Financial Support for Patients on ASPARLAS^®

ASPARLAS^® IMPORTANT SAFETY INFORMATION AND APPROVED USE

ASPARLAS should not be given to patients who have had

• Serious allergic reactions to ASPARLAS or any of its ingredients
• Serious blood clots, serious swelling of the pancreas (abdominal pain), or serious bleeding during previous L-asparaginase treatment
• Serious impairment of liver function

ASPARLAS may cause serious side effects including:

• Allergic reactions (Symptoms: hives and itching, a swollen tongue or throat, trouble breathing, dizziness, fainting)
• Inflammation of the pancreas (Symptoms: severe stomach pain, nausea, vomiting, fever, chills, diarrhea)
• Blood clots (Symptoms: severe headache, arm or leg swelling, shortness of breath, chest pain)
• Increased/excess sugar in the blood (Symptoms: Excessive thirst, increased urinary frequency)
• Unusual bleeding or bruising
• Liver problems, including severe, life-threatening, or fatal veno-occlusive liver disease (VOD), and abnormalities in liver tests may develop during ASPARLAS treatment. Contact your doctor immediately if you experience jaundice, rapid weight gain, abdominal swelling, or right upper abdominal pain or tenderness

Call or see your doctor right away if you develop any of these serious side effects or if symptoms get worse.

Before receiving ASPARLAS, tell your doctor about all your medical conditions, including if you:

• are pregnant or plan to become pregnant. ASPARLAS can harm your unborn baby. You should not become pregnant during treatment with ASPARLAS. Tell your doctor right away if you become pregnant or think you may be pregnant during treatment with ASPARLAS.
  Females who are able to become pregnant: You should use effective non-hormonal birth control (contraception) during treatment with ASPARLAS and for at least 3 months after the last dose.
• are breastfeeding or plan to breastfeed. It is not known if ASPARLAS passes into your breast milk. Do not breastfeed during treatment with ASPARLAS and for 3 months after your last dose.

How will I receive ASPARLAS?

• ASPARLAS will be given to you as an injection by your doctor as part of your chemotherapy treatment plan. It is important that you receive all of your treatment doses according to your doctor’s instructions.
• During treatment, you will be monitored, and if you experience side effects, your doctor may have to change your treatment.

The most common side effects of ASPARLAS include: Elevated liver enzymes, increased bilirubin level, inflammation of the pancreas, abnormal clotting studies, diarrhea, allergic reactions, embolic and thrombotic events, and sepsis.

This is not a complete list of side effects that may occur. Call your doctor for medical advice about any side effects especially if they do not go away.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also report side effects to Servier Pharmaceuticals LLC at 1-800-807-6124.

For additional information, please refer to the ASPARLAS Full Prescribing Information and discuss any questions with your doctor.

INDICATIONS AND USAGE

Approved use for ASPARLAS

ASPARLAS (calaspargase pegol-mknl) is a prescription medicine that is given as part of a chemotherapy treatment plan to treat children and young adult patients between the ages of 1 month to 21 years who have acute lymphoblastic leukemia (ALL). ALL is a type of cancer in which the bone marrow makes too many abnormal white blood cells that may crowd out normal red blood cells, white blood cells, and platelets.

Please see the Full Prescribing Information .

ASPARLAS is a registered trademark of Servier IP UK Ltd., a wholly-owned, indirect subsidiary of Les Laboratoires Servier. Servier and the Servier logo are trademarks of Les Laboratoires Servier.