Humulin 70/30

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

Humulin 70/30

Medically reviewed by Philip Thornton, DipPharm. Last updated on Aug 22, 2022.

What is Humulin 70/30?

Humulin 70/30 contains a combination of insulin isophane and insulin regular. Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin isophane is a intermediate-acting insulin. Insulin regular is an short-acting insulin. This combination insulin starts to work within 10 to 20 minutes after injection, peaks in 2 hours, and keeps working for up to 24 hours.

Humulin 70/30 is used to improve blood sugar control in adults with diabetes mellitus.

Humulin 70/30 may also be used for purposes not listed in this medication guide.

Warnings

Do not use Humulin 70/30 if you are having an episode of hypoglycemia (low blood sugar).

Hypoglycemia, or low blood sugar, is the most common side effect of Humulin 70/30. Symptoms of low blood sugar may include headache, hunger, sweating, pale skin, irritability, dizziness, feeling shaky, or trouble concentrating. Watch for signs of low blood sugar. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Never share an injection pen or syringe with another person, even if the needle has been changed.

Related/similar drugs

Before taking this medicine

You should not use Humulin 70/30 if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Humulin 70/30 is not approved for use by anyone younger than 18 years old.

To make sure this medicine is safe for you, tell your doctor if you have:

• congestive heart failure or other heart problems;
• liver or kidney disease; or
• low levels of potassium in your blood (hypokalemia).

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor’s instructions about using Humulin 70/30 if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

How should I take Humulin 70/30?

Use Humulin 70/30 exactly as it was prescribed for you. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Insulin is injected under the skin. You will be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.

Humulin 70/30 must not be given with an insulin pump, or mixed with other insulins. Do not inject Humulin 70/30 into a vein or a muscle.

Your care provider will show you the best places on your body to inject Humulin 70/30. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Do not inject this medicine into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

After using Humulin 70/30, you should eat a meal within 30 to 45 minutes.

If you use an injection pen, use only the injection pen that comes with Humulin 70/30. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe.

Never share a Humulin 70/30 injection pen or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

Use a disposable needle or syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof “sharps” disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your insulin dose or schedule.

Insulin is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

Keep Humulin 70/30 in its original container protected from heat and light. Do not draw insulin from a vial into a syringe until you are ready to give an injection. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) Humulin 70/30:

• Refrigerate and use until expiration date; or
• Store at room temperature, and use the vial within 31 days or use the injection pen within 10 days.

Storing opened (in use) Humulin 70/30:

• Store the vial in a refrigerator or at room temperature and use within 31 days.
• Store the injection pen at room temperature (do not refrigerate) and use within 10 days. Do not store the injection pen with a needle attached.

Humulin 70/30 should look cloudy after mixing. Do not use the mixture if it looks clear or has particles in it. Call your pharmacist for new medicine.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Wear a diabetes medical alert tag in case of emergency. Any medical care provider who treats you should know that you have diabetes.

What happens if I miss a dose?

Since Humulin 70/30 is used with a meal, you may not be on a timed dosing schedule. Whenever you use this insulin, be sure to eat a meal within 45 minutes. Do not use extra medicine to make up a missed dose.

Keep insulin on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

What to avoid

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how this medicine will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol. It can cause low blood sugar and may interfere with your diabetes treatment.

Humulin 70/30 side effects

Get emergency medical help if you have signs of insulin allergy to Humulin 70/30: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, wheezing, rapid pulse, sweating, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• fluid retention – weight gain, swelling in your hands or feet, feeling short of breath; or
• low potassium – leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common Humulin 70/30 side effects may include:

• low blood sugar;
• itching, mild skin rash; or
• thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Humulin 70/30?

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of insulin. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Popular FAQ

Injecting insulin is not difficult, but it does take a bit of practice. There are three main sites where insulin can be injected: the stomach area except for a 2-inch circle around your navel, and the soft part of your waist, but not anywhere near your spine; the top and outer part of your thighs, but not your inner thighs or anywhere close to your knee; the outer back of your upper arm where there is a pocket of fatty tissue. Continue reading

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• Humulin 70/30

Humulin 70/30 Prescribing Information

Medically reviewed by Drugs.com. Last updated on Oct 24, 2022.

On This Page

• Indications and Usage
• Dosage and Administration
• Dosage Forms and Strengths
• Contraindications
• Warnings and Precautions
• Adverse Reactions/Side Effects
• Drug Interactions
• Use In Specific Populations
• Overdosage
• Description
• Clinical Pharmacology
• Nonclinical Toxicology
• How Supplied/Storage and Handling
• Patient Counseling Information

Indications and Usage for Humulin 70/30

HUMULIN 70/30 is a fixed ratio premix recombinant human insulin formulation indicated to improve glycemic control in adult patients with diabetes mellitus.

Related/similar drugs

Humulin 70/30 Dosage and Administration

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. Do not mix HUMULIN 70/30 with any other insulins or diluents.

Route of Administration

HUMULIN 70/30 should only be administered subcutaneously. Administer in the subcutaneous tissue of the abdominal wall, thigh, upper arm, or buttocks. To reduce the risk of lipodystrophy, rotate the injection site within the same region from one injection to the next [see Adverse Reactions (6)] .

Do not administer HUMULIN 70/30 intravenously or intramuscularly and do not use HUMULIN 70/30 in an insulin infusion pump.

Dosage Information

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)] .

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.

Physiological factors, disease states and concomitant drugs may impact the onset and duration of action of all insulins. 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)] .

Timing of Subcutaneous Administration

HUMULIN 70/30 should be given subcutaneously approximately 30-45 minutes before a meal.

Dosage Forms and Strengths

HUMULIN 70/30 injectable suspension: 100 units per mL (U-100) is available as:

• 10 mL vials
• 3 mL vials
• 3 mL prefilled pens
• 3 mL HUMULIN 70/30 KwikPen (prefilled)

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 (5.4)] .

Warnings and Precautions

Never Share a Humulin 70/30 Pen, Humulin 70/30 KwikPen, or Syringe Between Patients

Humulin 70/30 pens and 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.

Changes in Insulin Regimen

Changes in insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia [see Warnings and Precautions (5.3)] or hyperglycemia. These changes should be made cautiously and under close medical supervision and the frequency of blood glucose monitoring should be increased.

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 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 (7)] , or in patients who experience recurrent hypoglycemia.

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 insulin preparations, 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 co-administered medication [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)] .

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.

Hypersensitivity Reactions

Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, 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 [see Contraindications (4)] .

Hypokalemia

All insulin products, 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).

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, particularly 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.

Adverse Reactions

The following adverse reactions are discussed elsewhere in the labeling:

• Hypoglycemia [see Warnings and Precautions (5.3)] .
• Hypokalemia [see Warnings and Precautions (5.5)] .

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.

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 (5.4)] .

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

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 (2.2)] in some patients.

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

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

Drug Interactions

Drugs That May Increase the Risk of Hypoglycemia

The risk of hypoglycemia associated with HUMULIN 70/30 use may be increased when co-administered with antidiabetic agents, salicylates, sulfonamide antibiotics, monoamine oxidase inhibitors, fluoxetine, disopyramide, fibrates, propoxyphene, pentoxifylline, ACE inhibitors, angiotensin II receptor blocking agents, and somatostatin analogs (e.g., octreotide). 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

The glucose lowering effect of HUMULIN 70/30 may be decreased when co-administered with corticosteroids, isoniazid, niacin, estrogens, oral contraceptives, phenothiazines, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, albuterol, terbutaline), somatropin, atypical antipsychotics, glucagon, protease inhibitors, and thyroid hormones. 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

The glucose lowering effect of HUMULIN 70/30 may be increased or decreased when co-administered with beta-blockers, clonidine, lithium salts, and alcohol. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. 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

The signs and symptoms of hypoglycemia [see Warnings and Precautions (5.3)] may be blunted when beta-blockers, clonidine, guanethidine, and reserpine are co-administered with HUMULIN 70/30.

USE IN SPECIFIC POPULATIONS

Pregnancy

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 70/30.

While there are no adequate and well-controlled studies of HUMULIN 70/30 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 toxicity studies were not performed in animals.

Nursing Mothers

Endogenous insulin is present in human milk; it is unknown whether HUMULIN 70/30 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. Good glucose control supports lactation in patients with diabetes. Women with diabetes who are lactating may require adjustments in their insulin dose.

Pediatric Use

Safety and effectiveness of HUMULIN 70/30 in patients less than 18 years of age has not been established.

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)] .

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.

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.

Overdosage

Excess insulin administration may cause hypoglycemia and hypokalemia [see Warnings and Precautions (5.3, 5.5)] . 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 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 70/30 Description

HUMULIN 70/30 (70% human insulin isophane suspension and 30% human insulin injection [rDNA origin]) is a human insulin suspension. Human insulin is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. HUMULIN 70/30 is a suspension of crystals produced from combining human insulin and protamine sulfate under appropriate conditions for crystal formation and mixing with human insulin injection. The amino acid sequence of HUMULIN 70/30 is identical to human insulin and has the empirical formula C 257 H 383 N 65 O 77 S 6 with a molecular weight of 5808.

HUMULIN 70/30 is a sterile white suspension. Each milliliter of HUMULIN 70/30 contains 100 units of insulin human, 0.24 mg of protamine sulfate, 16 mg of glycerin, 3.78 mg of dibasic sodium phosphate, 1.6 mg of metacresol, 0.65 mg of phenol, 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.

Humulin 70/30 – Clinical Pharmacology

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.

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)] .

Figure 1: Mean Insulin Activity Versus Time Profiles After Subcutaneous Injection of HUMULIN 70/30 or HUMULIN ® R U‑100 (0.3 unit/kg) in Healthy Subjects.

Pharmacokinetics

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.

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.

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.

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

Careful glucose monitoring and dose adjustments of insulin, including HUMULIN 70/30, may be necessary in patients with renal or hepatic dysfunction [see Use in Specific Populations (8.6, 8.7)] .

Nonclinical Toxicology

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.

How Supplied/Storage and Handling

How Supplied

HUMULIN 70/30 100 units per mL (U-100) is available as:

Each prefilled Humulin 70/30 pen and Humulin 70/30 KwikPen is for use by a single patient. Humulin 70/30 pens and 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.

Storage and Handling

Protect from heat and light. Do not freeze. Do not use after the expiration date.

Not In-Use (Unopened) HUMULIN 70/30 Vials

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.

If stored at room temperature, below 86°F (30°C) the vial must be discarded after 31days.

In-Use (Opened) HUMULIN 70/30 Vials

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 31 days or be discarded, even if they still contain HUMULIN 70/30.

If stored at room temperature, below 86°F (30°C) the vial must be discarded after 31 days, even if the vial still contains HUMULIN 70/30.

Not In-Use (Unopened) HUMULIN 70/30 Pen and KwikPen

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.

If stored at room temperature, below 86°F (30°C) the pen must be discarded after 10 days.

In-Use (Opened) HUMULIN 70/30 Pen and KwikPen

Do NOT store in a refrigerator.

Store at room temperature, below 86°F (30°C) and the pen must be discarded after 10 days, even if the pen still contains HUMULIN 70/30. See storage table below:

Patient Counseling Information

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

Never Share a Humulin 70/30 Pen, Humulin 70/30 KwikPen, or Syringe Between Patients

Advise patients that they must never share a Humulin 70/30 pen or 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.

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)] .

Inform patients that accidental mix-ups between HUMULIN 70/30 and other insulins 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.

Advise patients that hypersensitivity reactions have occurred with HUMULIN 70/30. Inform patients on the symptoms of hypersensitivity reactions [see Warnings and Precautions (5.4)] .

Females with Reproductive Potential

Advise females of reproductive potential with diabetes to inform their doctor if they are pregnant or are contemplating pregnancy [see Use in Specific Populations (8.1)] .

Visual Inspection Prior to Use

Instruct patients to visually inspect HUMULIN 70/30 before use and to use HUMULIN 70/30 only if it contains no particulate matter and appears uniformly cloudy after mixing [see Dosage and Administration (2.1)] .

Instruct patients not to use HUMULIN 70/30 after the printed expiration date.

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

Literature revised February 25, 2015

Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA
Copyright © 1992, 2015, Eli Lilly and Company. All rights reserved.

PATIENT INFORMATION
HUMULIN ® (HU-mu-lin) 70/30
(70% human insulin isophane suspension and
30% human insulin injection [rDNA origin])

Do not share your Humulin 70/30 Pen, 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?

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

Who should not use Humulin 70/30?

Do not use Humulin 70/30 if you:

• are having an episode of low blood sugar (hypoglycemia).
• have an allergy to Humulin 70/30 or any of the ingredients in Humulin 70/30.

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

• have liver or kidney problems.
• take any other medicines, especially ones commonly called TZDs (thiazolidinediones).
• have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Humulin 70/30.
• are pregnant, planning to become pregnant, or are breastfeeding.
• are taking new prescription or over-the-counter medicines, vitamins, or herbal supplements.

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?

• Read the Instructions for Use that come with your Humulin 70/30.
• Use Humulin 70/30 exactly as your healthcare provider tells you to.
• Know the type and strength of insulin you use. Do not change the type of insulin you use unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you use different types of insulin.
• Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.
• Do not share your Humulin 70/30 Pen, 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.

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

• change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet.

What should I avoid while using Humulin 70/30?

While using Humulin 70/30 do not:

• Drive or operate heavy machinery, until you know how Humulin 70/30 affects you.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

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

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

• low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:
  • dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger.
  • a rash over your whole body, trouble breathing, a fast heartbeat, or sweating.
  • shortness of breath, swelling of your ankles or feet, sudden weight gain Treatment with TZDs and Humulin 70/30 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:

  • trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.

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

  • low blood sugar (hypoglycemia), allergic reactions including reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, weight gain, and swelling of your hands and feet. These are not all the possible side effects of Humulin 70/30. 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 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 (rDNA origin)

  Inactive Ingredients: protamine sulfate, glycerin, dibasic sodium phosphate, metacresol, phenol, zinc oxide, water for injection, hydrochloric acid or sodium hydroxide

  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 February 25, 2015

  Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA
  Copyright © 1992, 2015, Eli Lilly and Company. All rights reserved.

  Instructions for Use
  HUMULIN ® 70/30 KwikPen ®
  (70% human insulin isophane suspension
  30% human insulin injection [rDNA origin])

  Read the Instructions for Use before you start taking HUMULIN 70/30 and each time you get another HUMULIN ® 70/30 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 pen containing 3 mL (300 units) of U-100 HUMULIN ® 70/30 (70% human insulin isophane suspension and 30% human insulin injection [rDNA origin]) insulin. You can inject from 1 to 60 units in a single injection.

  HUMULIN 70/30 KwikPen has a blue and brown Label with a matching brown Dose Knob (See the KwikPen Parts diagram below).

  This Pen is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of the product.

  Supplies you will need to give your HUMULIN 70/30 injection:

  • HUMULIN 70/30 KwikPen
  • KwikPen compatible Needle (Becton, Dickinson and Company Pen Needles recommended)
  • alcohol swab

  Preparing HUMULIN 70/30 KwikPen:

  • Wash your hands with soap and water.
  • Check the HUMULIN 70/30 KwikPen Label to make sure you are taking the right type of insulin. This is especially important if you use more than 1 type of insulin.
  • Do not use HUMULIN 70/30 past the expiration date printed on the Label or 10 days after you start using the Pen.
  • Always use a new needle for each injection to help ensure sterility and prevent blocked needles. Do not reuse or share needles with other people. You may give other people a serious infection or get a serious infection from them.

  Priming the HUMULIN 70/30 KwikPen:

  Prime the HUMULIN 70/30 KwikPen before each injection. Priming ensures the Pen is ready to dose and removes air that may collect in the cartridge during normal use. If you do not prime before each injection, you may get too much or too little insulin.

  • Turn the Dose Knob to select 2 units.
  • Hold the Pen with the Needle pointing up. Tap the Cartridge Holder gently to collect air bubbles at the top.
  • Hold the Pen with Needle pointing up. Push the Dose Knob in until it stops, and “0” is seen in the Dose Window.
  • Hold the Dose Knob in and count to 5 slowly . A stream of insulin should be seen from the needle. – If you do not see a stream of insulin, repeat steps 8 to 10, no more than 4 times. – If you still do not see a stream of insulin, change the needle and repeat steps 8 to 10.

  Selecting your dose:

  (Example: 10 units shown)

  • The HUMULIN 70/30 KwikPen will not let you dial more than the number of units left in the Pen.
  • If your dose is more than the number of units left in the Pen, you may either: – inject the amount left in your Pen and then use a new Pen to give the rest of your dose, or – get a new Pen and inject the full dose.
  • The Pen is designed to deliver a total of 300 units of insulin. The cartridge contains an additional small amount of insulin that cannot be delivered.

  Giving your HUMULIN 70/30 injection:

  • Inject your HUMULIN 70/30 exactly as your healthcare provider has shown you.
  • Change (rotate) your injection site for each injection.
  • Do not try to change your dose while injecting HUMULIN 70/30.
  • Choose your injection site. HUMULIN 70/30 is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms.
  • Wipe the skin with an alcohol swab, and let the injection site dry before you inject your dose.
  • Insert the Needle into your skin.
  • Put your thumb on the Dose Knob and push the Dose Knob in until it stops.
  • Hold the Dose Knob in and slowly count to 5.
  • Pull the Needle out of your skin. You should see “0” in the Dose Window. If you do not see “0” in the Dose Window, you did not receive your full dose. – If you see blood after you take the Needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab. Do not rub the area. – A drop of insulin at the needle tip is normal. It will not affect your dose. – If you do not think you received your full dose, do not take another dose. Call Lilly at 1-800-LillyRx (1-800-545-5979) or your healthcare provider for help.

  After your injection:

  • Put your used needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles in your household trash.
  • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is: – made of a heavy-duty plastic, – can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, – upright and stable during use, – leak-resistant, and – properly labeled to warn of hazardous waste inside the container.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.
  • Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
  • The used Pen may be discarded in your household trash after you have removed the needle.

  How should I store my HUMULIN 70/30 KwikPen?

  • Store unused HUMULIN 70/30 KwikPens in the refrigerator at 36°F to 46°F (2°C to 8°C). The Pen you are currently using should be stored at room temperature, below 86°F (30°C).
  • Do not freeze HUMULIN 70/30. Do not use HUMULIN 70/30 if it has been frozen.
  • Unused Pens may be used until the expiration date printed on the Label, if kept in the refrigerator.
  • The HUMULIN 70/30 Pen you are using should be thrown away after 10 days, even if it still has insulin left in it.
  • Keep HUMULIN 70/30 away from heat and out of the light.

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

  • Keep HUMULIN 70/30 KwikPen and needles out of the reach of children.
  • Always use a new needle for each injection.
  • Do not share your Pen or needles with other people. You may give other people a serious infection or get a serious infection from them.
  • Do not use the Pen if any part looks broken or damaged.
  • Always carry an extra Pen in case yours is lost or damaged.
  • If you cannot remove the Pen Cap, gently twist the Pen Cap back and forth, and then pull the Pen Cap straight off.
  • If it is hard to push the Dose Knob or the Pen is not working the right way: – Your Needle may be blocked. Put on a new Needle and prime the Pen. – You may have dust, food, or liquid inside the Pen. Throw the Pen away and get a new one. – It may help to push the Dose Knob more slowly during your injection.
  • Use the space below to keep track of how long you should use each HUMULIN 70/30 KwikPen. – Write down the date you start using your HUMULIN 70/30 KwikPen. Count forward 10 days. – Write down the date you should throw it away.

  First used on _______ + 10 days = Throw out on ______

  Pen 1 – First used on _______ Throw out on _______

  Pen 2 – First used on _______ Throw out on _______

  Pen 3 – First used on _______ Throw out on _______

  Pen 4 – First used on _______ Throw out on _______

  Pen 5 – First used on _______ Throw out on _______

  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.

  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: March 12, 2015

  Marketed by: Lilly USA, LLC
  Indianapolis, IN 46285, USA

  HUMULIN 70/30 KwikPen meets the current dose accuracy and functional requirements of ISO 11608-1:2000.

  PACKAGE LABEL – Humulin 7030 KwikPen 3mL

  Humulin ® 70/30 KwikPen ®

  70% human insulin isophane suspension

  30% human insulin injection (rDNA origin)

  For Single Patient Use Only

  Read Insulin Delivery Device Instructions for Use

  For subcutaneous use only.

  prefilled insulin delivery device

  U-100 100 units per mL

  Needles not included

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

  Product Information
  Product Type	HUMAN PRESCRIPTION DRUG LABEL	Item Code (Source)	NDC:0002-8803
  Route of Administration	SUBCUTANEOUS	DEA Schedule

  Active Ingredient/Active Moiety
  Ingredient Name	Basis of Strength	Strength
  Insulin human (Insulin human)	Insulin human	100 [iU] in 1 mL

  Inactive Ingredients
  Ingredient Name	Strength
  Glycerin	16 mg in 1 mL
  Metacresol	1.6 mg in 1 mL
  Zinc	0.025 mg in 1 mL
  Phenol	0.65 mg in 1 mL
  Protamine sulfate	0.241 mg in 1 mL
  Sodium Phosphate, Dibasic	3.78 mg in 1 mL
  Water
  Hydrochloric acid
  Sodium hydroxide

  Packaging
  #	Item Code	Package Description
  1	NDC:0002-8803-59	5 SYRINGE in 1 CARTON
  1	NDC:0002-8803-01	3 mL in 1 SYRINGE
  2	NDC:0002-8803-61	1 SYRINGE in 1 CARTON
  2	3 mL in 1 SYRINGE

  Marketing Information
  Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
  NDA	NDA019717	11/07/2013

  Labeler – Eli Lilly and Company (006421325)

  Eli Lilly and Company

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