REMSIMA® POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG/VIAL [SIN14972P]

Product Info

REMSIMA® POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG/VIAL

[SIN14972P]

Indications
Rheumatoid Arthritis
REMSIMA®, in combination with methotrexate (MTX), is indicated for:
The reduction of signs and symptoms as well as the improvement in physical function in

• patients with active disease when the response to disease-modifying drugs, including methotrexate, has been inadequate.

• 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 (see Pharmacodynamic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Crohn’s Disease
REMSIMA® is indicated for:

• Treatment of moderately to severely, active Crohn’s disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant: or who are intolerant to or have medical contraindications for such therapies.

• Treatment of fistulising Crohn’s disease, in 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
REMSIMA® is indicated for:
Treatment of severe, active Crohn’s disease, in paediatric patients 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. REMSIMA® has been studied only in combination with conventional immunosuppressive therapy.

Ulcerative Colitis
REMSIMA® is indicated for:
Treatment of moderately to severely active ulcerative colitis in 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
REMSIMA® is indicated for:
Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.

Ankylosing Spondylitis
REMSIMA® is indicated for:
Treatment of ankylosing spondylitis, in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy.

Psoriatic Arthritis
REMSIMA®, in combination with methotrexate, is indicated for:
Treatment of active and progressive psoriatic arthritis in patients who have responded inadequately to disease-modifying anti-rheumatoid drugs.

Psoriasis
REMSIMA® is indicated for:
Treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultraviolet A (PUVA) (see Pharmacodynamic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dosage and Administration
REMSIMA® treatment is to be administered under the supervision and monitoring of specialized physicians experienced in the diagnosis and treatment of rheumatoid arthritis, inflammatory bowel diseases, ankylosing spondylitis, psoriatic arthritis or psoriasis. REMSIMA® should be administered intravenously.

During REMSIMA® treatment, other concomitant therapies, e.g., corticosteroids and immunosuppressants should be optimized.

Adults (≥ 18 years)
Rheumatoid Arthritis
3 mg/kg given as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.

REMSIMA® must be given concomitantly with methotrexate.

Available data suggest that the clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within this time period.

Moderately to Severely, Active Crohn’s Disease
5 mg/kg given as an intravenous infusion over a 2-hour period. Available data do not support further infliximab treatment, in patients not responding within 2 weeks to the initial infusion. In responding patients, the strategy for continued treatment is.

• Maintenance: Additional infusions of 5 mg/kg at 2 and 6 weeks after the initial dose, followed by infusions every eight weeks.

Fistulising Crohn’s Disease
An initial 5 mg/kg infusion given over a 2-hour period is to be followed with additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion. If a patient does not respond after these 3 doses, no additional treatment with infliximab should be given.

In responding patients, the strategies for continued treatment are:

• Additional infusions of 5 mg/kg every 8 weeks or

• Readministration if signs and symptoms of the disease recur followed by infusions of 5 mg/kg every 8 weeks (see Readministration below and Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Ulcerative Colitis
5mg/kg given as intravenous infusion over a 2 hour period followed by additional 5mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.

Available data suggest that the clinical response is usually achieved within 14 weeks of treatment, i.e. three doses. Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within this time period.

Ankylosing Spondylitis
5 mg/kg given as an intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks. If a patient does not respond by 6 weeks (i.e. after 2 doses), no additional treatment with infliximab should be given.

Psoriatic Arthritis
5 mg/kg given as intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Efficacy and safety have been demonstrated in combination with methotrexate.

Psoriasis
5mg/kg given as intravenous over a 2-hour period followed by additional 5mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. If a patient shows no response after 14 weeks (i.e. after 4 doses), no additional treatment with infliximab should be given.

Readministration for Crohn’s Disease and Rheumatoid Arthritis
If the signs and symptoms of disease recur, REMSIMA® can be readministered within 16 weeks following the last infusion. In clinical studies, delayed hypersensitivity reactions have been uncommon and have occurred after drug free intervals of less than 1 year (see Warnings and Precautions and Adverse Reactions: Delayed Hypersensitivity – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). After a drug free interval of 16 weeks to 2 years, the risk of delayed hypersensitivity following readministration is not known. Therefore, after a drug free interval of 16 weeks, readministration is not recommended.

Readministration for Ulcerative Colitis
The safety and efficacy of readministration, other than every 8 weeks, has not been established. (see Warnings and Precautions and Adverse Reactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Readministration for Ankylosing Spondylitis
The safety and efficacy of readministration, other than every 6 to 8 weeks, has not been established. (see Warnings and Precautions and Adverse Reactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Readministration for Psoriatic Arthritis
The safety and efficacy of readministration, other than every 8 weeks, has not been established. (see Warnings and Precautions and Adverse Reactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Readministration for Psoriasis
Limited experience from retreatment with one single infliximab dose in psoriasis after an interval of 20 weeks suggests reduced efficacy and a higher incidence of mild to moderate infusion reactions when compared to the initial induction regimen (see Pharmacodynamic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatrics
Crohn’s Disease (6 to 17 years)
5mg/kg given as intravenous infusion over a 2-hour period followed by additional 5mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. For some patients a longer dosing interval may be sufficient. Available data do not support further infliximab treatment in paediatric patients not responding within the first 10 weeks of treatment.

Pediatric Crohn’s disease patients who have had their dose adjusted to greater than 5 mg/kg every 8 weeks, may be at greater risk for adverse reactions. Continued therapy with the adjusted dose should be carefully considered in patients who show no evidence of additional therapeutic benefit after dose adjustment.

Ulcerative Colitis (6 to 17 years)
5mg/kg given as intravenous infusion over a 2 hour period followed by additional 5mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.

Administration
REMSIMA® should be administered intravenously over a 2 hour period. All patients administered REMSIMA® are to be observed for at least 1–2 hours post-infusion for acute infusion-related reactions. Emergency equipment, such as adrenaline, antihistamines, corticosteroids and an artificial airway must be available. Patients may be pre-treated with e.g., an antihistamine hydrocortisone and/or paracetamol and infusion rate may be slowed in order to decrease the risk of infusion-related reactions especially if infusion-related reactions have occurred previously (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Shortened Infusions Across Adult Indications
In carefully selected adult patients who have tolerated at least 3 initial 2-hour infusions of REMSIMA® (induction phase) 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 >6mg/kg have not been studied.

For preparation and administration instructions, see Instructions for Use and Handling and Disposal – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Contraindications
REMSIMA® is contraindicated in patients with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

REMSIMA® is contraindicated in patients with moderate or severe heart failure (NYHA class III/IV) (see Warnings and Precautions and Adverse Reactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

REMSIMA® must not be given to patients with a history of hypersensitivity to infliximab (see Adverse Reactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), to other murine proteins, or to any of the excipients.