24-Hour Crisis Hotline: (877)SAFEGBC or (877)723-3422 Mental Health & Substance Abuse Issues

6502 Nursery Drive, Suite 100
Victoria, TX 77904
(361)575-0611
(800)421-8825
Fax: (361)578-5500

Child & Adolescent Development: Overview
Resources
Basic InformationMore InformationLatest News
Opioid Epidemic Doubled Number of U.S. Kids Sent to Foster CareSwimming Lessons a Must for EveryoneHow to Help When Your Child Weighs Too MuchHave Kids, Buy More Produce?Zika's Damage Continues in Children Infected Before BirthCDC Warns of Start to 'Season' for Mysterious Paralyzing Illness in KidsParent Who Listens Can Help Kids Thrive Despite TraumaHealth Tip: Ear Piercing For KidsReacting Against a 'Too Clean' World, Some Parents Go Too Far the Other WaySurvey Urges Grandparents to Lock Down Their Meds When Kids VisitCalifornia Took on Anti-Vaxxers, and WonHow Does Sunshine During Pregnancy Affect Learning?Surgery Helps Babies Missing a Heart Chamber Survive, But Problems LingerAbuse, Injury More Likely When Child is With Male Caregiver: StudyHow to Foster Your Child's ImaginationLow Vitamin D at Birth Linked to Kids' High Blood Pressure RiskHow Do Kids Learn To Turn Off Troublesome Tics?Meet 'Huggable,' the Robot Bear Who's Helping Hospitalized KidsWill Video Games Make Your Kid Obese? Maybe NotChildhood Brain Tumor Survivors Face More StrugglesFDA Expands Cystic Fibrosis Treatment Approval to Children Ages 6 to 12New Drug Combats Leading Cause of DwarfismHow Do Birth Defects Affect Childhood Cancer Risk?FDA Approves Victoza Injection for Children 10 Years and OlderHealth Tip: Preparing Your Child For Sleepaway CampTips for Keeping Your Child Healthy at CampA Simple Way to Help Prevent Child ObesityType 1 Diabetes Might Affect Young Kids' Brain DevelopmentHow to Put Limits on Your Family's Screen TimeChickenpox Vaccine Shields Kids From Shingles, TooWhooping Cough Vaccine Effectiveness Fades With Time: StudyHundreds of Young Kids Drown in Pools Each Year -- Keep Yours SafeWhich Dogs Are More Likely to Bite Your Kids?Health Tip: Preventing Swimmer's EarAHA News: With Summer Vacation Here, How Much Screen Time Is Too Much?Health Tip: Prevent BullyingHealth Tip: Avoid Mouth Injuries in ChildrenKids Still Being Poisoned by Detergent PodsViolent Video Games, Unlocked Guns a Dangerous Combo for KidsWhy Some Kids With Eczema Are at Higher Allergy Risk'Controlled Burns' Better for Kids' Health Than Wildfires: StudyHow Kids Benefit From Doing ChoresAHA News: Report Seeks Answers About Mysterious, Dangerous Heart Disease in KidsKids of Opioid-Using Parents May Be More Likely to Attempt SuicideCholesterol Levels Improving Among U.S. KidsEarlier Bedtimes Help Kids Fight Obesity1 in 5 Kids Don't Strap on Helmets Before BikingParents, Here's How to Protect Your Child During Measles OutbreaksMore Than 600,000 Opioid Abusers Raising Kids in U.S.2 of 3 Parents Read Texts While Driving
Questions and AnswersLinks
Related Topics

ADHD: Attention Deficit Hyperactivity Disorder
Childhood Mental Disorders and Illnesses
Child Development & Parenting: Infants (0-2)
Child Development & Parenting: Early (3-7)

FDA Expands Cystic Fibrosis Treatment Approval to Children Ages 6 to 12


HealthDay News
Updated: Jun 24th 2019

new article illustration

MONDAY, June 24, 2019 (HealthDay News) -- The indication for a cystic fibrosis treatment, Symdeko (tezacaftor/ivacaftor) tablets, has been expanded to treat children ages 6 years and older with cystic fibrosis and certain genetic mutations, the U.S. Food and Drug Administration announced today.

Symdeko is approved to treat patients with two copies of the F508del mutation, the most common type of mutation, and patients who have at least one of the mutations in the CFTR gene that is responsive to the active ingredients in Symdeko. The FDA approved Symdeko last year for treatment in children ages 12 years and older with the same genetic mutations. Dosage in children ages 6 to 12 years weighing less than 30 kg is one tablet of 50 mg tezacaftor and 75 mg ivacaftor in the morning and one tablet of 75 mg ivacaftor approximately 12 hours later. In patients aged 12 years and older or who weigh 30 kg or more, dosage is one tablet containing 100 mg tezacaftor and 150 mg ivacaftor and a tablet containing 150 mg ivacaftor 12 hours later.

Symdeko's approval was based on three phase 3, double-blind, placebo-controlled trials that showed improvements in lung function and a reduction in exacerbations. The expanded indication approval to children ages 6 to 12 years was based on data from patients aged 12 years and older and additional support from data on patients aged 6 to 12 years. Symdeko's safety in children ages 6 to 12 years was demonstrated in a 24-week, open-label study of 70 cystic fibrosis patients aged 6 to 12 years.

Symdeko's labeling indicates that it should always be taken with food containing fat and should never be combined with certain antibiotics, seizure medications, St. John's wort, or food containing grapefruit or Seville oranges. The prescribing information includes warnings of elevated transaminases and the risk for cataracts in children taking Symdeko and warns against taking Symdeko simultaneously with CYP3A inducers. The most commonly reported side effects were headache, nausea, sinus congestion, and dizziness.

Approval was granted to Vertex Pharmaceuticals.

More Information