CLOLAR Injectable By SANOFI U.S. LLC

Pain at the injection site, tiredness, flushing, headache, lightheadedness, drowsiness, back pain, diarrhea, nausea, vomiting, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly. People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk. Treatment with clofarabine may sometimes cause your hands/feet to develop a skin reaction called hand-foot syndrome (palmar-plantar erythrodysesthesia). You can prevent or reduce these problems by protecting your hands and feet from a great deal of heat or pressure. Avoid unnecessary exposure to heat (e.g., hot dishwater, long hot baths). Avoid pressure on elbows, knees, and soles of feet (e.g., leaning on elbows, kneeling, taking long walks). Wear loose clothing. Depending on how severe your hand-foot syndrome is, your doctor may prescribe a medication to reduce the symptoms or decrease/delay your next dose of clofarabine. If you experience pain/swelling/redness, blisters, or numbness of the hands/feet that affects your usual activities, tell your doctor right away. Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, muscle/joint pain, swelling feet/ankles, mental/mood changes (e.g., anxiety, depression), dark urine, yellowing skin/eyes, fast/difficult breathing, fast heartbeat. This medication can lower the body's ability to fight an infection. Tell your doctor right away if you develop any signs of an infection such as fever, chills, or persistent sore throat. This medication may rarely cause a serious bowel infection (enterocolitis). This infection is more likely to occur within 30 days of treatment and when clofarabine is used with other medications to treat cancer. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, mucus in your stool. Clofarabine sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness. This drug may rarely cause serious (rarely fatal) bleeding in the brain or lungs, or bleeding from the stomach or intestines. If you notice any of the following unlikely but serious side effects, get medical help right away: dizziness/fainting, sudden vision changes, persistent nausea, seizures, confusion, trouble breathing, black/bloody stools, vomit that contains blood or looks like coffee grounds. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.