INFLECTRA (infliximab for Injection) Dosage And Administration

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Recommended Dose and Dosage Adjustment

For recommended intravenous infusion duration for patients with each of the indications described below, see DOSAGE AND ADMINISTRATION, Administration.

Rheumatoid Arthritis
The recommended dose of INFLECTRA® (infliximab for injection) is 3 mg/kg given as an intravenous infusion followed by additional 3 mg/kg doses at 2 and 6 weeks after the first infusion then every 8 weeks thereafter. INFLECTRA® should be given in combination with methotrexate. For patients who have an incomplete response, consideration may be given to adjusting the dose up to 10 mg/kg and/or treating as often as every 4 weeks. Duration of treatment needed to achieve a response after dose escalation is not known. However, higher doses of INFLECTRA® were associated with a slightly higher proportion of patients experiencing adverse events (97% for the 3 mg/kg dose given every 8 weeks vs. 100% for the 10 mg/kg dose given every 4 weeks), including infections (84% for the 3 mg/kg dose given every 8 weeks vs. 91% for the 10 mg/kg dose given every 4 weeks).

Ankylosing Spondylitis
The recommended dose of INFLECTRA® is 5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks thereafter.

Ulcerative Colitis
The recommended dose of INFLECTRA® is 5 mg/kg given as an induction regimen at 0, 2 and 6 weeks followed by 5 mg/kg every 8 weeks thereafter, for the treatment of adult and pediatric patients (≥ 6 years of age) with moderately to severely active ulcerative colitis. In some adult patients, consideration may be given to adjusting the dose up to 10 mg/kg to sustain clinical response and remission. Some adult patients may not benefit from dose escalation. In addition to the physician’s clinical assessment, measurement of infliximab trough levels and titers of antibodies to infliximab should be taken into account before considering dose adjustment.

Crohn’s Disease
Adults
The recommended dose of INFLECTRA® is 5 mg/kg given as an induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of moderate to severe, active Crohn’s disease. For patients who have an incomplete response, consideration may be given to adjusting the dose up to 10 mg/kg. Some adult patients may not benefit from dose escalation. In addition to the physician’s clinical assessment, measurement of infliximab trough levels and titers of antibodies to infliximab should be taken into account before considering dose adjustment.

The recommended dose of INFLECTRA® is 5 mg/kg given as an induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of fistulising Crohn’s disease. Patients who do not respond by Week 14 are unlikely to respond with continued dosing and consideration should be given to discontinue INFLECTRA® in these patients. For patients who respond and then lose their response, consideration may be given to treatment with 10 mg/kg. In the ACCENT II clinical study, among patients who lost response at 5 mg/kg infliximab for iInjection and re-established response following dose escalation to 10 mg/kg infliximab for injection, most had done so after 1 dose and all had done so after 2 doses of 10 mg/kg.

Pediatric
The recommended dose of INFLECTRA® for pediatric patients (≥ 9 years of age) with moderately to severely active Crohn’s disease is 5 mg/kg given as an induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks. Patients who do not respond by week 14 are unlikely to respond with continued dosing and consideration should be given to discontinue INFLECTRA® in these patients.

Psoriatic Arthritis
The recommended dose of INFLECTRA® is 5 mg/kg given as an intravenous infusion followed with additional similar doses at 2 and 6 weeks after the first infusion then every 8 weeks thereafter. INFLECTRA® can be used with or without methotrexate. If a patient shows no response at 24 weeks, no additional treatment with INFLECTRA® should be given.

Plaque Psoriasis
The recommended dose of INFLECTRA® is 5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. If a patient does not show an adequate response at Week 14, after infusions at weeks 0, 2, and 6, no additional treatment with INFLECTRA® should be given.

Special Populations

Renal Impairment

Infliximab for injection has not been studied in patients with renal impairment. No dose recommendations can be made (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations).

Hepatic Impairment

Infliximab for injection has not been studied in patients with hepatic impairment. No dose recommendations can be made (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations).

The infusion solution must be administered over a period of not less than 2 hours. All patients administered INFLECTRA® should be observed for at least 1 to 2 hours post-infusion for side effects. Emergency equipment, such as adrenaline, antihistamines, corticosteroids and an artificial airway must be available (see ADVERSE REACTIONS, Infusion-related Reactions).

The INFLECTRA patient assistance program (PfizerFlexTM) facilitates the administration of INFLECTRA®. The INFLECTRA patient assistance program (PfizerFlexTM) clinics are staffed by qualified healthcare professionals specially trained in the administration of INFLECTRA® infusions and are available across Canada. Information about the INFLECTRA patient assistance program (PfizerFlexTM) can be obtained by calling 1-855-935-3539.

Administration

Use aseptic technique.

INFLECTRA® vials do not contain antibacterial preservatives. Therefore, after reconstitution, the vials should be used immediately, not re-entered or stored. The diluent to be used for reconstitution is 10 mL of Sterile Water for Injection, USP. The total dose of the reconstituted product must be further diluted to 250 mL with 0.9% Sodium Chloride Injection, USP. The infusion concentration should range between 0.4 mg/mL and 4 mg/mL. Since no preservative is present, it is recommended that the INFLECTRA® infusion be started within 3 hours of reconstitution and dilution.

  1. Calculate the dose and the number of INFLECTRA® vials needed. Each INFLECTRA® vial contains 100 mg of infliximab. Calculate the total volume of reconstituted INFLECTRA® solution required.
     
  2. Reconstitute each INFLECTRA® vial with 10 mL of Sterile Water for Injection, USP, using a syringe equipped with a 21-gauge or smaller needle. Remove the flip-top from the vial and wipe the top with an alcohol swab. Insert the syringe needle into the vial through the centre of the rubber stopper and direct the stream of Sterile Water for Injection, USP, to the glass wall of the vial. Gently swirl the solution by rotating the vial to dissolve the lyophilized powder. Avoid prolonged or vigorous agitation. DO NOT SHAKE. Foaming of the solution on reconstitution is not unusual. Allow the reconstituted solution to stand for 5 minutes. The solution should be colourless to light yellow and opalescent, and the solution may develop a few translucent particles as infliximab is a protein. Do not use if opaque particles, discoloration, or other foreign particles are present.
     
  3. Dilute the total volume of the reconstituted INFLECTRA® solution dose to 250 mL with 0.9% Sodium Chloride Injection, USP, by withdrawing a volume of 0.9% Sodium Chloride Injection, USP, equal to the volume of reconstituted INFLECTRA® from the 0.9% Sodium Chloride Injection, USP, 250 mL bottle or bag. Slowly add the total volume of reconstituted INFLECTRA® solution to the 250 mL infusion bottle or bag. Gently mix.
     
  4. For patients with Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis, the infusion solution must be administered over a period of not less than 2 hours.

    For patients with rheumatoid arthritis, the recommended infusion duration is over a period of not less than 2 hours in patients not previously treated with INFLECTRA®. At the discretion of the treating physician, some patients with rheumatoid arthritis who have tolerated 3 initial 2-hour infusions of INFLECTRA® may be considered for receiving subsequent infusions at the same dose over a period of not less than 1 hour (see CLINICAL TRIALS - REFERENCE BIOLOGIC DRUG, Rheumatoid Arthritis and ADVERSE REACTIONS, Infusion-Related Reactions). The safety of shortened infusions at doses >6 mg/kg has not been studied.

    Use only an infusion set with an in-line, sterile, non-pyrogenic, low-protein-binding filter (pore size of 1.2 μm or less). Do not store any unused portion of the infusion solution.
     
  5. Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit. If visibly opaque particles, discolouration or other foreign particulates are observed, the solution should not be used.
     
  6. No physical biochemical compatibility studies have been conducted to evaluate the co-administration of INFLECTRA® with other agents. INFLECTRA® should not be infused concomitantly in the same intravenous line with other agents.

Reconstitution

Table - Reconstitution

Vial Size

Volume of Diluent to be Added to Vial

Approximate Available Volume

Nominal Concentration per mL

100 mg as lyophilized powder

10 mL Sterile Water for Injection, USP

250 mL

The total volume of the reconstituted product must be further diluted to 250 mL with 0.9% Sodium Chloride Injection, USP.

Between 0.4 mg/mL and 4 mg/mL

Since no preservative is present, it is recommended that the INFLECTRA® infusion be started within 3 hours of reconstitution and dilution unless the INFLECTRA® infusion is prepared under controlled and validated aseptic conditions (see STORAGE, STABILITY and DISPOSAL and SPECIAL HANDLING INSTRUCTIONS).

Missed Dose

It is important to receive each scheduled dose of this medication as directed. If patients who forget or miss an appointment, contact your doctor as soon as possible to establish a new dosing schedule.