A1,
A2,
B,
C1,
C2,
D,
E,
F,
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Apidra Patient, Information, Instructions - Insulin glulisine
Apidra Patient, Information, Instructions - Insulin glulisine
PATIENT INFORMATION
APIDRA™ 10 mL vial (1000 units per vial) 100 units per
mL (U-100) (insulin glulisine [recombinant DNA origin] injection)
Read the Patient Information that comes with APIDRA (uh-PEE-druh)
before you start using it and each time you get a refill. There may be new information.
This leaflet does not take the place of talking with your healthcare provider
about your condition or treatment. If you have questions about APIDRA or about
diabetes, talk with your healthcare provider.
What is the most important information I should know about
APIDRA?
Do not change the insulin you are using without talking
to your healthcare provider. Any change in insulin strength, manufacturer,
type (regular, NPH, analog), or species (animal, human) may need a change in
the dose. This dose change may be needed right away or later on during the first
several weeks or months on the new insulin. Doses of oral anti-diabetic medicines
may also need to change, if your insulin is changed.
You must test your blood sugar levels while using an insulin
such as APIDRA. Your healthcare provider will tell you how often you should
test your blood sugar level, and what to do if it is high or low.
When used in a pump do not mix APIDRA with any other insulin
or liquid.
APIDRA comes as U-100 insulin and contains 100 units
of APIDRA. One milliliter (mL) of U-100 insulin contains 100 units of insulin.
(1 mL = 1 cc).
What is APIDRA?
APIDRA is a rapid-acting man-made insulin that is like insulin
made by your body. APIDRA is used to treat adults with diabetes for the control
of high blood sugar. APIDRA starts working faster than regular insulin and does
not work as long. APIDRA is used with a longer-acting insulin or by itself as
insulin pump therapy to maintain proper blood sugar control. Your body needs
insulin to turn sugar (glucose) into energy. If your body does not make enough
insulin, you need to take more insulin so you will not have too much sugar in
your blood.
Insulin injections are important in keeping your diabetes under
control. But the way you live, your diet, careful checking of your blood sugar
levels, exercise, and planned physical activity, all work with your insulin
to help you control your diabetes.
You need a prescription to get APIDRA. Always be sure you receive
the right insulin from the pharmacy.
Who should not take APIDRA?
Do not take APIDRA if you are allergic to insulin glulisine
or any of the inactive ingredients in APIDRA. See the end of this leaflet for
a list of the inactive ingredients.
Before starting APIDRA, tell your healthcare provider
• about all you medical problems including if you:
• have liver or kidney problems. Your dose may need to be adjusted.
• are pregnant or plan to become pregnant. It is not known if APIDRA
may harm your unborn baby. It is very important to maintain control of your
blood sugar levels during pregnancy. Your healthcare provider will decide
which insulin is best for during your pregnancy.
• are breast-feeding or plan to breast-feed. It is not known whether
APIDRA passes into your milk. Many medicines, including insulin, pass into
human milk, and could affect your baby. Talk to your healthcare provider about
the best way to feed your baby.
• about all the medicines you take including prescription
and non-prescription medicines, vitamins and herbal supplements.
How should I use APIDRA?
See the end of this leaflet for the "Instructions for Use"
including the sections "How do I draw the insulin into the syringe?"
and How do I use APIDRA with an external subcutaneous insulin infusion
pump?"
•Follow the instructions given by your healthcare provider
about the type or types of insulin you are using. Do not make any changes with
your insulin unless you have talked to your healthcare provider. Your insulin
needs may change because of illness, stress, other medicines, or changes in
diet or activity level. Talk to your healthcare provider about how to adjust
your insulin dose.
•You should take APIDRA within 15 minutes before a meal or within 20 minutes
after starting the meal. Only use APIDRA that is clear and colorless. If your
APIDRA is cloudy or colored, return it to your pharmacy for a replacement.
•Follow your healthcare provider's instructions for testing your blood sugar.
•Inject APIDRA under your skin (subcutaneously) in your upper arm, abdomen
(stomach area), or thigh (upper leg). Never inject it into a vein or muscle.
If you use a pump, infuse APIDRA through the skin of your abdomen.
•Change (rotate) injection sites within the same body area.
What kind of syringe should I use?
•Always use a syringe that is marked for U-100 insulin. If you use the wrong
syringe, you may get the wrong dose. You could get a blood sugar level that
is too low or too high.
Mixing with APIDRA
•If you are mixing APIDRA with NPH human insulin, draw APIDRA into the syringe
first. Inject the mixture right away. Do not mix APIDRA with any other
type of insulin than NPH.
•Do not mix APIDRA with any other insulin when used in a pump.
What can affect how much insulin I need?
Illness. Illness may change how much insulin you need.
It is a good idea to think ahead and make a "sick day" plan with your healthcare
provider in advance so you will be ready when this happens. Be sure to test
your blood sugar more often and call your healthcare provider if you are sick.
Medicines. Many medicines can affect your insulin
needs. Other medicines, including prescription and non-prescription medicines,
vitamins and herbal supplements, can change the way insulin works. You may need
a different dose of insulin when you are taking certain other medicines.
Know all the medicines you take, including prescription and non-prescription
medicines, vitamins and herbal supplements. You may want to keep a list
of the medicines you take. You can show this list to all your healthcare providers
and pharmacists anytime you get a new medicine or refill. They will tell you
if your insulin dose needs to be changed.
Meals. The amount of food you eat can affect your insulin
needs. If you eat less food, skip meals, or eat more food than usual, you may
need a different dose of insulin. Talk to your healthcare provider if you change
your diet so that you know how to adjust your APIDRA and other insulin doses.
Alcohol. Alcohol, including beer and wine, may affect
the way APIDRA works and affect your blood sugar levels. Talk to your healthcare
provider about drinking alcohol.
Exercise or Activity level. Exercise or activity level
may change the way your body uses insulin. Check with your healthcare provider
before you start an exercise program because your dose may need to be changed.
Travel. If you travel across time zones, talk with your
healthcare professional about how to time your injections. When you travel,
wear your medical alert identification. Take extra insulin and supplies with
you.
What are the possible side effects of APIDRA and other insulins?
Hypoglycemia (low blood glucose):
Hypoglycemia is often called an "insulin reaction" or "low
blood sugar". It may happen when you do not have enough sugar in your blood.
Common causes of hypoglycemia are illness, emotional or physical stress, too
much insulin, too little food or missed meals, and too much exercise or activity.
Early warning signs of hypoglycemia may be different, less noticeable or not
noticeable at all in some people. That is why it is important to check your
blood sugar as you have been advised by your healthcare provider.
Hypoglycemia can happen with:
•The wrong insulin dose. This can happen when too much insulin is
injected. For pump users it could happen if the pump dose is too high.
•Not enough carbohydrate (sugar or starch) intake. This can happen
if: a meal or snack is missed or delayed.
• you are vomiting or have diarrhea that decreases the amount of sugar absorbed
by your body.
• you drink alcohol.
•Medicines that affect insulin. Be sure to discuss all your medicines
with your healthcare provider. Do not start any new medicines until you
know how they may affect your insulin dose.
•Medical conditions that can affect your blood sugar levels or insulin.
These conditions include diseases of the adrenal glands, the pituitary,
the thyroid gland, the liver, and the kidney.
•Too much glucose use by the body. This can happen if you exercise
too much or have a fever.
•Injecting insulin the wrong way or in the wrong injection area.
Hypoglycemia can be mild to severe. Its onset may be rapid.
Some patients have few or no warning symptoms, including:
• patients with diabetes for a long time
• patients with diabetic neuropathy (nerve problems)
• or patients using certain medicines for high blood pressure or heart problems.
Hypoglycemia may reduce your ability to drive a car or use
mechanical equipment and you may risk injury to yourself or others.
Severe hypoglycemia can be dangerous and can cause temporary
or permanent harm to your heart or brain. It may cause unconsciousness, seizures,
or death.
Symptoms of hypoglycemia may include:
• anxiety, irritability, restlessness, trouble concentrating,
personality changes, mood changes, or other abnormal behavior
• tingling in your hands, feet, lips, or tongue
• dizziness, light-headedness, or drowsiness
• nightmares or trouble sleeping
• headache
• blurred vision
• slurred speech
• palpitations (fast heart beat)
• sweating
• tremor (shaking)
• unsteady gait (walking).
If you have hypoglycemia often or it is hard for you to know
if you have the symptoms of hypoglycemia, talk to your healthcare provider.
Mild to moderate hypoglycemia can be treated by eating or drinking
carbohydrates such as fruit juice, raisins, sugar candies, milk or glucose tablets.
Talk to your healthcare provider about the amount of carbohydrates you should
eat to treat mild to moderate hypoglycemia.
Severe hypoglycemia may require the help of another person
or emergency medical people. Someone with hypoglycemia who cannot take foods
or liquids with sugar by mouth needs medical help fast and will need treatment
with a glucagon injection or glucose given intravenously (IV). Without medical
help right away, serious reactions or even death could happen.
Hyperglycemia (high blood glucose):
Hyperglycemia occurs when you have too much sugar in your blood.
Usually, it means there is not enough insulin to break down the food you eat
into energy your body can use. Hyperglycemia can be caused by a fever, an infection,
stress, eating more than you should, taking less insulin than prescribed, or
it can mean your diabetes is getting worse.
Hyperglycemia can happen with:
•The wrong insulin dose. This can happen from:
- injecting too little or no insulin
- incorrect storage (freezing, excessive heat)
- use after the expiration date.
For pump users this can also be caused when the bolus dose
of APIDRA infusion or the basal infusion is set too low or the pump is delivering
too little insulin.
•Too much carbohydrate intake. This can happen if you eat larger meals,
eat more often or increase the amount of carbohydrate in your meals.
•Medicines that affect insulin. Be sure to discuss all your medicines
with your healthcare provider. Do not start any new medicines until you
know how they may affect your insulin dose.
•Medical conditions that affect insulin. These medical conditions
include fevers, infections, heart attacks, and stress.
•Injecting insulin the wrong way or in the wrong injection area.
Testing your blood or urine often will let you know if you
have hyperglycemia. If your tests are often high, tell your healthcare provider
so your dose of medicine can be changed.
Hyperglycemia can be mild or severe. It can progress to
diabetic acidosis (DKA) (ketoacidosis) or very high glucose levels (hyperosmolar
coma) and result in unconsciousness and death.
Diabetic ketoacidosis occurs most often in patients with type
1 diabetes. It can also happen in patients with type 2 diabetes who become very
sick. Because some patients get few symptoms of hyperglycemia, it is important
to check your blood sugar regularly. Symptoms of hyperglycemia include:
• confusion or drowsiness
• increased thirst
• decreased appetite, nausea, or vomiting
• rapid heart rate
• increased urination and dehydration (too little fluid in
your body).
Symptoms of DKA also include:
• fruity smelling breath
• fast, deep breathing
• stomach area (abdominal) pain.
Severe or continuing hyperglycemia or DKA needs evaluation
and treatment right away by your healthcare provider.
Other possible side effects of APIDRA include:
Serious allergic reactions:
Some times severe, life-threatening allergic reactions can
happen with insulin. If you think you are having a severe allergic reaction,
get medical help right away. Signs of insulin allergy include:
• a rash all over your body
• shortness of breath
• wheezing (trouble breathing)
• a fast pulse
• sweating
• low blood pressure.
Reactions at the injection site:
Injecting insulin can cause the following reactions on the
skin at the injection site:
• a little depression in the skin (lipoatrophy)
• skin thickening (lipohypertrophy)
• red, swelling, itchy skin (injection site reaction).
You can reduce the chance of getting an injection site reaction
if you change (rotate) the injection site each time. An injection site reaction
should clear up in a few days or a few weeks. If injection site reactions do
not go away or keep happening call your healthcare provider.
Tell your healthcare provider if you have any side effects
that bother you.
These are not all the side effects of APIDRA. Ask your healthcare
provider or pharmacist for more information.
How should I store APIDRA?
•Unopened vial:
Store new unopened APIDRA vials in the refrigerator (not the
freezer) between 36°F to 46°F (2°C to 8°C). Do not freeze APIDRA. Keep APIDRA
out of direct heat and light. If a vial freezes or overheats, throw it away.
•Open (In Use) vial:
Once a vial is opened, you can keep it in the refrigerator
or as cool as possible (below 77°F [25°C]), but the opened vial must be used
within 28 days. If refrigeration is not possible, the open vial in use can be
kept unrefrigerated for up to 28 days away from direct heat and light, as long
as the temperature is not greater than 77°F (25°C). For example, do not leave
it in a car on a summer day.
|
|
Not in-use (unopened) Refrigerated
|
Not in-use (unopened) Room Temperature below 77°F (25°C)
|
In-use (opened) Room temperature, below 77°F (25°C)
|
|
10 mL Vial
|
Until expiration date
|
28 days
|
28 days, refrigerated/room
temperature
|
•Insulin pump infusion sets: Infusion sets (reservoirs,
tubing, and catheters) and the APIDRA in the reservoir should be thrown away:
• after no more than 48 hours of use or
• after exposure to temperatures higher than 98.6°F (37°C).
•Do not use a vial of APIDRA after the expiration date
stamped on the label.
•Do not use APIDRA if it is cloudy or if you see particles.
General Information about APIDRA
Use APIDRA only to treat your diabetes. Do not give
or share APIDRA with another person, even if they have diabetes also. It may
harm them.
This leaflet summarizes the most important information about
APIDRA. If you would like more information, talk with your healthcare provider.
You can ask your healthcare provider or pharmacist for information about APIDRA
that is written for health professionals. For more information about APIDRA
call 1-800-633-1610 or go to website www.aventis-us.com.
What are the ingredients in APIDRA? Active Ingredient:
insulin glulisine
Inactive Ingredients: m-cresol, trometamoline, sodium
chloride, polysorbate 20, and water for injection.
Instructions for Use How do I draw the insulin into the syringe?
•The syringe must be new and not contain any other medicine.
•Do not mix APIDRA with any other type of insulin than NPH.
If you are mixing APIDRA with NPH human insulin, draw APIDRA into the syringe
first. Inject the mixture right away.
Follow these steps:
1. Wash your hands.
2. Check the insulin to make sure it is clear and colorless.
Do not use it after the expiration date or if it is cloudy or if you see particles.
3. If you are using a new vial, remove the protective cap.
Do not remove the stopper.
4. Wipe the top of the vial with an alcohol swab. You do
not have to shake the vial of APIDRA before use.
5. Use a new needle and syringe every time you take a dose.
Use disposable syringes and needles only once. Throw them away properly. Never
share needles and syringes.
6. Draw air into the syringe equal to your insulin dose.
Put the needle through the rubber top of the vial and push the plunger to inject
the air into the vial.
7. Leave the syringe in the vial and turn both upside down.
Hold the syringe and vial firmly in one hand.
8. Make sure the tip of the needle is in the insulin. With
your free hand, pull the plunger to withdraw the correct dose into the syringe.
9. Before you take the needle out of the vial, check the
syringe for air bubbles. If bubbles are in the syringe, hold the syringe straight
up and tap the side of the syringe until the bubbles float to the top. Push
the bubbles out with the plunger and draw insulin back in until you have the
correct dose. If you are mixing APIDRA with NPH insulin check with your healthcare
professional on how to mix. 10. Remove the needle from the vial. Do not let
the needle touch anything. You are now ready to inject.
How do I inject APIDRA?
Inject APIDRA under your skin. Take APIDRA as prescribed by
your healthcare provider.
You should look at the medicine in the vial. If the medicine
is cloudy or has particles in it, do not use it. Contact your healthcare provider.
Use a new vial.
Follow these steps:
1. Decide on an injection area - either upper arm, thigh
or abdomen. Injection sites within an injection area must be different from
one injection to the next.
2. Use alcohol or soap and water to clean the skin where
you are going to inject. The injection site should be dry before you inject.
3. Pinch the skin. Stick the needle in the way your healthcare
provider showed you. Release the skin.
4. Slowly push in the plunger of the syringe all the way,
making sure you have injected all the insulin. Leave the needle in the skin
for about 10 seconds. Pull the needle straight out and gently press on the spot
where you injected yourself for several seconds. Do not rub the area.
5. Follow your healthcare provider’s instructions for throwing
away the needle and syringe. Do not recap the syringe. Used needle and syringe
should be placed in sharps containers (such as red biohazard containers), hard
plastic containers (such as detergent bottles), or metal containers (such as
an empty coffee can). Such containers should be sealed and disposed of properly.
How should I infuse APIDRA with an external subcutaneous insulin
infusion pump?
Do not mix APIDRA with any other insulin or liquid when used
in a pump.
•APIDRA is recommended for use in the following pumps and infusion
sets: Disetronic® H-Tron® plus V100 and D-Tron® with Disetronic
catheters (Rapid™, Rapid C™, Rapid D™, and Tender™);
MiniMed® Models 506, 507, 507c and 508 with MiniMed catheters (Sof-set Ultimate
QR™, and Quick-set™)‡. Refer to the instruction manual
of your specific pump on proper use of insulin in a pump. Call your healthcare
provider if you have questions about using the pump.
•If the pump or infusion set does not work right you may not
receive the right dose of insulin. Hypoglycemia, hyperglycemia or ketosis can
happen. Problems should be identified and corrected as quickly as possible,
see instruction manual for your pump. Because APIDRA starts working faster and
does not work as long, you may have less time to identify and correct the problem
than with regular insulin.
•If you start using APIDRA by pump infusion, you may need to
adjust your insulin doses. Check with your healthcare provider.
•You must use insulin from a new vial of APIDRA if unexplained
hyperglycemia happens, or if pump alarms do not respond to all of the following:
• a repeat dose (injection or bolus) of APIDRA
• a change in the infusion set, including the reservoir with APIDRA
• a change in the infusion site.
If these actions do not work, you may need to restart your
injections with syringes and you must call your healthcare provider. Continue
to check your blood sugar often.
The infusion set, reservoir with insulin, and infusion site
should be changed:
• every 48 hours or less
• when unexpected hyperglycemia or ketosis occurs
• when alarms sound, as specified by your pump manual
• if the insulin has been exposed to temperatures over 98.6°F (37°C). If
the insulin or pump could have absorbed radiant heat, for example from sunlight,
that would heat the insulin to over 98.6°F (37°C). Dark colored pump cases
or sport covers can increase this type of heat. The location where the pump
is worn may affect the temperature.
•Patients who get skin reactions at the infusion site may need to change
infusion sites more often.
ADDITIONAL INFORMATION
DIABETES FORECAST is a national magazine designed especially
for patients with diabetes and their families and is available by subscription
from the American Diabetes Association, National Service Center, 1701 N. Beauregard
Street, Alexandria, Virginia 22311, 1-800-DIABETES (1-800-342-2383). You may
also visit the ADA website at www.diabetes.org. Another publication, DIABETES
COUNTDOWN, is available from the Juvenile Diabetes Research Foundation International
(JDRF), 120 Wall Street, 19th Floor, New York, New York 10005, 1-800-JDF-CURE
(1-800-533-2873). You may also visit the JDRF website at www.jdf.org. To get
more information about diabetes, check with your healthcare professional or
diabetes educator or visit www.DiabetesWatch.com.
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