What is efalizumab?
Efalizumab is a man-made form of a protein similar to human antibodies. Efalizumab is made to
target and destroy only certain cells in the body. This may help to protect healthy cells from damage.
Efalizumab is used to treat plaque psoriasis (raised, silvery flaking of the skin) in adults.
Efalizumab may also be used for other purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking efalizumab?
You should not use this medication if you are allergic to efalizumab.
Efalizumab increases the risk of a serious infections, including a viral infection of the brain
that can lead to disability or death. This risk is higher if you have a weak immune system or are
receiving certain medicines.
If you have certain conditions, you may need a dose adjustment or special tests to safely use
this medication. Before using efalizumab, tell your doctor if you have:
You should be current on all immunizations before you start using
efalizumab.
FDA pregnancy category C. It is not known whether this medication is harmful to an
unborn baby. Tell your doctor if you become pregnant while using efalizumab, or within 6 weeks after
you stop using the medication.
Your name may need to be listed on a pregnancy registry if you become pregnant while using
this medication. The purpose of this registry is to track the outcome of the pregnancy and delivery to
evaluate whether efalizumab had any effect on the baby.
It is not known whether efalizumab passes into breast milk or if it could harm a nursing
baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.
Treatment with efalizumab may increase your risk of developing certain types of cancer. Talk
with your doctor about your individual risk.
How should I take efalizumab?
Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for
longer than recommended. Follow the directions on your prescription label.
This medication comes with patient instructions for safe and effective use. Follow these
directions carefully. Ask your doctor or pharmacist if you have any questions.
Efalizumab is given as an injection under the skin. Your doctor, nurse, or other healthcare
provider will give you this injection. You may be shown how to inject your medicine at home. Do not
self-inject this medicine if you do not fully understand how to give the injection and properly dispose of
used needles and syringes.
Efalizumab is usually given once per week. Try to use the medicine on the same day each
week.
Use a different place on your stomach, thigh, buttocks, or upper arm each time you give
yourself an injection. Your care provider will show you the places on your body where you can safely
inject the medication. Do not inject into the same place two times in a row.
Efalizumab is a powder medicine that must be mixed with a liquid (diluent) before using it. If
you are using the injections at home, be sure you understand how to properly mix and store the
medication.
Do not shake the mixed medicine. Vigorous shaking can cause the mixture to foam. Do
not draw your efalizumab dose into a syringe 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.
Each single-use vial (bottle) of this medicine is for one use only. Throw away the vial after one
use, even if there is still some medicine left in it after injecting your dose.
Use each disposable needle only one time. Throw away used needles in a puncture-proof
container (ask your pharmacist where you can get one and how to dispose of it). Keep this container
out of the reach of children and pets.
A day or two after using your first dose of efalizumab, you may have nausea, vomiting, muscle
pain, and/or a headache. Call your doctor if these effects become severe.
Efalizumab can lower blood cells that help your body fight infections, making it easier for you to
bleed from an injury or get sick from being around others who are ill.
During your efalizumab treatment, it is extremely important that your doctor check you
every 3 to 6 months to make sure you are not developing any signs of serious infection.
Do
not miss any scheduled visits to your doctor.
Call your doctor if your symptoms do not improve, or if they get worse while using efalizumab.
Your psoriasis may get worse after you stop using efalizumab for any reason. Your doctor may want to
keep checking to make sure your psoriasis does not get worse. Do not miss any follow-up visits.
Store efalizumab in its original carton in the refrigerator, protected from light. Do not
freeze.
If you have mixed your medicine and cannot use it right away, keep the mixture at room
temperature and use it within 8 hours. Check to make sure the mixture is still clear or pale yellow and
does not contain any particles.
What happens if I miss a dose of efalizumab?
Call your doctor for instructions if you miss a dose of efalizumab.
Where can I get more information about efalizumab?
Your pharmacist has information about efalizumab written for health professionals that you may read.
What are the possible side effects of efalizumab?
Get emergency medical help if you have any of these
signs of an allergic
reaction:
hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
-
signs of infection such as fever, chills, sore throat, flu symptoms,
easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, or mouth sores;
-
signs of a skin infection, such as redness, tenderness, and
swelling;
-
pale or yellowed skin, dark colored urine, confusion or
weakness;
-
change in your mental state, problems with speech or
walking, decreased vision (these symptoms may start gradually and get worse quickly);
-
cough with yellow or green mucus, stabbing chest pain or
tightness, wheezing, trouble breathing;
-
neck stiffness, increased sensitivity to light, purple spots on
the skin, and/or seizure (convulsions);
-
numbness or tingly feeling in your feet and spreading
upward, muscle weakness in your face; or
-
problems with vision, speech, swallowing, or bladder and
bowel functions.
Less serious side effects may include:
-
headache, muscle pain, and nausea or vomiting (especially after
the first dose);
-
back pain;
-
joint pain, stiffness, or swelling; or
-
swelling in your hands or feet.
This is not a complete list of side effects and others may occur. Call your
doctor for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about efalizumab?
Efalizumab increases the risk of serious infections, including a viral infection of the brain that
can lead to disability or death. This risk is higher if you have a weak immune system or are receiving
certain medicines. Call your doctor right away if you have symptoms such as change in your mental
state, problems with speech or walking, or decreased vision. These symptoms may start gradually and
get worse quickly.
During your efalizumab treatment, it is extremely important that your doctor check you
every 3 to 6 months to make sure you are not developing any signs of serious infection.
Do
not miss any scheduled visits to your doctor.
You should also call your doctor right away if you develop signs of infection such as fever,
chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of
appetite, nausea and vomiting, mouth sores, or unusual weakness.
Before using efalizumab, tell your doctor about all other medications you are using, especially
other psoriasis medications or phototherapy, or drugs that weaken your immune system such as cancer
medicine, steroids, and medicines to prevent rejection of a transplanted organ.
What should I avoid while taking efalizumab?
Avoid being near people who have colds, the flu, or other contagious illnesses.
Do not receive a "live" vaccine while you are using efalizumab, and avoid coming into
contact with anyone who has recently received a live vaccine. There is a chance that the virus could be
passed on to you. Live vaccines include measles, mumps, rubella (MMR), oral polio, chickenpox
(varicella), and nasal flu vaccine.
What other drugs will affect efalizumab?
Tell your doctor about all other medications you are using, especially:
-
other psoriasis medications or phototherapy;
-
drugs that weaken your immune system (such as cancer
medicine or steroids);
-
cyclosporine (Neoral, Sandimmune, Gengraf);
-
sirolimus (Rapamune), tacrolimus (Prograf);
-
basiliximab (Simulect), efalizumab (Raptiva),
muromonab-CD3 (Orthoclone);
-
mycophenolate mofetil (CellCept); or
-
azathioprine (Imuran), leflunomide (Arava), etanercept
(Enbrel).
This list is not complete and there may be other drugs that can interact with
efalizumab. 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 efalizumab?
