− Keep this leaflet. If patient has been treated with a biologic or another therapy, please answer the following questions Excluding COSENTYX, does this patient have a contraindication, intolerance, or allergy to Cimzia®, Enbrel ®, Humira , Remicade ®, Simponi , Stelara ®, Taltz , or other biologic treatments, or to phototherapy, July 12, 2016 . Complete/review information, sign and date. 239280 READ THIS FOR SAFE AND EFFECTIVE US E OF YOUR MEDICINE . adalimumab. Humira (IL88) This fax machine is located in a secure location as required by HIPAA regulations. BOX 789 SAN BRUNO, CA 94066. Monitor all patients for active TB during treatment, even if initial . psoriatic arthritis (psa): previous trial of or contraindication to any two of the following preferred agents: humira, stelara, cosentyx, enbrel, tremfya, xeljanz. PATIENT MEDICATION INFORMATION . More specifically Humira is a tumor necrosis factor-α blocker, or TNF blocker. Please contact Aetna Better Health Illinois Medicaid at . latent TB test is negative. What it is used for. Risk of infection REMICADE is a medicine that affects your immune system. (select all that . Disclaimer. REMICADE can lower the ability of your immune system to fight infections. Humira is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments. 239280 READ THIS FOR SAFE AND EFFECTIVE US E OF YOUR MEDICINE . Ankylosing spondylitis (AS) in adults. preferred agents: humira, enbrel, xeljanz ir. Humira 40 mg solution for injection in pre-filled pen. Prior Authorization Form Revision date: 2/23/2021 Page 3 of 3--OR--14. The drug suppresses the immune system by blocking the activity of TNF. All patients recovered after treatment was stopped. patient was previously established on this drug, and is restarting after a break in therapy Please provide the dates your patient has received Taltz: Besides the drug being requested, other biological drugs include Actemra, Cimzia, Cosentyx, Enbrel, Entyvio, Humira, Ilumya, Inflectra, For detailed information on the use of Humira in all conditions, including when it can be used in children, see package leaflet or contact your doctor or pharmacist. Consumer medicine information (CMI) Reporting side effects. In addition to an indication for adults, recent major changes include indications and usage for pediatric Crohn's Disease. 1.2 Psoriatic Arthritis Patients with a low body weight (less than 65 kg), Asian, and female patients may have a higher risk of elevations in liver enzymes. 5-7 The reticence of physicians . (1.2).-----DOSAGE AND ADMINISTRATION----- Take one 150 mg tablet once monthlyon the same day each month(2.1) Instruct patient to: (2.2) o Swallow whole tablet with 6-8 oz of plain water only, at least . See full prescribing information, benefits and risks, including the BOXED WARNING. reported in children and adolescent patients treated with TNF blockers, of which HUMIRA is a member. It is important to use sunscreen and avoid prolonged sun exposure. MALIGNANCY (5.2) Lymphoma and other malignancies, some fatal, have been . Find essential HUMIRA forms and resources for your practice such as: enrollment and prescription forms as well as Humira Complete resources for your patients including savings cards, app, nurse ambassador. SELECTED SAFETY INFORMATION CUSTOMIZED INJECTION LOGGING & TRAINING. Anti-TNF drugs such as adalimumab block TNF and so reduce this inflammation. A yearly skin . HUMIRA is given by injection under the skin. You are encouraged to report negative side effects of prescription drugs to the FDA. HUMIRA is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab. Humira. Has the patient had a trial, intolerance, or contraindication to any of the following? What is the most important information I should know about REMICADE? Humira® (adalimumab) is a tumor necrosis factor (TNF) blocker. Please see full Terms and Conditions below. Has the patient had prior therapy with Cimzia (certolizumab pegol) within the last 365 days? No. If you received this document by mistake, please know that sharing, copying, distributing or using information in this document is against the law. indications. BLA 761024 The Complete App can help by providing resources that allow you to set reminders, track symptoms, and create personal goals that can support and encourage you throughout your treatment journey. UpToDate, electronic clinical resource tool for physicians and patients that provides information on Adult Primary Care and Internal Medicine, Allergy and Immunology, Cardiovascular Medicine, Emergency Medicine, Endocrinology and Diabetes, Family Medicine, Gastroenterology and Hepatology, Hematology, Infectious Diseases, Nephrology and Hypertension, Neurology, Obstetrics, Gynecology, and Women . For MAPD plans, Enbrel, Humira, Rinvoq, Skyrizi, and Xeljanz/Xeljanz XR are preferred. Preferred products vary based on indication. adalimumab. Please click here for the Full Prescribing Information and Medication Guide. Post-marketing cases of hepatosplenic T-cell . Yes . See the Enbrel (etanercept) "Instructions for Use" insert for detailed information on injection site selection and dose administration [see Dosage and Administration (2.3) and Patient Counseling Information (17)]. I affirm that the information given on this form is true and accurate as of this date. Is the requested drug prescribed for a patient with moderately to severely active ulcerative colitis? REMICADE may cause serious side effects, including: 1. INSTRUCTIONS FOR USE HUMIRA® (Hu-MARE-ah) (adalimumab) 40 MG/0.8 ML, 20 MG/0.4 ML AND 10 MG/0.2 ML SINGLE-USE PREFILLED SYRINGE Do not try to inject HUMIRA yourself until you have been shown the right way to give the injections and have read and understand this Instructions for Use. This is the most important information to know about HUMIRA. Has the patient had an inadequate response to methotrexate or another non-biologic DMARD administered at an adequate The information you get does not require you or your patient to use any Janssen product. Humira (adalimumab) is a biologic medicine that helps the pain and swelling of arthritis. 3 2. From 1 March 2022, two brands of adalimumab will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule, each with separate criteria for funding. Serious infections have happened in patients receiving REMICADE. condition. A few patients on Infliximab or Adalimumab have developed certain abnormal blood results and some symptoms (such as fever, weight loss, muscle or joint pain or a rash) that are found in patients with an immunological condition called systemic lupus erythematosus. − Keep this leaflet. From 1 February 2022, all people starting treatment with adalimumab for any funded indication would receive Amgevita. Patients now may pay $0 per INFLECTRA treatment for claims received by the program as of April 1, 2018 Eligible patients can receive assistance up to $20,000 per calendar year* *The co-pay program covers only drug costs, not procedures, administration fees, or office visits. AZA/6MP patient information June 2012 Adalimumab (Humira) in IBD Patient Information Leaflet General Information Adalimumab (also known as Humira) has been licensed by The National Institute for Clinical Excellence (NICE) for the treatment of severe Crohns disease. Does the patient meet either of the following criteria: A) Patient Information about your patient's insurance coverage, cost support options, and treatment support is given by service providers for Janssen CarePath. Yes . Do not use ORENCIA for a condition for which it was not prescribed. It is also approved for the treatment of psoriatic arthritis and ankylosing spondylitis, juvenile idiopathic arthritis, Crohn's disease, uveitis, and hidradenitis suppurativa. • For general cancer prevention, stopping smoking and taking skin cancer prevention measures are recommended. Rheumatoid Arthritis: Humira is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. Humira is used to reduce the signs and symptoms of moderately to severely active pJIA in patients 2 years of age and older. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. . The Complete App features personalized injection and symptom logging, medication reminders, and goal setting to support and encourage you throughout treatment. Enrollment form for HUMIRA For any questions, or to register by phone, please call 1-866-848-6472. Humira is used to treat Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Juvenile Inflammatory Arthritis, Psoriasis, Crohn's Disease, and other types of arthritis.It may also be used to treat other diseases outside of rheumatology. HUMIRA is given by injection under the skin. You are encouraged to report negative side effects of prescription drugs to the FDA. Support Program 1 HUMIRA will be supplied in boxes of two units, in one of the following formats: Prescriber Information - To be completed by prescriber.Please print clearly. [If no, skip to question 16.] HUMIRA can be used alone or with certain other medicines. Reported infections include: • Active tuberculosis (TB), including reactivation of latent TB. Read all of this leaflet carefully before you start using this medicine because it contains important information for you. patient information to be completed by patient application for humira® (adalimumab) d-617927, ap5 ne; 1 n. waukegan rd north chicago, il 60064 phone: 1-800-222-6885 fax: 1-866-250-2803 5 patient information patient name: dob: sex: m f 14. 1-4 While immunization significantly mitigates these risks, vaccination rates in patients with immune-mediated diseases (IMDs) treated with immunosuppressants remain suboptimal, primarily due to the absence of physician recommendations. Humira is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments. It usually affects the skin folds, such as the underarms, buttock crease, and groin area. Yusimry is expected to launch on or after July 1, 2023. Credit: Getty Images . Cardinal Health is committed to supporting our customers with education and information to If you are not the intended recipient, please notify the sender immediately. For patients taking anti-resorptive drugs for the treatment of osteoporosis or other non-malignant diseases of bone, the risk of developing this side effect is between 1 in 1000 and 1 in 10,000. Information on Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) Postmarket Drug Safety Information for Patients and Providers ©2021 AbbVie H-APP2-21K-1 noviembre 2021 Solicitud para HUMIRA® (adalimumab) myAbbVie Assist provee medicamentos gratuitos a pacientes que califican. A time period of 5 years from previous cancer has been suggested. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Kaiser Permanente Health Plan of Mid-Atlantic States, Inc. PRESCRIBER CERTIFICATION: I certify that the above therapy is medically necessary and that the information provided is accurate to the best of my knowled ge.I certify that I am the prescriber who has prescribed HUMIRA to the previously identifi ed patient and that I provided the patient with a description of the HUMIRA Complete patient support program. Yes . Discontinue HUMIRA if a patient develops a serious infection or sepsis. renewal: ra, pjia, psa: patient continues to benefit from the medication. Enbrel® ® Humira Methotrexate Otezla . Patients with TB have frequently presented with disseminated or extrapulmonary disease. Has the patient ever received (including current utilizers) a biologic (e.g., Humira) or targeted synthetic disease-modifying antirheumatic drug (DMARD) indicated for active articular juvenile idiopathic arthritis? Fax signed forms to Aetna Better Health Illinois Medicaidat 1-855-684-5250. HUMIRA Product Monograph Page 140 of 192 Date of Revision: April 21, 2021 and Control No. Patient Assistance Application for HUMIRA® (adalimumab) The AbbVie Patient Assistance Foundation provides HUMIRA at no cost to individuals who meet specific program eligibility criteria PLEASE COMPLETE ALL SECTIONS, SIGN, AND FAX THIS FORM TO 1-866-250-2803 OR MAIL TO: ABBVIE PATIENT ASSISTANCE FOUNDATION P.O. Enrollment Form Phone: 1.800.4HUMIRA (1.800.448.6472) Fax: 1.866.980.1066 The HCP and the patient or legally authorized person should complete this form before leaving the office. . greater than or equal to 3 times ULN was observed for 4.9% of patients in the OFEV group and for 0.7% of patients in the placebo group [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use HUMIRA safely and effectively. Typically, patients must have an inadequate response to conventional medications to be considered for biologics. HUMIRA® (adalimumab) Patient Assistance Application The Abbott Patient Assistance Foundation provides HUMIRA at no cost to individuals who meet specific program eligibility criteria Please see full Prescribing Information available at www.humira.com or by calling Abbott Medical Information at 1-800-633-9110. It works to improve such symptoms as joint swelling, pain, fatigue, and morning stiffness. You may need to read it again. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities. You may need to read it again. Please see the Full Prescribing Information, including the Medication Guide, for HUMIRA. PATIENT MEDICATION INFORMATION . If you have any questions or concerns with the Complete App, or you need to report medication side effects or adverse events, call 1.800.4HUMIRA (1.800 . New patients. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Please complete the cardholder portion, and have the prescribing physician complete the physician portion and submit this completed form. The black needle cover for the HUMIRA Pen 80 mg/0.8 mL, HUMIRA 80 mg/0.8 mL prefilled syringe, HUMIRA Pen 40 mg/0.4 mL, HUMIRA 40 mg/0.4 mL prefilled syringe, HUMIRA 20 mg/0.2 mL prefilled syringe, HUMIRA 10 mg/0.1 mL prefilled syringe and the vial stopper on the HUMIRA institutional use vial are not made with natural rubber or latex. Office use only: Humira_Comm_2019Mar-W . This would include patients who receive adalimumab treatment for newly funded uses and as a result of widened access. Humira is made by joining together DNA molecules. kinds of cancer in children and adult patients taking Humira or other TNF blockers. 15. In rheumatoid arthritis (room-a-toyd arth-rye-tus) and some other conditions, too much of a protein called TNF is produced in the body. − Keep this leaflet. 75-35829E 12/28/21 1 of 6 Dermatology Enrollment Form Medications A-C (Avsola, Cimzia) Six Simple Steps to Submitting a Referral ©2021 CVS Specialty and one of its affiliates. Test patients for latent TB before HUMIRA use and during therapy. HUMIRA ® (pronounced) < Hu- MEER-ah > adalimumab injection . FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Plaque Psoriasis COSENTYX® is indicated for the treatment of moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy. For more information, talk to your health care provider. Data sources include IBM Watson Micromedex (updated 6 Dec 2021), Cerner Multum™ (updated 1 Jan 2022), ASHP (updated 13 Dec 2021 . Immunosuppressive treatments dysregulate immunity and increase the risk of infections and associated morbidity and mortality. Package leaflet: Information for the patient . • Enthesitis-related arthritis (ERA) ERA is an inflammatory disease of the joints and the places where tendons join the bone. Discontinue HUMIRA if a patient develops a serious infection or sepsis. Humira (adalimumab) is a biologic medicine that helps the pain and swelling of arthritis. all fda-approved indications. PHI between these parties has been obtained. prior to starting HUMIRA. Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Humira. FDA Briefing Document . When Humira therapy is initiated, a loading dose of 40mg for patients < 30kg or 80mg for patients ≥30kg may be administered one week prior to the start of maintenance therapy.No clinical data are available on the use of a Humira loading dose in children <6years of age (see section 5.2). Humira is the first and only subcutaneous biologic treatment option for patients ages five and up with moderately to severely active ulcerative colitis. Certolizumab pegol is a drug that reduces the signs and symptoms of moderate to severe rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis, and Crohn's disease. Humira 40 mg solution for injection in pre-filled pen. HUMIRA® (adalimumab) injection, for subcutaneous use Initial U.S. Approval: 2002 WARNING: SERIOUS INFECTIONS AND MALIGNANCY Hepatitis C Enrollment Form Medications A-L (Epclusa, Harvoni, Ledipasvir/Sofosbuvir) Six Simple Steps to Submitting a Referral 1 PATIENT INFORMATION (Complete or include demographic sheet) Patient Name: _____Address: _____City, State, ZIP: _____ All fields marked with an asterisk (*) are required. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Humira is used to treat ERA in patients 6 years of age and older. Do not give ORENCIA to other people, even if they have the same symptoms that you have. HUMIRA ® (pronounced) < Hu- MEER-ah > adalimumab injection . Humira 20 mg solution for injection in pre-filled syringe. The brand name of certolizumab pegol is Cimzia®. Adalimumab is a drug that reduces the signs and symptoms of moderate to severe rheumatoid arthritis (RA), such as joint swelling, pain, and fatigue. Each patient is different, and the bumps may get better or worse over time. 6. Pharmac is proposing to widen funded access to adalimumab (Amgevita) for a range of uses. Member diagnosed with moderate to severe Crohn's disease or ulcerative colitis (UC) and has failed, intolerance to, Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. See full prescribing information for HUMIRA. For more information, talk to your health care provider. PATIENT COUNSELING INFORMATION _____ 3 FULL PRESCRIBING INFORMATION WARNING: SERIOUS INFECTIONS AND MALIGNANCY SERIOUS INFECTIONS Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)]. The illustration below may help you visualise what this means for you. Package leaflet: Information for the patient. Patient Counseling 17.2 Instruction on Injection Technique * Sections or subsections omitted from the full prescribing information are not listed. Reference ID: 3632562 dn2504v9-proposed-humira-peds-crohns-2014-sep-22 Page 2 of 90 This means that from 1 March 2022, all prescriptions for adalimumab should clearly specify the brand that should be supplied. Cardinal Health has developed the below table to provide a quick snapshot of the Humira® biosimilar landscape to assist providers, pharmacists, and patients that will be tasked with navigating the dynamic landscape in 2023. Read all of this leaflet carefully before your child starts using this medicine because it contains important information. . joints. Humira ® HUMIRA Product Monograph Page 140 of 192 Date of Revision: April 21, 2021 and Control No. 17 PATIENT COUNSELING INFORMATION 17.1 . The Food and Drug Administration (FDA) has approved Yusimry™ (adalimumab-aqvh), a biosimilar to Humira . With new indications being added for AbbVie products, your Complete App keeps you in the know of what HUMIRA, RINVOQ, and SKYRIZI can do for you. patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy, including corticosteroids and/or immunosuppressants. HUMIRA® (adalimumab) Patient Assistance Application The Abbott Patient Assistance Foundation provides HUMIRA at no cost to individuals who meet specific program eligibility criteria Please see full prescribing information available at www.humira.com or by calling Abbott Medical Information at 1-800-633-9110. General information about the safe and effective use of ORENCIA. CONSENT INFORMATION AND PATIENT DISCLOSURE (to be completed by the patient) HUM/4344A - April 2019 Please fax the completed form to 1-866-270-1727. It is what's known as a biologic. It has recently failed to get NICE clearance for use in Ulcerative . Test patients for latent TB before HUMIRA use and during therapy. Humira is used to treat Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Juvenile Inflammatory Arthritis, Psoriasis, Crohn's Disease, and other types of arthritis.It may also be used to treat other diseases outside of rheumatology. SYCAMORE Patient Information Leaflet November 2015 Adalimumab has effects on the immune system (the body's own defence system) and therefore may make you more likely to develop infections. For detailed information on the use of Humira in all conditions, including when it can be used in children, see package leaflet or contact your doctor or pharmacist. It may harm them. Because the information we give you comes from outside You should tell your doctor straight away if you develop any of the following: A sore throat A fever They develop chickenpox. Adalimumab is a type of drug known as a biological therapy. Hidradenitis suppurativa (HI-drad-en-I-tis sup-per-ah-TEE-vah or HS) is a chronic condition of painful bumps and draining sores of the skin. Arthritis Advisory Committee Meeting . This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 12/2020 cp-125611v8 1-866-212- 2851. with questions regarding the prior authorization process. adalimumab. The optimal duration of use has not been determined.For patients at low-risk for fracture, consider drug discontinuation after3 to 5 years of use. Package leaflet: Information for the patient. For more information, go to www.stelarainfo.com or call 1-800-JANSSEN (1-800-526-7736). Moderate to severe hidradenitis suppurativa (HS) in people 12 years and older. 40 mg/0.8 mL sterile solution (50 mg/mL) subcutaneous injection (Pre -filled syringe/Pen) Data sources. This causes inflammation, pain and damage to your joints. Irwin M. and Suzanne R. Rosenthal IBD Resource Center (IBD Help Center) 888-694-8872 •www.crohnscolitisfoundation.org 2 • Adalimumab-adbm (Cyltezo™) is a biosimilar to adalimumab (Humira®).It has been approved for the treatment of adult patients with moderately to severely active Crohn's disease or ulcerative colitis who have had an off label uses No . Has the patient had a tuberculosis (TB) test (e.g., tuberculosis skin test [PPD], interferon-release assay [IGRA], 40 mg/0.8 mL sterile solution (50 mg/mL) subcutaneous injection (Pre -filled syringe/Pen) Adult Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis Patients Information for prescribers. If Yes, skip to #8 Yes No 7. BLA 761024 AAC Brief ABP 501, a proposed biosimilar to Humira 1 . HUMIRA PRIOR APPROVAL REQUEST Additional information is required to process your claim for prescription drugs. Revisamos las solicitudes por caso individual. This is the most important information to know about HUMIRA. Hasthe patient ever received (including current utilizers) a biologic (e.g., Humira) or targeted synthetic DMARD (e.g., Olumiant, Xeljanz) associated with an increased risk of tuberculosis? You may need to read it again.
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