Peringatan Keamanan

Elevated transaminase levels with or without elevated bilirubin have occurred in patients who have received this drug. Progressive multifocal leukoencephalopathy (PML) has not been reported with the use of this drug, however, it has occurred in patients who have received different integrin receptor antagonists and is therefore considered a risk for this product.L48216 The use of vedolizumab may increase the risk of developing infections, and one study found that nasopharyngitis occurs more frequently with vedolizumab than with THE placebo for Crohn’s disease patients.A7610

Available pharmacovigilance data, data from the ongoing pregnancy registry, and data from published case reports and cohort studies in pregnant women have not identified a vedolizumab-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and the fetus associated with inflammatory bowel disease in pregnancy. No fetal harm was observed in animal reproduction studies with intravenous administration of vedolizumab to rabbits and monkeys at dose levels 20 times the recommended human dosage.L48216

Published data suggest that the risk of adverse pregnancy outcomes in women with inflammatory bowel disease (IBD) is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2,500 g) infants, and small for gestational age at birth.L48216

Vedolizumab administered during pregnancy could affect immune responses in the in-utero-exposed newborn and infant. The clinical significance of low levels of vedolizumab in utero-exposed infants is unknown. The safety of administering live or live-attenuated vaccines in exposed infants is unknown.L48216

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of vedolizumab. Studies to evaluate the possible impairment of fertility or mutagenic potential of vedolizumab have not been performed.L48216

Vedolizumab

DB09033

biotech approved

Deskripsi

Vedolizumab is a recombinant humanized IgG1 monoclonal antibody directed against the human lymphocyte ?4?7 integrin, a key mediator of gastrointestinal inflammation implicated in diseases like ulcerative colitis or Crohn's disease.L48216 ?4?7 integrin facilitates the interaction between lymphocytes and gut endothelial cells through the ?4?7 integrin-MAdCAM1 interaction, leading to the mobilization of lymphocytes and thus contributing to gastrointestinal inflammation.L48216 Integrins implicated in cell migration into the intestinal tract included ?2?2, ?4?1, and ?4?7; however, the selective activity of vedolizumab against ?4?7 integrin has been thought to contribute to its more favorable safety profile compared to its predecessor natalizumab, the first integrin receptor antagonist approved by the FDA.A261576 Vedolizumab is administered by IV infusion over a period of 30 minutes; after the first dose, it is given again at two and six weeks and then every 8 weeks thereafter.L48216

Vedolizumab was developed by Takeda and approved by the FDA under the brand name ENTYVIO for the maintenance therapy of moderately to severely active Ulcerative Colitis and Crohn’s Disease in April and September 2023, respectively.L48226,L48231

Struktur Molekul 2D

Struktur tidak tersedia

Peta Jejaring Molekuler
Legenda: Obat • Target • Gen • Enzim • (Panah → menunjukkan arah efek / relasi) • Transporter • Carrier

Profil Farmakokinetik

Waktu Paruh (Half-Life) Vedolizumab has a long terminal elimination half-life of 25 days.[L48216,L48221]
Volume Distribusi Serum apparent volume of distribution at steady-state has been found to be moderately greater than the serum volume (approximately 5L).[L48216,L48221] It is therefore expected to be confined to the systemic circulation, as expected for a high molecular weight protein.[L48221]
Klirens (Clearance) Vedolizumab clearance depends on both linear and nonlinear pathways; the nonlinear clearance decreases with increasing concentrations. Population pharmacokinetic analyses indicated that the linear clearance was approximately 0.157 L/day or 0.180 to 0.266 ml/hr/kg.[L48216,L48221]

Absorpsi

The intended route of administration is intravenous, therefore there is no absorption data and bioavailability is expected to be 100%. Following the administration of 300 mg of vedolizumab as a 30-minute intravenous infusion from week 0 to 2 and 300 mg every eight weeks starting from Week 6, the trough serum concentration of vedolizumab is 26.3 ± 12.9 and 27.4 ± 19.2 mcg/mL for Ulcerative Colitis and Crohn’s Disease patients respectively at week 6.L48221 At week 46, the trough serum concentration of vedolizumab is 11.2 ± 7.2 and 13.0 ± 9.1 mcg/mL for Ulcerative Colitis and Crohn’s Disease patients respectively.L48221

Metabolisme

The expected consequence of metabolism is proteolytic degradation to small peptides and individual amino acids, and receptor-mediated clearance.L48221

Rute Eliminasi

Renal clearance is negligible as vedolizumab is a high molecular weight protein.

Interaksi Obat

670 Data
Denosumab The risk or severity of adverse effects can be increased when Denosumab is combined with Vedolizumab.
Peginterferon alfa-2a The risk or severity of adverse effects can be increased when Peginterferon alfa-2a is combined with Vedolizumab.
Interferon alfa-n1 The risk or severity of adverse effects can be increased when Interferon alfa-n1 is combined with Vedolizumab.
Interferon alfa-n3 The risk or severity of adverse effects can be increased when Interferon alfa-n3 is combined with Vedolizumab.
Peginterferon alfa-2b The risk or severity of adverse effects can be increased when Peginterferon alfa-2b is combined with Vedolizumab.
Anakinra The risk or severity of adverse effects can be increased when Anakinra is combined with Vedolizumab.
Interferon gamma-1b The risk or severity of adverse effects can be increased when Interferon gamma-1b is combined with Vedolizumab.
Interferon alfa-2a The risk or severity of adverse effects can be increased when Interferon alfa-2a is combined with Vedolizumab.
Aldesleukin The risk or severity of adverse effects can be increased when Aldesleukin is combined with Vedolizumab.
Gemtuzumab ozogamicin The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Vedolizumab.
Pegaspargase The risk or severity of adverse effects can be increased when Pegaspargase is combined with Vedolizumab.
Interferon beta-1b The risk or severity of adverse effects can be increased when Interferon beta-1b is combined with Vedolizumab.
Interferon alfacon-1 The risk or severity of adverse effects can be increased when Interferon alfacon-1 is combined with Vedolizumab.
Rituximab The risk or severity of adverse effects can be increased when Rituximab is combined with Vedolizumab.
Basiliximab The risk or severity of adverse effects can be increased when Basiliximab is combined with Vedolizumab.
Muromonab The risk or severity of adverse effects can be increased when Muromonab is combined with Vedolizumab.
Ibritumomab tiuxetan The risk or severity of adverse effects can be increased when Ibritumomab tiuxetan is combined with Vedolizumab.
Tositumomab The risk or severity of adverse effects can be increased when Tositumomab is combined with Vedolizumab.
Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Vedolizumab.
Alefacept The risk or severity of adverse effects can be increased when Alefacept is combined with Vedolizumab.
Efalizumab The risk or severity of adverse effects can be increased when Efalizumab is combined with Vedolizumab.
Antithymocyte immunoglobulin (rabbit) The risk or severity of adverse effects can be increased when Antithymocyte immunoglobulin (rabbit) is combined with Vedolizumab.
Interferon alfa-2b The risk or severity of adverse effects can be increased when Interferon alfa-2b is combined with Vedolizumab.
Daclizumab The risk or severity of adverse effects can be increased when Daclizumab is combined with Vedolizumab.
Phenylalanine The risk or severity of adverse effects can be increased when Phenylalanine is combined with Vedolizumab.
Flunisolide The risk or severity of adverse effects can be increased when Flunisolide is combined with Vedolizumab.
Bortezomib The risk or severity of adverse effects can be increased when Bortezomib is combined with Vedolizumab.
Cladribine Vedolizumab may increase the immunosuppressive activities of Cladribine.
Carmustine The risk or severity of adverse effects can be increased when Carmustine is combined with Vedolizumab.
Amsacrine The risk or severity of adverse effects can be increased when Amsacrine is combined with Vedolizumab.
Bleomycin The risk or severity of adverse effects can be increased when Bleomycin is combined with Vedolizumab.
Chlorambucil The risk or severity of adverse effects can be increased when Chlorambucil is combined with Vedolizumab.
Raltitrexed The risk or severity of adverse effects can be increased when Raltitrexed is combined with Vedolizumab.
Mitomycin The risk or severity of adverse effects can be increased when Mitomycin is combined with Vedolizumab.
Bexarotene The risk or severity of adverse effects can be increased when Bexarotene is combined with Vedolizumab.
Vindesine The risk or severity of adverse effects can be increased when Vindesine is combined with Vedolizumab.
Floxuridine The risk or severity of adverse effects can be increased when Floxuridine is combined with Vedolizumab.
Indomethacin The risk or severity of adverse effects can be increased when Indomethacin is combined with Vedolizumab.
Tioguanine The risk or severity of adverse effects can be increased when Tioguanine is combined with Vedolizumab.
Vinorelbine The risk or severity of adverse effects can be increased when Vinorelbine is combined with Vedolizumab.
Dexrazoxane The risk or severity of adverse effects can be increased when Dexrazoxane is combined with Vedolizumab.
Beclomethasone dipropionate The risk or severity of adverse effects can be increased when Beclomethasone dipropionate is combined with Vedolizumab.
Sorafenib The risk or severity of adverse effects can be increased when Sorafenib is combined with Vedolizumab.
Streptozocin The risk or severity of adverse effects can be increased when Streptozocin is combined with Vedolizumab.
Trifluridine The risk or severity of adverse effects can be increased when Trifluridine is combined with Vedolizumab.
Gemcitabine The risk or severity of adverse effects can be increased when Gemcitabine is combined with Vedolizumab.
Betamethasone The risk or severity of adverse effects can be increased when Betamethasone is combined with Vedolizumab.
Teniposide The risk or severity of adverse effects can be increased when Teniposide is combined with Vedolizumab.
Epirubicin The risk or severity of adverse effects can be increased when Epirubicin is combined with Vedolizumab.
Chloramphenicol The risk or severity of adverse effects can be increased when Chloramphenicol is combined with Vedolizumab.
Lenalidomide The risk or severity of adverse effects can be increased when Lenalidomide is combined with Vedolizumab.
Altretamine The risk or severity of adverse effects can be increased when Altretamine is combined with Vedolizumab.
Zidovudine The risk or severity of adverse effects can be increased when Zidovudine is combined with Vedolizumab.
Cisplatin The risk or severity of adverse effects can be increased when Cisplatin is combined with Vedolizumab.
Oxaliplatin The risk or severity of adverse effects can be increased when Oxaliplatin is combined with Vedolizumab.
Cyclophosphamide The risk or severity of adverse effects can be increased when Cyclophosphamide is combined with Vedolizumab.
Vincristine The risk or severity of adverse effects can be increased when Vincristine is combined with Vedolizumab.
Fluorouracil The risk or severity of adverse effects can be increased when Fluorouracil is combined with Vedolizumab.
Propylthiouracil The risk or severity of adverse effects can be increased when Propylthiouracil is combined with Vedolizumab.
Pentostatin The risk or severity of adverse effects can be increased when Pentostatin is combined with Vedolizumab.
Methotrexate The risk or severity of adverse effects can be increased when Methotrexate is combined with Vedolizumab.
Carbamazepine The risk or severity of adverse effects can be increased when Carbamazepine is combined with Vedolizumab.
Vinblastine The risk or severity of adverse effects can be increased when Vinblastine is combined with Vedolizumab.
Fluticasone propionate The risk or severity of adverse effects can be increased when Fluticasone propionate is combined with Vedolizumab.
Fluocinolone acetonide The risk or severity of adverse effects can be increased when Fluocinolone acetonide is combined with Vedolizumab.
Linezolid The risk or severity of adverse effects can be increased when Linezolid is combined with Vedolizumab.
Imatinib The risk or severity of adverse effects can be increased when Imatinib is combined with Vedolizumab.
Triamcinolone The risk or severity of adverse effects can be increased when Triamcinolone is combined with Vedolizumab.
Clofarabine The risk or severity of adverse effects can be increased when Clofarabine is combined with Vedolizumab.
Prednisone The risk or severity of adverse effects can be increased when Prednisone is combined with Vedolizumab.
Pemetrexed The risk or severity of adverse effects can be increased when Pemetrexed is combined with Vedolizumab.
Fludrocortisone The risk or severity of adverse effects can be increased when Fludrocortisone is combined with Vedolizumab.
Mycophenolate mofetil The risk or severity of adverse effects can be increased when Mycophenolate mofetil is combined with Vedolizumab.
Daunorubicin The risk or severity of adverse effects can be increased when Daunorubicin is combined with Vedolizumab.
Irinotecan The risk or severity of adverse effects can be increased when Irinotecan is combined with Vedolizumab.
Methimazole The risk or severity of adverse effects can be increased when Methimazole is combined with Vedolizumab.
Etoposide The risk or severity of adverse effects can be increased when Etoposide is combined with Vedolizumab.
Sulfasalazine The risk or severity of adverse effects can be increased when Sulfasalazine is combined with Vedolizumab.
Dacarbazine The risk or severity of adverse effects can be increased when Dacarbazine is combined with Vedolizumab.
Temozolomide The risk or severity of adverse effects can be increased when Temozolomide is combined with Vedolizumab.
Penicillamine The risk or severity of adverse effects can be increased when Penicillamine is combined with Vedolizumab.
Prednisolone The risk or severity of adverse effects can be increased when Prednisolone is combined with Vedolizumab.
Sirolimus The risk or severity of adverse effects can be increased when Sirolimus is combined with Vedolizumab.
Mechlorethamine The risk or severity of adverse effects can be increased when Mechlorethamine is combined with Vedolizumab.
Azacitidine The risk or severity of adverse effects can be increased when Azacitidine is combined with Vedolizumab.
Carboplatin The risk or severity of adverse effects can be increased when Carboplatin is combined with Vedolizumab.
Methylprednisolone The risk or severity of adverse effects can be increased when Methylprednisolone is combined with Vedolizumab.
Dactinomycin The risk or severity of adverse effects can be increased when Dactinomycin is combined with Vedolizumab.
Cytarabine The risk or severity of adverse effects can be increased when Cytarabine is combined with Vedolizumab.
Azathioprine The risk or severity of adverse effects can be increased when Azathioprine is combined with Vedolizumab.
Doxorubicin The risk or severity of adverse effects can be increased when Doxorubicin is combined with Vedolizumab.
Hydroxyurea The risk or severity of adverse effects can be increased when Hydroxyurea is combined with Vedolizumab.
Busulfan The risk or severity of adverse effects can be increased when Busulfan is combined with Vedolizumab.
Mycophenolic acid The risk or severity of adverse effects can be increased when Mycophenolic acid is combined with Vedolizumab.
Topotecan The risk or severity of adverse effects can be increased when Topotecan is combined with Vedolizumab.
Mercaptopurine The risk or severity of adverse effects can be increased when Mercaptopurine is combined with Vedolizumab.
Thalidomide The risk or severity of adverse effects can be increased when Thalidomide is combined with Vedolizumab.
Melphalan The risk or severity of adverse effects can be increased when Melphalan is combined with Vedolizumab.
Fludarabine The risk or severity of adverse effects can be increased when Fludarabine is combined with Vedolizumab.
Flucytosine The risk or severity of adverse effects can be increased when Flucytosine is combined with Vedolizumab.

Target Protein

Integrin alpha-4 ITGA4
Integrin beta-7 ITGB7

Referensi & Sumber

Artikel (PubMed)
  • PMID: 19509315
    Soler D, Chapman T, Yang LL, Wyant T, Egan R, Fedyk ER: The binding specificity and selective antagonism of vedolizumab, an anti-alpha4beta7 integrin therapeutic antibody in development for inflammatory bowel diseases. J Pharmacol Exp Ther. 2009 Sep;330(3):864-75. doi: 10.1124/jpet.109.153973. Epub 2009 Jun 9.
  • PMID: 25526490
    Wang MC, Zhang LY, Han W, Shao Y, Chen M, Ni R, Wang GN, Wei FX, Zhang YW, Xu XD, Zhang YC: PRISMA--efficacy and safety of vedolizumab for inflammatory bowel diseases: a systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2014 Dec;93(28):e326. doi: 10.1097/MD.0000000000000326.
  • PMID: 26336591
    Cherry LN, Yunker NS, Lambert ER, Vaughan D, Lowe DK: Vedolizumab: an alpha4beta7 integrin antagonist for ulcerative colitis and Crohn's disease. Ther Adv Chronic Dis. 2015 Sep;6(5):224-33. doi: 10.1177/2040622315586970.

Contoh Produk & Brand

Produk: 13 • International brands: 0
Produk
  • Entyvio
    Injection, powder, lyophilized, for solution • 300 mg/5mL • Intravenous • US • Approved
  • Entyvio
    Powder, for solution • 300 mg / vial • Intravenous • Canada • Approved
  • Entyvio
    Solution • 108 mg / 0.68 mL • Subcutaneous • Canada • Approved
  • Entyvio
    Solution • 108 mg / 0.68 mL • Subcutaneous • Canada • Approved
  • Entyvio
    Injection, solution • 108 mg/0.68mL • Subcutaneous • US • Approved
  • Entyvio
    Injection, powder, for solution • 300 mg • Intravenous • EU • Approved
  • Entyvio
    Injection, solution • 108 mg • Subcutaneous • EU • Approved
  • Entyvio
    Injection, solution • 108 mg • Subcutaneous • EU • Approved
Menampilkan 8 dari 13 produk.

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