REMSIMA SOLUTION FOR SUBCUTANEOUS INJECTION 120 MG/ML IN PRE-FILLED SYRINGE [SIN16069P]

Product Info

REMSIMA SOLUTION FOR SUBCUTANEOUS INJECTION 120 MG/ML IN PRE-FILLED SYRINGE

[SIN16069P]

4.1 THERAPEUTIC INDICATIONS

Rheumatoid arthritis

Remsima, 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 (see section 5.1 – 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 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 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).

Ulcerative colitis

Remsima 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.

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

4.2 Posology and method of administration

Remsima treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of conditions for which Remsima is indicated. Patients treated with Remsima should be given the patient information leaflet. Instruction for use is provided in the patient information leaflet.

For subsequent injections and after proper training in subcutaneous injection technique, patients may self-inject with Remsima if their physician determines that it is appropriate and with medical follow-up as necessary. Suitability of the patient for subcutaneous home use should be assessed and patients should be advised to inform their healthcare professional if they experience symptoms of an allergic reaction before administering the next dose. Patients should seek immediate medical attention if developing symptoms of serious allergic reactions (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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

It is important to check the product labels to ensure that the correct formulation (intravenous or subcutaneous) is being administered to the patient, as prescribed. Remsima subcutaneous formulation is not intended for intravenous administration and should be administered via a subcutaneous injection only.

Posology

Adults (≥18 years)

Rheumatoid arthritis
Treatment with Remsima subcutaneous formulation should be initiated with loading doses of infliximab which may be intravenous or subcutaneous. When subcutaneous loading is used, Remsima 120 mg should be given as a subcutaneous injection followed by additional subcutaneous injections at 1, 2, 3 and 4 weeks after the first injection, then every 2 weeks thereafter. If intravenous loading doses of infliximab are given to initiate treatment, 2 intravenous infusions of infliximab 3 mg/kg should be given 2 weeks apart. The first treatment with Remsima administered subcutaneously should be initiated as maintenance therapy 4 weeks after the second intravenous administration. The recommended maintenance dose for Remsima subcutaneous formulation is 120 mg once every 2 weeks.

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 the first 12 weeks of treatment (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Moderately to severely active Crohn’s disease
Treatment with Remsima administered subcutaneously should be initiated as maintenance therapy 4 weeks after the last administration of two intravenous infusions of infliximab 5 mg/kg given 2 weeks apart. The recommended dose for Remsima subcutaneous formulation is 120 mg once every 2 weeks. If a patient does not respond within 2 weeks to the initial infusion, no additional treatment with infliximab should be given.

Fistulising Crohn’s disease
Treatment with Remsima 120 mg administered subcutaneously should be initiated as maintenance therapy 4 weeks after the last administration of two intravenous infusions of infliximab 5 mg/kg given 2 weeks apart. The recommended dose for Remsima subcutaneous formulation is 120 mg once every 2 weeks. If a patient does not respond after 6 doses (i.e. 2 intravenous infusions and 4 subcutaneous injections), no additional treatment with infliximab should be given.

Ulcerative colitis
Treatment with Remsima 120 mg administered subcutaneously should be initiated as maintenance therapy 4 weeks after the last administration of two intravenous infusions of infliximab 5 mg/kg given 2 weeks apart. The recommended dose for Remsima subcutaneous formulation is 120 mg once every 2 weeks.

Available data suggest that the clinical response is usually achieved within 14 weeks of treatment, i.e. 2 intravenous infusions and 4 subcutaneous injections (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within this time period.

Ankylosing spondylitis
Treatment with Remsima 120 mg administered subcutaneously should be initiated as maintenance therapy 4 weeks after the last administration of two intravenous infusions of infliximab 5 mg/kg given 2 weeks apart. The recommended dose of Remsima subcutaneous formulation is 120 mg once every 2 weeks. If a patient does not respond by 6 weeks (i.e. after 2 intravenous infusions), no additional treatment with infliximab should be given.

Psoriatic arthritis
Treatment with Remsima 120 mg administered subcutaneously should be initiated as maintenance therapy 4 weeks after the last administration of two intravenous infusions of infliximab 5 mg/kg given 2 weeks apart. The recommended dose for Remsima subcutaneous formulation is 120 mg once every 2 weeks.

Psoriasis
Treatment with Remsima 120 mg administered subcutaneously should be initiated as maintenance therapy 4 weeks after the last administration of two intravenous infusions of infliximab 5 mg/kg given 2 weeks apart. If a patient shows no response after 14 weeks (i.e. 2 intravenous infusions and 5 subcutaneous injections), no additional treatment with infliximab should be given. The recommended dose for Remsima subcutaneous formulation is 120 mg once every 2 weeks.

Re-administration for Crohn’s disease and rheumatoid arthritis
From experience with intravenous infliximab, if the signs and symptoms of disease recur, infliximab can be re-administered within 16 weeks following the last administration. In clinical studies with intravenous infliximab, delayed hypersensitivity reactions have been uncommon and have occurred after infliximab-free intervals of less than 1 year (see sections 4.4 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The safety and efficacy of re-administration after an infliximab-free interval of more than 16 weeks has not been established. This applies to both Crohn’s disease patients and rheumatoid arthritis patients.

Re-administration for ulcerative colitis
From experience with intravenous infliximab, the safety and efficacy of re-administration, other than every 8 weeks, has not been established (see sections 4.4 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Re-administration for ankylosing spondylitis
From experience with intravenous infliximab, the safety and efficacy of re-administration, other than every 6 to 8 weeks, has not been established (see sections 4.4 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Re-administration for psoriatic arthritis
From experience with intravenous infliximab, the safety and efficacy of re-administration, other than every 8 weeks, has not been established (see sections 4.4 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Re-administration for psoriasis
Limited experience from retreatment with one single intravenous 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 section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Switching to and from Remsima subcutaneous formulation across indications
When switching from the maintenance therapy of infliximab intravenous formulation to the subcutaneous formulation of Remsima, the subcutaneous formulation may be administered 8 weeks after the last administration of the intravenous infusions of infliximab.

There is insufficient information regarding the switching of patients who received the intravenous infusions of infliximab higher than 3 mg/kg for rheumatoid arthritis or 5 mg/kg for Crohn’s disease every 8 weeks to the subcutaneous formulation of Remsima.

Information regarding switching patients from the subcutaneous formulation to the intravenous formulation of Remsima is not available.

Missed dose
If patients miss an injection of Remsima subcutaneous formulation, they should be instructed to take the missed dose immediately in case this happens within 7 days from the missed dose, and then remain on their original bi-weekly dosing schedule. If the dose is delayed by 8 days or more, the patients should be instructed to skip the missed dose, wait until their next scheduled dose, and then remain on their original bi-weekly dosing schedule.

Special populations

Elderly

Specific studies of infliximab in elderly patients have not been conducted. No major age-related differences in clearance or volume of distribution were observed in clinical studies with infliximab intravenous formulations and the same is expected for subcutaneous formulation. No dose adjustment is required (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). For more information about the safety of infliximab in elderly patients (see sections 4.4 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal and/or hepatic impairment

Infliximab has not been studied in these patient populations. No dose recommendations can be made (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population

The safety and efficacy of Remsima subcutaneous therapy in children aged below 18 years of age have not yet been established. No data are available. Therefore, subcutaneous use of Remsima is recommended for use only in adults.

Method of administration

Remsima 120 mg solution for injection in pre-filled syringe or in pre-filled pen are administered by subcutaneous injection only. Full instructions for use are provided in the patient information leaflet. For the two initial intravenous infusions, 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 section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The physician should ensure appropriate follow-up of patients for any systemic injection reaction and localised injection site reaction after the initial subcutaneous injection is administered.

4.3 Contraindications

Hypersensitivity to the active substance, to other murine proteins or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Patients with tuberculosis or other severe infections such as sepsis, abscesses and opportunistic infections (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients with moderate or severe heart failure (NYHA class III/IV) (see sections 4.4 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).