Orencia

Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis or pJIA. 1). Posology Rheumatoid arthritis Adults To be administered as a 30-minute intravenous infusion at the dose specified in Table 1.

Following the initial administration, ORENCIA should be given 2 and 4 weeks after the first infusion, then every 4 weeks thereafter.

Table 1:

Dose of ORENCIAa Body Weight of Patient Dose Number of Vialsb < 60 kg 500 mg 2 ≥ 60 kg to ≤ 100 kg 750 mg 3 > 100 kg 1,000 mg 4 a Approximating 10 mg/kg. b Each vial provides 250 mg of abatacept for administration. No dose adjustment is required when used in combination with other DMARDs, corticosteroids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics.

Psoriatic arthritis Adults To be administered as a 30-minute intravenous infusion at the dose specified in Table 1. Following the initial administration, ORENCIA should be given 2 and 4 weeks after the first infusion, then every 4 weeks thereafter.

Paediatric population Polyarticular juvenile idiopathic arthritis The recommended dose of ORENCIA for patients 6 to 17 years of age with polyarticular juvenile idiopathic arthritis who weigh less than 75 kg is 10 mg/kg calculated based on the patient’s body weight at each administration.

Paediatric patients weighing 75 kg or more should be administered ORENCIA following the adult dosing regimen, not to exceed a maximum dose of 1,000 mg. ORENCIA should be administered as a 30-minute intravenous infusion. Following the initial administration, ORENCIA should be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter.

The safety and efficacy of intravenous ORENCIA in children below 6 years of age have not been studied and therefore, intravenous ORENCIA is not recommended for use in children under six years old. 4 ORENCIA solution for injection in pre-filled syringe for subcutaneous administration is available for paediatric patients 2 years of age and older for the treatment of pJIA (see Summary of Product Characteristics for ORENCIA solution for injection in pre-filled syringe).

4). Renal and hepatic impairment ORENCIA has not been studied in these patient populations. No dose recommendations can be made. Method of administration For intravenous use. 2 μm). 6.

Summary of the safety profile in rheumatoid arthritis Abatacept has been studied in patients with active rheumatoid arthritis in placebo-controlled clinical trials (2,653 patients with abatacept, 1,485 with placebo). 8% of placebo-treated patients.

The most frequently reported adverse reactions (≥ 5%) among abatacept-treated patients were headache, nausea, and upper respiratory tract infections (including sinusitis). 0% for placebo-treated patients. 1). 4%, respectively). There were no adverse reactions that occurred at ≥ 2% in either treatment group during the 24-week placebo-controlled period.

The overall safety profile was comparable between studies PsA-I and PsA-II and consistent with the safety profile in rheumatoid arthritis (Table 2). Tabulated list of adverse reactions Listed in Table 2 are adverse reactions observed in clinical trials and post-marketing experience presented by system organ class and frequency, using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Table 2:

Adverse reactions Infections and infestations Very Common Upper respiratory tract infection (including tracheitis, nasopharyngitis, and sinusitis) Common Lower respiratory tract infection (including bronchitis), urinary tract infection, herpes infections (including herpes simplex, oral herpes, and herpes zoster), pneumonia, influenza Uncommon Tooth infection, onychomycosis, sepsis, musculoskeletal infections, skin abscess, pyelonephritis, rhinitis, ear infection Rare Tuberculosis, bacteraemia, gastrointestinal infection, pelvic inflammatory disease Neoplasms benign, malignant and unspecified (incl.

1). 5). Abatacept is not recommended for use in combination with TNF-inhibitors. 1, study VII). 8). Anaphylaxis or anaphylactoid reactions can occur after the first infusion and can be life-threatening. In postmarketing experience, a case of fatal anaphylaxis following the first infusion of ORENCIA has been reported.

If any serious allergic or anaphylactic reaction occurs, intravenous or subcutaneous ORENCIA therapy should be discontinued immediately and appropriate therapy initiated, and the use of ORENCIA should be permanently discontinued. Effects on the immune system Medicinal products which affect the immune system, including ORENCIA, may affect host defences against infections and malignancies, and affect vaccination responses.

5). 8). Some of these infections have been fatal. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy which in addition to their underlying disease, could further predispose them to infections.

Treatment with ORENCIA should not be initiated in patients with active infections until infections are controlled. Physicians should exercise caution when considering the use of ORENCIA in patients with a history of recurrent infections or underlying conditions which may predispose them to infections.

Patients who develop a new infection while undergoing treatment with ORENCIA should be monitored closely. Administration of ORENCIA should be discontinued if a patient develops a serious infection. No increase of tuberculosis was observed in the pivotal placebo-controlled studies; however, all ORENCIA patients were screened for tuberculosis.

The safety of ORENCIA in individuals with latent tuberculosis is unknown. 8). Patients should be screened for latent tuberculosis prior to initiating ORENCIA. The available medical guidelines should also be taken into account. Anti-rheumatic therapies have been associated with hepatitis B reactivation.

1. 4).