Peginterferon alfa-2B
Highest phase reached
Approved
Drug type
Protein
First approval year
2000
- First approval year
- 2000
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Protein
- Drug name
- Peginterferon alfa-2B
- peg intron
- Peg-intron
- peginterferon alfa 2b component of sylatron
- Peginterferon alfa-2b component of sylatron
- pegintron
- Pegintron
- viraferonpeg
- Viraferonpeg
- boceprevir peg interferon alfa 2b and ribavirin
- Comparator: Pegylated Interferon (peg-IFN) alfa-2a
- Comparator: Pegylated-Interferon (Peg-IFN)
- Drug: SCH 900518 Biologic: Peginterferon alfa-2b(PegIntron)
- monocarboxyinterferon alfa 2b diesters with polyethylene glycol monomethyl ether
- MONOCARBOXYINTERFERON ALFA-2B, DIESTERS WITH POLYETHYLENE GLYCOL MONOMETHYL ETHER
- PEG -Intron
- peg interferon alfa 2b
- Peg interferon alfa-2b
- PEG Interferon Alfa-2b
- Peg Interferon Alpha 2b (Peg Intron)
- PEG INTRON
- Peg-alpha interferon (Peg-Intron)
- peg-IFN
- Peg-IFN
- PEG-IFN
- peg-IFN-α
- Peg-IFN-α
- PEG-IFN-α
- Peg-IFNα
- PEG-IFNα
- peg-interferon alfa-2b
- Peg-interferon alfa-2b
- PEG-interferon alfa-2b
- Peg-Interferon-alfa 2B
And 82 more, listed on the interactive page.
- CAS registry numbers
- 215647-85-1
- ChEMBL ID
- CHEMBL1201561
- RxNorm IDs (RxCUI)
- 253453
- FDA ingredient codes (UNII)
- G8RGG88B68
- L03AB10
- L03AB60
Sources for recorded values
- Applicant
- SCHERING
- Approval date
- 19 Jan 2001
- Application number
- BLA103949
- Status
- Withdrawn
- Status date
- 21 Apr 2021
- Authorisation date
- 24 May 2000
- Approved indications
- Adults (tritherapy) PegIntron in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-C (CHC) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. Please refer to the ribavirin and boceprevir summaries of product characteristics (SmPCs) when PegIntron is to be used in combination with these medicines. Adults (bitherapy and monotherapy) PegIntron is indicated for the treatment of adult patients (18 years of age and older) with CHC who are positive for hepatitis-C-virus RNA (HCV-RNA), including patients with compensated cirrhosis and / or co-infected with clinically stable HIV. PegIntron in combination with ribavirin (bitherapy) is indicated for the treatment of CHC infection in adult patients who are previously untreated including patients with clinically stable HIV co-infection and in adult patients who have failed previous treatment with interferon-alpha (pegylated or non-pegylated) and ribavirin combination therapy or interferon-alpha monotherapy. Interferon monotherapy, including PegIntron, is indicated mainly in case of intolerance or contraindication to ribavirin. Please refer to the ribavirin SmPC when PegIntron is to be used in combination with ribavirin. Paediatric population (bitherapy) PegIntron is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents who have CHC, previously untreated, without liver decompensation, and who are positive for HCV-RNA. When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. The decision to treat should be made on a case-by-case basis. Please refer to the ribavirin SmPC for capsules or oral solution when PegIntron is to be used in combination with ribavirin.
- Product number
- EMEA/H/C/000280
- Authorisation holder
- Merck Sharp & Dohme B.V.
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Hepatitis C, Chronic
European medicines record
- Patents
- 0
- Designations
- 1
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- peginterferon alfa-2b
- Type
- Peptide
- Drug name stem
- peg-
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Agonist
- Action type
- Agonist
- Target
- Interferon-α/β receptor
- Gene symbol
- IFNAR1
- Protein identifier
- P17181
- Primary target
- Yes
- Action
- Agonist
- Action type
- Agonist
- Target
- Interferon-α/β receptor
- Gene symbol
- IFNAR2
- Protein identifier
- P48551
- Primary target
- Yes
- Mechanism
- Interferon alpha/beta receptor agonist
- Action type
- Agonist
- Target
- Interferon alpha/beta receptor
- Protein identifier
- P17181
- Mechanism
- Interferon alpha/beta receptor agonist
- Action type
- Agonist
- Target
- Interferon alpha/beta receptor
- Protein identifier
- P48551
Open Targets mechanisms
- Mechanism
- Interferon alpha/beta receptor agonist
- Action type
- Agonist
- Target
- Interferon alpha/beta receptor
- Condition
- HIV Infections
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000180
- Subject identifier
- D015658
- Condition
- Carcinoma, Hepatocellular
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000182
- Subject identifier
- D006528
- Condition
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000339
- Subject identifier
- D015464
- Condition
- Melanoma
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000389
- Subject identifier
- D008545
- Condition
- Thrombocythemia, Essential
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000479
- Subject identifier
- D013920
- Condition
- Leukemia
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000565
- Subject identifier
- D007938
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Osteosarcoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000637
- Subject identifier
- D012516
- Condition
- Neurofibroma, Plexiform
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000658
- Subject identifier
- D018318
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000681
- Subject identifier
- D002292
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000707
- Subject identifier
- D002294
- Condition
- Melanoma
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000756
- Subject identifier
- D008545
- Condition
- HIV Infections
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000764
- Subject identifier
- D015658
- Condition
- Acquired Immunodeficiency Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000765
- Subject identifier
- D000163
- Condition
- Multiple Myeloma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
- Condition
- Liver Cirrhosis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001422
- Subject identifier
- D008103
- Condition
- Hematologic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001642
- Subject identifier
- D019337
- Condition
- Polycythemia Vera
- Highest recorded phase
- 3
- Condition identifier
- EFO:0002429
- Subject identifier
- D011087
- Condition
- Primary Myelofibrosis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0002430
- Subject identifier
- D055728
- Condition
- Melanoma
- Highest recorded phase
- 4
- Condition identifier
- EFO:0002617
- Subject identifier
- D008545
- Condition
- Hepatitis C
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003047
- Subject identifier
- D006526
- Condition
- Hepatitis C, Chronic
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004220
- Subject identifier
- D019698
- Condition
- Hepatitis B, Chronic
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004239
- Subject identifier
- D019694
- Condition
- Carcinoid Tumor
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004243
- Subject identifier
- D002276
- Condition
- Cholangiocarcinoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005221
- Subject identifier
- D018281
And 21 more, listed on the interactive page.
- Condition identifier
- EFO_0000180
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000182
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000339
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000389
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000658
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000756
- Condition identifier
- EFO_0000764
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000765
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001378
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001422
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001642
- Condition identifier
- EFO_0002429
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003047
- Condition identifier
- EFO_0004197
- Condition identifier
- EFO_0004220
- Condition identifier
- EFO_0004239
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004243
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004952
- Highest recorded phase
- 3
- Condition identifier
- EFO_0006859
- Highest recorded phase
- 2
- Condition identifier
- EFO_0006890
- Highest recorded phase
- 3
- Condition identifier
- EFO_0007304
- Highest recorded phase
- 3
- Condition identifier
- EFO_0009708
- Highest recorded phase
- 3
- Condition identifier
- EFO_1000209
- Highest recorded phase
- 2
- Condition identifier
- EFO_1000453
- Highest recorded phase
- 2
And 65 more, listed on the interactive page.
Warnings
- Warning
- Black Box Warning
Open Targets warnings
- Warning
- Black Box Warning
- Country
- United States
- Event
- alopecia
- Reports
- 296
- Reporting signal score
- 185.783
- Event
- anaemia
- Reports
- 3,993
- Reporting signal score
- 5,875.05
- Event
- asthenia
- Reports
- 1,330
- Reporting signal score
- 452.368
- Event
- chills
- Reports
- 649
- Reporting signal score
- 369.641
- Event
- decreased appetite
- Reports
- 1,181
- Reporting signal score
- 825.932
- Event
- depression
- Reports
- 1,323
- Reporting signal score
- 995.651
- Event
- dysgeusia
- Reports
- 664
- Reporting signal score
- 773.261
- Event
- fatigue
- Reports
- 2,758
- Reporting signal score
- 1,098.03
- Event
- haemoglobin decreased
- Reports
- 1,495
- Reporting signal score
- 1,650.35
- Event
- headache
- Reports
- 797
- Reporting signal score
- 213.56
- Event
- hepatitis c
- Reports
- 586
- Reporting signal score
- 1,163.43
- Event
- hyperuricaemia
- Reports
- 190
- Reporting signal score
- 396.389
- Event
- influenza like illness
- Reports
- 944
- Reporting signal score
- 1,139.77
- Event
- insomnia
- Reports
- 983
- Reporting signal score
- 483.327
- Event
- leukopenia
- Reports
- 646
- Reporting signal score
- 566.562
- Event
- malaise
- Reports
- 564
- Reporting signal score
- 165.027
- Event
- nausea
- Reports
- 2,180
- Reporting signal score
- 390.223
- Event
- neutropenia
- Reports
- 1,034
- Reporting signal score
- 560.889
- Event
- neutrophil count decreased
- Reports
- 821
- Reporting signal score
- 1,151.34
- Event
- pancytopenia
- Reports
- 639
- Reporting signal score
- 576.982
- Event
- platelet count decreased
- Reports
- 1,621
- Reporting signal score
- 1,989.3
- Event
- pruritus
- Reports
- 1,274
- Reporting signal score
- 592.368
- Event
- pyrexia
- Reports
- 1,740
- Reporting signal score
- 728.302
- Event
- rash
- Reports
- 2,132
- Reporting signal score
- 1,019.23
- Event
- red blood cell count decreased
- Reports
- 456
- Reporting signal score
- 636.152
And 5 more, listed on the interactive page.
- NCT00005012
- NCT00006325
- NCT00035360
- NCT00296972
- NCT01295515
- NCT00006249
- NCT00027742
- NCT00049530
- NCT00238329
- NCT00014261
- NCT00701298
- NCT03554005
- NCT00037882
- NCT00050531
- NCT00297570
- NCT00303290
- NCT00511121
- NCT00573378
- NCT01872442
- NCT03547154
- NCT00039871
- NCT00048724
- NCT00049842
- NCT00378599
- NCT00081770
And 154 more, listed on the interactive page.
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
Sequences
- Component
- Sequence
- Type
- Protein
- Sequence
- CDLPQTHSLGSRRTLMLLAQMRRISLFSCLKDRHDFGFPQEEFGNQFQKAETIPVLHEMIQQIFNLFSTKDSSAAWDETLLDKFYTELYQQLNDLEACVIQGVGVTETPLMKEDSILAVRKYFQRITLYLKEKKYSPCAWEVVRAEIMRSFSLSTNLQESLRSKE
Related records
Trials (360)
- 14 vs 24 Weeks HCV Treatment to Genotype 2/3 Patients With Rapid Virological Response
- 36 vs 48 Wks Peg-Intron Plus Ribavirin for HCV Patients Without Rapid Virologic Response But Without HCV RNA at wk 8
- 5 Year Long-term Follow up in Pediatric Participants Who Received PegIntron Plus Rebetol in P02538 Part I (P02538 Pt 2)
- 5-aza-2-deoxycytidine With Pegylated Interferon-alfa 2B: A Phase I Study With Molecular Correlates
- A Collaborative Trial in Injectors of Individualized Treatment for Genotype 2/3
- A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs
- A Multicenter, Randomized, Open, Parallel-designed Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B
- A Novel Combination Therapeutic Strategy Aiming to Functional Cure for Chronic Hepatitis B Virus Infection (Sustained HBsAg Loss) (B)
- A Pharmacokinetics/Pharmacodynamics Study of SCH 900518 in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C (Protocol No. P05104AM2)(COMPLETED)
- A Phase 1 Study of MP-424, Peginterferon Alfa 2b, and Ribavirin in Hepatitis C
- A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected With HIV and Hepatitis C (P05411 AM4)
- A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects
- A Phase Ⅱ Dose-escalating Study of PEG-IFN-SA and Ribavirin in IFN Naive Patients With Chronic Hepatitis C
- A Phase II Study of an Anti-Tumor Immunotherapy Regimen Comprised of Pegylated Interferon-Alpha 2b and HyperAcute Melanoma Vaccine for Subjects With Advanced Melanoma
- A Phase II Study of Hepalatide in Subjects With Chronic Hepatitis B
- A Phase II Study of Pegylated Interferon Alfa-2b for the Adjuvant Treatment of Melanoma Subjects in Russia (MK-4031-400)
- A Phase II Trial Comparing the Quality of Life, Tolerability and Toxicity of PEG Intron With INTRON® A in Patients With Multiple Myeloma
- A Pilot Study of Boceprevir for the Treatment of Genotype 6 HCV
- A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection
- A Prospective Clinical Trial in Chronic Hepatitis B Patients NAs (Nucleotides or Nucleosides) Experienced (Anchor Study)
Approved for (6)
- Cancer
- Chronic hepatitis C virus infection
- Cutaneous melanoma
- Melanoma
- Metastatic melanoma
- Neoplasm
In development for (37)
- Acquired polycythemia vera Phase 3
- Adult T-cell leukemia/lymphoma Phase 2
- AIDS Phase 3
- Carcinoid tumor Phase 2
- Cervical cancer Phase 2
- Cholangiocarcinoma Phase 2
- Chronic hepatitis B virus infection Phase 3
- Chronic myeloid leukemia Phase 3
- Cirrhosis of liver Phase 3
- Craniopharyngioma Phase 2
- Essential thrombocythemia Phase 3
- Fallopian tube cancer Phase 1
- Head and neck cancer Phase 2
- Hepatitis Phase 3
- Hepatitis C virus infection Phase 3
- Hepatitis D virus infection Phase 3
- Hepatocellular carcinoma Phase 3
- HIV infectious disease Phase 3
- Kidney cancer Phase 2
- Leukemia Phase 2