#Copay assistance interferon gamma 1b skin#
Skin and Subcutaneous Tissue Disorders - atopic dermatitis, (exacerbation of) dermatomyositis, transient cutaneous rash, and urticaria. Renal - acute renal failure (which may be reversible) and proteinuria. Pulmonary - tachypnea, bronchospasm, pulmonary edema, and interstitial pneumonitis. Psychiatric - confusion, depression, disorientation, hallucinations, mental status changes, and mental status decreased. Nervous System - dizziness (excluding vertigo), gait disturbance, headache, Parkinsonian symptoms, convulsion/seizure (including grand mal convulsions), and transient ischemic attacks. Musculoskeletal - back pain, clubbing, and muscle spasms. Metabolic - hyponatremia, hypokalemia, hyperglycemia, and hypertriglyceridemia. Investigations - blood alkaline phosphatase increased, liver function tests abnormal/elevation of hepatic enzymes, increased triglycerides, and weight decreased. Infections and Infestations - upper respiratory tract infection. Immunological - hypersensitivity, increased autoantibodies, lupus-like syndrome (including systemic lupus erythematosus-flares and drug-induced lupus erythematosus), and Stevens-Johnson syndrome. Hepatobiliary Disorders - hepatic insufficiency and hepatomegaly. General Disorders and Administration Site Conditions - asthenia, chest pain/discomfort, influenza-like illness/flu-like symptoms, injection site hemorrhage, injection site pain, malaise, rigors, and weakness. Gastrointestinal - abdominal pain, dyspepsia, gastrointestinal bleeding, granulomatous colitis, hepatic insufficiency, and pancreatitis, including pancreatitis with fatal outcome. The following adverse reactions are assessed as potentially related to ACTIMMUNE (interferon gamma-1b) therapy:īlood and Lymphatic System - neutropenia (reversible), febrile neutropenia, leukopenia, and thrombocytopenia.Ĭardiovascular - angina pectoris, arrhythmia, atrial fibrillation, atrioventricular block, cardiac failure (including congestive cardiac failure), tachyarrhythmia, heart block, (acute) myocardial infarction, myocardial ischemia, syncope, and tachycardia. In patients less than 1 year of age, liver function tests should be measured monthly. Blood chemistries – including renal and liver function tests.Hematologic tests – including complete blood counts, differential and platelet counts.Prior to the beginning of treatment and at three-month intervals during treatment the following laboratory tests are recommended for all patients on ACTIMMUNE (interferon gamma-1b) therapy :.Three times weekly (For example, Monday, Wednesday and Friday) This is equivalent to what was previously expressed as units (1.5 million units/50 mcg). * Note that the above activity is expressed in International Units (1 million International Units/50 mcg). Table 1: Recommended Dosage for ACTIMMUNE for the Treatment of Patients with CGD and SMO Body Surface Area (m 2)
#Copay assistance interferon gamma 1b full#
FULL PRESCRIBING INFORMATION: CONTENTS * 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1ĝosing Information 2.2 Important Administration Instructions 2.3ĝose Modification 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1Ĝardiovascular Disorders 5.2 Neurologic Disorders 5.3ěone Marrow Toxicity 5.4 Hepatic Toxicity 5.5 Hypersensitivity Reactions 5.6 Renal Toxicity 5.7Ěllergic Reactions to Natural Rubber 6 ADVERSE REACTIONS 6.1Ĝlinical Trials Experience 6.2 Postmarketing Experience 6.3 Immunogenicity 7 DRUG INTERACTIONS 7.1 Myelosuppressive Agents 7.2ĝrugs with Neurotoxic, Hematoxic or Cardiotoxic Effects 7.3 Immunological Preparations 7.4Ğffects on Cytochrome P-450 Pathways 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.3ğemales and Males of Reproductive Potential 8.4 Pediatric Use 8.5 Geriatric Use 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 14.1Ğffects in Chronic Granulomatous Disease (CGD) 14.2Ğffects in Severe, Malignant Osteopetrosis (SMO) 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 16.2 Storage and Handling 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed.
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