Sanofi Launches Authorized Generic Version of Eloxatin® (oxaliplatin injection)
Generics Division of Sanofi, Winthrop US, to Market the Drug
Eloxatin is a platinum–based drug used in combination with infusional 5–fluorouracil/leucovorin. This treatment is indicated for treatment of advanced colorectal cancer or as adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. The authorized generic version of Eloxatin will be available in the same sizes, 50 mg and 100 mg single–use vials.
“We are committed to broadening access to our medicines and providing more affordable treatment options for patients,” said Charles Hugh-Jones, MD, FRCP, Chief Medical Officer, North America, Sanofi. “The availability of an authorized generic version of Eloxatin is welcomed news for patients and physicians alike.”
According to the Centers for Disease Control and Prevention (CDC), “of cancers that affect both men and women, colorectal cancer is the second leading cancer killer in the United States.”1
Winthrop US 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 Eloxatin® (oxaliplatin injection)
ELOXATIN can cause serious allergic reactions, including allergic reactions that may cause death. ELOXATIN is a platinum–based medicine. Serious allergic reactions including death can occur in people who take ELOXATIN and who have had previous allergic reactions to platinum medicines. Serious allergic reaction can happen within a few minutes of your infusion or any time during your treatment with ELOXATIN.
- Do not take ELOXATIN if you are allergic to any of the ingredients in Eloxatin or other medicines that contain platinum. Tell your doctor right away if you feel like your throat is closing up, have shortness of breath, a flushed face, a rash, itching/hives, swelling of lips or tongue, sudden cough, dizziness, sweating or chest pain
- ELOXATIN can cause nerve problems. Tell your doctor right away if you become sensitive to cold temperatures and cold objects; have trouble breathing, swallowing or saying words; experience jaw tightness, odd feelings in your tongue, or chest pressure; pain; tingling or burning in your hands, feet or around your mouth or throat.
- ELOXATIN can cause a rare condition that affects the brain called Reversible Posterior Leukoencephalopathy, also known as RPLS. Tell your doctor right away if you have any of the following signs and symptoms of RPLS: headache, confusion or a change in the way you think, seizures, or vision problems, such as blurriness or vision loss. You should not operate heavy machines, or engage in dangerous activities if you have vision problems while receiving ELOXATIN.
- Tell your doctor if you develop dry cough or have trouble breathing; these may be signs of serious lung disease.
- ELOXATIN can cause liver problems (hepatotoxicity); your doctor will do blood tests to watch for this.
- Tell your doctor if you have any kidney problems before receiving ELOXATIN because this could change the amount of ELOXATIN which you receive for your treatment.
- Because of the potential risk of fetal harm, pregnant women should not receive ELOXATIN. Women of childbearing potential should avoid becoming pregnant while receiving ELOXATIN.
- ELOXATIN can cause a decrease in white blood cells, which can lead to infections. Tell your doctor right away if you develop any of the following signs of infection: fever, chills, or shivering; cough that brings up mucus; burning or pain on urination; pain on swallowing; sore throat; or redness or swelling at injection site.
- The most common side effects of ELOXATIN include a decrease in white blood cells, red blood cells and platelets, infection, high blood pressure, nausea, constipation, stomach pain, decreased appetite, hair loss, vomiting, injection site reactions, mouth sores, diarrhea, tiredness and bleeding or bruising. Tell your doctor about any signs or symptoms of bleeding or bruising.
- Tell your doctor about all the medications you take, including prescription and non–prescription medications, vitamins and herbal supplements.
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of ELOXATIN. For more information, ask your doctor or pharmacist.
Please click here for full Prescribing Information for Eloxatin® (oxaliplatin injection), including Boxed WARNING, and visit: http://products.sanofi.us/eloxatin/eloxatin.html
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Forward Looking Statements
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1Centers for Disease Control and Prevention. Basic information about colorectal cancer. Available at: http://www.cdc.gov/cancer/colorectal/basic_info/. Accessed July 28, 2014.