Your doctor has prescribed Arava to help you manage your
rheumatoid arthritis (RA).
The answers to these commonly asked questions may help you learn a little more about
Arava. If you have additional questions that are not answered here, talk with your
doctor or another member of your health care team.
Why has my doctor prescribed Arava?
Arava relieves pain and swelling in your joints, improves your physical function,
and slows RA disease. So while there is no cure for RA, you may be able
to do something to help prevent it from getting worse.
Because Arava can slow RA joint damage, it is classified as a DMARD (disease-modifying
antirheumatic drug).
How effective is Arava?
The effectiveness of Arava in the treatment of RA was demonstrated in 3 controlled
trials. Arava proved to reduce signs and symptoms including morning stiffness and
the number of tender and swollen joints. Patients in the controlled trials experienced
significant improvements in physical function, such as gripping, reaching, walking,
dressing, and rising from a chair. Feet and hand x-rays of those taking Arava in
the trials showed that Arava can also slow down joint damage caused by the disease.
You may want to talk with your doctor about the specific reasons Arava was chosen
for you.
Is Arava effective if I have had RA for several years?
In clinical trials, Arava was effective for both patients recently diagnosed with
RA and those who have had the condition for more than 5 years. Arava is indicated
as a first-line treatment for RA. Arava was studied in males and females, younger
and older adults, those just diagnosed with RA, and those who have had it for several
years.
Is Arava different from other RA medications?
Yes. Arava has a unique way of affecting the substances inside your joints.
How will I know if Arava is working?
You may begin to experience an improvement in joint swelling and tenderness after
about 4 weeks.
How often do I need to take Arava?
Every day. In addition to relieving pain and swelling and helping to slow RA, Arava
is also easy to take. Your doctor will probably start you with one 100-mg tablet
of Arava per day for 3 days, followed by just 1 smaller 20-mg tablet every day.
There are certain situations in which your doctor may prescribe the 10-mg dose tablet
for you. There are no injections or confusing schedules to worry about with Arava.
What should I do if I miss a dose of Arava?
If you miss a dose and it is almost time for your next dose, take only that dose.
Do not take double or extra doses. A tip to help you remember to take your Arava
is to take it at the same time that you do a specific activity every day, such as
brushing your teeth in the morning. Keeping your Arava near your toothpaste in your
medicine cabinet will be a visual reminder as well.
Should I take Arava with food?
Arava can be taken with or without food.
How long will I need to take Arava?
Remember, there is no cure for RA, but Arava can help improve the signs and symptoms
and slow down joint damage. You must follow your doctor's instructions for taking
Arava. Most people have to take
RA medications
for the rest of their lives. If you do not follow the treatment program, Arava will
not work properly, which may lead to worsening symptoms.
Is it okay to take Arava with other medications?
Let your doctor know about all of the medications you are taking, including vitamins,
nutritional supplements or herbs, and any prescription or over-the-counter medications
you are taking for conditions other than RA.
Most medications can be given with Arava.
Be sure to tell your doctor if you are taking or have recently taken cholestyramine,
rifampin, methotrexate, auranofin (oral gold), azathioprine, cyclophosphamide or
cyclosporine. You may require additional monitoring when Arava is taken with some
of these medications.
Can I take Arava if I am pregnant or wish to become pregnant?
No. Your doctor will verify that you are not pregnant before starting you on Arava
treatment. Your doctor also will counsel you on the risk of birth defects if you
become pregnant while taking Arava.
ARAVA MUST NOT BE USED IN PREGNANT WOMEN OR WOMEN WHO CAN BECOME PREGNANT WHO ARE
NOT USING RELIABLE BIRTH CONTROL BECAUSE ARAVA MAY INCREASE THE RISK OF BIRTH DEFECTS.
You may be at increased risk of death of your unborn child or of having a baby with
a birth defect if:
- You are pregnant when you start taking Arava
- You become pregnant while you are taking Arava
- You do not wait to become
pregnant until you have stopped taking Arava and followed the drug elimination procedure
described below
Can I take Arava if I'm trying to father a child?
Available information does not suggest that Arava taken by the father would be associated
with an increased risk to the unborn child. To minimize any possible risk, men wishing
to father a child should consider discontinuing use of Arava and taking cholestyramine
8 grams 3 times daily for 11 days.
What about using birth control with Arava?
If you are currently taking Arava or have discontinued Arava and are going through
the required drug elimination procedure, you and your partner should take every
precaution to avoid your becoming pregnant. Both partners should use reliable birth
control, as recommended by your doctor. It is VERY IMPORTANT that you contact your
doctor IMMEDIATELY if your menstrual period is late or if for any other reason you
believe you may be pregnant.
If you are a woman of childbearing potential and discontinue Arava treatment for
any reason, you should undergo the drug elimination procedure described below.
What is the drug elimination procedure for Arava?
After discontinuing Arava, your doctor will prescribe a drug elimination procedure
consisting of a full 11-day course of cholestyramine, 8 grams, 3 times daily, followed
by 2 separate laboratory blood tests at least 14 days apart to assure a very low
drug level in your body. If your drug levels are too high, your doctor may recommend
additional drug elimination medication.
After the drug elimination procedure, your risk of having a baby with a birth defect
is very low and should be no higher than the risk in the general population. If
you do not follow the drug elimination procedure, it could take up to 2 years to
reach this very low drug level in your blood.
Others who should not take Arava.
Those who should NOT take Arava include:
- Anyone who is hypersensitive to any of the ingredients of Arava
- Nursing
mothers
- Patients with serious immune deficiencies or severe uncontrolled infections
If you have other health conditions such as kidney problems, tell your doctor.
Can Arava affect my liver?
Arava can cause an increase in liver enzymes or, in rare cases, liver injury, with
the potential to be life threatening. Therefore, your doctor will monitor
your liver enzyme blood test to check for problems and, if necessary, adjust or
discontinue your dose of Arava. Liver blood tests are performed at the start of
treatment, at monthly intervals for 6 months, and then, once liver enzymes are stabilized,
every 6 to 8 weeks. Liver blood tests are required because of the possibility of
liver damage in people taking Arava. Arava is not recommended for patients with
significant liver disease or hepatitis B or C.
- In clinical studies with Arava, liver enzymes were elevated in a significant number
of Arava patients
- In clinical studies, most elevations were mild and usually
resolved while continuing treatment
- Few patients stopped taking Arava due to
elevations in their liver function tests
Can Arava affect my blood counts?
With Arava, you may develop very low blood counts, especially if you are taking
other medications. To check for this potential problem, your doctor will monitor
your blood regularly and, if necessary, discontinue treatment. Just as with liver
monitoring, your blood will be evaluated when you begin Arava, and at monthly intervals
for 6 months, and then every 6 to 8 weeks. If, however, you are taking Arava with
another medication that could suppress your bone marrow-like methotrexate-blood
monitoring must be done every month.
Arava is not recommended for anyone with serious immune system problems or severe,
uncontrolled infection. If a serious infection occurs, Arava may need to be stopped.
Contact your doctor immediately if you suspect you have any sign of infection.
What are the most common side effects associated with Arava therapy?
The majority of people with RA are able to take Arava without experiencing side
effects. In clinical trials involving 1,339 people, the most common side effects
associated with Arava were:
Are there any other side effects I might experience with Arava?
Your doctor may recommend medication if you develop stomach or digestive problems.
If you notice any of the listed side effects or any other problems, talk with your
doctor.
Contact your doctor if you experience any of the following:
- Cough or shortness of breath
- Skin rash or skin ulceration
- Sores
in your mouth
- Easy bruising or bleeding
- Frequent infections
-
Fever, paleness or unusual tiredness
- Abdominal pain
- Jaundice (yellow
skin color)
Also, if you notice any side effects that are not listed but concern you, do not
hesitate to speak to your doctor.
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