered by continuous subcutaneous infusion has not been determined.
HUMULIN R U-500 (500 units per mL) is available in a colorless solution as:
HUMULIN R U-500 (500 units per mL) is available as:
2 x 3 mL HUMULIN R U-500 KwikPen (prefilled) NDC 0002-8824-27
20 mL multiple dose vials NDC 0002-8501-01
The HUMULIN R U-500 KwikPen dials in 5 unit increments.
Protect from heat and light. Do not freeze. Do not use HUMULIN R U-500 after the expiration date printed on the label or if it has been frozen. Do not shake the vial.
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 28 days.
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 28 days, even if the pen still contains HUMULIN R U-500. See storage table below:
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 40 days.
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 40 days or be discarded, even if they still contain HUMULIN R U-500.
Room Temperature
If stored at room temperature, below 86°F (30°C) the vial must be discarded after 40 days, even if the vial still contains HUMULIN R U-500. See storage table below:
| Not In-Use (Unopened) Refrigerated | In-Use (Opened) | |
| 3 mL HUMULIN R U-500 KwikPen (prefilled) | Until expiration date | 28 days, room temperature. Do not refrigerate. |
| 20 mL multiple dose vial | Until expiration date | 40 days, refrigerated or room temperature |
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA. Revised: Nov 2018
The following adverse reactions are discussed elsewhere:
The following additional adverse reactions have been identified during post-approval use of HUMULIN R U-500. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure.
Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including HUMULIN R U-500 [see WARNINGS AND PRECAUTIONS].
Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, rash, angioedema, bronchospasm, hypotension, and shock may occur with any insulin, including HUMULIN R U-500 and may be life threatening [see WARNINGS AND PRECAUTIONS].
Long-term use of insulin, including HUMULIN R U-500, can cause lipodystrophy at the site of repeated insulin injections. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue) and may affect insulin absorption. Rotate insulin injections sites within the same region to reduce the risk of lipodystrophy [see DOSAGE AND ADMINISTRATION].
Patients taking HUMULIN R U-500 may experience injection site reactions, including injection site hematoma, pain, hemorrhage, erythema, nodules, swelling, discoloration, pruritus, warmth, and injection site mass.
Weight gain can occur with insulin therapy, including HUMULIN R U-500, and has been attributed to the anabolic effects of insulin.
Insulin, including HUMULIN R U-500, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
As with all therapeutic proteins, insulin administration may cause anti-insulin antibodies to form. The presence of antibodies that affect clinical efficacy may necessitate dose adjustments to correct for tendencies toward hyper- or hypoglycemia.
The incidence of antibody formation with HUMULIN R U-500 is unknown.
The risk of hypoglycemia associated with HUMULIN R U-500 use may be increased with antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics. Dose adjustment and increased frequency of glucose monitoring may be required when HUMULIN R U-500 is co-administered with these drugs.
The glucose lowering effect of HUMULIN R U-500 may be decreased when co-administered with atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline) and thyroid hormones. Dose adjustment and increased frequency of glucose monitoring may be required when HUMULIN R U-500 is co-administered with these drugs.
The glucose lowering effect of HUMULIN R U-500 may be increased or decreased when co-administered with alcohol, betablockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Dose adjustment and increased frequency of glucose monitoring may be required when HUMULIN R U-500 is co-administered with these drugs.
The signs and symptoms of hypoglycemia [see WARNINGS AND PRECAUTIONS] may be blunted when beta-blockers, clonidine, guanethidine, and reserpine are co-administered with HUMULIN R U-500.
Included as part of the PRECAUTIONS section.
Medication errors associated with the HUMULIN R U-500 vial presentation resulting in patients experiencing hyperglycemia, hypoglycemia or death have been reported. The majority of errors occurred due to errors in dispensing, prescribing or administration. Attention to details at all levels may prevent these errors.
Instruct patients to always inspect insulin vials to confirm that the correct insulin is dispensed including the correct insulin brand and concentration.
The HUMULIN R U-500 vial, which contains 20 mL, has a band of aqua coloring, a 500 units/mL concentration statement consisting of white lettering on a green rectangular background, and a green “U-500” statement prominently displayed next to the trade name. Additionally, the vial has a green flip top and a red warning on the front panel describing the highly concentrated dose and a statement advising use with only U-500 insulin syringes.
Dosing errors have occurred when the HUMULIN R U-500 dose was administered with syringes other than a U-500 insulin syringe. Patients should be prescribed U-500 syringes for use with the HUMULIN R U-500 vials. The prescribed dose of HUMULIN R U-500 should always be expressed in units of insulin [see DOSAGE AND ADMINISTRATION].
Instruct patients to always check the insulin label before each injection.
Use only a U-500 insulin syringe with HUMULIN R U-500 to avoid administration errors. Do not use any other type of syringe to administer Humulin R U-500. Adhere to administration instructions [see DOSAGE AND ADMINISTRATION].
Instruct the patient to inform hospital or emergency department staff of the dose of HUMULIN R U-500 prescribed, in the event of a future hospitalization or visit to the Emergency Department.
HUMULIN R U-500 KwikPens should never be shared between patients, even if the needle is changed. Patients using HUMULIN R U-500 vials should never share needles or U-500 insulin syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
Changes in insulin, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. These changes should be made cautiously and only under medical supervision and the frequency of blood glucose monitoring should be increased. For patients with type 2 diabetes, adjustments in concomitant oral anti-diabetic treatment may be needed.
Hypoglycemia is the most common adverse reaction associated with insulin, including HUMULIN R U-500. Severe hypoglycemia can cause seizures, may be life-threatening or cause death. Severe hypoglycemia may develop as long as 18 to 24 hours after an injection of HUMULIN R U-500. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving, or operating other machinery). Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers) [see DRUG INTERACTIONS], or in patients who experience recurrent hypoglycemia.
The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation. As with all insulin preparations, the glucose lowering effect time course of HUMULIN R U-500 may vary in different individuals or at different times in the same individual and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature. Other factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g., macronutrient content or timing of meals), changes in level of physical activity, or changes to co-administered medication [see DRUG INTERACTIONS]. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia [see Use In Specific Populations].
Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended. To minimize the risk of hypoglycemia do not administer HUMULIN R U-500 intravenously, intramuscularly or in an insulin pump or dilute or mix HUMULIN R U-500 with any other insulin products or solutions [see DOSAGE AND ADMINISTRATION].
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including HUMULIN R U-500 [see ADVERSE REACTIONS]. If hypersensitivity reactions occur, discontinue HUMULIN R U-500; treat per standard of care and monitor until symptoms and signs resolve [see ADVERSE REACTIONS].
All insulin products, including HUMULIN R U-500, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Use caution in patients who may be at risk for hypokalemia (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations).
Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause doserelated fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including HUMULIN R U-500, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.
See FDA-approved patient labeling.
Patients should be counseled that HUMULIN R U-500 is a 5-times concentrated insulin product. Extreme caution must be observed in the measurement of dosage because inadvertent overdose may result in serious adverse reaction or life-threatening hypoglycemia. Accidental mix-ups between HUMULIN R U-500 and other insulins have been reported. To avoid medication errors between HUMULIN R U-500 and other insulins, patients should be instructed to always check the insulin label before each injection [see WARNINGS AND PRECAUTIONS].
If using the HUMULIN R U-500 KwikPen, patients should be counseled to dial and dose the prescribed number of units of insulin (no dose conversion is required) [see DOSAGE AND ADMINISTRATION].
When using HUMULIN R U-500 from a vial, patients should be counseled to use only a U-500 insulin syringe and be informed that no dose conversion is required [see DOSAGE AND ADMINISTRATION].
Patients should be instructed on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia, especially at initiation of HUMULIN R U-500 therapy. Patients must be instructed 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. Refer patients to the HUMULIN R U-500 Patient Information Leaflet for additional information [see WARNINGS AND PRECAUTIONS].
Women with diabetes should be advised to inform their doctor if they are pregnant or are contemplating pregnancy. Â
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Never use HUMULIN R U-500 if it has become viscous (thickened) or cloudy; use it only if it is clear and colorless.
HUMULIN R U-500 should not be used after the printed expiration date.
Do not dilute or mix HUMULIN R U-500 with any other insulin products or solutions [see DOSAGE AND ADMINISTRATION].
Carcinogenicity and fertility studies were not performed with HUMULIN R U-500 in animals. Biosynthetic human insulin was not genotoxic in the in vivo sister chromatid exchange assay and the in vitro gradient plate and unscheduled DNA synthesis assays.
Pregnancy Category B
All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. This background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. It is essential for patients with diabetes or history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. In patients with diabetes or gestational diabetes, insulin requirements may decrease during the first trimester, generally increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring of glucose control is essential in these patients. Therefore, female patients should be advised to tell their physicians if they intend to become, or if they become pregnant while taking HUMULIN R U-500.
While there are no adequate and well-controlled studies in pregnant women, evidence from published literature suggests that good glycemic control in patients with diabetes during pregnancy provides significant maternal and fetal benefits.
Reproduction and fertility studies were not performed in animals.
Endogenous insulin is present in human milk. Insulin orally ingested is degraded in the gastrointestinal tract. No adverse reactions associated with infant exposure to insulin through the consumption of human milk have been reported. In a study of eight preterm infants between 26 to 30 weeks gestation, enteral administration of biosynthetic human insulin did not result in hypoglycemia. Good glucose control supports lactation in patients with diabetes. Women with diabetes who are lactating may require adjustments in their insulin dose.
There are no well-controlled studies of use of HUMULIN R U-500 in children. Standard precautions as applied to use of HUMULIN R U-500 in adults are appropriate for use in children. As in adults, the dosage of HUMULIN R U-500 in pediatric patients must be individualized based on metabolic needs and results of frequent monitoring of blood glucose.
The effect of age on the pharmacokinetics and pharmacodynamics of HUMULIN R U-500 has not been studied. Caution should be exercised when HUMULIN R U-500 is administered to geriatric patients. In elderly patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemia.
Frequent glucose monitoring and insulin dose reduction may be required in patients with renal impairment.
Frequent glucose monitoring and insulin dose reduction may be required in patients with hepatic impairment.
Excess insulin administration may cause hypoglycemia and hypokalemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise 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.
HUMULIN R U-500 is contraindicated:
Regulation of glucose metabolism is the primary activity of insulins, including HUMULIN R U-500. Insulins lower blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis, and enhance protein synthesis.
In a euglycemic clamp study of 24 healthy obese subjects (BMI=30-39 kg/m²), single doses of HUMULIN R U-500 at 50 units (0.4-0.6 unit/kg) and 100 units (0.8-1.3 unit/kg) resulted in a mean time of onset of action of less than 15 minutes at both doses and a mean duration of action of 21 hours (range 13-24 hours). The time action characteristics reflect both prandial and basal activity, consistent with clinical experience. This effect has been attributed to the high concentration of the preparation.
Figure 1 should be considered a representative example since the time course of action of insulin may vary in different individuals or within the same individual. The rate of insulin absorption and consequently the onset of activity is known to be affected by the site of injection, exercise, and other variables [see WARNINGS AND PRECAUTIONS].
Figure 1: Mean Insulin Activity Versus Time Profiles
After Subcutaneous Injection of a 100 U Dose of HUMULIN R U-500 in Healthy
Obese Subjects
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In a euglycemic clamp study of 24 healthy obese subjects, the median peak insulin level occurred between 4 hours (50 unit dose) and 8 hours (100 unit dose) with a range of 0.5-8 hours.
The uptake and degradation of insulin occurs predominantly in liver, kidney, muscle, and adipocytes, with the liver being the major organ involved in the clearance of insulin.
Mean apparent half-life after subcutaneous administration of single doses of 50 units and 100 units to healthy obese subjects (N≥21) was approximately 4.5 hours (range=1.9-10 hours) for HUMULIN R U-500.
Figure 2: Mean Serum Insulin Concentrations Versus
Time After Subcutaneous Injection of a 100 U Dose of HUMULIN R U-500 Healthy
Obese Subjects
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Humulin ®
(HU-mu-lin) R U-500 insulin human injection (500 units per mL)
Do not share your Humulin R U-500 KwikPen or U-500 insulin 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 R U-500?
Who should not take Humulin R U-500?
Do not take Humulin R U-500 if you:
What should I tell my healthcare provider before using Humulin R U-500?
Before using Humulin R U-500, tell your healthcare provider about all your medical conditions including, if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.
Before you start using Humulin R U-500, talk to your healthcare provider about low blood sugar and how to manage it.
How should I use Humulin R U-500?
Keep Humulin R U-500 and all medicines out of reach of children.
Your dose of Humulin R U-500 may need to change because of:
What should I avoid while using Humulin R U-500?
While using Humulin R U-500 do not:
This Patient Information has been approved by the U.S. Food and Drug Administration.
What are the possible side effects of Humulin R U-500?
Humulin R U-500 may cause serious side effects that can lead to death, including:
Treatment with TZDs and Humulin R U-500 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:
The most common side effects of Humulin R U-500 include:
These are not all of the possible side effects of Humulin R U-500. 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 R U-500
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Humulin R U-500 for a condition for which it was not prescribed. Do not give Humulin R U-500 to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information leaflet summarizes the most important information about Humulin R U-500. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Humulin R U-500 that is written for healthcare professionals. For more information go to www.humulin.com or call 1-800-545-5979.
What are the ingredients in Humulin R U-500?
Active ingredient: human insulin
Inactive ingredients: glycerin, metacresol, zinc oxide, water for injection, sodium hydroxide and hydrochloric acid
For more information about Humulin R U-500 go to www.humulin.com.
Instructions for Use
Humulin® R U-500
insulin human injection (500 units/mL, 20 mL vial)
Please read these instructions before use.
Warnings
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U-500 syringe – for single injection only
The U-500 syringe has a green U-500 symbol and a green Needle Shield on the syringe.
Important Information
Additional Safety Information
Supplies
Humulin R U-500 vial
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Before You Start
Use only a U-500 syringe to inject Humulin R U-500 insulin
Prepare
Step 1: Find the line on the U-500 syringe that matches your prescribed dose. This is your Dose Line.
Each line is 5 units.
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(Example: Arrow shows Dose Line at 85 units)
Step 2: If you are using a new vial, pull off the plastic Protective Cap.
Do not remove the Rubber Stopper.
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Step 3: Wipe the Rubber Stopper with an alcohol swab
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Step 4: Hold the syringe with the Needle pointing up. Pull down on the Plunger Rod until the Plunger Tip reaches your Dose Line.
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(Example Dose: 85 units shown)
Step 5: Push the Needle through the Rubber Stopper of the vial.
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Step 6: Push the Plunger all the way in. This puts air into the vial.
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Step 7: Turn the vial and syringe upside down and slowly pull the Plunger down until the Plunger Tip is past your Dose Line.
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(Example Dose: 85 units Plunger is shown at 100 units)
If there are air bubbles, tap the syringe gently a few times. This lets the air bubbles rise to the top.
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Step 8: Slowly push the Plunger up until the Plunger Tip reaches your Dose Line.
Check the syringe to make sure that you have the right dose.
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(Example Dose: 85 units shown)
Step 9: Pull the syringe out of the vial's Rubber Stopper.
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Inject
Step 10: Choose your injection site.
Humulin R U-500 is injected under the skin (subcutaneously). You may inject into your stomach area, buttocks, upper legs, or upper arms.
Wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose.
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Step 11: Insert the Needle into your skin.
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Step 12: Push down on the Plunger to inject your dose. Then keep the Needle in your skin for at least 5 seconds, to make sure you have injected all of your dose.
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Step 13: Pull the Needle out of your skin.
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Disposal of used syringes
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Storage and Handling
Unopened vials:
After the vial has been opened:
General Information
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Frequently Asked Questions
Why do I need to use a U-500 syringe?
Do I have to convert my Humulin R U-500 insulin dose when I use the U-500 syringe?
What should I do if I run out of U-500 syringes?
Where to get more information and help
Scan this code to launch the humulin.com website
These Instructions for Use have been approved by the U.S. Food and Drug Administration.
INSTRUCTIONS FOR USE
HUMULIN® R U-500 KwikPen®
insulin human injection U-500 (500 units/mL, 3 mL pen)
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Important:
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Read the Instructions for Use before you start taking HUMULIN R U-500 and each time you get another Pen. 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 R U-500 Pen 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 R U-500 KwikPen (“Pen”) is a disposable prefilled pen containing 1500 units of HUMULIN R. You can give yourself more than 1 dose from the Pen. Each turn (click) of the Dose Knob dials 5 units of insulin. You can give from 5 to 300 units in a single injection. The plunger only moves a little with each injection, and you may not notice that it moves. The plunger will only reach the end of the cartridge when you have used all 1500 units in the Pen.
People who are blind or have vision problems should not use the Pen without help from a person trained to use the Pen.
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How to recognize your HUMULIN R U-500 KwikPen
Supplies needed to give your injection
Preparing your Pen
Step 1:
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HUMULIN R U-500 should look clear and colorless. Do not use if it is cloudy, colored, or has particles or clumps in it.
Step 2:
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Step 3:
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Step 4:
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Priming your Pen
Prime before each injection.
Step 5:
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Step 6:
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Step 7:
Small air bubbles are normal and will not affect your dose.
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Selecting your dose
This Pen has been made to deliver the dose in insulin units that is shown in the Dose Window. Ask your healthcare provider what your dose should be for this Pen.
Step 8:
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Example: 80 units shown in Dose Window
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Example: 125 units shown in Dose Window
Giving your injection
Step 9:
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Step 10:
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Do not try to inject your insulin by turning the Dose Knob. You will not receive your insulin by turning the Dose Knob.
Step 11:
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The Plunger only moves a little with each injection, and you may not notice that it moves.
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.
After your injection
Step 12:
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Step 13:
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Step 14:
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Disposing of Pens and Needles
Storing your Pen
Unused Pens
In-use Pen
What you should know if you are switching to HUMULIN R U-500 KwikPen
Ask your healthcare provider what your dose should be for your Pen in insulin units. Always follow your healthcare provider's instructions for dosing.
| If you are: | It is important to know: |
| Switching from HUMULIN R U-500 vial (and syringe) | Your Pen may measure your dose differently. The markings in the Dose Window may not be the same as the markings on the syringe you used in the past. Ask your healthcare provider what dose in insulin units you should dial on your Pen. |
| Switching from another type of insulin device or pen. | The HUMULIN R U-500 KwikPen is different from other pens. It dials 5 insulin units with each click of the Dose Knob. Do not select your dose by counting clicks. You may not get enough insulin or you may get too much insulin. |
General information about the safe and effective use of your Pen
Troubleshooting
If you have any questions or problems with your HUMULIN R U-500 KwikPen, contact Lilly at 1-800-LillyRx (1- 800-545-5979) or call your healthcare provider for help. For more information on HUMULIN R U-500 KwikPen and insulin, go to www.humulin.com.
Scan this code to launch www.humulin.com
These Instructions for Use have been approved by the U.S. Food and Drug Administration.
