trikafta generic name

In a study with ivacaftor alone, subjects with moderately impaired hepatic function had similar ivacaftor Cmax, but an approximately 2.0-fold higher ivacaftor AUC0-∞ compared with healthy subjects matched for demographics. Know the medicines you take. This book is the first complete guide to valuation in life sciences for industry professionals, investors, and academics. In an EFD study in pregnant rats dosed during the period of organogenesis from gestation Days 6-17 and in pregnant rabbits dosed during the period of organogenesis from gestation Days 7-20, tezacaftor was not teratogenic and did not affect fetal development or survival at exposures up to 3 and 0.2 times, respectively the MRHD (based on summed AUCs of tezacaftor and M1-TEZ). It is not known if SYMDEKO will harm your unborn baby. The light blue tablet is marked with 'V 75' and contains the medicine ivacaftor. Co-administration of tezacaftor/ivacaftor with digoxin, a sensitive P-gp substrate, increased digoxin exposure by 1.3-fold in a clinical study. Co-administration of ivacaftor or tezacaftor/ivacaftor with digoxin, a sensitive P-gp substrate, increased digoxin AUC by 1.3-fold, consistent with weak inhibition of P-gp by ivacaftor. With the exception of sex differences in rash, the safety profile of Trikafta was generally similar across all subgroups of patients, including analysis by age, sex, baseline percent predicted FEV1 (ppFEV1) and geographic regions. Vertex Pharmaceuticals Incorporated Co-administration of ivacaftor with rifampin, a strong CYP3A inducer, significantly decreased ivacaftor area under the curve (AUC) by 89%. Average cash price. Following oral administration of Trikafta to patients 12 to less than 18 years of age (elexacaftor 200 mg qd/tezacaftor 100 mg qd/ivacaftor 150 mg q12h), the mean (±SD) AUCss was 147 (36.8) mcg∙h/mL, 88.8 (21.8) mcg∙h/mL and 10.6 (3.35) mcg∙h/mL, respectively for elexacaftor, tezacaftor and ivacaftor, similar to the AUCss in adult patients. Member’s Last Name: Member’s First Name: DIAGNOSIS AND MEDICAL INFORMATION TRIKAFTA™ – to receive a ONE (1) year approval for this drug, complete the following questions. Do not drive a car, use machinery, or do anything that needs you to be alert until you know how Trikafta affects you. Trikafta (elexacaftor, tezacaftor and ivacaftor tablets; ivacaftor tablets) is a combination of ivacaftor, a CFTR potentiator, tezacaftor, and elexacaftor used to treat cystic fibrosis (CF) in patients aged 12 years and older who have … Trikafta has been studied with ethinyl estradiol/levonorgestrel and was found to have no clinically relevant effect on the exposures of the oral contraceptive. Here is a fascinating no-holds-barred account of the business of science, which includes an updated epilogue about the most recent developments in the quest for a drug to cure AIDS. There are limited and incomplete human data from clinical trials on the use of Trikafta or its individual components, elexacaftor, tezacaftor and ivacaftor, in pregnant women to inform a drug-associated risk. Trikafta is a co-package of elexacaftor, tezacaftor and ivacaftor fixed-dose combination tablets and TRIKAFTA is a breakthrough treatment for people with CF age 6 years and older with at least one copy of the F508del mutation or at least one other responsive mutation. antifungal medicines including ketoconazole (such as NIZORAL, antibiotics including telithromycin (such as KETEK, other medicines including rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin and St. John's wort. The proportion of patients who had diastolic blood pressure >90 mmHg and 5 mmHg increase from baseline on at least two occasions was 1% in Trikafta-treated patients and 2% in placebo-treated patients. It offers a system, practices, and advice on how to avoid the pitfalls of renting in a country with different cultural and regulatory norms, and how to get a more luxurious place for less.More than just offering best practices, it also ... It is not known if TRIKAFTA passes into your breast milk. Examples include eggs, butter, peanut butter, whole-milk dairy products (such as whole milk, cheese and yogurt), etc. © 2021 Vertex Pharmaceuticals Incorporated | www.vrtx.com. By Kristi Birch. If used, Trikafta should be used with caution at a reduced dose (see Table 2) [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3) and Patient Counseling Information (17)]. Exposure of 14C-tezacaftor in milk was approximately 3 times higher than in plasma (based on AUC0-72h). When co-administered with itraconazole and ketoconazole, ivacaftor AUC increased by 15.6-fold and 8.5-fold, respectively. Liver function tests should be closely monitored. Who should not take Trikafta? Hormonal contraceptives may play a role in the occurrence of rash. No specific antidote is available for overdosage with Trikafta. Therefore, no dose adjustment is necessary during concomitant administration of Trikafta with ciprofloxacin [see Clinical Pharmacology (12.3)]. TRIKAFTA® is now approved for children as young as 6 years old. Potential for elexacaftor/tezacaftor/ivacaftor to affect other drugs. Is the member 12 years of age or older? Out of 6,122,890 records in the U.S. Social Security Administration public data, the first name Trikafta was not present. Avoid food or drink containing grapefruit during Trikafta treatment [see Warnings and Precautions (5.3), Drug Interactions (7.2), Clinical Pharmacology (12.3) and Patient Counseling Information (17)]. Trikafta is supplied as: Store at 68ºF - 77ºF (20ºC - 25ºC); excursions permitted to 59ºF - 86ºF (15ºC - 30ºC) [see USP Controlled Room Temperature]. It is not known if TRIKAFTA is safe and effective in children under 6 years of age. The tablet film coat contains carnauba wax, FD&C Blue #2, PEG 3350, polyvinyl alcohol, talc and titanium dioxide. SYMDEKO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have two copies of the F508del mutation, or who have at least one mutation in the CF gene that is responsive to treatment with SYMDEKO. Examples of strong CYP3A inducers include: Co-administration with itraconazole, a strong CYP3A inhibitor, increased elexacaftor AUC by 2.8-fold and tezacaftor AUC by 4.0 to 4.5-fold. The source of that financial success is Vertex's newest cystic fibrosis drug, Trikafta, which received approval in the U.S. in late October and then in Europe a couple weeks later. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Vertex Pharmaceuticals Inc. October 18, 2019 Following the resolution of liver function test elevations, consider the benefits and risks of resuming treatment. In an EFD study in pregnant rats dosed during the period of organogenesis from gestation Days 6-17, elexacaftor was not teratogenic and did not affect fetal survival at exposures up to 9 times the MRHD (based on summed AUC for elexacaftor and its metabolite at maternal doses up to 40 mg/kg/day). Based on population PK analyses, the clearance of elexacaftor and tezacaftor was similar in subjects with mild (eGFR 60 to <90 mL/min/1.73 m2) or moderate (eGFR 30 to <60 mL/min/1.73 m2) renal impairment relative to patients with normal renal function [see Use in Specific Populations (8.6)]. Make TRIKAFTA part of the equation—a triple combination therapy that treats the underlying cause. Do not use Trikafta after the expiration date on the package. There were no effects on male or female fertility and early embryonic development in rats at oral tezacaftor doses up to 100 mg/kg/day (approximately 3 times the MRHD based on summed AUC of tezacaftor and M1-TEZ). Renal excretion of elexacaftor, tezacaftor and ivacaftor is minimal. Ivacaftor was negative for genotoxicity in the following assays: Ames test for bacterial gene mutation, in vitro chromosomal aberration assay in Chinese hamster ovary cells and in vivo mouse micronucleus test. No adverse developmental effects were observed after oral administration of elexacaftor, tezacaftor or ivacaftor to pregnant rats from the period of organogenesis through lactation at doses that produced maternal exposures approximately 1 time, approximately 1 time and 3 times the exposures at the MRHD, respectively [based on summed AUCs of parent and metabolite(s)] (see Data). Trikafta elexacaftor 100 mg / ivacaftor 75 mg / tezacaftor 50 mg (T100), Trikafta is indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one, If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one, 6 to less than 12 years weighing less than 30 kgs, 6 to less than12 years weighing 30 kgs or more, No dose adjustment is recommended for patients with mild hepatic impairment (Child-Pugh Class A), Treatment is not recommended for patients with moderate hepatic impairment (Child-Pugh Class B). Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Trikafta (copackaged) is a drug marketed by Vertex Pharms Inc and is included in one NDA. There are twenty-one patents protecting this drug. This drug has three hundred and sixty-four patent family members in forty countries. The generic ingredient in TRIKAFTA (COPACKAGED) is elexacaftor, ivacaftor, tezacaftor; ivacaftor. Price history for 1 carton (84 tablets) of Trikafta 100mg/50mg/75mg. Here is some information about TRIKAFTA that may be helpful: Get to Know Vertex GPS™:!break Guidance & Patient Support, are pregnant or plan to become pregnant. In vitro studies showed that elexacaftor, tezacaftor and ivacaftor are all metabolized by CYP3A. All other trademarks referenced herein are the properties of their respective owners. The medicine is a breakthrough for … This finding has not been observed in older animals [see Warnings and Precautions (5.4) and Patient Counseling Information (17)]. TRIKAFTA, the TRIKAFTA logo, SYMDEKO, Vertex, and the Vertex triangle logo are registered trademarks of Vertex Pharmaceuticals Incorporated. Liver function tests (ALT, AST and bilirubin) should be assessed prior to initiating Trikafta, every 3 months during the first year of treatment, and annually thereafter. Last updated by Judith Stewart, BPharm on June 10, 2021. No studies of carcinogenicity, mutagenicity, or impairment of fertility were conducted with the combination of elexacaftor, tezacaftor and ivacaftor; however, separate studies of elexacaftor, tezacaftor and ivacaftor are described below. Trikafta with NDC 51167-331 is a a human prescription drug product labeled by Vertex Pharmaceuticals Incorporated. Trikafta Tablets (age 6 to less than 12 years weighing less than 30 kgs): The light orange tablet is marked with 'T50' and each tablet contains the medicines elexacaftor, tezacaftor and ivacaftor. The pharmacokinetic parameters for elexacaftor, tezacaftor and ivacaftor in patients with CF aged 12 years and older are shown in Table 6. Concomitant use of CYP3A inducers may result in reduced exposures and thus reduced Trikafta efficacy. Mean improvement in ppFEV1 was observed at the first assessment on Day 15 and sustained through the 24-week treatment period (see Figure 1). Neither CF gene mutation you entered is eligible for TRIKAFTA. The dosage of Trikafta should be reduced when co administered with moderate CYP3A inhibitors [see Dosage and Administration (2.4), Warnings and Precautions (5.3), Clinical Pharmacology (12.3) and Patient Counseling Information (17)]. There were no deaths in Trials 1, 2 and 3. Pocket Guide for Brand and Generic Drugs is an affordable, helpful reference tool for both students and clinicians alike. Bundle this Pocket Guide with additional Jones & Bartlett texts, and save up to 30%! How? The key secondary efficacy endpoints were absolute change in sweat chloride and CFQ-R Respiratory Domain Score from baseline at Week 4. While Vertex's cystic fibrosis franchise has long held a dominant position, the addition of Trikafta now lets the company treat around 90% of the patient population — a fact that has … AND Yes No 2. Placental transfer of elexacaftor was observed in pregnant rats. COMMON side effects If experienced, these tend to have a Severe expression i . Brand name: Trikafta Co-administration of Trikafta may increase exposures of medicinal products that are substrates of these transporters, such as statins, glyburide, nateglinide and repaglinide. Company: Vertex Pharmaceuticals Incorporated Therefore, co-administration with strong CYP3A inducers is not recommended [see Drug Interactions (7.1), Clinical Pharmacology (12.3) and Patient Counseling Information (17)]. Before taking Trikafta, tell your doctor about all of your medical conditions, including if you: Tell your doctor about all the medicines you take, Always take Trikafta with food that contains fat. The efficacy of Trikafta in patients with CF aged 12 years and older was evaluated in two double blind, controlled trials (Trials 1 and 2). Trikafta belongs to a class of drugs called CFTR modulators.It is designed for people with cystic fibrosis (CF) who have at least one of 178 different mutations in their CFTR (cystic fibrosis transmembrane conductance regulator) gene. For individual mutations, the magnitude of the net change over baseline in CFTR-mediated chloride transport in vitro is not correlated with the magnitude of clinical response. These are not all the possible side effects of Trikafta. Tezacaftor has a low potential to inhibit BCRP, OCT2, OAT1, or OAT3. In Trial 1, the incidence of maximum total bilirubin elevation >2 × ULN was 4% in Trikafta-treated patients and <1% in placebo-treated patients. Check your eligibility. Trikafta has not been studied in patients with severe hepatic impairment (Child-Pugh Class C), but the exposure is expected to be higher than in patients with moderate hepatic impairment. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Generic name: elexacaftor/tezacaftor/ivacaftor and ivacaftor Findings of convulsions and death were observed in juvenile rats that received a tezacaftor dose level of 100 mg/kg/day (approximately equivalent to 1.9 times the MRHD based on summed AUCs of tezacaftor and its metabolite, M1-TEZ). This book will support your growth as a biotechnology professional. Inform patients that abnormality of the eye lens (cataract) has been noted in some children and adolescents receiving ivacaftor-containing regimens. The in vitro CFTR chloride transport response threshold was designated as a net increase of at least 10% of normal over baseline because it is predictive or reasonably expected to predict clinical benefit. Potential for Elexacaftor, Tezacaftor and/or Ivacaftor to Affect Other Drugs. Co-administration of fluconazole increased ivacaftor AUC by 2.9-fold. Two-year studies were conducted in CD-1 mice and Sprague-Dawley rats to assess the carcinogenic potential of ivacaftor. Trikafta (elexacaftor/tezacaftor/ivacaftor), the first triple combination therapy to treat cystic fibrosis, gained FDA approval on Monday (October 21). Tezacaftor and its metabolite, M1-TEZ, are substrates for P-glycoprotein. GoodRx coupon price. CF will always be part of the equation, but you know there’s more to who you are. Always take TRIKAFTA with a meal or snack that contains fat to help your body absorb the medicine. Study published in NEJM shows breakthrough drug can benefit more people with cystic fibrosis. Trikafta Generic Name(s): elexacaftor-tezacaftor-ivacaft . We comply with the HONcode standard for trustworthy health information. Do not drive a car, use machinery, or do anything that needs you to be alert until you know how SYMDEKO affects you, Avoid food or drink that contains grapefruit while you are taking SYMDEKO, Vertex GPS™: Guidance and Patient Support, Trilandia Adventures: Resources for You and Your Child, You can view the list of eligible TRIKAFTA mutations here, You can view the list of eligible mutations here, antibiotics such as rifampin (RIFAMATE®, RIFATER®) or rifabutin (MYCOBUTIN®), seizure medicines such as phenobarbital, carbamazepine (TEGRETOL®, CARBATROL®, EQUETRO®), or phenytoin (DILANTIN®, PHENYTEK®), are pregnant or plan to become pregnant. TRIKAFTA is for people age 6 years and older with at least one F508del mutation or at least one other mutation in the CF gene that is responsive to TRIKAFTA. Decreased fetal body weights were observed at a maternally toxic dose that produced exposures 5 times the MRHD (based on summed AUCs of ivacaftor and its metabolites). TRIKAFTA is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or another mutation that is responsive to treatment with TRIKAFTA. Deepika Polineni, M.D., MPH, co-led a study showing that Trikafta can provide additional benefit for CF patients who have genetic mutations that made them eligible for previously approved CFTR modulators. Check your eligibility. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The Medicare program enables millions of beneficiaries to obtain health care services; however, lacks many of the essential elements of a high-quality, high-value and efficient health system. Trial 2 evaluated 107 patients with CF aged 12 years and older (mean age 28.4 years). This volume will consider one of ICH’s major categories, Safety i.e. topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Avoid or Use Alternate Drug. We comply with the HONcode standard for trustworthy health information. Trial 1 was a 24-week, randomized, double-blind, placebo-controlled study in patients who had an F508del mutation on one allele and a mutation on the second allele that results in either no CFTR protein or a CFTR protein that is not responsive to ivacaftor and tezacaftor/ivacaftor. How unique is the name Trikafta? Elexacaftor, tezacaftor, and ivacaftor are excreted into the milk of lactating rats (see Data). In Protein Tyrosine Kinases: From Inhibitors to Useful Drugs, leading researchers from the Novartis group that pioneered Gleevec/GlivecTM and from around the world comprehensively survey the state-of-the-art in the drug discovery processes ... Last updated by Judith Stewart, BPharm on June 10, 2021. Other medicinal products for which exposure may be increased by Trikafta include glimepiride and glipizide; these medicinal products should be used with caution [see Clinical Pharmacology (12.3)]. Food or drink containing grapefruit should be avoided [see Dosage and Administration (2), Warnings and Precautions (5), Drug Interactions (7) and Clinical Pharmacology (12.3)]. In a PPND study in pregnant rats dosed from gestation Day 6 through lactation Day 18, tezacaftor had no adverse developmental effects on pups at an exposure of approximately 1 time the MRHD (based on summed AUCs for tezacaftor and M1-TEZ at a maternal dose of 25 mg/kg/day). All other trademarks referenced herein are the property of their respective owners. It is not known if SYMDEKO passes into your breast milk. Trikafta consists of 2 different tablets. TRIKAFTA can cause serious side effects, including: Your doctor may do blood tests to check the liver more often if you have had high liver enzymes in your blood in the past. Examples include food prepared with butter or oils or those containing eggs, cheeses, nuts, whole milk, or meats Food or drink containing grapefruit should be avoided during treatment with TRIKAFTA Tablets are not actual size. Trikafta Generic Name: elexacaftor, ivacaftor, and tezacaftor (e LEX a KAF tor, EYE va KAF tor, and TEXZ a KAF for) This book traces Napoleon's victory over Prussia in 1806 and Prussia's effort to recover from defeat to show how in one particular historical episode operational analyses together with institutional and political decisions eventually turned ... Liver function tests should be closely monitored in patients with mild and moderate hepatic impairment. You and your doctor should decide if you will take TRIKAFTA while you are pregnant, are breastfeeding or planning to breastfeed. Generic Name & Formulations: Elexacaftor, tezacaftor, ivacaftor 100mg/50mg/75mg; with ivacaftor 150mg; tabs. Although other risk factors were present in some cases (such as corticosteroid use, exposure to radiation), a possible risk attributable to treatment with ivacaftor cannot be excluded. FDA Approved: Yes (First approved October 21, 2019) The Social Services Program Specialist Passbook(R) prepares you for your test by allowing you to take practice exams in the subjects you need to study. Fixed-dose combination containing elexacaftor 50 mg, tezacaftor 25 mg, and ivacaftor 37.5 mg co-packaged with ivacaftor 75 mg: Fixed-dose combination containing elexacaftor 100 mg, tezacaftor 50 mg, and ivacaftor 75 mg co-packaged with ivacaftor 150 mg: Elevated transaminases have been observed in patients with CF treated with Trikafta. Each tablet is debossed with "T100" on one side and plain on the other. Trial 1 evaluated 403 patients (200 Trikafta, 203 placebo) with CF aged 12 years and older (mean age 26.2 years). TRIKAFTA, the TRIKAFTA logo, Vertex, and the Vertex triangle logo are registered trademarks of Vertex Pharmaceuticals Incorporated. Its chemical name is 1-(2,2-difluoro-2H-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl}cyclopropane-1-carboxamide. Elexacaftor alone or in combination with tezacaftor and ivacaftor has not been studied in subjects with severe hepatic impairment (Child-Pugh Class C, score 10-15). Vertex GPS™: Guidance and Patient Support. The drug is approved to treat patients 12 and older who have at least one F508del genetic mutation, which is estimated to affect about 90% of the CF population, or about 27,000 people in the United States, according to FDA. Each tablet is debossed with "T50" on one side and plain on the other. Lower male and female fertility, male copulation and female conception indices were observed in males at 75 mg/kg/day and females at 35 mg/kg/day, equivalent to approximately 6 times and 7 times, respectively, the MRHD (based on summed AUCs of elexacaftor and its metabolite). Ivacaftor/Strong CYP3A4 Inducers Interactions . Found inside – Page 145... modulators □ elexacaftor/tezacaftor/ivacaftor and ivacaftor (Trikafta) □ Correct problems with the CFTR protein ivacaftor (Kalydeco) □ that ... Medication examples presented in alphabetical order as “generic name (Brand Name). In an EFD study in pregnant rabbits dosed during the period of organogenesis from gestation Days 7-20, elexacaftor was not teratogenic at exposures up to 4 times the MRHD (based on AUC of elexacaftor at maternal doses up to 125 mg/kg/day). Trikafta should be taken with fat-containing food. Oral administration of ivacaftor to pregnant rats and rabbits during organogenesis demonstrated no teratogenicity or adverse developmental effects at doses that produced maternal exposures up to approximately 5 and 14 times the exposure at the MRHD, respectively [based on summed AUCs of ivacaftor and its metabolites (for rat) and AUC of ivacaftor (for rabbit)]. The generic ingredient in TRIKAFTA (COPACKAGED) is elexacaftor, ivacaftor, tezacaftor; ivacaftor. When used concomitantly with digoxin or other substrates of P-gp with a narrow therapeutic index such as cyclosporine, everolimus, sirolimus and tacrolimus, caution and appropriate monitoring should be used [see Clinical Pharmacology (12.3)]. Trikafta is a combination drug that includes three different drugs: elexacaftor, tezacaftor, and ivacaftor. The mean ppFEV1 at baseline, following the 4-week open-label run-in period with tezacaftor/ivacaftor was 60.9% (range: 35.0%, 89.0%). Trikafta . You are encouraged to report side effects to FDA at 1-800-FDA-1088. CI = Confidence interval; ELX= elexacaftor; TEZ = tezacaftor; IVA = ivacaftor; PK = Pharmacokinetics, ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h, Number of pulmonary exacerbations from baseline through Week 24, Absolute change in sweat chloride from baseline through Week 24 (mmol/L), Absolute change in CFQ-R respiratory domain score from baseline through Week 24 (points), Absolute change in BMI from baseline at Week 24 (kg/m, Absolute change in sweat chloride from baseline at Week 4 (mmol/L), Absolute change in CFQ-R respiratory domain score from baseline at Week 4 (points), (4 wallets, each wallet containing 14 tablets of elexacaftor, tezacaftor and ivacaftor and 7 tablets of ivacaftor). It is not known if SYMDEKO is safe and effective in children under 6 years of age. Last updated on June 1, 2021. People with cystic fibrosis (CF) may be eligible if they are 6 years and older with at least one F508del mutation or at least one other mutation that is responsive to TRIKAFTA. Figure 1: Absolute Change from Baseline in Percent Predicted FEV1 at Each Visit in Trial 1. Elevations in bilirubin have also been observed with Trikafta treatment. Elexacaftor is a white solid that is practically insoluble in water (<1 mg/mL). F.I.S. Found insideThis book outlines the most updated clinical guidelines that are vital for the prevention infections and care of patients with joint infections following a replacement surgery, one of the highest volume medical interventions globally. No dose adjustment is recommended for patients with mild hepatic impairment (Child-Pugh Class A, score 5-6). 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