SIMPONI® I.V. CONCENTRATE FOR SOLUTION FOR INFUSION 12.5MG/1 ML [SIN14734P]

Product Info

SIMPONI® I.V. CONCENTRATE FOR SOLUTION FOR INFUSION 12.5MG/1 ML

[SIN14734P]

1 INDICATIONS AND USAGE
1.1 Rheumatoid arthritis (RA)
SIMPONI® I.V., in combination with methotrexate (MTX), is indicated for:

• Reducing signs and symptoms, inhibiting the progression of structural damage, improving physical function and improving health related quality of life in adult patients with moderate to severe active rheumatoid arthritis.

1.2 Psoriatic Arthritis (PsA)

SIMPONI® I.V. is indicated for the treatment of active psoriatic arthritis when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate in patients 2 years of age and older.

1.3 Ankylosing Spondylitis (AS)

SIMPONI® I.V. is indicated for the treatment of adult patients with active ankylosing spondylitis who have had an inadequate response to conventional therapy.

1.4 Polyarticular Juvenile Idiopathic Arthritis (pJIA)

SIMPONI® I.V., in combination with methotrexate, is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have responded inadequately to previous therapy with methotrexate.

2 DOSAGE AND ADMINISTRATION
2.1 Dosage in Adults with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis
The SIMPONI® I.V. dosage regimen is 2 mg per kg given as an intravenous infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter. Follow the dilution and administration instructions for SIMPONI® I.V. [see Dosage and Administration (2.4)].

For patients with rheumatoid arthritis (RA), SIMPONI® I.V. should be given in combination with methotrexate.

The efficacy and safety of switching between intravenous and subcutaneous formulations and routes of administration have not been established.

2.2 Dosage in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis and Psoriatic Arthritis

The SIMPONI® I.V. dosage regimen, based on body surface area (BSA), is 80 mg/m² given as an intravenous infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter. Follow the dilution and administration instructions for SIMPONI® I.V. [see Dosage and Administration (2.4)].

2.3 Evaluation for Tuberculosis and Hepatitis B Prior to Dosage

Prior to initiating SIMPONI® I.V. and periodically during therapy, evaluate patients for active tuberculosis and test for latent infection [see Warnings and Precautions (5.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. Prior to initiating SIMPONI® I.V., test patients for hepatitis B viral infection [see Warnings and Precautions (5.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

2.4 Important Administration Instructions

SIMPONI® I.V. solution for intravenous infusion should be diluted by a healthcare professional using aseptic technique as follows:

1. Calculate the dosage and the number of SIMPONI® I.V. vials needed based on the recommended adult dosage of 2 mg/kg and the patient’s weight for RA, PsA and AS. Calculate the dosage and number of SIMPONI® I.V. vials needed based on the recommended pediatric dosage of 80 mg/m² and the patient’s body surface area (BSA), for pJIA and pediatric patients with PsA. Each 4 mL vial of SIMPONI® I.V. contains 50 mg of golimumab.

2. Check that the solution in each vial is colorless to light yellow. The solution may develop a few fine translucent particles, as golimumab is a protein. Do not use if opaque particles, discoloration, or other foreign particles are present.

3. Dilute the total volume of the SIMPONI® I.V. solution with 0.9% Sodium Chloride Injection, USP to a final volume of 100 mL. For example, this can be accomplished by withdrawing a volume of the 0.9% Sodium Chloride Injection, USP from the 100-mL infusion bag or bottle equal to the total volume of SIMPONI® I.V.. Slowly add the total volume of SIMPONI® I.V. solution to the 100-mL infusion bag or bottle. Gently mix. Discard any unused solution remaining in the vials. Alternatively, SIMPONI® I.V. can be diluted using the same method described above with 0.45% Sodium Chloride Injection, USP.

4. Prior to infusion, visually inspect the diluted SIMPONI® I.V. solution for particulate matter or discoloration. Do not use if these are present.

5. Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.22 micrometer or less).

6. Do not infuse SIMPONI® I.V. concomitantly in the same intravenous line with other agents. No physical biochemical compatibility studies have been conducted to evaluate the use of SIMPONI® I.V. with other intravenous agents in the same intravenous line.

7. Infuse the diluted solution over 30 minutes.

8. Once diluted, the infusion solution can be stored for up to 4 hours at room temperature.

4 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients listed in section 17 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Concurrent administration of SIMPONI® I.V. with abatacept or anakinra (see sections 5.6 and 5.7 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Active tuberculosis or other severe infections such as sepsis, and opportunistic infections (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Moderate or severe heart failure (NYHA class III/IV) (see section 5.3 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).