These highlights do not include all the information needed to use HUMULIN 70/30 safely and effectively. See full prescribing information for HUMULIN 70/30.HUMULIN 70/30 (insulin isophane human and insulin human) injectable suspension, for subcutaneous useInitial U.S. Approval: 1989

1 INDICATIONS AND USAGE

HUMULIN 70/30 is a fixed ratio insulin formulation indicated to improve glycemic control in adults with diabetes mellitus.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

Inspect HUMULIN 70/30 visually before use. It should not contain particulate matter and should appear uniformly cloudy after mixing. Do not use HUMULIN 70/30 if particulate matter is seen.

Administer HUMULIN 70/30 subcutaneously into the abdominal wall, thigh, upper arm, or buttocks. Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions (5.2) and Adverse Reactions (6)].
The HUMULIN 70/30 KwikPen dials in 1 unit increments.
Use HUMULIN 70/30 KwikPen with caution in patients with visual impairment that may rely on audible clicks to dial their dose.
Do not administer HUMULIN 70/30 intravenously and do not use in an insulin infusion pump.
Do not mix HUMULIN 70/30 with any other insulins or diluents.

2.2 Dosage Information

Inject HUMULIN 70/30 subcutaneously approximately 30-45 minutes before a meal.
The proportion of rapid acting and long acting insulin is fixed in a premixed insulin such as HUMULIN 70/30. Independent adjustment of the basal or prandial dose is not possible when using a premixed insulin.
Individualize and adjust the dosage of HUMULIN 70/30 based on the individual's metabolic needs, blood glucose monitoring results and glycemic control goal. Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness [see Warnings and Precautions (5.2, 5.3), and Use in Specific Populations (8.6, 8.7)].
During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions (5.2)].
HUMULIN 70/30 dose requirements may change with changes in level of physical activity, meal patterns (i.e., macronutrient content or timing of food intake), during major illness, or with some coadministered drugs [see Warnings and Precautions (5.3), Drug Interactions (7), and Use in Specific Populations (8.6, 8.7)].

3 DOSAGE FORMS AND STRENGTHS

Injectable suspension: 70% insulin isophane human and 30% insulin human, 100 units/mL (U-100), white and cloudy suspension available as:

10 mL multiple-dose vial
3 mL multiple-dose vial
3 mL single-patient-use HUMULIN 70/30 KwikPen prefilled pen

4 CONTRAINDICATIONS

HUMULIN 70/30 is contraindicated:

During episodes of hypoglycemia [see Warnings and Precautions (5.3)], and
In patients who have had hypersensitivity reactions to HUMULIN 70/30 or any of its excipients [see Warnings and Precautions (5.5)].

5 WARNINGS AND PRECAUTIONS

5.1 Never Share a HUMULIN 70/30 KwikPen or Syringe Between Patients

HUMULIN 70/30 KwikPens must never be shared between patients, even if the needle is changed. Patients using HUMULIN 70/30 vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.

5.2 Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen

Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia [see Warnings and Precautions (5.3)] or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia [see Adverse Reactions (6)].

Make any changes to a patient's insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, dosage adjustments of concomitant antidiabetic products may be needed.

5.3 Hypoglycemia

Hypoglycemia is the most common adverse reaction associated with insulins, including HUMULIN 70/30. Severe hypoglycemia can cause seizures, may be life-threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place the patient 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 patient and change over time in the same patient. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic neuropathy, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers) [see Drug Interactions (7)], or in patients who experience recurrent hypoglycemia.

SPL UNCLASSIFIED SECTION

Risk Factors for Hypoglycemia

The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal. As with all insulins, the glucose lowering effect time course of HUMULIN 70/30 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 [see Clinical Pharmacology (12.2)].

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 concomitant drugs [see Drug Interactions (7)]. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia [see Use in Specific Populations (8.6, 8.7)].

SPL UNCLASSIFIED SECTION

Risk Mitigation Strategies for Hypoglycemia

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.

5.4 Hypoglycemia Due to Medication Errors

Accidental mix-ups between insulin products have been reported. To avoid medication errors between HUMULIN 70/30 and other insulins, instruct patients to always check the insulin label before each injection.

5.5 Hypersensitivity Reactions

Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulins, including HUMULIN 70/30. If hypersensitivity reactions occur, discontinue HUMULIN 70/30; treat per standard of care and monitor until symptoms and signs resolve [see Adverse Reactions (6)]. HUMULIN 70/30 is contraindicated in patients who have had hypersensitivity reactions to HUMULIN 70/30 or any of its excipients.

5.6 Hypokalemia

All insulins, including HUMULIN 70/30, 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. Monitor potassium levels in patients at risk for hypokalemia if indicated (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations).

5.7 Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists

Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including HUMULIN 70/30, 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.

6 ADVERSE REACTIONS

The following adverse reactions are discussed elsewhere in the labeling:

The following additional adverse reactions have been identified during post-approval use of HUMULIN 70/30. 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 [see Warnings and Precautions (5.3)].
Hypoglycemia Due to Medication Errors [see Warnings and Precautions (5.4)].
Hypersensitivity Reactions [see Warnings and Precautions (5.5)].
Hypokalemia [see Warnings and Precautions (5.6)].

SPL UNCLASSIFIED SECTION

Allergic Reactions

Some patients taking HUMULIN 70/30 have experienced erythema, local edema, and pruritus at the site of injection. These conditions were usually self-limiting. Severe cases of generalized allergy (anaphylaxis) have been reported [see Warnings and Precautions (5.5)].

SPL UNCLASSIFIED SECTION

Peripheral Edema

Some patients taking HUMULIN 70/30 have experienced sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.

SPL UNCLASSIFIED SECTION

Lipodystrophy

Administration of insulin subcutaneously, including HUMULIN 70/30, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) [see Dosage and Administration (2.1)] in some patients.

SPL UNCLASSIFIED SECTION

Localized Cutaneous Amyloidosis

Localized cutaneous amyloidosis at the injection site has occurred. Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.

SPL UNCLASSIFIED SECTION

Weight gain

Weight gain has occurred with insulins, including HUMULIN 70/30, and has been attributed to the anabolic effects of insulin and the decrease in glycosuria.

SPL UNCLASSIFIED SECTION

Immunogenicity

Development of antibodies that react with human insulin have been observed with all insulins, including HUMULIN 70/30.

7 DRUG INTERACTIONS

Drugs that May Increase the Risk of Hypoglycemia
Drugs:	Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), and sulfonamide antibiotics
Intervention:	Dose adjustment and increased frequency of glucose monitoring may be required when HUMULIN 70/30 is co-administered with these drugs.
Drugs that May Decrease the Blood Glucose Lowering Effect of HUMULIN 70/30
Drugs:	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.
Intervention:	Dose adjustment and increased frequency of glucose monitoring may be required when HUMULIN 70/30 is co-administered with these drugs.
Drugs that May Increase or Decrease the Blood Glucose Lowering Effect of HUMULIN 70/30
Drugs:	Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
Intervention:	Dose adjustment and increased frequency of glucose monitoring may be required when HUMULIN 70/30 is co-administered with these drugs.
Drugs that May Blunt Signs and Symptoms of Hypoglycemia
Drugs:	Beta-blockers, clonidine, guanethidine, and reserpine
Intervention:	Increased frequency of glucose monitoring may be required when HUMULIN 70/30 is co-administered with these drugs.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

SPL UNCLASSIFIED SECTION

Risk Summary

Available data from published studies over decades have not established an association with human insulin use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations). Animal reproduction studies were not performed.

The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a HbA1c >7% and has been reported to be as high as 20-25% in women with a HbA1c >10%. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

SPL UNCLASSIFIED SECTION

Clinical Considerations

SPL UNCLASSIFIED SECTION

Disease-associated maternal and/or embryo/fetal risk

Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity.

SPL UNCLASSIFIED SECTION

Data

Human Data

While available studies cannot definitively establish the absence of risk, published data from retrospective studies, open-label, randomized, parallel studies and meta-analyses over decades have not established an association with human insulin use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. All available studies have methodological limitations, including lack of blinding, unclear methods or randomization, and small sample size.

8.2 Lactation

SPL UNCLASSIFIED SECTION

Risk Summary

Available data from published literature suggests that exogenous human insulin products, including HUMULIN 70/30, are transferred into human milk. There are no adverse reactions reported in breastfed infants in the literature. There are no data on the effects of exogenous human insulin products, including HUMULIN 70/30 on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for HUMULIN 70/30 and any potential adverse effects on the breastfed child from HUMULIN 70/30 or from the underlying maternal condition.

8.4 Pediatric Use

The safety and effectiveness of HUMULIN 70/30 in pediatric patients have not been established.

8.5 Geriatric Use

The effect of age on the pharmacokinetics and pharmacodynamics of HUMULIN 70/30 has not been studied [see Clinical Pharmacology (12.3)]. Patients with advanced age using any insulin, including HUMULIN 70/30, may be at increased risk of hypoglycemia due to co-morbid disease and polypharmacy [see Warnings and Precautions (5.3)].

8.6 Renal Impairment

The effect of renal impairment on the pharmacokinetics and pharmacodynamics of HUMULIN 70/30 has not been studied [see Clinical Pharmacology (12.3)]. Patients with renal impairment are at increased risk of hypoglycemia and may require more frequent HUMULIN 70/30 dose adjustment and more frequent blood glucose monitoring.

8.7 Hepatic Impairment

The effect of hepatic impairment on the pharmacokinetics and pharmacodynamics of HUMULIN 70/30 has not been studied [see Clinical Pharmacology (12.3)]. Patients with hepatic impairment are at increased risk of hypoglycemia and may require more frequent HUMULIN 70/30 dose adjustment and more frequent blood glucose monitoring.

10 OVERDOSAGE

Excess insulin administration may cause hypoglycemia and hypokalemia [see Warnings and Precautions (5.3, 5.6)]. Mild episodes of hypoglycemia can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or physical activity level may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with a glucagon product for emergency use 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.

11 DESCRIPTION

Insulin human is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. The amino acid sequence of insulin human is identical to human insulin and has the empirical formula C257H383N65O77S6 with a molecular weight of 5.808 kDa.

HUMULIN 70/30 (insulin isophane human and insulin human) injectable suspension is a mixture of 70% insulin isophane human suspension, an intermediate-acting insulin, and 30% insulin human injection, a short-acting insulin. HUMULIN 70/30 is a suspension of crystals produced from combining insulin human and protamine sulfate under appropriate conditions for crystal formation and mixing with insulin human injection.

HUMULIN 70/30 is a sterile, white and cloudy suspension that contains insulin isophane human suspension (NPH) and insulin human injection (regular) for subcutaneous use. Each milliliter of HUMULIN 70/30 contains 100 units of insulin human, dibasic sodium phosphate (3.78 mg), glycerin (16 mg), metacresol (1.6 mg), phenol (0.65 mg), protamine sulfate (0.24 mg), zinc oxide content adjusted to provide 0.025 mg zinc ion, and Water for Injection. The pH is 7.0 to 7.8. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust the pH.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

HUMULIN 70/30 lowers 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.

12.2 Pharmacodynamics

HUMULIN 70/30 combines an intermediate-acting insulin with the more rapid onset of action of regular human insulin. In healthy males (n=18) given HUMULIN 70/30 (0.3 unit/kg) subcutaneously, the pharmacologic effect began at approximately 50 minutes (range: 30 to 90 minutes) (see Figure 1). The effect was maximal at approximately 3.5 hours (range: 1.5 to 6.5 hours) and the mean duration of action was relatively long (approximately 23 hours; range: 18-24 hours).

Figure 1 should be considered only as 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, physical activity level, and other variables [see Warnings and Precautions (5.3)].

12.3 Pharmacokinetics

SPL UNCLASSIFIED SECTION

Absorption — In healthy male subjects given HUMULIN 70/30 (0.3 unit/kg) subcutaneously, the mean peak serum concentration occurred at 2.2 hours (range: 1 to 5 hours) after dosing.

SPL UNCLASSIFIED SECTION

Metabolism — 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.

SPL UNCLASSIFIED SECTION

Elimination — Because of the absorption-rate limited kinetics of insulin mixtures, a true half-life cannot be accurately estimated from the terminal slope of the concentration versus time curve.

SPL UNCLASSIFIED SECTION

Specific Populations

The effects of age, gender, race, obesity, pregnancy, or smoking on the pharmacokinetics of HUMULIN 70/30 have not been studied.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity and fertility studies were not performed 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.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

HUMULIN 70/30 (insulin isophane human and insulin human) injectable suspension is 70% insulin isophane human and 30% insulin human, 100 units/mL (U-100), a white and cloudy suspension available as:

Each prefilled HUMULIN 70/30 KwikPen is for use by a single patient. HUMULIN 70/30 KwikPens must never be shared between patients, even if the needle is changed. Patients using HUMULIN 70/30 vials must never share needles or syringes with another person.

The HUMULIN 70/30 KwikPen dials in 1 unit increments.

10 mL multiple-dose vial	NDC 0002-8715-01 (HI-710)
3 mL multiple-dose vial	NDC 0002-8715-17 (HI-713)
5 x 3 mL single-patient-use HUMULIN 70/30 KwikPen	NDC 0002-8803-59 (HP-8803)

16.2 Storage and Handling

Dispense in the original sealed carton with the enclosed Instructions for Use.

Protect from heat and light. Do not freeze. Do not use if it has been frozen. See Table 2 below for storage conditions.

Not In-use(Unopened)	In-use(Opened)
Room Temperature(up to 86°F [30°C])	Refrigerated(36° to 46°F [2° to 8°C])	Room Temperature(up to 86°F [30°C])	Refrigerated(36° to 46°F [2° to 8°C])
10 mL multiple-dose viala3 mL multiple-dose viala	31 days	Until expiration date	31 days	31 days
3 mL single-patient-use HUMULIN 70/30 KwikPenb	10 days	Until expiration date	10 days	Do not refrigerate.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

SPL UNCLASSIFIED SECTION

Never Share a HUMULIN 70/30 KwikPen or Syringe Between Patients

Advise patients that they must never share a HUMULIN 70/30 KwikPen with another person, even if the needle is changed. Advise patients using HUMULIN 70/30 vials not to share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens [see Warnings and Precautions (5.1)].

SPL UNCLASSIFIED SECTION

Hyperglycemia or Hypoglycemia

Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia especially at initiation of HUMULIN 70/30 therapy. Instruct patients 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. Instruct patients on the management of hypoglycemia.

Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery [see Warnings and Precautions (5.3)].

Advise patients that changes in insulin regimen can predispose to hyperglycemia or hypoglycemia and that changes in insulin regimen should be made under close medical supervision [see Warnings and Precautions (5.2)].

Inform patients that accidental mix-ups between insulin products have been reported. Instruct patients to always carefully check that they are administering the correct insulin (e.g., by checking the insulin label before each injection) to avoid medication errors between HUMULIN 70/30 and other insulins.

SPL UNCLASSIFIED SECTION

Hypersensitivity Reactions

Advise patients that hypersensitivity reactions have occurred with HUMULIN 70/30. Inform patients on the symptoms of hypersensitivity reactions [see Warnings and Precautions (5.5)].

SPL UNCLASSIFIED SECTION

____________

HUMULIN® and HUMULIN® 70/30 KwikPen® are trademarks of Eli Lilly and Company.

Literature revised June 2022

LIN7030-0006-USPI-20220627

SPL PATIENT PACKAGE INSERT SECTION

PATIENT INFORMATIONHUMULIN® (HU-mu-lin) 70/30(insulin isophane human and insulin human)injectable suspension, for subcutaneous use

Do not share your HUMULIN 70/30 KwikPen 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.

What is HUMULIN 70/30?

Who should not use HUMULIN 70/30?

Do not use HUMULIN 70/30 if you:

Before using HUMULIN 70/30, tell your healthcare provider about all your medical conditions including, if you:

Before you start using HUMULIN 70/30, talk to your healthcare provider about low blood sugar and how to manage it.

How should I use HUMULIN 70/30?

Your HUMULIN 70/30 dose may need to change because of:

What should I avoid while using HUMULIN 70/30?

While using HUMULIN 70/30 do not:

What are the possible side effects of HUMULIN 70/30?

HUMULIN 70/30 may cause serious side effects that can lead to death, including:

Get emergency medical help if you have:

The most common side effects of HUMULIN 70/30 include:

General information about the safe and effective use of HUMULIN 70/30:

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about HUMULIN 70/30 that is written for health professionals. Do not use HUMULIN 70/30 for a condition for which it was not prescribed. Do not give HUMULIN 70/30 to other people, even if they have the same symptoms that you have. It may harm them.

What are the ingredients in HUMULIN 70/30?

Active Ingredient: insulin human

Inactive Ingredients: dibasic sodium phosphate, glycerin, metacresol, phenol, protamine sulfate, zinc oxide, and Water for Injection as inactive ingredients. Sodium hydroxide and/or hydrochloric acid may be added to adjust the pH.

For more information, call 1-800-545-5979 or go to www.humulin.com.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Patient Information revised June 2022

LIN7030-0005-PPI-20220627

HUMULIN 70/30 is a man-made insulin that is used to control high blood sugar in adults with diabetes mellitus.

VIAL INSTRUCTIONS FOR USE

Instructions for UseHUMULIN® (HU-mu-lin) 70/30(insulin isophane human and insulin human)injectable suspension, for subcutaneous use3 mL or 10 mL multiple-dose vial (100 units/mL)

Read the Instructions for Use before you start taking HUMULIN 70/30 and each time you get a new HUMULIN 70/30 vial. 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 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.

Supplies needed to give your injection:

Preparing your HUMULIN 70/30 dose:

Giving your HUMULIN 70/30 injection:

Disposing of used needles and syringes:

How should I store HUMULIN 70/30?

All unopened HUMULIN 70/30 vials:

After HUMULIN 70/30 vials have been opened:

General information about the safe and effective use of HUMULIN 70/30.

If you have any questions or problems with your HUMULIN, contact Lilly at 1-800-Lilly-Rx (1-800-545-5979) or call your healthcare provider for help. For more information on HUMULIN and insulin, go to www.humulin.com.

Scan this code to launch the humulin.com website

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Humulin® is a trademark of Eli Lilly and Company.

Instructions for Use revised: June 2022

LIN7030VL-0005-IFU-20220627

Vial	Syringe

Step 1:Gently roll the vial between the palms of your hands at least 10 times.
Step 2:Carefully invert the vial at least 10 times.Mixing is important to make sure you get the right dose. Humulin 70/30 should look white and cloudy after mixing. Do not use it if it looks clear or contains any lumps or particles.
Step 3:If you are using a new vial, pull off the plastic Protective Cap, but do not remove the Rubber Stopper.
Step 4:Wipe the Rubber Stopper with an alcohol swab.
Step 5:Hold the syringe with the needle pointing up. Pull down on the Plunger until the tip of the Plunger reaches the line for the number of units for your prescribed dose.	(Example Dose: 20 units shown)
Step 6:Push the needle through the Rubber Stopper of the vial.
Step 7:Push the plunger all the way in. This puts air into the vial.
Step 8:Turn the vial and syringe upside down and slowly pull the Plunger down until the tip is a few units past the line for your prescribed dose.If there are air bubbles, tap the syringe gently a few times to let any air bubbles rise to the top.	(Example Dose: 20 units Plunger is shown at 24 units)
Step 9:Slowly push the Plunger up until the tip reaches the line for your prescribed dose.Check the syringe to make sure that you have the right dose.	(Example Dose: 20 units shown)
Step 10:Pull the syringe out of the vial's Rubber Stopper.

Step 11:Choose your injection site.HUMULIN 70/30 is injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs or upper arms.Wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose.
Step 12:Insert the needle into your skin.
Step 13:Push down on the Plunger to inject your dose.The needle should stay in your skin for at least 5 seconds to make sure you have injected all of your insulin dose.
Step 14:Pull the needle out of your skin.If you see blood after you take the needle out of your skin, press the injection site with a piece of gauze or an alcohol swab. Do not rub the area. Do not recap the needle. Recapping the needle can lead to a needle stick injury.

a 3 mL or 10 mL multiple-dose HUMULIN 70/30 vial
a U-100 insulin syringe and needle
2 alcohol swabs
1 sharps container for throwing away used needles and syringes. See “Disposing of used needles and syringes” at the end of these instructions.

KWIKPEN INSTRUCTIONS FOR USE

Instructions for Use

HUMULIN® 70/30 KwikPen®

(insulin isophane human and insulin human)injectable suspension, for subcutaneous use3 mL single-patient-use pen (100 units/mL)

Read the Instructions for Use before you start taking HUMULIN 70/30 and each time you get another KwikPen. 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 70/30 KwikPen 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® 70/30 KwikPen® (“Pen”) is a disposable single-patient-use prefilled pen containing 300 units of HUMULIN 70/30. You can give yourself more than 1 dose from the Pen. Each turn (click) of the Dose Knob dials 1 unit of insulin. You can give from 1 to 60 units in a single injection. If your dose is more than 60 units, you will need to give yourself more than 1 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 300 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.

How to recognize your HUMULIN 70/30 KwikPen

Supplies you will need to give your injection

Preparing your Pen

Priming your Pen

Prime before each injection.

Selecting your dose

Giving your injection

After your injection

Disposing of Pens and Needles

Storing your Pen

Unused Pens

In-use Pen

General information about the safe and effective use of your Pen

Troubleshooting

If you have any questions or problems with your HUMULIN 70/30 KwikPen, contact Lilly at 1-800-LillyRx (1-800-545-5979) or call your healthcare provider for help. For more information on HUMULIN 70/30 KwikPen and insulin, go to www.lilly.com.

Scan this code to launch

www.humulin.com

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

HUMULIN® and HUMULIN® KwikPen® are trademarks of Eli Lilly and Company.

Revised: June 2022

Manufactured by:Eli Lilly and CompanyIndianapolis, IN 46285, USAUS License Number 1891

LIN7030KP-0008-IFU-20220627

Step 1:Pull the Pen Cap straight off.-Do not remove the Pen Label. Wipe the Rubber Seal with an alcohol swab.-Do not attach the Needle before mixing.
Step 2:Gently roll the Pen between your hands 10 times.
Step 3:Move the Pen up and down (invert) 10 times.Mixing by rolling and inverting the Pen is important to make sure you get the right dose.
Step 4:Check the liquid in the Pen. HUMULIN 70/30 should look white and cloudy after mixing. Do not use if it looks clear or has any lumps or particles in it.
Step 5:Select a new Needle.Pull off the Paper Tab from the Outer Needle Shield.
Step 6:Push the capped Needle straight onto the Pen and twist the Needle on until it is tight.
Step 7:Pull off the Outer Needle Shield. Do not throw it away. Pull off the Inner Needle Shield and throw it away.

Step 8:To prime your Pen, turn the Dose Knob to select 2 units.
Step 9:Hold your Pen with the Needle pointing up. Tap the Cartridge Holder gently to collect air bubbles at the top.
Step 10:Continue holding 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. You should see insulin at the tip of the Needle.-If you do not see insulin, repeat priming steps 8 to 10, no more than 4 times. -If you still do not see insulin, change the Needle and repeat priming steps 8 to 10. Small air bubbles are normal and will not affect your dose.

Step 11:Turn the Dose Knob to select the number of units you need to inject. The Dose Indicator should line up with your dose.-The Pen dials 1 unit at a time. -The Dose Knob clicks as you turn it. -Do not dial your dose by counting the clicks. You may dial the wrong dose. This may lead to you getting too much insulin or not enough insulin. -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 (for example, 12) are printed on the dial. -The odd numbers, (for example, 25) after the number 1, are shown as full lines. Always check the number in the Dose Window to make sure you have dialed the correct dose.	(Example: 12 units shown in the Dose Window)(Example: 25 units shown in the Dose Window)

Step 12:Choose your injection site.HUMULIN 70/30 is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms. Wipe your skin with an alcohol swab, and let your skin dry before you inject your dose.
Step 13:Insert the Needle into your skin. Push the Dose Knob all the way in. Continue to hold the Dose Knob in and slowly count to 5 before removing the Needle.Do not try to inject your insulin by turning the Dose Knob. You will not receive your insulin by turning the Dose Knob.
Step 14:Pull the Needle out of your skin.A drop of insulin at the Needle tip is normal. It will not affect your dose. Check the number in the Dose Window.-If you see “0” in the Dose Window, you have received the full amount you dialed. -If you do not see “0” in the Dose Window, do not redial. Insert the Needle into your skin and finish your injection. -If you still do not think you received the full amount you dialed for your injection, do not start over or repeat the injection. Monitor your blood glucose as instructed by your healthcare provider. -If you normally need to give 2 injections for your full dose, be sure to give your second injection. 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.

Step 15:Carefully replace the Outer Needle Shield.
Step 16:Unscrew the capped Needle and throw it away (see Disposing of Pens and Needles section). Do not store the Pen with the Needle attached to prevent leaking, blocking the Needle, and air from entering the Pen.
Step 17:Replace the Pen Cap by lining up the Cap Clip with the Dose Indicator and pushing straight on.

HUMULIN 70/30 KwikPen meets the current dose accuracy and functional requirements of ISO 11608-1.

Pen color: Beige
Dose Knob: Brown
Labels: White label with brown stripe

PACKAGE CARTON – HUMULIN 70/30 Vial 10 mL

NDC 0002-8715-01

100 units per mL (U-100)

Humulin® 70/30

(insulin isophane human and insulin human)

injectable suspension

10 mL multiple-dose vial

Use only with a U-100 syringe

For subcutaneous use only.

U-100

www.lilly.com

Lilly

PACKAGE LABEL – Humulin 7030 KwikPen 3mL

5 x 3 mL prefilled pens

NDC 0002-8803-59

HP-8803

Humulin® 70/30 KwikPen®

(insulin isophane human and insulin human)

injectable suspension

For Single Patient Use Only

Dispense in this sealed carton

Read Insulin Delivery Device Instructions for Use

For subcutaneous use only.

prefilled insulin delivery device

100 units per mL (U-100)

Needles not included

This device is suitable for use with Becton, Dickinson and Company's insulin pen needles.

Lilly

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