Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers e. Highlights of prescribing information these highlights do not. Nebulized brovana arformoterol tartrate inhalation solution is a longacting maintenance copd medication that may help control your symptoms for up to 12 hours. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for avonex interferon beta1a. Avonex is indicated for the treatment of relapsing forms of multiple sclerosis ms, to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults. Each 1 ml of reconstituted avonex powder for injection contains 30. Avonex should be injected into the thigh or upper arm see figures g and h.
Avonex interferon beta 1a injection is a sterile liquid for intramuscular injection available in a prefilled glass syringe or a prefilled glass syringe surrounded by an autoinjector. Always have a rescue inhaler medicine with you to treat sudden symptoms. Full prescribing information 1 indications and usage tecfidera is indicated for the treatment of relapsing forms of multiple sclerosis ms, to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults. Highlights of prescribing information these highlights do not include all the information needed to use ofev safely and effectively. The indications below including fdaapproved indications and compendial uses are considered covered benefits provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. Inject your avonex pen exactly as your healthcare provider has shown you. A separate needle to give the injection is also included in.
Avonex interferon beta1a injection, for intramuscular injection initial u. See patients instructions for use for complete administration instructions. Multiple sclerosis ms only prescribers registered in the ms touch prescribing program may prescribe tysabri for multiple sclerosis see warnings and precautions 5. Relapsing forms of multiple sclerosis ms, to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults primary progressive ms, in adults 2 dosage and administration. The enbreletanercept instructions for use insert for each presentation contains more detailed instructions on injection site selection and the preparation of enbrel. Sections or subsections omitted from the full prescribing. In ms, the immune system the bodys natural defences malfunctions and attacks parts of the central nervous system the brain, spinal cord and optic nerve nerve that sends signals from the eye to the.
This leaflet is part iii of a threepart product monograph. Instructions for use avonex pen avuhnecks interferon. No formal drug interaction studies have been conducted with avonex. Betaseron interferon beta1b prescription medication. The first avonex injection should be performed under the supervision of an appropriately qualified healthcare professional. Avonex interferon beta1a injection, for intramuscular injection. In a box of avonex there are four or twelve ready to use prefilled syringes, each with 0. I attended one other presentation hosted by the company who manufactures avonex and tysabri. Highlights of prescribing information these highlights do not include all the information needed to use avastin safely and effectively. Highlights of prescribing information who initially. Interferon beta1a avonex has been designated as an orphan drug by the fda. You can help by reporting any side effects you may get.
Highlights of prescribing information these highlights do not include all the information needed to use enbrel safely and effectively. Highlights of prescribing information who initially respond. These highlights do not include all the information needed to use ampyra safely and effectively. Avonex, inninterferon beta1a european medicines agency. Highlights of prescribing information discontinuation of. Full prescribing information 1 indications and usage avonex is indicated for the treatment of relapsing forms of multiple sclerosis ms, to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults.
Multiple sclerosis ms injectable drugs avonex, rebif. Page 2 full prescribing information tyvaso treprostinil inhalation solution for oral inhalation only 1 indications and usage tyvaso is indicated for the treatment of pulmonary arterial hypertension pah who group 1 to. See the end of section 4 for how to report side effects. These highlights do not include all the information needed to use apokyn safely and effectively. Highlights of prescribing information initiate promacta at. Mar 30, 2020 avonex pen interferon beta1a injection, solution avonex interferon beta1a injection, solution if this spl contains inactivated ndcs listed by the fda initiated compliance action, they will be specified as such. Brovana arformoterol tartrate maintenance copd treatment. Sanofi pasteur full prescribing information 306 adacel page 3 of 29 27 2. Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of the ms injectable drugs while maintaining optimal therapeutic outcomes. Avonex fda prescribing information, side effects and uses. Highlights of prescribing information these highlights do not include all the information needed to use. Even when i proved my credentials, the responses were the same drone words.
Hepatotoxicity and embryofetal toxicity 1 indications and usage 2 dosage and administration 3 dosage forms and strengths 4 contraindications 5 warnings and precautions 5. Hold the avonex prefilled syringe with the glass syringe tip pointing up. Avonex and rebif may also delay the accumulation of physical disability 17. Enbrel etanerceptinjection, for subcutaneous use enbrel etanercept for injection, for subcutaneous use initial u. This will allow quick identification of new safety information. Aortitis has been reported in patients receiving filgrastim products.
Highlights of prescribing information these highlights do not include all the information needed to use avonex safely and effectively. Instructions for use avonex pen avuhnecks interferon beta1a injection for intramuscular use singledose prefilled autoinjector pen read the instructions for use before you start using avonex and each time you get a refill. The safety and effectiveness of adacel vaccine used as a primary. Avonex solution for injection comes as a ready to use injection. Highlights of prescribing information these highlights do not include all the information needed to use betaseron safely and effectively. Avonex interferon beta1a dose, indications, adverse effects. The active substance in avonex is the protein interferon beta1a, one of a group of interferons that can be naturally produced by the body to help it fight against viruses and other attacks. Avonex pen interferon beta1a injection, solution avonex interferon beta1a injection, solution. Renflexis infliximababda for injection, for intravenous use. It may occur as early as the first week after start of therapy.
Insert the injection needle with a quick dartlike thrust at right angles to the skin, into the muscle. I am a nurse and i fully understand the package insert and clinical pharmacology on how a drug works. Do not use the same injection site for each injection. Injection site necrosis also occurred more frequently in rebiftreated patients 3% in the 44 mcg group and 1% in the 22 mcg group than in placebotreated patients 0 during the two years of therapy. Avonex administration, or when adding new agents to the regimen of patients already on. Avonex pen is injected into the muscle intramuscularly. These highlights do not include all the information needed to use glatopa safely and effectively. Learn about avonex interferon beta1a, an fda approved treatment for relapsing multiple sclerosis ms. Avostartgrip titration kit instructions for use avonex. Avonex is given 1 time each week by injection into the muscle intramuscular injection. Highlights of prescribing information platinumresistant. Betaseron interferon beta1b is a prescription medicine used to treat relapsing forms of multiple sclerosis ms, to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults.
Serious side effects may happen right after or within. Apokyn apomorphine hydrochloride injection, for subcutaneous use initial u. Highlights of prescribing information these highlights do not include all the information needed to usegilenya safely and effectively. Xgeva includes the same active ingredient denosumab found in prolia. Highlights of prescribing information these highlights do not include all the information needed to use harvoni safely and effectively. Betaseron interferon beta1b for injection, for subcutaneous use initial u. Highlights of prescribing information hypersensitivity to. Do not hold the pen cover with your hands while inserting the needle.
Full prescribing information 1 indications and usage betaseron is indicated for the treatment of relapsing forms of multiple sclerosis ms, to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults. Promacta eltrombopag tablets, for oral use promacta eltrombopag for oral suspension initial u. Full prescribing information 1 indications and usage gilenya is indicated for the treatment ofrelapsing forms of multiple sclerosis ms, to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease,in patients 10 years of age and older. Avonex is formulated as a sterile, white to offwhite lyophilized powder for intramuscular injection after reconstitution with supplied diluent sterile water for injection, usp. These highlights do not include all the information needed to use renflexis safely and effectively. Gilenyafingolimod capsules, for oral use initial u. The first avonex injection should be performed under the supervision of an appropriately qualified health care professional.
A healthcare provider should show you how to prepare your dose of avonex and how to inject your avonex before you use it for the first time. Interferon beta1a, avonex, biogen, inc package insert. Full prescribing information 1 indications and usage copaxone is indicated for the treatment of relapsing forms of multiple sclerosis ms, to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults. Issued 102000 1 novantrone package insert 016609 novantrone mitoxantrone for injection concentrate warning novantrone mitoxantrone for injection concentrate should be administered under the supervision of a physician experienced in the use of cytotoxic chemotherapy agents. Multiple sclerosis ms injectable drugs interferon beta1a. Renflexis infliximababda is biosimilar to remicade. Full prescribing information 1 indications and usage ocrevus is indicated for the treatment of. Avonex should be discontinued in patients who develop progressive ms. If patients or caregivers are to administer avonex, train them in the proper intramuscular injection technique and assess their ability to inject intramuscularly to ensure the proper administration of avonex. Avonex is injected into the muscle intramuscularly. Avonex interferon beta1a is a 166 amino acid glycoprotein with a. A healthcare provider or nurse should watch the first avonex injection you give yourself. Avonex is an interferon beta indicated for the treatment of patients with relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. Sanofi pasteur full prescribing information 306 adacel.
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