What is alemtuzumab?
Alemtuzumab is an antibody made from animal DNA.
Alemtuzumab is used to treat chronic lymphocytic leukemia.
Alemtuzumab is usually given after other medications have been tried without successful
treatment.
Alemtuzumab may also be used for purposes other than those listed in this medication
guide.
What should I discuss with my healthcare provider before taking alemtuzumab?
You should not receive this medication if you are allergic to alemtuzumab, or if you
have:
Before receiving alemtuzumab, tell your doctor if you are allergic to
any drugs, or if you have:
-
heart disease;
-
a bleeding or blood clotting disorder;
-
diabetes;
-
a stomach or intestinal disorder; or
-
asthma or other breathing disorder.
If you have any of these conditions, you may not be able to use
alemtuzumab, or you may need dosage adjustments or special tests during treatment.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell
your doctor if you are pregnant or plan to become pregnant during treatment.
If a man fathers a child while using this medication, the baby may have birth defects. Use
a condom to prevent pregnancy during your treatment. Continue using condoms for at least 6
months after you stop using alemtuzumab.
It is not known whether alemtuzumab passes into breast milk or if it could harm a
nursing baby. Do not breast-feed a baby while you are receiving alemtuzumab and for at least 3
months after your treatment ends.
How should I take alemtuzumab?
Alemtuzumab is given as an injection through a needle placed into a vein. You will
receive this injection in a clinic or hospital setting. The medicine must be given slowly through
an IV infusion, and can take up to 2 hours to complete.
Alemtuzumab is given as an injection through a needle placed into a vein. Your doctor,
nurse, or other healthcare provider will give you this injection. You may be given instructions on
how to inject your medicine at home. Do not use this medicine at home if you do not fully
understand how to give the injection and properly dispose of needles and other items used in
giving the medicine.
Use each needle and syringe only one time. Throw away used needles and syringes in a
puncture-proof container. If your medicine does not come with such a container, ask your
pharmacist where you can get one. Keep this container out of the reach of children and pets.
Your pharmacist can tell you how to properly dispose of the container.
Do not shake the medication vial (bottle). Vigorous shaking can ruin the medicine.
Do not mix your alemtuzumab dose until you are ready to give yourself an injection. Do not use
the medication if it has changed colors or has any particles in it. Call your doctor for a new
prescription.
You may be given other medications together with alemtuzumab to help prevent certain
side effects.
You may also need to take an antibiotic to prevent infections while you are receiving
alemtuzumab. Take the antibiotic for the entire length of time prescribed by your doctor.
Alemtuzumab can lower the blood cells that help your body fight infections. This can
make it easier for you to bleed from an injury or get sick from being around others who are ill.
To be sure your blood cells do not get too low, your blood will need to be tested on a regular
basis. Do not miss any scheduled visits to your doctor.
Tell your doctor if you have stopped using alemtuzumab for longer than 7 days for any
reason. You may need to restart the medication at a lower dose.
If you keep this medicine at home, store it in a refrigerator, and protect it from light.
Do not allow the medicine to freeze. If it does freeze, thaw in a refrigerator. Do not warm the
medication.
What happens if I miss a dose of alemtuzumab?
Call your doctor for instructions if you miss a dose of this medication.
Where can I get more information about alemtuzumab?
Your pharmacist has information about alemtuzumab written for health professionals that you may read.
What are the possible side effects of alemtuzumab?
Get emergency medical help if you have any of these
signs of an allergic
reaction:
hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Some people receiving a alemtuzumab injection have had a reaction to the infusion
(when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy,
hot or cold, nauseated, light-headed, sweaty, itchy, or have a fast heartbeat, chest tightness, or
trouble breathing during the injection.
Call your doctor at once if you have any of these serious side effects:
-
pale skin, easy bruising or bleeding, unusual weakness;
-
chest pain or heavy feeling, pain spreading to the arm or
shoulder, nausea, sweating, general ill feeling;
-
fever, chills, body aches, flu symptoms;
-
feeling light-headed, fainting;
-
confusion, hallucinations; or
-
white patches or sores inside your mouth or on your lips.
Less serious side effects include:
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nausea, vomiting, stomach pain;
-
diarrhea, constipation;
-
loss of appetite;
-
headache;
-
back or chest pain;
-
sleep problems (insomnia);
-
tired feeling;
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runny nose, sore throat; or
-
sweating, mild skin rash or itching;
Side effects other than those listed here may also occur. Talk to your
doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about alemtuzumab?
You should not receive this medication if you are allergic to alemtuzumab, or if you
have HIV or AIDS, any type of active infection, or if you are allergic to mouse or hamster
proteins.
Before receiving alemtuzumab, tell your doctor if you have heart disease, a bleeding or
blood clotting disorder, diabetes, a stomach or intestinal disorder, or asthma or other breathing
problem.
Tell your doctor if you are pregnant or plan to become pregnant during treatment.
If a man fathers a child while using this medication, the baby may have birth defects. Use
a condom to prevent pregnancy during your treatment. Continue using condoms for at least 6
months after you stop using alemtuzumab.
Do not breast-feed a baby while you are receiving alemtuzumab and for at least 3
months after your treatment ends.
You may be given other medications together with alemtuzumab to help prevent infection
or certain side effects.
Alemtuzumab can lower the blood cells that help your body fight infections. This can
make it easier for you to bleed from an injury or get sick from being around others who are ill.
To be sure your blood cells do not get too low, your blood will need to be tested on a regular
basis. Do not miss any scheduled visits to your doctor.
Avoid being near people who have colds, the flu, or other contagious illnesses. Contact
your doctor at once if you develop signs of infection.
Do not receive a "live" vaccine while you are being treated with alemtuzumab, and
for at least several weeks after your treatment ends. The live vaccine may not work as well
during this time, and may not fully protect you from disease.
What should I avoid while taking alemtuzumab?
Avoid being near people who have colds, the flu, or other contagious illnesses. Contact
your doctor at once if you develop signs of infection.
Do not receive a "live" vaccine while you are being treated with alemtuzumab, and
for at least several weeks after your treatment ends. The live vaccine may not work as well
during this time, and may not fully protect you from disease.
What other drugs will affect alemtuzumab?
There may be other drugs not listed that can affect alemtuzumab. Tell your doctor about
all the prescription and over-the-counter medications you use. This includes vitamins, minerals,
herbal products, and drugs prescribed by other doctors. Do not start using a new medication
without telling your doctor.
What happens if I have an overdose of alemtuzumab?