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| Primary information |
|---|
| ID | 10840 |
| Therapeutic ID | Th1203 |
| Protein Name | Peginterferon beta-1a |
| Sequence | >Th1203_Peginterferon_beta-1a
MSYNLLGFLQRSSNFQCQKLLWQLNGRLEYCLKDRMNFDIPEEIKQLQQFQKEDAALTIYEMLQNIFAIFRQDSSSTGWNETIVENLLANVYHQINHLKTVLEEKLEKEDFTRGKLMSSLHLKRYYGRILHYLKAKEYSHCAWTIVRVEILRNFYFINRLTGYLRN
|
| Molecular Weight | 22500 |
| Chemical Formula | NA |
| Isoelectric Point | 9.02 |
| Hydrophobicity | NA |
| Melting point | NA |
| Half-life | Approximately 78 hours |
| Description | Peginterferon beta-1a is an interferon beta-1a to which a single, linear 20,000 dalton (Da) methoxy poly(ethyleneglycol)-O-2-methylpropionaldehyde molecule is covalently attached to the alpha amino group of the N-terminal amino acid residue. The interferon beta-1a portion is produced as a glycosylated protein using genetically-engineered Chinese hamster ovary cells into which the human interferon beta gene has been introduced. The amino acid sequence of the recombinant interferon beta-1a is identical to that of the human interferon beta counterpart. |
| Indication/Disease | For the treatment of patients with relapsing forms of multiple sclerosis. |
| Pharmacodynamics | There is no biochemical or physiologic effect known to relate directly to the clinical effect of PLEGRIDY. |
| Mechanism of Action | The mechanism by which PLEGRIDY exerts its effects in patients with multiple sclerosis is unknown. |
| Toxicity | LD50 information for peginterferon beta-1a is not readily available in the literature. In clinical trials, no cases of overdoses occurred with the administration of interferon beta-1a at a dose of 75 µg administered subcutaneously 3 times a week.[L31428] In a case report, a 38-year-old patient attempted suicide with about 6 or 7 pre-filled syringes containing 44 mug (12 MIU) of subcutaneous interferon beta-1a; symptoms were limited to malaise and skin erythema, which resolved within 24 hours with no intervention. Laboratory test results were unremarkable.[A191871] In the case of an overdose with interferon-beta 1a, prescribing information suggests to contact the local poison control centre.[L31438] |
| Metabolism | Peginterferon beta-1a is not extensively metabolized in the liver.[L31428] |
| Absorption | Peginterferon beta-1a is almost completely absorbed after subcutaneous administration. After 125 microgram subcutaneous doses of peginterferon beta-1a to patient with MS, a Cmax of 280 pg/mL was reached between 1 and 1.5 days[A227983], and the AUC over a 14 day dosing interval was 34.8 ng.hr/mL.[L31428] The AUC ranges from 23.5-29.5 ng ml-1h, according to one pharmacokinetic study of patients with MS. Impairment of renal function may alter the Cmax and AUC of interferon beta-1a.[A227983] |
| The volume of distribution of peginterferon beta-1a is about 481 L.[L31428] One pharmacokinetic study of patients administered interferon beta-1a revealed a volume of distribution in the range of 248-726 L, depending on the week of treatment.[A227983] |
| Clearance | The average steady state clearance of peginterferon beta-1a is about 4.1 L/h.[L31428] One pharmacokinetic study revealed a clearance within the range of 3.68-7.89 L/h, depending on the week of treatment.[A227983] |
| Categories | NA |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | Theophylline, Zidovudine |
| Target | Interferon alpha/beta receptor 1 |
| Brand Name | Plegridy |
| Company | Biogen Canada Inc |
| Brand Description | Biogen Canada Inc |
| Prescribed For | PLEGRIDY (peginterferon beta-1a) is indicated for the treatment of patients with relapsing forms of multiple sclerosis. |
| Chemical Name | Methoxy poly(ethyleneglycol)-O-2-methylpropionaldehyde |
| Formulation | Prefilled glass syringe containing 0.5 mL of a sterile solution in water for injection of 63, 94, or 125 micrograms of peginterferon beta-1a |
| Physical Appearance | Sterile Solution |
| Route of Administration | Subcutaneous |
| Recommended Dosage | The recommended dosage of PLEGRIDY is 125 micrograms injected subcutaneously every 14 days. |
| Contraindication | PLEGRIDY is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta or peginterferon, or any other component of the formulation |
| Side Effects | Hepatic Injury; Depression and Suicide; Seizures; Anaphylaxis and Other Allergic Reactions; Injection Site Reactions; Congestive Heart Failure; Decreased Peripheral Blood Counts; Thrombotic Microangiopathy; Autoimmune Disorders. |
| Useful Link 1 | Link |
| Useful Link 2 | NA |
| Remarks | NA |