Medication Side Effects .info Disclaimer

Amgen has added an Aranesep warning (generic name: darbepoetin alfa), to its anemia drug, for kidney dialysis and cancer patients after studies on similar drugs showed higher doses can cause blood clots and death, the company said in a recent letter.

The new Aranesp warning stemmed from medical studies done outside the United States on two other anemia drugs: Eprex, made by the Johnson & Johnson unit Ortho Biotech Products, and NeoRecormon, made by Roche Holding.

The studies revealed major complications, including blood clots and death, when doctors used these drugs to try to raise hemoglobin levels beyond what was recommended, the letter said. A Food and Drug Administration panel of outside experts last year called for more study of the risks of the anemia drugs, including faster tumor growth and more blood clots.

Some researchers had thought elevating hemoglobin might increase the effectiveness of chemotherapy and radiation to fight cancer. An Amgen spokeswoman, Trish Hawkins, said that the F.D.A. had asked the company to add the trial information and warning to Aranesp.

If you or a loved one have been injured as a result of Aranesp side effects such as an Aranesp blood clot related issue or Aranesp death caused by blood clots or other cardiovascular side effects of Aranesp you want to contact an Aranesp lawyer. There are several qualified Aranesp attorneys that would be willing to take your case. For more information about an Amgen lawsuit contact an Aranesp lawyer.

Aranesp® is an erythropoietic protein that works in a similar way as the body’s natural erythropoietin — a glycoprotein produced by the kidneys that circulates through the bloodstream to bone marrow, where it stimulates red blood cell production. Red blood cells perform the essential function of transporting oxygen throughout the body. When the kidneys fail, production of erythropoietin decreases and the production of red blood cells is hindered, usually resulting in anemia. Certain cancer patients undergoing chemotherapy also suffer from anemia.

Aranesp Patient Information:

Aranesp®
(darbepoetin alfa)
Information for Patients
This patient package insert contains information and directions for those patients
whose doctor has determined may receive injections of Aranesp® at home, and
their caregivers. This patient package insert does not include all information
about Aranesp®. You should discuss any questions about treatment with
Aranesp® with your doctor.
What is Aranesp®?
Aranesp® (Air-uh-nesp) is a man made protein that acts like the natural protein
human erythropoietin (ee-rith-row-po-eh-tin). Erythropoietin is a hormone,
produced primarily by healthy kidneys, which stimulates the bone marrow to
make oxygen-carrying red blood cells.
What is Aranesp® used for?
Aranesp® is used to treat anemia (a lower than normal number of red blood cells)
in patients with kidney disease who may or may not be on dialysis. Aranesp® is
also used to treat anemia in cancer patients when the anemia is due to the
effects of chemotherapy.
People with anemia may feel tired or lack energy. Some people may also have
shortness of breath, chest pain, and feel cold much of the time.
How does Aranesp® work?
When kidneys are not working properly, they cannot produce enough
erythropoietin, so the body cannot make enough red blood cells. Also, some
forms of chemotherapy may prevent cancer patients from producing enough red
blood cells.
Aranesp® works by stimulating your bone marrow to make more red blood cells.
An increase in the number of red blood cells may relieve the symptoms of
anemia.
Your doctor will know when Aranesp® is working because your blood tests will
show an increase in the number of red blood cells. Your doctor may refer to the
results of your blood tests as hemoglobin and/or hematocrit, and your doctor will
be checking these tests while you are being treated with Aranesp®. The increase
in the number of red blood cells is not immediate; it may take several weeks.
The amount of time it takes to reach the red blood cell level that is right for you,
and the dose of Aranesp® needed to make the red blood cell level rise, is
different for each person. You may need Aranesp® dose adjustments before you
reach your correct dose of Aranesp® and the correct dose may change over time.
Who should not take Aranesp®?
• People with uncontrolled high blood pressure should not take Aranesp®.
• People who are allergic to Aranesp®, other erythropoietins, medicines made
using mammalian cells, or any of the ingredients (for example, albumin or
polysorbate 80) in Aranesp® should not take Aranesp®.
Talk to your doctor if you have any questions about this information.
What are the possible or reasonably likely side effects of Aranesp®?
Your blood pressure may increase when the number of red blood cells rises, so
your doctor or caregiver may monitor your blood pressure more frequently.
Some people have also had infections, fevers, headaches, muscle aches or
soreness, nausea, diarrhea, leg swelling, or chest pain. If you experience any of
these symptoms, you should call your doctor.
If you are on hemodialysis, there is a risk of blood clots forming at your vascular
access. Call your doctor if you think your access is blocked.
Patients with cancer may have an increased risk of blood clots in the veins
(thrombophlebitis) or the lungs (pulmonary embolus). Call your doctor if you
experience pain and/or swelling in the legs or worsening in shortness of
breath.
Some people experience redness, swelling, or itching at the site of injection.
This reaction may be an allergy to the ingredients in Aranesp®, or it may be a
local irritation. If you notice any signs of redness, swelling, or itching at the site
of injection, talk to your doctor.
Serious allergic reactions can also happen. These reactions can cause a rash
over the whole body, shortness of breath, wheezing, a drop in blood pressure,
swelling around the mouth or eyes, fast pulse, or sweating. If at any time a
serious allergic reaction occurs, stop using Aranesp® and call your doctor or
emergency medical personnel immediately (for example, call 911).
What about pregnancy or breastfeeding?
Aranesp® has not been studied in pregnant women and its effects on developing
babies are not known. It is also not known if Aranesp® can get into human breast
milk. If you are pregnant, plan to become pregnant, or think you may be
pregnant, or are breastfeeding, you should talk to your doctor before using
Aranesp®.
What important information do I need to know about taking Aranesp® at
home?
In some rare cases, your doctor may decide that you will be able to use
Aranesp® at home. If your doctor has determined that you can safely use
Aranesp® at home, you and/or your caregiver will receive instructions on how
much Aranesp® to use, how to inject it, how often it should be injected, and how
to dispose of the unused portions of each vial or prefilled syringe. Your doctor
will decide whether you use Aranesp® in vials or prefilled syringes. You should
always follow your doctor’s instructions.
Too much Aranesp® may cause your body to produce too many red blood cells
too fast (lead to a hemoglobin that is too high). Producing too many red blood
cells, or producing them too fast may cause serious problems. It is important that
your blood pressure be monitored often and to report any changes outside of the
guidelines that your doctor has given you, especially if you have heart disease.
In addition, symptoms of temporary confusion or seizures should be reported to
your doctor immediately. Certain laboratory tests, such as hemoglobin,
hematocrit, or iron level measurements, may also need to be done more often
and be reported to your doctor or dialysis center.
Over time, many kidney disease patients also need to take iron. Your doctor will
know when or if you need an iron supplement from your laboratory test results.
Do not change the dose of Aranesp®. You should ask your doctor what to do if
you miss a dose of Aranesp®.
Be sure to change the site for each injection to avoid soreness at any one site.
Occasionally a problem may develop at the injection site. If there is a lump,
swelling, or bruising at the injection site that does not go away, talk to your
doctor.
If you have a hemodialysis vascular access, continue to check the access to
make sure it is working. Call your doctor or dialysis center right away if you have
any problems or questions.
Always call your doctor if you do not feel well while using Aranesp®.
What do you and/or your caregiver need to do to prepare and give an
injection of Aranesp®?
When you receive your Aranesp®, always check to see that:
• The name Aranesp® appears on the package and vial or prefilled syringe
label.
• The expiration date on the vial or prefilled syringe label has not passed. You
should not use a vial or prefilled syringe after the date on the label.
• The strength of the Aranesp® vial or prefilled syringe (number of micrograms
[mcg] in the colored square on the package and on the vial or prefilled syringe
label) is the same as the doctor prescribed.
• The Aranesp® liquid in the vial or prefilled syringe is clear and colorless. Do
not use Aranesp® if the liquid in the vial or prefilled syringe appears discolored
or cloudy or if the liquid appears to contain lumps, flakes, or particles.
• The Aranesp® vial has a color cap on the top of the vial. Do not use a vial of
Aranesp® if the color cap on the top of the vial has been removed or is
missing.
• Do not use Aranesp® in a prefilled syringe if the grey cover on the needle is off, or
the needle guard (yellow sleeve on the syringe) has been activated (pulled to extend
over the needle). If you are using a vial of Aranesp®, only use the type of disposable
syringe that your doctor prescribes.
The doctor or nurse will give you instructions on how to measure your dose of
Aranesp®. This dose will be measured in milliliters. You should only use a
syringe that is marked in tenths of milliliters, or mL (for example, 0.2 mL). The
doctor or nurse may refer to an “mL” as a “cc” (1 mL = 1 cc). Using an unmarked
syringe can lead to a mistake in the dose. If you do not use the correct syringe,
you could inject too much or too little Aranesp®.
Only use disposable syringes and needles. Use the syringes and needles
only once and dispose of them as instructed by your healthcare provider.
IMPORTANT: TO HELP AVOID POSSIBLE INFECTION, FOLLOW THESE
INSTRUCTIONS.
Setting up for an injection
1. Find a clean, flat work surface such as a table.
2. If you are using a vial, remove a vial of Aranesp® from the refrigerator. If
you are using a prefilled syringe, tear off one syringe (in wrapper) from the
strip and place the others back in the refrigerator. Keep the syringe in its
wrapper until you are ready to prepare your dose. Do not freeze Aranesp®
or use a vial or prefilled syringe that has been frozen. Do not shake
Aranesp® or leave vials or syringes exposed to bright light. Vigorous
shaking or exposure to light may denature Aranesp® causing it to become
biologically inactive.
3. Remove the vial or prefilled syringe of Aranesp® from its carton and place
it on your flat work surface. Allow it to reach room temperature. This
should take about 30 minutes. During this time, cover the vial or prefilled
syringe to protect the solution from light.
4. You should use a vial or prefilled syringe only once. Do not put the needle
through the rubber stopper more than once. DO NOT SHAKE THE VIAL
OR PREFILLED SYRINGE. Shaking may damage the Aranesp®. If the
Aranesp® vial or prefilled syringe has been shaken vigorously, the solution
may appear foamy and it should not be used.
4. Assemble the supplies you will need for an injection:
• Aranesp® vial and the correct disposable syringe and needle
OR
• Aranesp® prefilled syringe with a transparent (clear) yellow plastic
needle guard attached
• Two alcohol swabs and one cotton ball or gauze. Open one alcohol
wipe if you are using a prefilled syringe. Open two alcohol wipes if you
are using a vial and disposable syringe.
• Puncture-proof disposal container
5. Wash your hands with soap and warm water.
How to prepare the dose of Aranesp®
If you are using Aranesp® in a vial, follow the instructions in Section A. If
you are using Aranesp® in a prefilled syringe, follow the instructions in
Section B.
Section A. Preparing the dose of Aranesp® using a vial and
disposable syringe
1. Take the color cap off the vial. Clean the rubber stopper with one alcohol
swab.
2. Check the package containing the syringe. If the package has been
opened or damaged, do not use that syringe. You should dispose of that
syringe in the puncture-proof disposal container. If the syringe package is
undamaged, open the package and remove the syringe.
3. Pull the needle cover straight off the syringe. Then, pull back on the
plunger to draw air into the syringe. The amount of air drawn into the
syringe should be the same amount (mL or cc) as the dose of Aranesp®
that your doctor prescribed.
4. Keep the vial on your flat work surface and insert the needle straight down
through the rubber stopper.
5. Push the plunger of the syringe down to inject the air from the syringe into
the vial of Aranesp®.
6. Keeping the needle inside the vial, turn the vial upside down. Make sure
that the tip of the needle is in the Aranesp® liquid.
7. Keeping the vial upside down, slowly pull back on the plunger to fill the
syringe with Aranesp® liquid to the number (mL or cc) that matches the
dose your doctor prescribed.
8. Keeping the needle in the vial, check for air bubbles in the syringe. If
there are air bubbles, gently tap the syringe with your fingers until the air
bubbles rise to the top of the syringe. Then slowly push the plunger up to
force the air bubbles out of the syringe. Keep the tip of the needle in the
liquid and once again pull the plunger back to the number on the syringe
that matches your dose. Check again for air bubbles. The air in the
syringe will not hurt you, but too large an air bubble can reduce your dose
of Aranesp®. If there are still air bubbles, repeat the steps above to
remove them.
9. Check again to make sure that you have the correct dose in the syringe. It
is important that you use the exact dose prescribed by your doctor.
10. Lay the vial on its side with the needle still in it until after you have
selected and prepared a site for injection. This will keep the needle from
touching anything before you use it.
Go directly to the section “Selecting and preparing the injection site.”
Section B. Preparing the dose of Aranesp® using a prefilled syringe
1. Open the package and remove the syringe from the tray. Check to see
that the needle cover is on and the yellow needle guard is covering the
barrel of the syringe. If the needle guard is covering the needle, then it
has already been activated. DO NOT use that syringe. Dispose of that
syringe in the puncture-proof disposal container. Use a new syringe. DO
NOT slide the needle guard over the needle cover before injection. This
will “activate” or lock the needle guard.
2. Hold the syringe with the needle pointing up to prevent the Aranesp® from
leaking out of the needle. Carefully pull the needle cover straight off.
3. Still holding the syringe up, slowly push the plunger to the line on the
syringe that matches the dose your doctor has prescribed.
4. Check the syringe for air bubbles. If there are air bubbles, gently tap the
syringe with your fingers until the air bubbles rise to the top of the syringe.
Slowly push the plunger up to force the air bubbles out of the syringe.
5. Check again to make sure that you have the correct dose in the syringe. It
is important that you use the exact dose prescribed by your doctor.
6. When you put the syringe down on your working surface, be careful not to
allow the needle to touch anything.
Selecting and preparing the injection site
1. Choose an injection site. Four recommended injection sites for Aranesp®
include:
• The outer area of the upper arms
• The abdomen (except for the two-inch area around the navel)
• The front of the middle thighs
• The upper outer areas of the buttocks
Choose a new site each time you inject Aranesp®. Choosing a new site
can help avoid soreness at any one site. Do not inject Aranesp® into an
area that is tender, red, bruised, hard, or that has scars or stretch marks.
2. Clean the injection site with a new alcohol swab.
Injecting the dose of Aranesp® from a vial or prefilled syringe
For patients not on hemodialysis:
1. Hold the syringe in the hand that you will use to inject Aranesp®. Use the
other hand to pinch a fold of skin at the cleaned injection site.
Note: If using a prefilled syringe with a needle guard, hold the syringe barrel
through the two needle guard windows when giving the injection.
2. Holding the syringe like a pencil, use a quick “dart like” motion to insert the
needle either straight up and down (90 degree angle) or at a slight angle
(45 degrees) into the skin.
or
3. After the needle is inserted, let go of the skin. Pull the plunger back
slightly. If no blood appears, slowly push the plunger all the way down,
until all the Aranesp® is injected. If blood comes into the syringe, do not
inject Aranesp® because the needle has entered a blood vessel.
Withdraw the syringe and discard it in the puncture-proof disposal
container. Repeat the steps to choose and clean a new injection site and
prepare a new syringe. Remember to check again for blood before
injecting Aranesp®.
4. When the syringe is empty, pull the needle out of the skin and place a
cotton ball or gauze over the injection site and press for several seconds.
5. You should ONLY use a disposable syringe and Aranesp® vial or prefilled
syringe once. You should discard the disposable syringe and vial or
prefilled syringe with any remaining Aranesp®.
If a prefilled syringe was used, go directly to the section “Activation of the
needle guard on used prefilled syringes.”
If a disposable syringe was used with a vial of Aranesp®, go directly to the
section “Disposal of syringes and needles.”
For patients on hemodialysis:
1. Clean the venous port of the hemodialysis tubing with a new alcohol swab.
2. Insert the needle of the syringe into the cleaned venous port and push the
plunger all the way down to inject all the Aranesp®.
Remove the syringe from the venous port.
If a disposable syringe was used with a vial of Aranesp®, go directly to the
section “Disposal of syringes and needles”.
Using prefilled syringe
with needle guard
Using
disposable syringe
Activation of the needle guard on used prefilled syringes
1. After injecting Aranesp® from the prefilled syringe, do not recap the
needle. Keep your hands behind the needle at all times. To activate the
needle guard, hold the finger grip of the syringe with one hand and grasp
the needle guard with your free hand, sliding it completely over the needle
until the needle guard clicks into place. NOTE: If an audible click is not
heard, the needle guard may not be completely activated.
Disposal of syringes and needles
Dispose of the syringe and needle or the syringe with activated needle guard as
instructed by your healthcare provider, or by following these steps:
• Do not throw the needle or syringe in the household trash or recycle.
• DO NOT put the needle cover back on the needle. Place the used
needle, needle cover, and syringe in a hard plastic disposal container
with a screw-on cap or a metal container with a plastic lid, such as a
coffee can, labeled “used syringes.” If a metal container is used, cut a
small hole in the plastic lid and tape the lid to the metal container. If a
hard plastic container is used, always screw the cap on tightly after
each use.
• Do not use glass or clear plastic containers.
• When the container is full, tape around the cap or lid to make sure the
cap or lid does not come off.
• Always keep the container out of the reach of children.
• You should always check first with your healthcare provider for
instructions on how to properly dispose of a filled disposal container.
There may be special state and local laws for disposing of used
needles and syringes. Do not throw the disposal container in
household trash. Do not recycle.
How should Aranesp® be stored?
Aranesp® should be kept in its original carton to protect it from light, and stored in
the refrigerator at 2° to 8°C (36° to 46°F). Do not place Aranesp® in the freezer.
Do not use a vial or prefilled syringe of Aranesp® that has been frozen, left in
light, or improperly refrigerated. It is important that Aranesp® be stored and used
as stated in these instructions. Contact your healthcare provider with any
questions about storage.
When traveling, transport Aranesp® in its original carton in an insulated container
with a coolant such as blue ice. To avoid freezing, make sure the Aranesp® vial
or prefilled syringe does not touch the coolant. Once you arrive, your Aranesp®
should be placed in a refrigerator as soon as possible.
[Amgen Logo]
Manufactured by:
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, California 91320-1799
 2002-2003 Amgen Inc. All rights reserved.
Issue Date: 12/12/03