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

6502 Nursery Drive, Suite 100
Victoria, TX 77904
Fax: (361)578-5500

Medical Disorders
Basic InformationLookupsLatest News
FDA Approves First Contact Lens That Slows Myopia ProgressionStatins Won't Harm Aging Brains, and May Even HelpGene Test Might Someday Gauge Your Cardiac Arrest RiskExpensive Device Used in Heart Surgeries Might Pose Dangers: StudyCheap, Older Gout Drug Could Be a Lifesaver After Heart AttackStudy Casts Doubt on Angioplasty, Bypass for Many Heart PatientsFasting Diet Could Benefit Heart Health: StudyFetroja Approved to Treat Complicated Urinary Tract InfectionsFlu Season Starting to Ramp Up in the SouthAHA News: Quitting Smoking Could Lead to Major Changes in Gut BacteriaHealth Tip: Do's and Don'ts for Calling 911Experimental Injection May Protect Against Peanut AllergyReblozyl Approved to Treat Anemia in Patients With Beta ThalassemiaAHA News: High Blood Pressure Common Among Black Young AdultsAHA News: Congenital Heart Disease Linked to Neighborhood Pollution, PovertySome Headway Made Against 'Superbugs,' but Threat Remains: CDCHealth Tip: A Well-Stocked First-Aid KitLung Cancer Report Delivers Good, Bad NewsAHA News: Millions Unaware of Common Heart Attack SymptomsWant Extra Years of Life? Keep Blood Pressure Tightly ControlledTestosterone Supplements Double Men's Odds for Blood Clots: StudyHealth Tip: Treating Post-Nasal DripOpioids Won't Help Arthritis Patients Long-Term: StudyCommon Muscle Relaxant Could Pose Mental Dangers for SeniorsKratom May Cause Liver Damage: StudySupplements Don't Prevent Kidney Disease in Type 2 DiabeticsNew Tool Predicts Odds of Kidney DiseaseVitamin E Acetate Is Leading Suspect in Vaping-Linked Lung Illnesses: CDCVaping-Linked Lung Illnesses Top 2,000, CDC SaysAHA News: Stroke Death Rate Increasing for Middle-Aged AmericansRural Americans Dying More From Preventable Causes Than City DwellersWhy Hand-Washing Beats Hand SanitizersSleepless Nights Could Raise Heart RisksScreening Truckers for Sleep Apnea Cuts Health Insurance CostsDo You Take Biotin Supplements? They Could Affect Your Medical TestsAHA News: Heart Disease Down Over A Generation Among American IndiansRisks Mount for Lonely Hearts After Cardiac SurgeryDaylight Saving Time Bad for Health, Experts ClaimHealth Tip: Prevent BloatingCould a Blood Test for Breast Cancer Become a Reality?One Dead, 8 Hospitalized in Salmonella Outbreak Tied to Ground BeefMost Americans Fear Cancer, but Feel Powerless to Prevent It: SurveyFewer Opioids After Eye Surgery Don't Mean More Post-Op PainDrug Trio Could Give Patients With Cystic Fibrosis a New OptionCould Tissue-Sealing Tape One Day Replace Stitches?Deep Sleep May 'Rinse' Day's Toxins From BrainClose to 1,900 Cases of Vaping-Linked Lung Illness, CDC SaysMeasles Leaves People More Vulnerable to Future InfectionsHealth Tip: Nausea After EatingSooner Is Usually Better for Gallbladder Surgery
Questions and AnswersLinks
Related Topics


FDA Approves First Treatment for ILD With Systemic Sclerosis, Scleroderma

HealthDay News
Updated: Sep 9th 2019

new article illustration

MONDAY, Sept. 9, 2019 (HealthDay News) -- The U.S. Food and Drug Administration granted the first approval for a drug to slow the decline of pulmonary function in interstitial lung disease associated with systemic sclerosis or scleroderma (SSc-ILD), the agency announced Friday.

Ofev (nintedanib) capsules were approved in 2014 to treat adults with idiopathic pulmonary fibrosis and are now approved for patients with SSc-ILD. The recommended dosage is 150 mg twice daily 12 hours apart.

Approval of Ofev was based on data from SENSCIS, a phase 3 randomized, double-blind, placebo-controlled trial of 576 patients (20 to 79 years old) with SSc-ILD. Patients received treatment for at least 52 weeks and up to 100 weeks. During 52 weeks, patients receiving Ofev had a 44 percent slower loss in pulmonary function (41 mL/year) as measured by forced vital capacity compared with patients who received placebo. The most frequently reported serious adverse event was pneumonia, which was reported in 2.8 and 0.3 percent of patients who received Ofev and placebo, respectively. Thirty-four percent of patients who received Ofev experienced adverse reactions that led to permanent dose reductions, compared with 4 percent of patients who received placebo. The most frequently reported adverse reaction leading to permanent dose reduction with Ofev was diarrhea.

The drug's prescribing information includes warnings for patients with moderate or severe hepatic impairment, elevated liver enzymes and drug-induced liver injury, and gastrointestinal disorders. The FDA notes that Ofev can also cause embryo-fetal toxicity resulting in fetal harm, arterial thromboembolic events, bleeding, and gastrointestinal perforation. Patients taking P-gp and CYP3A4 inhibitors should be closely monitored for tolerability of Ofev, as these inhibitors can increase nintedanib exposure. Commonly reported side effects with Ofev include diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, weight loss, and hypertension.

Approval of Ofev for patients with SSc-ILD was granted to Boehringer Ingelheim Pharmaceuticals.

More Information