FOR U.S. HEALTHCARE PROFESSIONALS ONLY
To obtain initiation doses (3 x 100mg tablets) of Arava for your patients, complete
the "Requests for Initiation Doses of Arava (leflunomide)" form online. Follow the
instructions below on completing the form. Then, click the "Click to Proceed" button
at the bottom of the page to access the form.
- To complete the form, type in the requested information, and click the "Submit"
button when you're finished.
- This page will display the information you provided so you may review it for accuracy.
If you need to make changes, click the "Back" button. If all your information is
correct, click the "Print" button.
- Sign the completed, printed form and fax it to: 877-543-1102
Manufacturer: sanofi-aventis U.S. LLC, Bridgewater, NJ, 08807
Authorized Distributor of Record: PROMOTECH Logistics Solutions, LLC
Requests for Initiation Doses of Arava Online
Important Safety Information
CONTRAINDICATIONS AND WARNINGS
Pregnancy must be excluded before the start of treatment with ARAVA. ARAVA is contraindicated
in pregnant women, or women of childbearing potential who are not using reliable
contraception. (see CONTRAINDICATIONS and WARNINGS.) Pregnancy must be avoided during
ARAVA treatment or prior to the completion of the drug elimination procedure after
Severe liver injury, including fatal liver failure, has been reported in some patients
treated with ARAVA. Patients with pre-existing acute or chronic liver disease, or
those with serum alanine aminotransferase (ALT) >2xULN before initiating treatment,
should not be treated with ARAVA. Use caution when ARAVA is given with other potentially
Monitoring of ALT levels is recommended at least monthly for six months after starting
ARAVA, and thereafter every 6-8 weeks. If ALT elevation > 3 fold ULN occurs, interrupt
ARAVA therapy while investigating the probable cause of the ALT elevation by close
observation and additional tests. If likely leflunomide-induced, start cholestyramine
washout and monitor liver tests weekly until normalized. If leflunomide-induced
liver injury is unlikely because some other probable cause has been found, resumption
of ARAVA therapy may be considered. (SEE WARNINGS – HEPATOTOXICITY).
Females of childbearing potential
- Do not start Arava® until the following steps are completed:
- Pregnancy is excluded
- Confirm that reliable contraception is being used
- Fully counsel patients on the potential for serious risk to the fetus
- If the patient becomes pregnant while taking this drug, the physician and patient
must discuss the risk to the pregnancy
- Upon discontinuation of Arava®, it is recommended that all females of childbearing
potential undergo the drug elimination procedure
Females on Arava® who wish to become pregnant
- Must discontinue Arava® and undergo the drug elimination procedure
- Human plasma levels of the active metabolite less than 0.02 mg/L (0.02 µg/mL) are
expected to have minimal risk based on available animal data
Drug elimination procedure for females
- Administer cholestyramine 8 grams 3 times daily
for 11 days. (The 11 days do not need to be consecutive unless there is a need to
lower the plasma level rapidly.)
- Verify plasma levels less than 0.02 mg/L (0.02
µg/mL) by 2 separate tests at least 14 days apart. If plasma levels are higher than
0.02 mg/L, additional cholestyramine treatment should be considered.
Without the drug elimination procedure, it may take up to 2 years for the active
metabolite of leflunomide to reach plasma levels less than 0.02 mg/L due to individual
variation in drug clearance.
Information for males
Available information does not suggest that Arava® would be associated with
an increased risk of male-mediated fetal toxicity. 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.
Additional safety information
- ARAVA is contraindicated in patients with known hypersensitivity to leflunomide, teriflunomide, or any of the other components of ARAVA.
- Arava® is not recommended for patients with severe immunodeficiency, bone marrow
dysplasia, or severe, uncontrolled infections. Severe infections including sepsis,
which may be fatal, have been reported. Rarely, interstitial lung disease, which
may be fatal, has been reported
- Rare reports of pancytopenia, agranulocytosis, thrombocytopenia, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and peripheral neuropathy have been reported in post marketing experience. In these or any other serious toxicities, Arava® should be stopped and a drug elimination procedure (eg, cholestyramine 8 g TID x 11 days) should be used to reduce the drug concentration more rapidly
- It would be prudent to monitor for hematologic toxicity when switching from Arava®
to another antirheumatic agent with a known potential for hematologic suppression
- Adverse reactions associated with the use of Arava® in clinical trials at 1
year (n=1339) included diarrhea (17%), respiratory infection (15%), alopecia (10%),
hypertension (10%), rash (10%), and elevated liver enzymes (ALT and AST) (5%)
- Co-administration of teriflunomide with leflunomide is not recommended, as leflunomide is the parent compound of teriflunomide
- At minimum, ALT (SGPT) must be performed at baseline and at least monthly for six
months after starting ARAVA, and thereafter every 6 to 8 weeks.
- At minimum, patients taking Arava® should have platelet, white blood cell count,
and hemoglobin or hematocrit monitored at baseline and monthly for 6 months following
initiation of therapy and every 6 to 8 weeks thereafter
- If used concomitantly with immunosuppressants such as methotrexate, chronic monitoring
should be monthly
Please see Full Prescribing Information, including
boxed WARNING, for additional important information.