Proactive’s Post

Lutetium Lu 177 Dotate has been approved by the FDA for treatment of pediatric patients aged 12 years and above. According to Dr. Anish K. Shah, "The approval was based on the pharmacokinetic (PK), dosimetry, and safety data frombNETTER-P, an ongoing, international, multi-center, open-label, single-arm study ofblutetium Lu 177 dotatate in adolescent patients with locally advanced/inoperable or metastatic SSTR-positive GEP-NETs." Read to learn more about this option for #pediatriccancerpatients ⬇ https://lnkd.in/gMfHE6Sv

Barriers Persist To Implement Teplizumab In Clinical Practice: Teplizumab is indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients 8 years of age and older with stage 2 T1D. #finance #pharmacy #lifesciences

FDA Announces Availability of a Revised Final Guidance on Extrapolating Efficacy Data to Treat Partial Onset Seizures in Pediatric Patients On July 15, 2024, the FDA announced the availability of a revised final guidance for industry entitled Drugs for the Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults to Pediatric Patients 1 Month of Age and Older, replacing the 2019 final guidance which discussed extrapolation to pediatric patients 4 years of age and older. This revised final guidance provides recommendations to sponsors on the clinical development of drugs for the treatment of partial onset seizures (POS) in pediatric patients. Specifically, this guidance addresses FDA’s current thinking regarding clinical development programs that can support extrapolation of the efficacy of drugs approved for the treatment of POS in adults to pediatric patients 1 month of age and older. This guidance discusses formulation development, efficacy and safety considerations, and clinical pharmacology and dosing considerations. This guidance does not address the development of drugs to treat other types of seizures.  #fda #drugdevelopment #pediatric #epilepsy #seizures #partialonset https://lnkd.in/ehBG3dUA

Aquestive Therapeutics has achieved a significant milestone with the U.S. FDA approval of Libervant™ (diazepam) Buccal Film for the treatment of seizure clusters in children aged 2 to 5 years. This is the first and only orally administered rescue therapy approved for this patient population, addressing a critical unmet need. Libervant™ offers a novel and convenient method of delivering diazepam, a benzodiazepine medication, through a buccal film formulation. Until now, the only approved treatment for seizure clusters in young children has been Diastat® (diazepam) Rectal Gel, an invasive and often distressing option for both patients and caregivers. Libervant™ represents a significant advancement, offering a non-invasive and user-friendly solution. Another competitor in the market is Nayzilam® (midazolam) Nasal Spray, approved for seizure clusters in patients aged 12 and older. However, Libervant™ fills a crucial gap by addressing the needs of younger children, a population previously underserved. Congratulations to Aquestive Therapeutics on this groundbreaking approval, bringing a much-needed alternative to currently available options for the treatment of seizure clusters in young children. #SeizureClusters #FDAApproval #InnovativeTreatment #PatientCare

As the world of #pharmacogenomics and its applications continues to evolve, here is a new practice point statement from Canadian Pediatric Society regarding the recommendations for PGx testing in children for psychoactive medications. #pgx testing is strongly recommended in the case where a child or youth needs to start carbamazepine or valproic acid(<2 years), or tetrabenazine. The statement also lists very important guidelines for #healthcare professionals when presented with PGx results on how to use these results to guide drug selection. #precisionmedicine is always about the whole picture, and PGx test results are one part of that picture. As I continue my journey in #pgx learning, the field of #pharmacogenomics continues to amaze me !

Study Reveals Impact of Antiseizure Medications on Anticoagulant Efficacy and Safety in Adults with Atrial Fibrillation and Epilepsy A recent study examined the effect of concurrent prescription of direct-acting oral anticoagulants

FDA Issues Draft Guidance for Industry on Pediatric IBD Treatment Development    FDA issued a draft guidance for industry, “Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment,” to help sponsors in the clinical development of drugs to treat pediatric patients with inflammatory bowel disease (IBD).  Specifically, this guidance provides the agency’s recommendations for clinical study attributes for pediatric ulcerative colitis or pediatric Crohn’s disease treatments, including:  study design,  study population,  efficacy considerations,   and safety assessments.  This is the agency’s first guidance focused on clinical studies for pediatric IBD treatments. When finalized, this guidance will represent FDA’s current thinking on this topic. We encourage interested parties to submit comments by September 16, 2024, to ensure consideration before FDA begins work to finalize this guidance.  #fda #pediatric #ibd #drugdevelopment  https://lnkd.in/gJNZd5nJ

▎why is Ceftriaxone 💉 contraindicated in neonate ? In neonates, it is essential not to use it in patients with hyperbilirubinemia. ✅ Because it causes the displacement of bilirubin bound to albumin. ♻️ This increases the level of free bilirubin, thereby increasing the chance of it spreading to the brain, which makes them more susceptible to kernicterus. ✅ So, what is kernicterus? 🤔 It is a type of brain damage that occurs due to high levels of bilirubin in the brain. So Ceftriaxone is contraindicated in neonates who are less than 28 days old and are receiving calcium-containing IV solutions. 📖 Reference: Nelson Pediatric Antimicrobial Therapy, 29th Edition, 2023, Page 78. #pharmacology #medicine #MedEd #cephalosporins #Ceftriaxone #antibiotics

👏 SpineX Inc. has closed recruitment for a clinical study investigating its neuromodulation device to treat urinary incontinence. Data from the trial, which began in May 2022, will be used to support a De Novo submission to the US Food and Drug Administration “in the coming months”, according to SpineX’s CEO Parag Gad. 🔗 Read more: https://lnkd.in/ehY4xj2n 📰 Follow Guided Solutions to receive the latest #MedTech news daily and subscribe to our weekly newsletter: https://lnkd.in/eBu_EP6V #MedicalDevices #MedicalDevice #MedicalEquipment #Medicine #Surgeons #GuidedSolutions

𝗢𝘂𝗿 𝗱𝗿𝘂𝗴 𝘀𝘂𝗿𝘃𝗶𝘃𝗮𝗹 𝘀𝘁𝘂𝗱𝘆 𝗼𝗳 𝗱𝘂𝗽𝗶𝗹𝘂𝗺𝗮𝗯, 𝗰𝘆𝗰𝗹𝗼𝘀𝗽𝗼𝗿𝗶𝗻𝗲 𝗔 𝗮𝗻𝗱 𝗺𝗲𝘁𝗵𝗼𝘁𝗿𝗲𝘅𝗮𝘁𝗲 𝗶𝗻 𝗽𝗲𝗱𝗶𝗮𝘁𝗿𝗶𝗰 𝗔𝗗 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀 𝗶𝘀 𝗼𝘂𝘁 𝗻𝗼𝘄 𝗶𝗻 𝙅𝘼𝙈𝘼 𝘿𝙚𝙧𝙢𝙖𝙩𝙤𝙡𝙤𝙜𝙮! This multicenter study provides key insights into the long-term effectiveness, safety, and tolerability of these treatments. 𝗞𝗲𝘆 𝗳𝗶𝗻𝗱𝗶𝗻𝗴𝘀:  ➡ Among 502 treatment episodes, dupilumab demonstrated superior 1-year, 2-year, and 3-year overall drug survival, followed by methotrexate and cyclosporine A in pediatric AD patients. ➡ The introduction of dupilumab was associated with decreased drug survival of methotrexate and cyclosporine A. ➡ Several factors were associated with treatment discontinuation due to adverse effects and/or ineffectiveness, including methotrexate and cyclosporine A use, and initiation of treatment in patients aged 12-17 years. 🔍 Access the full article below. We would like to thank all co-authors for their significant contributions: Lisa van der Rijst Esmé Kamphuis Marie-Louise Schuttelaar Rimoon Hurmuz 𝗠𝗮𝗿𝗶𝗲𝗸𝗲 𝗦𝗲𝘆𝗴𝗲𝗿, Anouk Caron 𝗡𝗶𝗰𝗼𝗹𝗮𝗮𝘀 𝗭𝘂𝗶𝘁𝗵𝗼𝗳𝗳, Tan Nguyen , Marijke Kamsteeg-Lemstra Marjolein de Bruin-Weller, Suzanne Pasmans, Pina Middelkamp Hup, Marlies de Graaf. 🙌 #AtopicDermatitis #Dermatology #Children #DrugSurvival #WilhelminaKinderziekenhuis #UMCUtrecht #UMCG #AmsterdamUMC #RadboudUMC #ErasmusMC #JAMADermatology