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SYLATRON
Overview
What is SYLATRON?
SYLATRON, peginterferon alfa-2b, is a covalent conjugate of recombinant alfa-2b interferon with monomethoxy polyethylene glycol (PEG). The average molecular weight of the PEG portion of the molecule is 12,000 daltons. The average molecular weight of the SYLATRON molecule is approximately 31,000 daltons. The specific activity of pegylated interferon alfa-2b is approximately 0.7 × 10 international units/mg protein.
Interferon alfa-2b is a protein with a molecular weight of 19,271 daltons produced by recombinant DNA techniques. It is obtained from the bacterial fermentation of a strain of bearing a genetically engineered plasmid containing an interferon gene from human leukocytes.
Each vial contains either 296 mcg, 444 mcg or 888 mcg of peginterferon alfa-2b as a sterile, white to off-white lyophilized powder, and dibasic sodium phosphate anhydrous (1.11 mg), monobasic sodium phosphate dihydrate (1.11 mg), polysorbate 80 (0.074 mg), and sucrose (59.2 mg).
What does SYLATRON look like?
What are the available doses of SYLATRON?
What should I talk to my health care provider before I take SYLATRON?
How should I use SYLATRON?
SYLATRON is an alpha interferon indicated for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy.
6 mcg/kg/week subcutaneously for 8 doses followed by;
3 mcg/kg/week subcutaneously for up to 5 years. ()
What interacts with SYLATRON?
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What are the warnings of SYLATRON?
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What are the precautions of SYLATRON?
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What are the side effects of SYLATRON?
Sorry No records found
What should I look out for while using SYLATRON?
SYLATRON is contraindicated in patients with:
The risk of serious depression, with suicidal ideation and completed suicides, and other serious neuropsychiatric disorders are increased with alpha interferons, including SYLATRON. Permanently discontinue SYLATRON in patients with persistently severe or worsening signs or symptoms of depression, psychosis, or encephalopathy. These disorders may not resolve after stopping SYLATRON
What might happen if I take too much SYLATRON?
The experience with overdose of SYLATRON is limited. Patients who were over dosed experienced the following adverse reactions: severe fatigue, headache, myalgia, neutropenia, and thrombocytopenia. The highest single dose administered was 14 mcg/kg.
How should I store and handle SYLATRON?
Potassium citrate extended-release tablets 5 mEq are uncoated, tan to yellowish in color, modified ball shaped, debossed with "USL" on one side and "070" on the other, supplied in bottles as:Potassium citrate extended-release tablets 10 mEq are uncoated, tan to yellowish in color, elliptical shaped, debossed with "USL" on one side and "071" on the other, supplied in bottles as:Potassium citrate extended-release tablets 5 mEq are uncoated, tan to yellowish in color, modified ball shaped, debossed with "USL" on one side and "070" on the other, supplied in bottles as:Potassium citrate extended-release tablets 10 mEq are uncoated, tan to yellowish in color, elliptical shaped, debossed with "USL" on one side and "071" on the other, supplied in bottles as:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Peginterferon alfa-2b is a pleiotropic cytokine; the mechanism by which it exerts its effects in patients with melanoma is unknown.
Non-Clinical Toxicology
SYLATRON is contraindicated in patients with:The risk of serious depression, with suicidal ideation and completed suicides, and other serious neuropsychiatric disorders are increased with alpha interferons, including SYLATRON. Permanently discontinue SYLATRON in patients with persistently severe or worsening signs or symptoms of depression, psychosis, or encephalopathy. These disorders may not resolve after stopping SYLATRON
Interactions between INTRON A and other drugs have not been fully evaluated. Caution should be exercised when administering INTRON A therapy in combination with other potentially myelosuppressive agents such as zidovudine. Concomitant use of alpha interferon and theophylline decreases theophylline clearance, resulting in a 100% increase in serum theophylline levels.
Peginterferon alfa-2b can cause life-threatening or fatal neuropsychiatric reactions. These include suicide, suicidal and homicidal ideation, depression, and an increased risk of relapse of recovering drug addicts. In the clinical trial, depression occurred in 59% of SYLATRON-treated patients and 24% of patients in the observation group. Depression was severe or life threatening in 7% of SYLATRON-treated patients compared with <1% of patients in the observation arm.
In post-marketing experience, neuropsychiatric adverse reactions have been reported up to 6 months after discontinuation of peginterferon alfa-2b. Based on post-marketing experience with peginterferon alfa-2b and interferon alfa-2b, treatment may also result in aggressive behavior, psychoses, hallucinations, bipolar disorders, mania, and encephalopathy.
Advise patients and their caregivers to immediately report any symptoms of depression or suicidal ideation to their healthcare provider. Monitor and evaluate patients for signs and symptoms of depression and other psychiatric symptoms every 3 weeks during the first 8 weeks of treatment and every 6 months thereafter. Monitor patients during treatment and for at least 6 months after the last dose of SYLATRON. Permanently discontinue SYLATRON for suicidal or homicidal ideation, aggressive behavior towards others, or other severe or persistent psychiatric symptoms; institute psychiatric intervention and follow-up as appropriate.
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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