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RAPTIVA Patient, Information, Instructions - Efalizumab
RAPTIVA Patient, Information, Instructions - Efalizumab
PATIENT INFORMATION
RAPTIVA (Rap-TEE-vah) (efalizumab) for injection,
subcutaneous
Read the Patient Information that comes with RAPTIVA
(efalizumab) before you start using it and each time you get a refill. There
may be new information. This information does not take the place of talking
with your healthcare provider about your medical condition or treatment. It
is important to remain under a healthcare provider's care while using RAPTIVA.
Do not change or stop treatment without first talking with your healthcare
provider. Talk to your healthcare provider or pharmacist if you have any
questions about RAPTIVA.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT
RAPTIVA?
RAPTIVA can decrease the activity of your immune system.
Therefore, people using RAPTIVA may have an increased chance of getting:
· Serious infections.
Some infections could become serious. If you have an infection, tell your healthcare
provider before you start using RAPTIVA. If you get an infection that does not
go away while taking RAPTIVA, tell your healthcare provider right away.
· Cancers. Many drugs
that decrease the activity of the immune system can increase the risk of cancer.
If you have had cancer you should tell your healthcare provider before you start
taking RAPTIVA. The role of RAPTIVA in the development of cancer is not known.
· Low platelet counts (thrombocytopenia).
Platelets help your blood clot. Low platelets give you a higher chance for
bleeding. Call your doctor right away if you have increased bruising or bleeding.
Your healthcare provider may do regular blood tests to check your platelets
while you are taking RAPTIVA.
· Worsening of psoriasis.
Some patients have had severe worsening or new forms of psoriasis while
taking RAPTIVA or after stopping RAPTIVA. Tell your healthcare provider right
away if your psoriasis gets worse or if you see any new rashes during or after
treatment with RAPTIVA.
You should not receive vaccines while using RAPTIVA. RAPTIVA
may prevent a vaccine from working. Talk to your healthcare provider if you
need to receive a vaccine while using RAPTIVA.
WHAT IS RAPTIVA?
RAPTIVA is a medicine used to treat adult patients with moderate
to severe plaque psoriasis who can be treated with medicines that affect the
whole body (systemic therapy) or with phototherapy.
RAPTIVA is a man-made protein that is like proteins made in
the body called antibodies. Antibodies fight disease in the human body. RAPTIVA
may decrease the skin changes in the body that are the main problems of moderate
to severe plaque psoriasis.
RAPTIVA has not been studied in children under 18 years of
age.
WHO SHOULD NOT USE RAPTIVA?
Do not use RAPTIVA if you have ever had an allergic reaction
to RAPTIVA.
Before using RAPTIVA, tell your healthcare provider 1. about
the following medical conditions:
· If you are pregnant, planning
to become pregnant, or become pregnant while using RAPTIVA. It is not known
if RAPTIVA can harm your unborn baby. If you become pregnant while taking RAPTIVA,
notify your healthcare provider immediately. You and your healthcare provider
will have to decide if RAPTIVA is right for you during pregnancy. If you use
RAPTIVA when you are pregnant, ask your healthcare provider how you can be on
the RAPTIVA pregnancy registry.
· If you are breast feeding.
It is not known if RAPTIVA passes into your milk. It may harm your baby.
You will need to decide whether to use RAPTIVA or breast feed, but you may not
do both.
· If you have any infections
(see WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT RAPTIVA?).
· If you have immune system
problems
2. about all the medicines you take including prescription
and nonprescription medicines, vitamins, and herbal supplements.
It is not known if RAPTIVA and other medicines affect each
other.
Especially, tell your healthcare provider if you are using:
· Other medicines or treatments
for your psoriasis
· Medicines called immunosuppressives
or any medicine that affects your immune system. Ask your healthcare provider
or pharmacist if you are not sure if any of your medicines are immunosuppressives.
HOW SHOULD I USE RAPTIVA?
· RAPTIVA is an injection that
you give yourself once a week.
· Ask your healthcare provider
or pharmacist if you have any questions about using RAPTIVA.
· Use RAPTIVA exactly as prescribed
by your healthcare provider. Your dose of RAPTIVA is based on your body weight.
Tell your healthcare provider if your weight changes. Do not change your dose
without talking to your healthcare provider. Do not stop using RAPTIVA without
talking to your healthcare provider.
· RAPTIVA is injected under the
skin (subcutaneous) of your upper leg (thigh), upper arm, abdomen, or buttocks
once a week. Change (rotate) your skin injection site with each injection.
· Use RAPTIVA the same day each
week. If you miss your dose of RAPTIVA contact your healthcare provider to find
out when to take your next dose of RAPTIVA and what schedule to follow after
that.
· If you take more than your
regular dose of RAPTIVA, call your healthcare provider right away.
· See your healthcare provider
regularly while using RAPTIVA. Do not miss your appointments. Your healthcare
provider may do blood tests including platelet counts before and during treatment
with RAPTIVA to check its affect on your body.
WHAT SHOULD I AVOID WHILE USING RAPTIVA?
Unless directed by your healthcare provider, do not:
·take other medicines called immunosuppressives.
·take treatments called phototherapy.
You should not receive vaccines while using RAPTIVA. Talk
to your healthcare provider if you need to receive a vaccine while taking RAPTIVA
(see WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT RAPTIVA?).
WHAT ARE THE POSSIBLE SIDE EFFECTS OF RAPTIVA?
RAPTIVA can cause serious side effects including the following
(see WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT RAPTIVA?):
RAPTIVA can affect your immune system and might cause:
· Serious infections
· Cancers
· Low platelet counts (thrombocytopenia)
· Worsening of psoriasis
The most common side effects of RAPTIVA include headache,
chills, fever, nausea, and muscle aches. These reactions usually happen within
the first 48 hours following RAPTIVA injection, and often decrease after the
first few weeks of use of RAPTIVA. Back pain, joint pain, and swelling of the
arms or legs (peripheral edema) can also happen with RAPTIVA. Talk to your healthcare
provider about any symptoms that bother you.
If you get any side effect that concerns you or if you get
an infection, call your healthcare provider.
These are not all the side effects of RAPTIVA. For more information,
ask your healthcare provider or pharmacist.
HOW SHOULD I STORE RAPTIVA?
· Store RAPTIVA vials in the
refrigerator at 36° to 46°F (2° to 8°C) until you are ready to prepare your
injection. Do not freeze or store at room temperature. Once RAPTIVA has
been mixed with sterile water, you should use it right away to inject yourself.
If you are unable to inject the drug after mixing, the mixture can stay at room
temperature for up to 8 hours. Do not use RAPTIVA that was mixed more than 8
hours earlier. If you are traveling, be sure to store RAPTIVA at the right temperature.
If you have any questions, ask your healthcare provider or pharmacist.
· Protect RAPTIVA vials from
light while stored.
· Throw away RAPTIVA vials that
are out of date.
· Keep RAPTIVA and all medicines
out of the reach of children.
GENERAL INFORMATION ABOUT RAPTIVA
Medicines are sometimes prescribed for conditions that are
not mentioned in patient information leaflets. Do not use RAPTIVA for a condition
for which it was not prescribed. Do not give RAPTIVA to other people, even if
they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about
RAPTIVA. If you would like more information, talk with your healthcare provider.
You can ask your healthcare provider or pharmacist for information about RAPTIVA
that is written for health professionals. For more information, you can also
call 1-877-RAPTIVA (toll free).
RAPTIVAä [efalizumab]
Manufactured by: Genentech, Inc., 1 DNA Way
South San Francisco, CA 94080-4990 4826400 FDA Approval October 2003, Ó2003
Genentech, Inc.
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