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Peginterferon Alfa-2b (Pegintron)

Trade Name : PEGINTRON

Merck Sharp & Dohme Corp.

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 120 ug/.5mL

PEGINTERFERON ALFA-2B Interferon-alpha [CS],Interferon alpha [EPC],Interferon-alpha [CS]

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

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Peginterferon Alfa-2b (Pegintron) which is also known as PEGINTRON and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 120 ug/.5mL per ml. Read more

Peginterferon Alfa-2b (Pegintron) 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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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Alpha interferons, including PEGINTRON, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many, but not all cases, these disorders resolve after stopping PEGINTRON therapy n
  • WARNING: RISK OF SERIOUS DISORDERS
  • See full prescribing information for complete boxed warning
  • May cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Monitor closely and withdraw therapy with persistently severe or worsening signs or symptoms of the above disorders. ()
  • PEGINTRON, as part of a combination regimen, is indicated for the treatment of Chronic Hepatitis C (CHC) in patients with compensated liver disease.
  • PEGINTRON monotherapy should only be used in the treatment of CHC in patients with compensated liver disease if there are contraindications to or significant intolerance of ribavirin and is indicated for use only in previously untreated adult patients. Combination therapy provides substantially better response rates than monotherapy .
  • PEGINTRON is an antiviral indicated for treatment of Chronic Hepatitis C (CHC) in patients with compensated liver disease. ()
  • No data
  • PEGINTRON is administered by subcutaneous injection. () tttttttttn
  • PEGINTRON is used in combination with other products including ribavirin and HCV direct-acting antivirals. For further information on dosing and administration, refer to the respective prescribing information.
  • Dose reduction is recommended in patients experiencing certain adverse reactions or renal dysfunction. (, )
  • Injection: 50 mcg per 0.5 mL, 80 mcg per 0.5 mL, 120 mcg per 0.5 mL, 150 mcg per 0.5 mL in single-dose vial (with 5 mL diluent) and single-dose pre-filled pens ()
  • PEGINTRON is contraindicated in patients with:
  • If PEGINTRON is administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen. Refer to the ribavirin prescribing information for a list of contraindications for ribavirin. PEGINTRON combination treatment with ribavirin is contraindicated in women who are or may become pregnant and men whose female partners are pregnant. Advise pregnant women about the potential risk to a fetus n
  • Known hypersensitivity reactions, such as urticaria, angioedema, bronchoconstriction, anaphylaxis, Stevens-Johnson syndrome, and toxic epidermal necrolysis to interferon alpha or any other product component. ()
  • Autoimmune hepatitis. ()
  • Hepatic decompensation (Child-Pugh score greater than 6 [class B and C]) in cirrhotic CHC patients before or during treatment. ()
  • If PEGINTRON is administered with ribavirin, the contraindications to ribavirin also apply to this combination regimen. ()
  • Patients exhibiting the following conditions should be closely monitored and may require dose reduction or discontinuation of therapy:
  • Most common adverse reactions (greater than 40%) in adult patients receiving either PEGINTRON or PEGINTRON/REBETOL are injection site inflammation/reaction, fatigue/asthenia, headache, rigors, fevers, nausea, myalgia and anxiety/emotional lability/irritability (). Most common adverse reactions (greater than 25%) in pediatric patients receiving PEGINTRON/REBETOL are pyrexia, headache, neutropenia, fatigue, anorexia, injection-site erythema, vomiting ().
  • 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/medwatchn
  • No data
  • Drugs metabolized by CYP450: Caution with drugs metabolized by CYP1A2 (e.g., caffeine) or CYP2D6 (e.g., thioridazine). ()
  • Methadone: Dosage reduction may be necessary. ()
  • Nucleoside analogues: Closely monitor for toxicities. Discontinue nucleoside reverse transcriptase inhibitors or reduce dose or discontinue interferon, ribavirin, or both with worsening toxicities. ()
  • Didanosine: Concurrent use with ribavirin is not recommended. ()
  • No data
  • Pregnancy: Based on animal data, may cause fetal harm ().
  • Pediatrics: safety and efficacy in pediatrics less than 3 years old have not been established. ()
  • Geriatrics: neuropsychiatric, cardiac, pulmonary, GI, and systemic (flu-like) adverse reactions may be more severe. ()
  • Organ transplant: safety and efficacy have not been studied. ()
  • HIV or HBV co-infection: safety and efficacy have not been established. ()
  • There is limited experience with overdosage. In the clinical trials, a few subjects accidentally received a dose greater than that prescribed. There were no instances in which a participant in the monotherapy or combination therapy trials received more than 10.5 times the intended dose of PEGINTRON. The maximum dose received by any subject was 3.45 mcg/kg weekly over a period of approximately 12 weeks. The maximum known overdosage of ribavirin was an intentional ingestion of 10 g (fifty 200 mg capsules). There were no serious reactions attributed to these overdosages. In cases of overdosing, symptomatic treatment and close observation of the patient are recommended.
  • PEGINTRON, 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 PEGINTRON molecule is approximately 31,000 daltons. The specific activity of peginterferon alfa-2b is approximately 0.7 u00d7 10 IU/mg protein.
  • Interferon alfa-2b is a water-soluble 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.
  • PEGINTRON is supplied in both vials and the REDIPEN single-dose pre-filled pen for subcutaneous use.
  • No data
  • No data
  • No data
  • No data
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use)
  • A patient should self-inject PEGINTRON only if it has been determined that it is appropriate, the patient agrees to medical follow-up as necessary, and training in proper injection technique has been given to him/her.
  • Manufactured by:Merck Sharp & Dohme Corp., a subsidiary of 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 2001-2019 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
  • uspi-mk4031-mf-5mL-1908r009
  • No data
  • PEGINTRON (peg-In-tron)(peginterferon alfa-2b)Powder for Injection
  • This Instructions for Use is only for use with the single-dose vials of Powder for injection. If your healthcare provider prescribes the REDIPEN Pre-filled Pen for you, use only those Instructions for Use.
  • Be sure that you read, understand and follow these instructions before injecting PEGINTRON. Your healthcare provider should show you how to prepare, measure, and inject PEGINTRON properly using a vial before you use it for the first time. Ask your healthcare provider if you have any questions.
  • Important:
  • Before starting, collect all of the supplies that you will need to use for preparing and injecting PEGINTRON. For each injection you will need a PEGINTRON vial package that contains:
  • You will also need:
  • How should I prepare a dose of PEGINTRON?
  • Before you inject PEGINTRON, the powder must be mixed with 0.7 mL of the sterile water for injection (diluent) that comes in the PEGINTRON 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 belly-button (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 PEGINTRON to avoid soreness at any one site. n
  • How should I inject a dose of PEGINTRON?
  • How should I dispose of the used syringes, needles, and vials?
  • Always keep the sharps disposal container out of the reach of children.
  • How should I store PEGINTRON?
  • Keep PEGINTRON 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:
  • Merck Sharp & Dohme Corp.,n- Merck & Co., Inc.,
  • U.S. License Number 0002
  • Revised: 08/2019
  • Copyright u00a9 2001-2019 a subsidiary of n
  • All rights reserved
  • For patent information: www.merck.com/product/patent/home.html
  • B-D is a registered trademark of Becton, Dickinson and Company.
  • usifu-mk4031-pwi-5mL-1908r003
  • PEGINTRON (peg-In-tron)(Peginterferon alfa-2b)
  • REDIPEN single-dose pre-filled pen
  • This Instructions for Use is only for use with the REDIPEN single-dose pre-filled pen.
  • Be sure that you read, understand, and follow these instructions before injecting PEGINTRON. Your healthcare provider should show you how to prepare and inject PEGINTRON properly using the REDIPEN single-dose pre-filled pen before you use it for the first time. Ask your healthcare provider if you have any questions.
  • Important:
  • Before starting, collect all of the supplies that you will need to use for preparing and injecting PEGINTRON. For each injection you will need a package that contains:
  • The REDIPEN single-dose pre-filled pen should only be used with the injection needle that comes in the package. If you use other needles, the pen may not work the right way.
  • How should I prepare a dose of PEGINTRON using the REDIPEN single-dose pre-filled pen?
  • Mix the PEGINTRON
  • Attach the Needle
  • How should I set the dose prescribed by my healthcare provider?
  • Dial the Dose
  • Choosing an Injection Site
  • 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 belly-button (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 PEGINTRON to avoid soreness at any one site. Do not inject PEGINTRON 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 PEGINTRON?
  • Disposal of the used needles and pre-filled pens
  • Always keep the sharps disposal container out of the reach of children.
  • How should I store PEGINTRON REDIPEN pre-filled pen?
  • Keep PEGINTRON and all medicines out of reach of children.
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • Manufactured by:
  • Merck Sharp & Dohme Corp.,n- Merck & Co., Inc.
  • U.S. License Number 0002
  • Revised: 08/2019
  • For patent information: www.merck.com/product/patent/home.html
  • Copyright u00a9 2001-2019 a subsidiary of n
  • All rights reserved.
  • B-D is a registered trademark of Becton, Dickinson and Company.
  • usifu-mk4031-pwi-p-redipen-1908r005
  • NDC 0085-1323-02
  • Peginterferon alfan Powder for Injection and Diluent (Sterile Water for Injection USP)
  • PAK 4
  • Contains four 50 mcg/0.5 mL REDIPEN UNITS
  • ATTENTION PHARMACIST:
  • REFRIGERATERx only
  • 50 mcg/0.5 mL
  • For Subcutaneous Use
  • NDC 0085-1316-02
  • Peginterferon alfan Powder for Injection and Diluent (Sterile Water for Injection USP)
  • PAK 4
  • Contains four 80 mcg/0.5 mL REDIPEN UNITS
  • ATTENTION PHARMACIST:
  • REFRIGERATERx only
  • 80 mcg/0.5 mL
  • For Subcutaneous Use
  • NDC 0085-1297-02
  • Peginterferon alfan Powder for Injection and Diluent (Sterile Water for Injection USP)
  • PAK 4
  • Contains four 120 mcg/0.5 mL REDIPEN UNITS
  • ATTENTION PHARMACIST:
  • REFRIGERATERx only
  • 120 mcg/0.5 mL
  • For Subcutaneous Use
  • NDC 0085-1370-02
  • Peginterferon alfan Powder for Injection and Diluent (Sterile Water for Injection USP)
  • PAK 4
  • Contains four 150 mcg/0.5 mL REDIPEN UNITS
  • ATTENTION PHARMACIST:
  • REFRIGERATERx only
  • 150 mcg/0.5 mL
  • For Subcutaneous Use
  • SINGLE USE ONLY
  • 5 mL DILUENT
  • STERILE WATER FORINJECTION USP
  • Rx only
  • NDC 0085-4353-01
  • Peginterferon alfan Powder for Injectionn n
  • Rx only
  • Medication Guide for patient enclosed.
  • Dosage and Administration:
  • 50 mcg per 0.5 mL
  • For Subcutaneous Use
  • NDC 0085-4354-01
  • Peginterferon alfan Powder for Injectionn n
  • Rx only
  • Medication Guide for patient enclosed.
  • Dosage and Administration:
  • 80 mcg per 0.5 mL
  • For Subcutaneous Use
  • NDC 0085-4355-01
  • Peginterferon alfan Powder for Injectionn n
  • Rx only
  • Medication Guide for patient enclosed.
  • Dosage and Administration:
  • 120 mcg per 0.5 mL
  • For Subcutaneous Use
  • NDC 0085-4356-01
  • Peginterferon alfan Powder for Injectionn n
  • Rx only
  • Medication Guide for patient enclosed.
  • Dosage and Administration:
  • 150 mcg per 0.5 mL
  • For Subcutaneous Use

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