justment and increased frequency of glucose monitoring may be required when humalog mix75/25 is co-administered with these drugs. drugs that may increase or decrease the blood glucose lowering effect of humalog mix75/25 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 humalog mix75/25 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 humalog mix75/25 is co-administered with these drugs. drugs that may increase the risk of hypoglycemia: 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. ( 7 ) drugs that may decrease the blood glucose lowering effect: atypical antipsychotics, 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. ( 7 ) drugs that may increase or decrease the blood glucose lowering effect: alcohol, beta-blockers, clonidine, lithium salts, and pentamidine. ( 7 ) drugs that may blunt the signs and symptoms of hypoglycemia: beta-blockers, clonidine, guanethidine, and reserpine. ( 7 )

inue humalog mix75/25, monitor and treat if indicated. ( 5.5 ) hypokalemia: may be life-threatening. monitor potassium levels in patients at risk of hypokalemia and treat if indicated. ( 5.6 ) fluid retention and heart failure with concomitant use of thiazolidinediones (tzds) : observe for signs and symptoms of heart failure; consider dosage reductions or discontinuation if heart failure occurs. ( 5.7 ) 5.1 never share a humalog mix75/25 kwikpen or syringe between patients humalog mix75/25 kwikpens must never be shared between patients, even if the needle is changed. patients using humalog mix75/25 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 anti-diabetic products may be needed. 5.3 hypoglycemia hypoglycemia is the most common adverse reaction associated with all insulin therapies, including humalog mix75/25. severe hypoglycemia can cause seizures, may lead to unconsciousness, 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 humalog mix75/25 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. 5.4 hypoglycemia due to medication errors accidental mix-ups between humalog mix75/25 and other insulin products have been reported. to avoid medication errors between humalog mix75/25 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 insulin products, including humalog mix75/25. if hypersensitivity reactions occur, discontinue humalog mix75/25; treat per standard of care and monitor until symptoms and signs resolve. humalog mix75/25 is contraindicated in patients who have had hypersensitivity reactions to humalog mix75/25 or any of its excipients [see contraindications ( 4 )] . 5.6 hypokalemia all insulin products, including humalog mix75/25, 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, particularly when used in combination with insulin. fluid retention may lead to or exacerbate heart failure. patients treated with insulin, including humalog mix75/25, 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.

om temperature. to resuspend vial, carefully invert the vial at least 10 times until the suspension appears uniformly white and cloudy. inject immediately. to resuspend kwikpen, gently roll the kwikpen at least 10 times and then carefully invert the kwikpen at least 10 times until the suspension appears uniformly white and cloudy. inject immediately. inspect humalog mix75/25 visually before use. do not use if discoloration or particulate matter is seen. administer humalog mix75/25 by subcutaneous injection into the abdominal wall, thigh, upper arm, or buttocks. rotate the injection site 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 )] . during changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring [see warnings and precautions ( 5.2 )] . the humalog mix75/25 kwikpen dials in 1 unit increments. use humalog mix75/25 kwikpen with caution in patients with visual impairment that may rely on audible clicks to dial their dose. do not administer humalog mix75/25 intravenously, intramuscularly or by a continuous subcutaneous insulin infusion pump. do not mix humalog mix75/25 with any other insulins or diluents. 2.2 dosage information individualize and adjust the dosage of humalog mix75/25 based on the individual's metabolic needs, blood glucose monitoring results and glycemic control goal. inject humalog mix75/25 subcutaneously within 15 minutes before a meal. humalog mix75/25 is typically dosed twice-daily (with each dose intended to cover 2 meals or a meal and a snack) 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 )] . dosage adjustment may be needed when switching from another insulin to humalog mix75/25. 2.3 dosage adjustment due to drug interactions dosage adjustment may be needed when humalog mix75/25 is coadministered with certain drugs [see drug interactions ( 7 )] .

onship to drug exposure. adverse reactions associated with insulin initiation and glucose control intensification intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. over the long-term, improved glycemic control decreases the risk of diabetic retinopathy and neuropathy. hypersensitivity reactions severe, life-threatening, generalized allergy, including anaphylaxis. hypoglycemia hypoglycemia is the most commonly observed adverse reaction in humalog mix75/25. hypokalemia humalog mix75/25 can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. injection site reactions humalog mix75/25 can cause local injection site reactions including redness, swelling, or itching at the site of injection. these reactions usually resolve in a few days to a few weeks, but in some occasions, may require discontinuation. localized reactions and generalized myalgias have been reported with the use of meta-cresol, which is an excipient in humalog mix75/25. lipodystrophy administration of insulin subcutaneously, including humalog mix75/25, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) [see dosage and administration ( 2.1 )] in some patients. 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. medication errors medication errors in which other insulins have been accidentally substituted for humalog mix75/25 have been identified during postapproval use. peripheral edema insulin, including humalog mix75/25, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy. weight gain weight gain can occur with insulin therapy, including humalog mix75/25, and has been attributed to the anabolic effects of insulin and the decrease in glycosuria. immunogenicity as with all therapeutic peptides, insulin administration may cause anti-insulin antibodies to form. the incidence of antibody formation with humalog mix75/25 is unknown.

justment and increased frequency of glucose monitoring may be required when humalog mix75/25 is co-administered with these drugs. drugs that may increase or decrease the blood glucose lowering effect of humalog mix75/25 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 humalog mix75/25 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 humalog mix75/25 is co-administered with these drugs. drugs that may increase the risk of hypoglycemia: 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. ( 7 ) drugs that may decrease the blood glucose lowering effect: atypical antipsychotics, 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. ( 7 ) drugs that may increase or decrease the blood glucose lowering effect: alcohol, beta-blockers, clonidine, lithium salts, and pentamidine. ( 7 ) drugs that may blunt the signs and symptoms of hypoglycemia: beta-blockers, clonidine, guanethidine, and reserpine. ( 7 )

up to approximately 0.2 times the human subcutaneous dose of 1 unit/kg/day (see data). 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. clinical considerations 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, still birth, and macrosomia related morbidity. data human data published data from retrospective studies and meta-analyses do not report an association with insulin lispro and major birth defects, miscarriage, or adverse maternal or fetal outcomes when insulin lispro is used during pregnancy. however, these studies cannot definitely establish or exclude the absence of any risk because of methodological limitations including small sample size, selection bias, confounding by unmeasured factors, and some lacking comparator groups. animal data animal reproduction studies have not been performed with humalog mix75/25. however, subcutaneous reproduction and teratology studies have been conducted with insulin lispro (a component of humalog mix75/25). in a combined fertility and embryo-fetal development study, female rats were given subcutaneous insulin lispro injections of 1, 5, and 20 units/kg/day (0.2, 0.8, and 3 times the human subcutaneous dose of 1 unit insulin lispro/kg/day, based on units/body surface area, respectively) from 2 weeks prior to cohabitation through gestation day 19. there were no adverse effects on female fertility, implantation, or fetal viability and morphology. however, fetal growth retardation was produced at the 20 units/kg/day-dose as indicated by decreased fetal weight and an increased incidence of fetal runts/litter. in an embryo-fetal development study in pregnant rabbits, insulin lispro doses of 0.1, 0.25, and 0.75 unit/kg/day (0.03, 0.08, and 0.2 times the human subcutaneous dose of 1 unit insulin lispro/kg/day, based on units/body surface area, respectively) were injected subcutaneously on gestation days 7 through 19. there were no adverse effects on fetal viability, weight, and morphology at any dose. 8.2 lactation risk summary there are no data on the presence of humalog mix75/25 in human milk, the effects on the breastfed infant, or the effect on milk production. one small published study reported that exogenous insulin was present in human milk. however, there is insufficient information to determine the effects of humalog mix75/25 on the breastfed infant and no available information on the effects of humalog mix75/25 on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for insulin, any potential adverse effects on the breastfed child from humalog mix75/25 or from the underlying maternal condition. 8.4 pediatric use safety and effectiveness of humalog mix75/25 in patients less than 18 years of age has not been established. 8.5 geriatric use clinical studies of humalog mix75/25 did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients. in elderly patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to reduce the risk of hypoglycemia [see warnings and precautions ( 5.3 )]. 8.6 renal impairment the effect of renal impairment on the pharmacokinetics of humalog mix75/25 has not been studied. patients with renal impairment may be at increased risk of hypoglycemia and may require more frequent humalog mix75/25 dose adjustment and more frequent glucose monitoring [see warnings and precautions ( 5.3 )] . 8.7 hepatic impairment the effect of hepatic impairment on the pharmacokinetics of humalog mix75/25 has not been studied. patients with hepatic impairment may be at increased risk of hypoglycemia and may require more frequent humalog mix75/25 dose adjustment and more frequent glucose monitoring [see warnings and precautions ( 5.3 )] .

the human subcutaneous dose of 1 unit/kg/day (see data). 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. clinical considerations 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, still birth, and macrosomia related morbidity. data human data published data from retrospective studies and meta-analyses do not report an association with insulin lispro and major birth defects, miscarriage, or adverse maternal or fetal outcomes when insulin lispro is used during pregnancy. however, these studies cannot definitely establish or exclude the absence of any risk because of methodological limitations including small sample size, selection bias, confounding by unmeasured factors, and some lacking comparator groups. animal data animal reproduction studies have not been performed with humalog mix75/25. however, subcutaneous reproduction and teratology studies have been conducted with insulin lispro (a component of humalog mix75/25). in a combined fertility and embryo-fetal development study, female rats were given subcutaneous insulin lispro injections of 1, 5, and 20 units/kg/day (0.2, 0.8, and 3 times the human subcutaneous dose of 1 unit insulin lispro/kg/day, based on units/body surface area, respectively) from 2 weeks prior to cohabitation through gestation day 19. there were no adverse effects on female fertility, implantation, or fetal viability and morphology. however, fetal growth retardation was produced at the 20 units/kg/day-dose as indicated by decreased fetal weight and an increased incidence of fetal runts/litter. in an embryo-fetal development study in pregnant rabbits, insulin lispro doses of 0.1, 0.25, and 0.75 unit/kg/day (0.03, 0.08, and 0.2 times the human subcutaneous dose of 1 unit insulin lispro/kg/day, based on units/body surface area, respectively) were injected subcutaneously on gestation days 7 through 19. there were no adverse effects on fetal viability, weight, and morphology at any dose.

oximately 2 hours (range: 1-6 hours); glucose lowering activity was detectable for a median of 22 hours (range: 13 to 22 hours), which was the end of the clamp. in separate glucose clamp studies performed in healthy subjects, pharmacodynamics of humalog mix75/25 and humulin ® 70/30 were assessed and are presented in figure 2 . humalog mix75/25 has a duration of activity similar to that of humulin 70/30. figures 1 and 2 should be considered only as representative examples since the time course of action of insulin and insulin analogs, may vary in different individuals or within the same individual. figure 1: mean insulin activity versus time profiles after injection of 0.3 units/kg of humalog, humalog mix50/50, humalog mix75/25, or insulin lispro protamine suspension (ilps) in 30 healthy subjects. figure 2: mean insulin activity versus time profiles after injection of 0.3 units/kg of humalog mix75/25 or humulin 70/30 in healthy subjects. figure 1 figure 2 12.3 pharmacokinetics absorption — humalog mix75/25 has two phases of absorption. the early phase represents insulin lispro and its distinct characteristics of rapid onset. the late phase represents the prolonged absorption of insulin lispro protamine suspension. in 31 healthy subjects given subcutaneous doses (0.3 unit/kg) of humalog mix75/25, the median peak serum concentration was 60 minutes (range: 30 minutes to 4 hours) after dosing. identical results were found in patients with type 1 diabetes. the rapid absorption characteristics of humalog are maintained with humalog mix75/25. humalog mix75/25 has a more rapid absorption than humulin 70/30, which has been confirmed in patients with type 1 diabetes. metabolism — human metabolism studies of humalog mix75/25 have not been conducted. however, studies in animals indicate that the metabolism of humalog, the rapid-acting component of humalog mix75/25, is identical to that of regular human 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. specific populations the effects of age, race, obesity, pregnancy, smoking, or renal or hepatic impairment on the pharmacokinetics of humalog mix75/25 have not been studied. gender — pharmacokinetic and pharmacodynamic comparisons between men and women administered humalog mix75/25 showed no gender differences.

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. specific populations the effects of age, race, obesity, pregnancy, smoking, or renal or hepatic impairment on the pharmacokinetics of humalog mix75/25 have not been studied. gender — pharmacokinetic and pharmacodynamic comparisons between men and women administered humalog mix75/25 showed no gender differences.

a) for 6 months were mated with untreated female rats. in a combined fertility, perinatal, and postnatal study in male and female rats given 1, 5, and 20 units/kg/day subcutaneously (0.2, 0.8, and 3 times the human subcutaneous dose of 1 unit insulin lispro/kg/day, based on units/body surface area), mating and fertility were not adversely affected in either gender at any dose.

with untreated female rats. in a combined fertility, perinatal, and postnatal study in male and female rats given 1, 5, and 20 units/kg/day subcutaneously (0.2, 0.8, and 3 times the human subcutaneous dose of 1 unit insulin lispro/kg/day, based on units/body surface area), mating and fertility were not adversely affected in either gender at any dose.

86°f [30°c]) in-use (opened) room temperature, (below 86°f [30°c]) 10 ml multiple-dose vial until expiration date 28 days 28 days, refrigerated/room temperature 3 ml single-patient-use kwikpen until expiration date 10 days 10 days, room temperature. do not refrigerate.

inadequate food intake, and skipped meals. instruct patients on the management of hypoglycemia [see warnings and precautions ( 5.3 )]. 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. 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 )] . hypoglycemia due to medication errors instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products [see warnings and precautions ( 5.4 )] . hypersensitivity reactions advise patients that hypersensitivity reactions have occurred with humalog mix75/25. inform patients on the symptoms of hypersensitivity reactions and to seek medical attention if they occur [see warnings and precautions ( 5.5 )] . marketed by: lilly usa, llc, indianapolis, in 46285, usa copyright © 1999, 2019, eli lilly and company. all rights reserved. log7525-0005-uspi-20191115

og mix75/25. what should i tell my healthcare provider before taking humalog mix75/25? before taking humalog mix75/25, tell your healthcare provider about all of your medical conditions, including if you: have liver or kidney problems. take any other medicines, especially ones called tzds (thiazolidinediones). have heart failure or other heart problems. if you have heart failure, it may get worse while you take tzds with humalog mix75/25. are pregnant or plan to become pregnant. talk with your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant. are breastfeeding or plan to breastfeed. talk with your healthcare provider about the best way to feed your baby while taking humalog mix75/25. tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. before you start taking humalog mix75/25, talk to your healthcare provider about low blood sugar and how to manage it. how should i take humalog mix75/25? read the instructions for use that comes with your humalog mix75/25. take humalog mix75/25 exactly as your healthcare provider tells you to. your healthcare provider should tell you how much humalog mix75/25 to take and when to take it. humalog mix75/25 starts acting fast. inject humalog mix75/25 within 15 minutes before you eat a meal. know the type, strength, and amount of insulin you take. do not change the type or amount of insulin you take 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 take different types of insulin. check your insulin label each time you give your injection to make sure you are taking the correct insulin. inject humalog mix75/25 under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs or upper arms. do not inject humalog mix75/25 into your vein (intravenously) or muscle (intramuscularly) or use in an insulin infusion pump. change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. do not use the exact same spot for each injection. do not inject where the skin has pits, is thickened, or has lumps. do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. do not mix humalog mix75/25 with other insulins or liquids. check your blood sugar levels. ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels. keep humalog mix75/25 and all medicines out of the reach of children. your dose of humalog mix75/25 may need to change because of a: change in physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take. what should i avoid while taking humalog mix75/25? while taking humalog mix75/25 do not: drive or operate heavy machinery until you know how humalog mix75/25 affects you. drink alcohol or take prescription or over-the-counter medicines that contain alcohol. what are the possible side effects of humalog mix75/25? humalog mix75/25 may cause serious side effects that can lead to death, including: low blood sugar (hypoglycemia). signs and symptoms of low blood sugar may include: dizziness or light-headedness sweating confusion headache blurred vision slurred speech shakiness fast heartbeat anxiety, irritability or mood changes hunger your healthcare provider may prescribe a glucagon emergency kit so that someone else can give you glucagon if your blood sugar becomes too low (severe hypoglycemia) and you are unable to take sugar by mouth. severe allergic reaction (whole body reaction). get medical help right away, if you have any of these signs or symptoms of a severe allergic reaction: a rash over your whole body trouble breathing a fast heartbeat sweating low potassium in your blood (hypokalemia). heart failure. taking certain diabetes pills called thiazolidinediones or “tzds” with humalog mix75/25 may cause heart failure in some people. this can happen even if you have never had heart failure or heart problems before. if you already have heart failure it may get worse while you take tzds with humalog mix75/25. your healthcare provider should monitor you closely while you are taking tzds with humalog mix75/25. tell your healthcare provider if you have any new or worse symptoms of heart failure including: shortness of breath swelling of your ankles or feet sudden weight gain treatment with tzds and humalog mix75/25 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 humalog mix75/25 include: low blood sugar (hypoglycemia) reactions at your injection site skin thickening or pits at the injection site (lipodystrophy) weight gain swelling in your hands or feet itching rash these are not all the possible side effects of humalog mix75/25. 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 humalog mix75/25. medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. do not take humalog mix75/25 for a condition for which it was not prescribed. do not give humalog mix75/25 to other people, even if they have the same symptoms that you have. it may harm them. this patient information leaflet summarizes the most important information about humalog mix75/25. if you would like more information, talk with your healthcare provider. you can ask your pharmacist or healthcare provider for information about humalog mix75/25 that is written for health professionals. what are the ingredients in humalog mix75/25? active ingredients: insulin lispro inactive ingredients: protamine sulfate, glycerin, dibasic sodium phosphate, metacresol, zinc oxide (zinc ion), phenol and water for injection. humalog ® , humalog ® mix75/25™ and humalog ® mix75/25™ kwikpen ® are trademarks of eli lilly and company. marketed by: lilly usa, llc, indianapolis, in 46285, usa copyright © 1999, 2019, eli lilly and company. all rights reserved. for more information, go to www.humalog.com or call 1-800-545-5979. log7525-0003-ppi-20191115