ONCASPAR: A Well-Established Safety Profile

An acute lymphoblastic leukemia patient poses with their hand on their chin.

Here’s some important safety information about ONCASPAR

The most common serious side effects with ONCASPAR include

  • Low albumin blood level (hypoalbuminemia)
  • Elevated liver enzymes (elevated transaminase)
  • Fever with low white blood cell count (febrile neutropenia)
  • Abnormal elevation of triglyceride levels in the blood (hypertriglyceridemia)
  • A high level of blood sugar (hyperglycemia)
  • Jaundice (increased bilirubin level)
  • Swelling of the pancreas (pancreatitis)
  • Abnormal clotting studies
  • Blood clots (embolic and thrombotic events)
  • Allergic reactions (hypersensitivity)
  • Blood infections (sepsis)
  • Infections

There are certain side effects that require medical attention.

Call your healthcare professional or go to the emergency room right away if you experience any of the following:

  • Allergic reactions (symptoms: hives and itching, a swollen tongue or throat, trouble breathing, dizziness, fainting)
  • Swelling 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 amount of urine or urinary frequency)
  • Unusual bleeding or bruising
  • Abnormal liver function or damage (symptoms: jaundice, severe nausea, vomiting)

These are not all the possible side effects with ONCASPAR. Talk to your healthcare professional about any side effects that bother you or that don’t 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.

Please see Full Prescribing Information for more information and discuss any questions with your doctor.

Read about what to expect with ONCASPAR

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A nurse administers IV treatment to an acute lymphoblastic leukemia patient.

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION Section

ONCASPAR should not be given to patients who have had:

  • Serious allergic reactions to ONCASPAR (pegaspargase) 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

IMPORTANT SAFETY INFORMATION

ONCASPAR should not be given to patients who have had:

  • Serious allergic reactions to ONCASPAR (pegaspargase) 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

ONCASPAR may cause serious side effects including:

  • Allergic reactions (Symptoms: hives and itching, a swollen tongue or throat, trouble breathing, dizziness, fainting)
  • Swelling 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 amount of urine or urinary frequency)
  • Unusual bleeding or bruising
  • Abnormal liver function or damage (Symptoms: jaundice, severe nausea, vomiting)

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

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

  • are pregnant or plan to become pregnant. ONCASPAR can harm your unborn baby. You should not become pregnant during treatment with ONCASPAR. Tell your doctor right away if you become pregnant or think you may be pregnant during treatment with ONCASPAR.
  • Females who are able to become pregnant: You should use effective non-hormonal birth control (contraception) during treatment with ONCASPAR and for at least 3 months after the last dose.
  • are breastfeeding or plan to breastfeed. It is not known if ONCASPAR passes into your breast milk. Do not breastfeed during treatment with ONCASPAR and for 1 month after your last dose.

How will I receive ONCASPAR?

  • ONCASPAR 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 ONCASPAR include: low albumin blood level (hypoalbuminemia), elevated liver enzymes, fever with low white blood cell count, abnormal elevation of triglyceride levels in the blood (hypertriglyceridemia), a high level of blood sugar (hyperglycemia), increased bilirubin level, swelling of the pancreas, abnormal clotting studies, embolic and thrombotic events, allergic reactions, sepsis, and infections.

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

, 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 ONCASPAR Full Prescribing Information and discuss any questions with your doctor.

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