Indicated for:

Adult Rheumatoid Arthritis:

• The treatment of adult patients with moderately to severely active rheumatoid arthritis.

Polyarticular Juvenile Idiopathic Arthritis:

• The treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis.

Adult Psoriatic Arthritis:

The treatment of adult patients with active psoriatic arthritis (PsA).

For adult patients with psoriatic arthritis, ORENCIA may be administered as an intravenous infusion (IV) or a subcutaneous (SC) injection.

Prophylaxis for Acute Graft versus Host Disease:

• The prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated-donor.

ORENCIA may be used as monotherapy or concomitantly with disease-modifying antirheumatic drugs (DMARDs) other than JAK inhibitors or bDMARDs (e.g., TNF antagonists).

The concomitant use of ORENCIA with other potent immunosuppressants [e.g., biologic disease modifying antirheumatic drugs (bDMARDS), Janus kinase (JAK) inhibitors] is not recommended.

ORENCIA can be used with or without non-biologic DMARDs.

For adult patients with RA, administer as an intravenous infusion or as a subcutaneous injection.

The safety and efficacy of ORENCIA ClickJect autoinjector for subcutaneous injection has not been studied in patients under 18 years of age.

For patients with polyarticular juvenile idiopathic arthritis (pJIA), may administer ORENCIA as an intravenous infusion (only patients 6 years of age and older) or a subcutaneous injection (only
patients 2 years of age and older). ORENCIA may be used as monotherapy or concomitantly with methotrexate.

Patients with juvenile idiopathic arthritis should be brought up to date with all immunizations prior to ORENCIA therapy. 

Prior to initiating ORENCIA in pediatric and adult patients, update vaccinations in accordance with current vaccination guidelines. ORENCIA-treated patients may receive current non-live vaccines. Live vaccines should not be given concurrently with ORENCIA or within 3 months after discontinuation. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving ORENCIA. In addition, there are clinical considerations for administering live vaccines to infants who were exposed to ORENCIA while in utero. Based on its mechanism of action, ORENCIA may blunt the effectiveness of some immunizations.

The safety and efficacy of ORENCIA in pediatric patients for uses other than juvenile idiopathic arthritis have not been established.

Before administering ORENCIA, administer recommended antiviral prophylactic treatment for Epstein-Barr Virus (EBV) reactivation, and continue for six months following HSCT. In addition, consider prophylactic antivirals for Cytomegalovirus (CMV) infection/reactivation during treatment and for six months following HSCT.

Post-Transplant Lymphoproliferative Disorder (PTLD) occurred in patients who received ORENCIA for aGVHD prophylaxis during unrelated HSCT. Monitor patients for CMV infection/reactivation for 6 months post-transplant regardless of the results of donor and recipient pre-transplant CMV serology.

In controlled clinical trials in patients with adult RA, patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections and serious infections compared to patients treated with only TNF antagonists.

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.Appropriate medical support measures for the treatment of hypersensitivity reactions should be available for immediate use in the event of a reaction.

Serious infections, including sepsis and pneumonia, have been reported in patients receiving ORENCIA. Antirheumatic therapies have been associated with hepatitis B reactivation.

Screen for latent TB infection prior to initiating therapy. Patients testing positive should be treated prior to initiating ORENCIA.

Adult COPD patients treated with ORENCIA developed adverse events more frequently than those treated with placebo, including COPD exacerbations, cough, rhonchi, and dyspnea.

The possibility exists for drugs inhibiting T cell activation, including ORENCIA, to affect host defenses against infections and malignancies since T cells mediate cellular immune responses. In clinical trials in patients with adult RA, a higher rate of infections was seen in ORENCIA-treated patients compared to placebo-treated patients.

The impact of treatment with ORENCIA on the development and course of malignancies is not fully understood. There have been reports of malignancies, including skin cancer in patients receiving ORENCIA. Periodic skin examinations are recommended for all ORENCIA-treated patients, particularly those with risk factors for skin cancer.

ORENCIA should not be administered concomitantly with TNF antagonists. ORENCIA is not recommended for use concomitantly with other biologic rheumatoid arthritis (RA) therapy, such as anakinra.

Live vaccines should not be given concurrently or within 3 months of discontinuation.

Parenteral drug products containing maltose can interfere with the readings of blood glucose monitors that use test strips with glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ).

The data with ORENCIA use in pregnant women are insufficient to inform on drug-associated risk. Animal studies: altered immune function.

There is no information regarding the presence of abatacept in human milk, the effects on the breastfed infant, or the effects on milk production. However, abatacept was present in the milk of lactating rats dosed with abatacept.

GoToSource

• Use in patients under the age of 2. GoToSource

• Systemic lupus erythematosus. GoToSource

• Psoriasis. GoToSource

• Multiple sclerosis. GoToSource

• Sarcoidosis, hidradenitis suppurativa, cicatricial pemphigoid, behçet’s disease, pyoderma gangrenosum, multicentric reticulohistiocytosis, aphthous stomatitis, sneddon-wilkinson disease, SAPHO syndrome, pityriasis rubra pilaris, eosinophilic fasciitis, panniculitis, crohn’s disease, necrobiosis lipoidica diabeticorum, dermatomyositis, scleroderma gouty arthropathy, arthropathy, familial mediterranean fever, inflammatory myopathy, pseudocyst retina, cogan’s syndrome, scleritis and episcleritis, granulomatosis with polyangiitis (GPA), temporal arteritis, and ulcerative colitis. GoToSource

• Alopecia areata. GoToSource

• Vasculitis. GoToSource

• B7-1-positive proteinuric kidney disease. GoToSource

Acute encephalomyelitis (inflammation in the brain and spinal cord) associated with herpes virus reactivation. GoToSource

Interstitial pneumonia (disorder causing scarring of lungs). GoToSource

Acute hepatitis E. GoToSource

Progressive multifocal leukoencephalopathy (disease of the white matter of the brain). GoToSource

Lymphoma (cancer originating in lymphatic system), reactivation of latent tuberculosis, hepatitis B and C, increased liver transaminase levels and hyperlipidaemia (high level of fats or lipids in the blood). GoToSource

Serious infections such as bronchopulmonary, streptococcal and pyogenic septicemia, staphylococcal arthritis, abscesses, gastrointestinal (diverticulitis), pyelonephritis (kidney infection) and pulmonary aspergillosis. GoToSource

Injection site and infusion reactions, upper respiratory tract infection, erythema nodosum (skin inflammation), episcleritis (inflammation of membrane covering the white of the eye), raynaud’s syndrome (disorder of blood vessels usually in fingers and toes) and sjögren’s syndrome disorder of immune system). GoToSource

Increased risk of malignancies including solid tumors, skin cancers and hematologic non lymphomas. GoToSource

Lawsuits filed for fungal infections.