Indications/Usage and Important Safety Information for ORENCIA® (abatacept)

Indications/Usage

Adult Rheumatoid Arthritis (RA): ORENCIA® (abatacept) is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. ORENCIA may be used as monotherapy or concomitantly with disease-modifying, anti-rheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists.

Juvenile Idiopathic Arthritis (JIA): ORENCIA® (abatacept) is also indicated for reducing signs and symptoms in pediatric patients aged 6 years and older with moderately to severely active polyarticular JIA. ORENCIA may be used as monotherapy or concomitantly with methotrexate (MTX).

Important Limitations of Use: ORENCIA should not be administered concomitantly with TNF antagonists, and is not recommended for use concomitantly with other biologic RA therapy, such as anakinra.

Important Safety Information

Concomitant Use with TNF Antagonists: Concurrent therapy with ORENCIA® (abatacept) and a biologic DMARD is not recommended. In controlled clinical trials, adult 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), without an important enhancement of efficacy.

Hypersensitivity: Anaphylaxis or anaphylactoid reactions can occur during or after an infusion and can be life-threatening. In controlled, double-blind and open-label clinical trials, anaphylaxis and anaphylactoid reactions were reported in <0.1% of adult patients dosed with intravenous ORENCIA® (abatacept). Other reactions potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, that occurred within 24 hours of ORENCIA® (abatacept) infusion, were uncommon (<1% each). There was one case of a hypersensitivity reaction with ORENCIA in JIA clinical trials (0.5%; n=190). In postmarketing experience, a case of fatal anaphylaxis following the first infusion of ORENCIA was reported. Appropriate medical support measures for treating hypersensitivity reactions should be available for immediate use. If an anaphylactic or other serious allergic reaction occurs, administration of ORENCIA® (abatacept) should be stopped immediately and permanently discontinued, with appropriate therapy instituted.

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. Caution should be exercised in patients with a history of infection or underlying conditions which may predispose them to infections. Treatment with ORENCIA® (abatacept) should be discontinued if a patient develops a serious infection. Patients should be screened for tuberculosis, and viral hepatitis in accordance with published guidelines, and if positive, treated according to standard medical practice prior to therapy with ORENCIA® (abatacept).

Immunizations: Live vaccines should not be given concurrently with ORENCIA or within 3 months of its discontinuation as it may blunt the effectiveness of some immunizations. It is recommended that JIA patients be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating therapy with ORENCIA.

Use in Patients with Chronic Obstructive Pulmonary Disease (COPD): Adult COPD patients treated with ORENCIA® (abatacept) developed adverse events more frequently than those treated with placebo (97% vs 88%, respectively). Respiratory disorders occurred more frequently in patients treated with ORENCIA compared to those on placebo (43% vs 24%, respectively), including COPD exacerbations, cough, rhonchi, and dyspnea. A greater percentage of patients treated with ORENCIA developed a serious adverse event compared to those on placebo (27% vs 6%), including COPD exacerbation [3 of 37 patients (8%)] and pneumonia [1 of 37 patients (3%)]. Use of ORENCIA® (abatacept) in patients with RA and COPD should be undertaken with caution, and such patients monitored for worsening of their respiratory status.

Blood Glucose Testing: ORENCIA for intravenous administration contains maltose, which may result in falsely elevated blood glucose readings on the day of infusion when using blood glucose monitors with test strips utilizing glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ). Consider using monitors and advising patients to use monitors that do not react with maltose, such as those based on glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase, or glucose hexokinase test methods. ORENCIA® (abatacept) for subcutaneous (SC) administration does not contain maltose; therefore, patients do not need to alter their glucose monitoring.

Pregnant and Nursing Mothers: ORENCIA® (abatacept) should be used during pregnancy only if clearly needed. The risk for development of autoimmune diseases in humans exposed in utero to abatacept has not been determined. Nursing mothers should be informed of the risk/benefit of continued breast-feeding or discontinuation of the drug. A pregnancy registry has been established to monitor fetal outcomes. Healthcare professionals are encouraged to register pregnant patients exposed to ORENCIA® (abatacept) by calling 1-877-311-8972.

Most Serious Adverse Reactions: Serious infections (3% ORENCIA vs 1.9% placebo) and malignancies (1.3% ORENCIA vs 1.1% placebo). In general, adverse events in pediatric and adolescent patients were similar in frequency and type to those seen in adult patients.

Malignancies: The overall frequency of malignancies was similar between adult patients treated with ORENCIA® (abatacept) or placebo. However, more cases of lung cancer were observed in patients treated with ORENCIA (0.2%) than those on placebo (0%). A higher rate of lymphoma was seen compared to the general population; however, patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of ORENCIA® (abatacept) in the development of malignancies in humans is unknown.

Most Frequent Adverse Events (≥10%): Headache, upper respiratory tract infection, nasopharyngitis, and nausea were the most commonly reported adverse events in the adult RA clinical studies.

Note concerning SC ORENCIA: The safety and efficacy of SC ORENCIA® (abatacept) has not been studied in patients under 18 years of age.

Please see Full Prescribing Information.

CALL 1-800-861-0048 FOR MORE INFORMATION

ORENCIA SC Dosing and Administration

For moderate to severe adult RA patients initiating ORENCIA SC therapy1


Note: ORENCIA SC is intended for use under the guidance of a physician or healthcare practitioner.
  • ORENCIA 125 mg should be administered by SC injection once weekly and may be initiated with or without an IV loading dose.
  • For patients initiating therapy with an IV loading dose, ORENCIA should be initiated with a single IV infusion (as per body weight categories in the IV Loading Dose tab below), followed by the first 125 mg SC injection administered within a day of the IV infusion.
  • Patients transitioning from ORENCIA IV therapy to SC administration should administer the first SC dose instead of the next scheduled IV dose.

After proper training in the ORENCIA SC injection technique, a patient may self-inject with ORENCIA SC if a physician or healthcare practitioner determines that it is appropriate. Patients should be instructed to follow the directions provided in the Instructions for Use brochure for additional details on medication administration.

ORENCIA IV loading dose should be given as a 30-minute intravenous infusion based on body weight categories listed in the table below.

Intravenous Administration for Adult RA1

a1 kg=2.2 lb
bEach vial provides 250 mg of abatacept for administration

ORENCIA IV Supplies

  • ORENCIA IV lyophilized powder in preservative-free, single-use vials (each vial provides 250 mg of abatacept)
  • Sterile Water for Injection, USP
  • Silicone-free disposable syringe and 18- to 21-gauge needle
  • 100 mL infusion bag or bottle of 0.9% Sodium Chloride Injection, USP
  • Infusion set and sterile, nonpyrogenic, low-protein-binding filter (pore size of 0.2 µm to 1.2 µm)
  • Sharps container
  • Alcohol swabs

General infusion instructions

For more detailed administration information, see the Full Prescribing Information.

1.
Use aseptic technique throughout. Remove flip-top from ORENCIA IV vial and wipe the top with an alcohol swab.
2.
Reconstitute the ORENCIA IV powder in each vial with 10 mL of Sterile Water for Injection, USP, using only the silicone-free disposable syringe provided with each vial and an 18- to 21-gauge needle. If syringe is dropped or becomes contaminated, use a new one. For information on obtaining additional syringes, contact Bristol-Myers Squibb at 1-877-O SOURCE. Discard any solution prepared using siliconized syringes.
3.
Insert the syringe needle into the vial through the center of the rubber stopper and direct the stream of Sterile Water for Injection, USP, to the glass wall of the vial. Do not use the vial if the vacuum is not present. Do not shake.
4.
Rotate the vial with a gentle swirling motion until contents completely dissolve. After mixing, each milliliter will contain 25 mg (250 mg/10 mL) of ORENCIA® (abatacept).
5.
Vent the vial with a needle to dissipate any foam that may be present. The solution should be clear and colorless to pale yellow. Do not use if opaque particles, discoloration, or other foreign particles are present.
6.
Further dilute the reconstituted ORENCIA IV solution to 100 mL as follows: from a 100 mL infusion bag or bottle, withdraw a volume of 0.9% Sodium Chloride Injection, USP, equal to the volume of the reconstituted ORENCIA solution (for 2 vials remove 20 mL, for 3 vials remove 30 mL, for 4 vials remove 40 mL).

Slowly add the reconstituted ORENCIA solution from each vial to the infusion bag or bottle using the same silicone-free disposable syringe provided with each vial.

7.
Gently mix. Do not shake the bag or bottle. The concentration of the fully diluted ORENCIA IV solution in the infusion bag or bottle will be approximately 5, 7.5, or 10 mg of ORENCIA IV per mL of solution depending on whether 2, 3, or 4 vials of ORENCIA IV are used. Discard any unused portion in the vials.

Prior to administration, visually inspect the ORENCIA IV solution for particulate matter and discoloration. Discard if any particulate matter or discoloration is observed.

8.
Administer the entire, fully diluted ORENCIA solution over a period of 30 minutes with an infusion set and a sterile, nonpyrogenic, low-protein-binding filter (pore size of 0.2 µm to 1.2 µm).

Complete the infusion within 24 hours of reconstitution of the ORENCIA IV vials. The fully diluted ORENCIA IV solution may be stored at room temperature or refrigerated at 36°F to 46°F (2°C to 8°C) before use.

Important Safety Information: Concomitant Use with TNF Antagonists —

Concurrent therapy with ORENCIA and a biologic DMARD is not recommended. In controlled clinical trials, adult 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), without an important enhancement of efficacy.

NEXT: ORENCIA SC Preparation