Strength300 mg
Forminjection
Intravenous infusion at a fixed 300 mg dose, not by weight. US label verbatim: "Week 0: Administer ENTYVIO 300 mg by intravenous infusion over approximately 30 minutes. Week 2: Administer ENTYVIO 300 mg by intravenous infusion over approximately 30 minutes. Week 6: Patients may remain on ENTYVIO intravenous therapy or switch to subcutaneous injection after receiving two ENTYVIO intravenous doses administered at Week 0 and Week 2. Intravenous Infusion: Administer ENTYVIO 300 mg by intravenous infusion over approximately 30 minutes and then every eight weeks thereafter. Subcutaneous Injection: Administer ENTYVIO 108 mg subcutaneously once every 2 weeks." - Judged at week 14 and stopped there if nothing has changed. US label verbatim: "Discontinue therapy in patients who show no evidence of therapeutic benefit by Week 14."
Paediatric doseNot a paediatric prescription on this label. US label verbatim: "Safety and effectiveness of ENTYVIO in pediatric patients have not been established." A child or adolescent with inflammatory bowel disease belongs with paediatric gastroenterology.
Dose sourceENTYVIO (vedolizumab) for injection US prescribing information, section 1 Indications and Usage, section 2.2 Recommended Dosage in Adults with Ulcerative Colitis and Crohn's Disease, section 4 Contraindications and section 5 Warnings and Precautions (DailyMed SetID 6e94621c-1a95-4af9-98d1-52b9e6f1949c)
WhyThe disease article names the drug and what it does in this disease, verbatim: "Vedolizumab, the agent in this class used for Crohn disease, has demonstrated superior efficacy compared with placebo in both inducing and maintaining remission, with or without concomitant immunomodulators." The US label's indication section names the disease, verbatim: ENTYVIO "is indicated in adults for the treatment of: moderately to severely active Crohn's disease (CD)." The card carried budesonide and prednisolone alone - the steroids that induce remission and cannot maintain it - so the maintenance step the article describes was not shown at all. Gastroenterology starts it.
Cautions- Tuberculosis is assessed before the first infusion. US label verbatim: "Consider evaluating patients for TB infection prior to initiating treatment with ENTYVIO. Treatment with Entyvio should not be administered to patients with active TB infection. Initiate treatment of latent TB prior to administering ENTYVIO." Latent tuberculosis is common in Egypt, so this is a real gate rather than a formality.
- Infection risk is lower than with the anti-TNF drugs but it is not absent. US label verbatim: "Patients treated with ENTYVIO are at increased risk for developing infections. Serious infections reported in clinical trials include anal abscess, sepsis (some fatal), tuberculosis (TB), salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis." and "Treatment with ENTYVIO should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated."
- RED FLAG - new neurological symptoms. US label verbatim: "Monitor patients on ENTYVIO for any new onset, or worsening, of neurological signs and symptoms. Typical signs and symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes... If PML is suspected, withhold dosing with ENTYVIO and refer to a neurologist; if confirmed, discontinue dosing permanently."
- Infusion and hypersensitivity reactions, including anaphylaxis. US label verbatim: "Infusion-related reactions and hypersensitivity reactions have been reported, including anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate. These reactions may occur with the first or subsequent infusions of ENTYVIO and may vary in their time of onset from during infusion or up to several hours post-infusion." It is given by staff able to treat anaphylaxis, and a prior severe reaction to it is a contraindication.
- Liver injury. US label verbatim: "ENTYVIO should be discontinued in patients with jaundice or other evidence of significant liver injury."
- Get the vaccinations done first. US label verbatim: "Prior to initiating treatment with ENTYVIO, all patients should be brought up to date with all immunizations according to current immunization guidelines."
- A hospital drug, not a prescription-pad drug. Egypt registers one product, ENTYVIO 300 mg vial for infusion at roughly 48,800 EGP, and an eight-weekly schedule means that cost recurs. The regimen is printed here so a shared-care clinic can recognise it, hold it during infection and know when the next infusion is due.