HOW TO ADMINISTER FLIXABI™
IV INFUSION1
Flixabi™ treatment must be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatologic diseases, inflammatory bowel diseases and dermatological diseases. Flixabi™ should be administered intravenously.
The infusions should be administered by qualified healthcare professionals trained to detect any infusion-related issues.
Patients treated with Flixabi™ should be given the package leaflet and the patient reminder card.
Recommended infusion time and follow-up in the practice
Flixabi™ should be administered intravenously over a 2 hour period. All patients administered Flixabi™ 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 bw bw have not been studied (see section 4.8 of the Summary of Product Characteristics).
PACK SIZE AND DOSAGE1
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 lNFUSlON1
Read the full Summary of Product Characteristics for complete instructions on how to use Flixabi™.
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 Flixabi™ vials needed. Each Flixabi™ vial contains 100 mg infliximab. Calculate the total volume of reconstituted Flixabi™ 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, as infliximab is a protein.
Do not use if opaque particles, discolouration, or other foreign particles are present.
Dilute the total volume of the reconstituted Flixabi™ solution dose to 250 ml with sodium chloride (NaCl) 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 Flixabi™ 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.a
Do not infuse Flixabi™ concomitantly in the same intravenous line with other agents.
Do not store any unused portion of the infusion solution for reuse.
a 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.
