Diagnosis and treatment of myositis

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Check for air bubbles in the syringe. Small air bubbles are harmless but can reduce the dose of INFERGEN that you receive. Take the needle out of the vial and hold the syringe needle facing up in the hand that you will use to inject yourself.

Do not lay the syringe down or allow the needle to touch anything. Hold the diagnosis and treatment of myositis the way you would hold a pencil and insert the needle into your skin either straight up and down (90 degree angle) or at a slight angle (45 degree angle) to the skin.

Place the needle and syringe in the puncture-proof disposal container right away. Never reuse the syringe or needle. Do not recap the needle. The following points should be considered when initiating treatment with Diagnosis and treatment of myositis Use of monotherapy with an interferon such as INFERGEN for the treatment of hepatitis C is not recommended unless a patient is unable to take ribavirin.

No safety and efficacy data are available for treatment of longer than one year. INFERGEN Monotherapy Dose Modifications Dose reduction to 7. Preparation and Administration Just prior to injection, INFERGEN may diagnosis and treatment of myositis allowed to reach room temperature.

Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse diagnosis and treatment of myositis rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Postmarketing Experience The following adverse reactions have been identified and reported during post-approval use of INFERGEN. Combination Use with Ribavirin Please refer to ribavirin labeling for details on ribavirin's drug interaction potential.

Use with Ribavirin Pregnancy Ribavirin may become who are you birth defects and death of the unborn child. Neuropsychiatric Disorders Severe psychiatric adverse reactions may manifest in patients receiving therapy with interferon alphas, including INFERGEN. Cardiovascular Events Cardiovascular events, which include hypotension, arrhythmia, tachycardia, cardiomyopathy, angina pectoris, and myocardial infarction, have been observed in patients treated with INFERGEN.

Hepatic Failure Chronic hepatitis C patients with cirrhosis may be at risk of varicose veins treatment decompensation when treated with interferon alphas, including INFERGEN. Renal Insufficiency Increases in serum creatinine levels, including renal failure, have been observed in patients receiving INFERGEN. Cerebrovascular Disorders Ischemic and hemorrhagic cerebrovascular events have been observed in patients treated with interferon alpha-based therapies, including INFERGEN.

Pancreatitis Pancreatitis, sometimes fatal, has been observed in pregnant dog treated with interferon alphas, including INFERGEN.

Hypersensitivity Serious acute hypersensitivity reactions have been reported following treatment with interferon alphas. Autoimmune Disorders Development or exacerbation of autoimmune disorders (e. Peripheral Neuropathy Peripheral neuropathy has been reported when interferon alphas were given in combination with telbivudine.

Endocrine Disorders INFERGEN should be administered with caution to patients with a history diagnosis and treatment of myositis endocrine disorders.

Laboratory Tests Laboratory tests are recommended for all patients on INFERGEN therapy, as follows: prior to beginning treatment (baseline), 2 weeks after initiation of therapy, and periodically thereafter during the 24 or 48 weeks of therapy at the discretion of the physician. Patient Counseling Information Information for Patients Patients should be instructed on appropriate use by a health care professional.

Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No carcinogenicity data for INFERGEN are available in animals or humans. Mutagenesis INFERGEN was not mutagenic when tested in several in vitro assays, including the Ames bacterial mutagenicity assay and an in vitro cytogenetic assay in human lymphocytes, either in the presence or absence of metabolic activation.



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