EUROPEAN LlCENSED lNDlCATlONS1

RHEUMATOlD ARTHRlTlS (RA)

Flixabi™ in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:

  • adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate.
  • adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.

In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated (please see section 5.1 of the Summary of Product Characteristics).

ADULT CROHN’S DISEASE

Flixabi™ is indicated for:

  • treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
  • treatment of fistulising, active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).
PAEDIATRIC CROHN’S DISEASE

Flixabi™ is indicated for treatment of severe, active Crohn’s disease in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Infliximab has been studied only in combination with conventional immunosuppressive therapy.

ULCERATIVE COLITIS

Flixabi™ is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

PAEDIATRIC ULCERATIVE COLITIS

Flixabi™ is indicated for treatment of severely active ulcerative colitis in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.

ANKYLOSING SPONDYLITIS

Flixabi™ is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.

PSORIATIC ARTHRITIS

Flixabi™ is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.

Flixabi™ should be administered:

  • in combination with methotrexate.
  • or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.

Infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1 of the Summary of Product Characteristics).

PSORIASIS

Flixabi™ is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen ultra-violet A (PUVA) (see section 5.1 of the Summary of Product Characteristics).

ATTENTION

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Please consult your application support team.

ADMINISTRATION

HOW TO ADMINISTER

FlixabiTM treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, inflammatory bowel diseases, ankylosing spondylitis, psoriatic arthritis or psoriasis. FlixabiTM should be administered intravenously. 

FlixabiTM infusions should be administered by qualified healthcare professionals trained to detect any infusion-related issues. 

Patients treated with FlixabiTM should be given the package leaflet and the patient reminder card.

During FlixabiTM treatment, other concomitant therapies, e.g. corticosteroids and immunosuppressants should be optimised.

Recommended infusion time and follow-up in the practice
Please see the full Summary of Product Characteristics for further information.
FlixabiTM should be administered intravenously over a 2-hour period. All patients administered FlixabiTM must be observed for at least 1-2 hours post-infusion for acute infusion-related reactions.

Induction phase

 

1. Infusion

2. Infusion
(At 2 weeks after 1st infusion)
3. Infusion
(At 6 weeks after 1st infusion)

MAINTENANCE THERAPY: shortened infusion as an option in adults after the induction phase

In carefully selected adult patients who have tolerated at least 3 initial 2-hour infusions of FlixabiTM and are receiving maintenance therapy, consideration may be given to administering subsequent infusions over a period of not less than 1 hour. If an infusion reaction occurs in association with a shortened infusion, a slower infusion rate may be considered for future infusions if treatment is to be continued.

Shortened infusions at doses >6 mg/kg have not been studied (see section 4.8 of the SmPC).

PACK SlZE AND DOSlNG1

Depending on indication and body weight, the required total dose determines the number of FlixabiTM vials.
For dosing intervals please refer to the full Summary of Product Characteristics for further information.

STEP BY STEP RECONSTlTUTlON OF THE lNFUSlON

In order to improve the traceability of biological medicinal products, the tradename and batch number of the administered medicinal product should be clearly recorded.
Calculate the dose and the number of FlixabiTM vials needed. Each FlixabiTM vial contains 100 mg infliximab. Calculate the total volume of reconstituted FlixabiTM solution required.

Remove flip-top from the vial and wipe the top with a 70% alcohol swab.

Under aseptic conditions, insert the 21G (0.8 mm) or smaller syringe needle into the vial through the centre of the rubber stopper.

Allow 10 ml water for injections to flow down the inner wall of each vial.

Gently swirl the solution by rotating the vial to dissolve the lyophilised powder. Avoid prolonged or vigorous agitation. Do not shake.

Foaming of the solution on reconstitution is not unusual.

Leave the reconstituted solution to stand for 5 minutes.

Checking the solution: It should be colourless to light yellow and opalescent; the solution may develop a few fine translucent particles.

Do not use if opaque particles, discolouration, or other foreign particles are present.

Dilute the total volume of the reconstituted FlixabiTM solution dose to 250 ml with sodium chloride 0.9% solution for infusion. Do not dilute the reconstituted Flixabi™ solution with any other diluent.

Withdraw a volume from the 250 ml 0.9% NaCl solution equal to the volume of reconstituted Flixabi™ solution(s).

Slowly add the total volume of reconstituted FlixabiTM solution to the 250 ml infusion bottle or bag and gently mix.

Please refer to the SmPC, section 6.6 Special precautions for disposal and other handling for volumes greater than 250 ml.

Administer the infusion solution over a period of not less than the infusion time recommended (see section 4.2 on Dosing and Administration of the Summary of Product Characteristics).

Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 1.2 micrometre or less).

Since no preservative is present, it is recommended that the administration of the solution for infusion is to be started as soon as possible and within 3 hours of reconstitution and dilution.

If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless reconstitution/dilution has been taken place in controlled and validated aseptic conditions.

Do not infuse FlixabiTM concomitantly in the same intravenous line with other agents.

Do not store any unused portion of the infusion solution for reuse.

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