Vedolizumab parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Parenteral formulations of vedolizumab.
Drugs List
Therapeutic Indications
Uses
Crohn's disease
Pouchitis
Ulcerative colitis
Dosage
Adults
Ulcerative Colitis
108mg - Maintenance treatment
108mg subcutaneous injection once every 2 weeks following at least 2 intravenous infusions. The first subcutaneous dose should be administered in place of the next scheduled intravenous dose and every 2 weeks thereafter.
300mg infusion
300mg by intravenous infusion at 0, 2 and 6 weeks and then every 8 weeks thereafter. If there is no evidence of therapeutic benefit observed by week 10, then therapy should be stopped.
Dosing frequency may be increased to 300mg every 4 weeks in patients who have had a decrease in their response.
Crohn's disease
108mg - Maintenance treatment
108mg subcutaneous injection once every 2 weeks following at least 2 intravenous infusions. The first subcutaneous dose should be administered in place of the next scheduled intravenous dose and every 2 weeks thereafter.
300mg infusion
300mg by intravenous infusion at 0, 2 and 6 weeks and then every 8 weeks thereafter. Patients who have not shown a response may benefit from a dose of vedolizumab at week 10. Continue therapy every 8 weeks from week 14 in responding patients. If there is no evidence of therapeutic benefit observed by week 14 in patient's with Crohn's disease then therapy should be stopped.
Dosing frequency may be increased to 300mg every 4 weeks in patients who have had a decrease in their response.
Pouchitis
300mg infusion
300mg by intravenous infusion at 0, 2 and 6 weeks and then every 8 weeks thereafter. Concomitant antibiotics should be given with vedolizumab treatment (e.g. four weeks of Ciprofloxacin). If there is no evidence of therapeutic benefit observed by week 14 in patient's with pouchitis then therapy should be stopped.
Additional Dosage Information
There is currently insufficient data to determine if patients who experience a decrease in response on maintenance treatment with subcutaneous vedolizumab would benefit from an increase in dosing frequency.
No data is available on the transition of patients from subcutaneous vedolizumab to intravenous vedolizumab during maintenance treatment.
300mg
In patients who have responded to treatment with vedolizumab, corticosteroids may be reduced and/or discontinued.
If therapy is interrupted and there is a need to restart treatment, dosing at every 4 weeks may be considered for ulcerative colitis and Crohn's disease. No retreatment data is available in patients with pouchitis.
Administration
108mg
For subcutaneous injection only.
300mg
For intravenous infusion only, over 30 minutes. Patients should be monitored during and after infusion.
Contraindications
Children under 18 years
Cytomegalovirus infection
Sepsis
Severe infection
Progressive multifocal leukoencephalopathy (PML)
Tuberculosis
Precautions and Warnings
Females of childbearing potential
History of recurrent infection
Predisposition to infection
Breastfeeding
Pregnancy
Advise patient dizziness may affect ability to drive or operate machinery
Before starting therapy ensure immunisations are up to date
Consider premedication for patients with history of infusion reactions
Not all formulations are licensed for all uses
Prior to starting therapy screen for latent tuberculosis
Treat and control infections prior to commencing therapy
Record name and batch number of administered product
Treatment to be administered under the supervision of a specialist
Monitor neurological function
Monitor patient constantly for signs of new infection
Monitor patient for infusion-associated reactions (IARs)
Discontinue if a serious infection develops
Immunosuppressive drugs may increase risk of malignancy
Monitor for hypersensitivity reactions for 1 hour after administration
Risk of developing opportunistic infections
Discontinue if Progressive multifocal leukoencephalopathy (PML) develops
Discontinue if serious allergic or anaphylactic reaction occurs
Female: Contraception required during and for 18 weeks after treatment
Remind patient of importance of carrying Alert Card with them at all times
Induction of remission in Crohn's disease may take up to 14 weeks in some patients.
Patients receiving vedolizumab treatment may continue to receive non-live vaccines. Administration of the influenza vaccine should be by injection in line with routine clinical practice. Other live vaccines may be administered concurrently with vedolizumab only if the benefits clearly outweigh the risks.
Observe the patient continuously during each infusion. For the first two infusions, the patient should be observed for two hours following completion of the infusion for signs and symptoms of acute hypersensitivity reactions. For all subsequent infusions patients should be observed for approximately one hour following completion of the infusion.
Use vedolizumab with caution in patients previously treated with other biological products (e.g. natalizumab or rituximab) as no clinical data exists. Patients previously exposed to natalizumab should normally wait a minimum of 12 weeks prior to initiating therapy with vedolizumab, unless otherwise indicated by the patient's clinical condition.
Pregnancy and Lactation
Pregnancy
Use vedolizumab with caution during pregnancy.
The manufacturer recommends vedolizumab should only be used in pregnancy if the benefits clearly outweigh any potential risk to both the mother and foetus. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. At this time there is limited published information regarding the use of vedolizumab during pregnancy. The potential risk is unknown.
Lactation
Use vedolizumab with caution during breastfeeding.
The manufacturer advises that the use of vedolizumab in breastfeeding women should take into account the benefit of vedolizumab therapy for the woman and the potential risks to the infant. Vedolizumab has been detected in breast milk, however, the effect on the infant is unknown.
Side Effects
Abdominal distension
Abscess
Acne
Anal fissure
Anaphylactic reaction
Anaphylactic shock
Arthralgia
Asthenia
Back pain
Blurred vision
Bronchitis
Candidiasis (mouth or throat)
Chest discomfort
Chills
Constipation
Cough
Dyspepsia
Eczema
Erythema
Extremity pain
Fatigue
Flatulence
Folliculitis
Gastro-enteritis
Haemorrhoids
Headache
Herpes zoster
Hypersensitivity reactions
Hypertension
Influenza
Infusion-related symptoms
Injection site reactions
Muscle spasm
Muscle weakness
Nasal congestion
Nasopharyngitis
Nausea
Night sweats
Oropharyngeal pain
Paraesthesia
Pharyngitis
Pneumonia
Pruritus
Pyrexia
Rash
Rectal haemorrhage
Respiratory tract infection
Sensation of cold
Sinusitis
Vaginal candidiasis
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: May 2020
Reference Sources
Summary of Product Characteristics: Entyvio 108mg solution for injection in pre-filled pen. Takeda UK Ltd. Revised January 2022.
Summary of Product Characteristics: Entyvio 108mg solution for injection in pre-filled syringe. Takeda UK Ltd. Revised January 2022.
Summary of Product Characteristics: Entyvio 300mg powder for concentrate for solution for infusion. Takeda UK Ltd. Revised March 2022.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 21 May 2020.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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