This summary of the RMP for ORKAMBI should be read in the context of all this information including the assessment report of the evaluation and its plain-language summary, all which is part of the European Public Assessment Report (EPAR). Licensing protects the health, safety and rights of those receiving services by requiring that providers meet minimum standards of care and physical environment. Prescriber Checkup. According to the manufacturer, Kalydeco and Orkambi can be dosed up to a maximum daily dose at the interval(s) as indicated in the table below. ... herein is not sufficient to make a benefit determination or requires clarification and I agree to provide any such information to the insurer. "Lumacaftor and Ivacaftor". CLINICAL EFFICACY SUMMARY CFTR Modulators You can add location information to your Tweets, such as your city or precise location, from the web and via third-party applications. Sources: www.fda.gov and Orkambi prescribing information Articles from Pharmacy and Therapeutics are provided here courtesy of MediMedia, USA Complete/review information, sign and date. Cystic fibrosis is an inherited disease that has severe effects on the lungs and the digestive system. 3. Fax signed forms to Aetna Better Health of West Virginia at 1-855-799-2555. A menudo tienen una mejor calidad de vida que la que tenían las personas con fibrosis quística en décadas anteriores. In the U.S., because of newborn screening, cystic fibrosis can be diagnosed within the first month of life, before symptoms develop. Clinical Information Requests for Kalydeco: 1. ORKAMBI (WV88) This fax machine is located in a secure location as required by HIPAA regulations. the prescribing information. But people born before newborn screening became available may not be diagnosed until the signs and symptoms of CF show up.. Cystic fibrosis signs and symptoms vary, depending on the severity of the disease. Serious and most common side effects are listed here, along with additional safety considerations. 03/09/2016 Added coverage for Orkambi 04/06/2017 Changed age for Kalydeco to 2 yrs and older and for Orkambi to 6 yrs and older 10/03/2017 Added genetic mutations E56K, K1060T, P67L, Does the beneficiary have a documented mutation in the CFTR gene that is responsive to ivacaftor? To prevent pregnancy while using Orkambi , use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge. F508del. When conditions are met, we will authorize the coverage of Orkambi (Medicaid). It may not always contain all the information necessary for prescribing, dispensing, or administration. FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE ORKAMBI is a combination of lumacaftor and ivacaftor indicated for the treatment of cystic fibrosis (CF) in … Please refer to the Preferred Drug List (PDL) when prescribing for our members. ORKAMBI dose to 1 tablet daily ( lumacaftor 200 mg/ivacaftor 125 mg total daily dose) for the first week of treatment. See full prescribing information for CAYSTON. Sources: www.fda.gov and Orkambi prescribing information Articles from Pharmacy and Therapeutics are provided here courtesy of MediMedia, USA Complete/review information, sign and date. If the information you need is not available, call Provider Services at 1-844-325-6251. This medicine is authorised for use in the European Union. Orkambi is a medicine used to treat cystic fibrosis in patients aged 2 years and above. Cystic fibrosis is an inherited disease that has severe effects on the lungs and the digestive system. View a list of Authorized Specialty Pharmacies and Distributors for SYMDEKO®, ORKAMBI®, KALYDECO® and TRIKAFTA®. 2 of 15 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE ORKAMBI is a combination of lumacaftor and ivacaftor indicated for the treatment of cystic fibrosis (CF) in patients age 12 years and older who are homozygous for Has a diagnosis of cystic fibrosis AND 2. an inherited disorder that causes severe damage to the lungs, digestive system and other organs in the body. For the full list of excipients, see section 6.1. a physical exam, review your symptoms and conduct several tests. Product details on treatment with ORKAMBI, including how to take it, how it works, study results, and possible side effects. Please see full prescribing information for ORKAMBI available at www.ORKAMBI.com. Common side effects of Orkambi include sore throat and stuffy nose, nausea, diarrhea, upper respiratory tract infection, fatigue, increased blood creatine phosphokinase, rash, gas, runny nose, flu symptoms, menstrual changes, and increased blood pressure. KALYDECO®, the KALYDECO logo, ORKAMBI®, the ORKAMBI logo, SYMDEKO®, the SYMDEKO logo, TRIKAFTA®, and the TRIKAFTA … Summary of Efficacy in Trial 2 LS = least squares ORKAMBI Placebo. Following this period, continue with the Please click here to see the full Prescribing Information for ORKAMBI. MedlinePlus. See Important Safety Information and full Prescribing Information. • Beneficiary is age 6 or greater and • Beneficiary is documented as homozygous for the F508del mutation in the CFTR gene. * Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQ), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products). Orkambi is a combination of two drugs, lumacaftor and ivacaftor (Kalydeco) and is used for treating cystic fibrosis.Cystic fibrosis (CF) is an inherited disease that affects the secretory glands, including the mucus and sweat glands. • Utilized … Orkambi – FEP MD Fax Form Revised 4/9/2021 Send completed form to: Service Benefit Plan … For further information, please see full Prescribing Information, including Patient Information. ... Novartis’ Promacta, Vertex’s Kalydeco, Orkambi, Symdeko and Trikafta, and nine development-stage product candidates. Watch videos of patients, get recipes, and download educational resources. About Vertex. For further information, please see full Prescribing Information, including Patient Information. Drug Trials Snapshots: breaking down the what, how and why. The domain orkambihcp.com uses a Commercial suffix and it's server(s) are located in N/A with the IP number 45.60.1.246 and it is a .com domain.. Nothing contained on the Website shall be considered a recommendation, solicitation, or offer to buy or sell a security to any person in any jurisdiction. View information about the Vertex Guidance and Patient Support Program for SYMDEKO®, ORKAMBI®, KALYDECO® and TRIKAFTA®. 800 Delaware Avenue, Wilmington, DE 19801 Highmark Health Options is an independent licensee of the Blue Cross Blue Shield Association, an association of independent Blue Cross Blue Shield Plans. These are not all the possible side effects of KALYDECO. Information for healthcare providers on study results from Trials 1 and 2. For additional information regarding drug interactions, see full Prescribing Information. Sign up to receive email updates. It is also included in combination drugs, lumacaftor/ivacaftor and tezacaftor/ivacaftor, which are used to treat people with cystic fibrosis. Identification of the indicated genotype is required in order to receive treatment with one of thiese agents. For further information, please see full Prescribing Information, including Patient Information. Kalydeco 25mg granules Orkambi 200mg/125mg tablets Orkambi 100mg/125mg tablets ; Orkambi 150/188mg granules . and a CFTR potentiator (ivacaftor), which makes the CFTR protein at the cell surface function better because the chloride ion channel is open more often. Product details on treatment with ORKAMBI, including how to take it, how it works, study results, and possible side effects. Call your doctor for medical advice about side effects. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CAYSTON safely and effectively. NHS England has today announced it has secured a definitive agreement with Vertex Pharmaceuticals to make available all three of their UK-licensed cystic fibrosis medicines. See Important Safety Information and full Prescribing Information. For further information, please see full Prescribing Information, including Patient Information. (Prescribing information: Kalydeco 2019, Orkambi 2018, Pulmozyme 2018, Symdeko 2019, Trikafta 2019) • Information on indications, mechanism of action, pharmacokinetics, dosing, and safety has been obtained from the prescribing information for the individual products, except where noted otherwise. Talk to your doctor if you have any questions about the possible side effects of ORKAMBI. HIGHLIGHTS OF PRESCRIBING INFORMATION Liver-related events: Elevated transaminases (ALT/AST) have been These highlights do not include all the information needed to use observed in some cases associated with elevated bilirubin. These highlights do not include all the information needed to use 3 months during the first year of treatment, and annually thereafter. Provided by Alexa ranking, orkambihcp.com has ranked N/A in N/A and 1,500,765 on the world.orkambihcp.com reaches roughly 2,080 users per day and delivers about 62,407 users each month. Symptoms. Aunque la fibrosis quística es progresiva y requiere cuidados médicos diarios, las personas con fibrosis quística suelen ser capaces de estudiar y trabajar. Orkambi 200mg/125mg tablets Orkambi 100mg/125mg tablets Orkambi 150/188mg granules Orkambi 100/125mg granules 39008, 42366, 42848, 36937 Symdeko 50mg/75mg -75 mg tablets Symdeko 100/150 mg - 150 mg tablets 44444, 46553 . Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. Prior Authorization Lookup Tool . If you would like more information, talk with your doctor. these issues are found in the prescribing information. Sign up to receive email updates. Orkambi 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 ( F508del/F508del) in their CFTR gene. Orkambi should not be used in patients other than those who have two copies of the F508del mutation in their CFTR gene. ORKAMBI is a combination product that contains: a CFTR corrector (lumacaftor), which increases the amount of working CFTR at the cell surface. Has a documented genetic mutation as noted in the package labeling AND 3. Download the clinical brochure for ORKAMBI. "Elexacaftor, Tezacaftor, and Ivacaftor". By Ryann Grochowski Jones, Lena V. Groeger and Charles Ornstein, ProPublica, Updated February 2019 . Find information about insurance, co-pay, and reimbursement support in addition to educational resources. lumacaftor/ivacaftor (Orkambi®) SELF ADMINISTRATION - ORAL. ULN and bilirubin >2 times the ULN Interrupt treatment in patients with … Please click here to see the full Prescribing Information for ORKAMBI. *Sections or subsections omitted from the full prescribing information are not listed. Does the beneficiary have a diagnosis of cystic fibrosis? ☐ Yes ☐ No 4. Orkambi® (lumacaftor/ivacaftor) Orkambi® (lumacaftor/ivacaftor) may be considered medically necessary for the treatment of cystic fibrosis (CF): • In patients age 2 years and older AND • Homozygous for the F508del mutation in the CFTR gene AND • The patient does not have liver function tests (LFT) above 3X upper limit of normal (ULN) If the patient's genotype is unknown, an accurate and validated genotyping method should be performed to confirm the presence of the F508del mutation on both alleles of the CFTR gene. Age 2 to 5 years weighing < 14 kg: lumacaftor 200 mg/ivacaftor 250 mg (2 packets) per day; b. Consult your doctor before taking Orkambi if … To prevent pregnancy while using Orkambi , use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge. Orkambi received breakthrough and orphan drug designations and was approved through the priority review program. This guide does not contain a complete list of drugs; rather, it lists the preferred drugs within the most commonly prescribed therapeutic categories. NHS England concludes wide-ranging deal for cystic fibrosis drugs. Orkambi (Medicaid) This fax machine is located in a secure location as required by HIPAA regulations. essential information to healthcare professionals and patients on how ORKAMBI should be used.
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