BRIEF SUMMARY

CALASPARGASE pego-mknl- (Dec 2018)

Indn-        To treat acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years

Comp-         Injection: 3,750 units/5 mL (750 units/mL) in a single-dose vial. • Recommended Dosage: 2,500 units/m2 intravenously no more frequently than every 21 days. 

ADR-     ­ The most common (incidence =10%) grade > 3 adverse reactions were elevated transaminase, bilirubin increased, pancreatitis and abnormal clotting studies.

CI-     • History of serious hypersensitivity reactions to pegylated L-asparaginase.            • History of serious thrombosis during L-asparaginase therapy.                                          • History of serious pancreatitis related to previous L-asparaginase treatment.                  • History of serious hemorrhagic events during previous L-asparaginase therapy.              • Severe hepatic impairment.

 WARNINGS-­ • Hypersensitivity: Observe patients for one hour after administration. Discontinue ASPARLAS in patients with serious hypersensitivity reactions.   

 • Pancreatitis: Discontinue ASPARLAS in patients with pancreatitis. Monitor blood glucose                                                                                           

Pat Infm-   

 Hypersensitivity-                                                                                                       Inform patients on the possibility of serious allergic reactions, including anaphylaxis. Instruct the patient on the symptoms of allergic reactions and to seek medical advice immediately if they experience such symptoms

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U.S. FDA APPROVED  DRUGS DURING 2018

Sr.No-  57

ADVERSE REACTIONS

­ The most common (incidence =10%) grade > 3 adverse reactions were elevated transaminase, bilirubin increased, pancreatitis and abnormal clotting studies.

 WARNINGS AND PRECAUTIONS

­ • Hypersensitivity: Observe patients for one hour after administration. Discontinue ASPARLAS in patients with serious hypersensitivity reactions.   

 • Pancreatitis: Discontinue ASPARLAS in patients with pancreatitis. Monitor blood glucose                                                                                                                                 

• Thrombosis: Discontinue ASPARLAS for severe or life-threatening thrombosis. Provide anticoagulation therapy as indicated.                                                                     

• Hemorrhage: Discontinue ASPARLAS for severe or life-threatening hemorrhage. Evaluate for etiology and treat.                                                                                           

• Hepatotoxicity: Monitor for toxicity through recovery from cycle. .

USE IN SPECIFIC POPULATIONS

1 Pregnancy Risk Summary                                                                                             There are no available data on the use of ASPARLAS in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.

Published literature studies in pregnant animals suggest asparagine depletion may cause harm to the animal offspring (see Data).

Advise patients of the potential risk to a fetus.

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2%-4% and 15%-20%, respectively.

2.Lactation Risk Summary                                                                                        There are no data on the presence of calaspargase pegol-mknl in human milk, the effects on the breastfed child, or the effects on milk production

. Because many drugs are excreted in human milk and because of the potential for adverse reactions in a breastfed child, advise lactating women not to breastfeed while receiving ASPARLAS and for 3 months after the last dose.

3. Females and Males of Reproductive Potential                                                      Based on published literature studies in pregnant animals, ASPARLAS can cause fetal harm when administered to a pregnant woman 

Pregnancy Testing                                                                                                     Conduct pregnancy testing in females of reproductive potential prior to starting treatment with ASPARLAS.

Contraception                                                                                                                   Advise females of reproductive potential to avoid becoming pregnant while receiving ASPARLAS.                                                                                                                 

Females should use effective contraceptive methods, including a barrier method, during treatment and for at least 3 months after the last dose of ASPARLAS.

Since there is a potential for an indirect interaction between ASPARLAS and oral contraceptives, the concomitant use of ASPARLAS and oral contraceptives is not recommended.

Another, non-oral contraceptive method should be used in women of childbearing potential.

4 Pediatric Use                                                                                                               The safety and effectiveness of ASPARLAS in the treatment of ALL have been established in pediatric patients 1 month to < 17 years (no data for the age group < 1 month old).

Use of ASPARLAS in these age groups is supported by evidence from an adequate and well-controlled trial with additional safety 6 Reference ID: 4366561 from a second trial.

There were no clinically meaningful differences in safety or nadir serum asparaginase activity across age groups