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Orencia

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Orencia

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Concomitant Use With TNF Antagonists

In controlled clinical trials in patients with adult RA, patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63%) and serious infections (4.4%) compared to patients treated with only TNF antagonists (43% and 0.8%, respectively) [see ADVERSE REACTIONS]. These trials failed to demonstrate an important enhancement of efficacy with concomitant administration of ORENCIA with TNF antagonist; therefore, concurrent therapy with ORENCIA and a TNF antagonist is not recommended. While transitioning from TNF antagonist therapy to ORENCIA therapy, patients should be monitored for signs of infection.

Hypersensitivity

In controlled, double-blind and open-label clinical trials, the occurrence of anaphylaxis and anaphylactoid reactions was rare ( < 0.1%) and was only observed in patients dosed with intravenous ORENCIA. Other reactions potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea that occurred within 24 hours of ORENCIA infusion, were uncommon ( < 1%). Of the 190 patients with juvenile idiopathic arthritis treated with ORENCIA in clinical trials, there was one case of a hypersensitivity reaction (0.5%). Appropriate medical support measures for the treatment of hypersensitivity reactions should be available for immediate use in the event of a reaction [see ADVERSE REACTIONS]. 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 an anaphylactic or other serious allergic reaction occurs, administration of ORENCIA should be stopped immediately with appropriate therapy instituted, and the use of ORENCIA should be permanently discontinued.

Infections

Serious infections, including sepsis and pneumonia, have been reported in patients receiving ORENCIA. 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 infection. Physicians should exercise caution when considering the use of ORENCIA in patients with a history of recurrent infections, underlying conditions which may predispose them to infections, or chronic, latent, or localized 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 [see ADVERSE REACTIONS]. A higher rate of serious infections has been observed in adult RA patients treated with concurrent TNF antagonists and ORENCIA.

Prior to initiating immunomodulatory therapies, including ORENCIA, patients should be screened for latent tuberculosis infection with a tuberculin skin test. ORENCIA has not been studied in patients with a positive tuberculosis screen, and the safety of ORENCIA in individuals with latent tuberculosis infection is unknown. Patients testing positive in tuberculosis screening should be treated by standard medical practice prior to therapy with ORENCIA.

Antirheumatic 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. In clinical studies with ORENCIA, patients who screened positive for hepatitis were excluded from study.

Immunizations

Live vaccines should not be given concurrently with ORENCIA or within 3 months of its discontinuation. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving ORENCIA. The efficacy of vaccination in patients receiving ORENCIA is not known. Based on its mechanism of action, ORENCIA may blunt the effectiveness of some immunizations.

It is recommended that patients with juvenile idiopathic arthritis be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating ORENCIA therapy.

Use In Patients With Chronic Obstructive Pulmonary Disease (COPD)

Adult COPD patients treated with ORENCIA developed adverse events more frequently than those treated with placebo, including COPD exacerbations, cough, rhonchi, and dyspnea. Use of ORENCIA in patients with RA and COPD should be undertaken with caution and such patients should be monitored for worsening of their respiratory status [see ADVERSE REACTIONS].

Immunosuppression

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. The impact of treatment with ORENCIA on the development and course of malignancies is not fully understood [see ADVERSE REACTIONS]. In clinical trials in patients with adult RA, a higher rate of infections was seen in ORENCIA-treated patients compared to placebo [see ADVERSE REACTIONS].

Patient Counseling Information

See FDA-approved patient labeling (Patient Information and Instructions for Use)

Concomitant Use With Biologic Medications For RA

Patients should be informed that they should not receive ORENCIA treatment concomitantly with a TNF antagonist, such as adalimumab, etanercept, and infliximab because such combination therapy may increase their risk for infections [see INDICATIONS AND USAGE, WARNINGS AND PRECAUTIONS, and DRUG INTERACTIONS], and that they should not receive ORENCIA concomitantly with other biologic RA therapy, such as anakinra because there is not enough information to assess the safety and efficacy of such combination therapy [see INDICATIONS AND USAGE, DRUG INTERACTIONS].

Hypersensitivity

Patients should be instructed to immediately tell their healthcare professional if they experience symptoms of an allergic reaction during or for the first day after the administration of ORENCIA [see WARNINGS AND PRECAUTIONS].

Infections

Patients should be asked if they have a history of recurrent infections, have underlying conditions which may predispose them to infections, or have chronic, latent, or localized infections. Patients should be asked if they have had tuberculosis (TB), a positive skin test for TB, or recently have been in close contact with someone who has had TB. Patients should be instructed that they may be tested for TB before they receive ORENCIA. Patients should be informed to tell their healthcare professional if they develop an infection during therapy with ORENCIA [see WARNINGS AND PRECAUTIONS].

Immunizations

Patients should be informed that live vaccines should not be given concurrently with ORENCIA or within 3 months of its discontinuation. Caregivers of patients with juvenile idiopathic arthritis should be informed that the patient should be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating ORENCIA therapy and to discuss with their healthcare provider how best to handle future immunizations once ORENCIA therapy has been initiated [see WARNINGS AND PRECAUTIONS].

Pregnancy And Nursing Mothers

Patients should be informed that ORENCIA has not been studied in pregnant women or nursing mothers so the effects of ORENCIA on pregnant women or nursing infants are not known. Patients should be instructed to tell their healthcare professional if they are pregnant, become pregnant, or are thinking about becoming pregnant [see Use In Specific Populations]. Patients should be instructed to tell their healthcare professional if they plan to breastfeed their infant [see Use In Specific Populations].

Blood Glucose Testing

Intravenous Administration

Patients should be asked if they have diabetes. Maltose is contained in ORENCIA for intravenous administration and can give falsely elevated blood glucose readings with certain blood glucose monitors on the day of ORENCIA infusion. If a patient is using such a monitor, the patient should be advised to discuss with their healthcare professional methods that do not react with maltose [see DRUG INTERACTIONS].

Subcutaneous Administration

ORENCIA for subcutaneous administration does not contain maltose; therefore, patients do not need to alter their glucose monitoring.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

In a mouse carcinogenicity study, weekly subcutaneous injections of 20, 65, or 200 mg/kg of abatacept administered for up to 84 weeks in males and 88 weeks in females were associated with increases in the incidence of malignant lymphomas (all doses) and mammary gland tumors (intermediate- and high-dose in females). The mice from this study were infected with murine leukemia virus and mouse mammary tumor virus. These viruses are associated with an increased incidence of lymphomas and mammary gland tumors, respectively, in immunosuppressed mice. The doses used in these studies produced exposures 0.8, 2.0, and 3.0 times higher, respectively, than the exposure associated with the maximum recommended human dose (MRHD) of 10 mg/kg based on AUC (area under the time-concentration curve). The relevance of these findings to the clinical use of ORENCIA is unknown.

In a one-year toxicity study in cynomolgus monkeys, abatacept was administered intravenously once weekly at doses up to 50 mg/kg (producing 9 times the MRHD exposure based on AUC). Abatacept was not associated with any significant drug-related toxicity. Reversible pharmacological effects consisted of minimal transient decreases in serum IgG and minimal to severe lymphoid depletion of germinal centers in the spleen and/or lymph nodes. No evidence of lymphomas or preneoplastic morphologic changes was observed, despite the presence of a virus (lymphocryptovirus) known to cause these lesions in immunosuppressed monkeys within the time frame of this study. The relevance of these findings to the clinical use of ORENCIA is unknown.

No mutagenic potential of abatacept was observed in the in vitro bacterial reverse mutation (Ames) or Chinese hamster ovary/hypoxanthine guanine phosphoribosyl-transferase (CHO/HGPRT) forward point mutation assays with or without metabolic activation, and no chromosomal aberrations were observed in human lymphocytes treated with abatacept with or without metabolic activation.

Abatacept had no adverse effects on male or female fertility in rats at doses up to 200 mg/kg every three days (11 times the MRHD exposure based on AUC).

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies of ORENCIA use in pregnant women. Abatacept has been shown to cross the placenta in animals, and in animal reproduction studies alterations in immune function occurred. ORENCIA should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

Abatacept was not teratogenic when administered to pregnant mice at doses up to 300 mg/kg and in pregnant rats and rabbits at doses up to 200 mg/kg daily representing approximately 29 times the exposure associated with the maximum recommended human dose (MRHD) of 10 mg/kg based on AUC (area under the time-concentration curve).

Abatacept administered to female rats every three days during early gestation and throughout the lactation period, produced no adverse effects in offspring at doses up to 45 mg/kg, representing 3 times the exposure associated with the MRHD of 10 mg/kg based on AUC. However, at 200 mg/kg, 11 times the MRHD exposure, alterations in immune function were observed consisting of a 9-fold increase in T-cell dependent antibody response in female pups and thyroid inflammation in one female pup. It is not known whether these findings indicate a risk for development of autoimmune diseases in humans exposed in utero to abatacept. However, exposure to abatacept in the juvenile rat, which may be more representative of the fetal immune system state in the human, resulted in immune system abnormalities including inflammation of the thyroid and pancreas [see Nonclinical Toxicology].

Pregnancy Registry

To monitor maternal-fetal outcomes of pregnant women exposed to ORENCIA, a pregnancy registry has been established. Healthcare professionals are encouraged to register patients and pregnant women are encouraged to enroll themselves by calling 1-877-311-8972.

Nursing Mothers

It is not known whether ORENCIA is excreted into human milk or absorbed systemically after ingestion by a nursing infant. However, abatacept was excreted in rat milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from ORENCIA, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Intravenous ORENCIA is indicated for reducing signs and symptoms in pediatric patients with moderately to severely active polyarticular juvenile idiopathic arthritis ages 6 years and older. ORENCIA may be used as monotherapy or concomitantly with methotrexate.

Studies in juvenile rats exposed to ORENCIA prior to immune system maturity have shown immune system abnormalities including an increase in the incidence of infections leading to death as well as inflammation of the thyroid and pancreas [see Nonclinical Toxicology]. Studies in adult mice and monkeys have not demonstrated similar findings. As the immune system of the rat is undeveloped in the first few weeks after birth, the relevance of these results to humans greater than 6 years of age (where the immune system is largely developed) is unknown.

ORENCIA is not recommended for use in patients below the age of 6 years.

The safety and effectiveness of ORENCIA in pediatric patients below 6 years of age have not been established. The safety and efficacy of ORENCIA in pediatric patients for uses other than juvenile idiopathic arthritis have not been established.

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

Geriatric Use

A total of 323 patients 65 years of age and older, including 53 patients 75 years and older, received ORENCIA in clinical studies. No overall differences in safety or effectiveness were observed between these patients and younger patients, but these numbers are too low to rule out differences. The frequency of serious infection and malignancy among ORENCIA-treated patients over age 65 was higher than for those under age 65. Because there is a higher incidence of infections and malignancies in the elderly population in general, caution should be used when treating the elderly.

Last reviewed on RxList: 1/6/2014
This monograph has been modified to include the generic and brand name in many instances.

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