Confidence Comes With ASPARLAS:

contraindications

• History of serious hypersensitivity reactions to pegylated L-asparaginase

• History of serious thrombosis during L-asparaginase therapy

• History of serious pancreatitis during previous L-asparaginase treatment

• History of serious hemorrhagic events during previous L-asparaginase therapy

• Severe hepatic impairment

warnings and precautions

Hypersensitivity: Grade 3 and 4 hypersensitivity reactions including anaphylaxis have been reported in clinical trials with ASPARLAS with an incidence of 7% to 21%. Because of the risk of serious allergic reactions, administer ASPARLAS in a clinical setting with resuscitation equipment and other agents necessary to treat anaphylaxis. Premedicate patients 30-60 minutes prior to administration of ASPARLAS. Observe patients for 1 hour after administration. Discontinue ASPARLAS in patients with serious hypersensitivity reactions.

Pancreatitis: Cases of pancreatitis have been reported in clinical trials with ASPARLAS with an incidence of 12% to 16%. Inform patients of the signs and symptoms of pancreatitis, which, if left untreated, could be fatal. Assess serum amylase and/or lipase levels to identify early signs of pancreatic inflammation. Discontinue ASPARLAS in case of suspicion of pancreatitis. If pancreatitis is confirmed, do not resume ASPARLAS.

Thrombosis: Serious thrombotic events, including sagittal sinus thrombosis, have been reported in clinical trials with ASPARLAS with an incidence of 9% to 12%. Discontinue ASPARLAS in patients experiencing serious thrombotic events.

Hemorrhage: Hemorrhage associated with increased prothrombin time (PT), increased partial thromboplastin time (PTT), and hypofibrinogenemia have been reported. Evaluate patients with signs and symptoms of hemorrhage with coagulation parameters including PT, PTT, and fibrinogen. Consider appropriate replacement therapy in patients with severe or symptomatic coagulopathy.

Hepatotoxicity: Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of hepatic veno-occlusive disease (VOD), have been observed in patients treated with ASPARLAS in combination with standard chemotherapy, including during the induction phase of multiphase chemotherapy. Do not administer ASPARLAS to patients with severe hepatic impairment. Evaluate bilirubin and transaminases prior to each dose of ASPARLAS and at least weekly, during cycles of treatment that include ASPARLAS, through 6 weeks after the last dose of ASPARLAS. Monitor frequently for signs and symptoms of hepatic VOD, which may include rapid weight gain, fluid retention with ascites, hepatomegaly (which may be painful), and rapid increase of bilirubin. For patients who develop abnormal liver tests after ASPARLAS, more frequent monitoring for liver test abnormalities and clinical signs and symptoms of VOD is recommended. In the event of serious liver toxicity, including VOD, discontinue treatment with ASPARLAS and provide supportive care.

adverse reactions

The most common grade 3 and above adverse reactions (incidence ≥10%) for patients receiving ASPARLAS with multiagent chemotherapy observed in the DFCI clinical trial are elevated transaminases (52%), increased bilirubin (20%), pancreatitis (18%) and abnormal clotting studies (14%). There was 1 fatal adverse reaction (multi-organ failure in the setting of chronic pancreatitis associated with a pancreatic pseudocyst). Not all grade 1 and 2 adverse reactions were collected prospectively.

indications and usage

ASPARLAS^® (calaspargase pegol-mknl) is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years.

Please see ASPARLAS Full Prescribing Information. .