Loading…
ENTYVIO is a brand name for Vedolizumab, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ENTYVIO® (vedolizumab) is indicated for: Ulcerative Colitis (Adults ≥ 18 years) the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, loss of response to, or were intolerant to either conventional therapy or infliximab, a tumor necrosis factor-alpha…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Entyvio® [IV] • Entyvio® is administered as an intravenous infusion over 30 minutes. ENTYVIO® (vedolizumab) - Product Monograph Page 5 of 62 • Entyvio® must be reconstituted and diluted prior to administration (see Instructions for Reconstitution and Infusion).
Do not administer as an intravenous push or bolus. 9% sodium chloride solution or 250 mL of sterile Lactated Ringer’s solution prior to administration. 9% sodium chloride solution or 30 mL of sterile Lactated Ringer’s solution. • Entyvio® should be administered by a healthcare professional prepared to manage hypersensitivity reactions including anaphylaxis, if they occur.
Entyvio® [SC] Pre-filled Syringe/Pen • All patients should begin treatment with Entyvio® using intravenous administration (see Intravenous Administration section above). It is recommended that the first subcutaneous injection be administered under health professional supervision, with observation after injection to monitor for signs of severe injection site reactions or anaphylaxis.
• Patients should receive adequate instruction on how to use the subcutaneous injection device (prefilled syringe or pen) prior to attempting self-administration. After proper training on correct subcutaneous injection technique, a patient or caregiver may inject subcutaneous vedolizumab if the health provider determines it is appropriate.
Please refer to comprehensive instructions for the administration of subcutaneous Entyvio® in PATIENT MEDICATION INFORMATION • At this time there are no data on transition of patients from subcutaneous Entyvio® to intravenous Entyvio® during maintenance treatment.
Takeda’s ONEPath® Patient Support Program has been established to facilitate the administration of Entyvio® (IV and SC). OnePath® program is available across Canada through a network of qualified health professionals who will assist in administering and/or instructing on how to use Entyvio®.
2 Recommended Dose and Dosage Adjustment (Adults ≥ 18 years) Intravenous Administration (Entyvio® [IV]) Ulcerative Colitis • The recommended dose regimen of Entyvio® is 300 mg administered by intravenous infusion at zero, two and six weeks and then every eight weeks thereafter.
• Discontinue therapy in patients who show no evidence of therapeutic benefit by Week 10. • During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines. ENTYVIO® (vedolizumab) - Product Monograph Page 6 of 62 • No clinical trial data with Entyvio® are available for patients previously treated with biologic agents other than infliximab.
). In the post-marketing setting, reports of anaphylaxis have been identified. Experience with other biologic medications suggest that hypersensitivity reactions and anaphylaxis may vary in their time of onset from during or immediately after administration to occurring up to several hours later.
g. epinephrine and antihistamines).
Additional information for IV infusion:
If a mild to moderate IRR occurs during infusion, the infusion rate can be slowed or interrupted and appropriate treatment initiated. Once the mild or moderate IRR subsides, the healthcare professional may continue the infusion with monitoring.
1 DOSAGE AND ADMINISTRATION). Infections Physicians should be aware of the potential increased risk of infections or opportunistic infections. Vedolizumab is a gut-selective integrin antagonist (see 10 CLINICAL PHARMACOLOGY) with no identified systemic immunosuppressive activity.
Treatment with Entyvio® is not to be initiated in patients with active, severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections until the infections are controlled. Treatment should be withheld in patients who develop a severe infection while on chronic treatment with Entyvio®.
Caution should be exercised when considering the use of Entyvio® in patients with a controlled chronic severe infection or a history of recurring severe infections. Prior to the initiation of treatment, screening for tuberculosis (TB) should be considered according to local practice.
Progressive Multifocal Leukoencephalopathy (PML) Some integrin antagonists and some systemic immunosuppressive agents have been associated with progressive multifocal leukoencephalopathy (PML), which is a rare and often fatal opportunistic infection, of the central nervous system (CNS), caused by the John Cunningham (JC) virus.
). Appropriate monitoring and medical support measures should be available for immediate use when administering Entyvio®. Observe patients during infusion and until the infusion is complete. If an acute severe infusion reaction occurs, discontinue administration of Entyvio® immediately and initiate appropriate therapy (see 7 WARNINGS AND PRECAUTIONS).
Subcutaneous Administration (Entyvio® [SC] Pre-Filled Syringe/Pen) After removing the pre-filled syringe or pre-filled pen from the refrigerator, wait 30 minutes before injecting to allow the solution to reach room temperature. Do not leave the pre-filled syringe or pre-filled pen in direct sunlight.
Do not freeze. Do not use if it has been frozen. Inspect the solution visually for particulate matter and discolouration prior to administration. The solution should be colourless to yellow. Do not use pre-filled syringe or pre-filled pen with visible particulate matter or discolouration.
ENTYVIO® (vedolizumab) - Product Monograph Page 9 of 62 Each pre-filled syringe or pre-filled pen is for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 5 Missed Dose Intravenous Administration (Entyvio® [IV]) Patients who miss their scheduled infusion should be advised to contact their health professional and to schedule another appointment as soon as possible.
Subcutaneous Administration (Entyvio® [SC] Pre-Filled Syringe/Pen) If treatment with subcutaneous Entyvio® is interrupted or if a patient misses a scheduled dose(s) of subcutaneous vedolizumab, advise the patient to inject the next subcutaneous dose as soon as possible and then every 2 weeks thereafter.
5 OVERDOSAGE There were no reported cases of overdose in clinical trials. 5 times the recommended dose) have been administered in clinical trials without dose-limiting toxicity. In case of overdose, monitor patients for any signs or symptoms of adverse reactions or effects and institute appropriate symptomatic treatment immediately.
• Patients who are hypersensitive to vedolizumab or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Patients with active severe infections or opportunistic infections.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Caution should be exercised when considering the use of Entyvio® in these patients. • After completion of at least 2 intravenous doses of Entyvio®, ulcerative colitis patients showing clinical response may switch to subcutaneous maintenance dosing (see Subcutaneous Administration section below).
• Some patients who have experienced a decrease in their response may benefit from an increase in dosing frequency to intravenous vedolizumab 300 mg every four weeks. Crohn’s Disease • The recommended dose regimen of Entyvio® is 300 mg administered by intravenous infusion at zero, two and six weeks and then every eight weeks thereafter.
• Discontinue therapy in patients who show no evidence of therapeutic benefit by Week 14. • During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines. • Some patients who have experienced a decrease in their response may benefit from an increase in dosing frequency to intravenous vedolizumab 300 mg every four weeks.
Subcutaneous Administration (Entyvio® [SC] Pre-filled Syringe/Pen) Ulcerative Colitis • The recommended dose regimen of subcutaneous Entyvio® as a maintenance treatment, following at least two intravenous infusions, is 108 mg administered by subcutaneous injection once every 2 weeks.
The first subcutaneous dose should be administered in place of the next scheduled intravenous dose and every 2 weeks thereafter. See Intravenous Administration section above for intravenous dosing schedule. • During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
• Entyvio® prefilled syringe or Entyvio® pre-filled pen is for subcutaneous injection only. • Insufficient data are available to determine if patients who experience a decrease in response on maintenance treatment with subcutaneous vedolizumab would benefit from an increase in dosing frequency.
Crohn’s Disease • The recommended dose regimen of subcutaneous Entyvio® as a maintenance treatment, following at least two intravenous infusions, is 108 mg administered by subcutaneous injection once every 2 weeks. The first subcutaneous dose should be ENTYVIO® (vedolizumab) - Product Monograph Page 7 of 62 administered in place of the next scheduled intravenous dose and every 2 weeks thereafter.
See Intravenous Administration section above for intravenous dosing schedule. • During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines. • Entyvio® pre-filled syringe or Entyvio® pre-filled pen is for subcutaneous injection only.
• Insufficient data are available to determine if patients who experience a decrease in response on maintenance treatment with subcutaneous vedolizumab would benefit from an increase in dosing frequency. • Health Canada has not authorized an indication for pediatric use.
9% Sodium Chloride Injection or Lactated Ringer’s […]
Entyvio® has no known systemic immunosuppressive activity; however, a risk of PML cannot be ruled out. Health professionals should monitor patients on Entyvio® for any new onset or worsening of neurological signs and symptoms, and consider neurological referral if they occur.
If PML is suspected, withhold dosing with Entyvio®; if confirmed, discontinue dosing permanently. Typical signs and symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body, clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
The progression of deficits usually leads to death or severe disability over weeks or months. ENTYVIO® (vedolizumab) - Product Monograph Page 12 of 62 Prior and Concurrent Drug Exposures Patients who had previously been treated with natalizumab or rituximab were excluded from the clinical trials.
No clinical trial data for concomitant use of Entyvio® with biologic immunosuppressants are available. The use of Entyvio® in such patients is not recommended. Hepatic/Biliary No formal studies have been conducted to examine the effects of hepatic impairment on the pharmacokinetics of vedolizumab.
No dose recommendation can be made. Liver Injury There have been reports of elevations of transaminase and/or bilirubin in patients receiving Entyvio® (see 8 ADVERSE REACTIONS). Entyvio® should be discontinued in patients with jaundice or other evidence of significant liver injury.
Immune Live and Oral Vaccines It is recommended that all patients be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating treatment with Entyvio®. g. subunit or inactivated vaccines).
There are no data on the secondary transmission of infection by live vaccines in patients receiving Entyvio®. Live vaccines may be administered concurrently with Entyvio® only if the benefits outweigh the risks. Administration of the influenza vaccine should be by injection in line with routine clinical practice.
In a placebo-controlled study of healthy volunteers, a single 750 mg dose of Entyvio® did not lower rates of protective immunity to Hepatitis B virus in volunteers who were vaccinated intramuscularly with three doses of recombinant Hepatitis B surface antigen.
Entyvio® exposed subjects had lower seroconversion rates after receiving two doses of a killed, oral cholera vaccine (see 10 CLINICAL PHARMACOLOGY). The impact on other oral and nasal vaccines is unknown. Renal No formal studies have been conducted to examine the effects of renal impairment on the pharmacokinetics of vedolizumab.
No dose recommendation can be made. 1 Pregnant Women There are no studies with vedolizumab in pregnant women. It is strongly recommended that women of childbearing potential use adequate contraception to prevent pregnancy and to continue its use for at least 18 weeks after the last treatment with Entyvio®.
2 Breast-feeding Vedolizumab has been detected in human milk. The effect of vedolizumab on breast-fed infants and the effects on milk production are unknown. 26 mcg/mL. 3 Pediatrics Pediatrics (< 18 years of […]
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING To help ensure the traceability of biologic products, including biosimilars, health professionals should recognise the importance of recording both the brand name and the non-proprietary (active ingredient) name as well as other product-specific identifiers such as the Drug Identification Number (DIN) and the batch/lot number of the product supplied.
68 mL single-use pre-filled syringe or single-use pre-filled pen citric acid monohydrate, sodium citrate dihydrate, L-histidine, L-histidine monohydrochloride, L-arginine hydrochloride, polysorbate 80, sterile water for injection ENTYVIO® (vedolizumab) - Product Monograph Page 10 of 62 Entyvio® [IV] Entyvio® is supplied in sterile 20 mL single-use glass vials, containing 300 mg of vedolizumab as a white to off-white cake.
Each individual carton contains one single-use vial.
Non-medicinal ingredients:
L-histidine, L-histidine monohydrochloride, L-arginine hydrochloride, sucrose, polysorbate 80. Entyvio® [SC] Entyvio® for subcutaneous injection is supplied as a single-dose in a Type I 1 mL long glass syringe with a fixed 27 gauge thin wall, ½ inch needle.
The syringe is pre-filled and assembled into either a needle safety device pre-filled syringe or autoinjector. The syringe has a rubber needle cover encased in a plastic shell and rubber stopper. Pre-filled Syringe The Entyvio® pre-filled syringe (Entyvio® PFS) is a single-dose, disposable drug delivery system with manual injection operation.
Each Entyvio® pre-filled syringe is equipped with a safety device that activates to extend and lock a guard over the needle once the injection is completed. 68 mL single-dose pre-filled syringe available in pack sizes of one, two or six pre-filled syringes.
Pen The Entyvio® pre-filled pen (Entyvio® Pen) is a single-dose, disposable drug delivery system with mechanical injection operation. Each Entyvio® pre-filled pen is equipped with an automated needle shield to extend and lock over the needle once the injection is completed and the device is removed from the injection site.
68 mL single-dose pre-filled pen available in pack sizes of one, two or six pre-filled pen. 7 WARNINGS AND PRECAUTIONS General Infusion Reactions and Hypersensitivity In clinical trials with Entyvio®, infusion related reactions (IRR), and hypersensitivity reactions have been reported, with the majority being mild to moderate in severity (see 8.