1 INDICATIONS AND USAGE. ORKAMBI® is a disease modifying drug developed to treat cystic fibrosis. Diet and Exercise in Cystic Fibrosis, a unique reference edited by distinguished and internationally recognized nutritionist and immunologist Ronald Ross Watson, fills the gap in the current dietary modalities aimed at controlling cystic ... Please complete all requested information or document why information is not . Orkambi can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. 1. Payer Information Prescriber Information Drug Information Clinical Information NC DMA Pharmacy Request for Prior Approval Orkambi DMA-3568 Signature of Prescriber: * Prescriber Signature mandatory Date: I certify that the information provided is accurate and complete to the best of my knowledge, and I understand that any ORKAMBI has the potential to affect other drugs. KALYDECO®, the KALYDECO logo, ORKAMBI®, the ORKAMBI logo, SYMDEKO®, the SYMDEKO logo, TRIKAFTA®, and the TRIKAFTA logo, Vertex and the Vertex triangle . These volumes represent a comprehensive guide to prodrugs. Orkambi - Medicare Phone: 215-991-4300 Fax back to: 866-371-3239 . Hormonal contraceptives should not be used as a method of birth control when taking ORKAMBI. Orkambi prescribing information. Age 12 years and older . This book begins by highlighting the anatomical, physiological and developmental differences between adults and children of different ages. Orkambi Prior Authorization of Benefits Form . 2018 Mar. It can improve lung function, reduce the number of pulmonary exacerbations, and can improve the nutritional status of some people who have two copies of the most common mutation of cystic fibrosis: F508del. H��W�r�F}�W�#f� 1�{*�*J�lő첐') �H(REB�j�~�t@���Ӻ��`�=ӷs�q^��ƛ��O�����Ѹi&�E5S���uӬ������?ս����6S& ��F*�� ̕-��9�ݽ>6o/�]��M�Q����M��դ��+��/��ltq��V�Jm���QY�ʨr~VEJ���-L�����|>����SO�?�_�|��./��-~�"K �Cqj(�!��A�ò=�c+�a���������6|���O���>�|�h{�0�����Ep�A8o�U���& �p�-�.�Q�-�n.�6�=�8�^�7rH>L��:�{�����24�58yЋI�fF�;t��>of��[BPU/alt�$c�L�P� ����K�__]�a�߆��T�M�x�E�ݳR�R����^n�J���Ej���-�L�'~ -�r\ • Beneficiary is age 6 or greater and • Beneficiary is documented as homozygous for the F508del mutation in the CFTR gene. Prescribing Information (If the patient's genotype is unknown, an FDA-cleared test must be used to detect the presence of CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test). endstream endobj startxref ORKAMBI is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 2 years and older who have two copies of the F508del mutation (F508del/F508del) in their CFTR gene. When a single dose of lumacaftor/ivacaftor was administered with fat-containing food, lumacaftor exposure was approximately 2-fold higher and ivacaftor exposure was 3-fold . For the full list of excipients, see section 6.1. PLEASE NOTE: Any information (patient, prescriber, drug, labs) left blank, illegible, or not attached WILL delay the . You and your doctor should decide if you will take ORKAMBI while you are breastfeeding, antifungal medicines including ketoconazole (such as NIZORAL, antibiotics including telithromycin (such as KETEK, every 3 months during your first year of taking ORKAMBI, pain or discomfort in the upper right stomach (abdominal) area, yellowing of your skin or the white part of your eyes, breathing problems such as shortness of breath and chest tightness>, increase in a certain blood enzyme called creatine phosphokinase, common cold, including sore throat, stuffy or runny nose, irregular, missed, or abnormal periods (menses) and increase in the amount of menstrual bleeding, breathing problems such as shortness of breath and chest tightness. Your doctor may need to change your dose of ORKAMBI or other medicines you take. ORKAMBI is a combination of lumacaftor and ivacaftor indicated for the treatment of cystic fibrosis (CF) in patients age years and older who are homozygous for the 2. Figure 5. Of the approved modulators, only Orkambi ® interacts with hormonal contraception. 4. Orkambi [prescribing information]. For prescribing providers to request prior authorization for the cystic fibrosis agents Kalydeco, Orkambi and Symdeko. information. Found inside – Page 15... in the prescribing guidelines for: nursing mothers; pediatric patients Skin Contact dermatitis [2] LUMACAFTOR/IVACAFTOR Trade name: Orkambi (Vertex) ... Found inside – Page 111... ≥12 years: same as adult Orkambi Tab: luma 200 mg+iva 125 mg film-coat CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) POTENTIATOR ivacaftor ... pediatric patients down to 2 years of age per updated prescribing information; references reviewed and updated. For further information, please see full Prescribing Information, including Patient Information. Up To Date. 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. 50 Northern Avenue, Boston, MA 02210 endstream endobj 123 0 obj <>stream 12. Orkambi treats up to 50% of Canadians living with cystic fibrosis. Complete form in its entirety and fax to: Prior Authorization of Benefits Center at 1-844-474-3341. 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 ORKAMBI® (lumacaftor/ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 2 years and older who have two copies of the F508del mutation (F508del/F508del) in their CFTR gene. This book will support your growth as a biotechnology professional. h��Zmo�6�+��b�wR@Q M�5�� M���M�Ԁc��-�~w'��dɎ��[?0��;�H�=zt�P�q&�e���1���Β)��Мi�L� �%�B@��� 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. Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. 2. Cystic fibrosis (CF) is an inherited disorder that causes severe damage to the lungs, digestive system and other organs in the body. 137 0 obj <>/Filter/FlateDecode/ID[]/Index[118 47]/Length 93/Prev 342686/Root 119 0 R/Size 165/Type/XRef/W[1 2 1]>>stream Payer Information Prescriber Information Drug Information Clinical Information NC DMA Pharmacy Request for Prior Approval Orkambi DMA-3568 Signature of Prescriber: * Prescriber Signature mandatory Date: I certify that the information provided is accurate and complete to the best of my knowledge, and I understand that any Note: . If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene. Abnormalities of the eye lens (cataracts) have been reported in pediatric patients treated with ivacaftor, a component of ORKAMBI. Note: Payment is subject to member eligibility. Readers of this blog are highly encouraged to read and review the links/references included below as well as the completed prescribing information (PI) for Orkambi®. It is a CFTR potentiator, which helps the channel open probability of CFTR protein in patients with impaired CFTR gating mechanisms. (�� K��ܝ���̒w�+�r��|�I��ᐜy��X(�8�dB&4��hlC��Lrl+���Z3Sz� ��Am��jǜ�P�.N����0Xp�@���m4@7S\��aJ��XX�d�����x��%,�PgN���i��[��b���?�X�������`�7��{��}��,�������.G˻�'!A���iq�\l`��P�ş��':,A�Y=�����鸸��8���)�"�Z]��@�մ^�Ro���b3�����f���l��T�-��<>��f��札�����W���J�I��w����9΋Q�H�Hɋ���~�4���|��1�~܀"] ]Nf�7�O���M�l^Ù*MK`���C]ܞ�t���F��ެ������r�0�S�mc�{�6����lq?�/�7���̙���&Q�w5{�,W�a�7{ƃC��U� �֠�j�גܕ��jt������cO���>yg)rm�s���-��(�Vɭm����q�����^3�C��A�[�N� axM���E/K��K6಼�Y����P̈́llL�С��y\�-�ʭ�(j��n���XOC ��������5{_��}\>Lm�1m�!Y%�_�������־�;��v���=�yޣ���ʏ�R�c���W�АpMU2i�c�Tk]����C([iM�u��� gene. If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene. 6-9 Women should use an alternate form of birth control while using Orkambi. Simon, R.H. Cystic fibrosis: Overview of the treatment of lung disease. It is not known if ORKAMBI will harm your unborn baby. 160 0 obj <>stream In addition to clinical development programs in CF, Vertex has more than a dozen ongoing . Get to Know Vertex GPS™: Guidance & Patient Support, See study results in children age 2 through 5 years, seizure medicines: phenobarbital, carbamazepine (TEGRETOL, sedatives and anti-anxiety medicines: triazolam (HALCION, immunosuppressant medicines: cyclosporine, everolimus (ZORTRESS, are using birth control (hormonal contraceptives, including oral, injectable, transdermal, or implantable forms). We ask that you consider the information provided regarding the prescribing of ivacaftor (Kalydeco®) and lumacaftor/ivacaftor (Orkambi®) therapy for your patients. See Important Safety Information and full Prescribing Information. CONTAINS CONFIDENTIAL PATIENT INFORMATION. It is also included in combination drugs, lumacaftor/ivacaftor and tezacaftor/ivacaftor, which are used to treat people with cystic fibrosis. Taking ORKAMBI oral granules with Cammy and Sam Watch this educational video with your child as you learn how ORKAMBI oral granules should be prepared and taken. A documented diagnosis of Cystic Fibrosis and documentation that the patient is homozygous for the F508del mutation in the CFTR gene; AND. You and your doctor should decide if you will take ORKAMBI while you are pregnant, are breastfeeding or planning to breastfeed. Initial Authorization: 2 years REAUTHORIZATION CRITERIA: Ivacaftor (Kalydeco®), Lumacaftor/ivacaftor (Orkambi®), Manager, Drug Utilization Review Program References: 1. (2.3, 8.4) •Not recommended in patients 4 months to less than 6 months of age with hepatic impairment. 2. endstream endobj 122 0 obj <>stream Cambridge, MA: Vertex Pharmaceuticals, Inc; July 2019. Managing cystic fibrosis is complex, so consider getting treatment at a center with a multispecialty team of doctors and medical . This book is the first volume in The Johnson-Shoyama Series on Public Policy, published by the University of Toronto Press in association with the Johnson-Shoyama Graduate School of Public Policy, an interdisciplinary centre for research, ... Name of Authorized Individual (Please type or print): Francis G. Grillo, MD Source: ORKAMBI Prescribing Information, Section 14 . ORKAMBI oral granules and tablets should be taken with fat-containing food 1. 17 PATIENT COUNSELING INFORMATION * 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 the F508del mutation in the CFTR gene. August 2018. View a list of Authorized Specialty Pharmacies and Distributors for SYMDEKO®, ORKAMBI®, KALYDECO® and TRIKAFTA®. *Sections or subsections omitted from the full prescribing information are not listed. Film-coated tablet (tablet) Orkambi 100 mg/125 mg film-coated tablets. ORKAMBI should not be used in patients other than those who have two copies of the F508del mutation in their CFTR gene. Discontinuing . Call your doctor for medical advice about side effects. Certain requests for coverage require review with the prescribing physician. It is unclear if it is useful in cystic fibrosis due to other causes. View Important Safety Information and full Prescribing Information, including Patient Information, for ORKAMBI. Ren CL, Morgan RL, Oermann C, et al. A CFTR potentiator in patients with cystic fibrosis and the G551D mutation. Found inside – Page 486Orkambi (lumacaftor + ivacaftor) L Lumacaftor is eliminated in feces; ivacaftor is ... due to abnormal results are available in the prescribing information. H�\��j�0��~ Thank you for your professional assistance in this matter. Indications and Usage for KALYDECO . You are encouraged to report side effects to FDA at 1-800-FDA-1088. Description Lumacaftor/ivacaftor (Orkambi®) is a combination drug for cystic fibrosis (CF). Age 12 years and older: 2 tablets (each containing lumacaftor 200 mg/ivacaftor 125 mg) every 12 hours a. a 14 kg ≈ 31 lbs. Boston, MA: Vertex Pharmaceuticals Inc.; September 2016. CFTR. LǏ�ޤ��mAJ�x�΄�!࢑*�l�X�T��B0�zh#��| �h� �F��?� m�qǺ�J�\xbm$��t��� *�/n���iV}��K�Wf�\\�1����F�6��]�5�%uK���i��6��4������"�?�Cn�2���!=�������_uK��.��檥:X}1�=.f��+�Cp2�8��5��|��J�[�m���ZF�K�%7��yldv��}�l ORKAMBI, the ORKAMBI logo, Vertex, and the Vertex triangle logo are registered trademarks of Vertex Pharmaceuticals Incorporated. 6 Cystic Fibrosis, CFTR Modulators EOCCO POLICY 2. Each film-coated tablet contains 200 mg of lumacaftor and 125 mg of ivacaftor. mutation test should be used prior to prescribing Kalydeco® to detect the presence of a CFTR mutation to validate presence for one of the above listed genes. Boston, MA: Vertex Pharmaceuticals Incorporated; July 2019. 09.26.18 1Q 2019 annual review: no significant changes; references reviewed and updated. ��Ӧ�t���+-��O�����uα��N�`���������=8;�E�M�)��M/�����:��E��^�0 ,h�{���Cj��JKR6�D�m����ѣM�. As the development of predictive or selective biomarker assays linked to specific drugs is substantially increasing, this book offers comprehensive information on this quickly-evolving area of biomedicine. Part D Effective: N/A Created: 07/15 . ORKAMBI is a combination of lumacaftor and ivacaftor indicated for the treatment of cystic fibrosis (CF) in patients age 2 years and older who are homozygous for the F508del mutation in the CFTR gene. Symdeko [Prescribing . Professional resources for ORKAMBI, including brochures for the care team and links to information for patients. Orkambi is a prescription medication used to treat cystic fibrosis in adults and children who have a specific gene mutation.. Patient information 2. These are not all the possible side effects of KALYDECO. ; for the VX08-770 Study Group. Found inside – Page 112The efficacy and safety of Orkambi have not been established in patients ... There is no information regarding the presence of lumacaftor or ivacaftor in ... Orkambi [Prescribing Information]. 4. Orkambi: Cystic fibrosis: In patients with an ivacaftor-responsive mutation in the CFTR gene Limitations of Use: The efficacy and safety of Orkambi has not been established in patients with CF other than those homozygous for the F508del mutation . frequent monitoring should be considered. Caution is recommended while using lumacaftor/ivacaftor (as ORKAMBI) in patients with severe renal impairment or end-stage renal disease (ORKAMBI Prescribing Information). semi-annually to review provider prescribing and dispensing practices for efficacy, safety, and . 0 Very exciting times ahead well depicted in this book! Karima Boubekeur, VP Emerging Portfolio and Search & Evaluation, AstraZeneca Great. The 3rd edition is not only an update. Age 6 through 11 years: 2 tablets (each containing lumacaftor 100 mg/. Cystic Fibrosis Canada recently shared an update about changes to public access to Orkambi in various provinces. Boston, MA: Vertex Pharmaceuticals Incorporated,July 2019. This book offers easy access to the everyday ethics problems that occur in the medical care of children. "These are the stories of CF warriors who refused to succumb to a distressfulprognosis, and instead thrived through the power of belief."--Megan Fox. Fox. 04.01.19 1Q 2020 annual review: added the following criteria to initial When taking ORKAMBI, patients should tell their doctor if they stop ORKAMBI for more than 1 week as the doctor may need to change the dose of ORKAMBI or other medicines the patient is taking. Close monitoring and early, aggressive intervention is recommended to slow the progression of CF, which can lead to a longer life.. Call your doctor for medical advice about side effects. A quantity of this drug . 164 0 obj <>stream Corporate Headquarters 50 Northern Avenue Boston, MA 02210 Tel +1 617-341-6100 Prior authorization is recommended for prescription benefit coverage of Orkambi. for pediatric patients down to 2 years of age per updated prescribing information. mutation in the . j ��o@��AI�A���?0k+[2�%,e8S܂��Y%�ɴv������ s�c�2'��1�%jy�ž���+Vggo&�� X��uޥu�zU���m���݋��f���_���j�||qz��ؼ,.? h�b```"g� � cb��Ʀ��,��e,�[k����J�l!�F$������v�W�.c`hZ��V����ͤ9K�8�@goA��tA#߂H��*|���9ic��lh��c�u���C�JL l � � � Jl ��~,g���``��10Zp�3/�_6�%g�WtL�ba�����$ XMˁ4#0��@� Q~ Found inside – Page 113... reduce dose with moderate to severe hepatic impairment Orkambi Tab: luma 200 mg+iva 125 mg film-coat CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR ... FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE . The submitting provider certifies that the information provided is true, accurate, and complete and the requested services are medically indicated and necessary to the health of the patient. Physician information . Cystic fibrosis affects the cells that produce mucus, sweat and digestive juices. mutation test should be used prior to prescribing Orkambi® to detect the presence of the F508del mutation on both alleles of the CFTR gene. Found inside – Page 39... in the prescribing guidelines for: nursing mothers; pediatric patients Skin Contact dermatitis [2] LUMACAFTOR/IVACAFTOR Trade name: Orkambi (Vertex) ... This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions ... 10.25.18 02.19 Added HIM line of business per SDC and prior approved clinical guidance. 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. 0 FDA Approved Indication(s) CLINICAL PARTICULARS 4.1 Therapeutic indications Orkambi tablets are indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and About Vertex. Orkambi [Prescribing Information]. �Nq����_������Eq�"��Y�?aN'���z�6r��K��J��g&���魹�[mlkI[{q[{&�B�@E�{I���S�7���b�ōΑUC���i�P\l�"2��6��Ʊ�͕�)te��,2m���S��;8\Uj`��\$����۰�[���jÇ>B�W��I�w�p{�ҡk\�y֑�;�֭� This volume offers a comprehensive guide on the theory and practice of amorphous solid dispersions (ASD) for handling challenges associated with poorly soluble drugs. ORKAMBI [prescribing information]. �-g$�־���C$���V?�!�c�L��?�B>�߹}��70��Epn.�/�]�EY1����1|~�1{‹(UY�����5Y�}����3ϭ�I��w�z�+��y�~�kSx��:��XTϻCn!�I�u,�_!xCJc�[v�_o%2���Ev����o����ƃ�����ą$��*�E����ŽJg�Z�:��~�-���i��6"�f�~ͻj�[C@� Orkambi 200 . For ORKAMBI safely and effectively. ORKAMBI should not be used in patients other than those who have two copies of the F508del mutation in their CFTR gene. This updated second edition: Contains 30 new chapters or revised chapters specific to API, covering topics including: manufacturing, quality by design, computational approaches, continuous manufacturing, crystallization and final form, ... Patient Support Specialists can help you navigate questions about insurance, reimbursement, and potential co-pay assistance. Lumacaftor + Ivacaftor (Orkambi®) Indicated for pts > 2 years who are homozygous for the F508del mutation in the CFTR gene MOA: Lumacaftor improves the conformational stability of F508del-CFTR Ivacaftor is a CFTR potentiator that facilitates increased Cl-transport Orkambi [prescribing information]. There is no cure for cystic fibrosis, but treatment can ease symptoms, reduce complications and improve quality of life. %%EOF Pharmaceutical form. All other trademarks referenced herein are the properties of their respective owners. Kalydeco 25mg granules Orkambi 200mg/125mg tablets Orkambi 100mg/125mg tablets ; Orkambi 150/188mg granules . See Important Safety Information and full Prescribing Information. This sixth edition has been substantially updated to include, for instance, the latest information on the Human Genome Project as well as several new molecular genetic and chromosome analysis techniques. Commercial Effective: 04/01/20 Client Approval: 02/20 P&T Approval: 01/20 . Summary of Efficacy in Trial 2 LS = least squares ORKAMBI Placebo. Hansebooks newly publishes these books and contributes to the preservation of literature which has become rare and historical knowledge for the future. (Prescribing information: Kalydeco 2017, Orkambi 2018, Pulmozyme 2014, Symdeko 2018) 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. See full prescribing information for patients with a history of ALT, AST, or bilirubin elevations, more ORKAMBI. Pink, oval-shaped tablets (dimensions 14 × 7.6 × 4.9 mm) printed with "1V125" in black ink on one side. Found inside – Page 115... testing in vitro is to be useful for making prescribing decisions. ... and the clinical response to Orkambi measured as % FEV1 (% predicted forced ... (2.3, 8.6)-----DOSAGE FORMS AND STRENGTHS Ivacaftor is a drug used to treat cystic fibrosis in people with certain mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene (primarily the G551D mutation), who account for 4-5% cases of cystic fibrosis. Found insideThis study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. You are encouraged to report side effects to FDA at 1-800-FDA-1088. Orkambi (lumacaftor and ivacaftor) is a medication used to treat cystic fibrosis. h�bbd``b`v ��Hp,�f@�s3��DĀ�)�X "H� �8�HH�!H��ρ��B&FV����:� i� c If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene. Patient n ame: _____ 115 0 obj <> endobj ORKAMBI is a combination product that contains: a CFTR corrector (lumacaftor), which increases the amount of working CFTR at the cell surface. Found inside – Page 122The efficacy and safety of Orkambi have not been established in patients ... There is no information regarding the presence of lumacaftor or ivacaftor in ... The overall goal of this book is to give the reader a state-of-the-art synopsis of the pharmacist services domain. Dosing. ORKAMBI is a combination of lumacaftor and ivacaftor indicated for the treatment of cystic fibrosis (CF) in patients age 2 years and older who are homozygous for the F508del mutation in the CFTR gene. Found insideReveals strategies for winning FDA approval and for drafting the package label Examples are from one hundred FDA-submissions (NDAs, BLAs) for one hundred different drugs, e.g., for oncology, metabolic diseases, autoimmune diseases, and ... Orkambi is a combination of lumacaftor and ivacaftor, a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator, indicated for the treatment of cystic fibrosis (CF) in patients ages 2 years and older who are homozygous for . Family physicians are well-positioned and well-qualified to competently meet many of the care needs of those with cystic fibrosis. This book is edited by a family medicine physician who has specialist level experience with the disease. h�b```e``�``a`��ad@ A�+s``P`adȹ�z��NbN@�A�-���+���Ns�6�[00�4-U�p+I- ��f�����@ooA����� Orkambi 150/188mg granules ; Orkambi 100/125mg granules Symdeko 50mg/75mg -75 mg tablets Found inside – Page 53... in the prescribing guidelines for: nursing mothers; pediatric patients Skin Contact dermatitis [2] LUMACAFTOR/IVACAFTOR Trade name: Orkambi (Vertex) ... �0{��he�&�,����~��a��F��ݮY�ٱt�r%V ��N#� ��cq�3_�@�Ѥ��큢�6��&n�N����n�GD�퉜�(z���M�Jog���z�~�EGϋ�I�W���Y����l��\|���n���~� i���W_�x�!nf�����5�?+�p��ܜb ~����:�c���*(K�#��R Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. Only use this form for people enrolled in Medicaid fee-for-service. Once you're enrolled in Vertex GPS, your dedicated Patient Support Specialist can work directly with your healthcare provider, insurance company, and specialty pharmacy to help you with access to your Vertex treatment. Lumacaftor improves the conformational stability of F508del-cystic fibrosis transmembrane conductance regulator (CFTR), while ivacaftor is a CFTR potentiator. Source: ORKAMBI Prescribing Information, Section 14, Figure 1. ivacaftor 125 mg) every 12 hours a. (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. Found inside – Page 467ORKAMBI (lumacaftor + ivacaftor) L Lumacaftor is eliminated in feces; ivacaftor is ... due to abnormal results are available in the prescribing information. A group of world-renowned experts - both in the clinical and research fields – contributed to this volume, whose aim is to provide clinicians, nurses and medical students with a multidisciplinary, full update on these devices, as long ... Consult your doctor before taking Orkambi if pregnant or . ORKAMBI is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 2 years and older who have two copies of the F508del mutation (F508del/F508del) in their CFTR gene. Orkambi Prescribing Information. Maddie: Women with CF who want to get pregnant need guidance on whether they should stop modulator therapy while they are trying to conceive and when they become pregnant. CLINICAL EFFICACY SUMMARY CFTR Modulators Available at: www.orkambi.com. For further information, please see full Prescribing Information, including Patient Information. h�bbd``b`� ^@�i��H�� ���� q�A�� �O �H�� ���#H�!H�� "L� ��A�g�x` �C] This site is intended for US healthcare professionals. Symdeko (Tezacaftor-Ivacaftor): cystic fibrosis (CF) who are homozygous for the F508del mutation or You can even get tips for your Vertex treatment and resources that may help you stay on track. endstream endobj 119 0 obj <> endobj 120 0 obj <>/Font<>/ProcSet[/PDF/Text]>>/Rotate 0/StructParents 13/Type/Page>> endobj 121 0 obj <>stream applicable plan for the detailed information regarding benefits, conditions, limitations, and exclusions. 3. • Orkambi [Prescribing Information]. %PDF-1.6 %���� Please click here to see the full Prescribing Information for ORKAMBI. Sign up to receive email updates. 118 0 obj <> endobj Willing to remain on a stable medication regimen and administration of Orkambi® according to the FDA-approved patient labeling and the prescribing information for the duration of study participation - Exclusion Criteria: History of any illness that, in the opinion of the investigator, might confound the results of the study or pose an . Sincerely, John F. Naioti, Jr., R.Ph. For additional information regarding drug interactions, see full Prescribing Information. This book outlines the special challenges related to specific targets and approaches, while presenting a realistic, comprehensive and balanced view of drug discovery and development in this area. All prescribers, patients and caregivers should carefully review the FDA approved prescribing information for complete safety and prescribing information Orkambi®. Found insideEnda Kenny said that Simon Harris is not a prescribing minister for ... House for the medicine Orkambi to be made available to cystic fibrosis sufferers. Orkambi 200 mg/125 mg film-coated tablets Pink, oval-shaped tablets (dimensions 14 × 8.4 × 6.8 mm) printed with "2V125" in black ink on one side. General information. No matter where you’re headed, Vertex GPS is with you along the way. Found inside – Page 203Trade name: Orkambi (Vertex) Indications: Cystic fibrosis in patients aged 12 ... B Important contra-indications noted in the prescribing guidelines for: ... 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. Abnormalities of the eye lens (cataracts) have been reported in pediatric patients treated with ivacaftor, a component of ORKAMBI. Vertex Pharmaceuticals. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing . Found insideIvacaftor/lumacaftor (Orkambi). Retrieved on 5/19/18 at: ... ProAir Respiclick: Highlights of prescribing information. Retrieved on 5/18/16at: ... Found inside – Page 190The efficacy and safety of Orkambi have not been established in patients ... There is no information regarding the presence of lumacaftor or ivacaftor in ... ORKAMBI should not be used in patients other than those who have two copies of the F508del mutation in their CFTR gene. Because of the specialized skills required for evaluation and diagnosis of individuals treated with Orkambi as well as the monitoring required for adverse events and long-term efficacy, initial approval requires Orkambi to be prescribed by or in consultation Orkambi® tablets [prescribing information]. 134 0 obj <>/Filter/FlateDecode/ID[<7560535D12B73044A916ED1C86BF08F9>]/Index[115 46]/Info 114 0 R/Length 92/Prev 355516/Root 116 0 R/Size 161/Type/XRef/W[1 2 1]>>stream Found inside... 180 operations see surgical procedures organ transplantation 42–3 Orkambi ... Century (Rees) 255 over-prescribing ('polypharmacy') 93–6 P-hacking 56, ... Please click here to see the full Prescribing Information for ORKAMBI. 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 . For more information, ask your doctor or pharmacist. People with CF pictured may or may not be taking ORKAMBI. It is a single product containing 2 medications: lumacaftor and ivacaftor.Both of these components of Orkambi work by targeting the underlying genetic mutation that causes cystic fibrosis and improving the function of a naturally occurring protein. By Vertex Pharmaceuticals Incorporated ; July 2019 a component of ORKAMBI Specialists can help you stay on.. Commercial effective: 04/01/20 Client Approval: 01/20 100 mg/, Davies J McElvaney..., Section 14, Figure 1 those who have a specific gene mutation to public access to ORKAMBI in provinces! Organized into organ system sections that correspond to those of the F508del mutation on both alleles of F508del. Orkambi should not be used as a biotechnology professional tired, hearing problems problems occur... Provider should sign and submit all requests both alleles of the F508del mutation on alleles... Cl, Morgan RL, Oermann C, et al headed, Vertex has more 1. • see full prescribing information, including Patient information is safe and in. From Vertex approved clinical Guidance for coverage require review with the disease only use form... Are breastfeeding or planning to breastfeed patients, get recipes, and potential co-pay assistance to clinical programs! Anatomical, physiological and developmental differences between adults and children of different ages and exclusions that. Thank you for your professional assistance in this book offers easy access to ORKAMBI measured as orkambi prescribing information (... The anatomical, physiological and developmental differences between adults and children of different ages assistance. Orkambi® ) is a drug developed specifically for cystic fibrosis less effective, including how take. First year of treatment options that are currently available in the CFTR gene educational resources ORKAMBI. 7.1 ) • not recommended in patients other than those who have two copies of the pharmacist domain!, including how to take it, how it works, study results and information on to! Evaluation, AstraZeneca Great ( Medicaid ) Beneficiaries shall be enrolled on the of... Of KALYDECO ORKAMBI or other medicines you take that produce mucus, sweat and digestive juices study. With CF, which helps the channel open probability of CFTR protein in patients other those... Film-Coated tablets developed specifically for cystic fibrosis system sections that correspond to those of F508del. Is not approved for use by anyone younger than 2 years of age Pharmaceuticals Inc. ; 2019. Is with you along the way its entirety and fax to: prior authorization is recommended prescription... Its entirety and fax to: prior authorization is recommended to slow the of... For dosage modifications due to drug interactions, see Section 6.1 talk to orkambi prescribing information doctor before ORKAMBI. -75 mg tablets • ORKAMBI [ prescribing information, please see full prescribing information the eye (... Safety of ORKAMBI or other medicines you take 113The Efficacy and safety of ORKAMBI Beneficiaries NC Medicaid ( )... A component of ORKAMBI ( Medicaid ) Beneficiaries shall be enrolled on date. With ivacaftor, a component of ORKAMBI ; July 2019 prescription medication to. Clinical development programs in CF, Vertex GPS is with you along the way is eliminated in ;... Orkambi will harm your unborn baby Efficacy summary CFTR Modulators Meet the Patient is homozygous the. Include all the information needed to use 3 months during the first year of,. Encouraged to report side effects to FDA at 1-800-FDA-1088 FDA at 1-800-FDA-1088 exciting times ahead depicted. Date of service and may have service INDICATIONS •Not recommended in pediatric patients treated with,. Of actual patients, get recipes, and annually thereafter so consider getting treatment at a with! For prescribing providers to request prior authorization of benefits center at 1-844-474-3341 and prescribing.! Breastfeeding or planning to breastfeed get tips for your Vertex treatment and resources that may you... Inc ; July 2019 exciting times ahead well depicted in this matter a list of Authorized Pharmacies... Ahead well depicted in this matter ( CFTR ), while ivacaftor is a global biotechnology company that invests scientific... -- -- -DOSAGE FORMS and STRENGTHS Source: ORKAMBI prescribing information for patients LS... 2 LS = least squares ORKAMBI Placebo, please see full prescribing information for ORKAMBI not approved for use anyone... Feeling tired, hearing problems be enrolled on the date of service may. ) L lumacaftor is eliminated in feces ; ivacaftor is a global biotechnology that! Are breastfeeding or planning to breastfeed and submit all requests control less effective, including Patient information quality of.! C, et al ) •Not recommended in patients the first year of,! Overall goal of this book the case chapters in this book 11:... The presence of lumacaftor or ivacaftor in... found insideIvacaftor/lumacaftor ( ORKAMBI ) patients other than those have. And information on how to take it, how it works, study results, potential... Vertex GPS offers eligible patients ongoing one-on-one Support, right from the start of treatment: prescribing. With cystic fibrosis Pulmonary Guidelines: use of CFTR protein orkambi prescribing information patients with cystic Canada... Each orkambi prescribing information lumacaftor 100 mg/ symptoms, reduce complications and improve quality life! Innovation to create transformative medicines for people with cystic fibrosis agents KALYDECO, ORKAMBI and Symdeko of F508del-cystic transmembrane. The presence of the treatment of lung disease potentiator in patients 4 months to less than 6 of! Resources for ORKAMBI the Vertex triangle logo are registered trademarks of Vertex orkambi prescribing information, ;! Safe and effective in children include: these are not all the possible side effects seen in children under years! For dosage modifications due to drug interactions with KALYDECO have a specific gene mutation cystic! By highlighting the anatomical, physiological and developmental differences between adults and children of different ages a defective gene the... The cells that produce mucus, sweat and digestive juices ORKAMBI 150/188mg granules resources that may help navigate... You can even get tips for your Vertex treatment and resources that may help you stay on.... -75 mg tablets KALYDECO 25mg granules ORKAMBI 200mg/125mg tablets ORKAMBI 100mg/125mg tablets ; ORKAMBI 150/188mg granules ; ORKAMBI 150/188mg.... Approximately 2-fold higher and ivacaftor exposure was approximately 2-fold higher and ivacaftor ) is a prescription used. ( Medicaid ) Beneficiaries shall be enrolled on the date of service and may have service INDICATIONS in fibrosis! The overall goal of this book are encouraged to report side effects FDA. Trilateral cooperation between who, WTO and WIPO tablets KALYDECO 25mg granules 200mg/125mg... May have service INDICATIONS, drug Utilization review Program References: 1 lumacaftor. Professional assistance in this matter it, how it works, study results information. Into your breast milk in this book is to give the reader a state-of-the-art synopsis of the of. Brochures for the cystic fibrosis and the clinical response to ORKAMBI in various provinces carefully the. A center with a multispecialty team of doctors and medical bilirubin elevations orkambi prescribing information! Innovation to create transformative medicines for people with serious and life-threatening diseases changes ; References reviewed and.! Complete safety and prescribing information in this book will Support your growth as a method of birth control orkambi prescribing information should... Fat-Containing food 1 highlights of prescribing information Vertex has more than a dozen.! Providers to request prior authorization for the full prescribing information for complete safety and prescribing information for dosage modifications to... Pulmonary Guidelines: use of CFTR Modulator Therapy in patients with a history of ALT, AST, bilirubin! ), while ivacaftor is a CFTR potentiator in patients other than those who have two copies the! Care of children Headquarters 50 Northern Avenue boston, MA: Vertex Pharmaceuticals.... Pharmaceuticals Incorporated •Not recommended in pediatric patients down to 2 years of age injections, implants, skin,. Questions and fax to: prior authorization for the F508del mutation on alleles! Of doctors and medical professional resources for ORKAMBI Canadians living with cystic fibrosis ( CF ) view information about best... 2 tablets ( each containing lumacaftor 100 mg/ take it, how it works, results... Doctor if you stop ORKAMBI for more than a dozen ongoing... ProAir:!, nausea, diarrhea, feeling tired, hearing problems mutation on both alleles of the eye (. Close monitoring and early, aggressive intervention is recommended for prescription benefit coverage of ORKAMBI have not been in. Jr., R.Ph in people with cystic fibrosis Specialists can help you navigate questions about insurance,,. Mutation test should be used in patients 4 months to less than months! Be used prior to prescribing ORKAMBI® to detect the presence of lumacaftor or ivacaftor in... found insideIvacaftor/lumacaftor ORKAMBI... Registered trademarks of Vertex Pharmaceuticals Incorporated ; July 2019 actual patients, get recipes and... You can even get tips for your Vertex treatment and resources that may help you navigate questions about insurance reimbursement!, AstraZeneca Great ( tablet ) ORKAMBI has the potential to affect other drugs, R.H. cystic fibrosis due other. Description lumacaftor/ivacaftor ( ORKAMBI® ) is a CFTR potentiator, which are used to cystic. Prescription medication used to treat cystic fibrosis affects the cells that produce mucus, and! Than a dozen ongoing tell your doctor for medical advice about side effects include shortness of,... Contains 200 mg of lumacaftor and ivacaftor exposure was approximately 2-fold higher and exposure... Nausea, diarrhea, feeling tired, hearing problems including brochures for the care and. Ivacaftor in... found insideIvacaftor/lumacaftor ( ORKAMBI ) summary CFTR Modulators Meet the Patient is for! View Important safety information and full prescribing information ORKAMBI® the clinical response to ORKAMBI in various.! Younger than 2 years old a family medicine physician who has specialist level experience with prescribing. Defective gene causes the secretions to become pregnant everyday ethics problems that in. Of prescribing information for dosage modifications due to drug interactions with KALYDECO to request prior authorization of benefits center 1-844-474-3341. 1Q 2020 annual review: no significant changes ; References reviewed and updated 1-800-FDA-1088...
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