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Related Concept Videos

Drug Dosing: Infants and Children01:29

Drug Dosing: Infants and Children

46
Pediatric patient dosages diverge from adults due to disparities in body surface area, total body water, and extracellular fluid per kilogram of body weight. The dosing regimen considers the variations in pharmacokinetics and pharmacology across distinct age groups, encompassing preterm newborns, infants, young children, older children, and adolescents. Calculation of pediatric patient doses is predicated on determining body surface area, which exhibits a superior correlation with the child's...
46
Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption01:23

Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption

31
Understanding the physiological differences in the pediatric population is crucial for effective pharmacotherapy. Neonates, infants, and children exhibit significant variations in gastric pH, gastric emptying time, intestinal transit time, and biliary function. These variations profoundly affect oral drug absorption, necessitating a nuanced approach to pediatric dosing.Neonates present with a unique physiological profile, having a gastric pH greater than 4 and faster and more irregular gastric...
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Pharmacokinetics in Pediatric Patients: Drug Metabolism01:24

Pharmacokinetics in Pediatric Patients: Drug Metabolism

35
In pediatric care, understanding the nuances of hepatic drug metabolism is crucial, as it significantly differs from that of adults. This divergence is primarily due to the developmental stage of drug-metabolizing enzymes, which affects how medications are processed in the body. In neonates, for instance, the activity of Phase I enzymes—critical for the initial breakdown of drugs—is markedly reduced, functioning at just 20–40% of the levels seen in adults. This reduction poses...
35
Pharmacokinetics in Pediatric Patients: Drug Distribution01:17

Pharmacokinetics in Pediatric Patients: Drug Distribution

37
Drug distribution in the pediatric population exhibits unique challenges and considerations due to the physiological differences between children, particularly neonates and infants, and adults. A crucial aspect of pediatric pharmacology is understanding how these differences impact the pharmacokinetics of various drugs, necessitating age-specific dosing strategies to ensure efficacy and safety.Neonates and infants have a higher total body water content, ~75%–90% of their body weight,...
37
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

22
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Pharmacokinetics in Pediatric Patients: Drug Excretion01:26

Pharmacokinetics in Pediatric Patients: Drug Excretion

37
In pediatric medicine, understanding the renal function and drug elimination nuances is crucial for administering safe and effective treatments. Newborns, in particular, display markedly slower renal functions than adults, profoundly affecting how drugs are cleared from their bodies. This slower drug clearance requires clinicians to extend the dosing intervals for many medications to prevent drug accumulation and toxicity while ensuring therapeutic efficacy.One key area where these adjustments...
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Teriflunomide: Pediatric First Approval.

Julia Paik1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. pdd@adis.com.

Paediatric Drugs
|October 1, 2021
PubMed
Summary
This summary is machine-generated.

Teriflunomide is now approved in the EU for pediatric patients aged 10 years and older with relapsing-remitting multiple sclerosis (MS). This oral immunomodulatory treatment targets a key enzyme in immune cell proliferation.

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Area of Science:

  • Immunology
  • Neurology
  • Pharmacology

Background:

  • Teriflunomide is an oral immunomodulatory drug targeting dihydroorotate dehydrogenase.
  • It is approved for treating relapsing-remitting multiple sclerosis (MS) in adults.

Purpose of the Study:

  • To summarize the development milestones of teriflunomide.
  • To highlight the first approval of teriflunomide for pediatric patients with relapsing-remitting MS in the EU.

Main Methods:

  • Review of teriflunomide's development pathway.
  • Analysis of regulatory milestones for pediatric indication.

Main Results:

  • Teriflunomide received EU approval for pediatric patients (≥10 years) with relapsing-remitting MS on June 18, 2021.
  • This marks the first pediatric indication for teriflunomide.

Conclusions:

  • Teriflunomide offers a new oral treatment option for pediatric relapsing-remitting MS.
  • The approval signifies an important advancement in managing MS in younger populations.