Wednesday 23 January 2019 ,
Wednesday 23 January 2019 ,
Latest News
  • Seventh span of Padma Bridge installed
  • 6 members of a family among 7 killed in Laxmipur road crash
  • Rohingya plight peaks
  • HC ‘ashamed’ over Tabligh Jamaat split
  • Field-level workers push for reshuffle in BNP leadership
  • All Bengali ‘refugees’ will be given citizenship
  • Expedite project work, ensure quality: PM
  • PM orders expediting project works maintaining quality
7 January, 2019 00:00 00 AM

FDA approves Asparlas (calaspargase pegol-mknl) for Acute Lymphoblastic Leukemia (ALL)

FDA
FDA approves Asparlas (calaspargase pegol-mknl) for Acute Lymphoblastic Leukemia (ALL)

Recently, the Food and Drug Administration approved calaspargase pegol-mknl (Asparlas, Servier Pharmaceuticals LLC), an asparagine specific enzyme, as a component of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years. This new product provides for a longer interval between doses compared to other available pegaspargase products.

Approval was based on a demonstration of the achievement and maintenance of nadir serum asparaginase activity above the level of 0.1 U/mL when using calaspargase pegol-mknl, 2500 U/m2 intravenously, every 3 weeks. The pharmacokinetics of calaspargase pegol-mknl were studied when administered in combination with multiagent chemotherapy in 124 patients with B-cell lineage ALL.

The most common (incidence ≥ 10%) grade ≥ 3 adverse reactions were elevated transaminase, increased bilirubin, pancreatitis, and abnormal clotting studies. In a randomized trial, the safety profile of calaspargase pegol-mknl administered every 3 weeks was similar to that of pegaspargase administered every 2 weeks.

The recommended calaspargase pegol-mknl dose is 2,500 units/m2 intravenously administered at a minimum dosing interval of every 21 days.

 

Comments

Most Viewed
Digital Edition
More story
From the Editor

From the Editor

Infections are invasion and multiplication of micro-organisms in body tissues, especially that causing local cellular injury due to competitive metabolism,…
Infectious diseases

Infectious diseases

Infectious diseases are caused by pathogenic microorganisms, such as bacteria, viruses, parasites or fungi; the diseases can be spread, directly or indirectly,…
FAQ on streptococcal infections

FAQ on streptococcal infections

Group B streptococcus (group B strep) is a type of bacteria that causes illness in newborn babies, pregnant women, the elderly, and adults with other…
Viral infections

Viral infections

A viral infection is any type of infection that is caused by a virus, which is even smaller than bacteria and is encapsulated by a protective coating…
Respiratory tract infections

Respiratory tract infections

Respiratory tract infections are infections that occur anywhere in the respiratory tract. Parts of the body that we use in the breathing process are referred…
How to treat and prevent cold sores on your lips

How to treat and prevent cold sores on your lips

If you've ever looked in the mirror and saw a pimple-looking dot on your mouth that hurts a lot, you're not alone — but it's not always…
What do the different poop colors and shapes mean?

What do the different poop colors and shapes mean?

CATHY WONG    Although you may not pay much attention to your stools, looking at them regularly can help you pick up on variations in color,…
Splint for burn patient

Splint for burn patient

Burn disaster is a common disaster in Bangladesh. Each year, approximately 265,000 deaths occur due to burns on a global scale. In Bangladesh, around…
Type 2 diabetes before 40 tied to mental illness hospitalizations

Type 2 diabetes before 40 tied to mental illness hospitalizations

People who develop type 2 diabetes before they turn 40 are twice as likely to be hospitalized for mental illness as those who develop the blood sugar…
AHA: Hookah smoking trendy, despite evidence of health risks

AHA: Hookah smoking trendy, despite evidence of health risks

While cigarette smoking has hit an all-time low, another form of tobacco use is rising in popularity -- hookah smoking -- and researchers are concerned…
New birth control skin patch being developed

New birth control skin patch being developed

A skin patch that provides a month's worth of birth control for women is being developed by U.S. researchers. The patch, which can be pressed into…
FDA approves expanded use of Adacel (Tdap) vaccine for repeat vaccination

FDA approves expanded use of Adacel (Tdap) vaccine for repeat vaccination

The U.S. Food and Drug Administration has approved the expanded use of Adacel® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis…

Copyright © All right reserved.

Editor : M. Shamsur Rahman

Published by the Editor on behalf of Independent Publications Limited at Media Printers, 446/H, Tejgaon I/A, Dhaka-1215.
Editorial, News & Commercial Offices : Beximco Media Complex, 149-150 Tejgaon I/A, Dhaka-1208, Bangladesh. GPO Box No. 934, Dhaka-1000.

Editor : M. Shamsur Rahman
Published by the Editor on behalf of Independent Publications Limited at Media Printers, 446/H, Tejgaon I/A, Dhaka-1215.
Editorial, News & Commercial Offices : Beximco Media Complex, 149-150 Tejgaon I/A, Dhaka-1208, Bangladesh. GPO Box No. 934, Dhaka-1000.

Disclaimer & Privacy Policy
....................................................
About Us
....................................................
Contact Us
....................................................
Advertisement
....................................................
Subscription

Powered by : Frog Hosting