Asparlas

What Is Asparlas?

Asparlas (calaspargase pegol - mknl) is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years.

What Are Side Effects of Asparlas?

Common side effects of Asparlas include:

• elevated transaminase,
• bilirubin increased,
• pancreatitis,
• abnormal clotting studies,
• diarrhea,
• hypersensitivity,
• shortness of breath,
• bleeding,
• pneumonia, and
• abnormal heart rate

Dosage for Asparlas?

The recommended dosage of Asparlas is 2,500 units/m2 intravenously no more frequently than every 21 days.

What Drugs, Substances, or Supplements Interact with Asparlas?

Asparlas may interact with oral contraceptives. Tell your doctor all medications and supplements you use.

Asparlas During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Asparlas; it may harm a fetus. It is unknown if Asparlas passes into breast milk. Because of the potential for adverse reactions in a breastfed child, Breastfeeding is not recommended while using Asparlas and for 3 months after the last dose.

Additional Information

Our Asparlas (calaspargase pegol - mknl) Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Asparlas Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, itching, redness; feeling light-headed; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

You will be watched closely for at least 1 hour after each injection, to make sure you do not have an allergic reaction.

Call your doctor at once if you have:

• easy bruising, unusual bleeding;
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
• pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting;
• liver problems--loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes); or
• signs of a blood clot--headache, sudden numbness or weakness, blurred vision, chest pain, swelling or redness in an arm or leg.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• pancreatitis;
• blood clotting problems; or
• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Asparlas (Calaspargase Pegol-mknl Injection)

 

Asparlas Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described in greater detail in other sections of the labeling:

• Hypersensitivity [see WARNINGS AND PRECAUTIONS].
• Pancreatic Toxicity [see WARNINGS AND PRECAUTIONS].
• Thrombosis [see WARNINGS AND PRECAUTIONS].
• Hemorrhage [see WARNINGS AND PRECAUTIONS].
• Hepatotoxicity [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of ASPARLAS was investigated in Study DFCI 11-001, an open-label, randomized, active-controlled multicenter clinical trial that treated 237 children and adolescents with newly-diagnosed ALL or lymphoblastic lymphoma, with ASPARLAS 2,500 U/m² (n=118) or pegaspargase 2,500 U/m² (n=119) as part of a Dana Farber Cancer Institute (DFCI) ALL Consortium backbone therapy. The median age on enrollment was 5 years (range, 1-20) years. The majority of patients were male (62%) and white (70%). Most patients were considered standard risk (SR, 59%) and had B-cell lineage ALL (87%).

The median number of doses during the study was 11 doses for ASPARLAS (administered every three weeks) and 16 doses for pegaspargase (administered every two weeks). The median duration of exposure was 8 months for both ASPARLAS and pegaspargase.

There was 1 fatal adverse reaction (multi-organ failure in the setting of chronic pancreatitis associated with a pancreatic pseudocyst).

Table 2 summarizes the incidence of selected Grades ≥3 adverse reactions that occurred in 2 or more patients receiving ASPARLAS. Because not all grade 1 and 2 adverse reactions were collected prospectively, only grade 3 and 4 adverse events are presented in Table 2.

Table 2: Selected Grades ≥ 3 Adverse Reactions in Patients Receiving ASPARLAS With Multi- Agent Chemotherapy (Study DFCI 11-001)*

Adverse Reaction†	ASPARLAS 2,500 U/m2 N=118	Pegaspargase 2,500 U/m2 N=119
	Grades ≥3 n (%)§	Grades ≥3 n (%)§
Elevated transaminase	61 (52)	79 (66)
Bilirubin increased	24 (20)	30 (25)
Pancreatitis	21 (18)	29 (24)
Abnormal clotting studies	17 (14)	25 (21)
Diarrhea	10 (9)	6 (5)
Hypersensitivity	9 (8)	8 (7)
Embolic and thrombotic events	9 (8)	10 (8)
Sepsis	6 (5)	7 (6)
Dyspnea	5 (4)	1 (1)
Hemorrhages	5 (4)	5 (4)
Fungal infection	4 (3)	3 (3)
Pneumonia	4 (3)	8 (7)
Arrhythmia	2 (2)	1 (1)
Cardiac failure	2 (2)	1 (1)
* ASPARLAS or pegaspargase were administered as a component of multi-agent chemotherapy regimens. † Grouped terms: Elevated transaminase: Alanine aminotransferase increased, Aspartate aminotransferase increased, Transaminases increased; Bilirubin increased: Bilirubin conjugated increased, Blood bilirubin increased; Pancreatitis: Amylase increased, Lipase increased, Pancreatic necrosis, Pancreatitis, Pancreatitis relapsing; Abnormal clotting studies: Activated partial thromboplastin time prolonged, Blood fibrinogen decreased; Diarrhea: Colitis, Diarrhea, Enterocolitis, Neutropenic colitis; Hypersensitivity: Anaphylactic reaction, Drug hypersensitivity, Hypersensitivity; Embolic and thrombotic events SMQ: Device related thrombosis, Disseminated intravascular coagulation, Embolism, Intracardiac thrombus, Intracranial venous sinus thrombosis, Pulmonary embolism, Superior sagittal sinus thrombosis, Thrombosis in device, Venous thrombosis, Venous thrombosis limb; Sepsis: Bacterial sepsis, Sepsis; Dyspnea: Hypoxia, Respiratory failure; Hemorrhages SMQ (excludes laboratory terms): Disseminated intravascular coagulation, Epistaxis, Hematoma, Hemorrhage intracranial, Melena, Esophageal ulcer hemorrhage, Small intestinal hemorrhage, Upper gastrointestinal hemorrhage; Fungal infection: Fungal infection, Hepatic infection fungal, Respiratory tract infection fungal, Splenic infection fungal, Systemic candida; Pneumonia: Lung infection, Pneumonia, Pneumonitis; Arrhythmia: Atrioventricular block complete, Sinus tachycardia, Ventricular arrhythmia; Cardiac failure: Ejection fraction decreased, Left ventricular dysfunction. § Grading is based on the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

In the subgroup of patients with B-cell lineage ALL, the complete remission rate in the ASPARLAS arm was 98% (95/97), compared to 99% in the pegaspargase arm; the Kaplan-Meier estimates of overall survival of the treatment arms were comparable.

Study AALL07P4

The safety of ASPARLAS was also evaluated in Study AALL07P4, an open-label, randomized, active-controlled, multicenter clinical trial that treated patients with newly-diagnosed high-risk B-precursor ALL using ASPARLAS 2,500 U/m² (n=43) or 2,100 U/m² (n=68), or pegaspargase 2,500 U/m² (n=52), as a component of an augmented Berlin-Frankfurt-Münster (BFM) therapy regimen. The median age was 11 years (range 1 to 26 years); the median duration of exposure was 7 months for both ASPARLAS and pegaspargase. In this study, the induction mortality of patients treated with ASPARLAS was 2.8% (3 out of 111); there were no induction deaths among 52 patients treated with pegaspargase.

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity.

Read the entire FDA prescribing information for Asparlas (Calaspargase Pegol-mknl Injection)