5/31/2016
`
`Rasuvo® (methotrexate) injection and RA, pJIA, and psoriasis
`
`Important Safety Information
`()
`
`Sign Up
`
`For Healthcare
`Professionals (./HCP)
`
`Full Prescribing Information
`(http://cdn.rasuvo.com/assets/pdf/Prescribing-
`Information-July-2014.pdf)
`
`Patient Information
`(http://cdn.rasuvo.com/assets/pdf/Patie
`Information-July-2014.pdf)
`
`(http://www.rasuvo.com/)
`
`What is Rasuvo (methotrexate) injection?
`®
`Rasuvo (methotrexate) injection is a single‑dose auto‑injector containing a prescription medicine,
`®
`methotrexate. Methotrexate is used to:
`
`•
`
`•
`
`Treat certain adults with severe, active rheumatoid arthritis, and children with active polyarticular
`juvenile idiopathic arthritis (pJIA), after treatment with other medicines including non‑steroidal
`anti‑inflammatory (NSAIDS) have been used and did not work well.
`Control the symptoms of severe, resistant, disabling psoriasis in adults when other types of treatment
`have been used and did not work well.
`
`Rasuvo should not be used for the treatment of cancer.
`
`Rasuvo should not be used for the treatment of children with psoriasis.
`
`Rasuvo is available in doses of 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, and 30 mg. Your doctor will
`prescribe a different way to take methotrexate if you need to take methotrexate by mouth or in some
`other way.
`ABOUT RHEUMATOID ARTHRITIS
`Rheumatoid arthritis (RA) is a disease of the immune system—a network of cells, tissues, and organs
`that normally protect us from infection and disease. During RA, inflammation can lead to swelling, joint
`pain, and an inability to move or function normally.
`
`Treatment goals of RA
`
`The goals of RA treatment are to:
`Improve the person's sense of well‑being and ability to function
`•
`Minimize RA symptoms such as painful joint swelling, fatigue, and stiffness
`•
`Prevent the disease from getting worse
`•
`
`Methotrexate in the treatment of RA
`Methotrexate has been the most commonly used disease‑modifying antirheumatic drug (DMARD) for the
`treatment of RA since the 1990s.
`ABOUT PSORIASIS
`Indications and Important Safety Information, Including Boxed Warning
`
`http://www.rasuvo.com/patients/background
`
`1/5
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`Koios Pharmaceuticals v. Medac
`IPR2016-01370
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`Rasuvo® (methotrexate) injection and RA, pJIA, and psoriasis
`5/31/2016
`Psoriasis is a condition in which the immune system doesn't work the way it should. This results in the
`formation of red skin with silvery, white, scaly patches covered with a buildup of dead skin cells. This can
`be painful and itchy, creating problems in patients' daily lives.
`
`Treatment goals of psoriasis
`
`The goals of psoriasis treatment are to:
`Control the disease quickly
`•
`Minimize the areas of the body affected by disease
`•
`Minimize side effects and improve quality of life
`•
`
`Methotrexate in the treatment of psoriasis
`
`Despite the availability of newer medicines, methotrexate has been commonly prescribed for psoriasis for
`nearly 5 decades. It is considered to be a backbone of psoriasis therapy.
`ABOUT JUVENILE IDIOPATHIC ARTHRITIS
`During juvenile idiopathic arthritis, or JIA, the body's immune system doesn't work the way it should and
`mistakenly attacks the lining of joints. This results in inflammation, marked by redness, heat, pain, and
`swelling. When this inflammation persists, it can cause joint damage and growth problems in some
`children.
`
`Treatment goals of JIA
`
`The goals of treating JIA are to:
`Control symptoms
`•
`Prevent joint damage
`•
`Allow the person to continue to function normally
`•
`
`Methotrexate in the treatment of JIA
`
`Methotrexate is considered to be an important component of therapy for JIA.
`
`CORE Connections: Administration Video
`Learn how to self‑inject with this demonstration video
`
`Watch now
`
`(assets/includes/video_modal.php?video=1&url=http://cdn.rasuvo.com/assets/)
`
`CORE Connections: Patient Support Brochure
`Learn more about getting started on Rasuvo
`
`Download now
`
`(http://cdn.rasuvo.com/assets/pdf/patient-support-brochure.pdf)
`
`http://www.rasuvo.com/patients/background
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`5/31/2016
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`Rasuvo® (methotrexate) injection and RA, pJIA, and psoriasis
`|Home (http://www.rasuvo.com/) Why Rasuvo?
`
`
`
`What is Rasuvo (methotrexate) injection?
`
`Rasuvo (methotrexate) injection is a single‑dose auto‑injector containing a prescription medicine,
`methotrexate. Methotrexate is used to:
`
`•
`
`•
`
`Treat certain adults with severe, active rheumatoid arthritis, and children with active polyarticular
`juvenile idiopathic arthritis (pJIA), after treatment with other medicines including non‑steroidal
`anti‑inflammatory (NSAIDS) have been used and did not work well.
`Control the symptoms of severe, resistant, disabling psoriasis in adults when other types of treatment
`have been used and did not work well.
`
`Rasuvo should not be used for the treatment of cancer.
`
`Rasuvo should not be used for the treatment of children with psoriasis.
`
`Rasuvo is available in doses of 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5, and 30 mg. Your doctor will
`prescribe a different way to take methotrexate if you need to take methotrexate by mouth or in some
`other way.
`
`Important Safety Information, Including Boxed Warning, for Rasuvo
`
`What is the most important information I should know about Rasuvo?
`
`This product includes the following Boxed Warning:
`
`Rasuvo can cause serious side effects that can lead to death, including:
`
`Organ system toxicity. People who use methotrexate for the treatment of cancer, psoriasis, or
`rheumatoid arthritis, have an increased risk of death from organ toxicity. Types of organ toxicity can
`include: gastrointestinal, nerve, bone marrow, lung, liver, kidneys, immune system, and skin.
`
`Your doctor will do blood tests and other types of tests before you take and while you are taking
`Rasuvo to check for signs and symptoms of organ toxicity. Call your doctor right away if you have any
`of the following symptoms of organ toxicity: vomiting, neck stiffness, diarrhea, paralysis, mouth sores,
`irritability, fever, sleepiness, confusion, problems with coordination, weakness, dry cough, temporary
`blindness, trouble breathing, seizures, severe skin rash, headache, and back pain.
`
`Women who are pregnant are at increased risk for death of the baby and for birth defects in
`the baby. Women who are pregnant or who plan to become pregnant must not take Rasuvo. A
`pregnancy test should be performed before starting Rasuvo. Contraception should be used by both
`females and males while taking Rasuvo. Pregnancy should be avoided if either partner is receiving
`Rasuvo:
`–
`for a minimum of 3 months after treatment with Rasuvo for males.
`during and for at least 1 menstrual cycle after treatment with Rasuvo for females.
`–
`
`What are the possible side effects of Rasuvo?
`
`Rasuvo may cause serious side effects, including:
`
`•
`
`Fertility problems. Methotrexate, the active ingredient in Rasuvo, may affect your ability to have
`a baby. Males may have a decreased sperm count, and females may have changes to their
`menstrual cycle. This can happen while taking Rasuvo and for a short period of time after you
`
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`Rasuvo® (methotrexate) injection and RA, pJIA, and psoriasis
`
`•
`
`•
`
`stop.
`Certain cancers. Some people who have taken methotrexate have had a certain type of cancer
`called Non‑Hodgkin's lymphoma and other tumors. Your doctor may tell you to stop taking Rasuvo
`if this happens.
`Tissue and bone problems. Taking methotrexate while having radiation therapy may increase
`the risk of your tissue or bone not receiving enough blood. This may lead to death of the tissue or
`bone.
`
`Common side effects of Rasuvo include: nausea, stomach pain, indigestion (dyspepsia), mouth sores,
`and rash.
`
`Who should not take Rasuvo?
`
`Do not take Rasuvo if you:
`
`•
`•
`•
`•
`•
`•
`
`•
`
`Are pregnant or planning to become pregnant
`Are breastfeeding; Rasuvo can pass into your breast milk and may harm your baby.
`Have alcohol problems (alcoholism)
`Have liver problems
`Have problems fighting infection (immunodeficiency syndrome)
`Have been told you have (or think you have) a blood disorder, such as low levels of white blood cells,
`red blood cells (anemia), or platelets
`Have had an allergy to methotrexate or any of the ingredients in Rasuvo
`
`What should I tell my doctor before taking Rasuvo?
`
`Before you take Rasuvo, tell your doctor if you have any other medical conditions. Tell your doctor about
`all of the medicines you take, including prescription medicines, over‑the‑counter medicines, vitamins,
`and herbal supplements.
`
`Rasuvo may affect how other medicines work, and other medicines may affect how Rasuvo works,
`causing side effects. Ask your doctor or pharmacist for a list of medicines if you are not sure.
`
`Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all
`the possible side effects of Rasuvo. For more information, ask your doctor or pharmacist.
`
`For additional information about Rasuvo, please refer to the Patient Information
`(http://cdn.rasuvo.com/assets/pdf/Patient-Information-current.pdf) Leaflet and Instructions for
`Use, which can be found at www.rasuvo.com (index.php) or call 1-855-33MEDAC (1-855-336-3322).
`
`You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
`www.fda.gov/medwatch (http://www.fda.gov/Safety/MedWatch/default.htm), or call 1-800-FDA-
`1088.
`
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`5/31/2016
`
`Rasuvo® (methotrexate) injection and RA, pJIA, and psoriasis
`
`(http://www.medacpharma.com/)
`For adverse events, medical inquiries and product related concerns, please call 1‑855‑33MEDAC
`(1‑855‑336‑3322)
`This site is intended for US residents only.
`
`
`Legal (terms) | Contact Us (contact-us)
`
`Copyright © 2016 Medac Pharma, Inc.
`All rights reserved.
`MP‑RA‑0288
`March 2016
`Rasuvo is a registered trademark of Medac Pharma, Inc.
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