ORENCIA

Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis. 1). Posology Rheumatoid arthritis Adults ORENCIA subcutaneous (SC) may be initiated with or without an intravenous (IV) loading dose.

1). 2 of ORENCIA 250 mg powder for concentrate for solution for infusion). Patients switching from abatacept intravenous therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled intravenous dose.

No dose adjustment is required when used in combination with other DMARDs, corticosteroids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics. Psoriatic arthritis Adults ORENCIA should be administered weekly at a dose of 125 mg by subcutaneous (SC) injection without the need for an intravenous (IV) loading dose.

Patients switching from ORENCIA intravenous therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled intravenous dose. 5 mg 50 kg or more 125 mg Patients switching from abatacept intravenous therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled intravenous dose.

ORENCIA powder for concentrate for solution for infusion for intravenous administration is available for paediatric patients 6 years of age and older for the treatment of pJIA (see Summary of Product Characteristics for ORENCIA powder for concentrate for solution for infusion).

Missed dose If a patient misses an injection of abatacept and is within three days of the planned date, he/she should be instructed to take the missed dose immediately and remain on the original weekly schedule. If the dose is missed by more than three days, the patient should be instructed when to take the next dose based on medical judgment (condition of the patient, status of disease activity, etc).

4). Renal and hepatic impairment ORENCIA has not been studied in these patient populations. No dose recommendations can be made. Paediatric population The safety and efficacy of ORENCIA in children below 2 years of age have not been established.

No data are available. There is no relevant use of ORENCIA in children under two years old. Method of administration For subcutaneous use. ORENCIA is intended for use under the guidance of a healthcare professional. After proper training in subcutaneous injection technique, a patient or caregiver may inject with ORENCIA if a physician/healthcare professional determines that it is appropriate.

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. 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, muskuloskeletal infections, skin abscess, pyelonephritis, rhinitis, ear infection Rare Tuberculosis, bacteraemia, gastrointestinal infection, pelvic inflammatory disease Uncommon Basal cell carcinoma, skin papillomaNeoplasms benign, malignant and unspecified (incl.

g. 5% of placebo-treated patients. 1% of placebo-treated patients. 4). 3) per 100 patient-years for placebo-treated patients in the double-blind studies. 4 per 100 patient-years, and the annualised incidence rate remained stable. 9% (14/1,485) of placebo-treated patients.

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.

8). 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.

Therefore, screening for viral hepatitis should be performed in accordance with published guidelines before starting therapy with ORENCIA. Progressive multifocal leukoencephalopathy (PML) Cases of PML have been reported in patients receiving abatacept mostly in combination with other immunosuppressive medication.

1. 4).