ENTYVIO SOLUTION FOR INJECTION IN PRE-FILLED PEN 108MG/0.68ML [SIN16673P]

Product Info

ENTYVIO SOLUTION FOR INJECTION IN PRE-FILLED PEN 108MG/0.68ML

[SIN16673P]

4.1 Therapeutic indications

Ulcerative colitis

Entyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.

Crohn’s disease

Entyvio is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.

4.2 Posology and method of administration

Entyvio treatment should be initiated and supervised by specialist healthcare professionals experienced in the diagnosis and treatment of ulcerative colitis or Crohn’s disease (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information ).

Posology

Ulcerative colitis and Crohn’s disease

The recommended dose regimen of subcutaneous vedolizumab as a maintenance treatment, following at least 2 intravenous infusions, is 108 mg administered by subcutaneous injection once every 2 weeks. The first subcutaneous maintenance dose should be administered in place of the next scheduled intravenous dose and every 2 weeks thereafter.

For the intravenous dose regimen, see section 4.2 of the Entyvio 300 mg powder for concentrate for solution for infusion package insert.

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.

There are no data on transition of patients from subcutaneous vedolizumab to intravenous vedolizumab during maintenance treatment.

In patients who have responded to treatment with vedolizumab, corticosteroids may be reduced and/or discontinued in accordance with standard of care.

Retreatment and missed dose(s)
If treatment with subcutaneous vedolizumab is interrupted or if a patient misses a scheduled dose(s) of subcutaneous vedolizumab, patient should be advised to inject the next subcutaneous dose as soon as possible and then every 2 weeks thereafter. The treatment interruption period in clinical studies extended up to 46 weeks with no evident increase in adverse reactions or injection site reactions during re-initiation of treatment with subcutaneous vedolizumab (see section 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Special populations

Elderly patients

No dose adjustment is required in elderly patients. Population pharmacokinetic analyses showed no effect of age (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients with renal or hepatic impairment

Vedolizumab has not been studied in these patient populations. No dose recommendations can be made.

Paediatric population

The safety and efficacy of vedolizumab in children aged 0 to 17 years old have not been established. No data are available.

Method of administration

Entyvio solution for injection (in a pre-filled pen) is for subcutaneous injection only.

After proper training on correct subcutaneous injection technique, a patient or caregiver may inject with subcutaneous vedolizumab if their physician determines it is appropriate. Comprehensive instructions for administration using the pre-filled pen are given in the respective package leaflet.

For further instructions on preparation and special precautions for handling, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Active severe infections such as tuberculosis (TB), sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML) (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).