Peginterferon Alfa-2b (Sylatron)

Trade Name : SYLATRON

Merck Sharp & Dohme Corp.

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Peginterferon Alfa-2b (Sylatron) which is also known as SYLATRON and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of per ml. Read more

Peginterferon Alfa-2b (Sylatron) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

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 n
WARNING: DEPRESSION AND OTHER NEUROPSYCHIATRIC DISORDERS
See full prescribing information for complete boxed warning.
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 n

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.
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. ()

No data

6 mcg/kg/week subcutaneously for 8 doses followed by;
3 mcg/kg/week subcutaneously for up to 5 years. ()

No data

200 mcg of deliverable lyophilized powder per single-dose vial ()
300 mcg of deliverable lyophilized powder per single-dose vial ()
600 mcg of deliverable lyophilized powder per single-dose vial ()

SYLATRON is contraindicated in patients with:

Known serious hypersensitivity reactions to peginterferon alfa-2b or interferon alfa-2b. ()
Autoimmune hepatitis. ()
Hepatic decompensation (Child-Pugh score >6 [class B and C]). ()

No data

Depression and other serious neuropsychiatric adverse reactions. ()
History of significant or unstable cardiac disease. ()
Retinal disorders. ()
Child-Pugh score >6 (class B and C). (, )
Hypothyroidism, hyperthyroidism, hyperglycemia, diabetes mellitus that cannot be effectively treated by medication. (, )

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
Most common adverse reactions (>60%) are: fatigue, increased ALT, increased AST, pyrexia, headache, anorexia, myalgia, nausea, chills, and injection site reaction. ()
To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Peginterferon alfa-2b inhibits CYP1A2 and CYP2D6 activity. When caffeine (CYP1A2 substrate) or desipramine (CYP2D6 substrate) was coadministered with peginterferon alfa-2b (3 mcg/kg once weekly for two weeks), the exposure to caffeine increased 36% and the exposure to desipramine increased 30% as compared to when caffeine or desipramine was administered alone. Monitor for potential increased toxicities of drugs with a narrow therapeutic range metabolized by CYP1A2 or CYP2D6 when coadministered with SYLATRON. n

Drugs metabolized by cytochrome P-450 (CYP) enzymes: Monitor for potential increased toxicities of drugs with a narrow therapeutic range metabolized by CYP1A2 or CYP2D6 when coadministered with SYLATRON. ()

No data

Pregnancy: Based on animal data, may cause fetal harm. ()
Pediatrics: Safety and efficacy in patients <18 years old have not been established. ()
Renal Impairment: Reduce the dose of SYLATRON by 25% in patients with moderate renal impairment and 50% in patients with severe renal impairment or end-stage renal disease (ESRD) requiring dialysis. (, )

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.

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 u00d7 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).

No data

Carcinogenicity studies have not been conducted with SYLATRON. Neither peginterferon alfa-2b nor its components, interferon or methoxypolyethylene glycol, caused damage to DNA when tested in the standard battery of mutagenesis assays, in the presence and absence of metabolic activation.
Irregular menstrual cycles were observed in female cynomolgus monkeys given subcutaneous injections of 4239 mcg/m peginterferon alfa-2b alone every other day for 1 month (approximately 72 to 144 times the recommended weekly human dose based upon body surface area). These effects included transiently decreased serum levels of estradiol and progesterone, suggestive of anovulation. Normal menstrual cycles and serum hormone levels resumed in these animals 2 to 3 months following cessation of peginterferon alfa-2b treatment. Every other day dosing with 262 mcg/m (approximately 3.5 to 7 times the recommended weekly human dose) had no effects on cycle duration or reproductive hormone status. The effects of SYLATRON on male fertility have not been studied.

The safety and effectiveness of SYLATRON were evaluated in an open-label, multicenter, randomized (1:1) study conducted in 1256 patients with surgically resected, AJCC Stage III melanoma within 84 days of regional lymph node dissection. Patients were randomized to observation (no therapy) (n=629) or to SYLATRON (n=627) at a dose of 6 mcg/kg by subcutaneous injection once weekly for 8 doses followed by a 3 mcg/kg subcutaneous injection once weekly for a period of up to 5 years total treatment. The dose of SYLATRON was adjusted to maintain an ECOG Performance Status of 0 to 1.
The median age of the population was 50 years with 11% of patients 65 years or older, and 42% were female. Forty percent of the study population had microscopic, nonpalpable nodal involvement and 59% had clinically palpable nodes prior to lymphadenectomy. A total of 54% of subjects had one pathologically positive lymph node, 34% had 2 to 4 positive nodes, and 12% had 5 or more. Most subjects had no second primary lesion (98%). Ulceration of the primary lesion was present in 30% of subjects (52% had no ulceration of the primary lesion, and the status was missing/unknown for 18% of subjects). The most common sites were the trunk (43%) or the leg (32%). Eighty-four percent had an International Prognostic Index (IPI) score of 0 and 16% had an IPI score of 1. The main outcome measure was relapse-free survival (RFS), defined as the time from randomization to the earliest date of any relapse (local, regional, in-transit, or distant), or death from any cause. Secondary outcome measures included overall survival.
Patients in the SYLATRON arm received 6 mcg/kg/week for a median of 8.0 weeks. Less than 1% of patients took longer than 9 weeks to complete the 6 mcg/kg/week dosing regimen. Approximately one-third (36%) of patients required dose reductions and 29% of patients required a dose delay, with an average delay of 1.2 weeks, during the initial 8 weeks of SYLATRON. Ninety-four patients (16%) did not continue on to the 3 mcg/kg/week dosing regimen.
Patients who continued on SYLATRON after the initial 8 doses, received 3 mcg/kg/week for a median duration of treatment of 14.3 months. Approximately half (52%) of the patients underwent dose reductions and 70% required dose delays (average delay 2.2 weeks).
Based on 696 RFS events, determined by the Independent Review Committee, median RFS was 34.8 months (95% CI: 26.1, 47.4) and 25.5 months (95% CI: 19.6, 30.8) in the SYLATRON and observation arms, respectively. The estimated hazard ratio for RFS was 0.82 (95% CI: 0.71, 0.96; unstratified log-rank p =0.011) in favor of SYLATRON. Figure 1 shows the Kaplan-Meier curves of RFS.
There was no statistically significant difference in survival between the SYLATRON and the observation arms. Based on 525 deaths, the estimated hazard ratio of SYLATRON versus observation was 0.98 (95% CI: 0.82, 1.16).

Storage:
SYLATRON should be stored at 25u00b0C (77u00b0F); excursions permitted to 15u00b0-30u00b0C (59-86u00b0F) [see USP Controlled Room Temperature]. n

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Manufactured by: Merck Sharp & Dohme Corp., a subsidiary of n Whitehouse Station, NJ 08889, USAU.S. License Number 0002
For patent information: www.merck.com/product/patent/home.html
BD and Safety-Lok are registered trademarks of Becton, Dickinson and Company.
Copyright u00a9 2011-2019 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
uspi-mk4031-pwi-5ml-1908r008

No data

SYLATRON (SY-LA-TRON)(peginterferon alfa-2b)for injectionPowder for Injection
Be sure that you read, understand and follow these instructions before injecting SYLATRON. Your healthcare provider should show you how to prepare, measure, and inject SYLATRON properly before you use it for the first time. Ask your healthcare provider if you have any questions.
Before starting, collect all of the supplies that you will need to use for preparing and injecting SYLATRON. For each injection you will need a SYLATRON vial package that contains:
You will also need:
Important:
How should I prepare a dose of SYLATRON?
Before you inject SYLATRON, the powder must be mixed with 0.7 mL of the sterile water for injection (diluent) that comes in the SYLATRON vial package.
How should I choose a site for injection?
The best sites for giving yourself an injection are those areas with a layer of fat between the skin and muscle, like your thigh, the outer surface of your upper arm, and abdomen (See ). Do not inject yourself in the area near your navel or waistline. If you are very thin, you should only use the thigh or outer surface of the arm for injection.
You should use a different site each time you inject SYLATRON to help avoid soreness at any one site. Do not inject SYLATRON solution into an area where the skin is irritated, red, bruised, infected or has scars, stretch marks, or lumps.
How should I inject a dose of SYLATRON?
How should I dispose of used syringes, needles, and vials?
Always keep the sharps disposal container out of the reach of children.
How should I store SYLATRON?
Keep SYLATRON and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:tttttttMerck Sharp & Dohme Corp., a subsidiary of Whitehouse Station, NJ 08889, USAU.S. License Number 0002
Revised: August 2019
For patent information: www.merck.com/product/patent/home.html
Copyright u00a9 2011- 2019 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved
usifu-mk4031-pwi-5ml-1908r002

This carton contains:One vial of SYLATRONOne vial of diluentTwo syringes with 1/2-inch 27-gauge needlesTwo alcohol swabs
NDC 0085-4347-01
Rx only
SYLATRON
Do not reuse vialDispense the enclosedMedication Guide to each patient.n n See package insert. Read accompanying directions.Reconstitute as directed in package insert.
200 mcg per vial*For Subcutaneous UseDelivers 200 mcg in 0.5 mL.

This carton contains:One vial of SYLATRONOne vial of diluentTwo syringes with 1/2-inch 27-gauge needlesTwo alcohol swabs
NDC 0085-4348-01
Rx only
SYLATRON
Do not reuse vialDispense the enclosedMedication Guide to each patient.n n See package insert. Read accompanying directions.Reconstitute as directed in package insert.
300 mcg per vial*For Subcutaneous UseDelivers 300 mcg in 0.5 mL.

This carton contains:One vial of SYLATRONOne vial of diluentTwo syringes with 1/2-inch 27-gauge needlesTwo alcohol swabs
NDC 0085-4349-01
Rx only
SYLATRON
Do not reuse vialDispense the enclosedMedication Guide to each patient.n n See package insert. Read accompanying directions.Reconstitute as directed in package insert.
600 mcg per vial*For Subcutaneous UseDelivers 600 mcg in 0.5 mL.

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Peginterferon Alfa-2b (Sylatron)

Trade Name : SYLATRON

KIT

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Peginterferon Alfa-2b (Sylatron)

Trade Name : SYLATRON

KIT

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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