Lilly HUMALOG 4 Mix75/25 Pen User manual

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5.01 PA 9235 FSAMP1
INFORMATION FOR THE PATIENT2
3 ML DISPOSABLE INSULIN DELIVERY DEVICE3
HUMALOG®Mix75/25™Pen4
75% INSULIN LISPRO PROTAMINE SUSPENSION AND5
25% INSULIN LISPRO INJECTION6
(rDNA ORIGIN)7
100 UNITS PER ML (U-100)8
WARNINGS9
THIS LILLY HUMAN INSULIN ANALOG MIXTURE IS DIFFERENT FROM 10
OTHER INSULIN MIXTURES IN THAT ITS ONSET OF ACTION IS VERY 11
QUICK. THE QUICK ONSET OF ACTION MEANS THAT YOU SHOULD 12
TAKE YOUR DOSE OF HUMALOG
®
Mix75/25™ (75% INSULIN LISPRO 13
PROTAMINE SUSPENSION AND 25% INSULIN LISPRO INJECTION, [rDNA 14
ORIGIN]) WITHIN 15 MINUTES BEFORE YOU EAT. 15
ANY CHANGE OF INSULIN SHOULD BE MADE CAUTIOUSLY AND ONLY 16
UNDER MEDICAL SUPERVISION. CHANGES IN STRENGTH, 17
MANUFACTURER, TYPE (E.G., REGULAR, NPH, ANALOG), SPECIES (BEEF, 18
PORK, BEEF-PORK, HUMAN), OR METHOD OF MANUFACTURE (rDNA 19
VERSUS ANIMAL-SOURCE INSULIN) MAY RESULT IN THE NEED FOR A 20
CHANGE IN THE TIMING OR DOSAGE OF HUMALOG Mix75/25. 21
PATIENTS TAKING HUMALOG Mix75/25 MAY REQUIRE A CHANGE IN 22
DOSAGE FROM THAT USED WITH OTHER INSULINS. IF AN ADJUSTMENT 23
IS NEEDED, IT MAY OCCUR WITH THE FIRST DOSE OR DURING THE 24
FIRST SEVERAL WEEKS OR MONTHS. 25
TO OBTAIN AN ACCURATE DOSE, CAREFULLY READ AND FOLLOW 26
THE “DISPOSABLE INSULIN DELIVERY DEVICE USER MANUAL” AND 27
THIS “INFORMATION FOR THE PATIENT” INSERT BEFORE USING THIS 28
PRODUCT. 29
BEFORE EACH INJECTION, YOU SHOULD PRIME THE PEN, A 30
NECESSARY STEP TO MAKE SURE THE PEN IS READY TO DOSE. 31
PRIMING THE PEN IS IMPORTANT TO CONFIRM THAT INSULIN COMES 32
OUT WHEN YOU PUSH THE INJECTION BUTTON AND TO REMOVE AIR 33
THAT MAY COLLECT IN THE INSULIN CARTRIDGE DURING NORMAL 34
USE. IF YOU DO NOT PRIME, YOU MAY RECEIVE TOO MUCH OR TOO 35
LITTLE INSULIN ( see also INSTRUCTIONS FOR INSULIN PEN USE section). 36
DIABETES37
Insulin is a hormone produced by the pancreas, a large gland that lies near the stomach. This38
hormone is necessary for the body’s correct use of food, especially sugar. Diabetes occurs when39
the pancreas does not make enough insulin to meet your body’s needs.40
To control your diabetes, your doctor has prescribed injections of insulin products to keep your41
blood glucose at a near-normal level. You have been instructed to test your blood and/or urine42
regularly for glucose. Studies have shown that some chronic complications of diabetes such as43
eye disease, kidney disease, and nerve disease can be significantly reduced if the blood sugar is44
maintained as close to normal as possible. The American Diabetes Association recommends that45
if your pre-meal glucose levels are consistently above 130 mg/dL, bedtime glucose levels are46

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consistently above 160 mg/dL or your hemoglobin A1c (HbA1c) is more than 7%, consult your47
doctor. A change in your diabetes therapy may be needed. If your blood tests consistently show48
below-targeted glucose levels, you should also let your doctor know. Proper control of your49
diabetes requires close and constant cooperation with your doctor. Despite diabetes, you can lead50
an active and healthy life if you eat a balanced diet, exercise regularly, and take your insulin51
injections as prescribed.52
Always keep an extra Humalog Mix75/25 Pen as well as a spare needle on hand. Always wear53
diabetic identification so that appropriate treatment can be given if complications occur away54
from home.55
HUMALOG Mix75/2556
Description57
Humalog (insulin lispro [rDNA origin]) is made by a special non-disease-producing laboratory58
strain of Escherichia coli bacteria that has been genetically altered by the addition of the gene59
for this human insulin analog. Humalog Mix75/25 is a mixture of 75% insulin lispro protamine60
suspension and 25% insulin lispro. It is a longer-acting insulin combined with the more rapid61
onset of action of Humalog. The duration of activity is similar to that of Humulin®70/30 and62
may last up to 24 hours following injection. The time course of Humalog Mix75/25 action, like63
that of other insulins, may vary in different individuals or at different times in the same64
individual, based on dose, site of injection, blood supply, temperature, and physical activity.65
Humalog Mix75/25 is a sterile suspension and is for subcutaneous injection. It should not be66
used intravenously. The concentration of Humalog Mix75/25 is 100 units/mL (U-100).67
Humalog Mix75/25 starts lowering blood glucose more quickly than regular human insulin,68
allowing for convenient dosing immediately before a meal (within 15 minutes). In contrast,69
mixtures containing regular human insulin should be given 30 to 60 minutes before a meal.70
Identification71
Insulin lispro (rDNA origin) injection (rDNA origin), by Eli Lilly and Company, has the72
trademark Humalog. Humalog products are available in two formulations — Humalog and73
Humalog Mix75/25. Your doctor has prescribed the type of insulin that he/she believes is best74
for you.75
DO NOT USE ANY OTHER INSULIN EXCEPT ON YOUR DOCTOR’S ADVICE AND76
DIRECTION. YOU SHOULD NOT MIX HUMALOG Mix75/25 WITH ANOTHER77
INSULIN.78
The Humalog Mix75/25 Pen is available in boxes of 5 disposable insulin delivery devices79
(“insulin Pens”). The Humalog Mix75/25 Pen is not designed to allow any other insulin to be80
mixed in its cartridge of Humalog Mix75/25, or for the cartridge to be removed.81
Always examine the appearance of Humalog Mix75/25 suspension in the insulin Pen before82
administering a dose. Roll the Pen between the palms 10 times (see Figure 1). Holding the Pen83
by one end, invert it 180° slowly 10 times to allow the small glass bead to travel the full length84
of the cartridge with each inversion (see Figure 2).85
Figure 1. Figure 2.86
Humalog Mix75/25 should look uniformly cloudy or milky after mixing. If not, repeat the87
above steps until the contents are mixed. Pens containing Humalog Mix75/25 suspension should88

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be examined frequently. Do not use if the insulin substance (the white material) remains visibly89
separated from the liquid after mixing. Do not use a Humalog Mix75/25 Pen if there are clumps90
in the insulin after mixing. Do not use a Humalog Mix75/25 Pen if solid white particles stick to91
the bottom or wall of the cartridge, giving a frosted appearance. Always check the appearance of92
the Humalog Mix75/25 suspension before using. If you note anything unusual in its appearance93
or notice your insulin requirements changing markedly, consult your doctor.94
Storage95
Not in-use (unopened): Humalog Mix75/25 Pens not in-use should be stored in a refrigerator96
but not in the freezer. Do not use Humalog Mix75/25 Pen is it has been frozen.97
In-use: Humalog Mix75/25 Pens in-use should NOT be refrigerated but should be kept at98
room temperature (below 86°F [30°C]) away from direct heat and light. Humalog Mix75/2599
Pens in-use must be discarded after 10 days, even if they still contain Humalog Mix75/25.100
Do not use Humalog Mix75/25 Pens after the expiration date stamped on the label.101
INSTRUCTIONS FOR INSULIN PEN USE102
It is important to read, understand, and follow the instructions in the “Disposable Insulin103
Delivery Device User Manual” before using. Failure to follow instructions may result in104
getting too much or too little insulin. The needle must be changed and the Pen must be105
primed before each injection to make sure the Pen is ready to dose. Performing these steps106
before each injection is important to confirm that insulin comes out when you push the107
injection button, and to remove air that may collect in the insulin cartridge during normal108
use.109
Every time you inject:110
• Use a new needle.111
• Prime to make sure the Pen is ready to dose.112
• Make sure you got your full dose.113
NEVER SHARE INSULIN PENS, CARTRIDGES, OR NEEDLES.114
PREPARING THE INSULIN PEN FOR INJECTION115
1. Inspect the appearance of Humalog Mix75/25 suspension in the Humalog Mix75/25 Pen.116
It should look uniformly cloudy or milky after mixing. Once the Humalog Mix75/25 Pen117
is in use, inspect the insulin in the Humalog Mix75/25 Pen before each injection.118
2. Follow the instructions in the “Disposable Insulin Delivery Device User Manual” for119
these steps:120
• Preparing the Pen121
• Attaching the Needle. Use a new needle for each injection.122
• Priming the Pen. The Pen must be primed before each injection to make sure123
the Pen is ready to dose. Performing the priming step is important to confirm that124
insulin comes out when you push the injection button, and to remove air that may125
collect in the insulin cartridge during normal use.126
• Setting a Dose127
• Injecting a Dose. To make sure you have received your full dose, you must128
push the injection button all the way down until you see a diamond (◆) or an arrow129
(→) in the center of the dose window.130
• Following an Injection131
PREPARING FOR INJECTION132
1. Wash your hands.133
2. To avoid tissue damage, choose a site for each injection that is at least 1/2 inch from the134
previous injection site. The usual sites of injection are abdomen, thighs, and arms.135
3. Cleanse the skin with alcohol where the injection is to be made.136
4. With one hand, stabilize the skin by spreading it or pinching up a large area.137
5. Inject the dose as instructed by your doctor. Hold the needle under the skin for at least138
5 seconds after injecting.139

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6. After injecting a dose, pull the needle out and apply gentle pressure over the injection site140
for several seconds. Do not rub the area.141
7. Immediately after an injection, remove the needle from the Humalog Mix75/25 Pen.142
Doing so will guard against contamination, and prevent leakage of Humalog Mix75/25,143
reentry of air, and needle clogs. Do not reuse needles. Place the used needle in a144
puncture-resistant disposable container and properly dispose of it as directed by your145
Health Care Professional.146
DOSAGE147
Your doctor has told you which insulin to use, how much, and when and how often to inject it.148
Because each patient’s case of diabetes is different, this schedule has been individualized for149
you. Your usual Humalog Mix75/25 dose may be affected by changes in your food, activity, or150
work schedule. Carefully follow your doctor’s instructions to allow for these changes. Other151
things that may affect your Humalog Mix75/25 dose are:152
Illness153
Illness, especially with nausea and vomiting, may cause your insulin requirements to change.154
Even if you are not eating, you will still require insulin. You and your doctor should establish a155
sick day plan for you to use in case of illness. When you are sick, test your blood glucose/urine156
glucose and ketones frequently and call your doctor as instructed.157
Pregnancy158
Good control of diabetes is especially important for you and your unborn baby. Pregnancy may159
make managing your diabetes more difficult. If you are planning to have a baby, are pregnant, or160
are nursing a baby, consult your doctor. Humalog Mix75/25 has not been tested in pregnant or161
nursing women.162
Medication163
Insulin requirements may be increased if you are taking other drugs with hyperglycemic164
activity, such as oral contraceptives, corticosteroids, or thyroid replacement therapy. Insulin165
requirements may be reduced in the presence of drugs with blood-glucose-lowering activity,166
such as oral antidiabetic agents, salicylates (for example, aspirin), sulfa antibiotics, alcohol, and167
certain antidepressants. Your Health Care Professional is aware of these and other medications168
that may affect your diabetes control. Therefore, always discuss any medications you are taking169
with your doctor.170
Exercise171
Exercise may lower your body’s need for insulin products during and for some time after the172
physical activity. Exercise may also speed up the effect of a Humalog Mix75/25 dose, especially173
if the exercise involves the area of your injection site. Discuss with your doctor how you should174
adjust your regimen to accommodate exercise.175
Travel176
Persons traveling across more than 2 time zones should consult their doctor concerning177
adjustments in their insulin schedule.178
COMMON PROBLEMS OF DIABETES179
Hypoglycemia (Low Blood Sugar)180
Hypoglycemia (too little glucose in the blood) is one of the most frequent adverse events181
experienced by insulin users. It can be brought about by:182
1. Missing or delaying meals.183
2. Taking too much insulin.184
3. Exercising or working more than usual.185
4. An infection or illness (especially with diarrhea or vomiting).186
5. A change in the body's need for insulin.187
6. Diseases of the adrenal, pituitary or thyroid gland, or progression of kidney or liver188
disease.189

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7. Interactions with other drugs that lower blood glucose, such as oral antidiabetic agents,190
salicylates (for example, aspirin), sulfa antibiotics, and certain antidepressants.191
8. Consumption of alcoholic beverages.192
Symptoms of mild to moderate hypoglycemia may occur suddenly and can include:193
• sweating • drowsiness194
• dizziness • sleep disturbances195
• palpitation • anxiety196
• tremor • blurred vision197
• hunger • slurred speech198
• restlessness • depressed mood199
• tingling in the hands, feet, lips, or tongue • irritability200
• lightheadedness • abnormal behavior201
• inability to concentrate • unsteady movement202
• headache • personality changes203
Signs of severe hypoglycemia can include:204
• disorientation • seizures205
• unconsciousness • death206
Therefore, it is important that assistance be obtained immediately.207
Early warning symptoms of hypoglycemia may be different or less pronounced under certain208
conditions, such as long duration of diabetes, diabetic nerve disease, use of medications such as209
beta-blockers, changing insulin preparations, or intensified control (3 or more injections per day)210
of diabetes. A few patients who have experienced hypoglycemic reactions after transfer from211
animal-source insulin to human insulin have reported that the early warning symptoms of212
hypoglycemia were less pronounced or different from those experienced with their previous213
insulin.214
Without recognition of early warning symptoms, you may not be able to take steps to avoid215
more serious hypoglycemia. Be alert for all of the various types of symptoms that may indicate216
hypoglycemia. Patients who experience hypoglycemia without early warning symptoms should217
monitor their blood glucose frequently, especially prior to activities such as driving. If the blood218
glucose is below your normal fasting glucose, you should consider eating or drinking sugar-219
containing foods to treat your hypoglycemia.220
Mild to moderate hypoglycemia may be treated by eating foods or drinks that contain sugar.221
Patients should always carry a quick source of sugar, such as candy mints or glucose tablets.222
More severe hypoglycemia may require the assistance of another person. Patients who are unable223
to take sugar orally or who are unconscious require an injection of glucagon or should be treated224
with intravenous administration of glucose at a medical facility.225
You should learn to recognize your own symptoms of hypoglycemia. If you are uncertain226
about these symptoms, you should monitor your blood glucose frequently to help you learn to227
recognize the symptoms that you experience with hypoglycemia.228
If you have frequent episodes of hypoglycemia or experience difficulty in recognizing the229
symptoms, you should consult your doctor to discuss possible changes in therapy, meal plans,230
and/or exercise programs to help you avoid hypoglycemia.231
Hyperglycemia and Diabetic Ketoacidosis (DKA)232
Hyperglycemia (too much glucose in the blood) may develop if your body has too little insulin.233
Hyperglycemia can be brought about by any of the following:234
1. Omitting your insulin or taking less than the doctor has prescribed.235
2. Eating significantly more than your meal plan suggests.236
3. Developing a fever, infection, or other significant stressful situation.237
In patients with type 1 or insulin-dependent diabetes, prolonged hyperglycemia can result in238
DKA. The first symptoms of DKA usually come on gradually, over a period of hours or days,239
and include a drowsy feeling, flushed face, thirst, loss of appetite, and fruity odor on the breath.240

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With DKA, urine tests show large amounts of glucose and ketones. Heavy breathing and a rapid241
pulse are more severe symptoms. If uncorrected, prolonged hyperglycemia or DKA can lead to242
nausea, vomiting, stomach pains, dehydration, loss of consciousness, or death. Therefore, it is243
important that you obtain medical assistance immediately.244
Lipodystrophy245
Rarely, administration of insulin subcutaneously can result in lipoatrophy (depression in the246
skin) or lipohypertrophy (enlargement or thickening of tissue). If you notice either of these247
conditions, consult your doctor. A change in your injection technique may help alleviate the248
problem.249
Allergy250
Local Allergy — Patients occasionally experience redness, swelling, and itching at the site of251
injection. This condition, called local allergy, usually clears up in a few days to a few weeks. In252
some instances, this condition may be related to factors other than insulin, such as irritants in the253
skin cleansing agent or poor injection technique. If you have local reactions, contact your doctor.254
Systemic Allergy — Less common, but potentially more serious, is generalized allergy to255
insulin, which may cause rash over the whole body, shortness of breath, wheezing, reduction in256
blood pressure, fast pulse, or sweating. Severe cases of generalized allergy may be life257
threatening. If you think you are having a generalized allergic reaction, notify a doctor258
immediately.259
ADDITIONAL INFORMATION260
Additional information about diabetes may be obtained from your diabetes educator.261
DIABETES FORECAST is a magazine designed especially for people with diabetes and their262
families. It is available by subscription from the American Diabetes Association (ADA), P.O.263
Box 363, Mt. Morris, IL 61054-0363, 1-800-DIABETES (1-800-342-2383).264
Another publication, COUNTDOWN, is available from the Juvenile Diabetes Research265
Foundation International (JDRFI), 120 Wall Street 19th Floor, New York, NY 10005,266
1-800-533-CURE (1-800-533-2873).267
Additional information about Humalog Mix75/25 and Humalog Mix75/25 Pens can be268
obtained by calling The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979).269
Literature revised XXX, 2004270
Manufactured by Lilly France S.A.S.271
F-67640 Fegersheim, France272
For Eli Lilly and Company273
Indianapolis, IN 46285, USA274
Copyright © 1999, 2004, Eli Lilly and Company. All rights reserved.275
5.01 PA 9235 FSAMP276

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5.01 PA 9115 FSAMP
Lilly
Disposable Insulin Delivery Device
User Manual
Instructions for Use
Read and follow all of these instructions carefully. If you
do not follow these instructions completely, you may
get too much or too little insulin.
Every time you inject:
•Use a new needle
•Prime to make sure the Pen is ready to
dose
•Make sure you got your full dose (see
page 18)
Also, read the Information for the Patient insert
enclosed in your Pen box.
Pen Features
•A multiple dose, disposable insulin
delivery device (“insulin Pen”)
containing 3 mL (300 units) of U-100
insulin
•Delivers up to 60 units per dose
•Doses can be dialed by single units

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Table of Contents
_______________________________________________________________
Pen Parts............................................................................................................ 3
Important Notes..................................................................................................4
Preparing the Pen ..............................................................................................6
Attaching the Needle ..........................................................................................8
Priming the Pen ................................................................................................ 10
Setting a Dose .................................................................................................. 14
Injecting a Dose................................................................................................ 16
Following an Injection....................................................................................... 18
Questions and Answers ................................................................................... 20
_______________________________________________________________
2

3
3
Pen Parts
In
ject
i
o
n B
utton
D
ose
Kn
ob
Raised Notch
R
a
i
sed
Notc
h
Dose Window
L
abe
l
Insulin Cartridge
Clear Cartridge Holder
Rubber Seal
Paper
Tab
Outer Needle Shield
Inner Needle Shield
Needle
Pen Cap

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Important Notes
•Read and follow all of these instructions carefully. If you do not follow these
instructions completely, you may get too much or too little insulin.
•Use a new needle for each injection.
•Be sure a needle is completely attached to the Pen before priming, setting
the dose and injecting your insulin.
•Prime every time.
•The Pen must be primed before each injection to make sure the Pen is
ready to dose. Performing the priming step is important to confirm that insulin
comes out when you push the injection button, and to remove air that may collect
in the insulin cartridge during normal use. See Section III. “Priming the Pen”,
pages 10-13.
•If you do not prime, you may get too much or too little insulin.
•Make sure you get your full dose.
•To make sure you get your full dose, you must push the injection button all the
way down until you see a diamond (♦) or an arrow (→) in the center of the dose
window. See “Following an Injection”, page 18.
•The numbers on the clear cartridge holder give an estimate of the amount of insulin
remaining in the cartridge. Do not use these numbers for measuring an insulin dose.
•Do not share your Pen.
•Keep your Pen out of the reach of children.
•Pens that have not been used (unopened) should be stored in a refrigerator but not
in a freezer. Do not use a Pen if it has been frozen. Refer to the INFORMATION
FOR THE PATIENT insert for complete storage instructions.
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