INFORMATION FOR THE PATIENT
3 ML PREFILLED INSULIN
DELIVERY DEVICE
HUMULIN
® 70/30 Pen
70% HUMAN
INSULIN
ISOPHANE SUSPENSION
AND
30% HUMAN INSULIN INJECTION
(rDNA
ORIGIN)
100 UNITS PER ML (U-100)
WARNINGS
THIS LILLY HUMAN INSULIN PRODUCT DIFFERS FROM ANIMAL–SOURCE
INSULINS BECAUSE IT IS STRUCTURALLY IDENTICAL TO THE INSULIN PRODUCED BY YOUR
BODY’S PANCREAS AND BECAUSE OF ITS UNIQUE MANUFACTURING PROCESS.
ANY CHANGE OF INSULIN SHOULD BE MADE CAUTIOUSLY AND ONLY
UNDER MEDICAL SUPERVISION. CHANGES IN STRENGTH, MANUFACTURER, TYPE (E.G.,
REGULAR, NPH, ANALOG), SPECIES, OR METHOD OF MANUFACTURE MAY RESULT IN THE NEED
FOR A CHANGE IN DOSAGE.
SOME PATIENTS TAKING HUMULIN® (HUMAN
INSULIN, rDNA ORIGIN) MAY REQUIRE A CHANGE IN DOSAGE FROM THAT USED WITH OTHER
INSULINS. IF AN ADJUSTMENT IS NEEDED, IT MAY OCCUR WITH THE FIRST DOSE OR DURING
THE FIRST SEVERAL WEEKS OR MONTHS.
TO OBTAIN AN ACCURATE DOSE, CAREFULLY READ AND FOLLOW THE
INSULIN DELIVERY DEVICE USER MANUAL AND THIS “INFORMATION FOR THE PATIENT”
INSERT BEFORE USING THIS PRODUCT.
THE PEN MUST BE PRIMED TO A STREAM OF INSULIN (NOT JUST A
FEW DROPS) BEFORE EACH INJECTION TO MAKE SURE THE PEN IS READY TO DOSE. YOU MAY
NEED TO PRIME A NEW PEN UP TO SIX TIMES BEFORE A STREAM OF INSULIN
APPEARS.
PRIMING THE PEN 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. IF YOU DO NOT PRIME, YOU MAY RECEIVE TOO
MUCH OR TOO LITTLE INSULIN (see also INSTRUCTIONS FOR INSULIN PEN USE section).
DIABETES
Insulin is a hormone produced by the pancreas, a large gland that lies near
the stomach. This hormone is necessary for the body’s correct use of food,
especially sugar. Diabetes occurs when the pancreas does not make enough insulin
to meet your body’s needs.
To control your diabetes, your doctor has prescribed injections of insulin
products to keep your blood glucose at a near–normal level. You have been
instructed to test your blood and/or your urine regularly for glucose. Studies
have shown that some chronic complications of diabetes such as eye disease,
kidney disease, and nerve disease can be significantly reduced if the blood
sugar is maintained as close to normal as possible. The American Diabetes
Association recommends that if your pre-meal glucose levels are consistently
above 130 mg/dL or your hemoglobin A1c (HbA1c) is more than 7%, you should talk to your doctor. A change
in your diabetes therapy may be needed. If your blood tests consistently show
below–normal glucose levels, you should also let your doctor know. Proper
control of your diabetes requires close and constant cooperation with your
doctor. Despite diabetes, you can lead an active and healthy life if you eat a
balanced diet, exercise regularly, and take your insulin injections as
prescribed by your doctor.
Always keep an extra supply of insulin as well as a spare syringe and needle
on hand. Always wear diabetic identification so that appropriate treatment can
be given if complications occur away from home.
70/30 HUMAN INSULIN
Description
Humulin is synthesized in a special non–disease–producing laboratory strain
of Escherichia coli bacteria that has been
genetically altered to produce human insulin. Humulin 70/30 is a mixture of 70%
Human Insulin Isophane Suspension and 30% Human Insulin Injection, (rDNA
origin). It is an intermediate-acting insulin combined with the more rapid onset
of action of Regular human insulin. The duration of activity may last up to 24
hours following injection. The time course of action of any insulin may vary
considerably in different individuals or at different times in the same
individual. As with all insulin preparations, the duration of action of Humulin
70/30 is dependent on dose, site of injection, blood supply, temperature, and
physical activity. Humulin 70/30 is a sterile suspension and is for subcutaneous
injection only. It should not be used intravenously or intramuscularly. The
concentration of Humulin 70/30 is 100 units/mL (U–100).
Identification
Human insulin from Eli Lilly and Company has the trademark Humulin.
Your doctor has prescribed the type of insulin that he/she believes is best
for you.
DO NOT USE ANY OTHER INSULIN EXCEPT ON YOUR DOCTOR’S ADVICE
AND DIRECTION.
The Humulin 70/30 Pen is available in boxes of 5 prefilled
insulin delivery devices (“insulin Pens”). The Humulin 70/30 Pen is not designed
to allow any other insulin to be mixed in its cartridge, or for the cartridge to
be removed.
Always check the carton and the Pen label for the name and letter designation
of the insulin you receive from your pharmacy to make sure it is the same as
prescribed by your doctor.
Always check the appearance of Humulin 70/30 suspension in your insulin Pen
before using. A cartridge of Humulin 70/30 contains a small glass bead to assist
in mixing. Roll the Pen back and forth between the palms 10 times (see Figure 1). Gently turn the Pen up and down 10 times
until the insulin is evenly mixed (see Figure 2).
If not evenly mixed, repeat the above steps until contents are mixed. Pens
containing Humulin 70/30 suspension should be examined frequently.
Do not use Humulin 70/30:
if the insulin substance (the white material) remains visibly
separated from the liquid after mixing or
if there are clumps in the insulin after mixing, or
if solid white particles stick to the walls of the cartridge,
giving a frosted appearance.
If you see anything unusual in the appearance of the Humulin 70/30 suspension
in your Pen or notice your insulin requirements changing, talk to your
doctor.
Never attempt to remove the cartridge from the Humulin 70/30 Pen. Inspect the
cartridge through the clear cartridge holder.
Storage
Not in-use (unopened): Humulin 70/30 Pens not in-use
should be stored in a refrigerator, but not in the freezer.
In-use (opened): Humulin 70/30 Pens in-use should
NOT be refrigerated but should be kept at room
temperature [below 86°F (30°C)] away from direct heat and light. The Humulin
70/30 Pen you are currently using must be discarded 10
days after the first use, even if it still contains Humulin 70/30.
Do not use Humulin 70/30 after the expiration date stamped
on the label or if it has been frozen.
INSTRUCTIONS FOR INSULIN PEN USE
It is important to read, understand, and follow the
instructions in the Insulin Delivery Device User Manual before using. Failure to
follow instructions may result in getting too much or too little insulin. The
needle must be changed and the Pen must be primed to a stream of insulin (not
just a few drops) before each injection to make sure the Pen is ready to dose.
You may need to prime a new Pen up to six times before a stream of insulin
appears. Performing these steps before each injection 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.
Every time you inject:
Use a new needle.
Prime to a stream of insulin (not just a few
drops) to make sure the Pen is ready to dose.
Make sure you got your full dose.
NEVER SHARE INSULIN PENS, CARTRIDGES, OR NEEDLES.
PREPARING FOR INJECTION
Wash your hands.
To avoid tissue damage, choose a site for each injection that is
at least 1/2 inch from the previous injection site. The usual sites of injection
are abdomen, thighs, and arms.
Follow the instructions in your Insulin Delivery Device User
Manual to prepare for injection.
After injecting the dose, pull the needle out and apply gentle
pressure over the injection site for several seconds. Do not
rub the area.
After the injection, remove the needle from the Humulin 70/30
Pen. Do not reuse needles.
Place the used needle in a puncture-resistant disposable
container and properly dispose of the puncture-resistant container as directed
by your Health Care Professional.
DOSAGE
Your doctor has told you which insulin to use, how much, and when and how
often to inject it. Because each patient’s diabetes is different, this schedule
has been individualized for you.
Your usual dose of Humulin 70/30 may be affected by changes in your diet,
activity, or work schedule. Carefully follow your doctor’s instructions to allow
for these changes. Other things that may affect your Humulin 70/30 dose are:
Illness
Illness, especially with nausea and vomiting, may cause your insulin
requirements to change. Even if you are not eating, you will still require
insulin. You and your doctor should establish a sick day plan for you to use in
case of illness. When you are sick, test your blood glucose frequently. If
instructed by your doctor, test your ketones and report the results to your
doctor.
Pregnancy
Good control of diabetes is especially important for you and your unborn
baby. Pregnancy may make managing your diabetes more difficult. If you are
planning to have a baby, are pregnant, or are nursing a baby, talk to your
doctor.
Medication
Insulin requirements may be increased if you are taking other drugs with
blood–glucose–raising activity, such as oral contraceptives, corticosteroids, or
thyroid replacement therapy. Insulin requirements may be reduced in the presence
of drugs that lower blood glucose or affect how your body responds to insulin,
such as oral antidiabetic agents, salicylates (for example, aspirin), sulfa
antibiotics, alcohol, certain antidepressants and some kidney and blood pressure
medicines. Your Health Care Professional may be aware of other medications that
may affect your diabetes control. Therefore, always discuss any medications you
are taking with your doctor.
Exercise
Exercise may lower your body’s need for insulin during and for some time
after the physical activity. Exercise may also speed up the effect of an insulin
dose, especially if the exercise involves the area of injection site (for
example, the leg should not be used for injection just prior to running).
Discuss with your doctor how you should adjust your insulin regimen to
accommodate exercise.
Travel
When traveling across more than 2 time zones, you should talk to your doctor
concerning adjustments in your insulin schedule.
COMMON PROBLEMS OF DIABETES
Hypoglycemia (Low Blood Sugar)
Hypoglycemia (too little glucose in the blood) is one of the most frequent
adverse events experienced by insulin users. It can be brought about by:
Missing or delaying meals.
Taking too much insulin.
Exercising or working more than usual.
An infection or illness associated with diarrhea or
vomiting.
A change in the body’s need for insulin.
Diseases of the adrenal, pituitary, or thyroid gland, or
progression of kidney or liver disease.
Interactions with certain drugs, such as oral antidiabetic
agents, salicylates (for example, aspirin), sulfa antibiotics, certain
antidepressants and some kidney and blood pressure medicines.
Consumption of alcoholic beverages.
Symptoms of mild to moderate hypoglycemia may occur suddenly and can
include:
Signs of severe hypoglycemia can include:
Therefore, it is important that assistance be obtained immediately.
Early warning symptoms of hypoglycemia may be different or less pronounced
under certain conditions, such as long duration of diabetes, diabetic nerve
disease, use of medications such as beta–blockers, changing insulin
preparations, or intensified control (3 or more insulin injections per day) of
diabetes.
A few patients who have experienced hypoglycemic reactions
after transfer from animal–source insulin to human insulin have reported that
the early warning symptoms of hypoglycemia were less pronounced or different
from those experienced with their previous insulin.
Without recognition of early warning symptoms, you may not be able to take
steps to avoid more serious hypoglycemia. Be alert for all of the various types
of symptoms that may indicate hypoglycemia. Patients who experience hypoglycemia
without early warning symptoms should monitor their blood glucose frequently,
especially prior to activities such as driving. If the blood glucose is below
your normal fasting glucose, you should consider eating or drinking
sugar–containing foods to treat your hypoglycemia.
Mild to moderate hypoglycemia may be treated by eating foods or drinks that
contain sugar. Patients should always carry a quick source of sugar, such as
hard candy or glucose tablets. More severe hypoglycemia may require the
assistance of another person. Patients who are unable to take sugar orally or
who are unconscious require an injection of glucagon or should be treated with
intravenous administration of glucose at a medical facility.
You should learn to recognize your own symptoms of hypoglycemia. If you are
uncertain about these symptoms, you should monitor your blood glucose frequently
to help you learn to recognize the symptoms that you experience with
hypoglycemia.
If you have frequent episodes of hypoglycemia or experience difficulty in
recognizing the symptoms, you should talk to your doctor to discuss possible
changes in therapy, meal plans, and/or exercise programs to help you avoid
hypoglycemia.
Hyperglycemia (High Blood Sugar) and Diabetic Ketoacidosis
(DKA)
Hyperglycemia (too much glucose in the blood) may develop if your body has
too little insulin. Hyperglycemia can be brought about by any of the
following:
Omitting your insulin or taking less than your doctor has
prescribed.
Eating significantly more than your meal plan suggests.
Developing a fever, infection, or other significant stressful
situation.
In patients with type 1 or insulin–dependent diabetes, prolonged
hyperglycemia can result in DKA (a life-threatening emergency). The first
symptoms of DKA usually come on gradually, over a period of hours or days,and
include a drowsy feeling, flushed face, thirst, loss of appetite, and fruity
odor on the breath. With DKA, blood and urine tests show large amounts of
glucose and ketones. Heavy breathing and a rapid pulse are more severe symptoms.
If uncorrected, prolonged hyperglycemia or DKA can lead to nausea, vomiting,
stomach pain, dehydration, loss of consciousness, or death. Therefore, it is
important that you obtain medical assistance immediately.
Lipodystrophy
Rarely, administration of insulin subcutaneously can result in lipoatrophy
(seen as an apparent depression of the skin) or lipohypertrophy (seen as a
raised area of the skin). If you notice either of these conditions, talk to your
doctor. A change in your injection technique may help alleviate the problem.
Allergy
Local Allergy — Patients occasionally experience
redness, swelling, and itching at the site of injection. This condition, called
local allergy, usually clears up in a few days to a few weeks. In some
instances, this condition may be related to factors other than insulin, such as
irritants in the skin cleansing agent or poor injection technique. If you have
local reactions, talk to your doctor.
Systemic Allergy — Less common, but potentially
more serious, is generalized allergy to insulin, which may cause rash over the
whole body, shortness of breath, wheezing, reduction in blood pressure, fast
pulse, or sweating. Severe cases of generalized allergy may be life threatening.
If you think you are having a generalized allergic reaction to insulin, call
your doctor immediately.
ADDITIONAL INFORMATION
Information about diabetes may be obtained from your diabetes educator.
Additional information about diabetes and Humulin can be obtained by calling
The Lilly Answers Center at 1–800–LillyRx (1–800–545–5979) or by visiting
www.LillyDiabetes.com.
Patient Information revised March 16, 2009
Pens manufactured by
Eli Lilly and Company, Indianapolis, IN 46285, USA or
Lilly France, F-67640 Fegersheim, France
for Eli Lilly and Company, Indianapolis, IN 46285, USA
Copyright © 1998, 2009, Eli Lilly and Company. All rights reserved.
PA 9147 FSAMP
