SANOFI BRIDGEWATER, N.J., Oct. 1, 2015 /PRNewswire/ -- Sanofi US announced today the availability of an authorized generic version of Arava(®), Leflunomide tablets through Winthrop, the company's US generics division. For people living with rheumatoid arthritis (RA), Leflunomide blocks autoimmune antibodies that reduce inflammation with the aim of improving mobility. Sanofi's authorized generic version is the same formulation as the original drug, Arava, for which the company holds the original patent.
Experience the interactive Multimedia News Release here: http://www.multivu.com/players/English/7637151-sanofi-winthrop-arava/
http://www.multivu.com/players/English/7637151-sanofi-winthrop-arava/gallery/image/e3bdb7ac-fff1-41a1-8215-f1b92b7b2d0c.HR.jpg
"The Arava authorized generic assures patients that they receive the same quality treatment of the original drug," said Dr. Cary Yonce, Vice President, General Therapeutics and Life Cycle Management, Sanofi. "We are committed to making authorized generics like Arava available and affordable to patients who need them."
Rheumatoid arthritis is a chronic disease for which signs and symptoms can be lessened with treatment. Because joint damage is irreversible, early diagnosis and treatment are recommended.(1)
Disease-modifying anti-rheumatic drugs (DMARDs) such as Arava help to reduce signs and symptoms, inhibit structural damage as evidenced by X-Ray erosions and joint space narrowing and improve physical function. Since treatment is highly individualized based on patient response, Arava provides the ability to be used either alone or in combination with other DMARDs or biologics.
"More than 1.5 million Americans live with rheumatoid arthritis," said Dr. Paul Chew, Global Chief Medical Officer, Sanofi. "RA can cause swelling, pain and deformity in your joints, making simple tasks like getting out of a car or buttoning a shirt difficult. We want to lessen that burden for people living with RA."
The authorized generic version of Arava has the identical chemical makeup as the original Arava first approved by the FDA in 1998. Authorized generics possess the identical active ingredients as the original medications. Generic medications often include a variety of different inactive ingredients than brand-name medications. These may include fillers, dyes or other ingredients that may cause adverse events for people with allergies or sensitivities.
Winthrop delivers affordable solutions to the healthcare community by transforming Sanofi's branded products into authorized generics and is devoted to supplying high quality products to its customers with excellent service.
Important Safety Information for Leflunomide Tablets:
CONTRAINDICATIONS AND WARNINGS
Pregnancy
Leflunomide is contraindicated in pregnant women, or women of childbearing potential who are not using reliable contraception. Pregnancy must be excluded before the start of treatment with Leflunomide. Pregnancy must be avoided during Leflunomide treatment and during an accelerated drug elimination procedure after Leflunomide treatment. Leflunomide should be stopped and an accelerated drug elimination procedure should be started if the patient becomes pregnant.
Hepatotoxicity
Severe liver injury, including fatal liver failure, has been reported in some patients treated with Leflunomide. Patients with pre-existing acute or chronic liver disease, or those with serum alanine aminotransferase (ALT) >2xULN (upper limit of normal) before initiating treatment, should not be treated with Leflunomide. Use caution when Leflunomide is given with other potentially hepatotoxic drugs.
Monitoring of ALT levels is recommended at least monthly for six months after starting Leflunomide, and thereafter every 6-8 weeks. If ALT elevation > 3 fold ULN occurs, interrupt 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 probably cause has been found, resumption of Leflunomide therapy may be considered.
Females of childbearing potential:
There are no adequate and well-controlled studies evaluating Leflunomide in pregnant women. Thus, do not start Leflunomide 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 Leflunomide, it is recommended that all females of childbearing potential undergo the drug elimination procedure
Suspicion of Pregnancy
The patient must be advised that if there is any delay in onset of menses or any other reasons to suspect pregnancy, they must stop Leflunomide and notify the physician immediately for pregnancy testing and if positive, the physician and patient must discuss the risk of pregnancy. It is possible that rapidly lowering the blood level of the active metabolite by instituting the drug elimination procedure described below at the first delay of menses may decrease the risk to the fetus from Leflunomide.
Females on Leflunomide who wish to become pregnant:
-- Must discontinue Leflunomide 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
1. 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.)
2. 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 Leflunomide 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 Leflunomide and taking cholestyramine 8 grams 3 times daily for 11 days.
Additional safety information
-- Leflunomide is contraindicated in patients with known hypersensitivity
to Leflunomide, teriflunomide, or any of the other components of
Leflunomide.
-- Severe liver injury, including fatal liver failure, has been reported in
some patients treated with Leflunomide. Patients with pre-existing
acute or chronic liver disease, or those with serum ALT > 2 X ULN before
initiating treatment, should not be treated with Leflunomide.
-- Leflunomide 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, Leflunomide 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 Leflunomide to another antirheumatic agent with a known potential
for hematologic suppression
-- Adverse reactions associated with the use of Leflunomide 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
-- Prior to initiating immunomodulatory therapies, including Leflunomide,
all patients should be screened for active and inactive (²latent²)
tuberculosis infection as per commonly used diagnostic tests.
Leflunomide has not been studied in patients with a positive
tuberculosis screen, and the safety of Leflunomide in individuals with
latent tuberculosis infection is unknown. Patients with a history of
tuberculosis should be carefully monitored because of the possibility of
reactivation of the infection. Patients testing positive in tuberculosis
screening should be treated by standard medical practice prior to
therapy with Leflunomide.
Laboratory tests
-- At minimum, ALT (SGPT) must be performed at baseline and at least
monthly for six months after starting Leflunomide, and thereafter every
6 to 8 weeks.
-- At minimum, patients taking Leflunomide 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.
References
(1)Arthritis Foundation: http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid-arthritis.php
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2014. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
Contacts:
Media Relations Investor Relations
Mary Kathryn Steel George Grofik
Tel.: 908-989-0726 Tel.: 908-981-5560
usmediarelations@sanofi.com IR@sanofi.com
-------------
http://www.multivu.com/players/English/7637151-sanofi-winthrop-arava/gallery/image/79b1f41e-9293-47a4-930c-93c0802efcd6.HR.jpg
http://www.multivu.com/players/English/7637151-sanofi-winthrop-arava/gallery/image/ee47ec93-07d5-4b1b-bd51-0187e4b48843.HR.jpg
http://www.multivu.com/players/English/7637151-sanofi-winthrop-arava/gallery/image/40afe442-23ef-4e92-bffe-bf9112afec1d.HR.jpg
http://www.multivu.com/players/English/7637151-sanofi-winthrop-arava/gallery/image/5e49de0d-4e31-4819-bcff-1cdb068b54dc.HR.jpg
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/sanofi-announces-launch-of-authorized-generic-version-of-arava-leflunomide-tablets-300152399.html
SOURCE Sanofi
