Abatacept

Name: Abatacept

What is abatacept?

Abatacept a protein that prevents your body's immune system from attacking healthy tissues such as joints. The immune system helps your body fight infections. In people with autoimmune disorders, the immune system mistakes the body's own cells for invaders and attacks them.

Abatacept is used to treat the symptoms of rheumatoid arthritis, and to prevent joint damage caused by these conditions. This medicine is for adults and children who are at least 2 years old.

Abatacept is not a cure for any autoimmune disorder and will only treat the symptoms of your condition.

Abatacept may also be used for purposes not listed in this medication guide.

What other drugs will affect abatacept?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • anakinra (Kineret);

  • adalimumab (Humira);

  • certolizumab (Cimzia);

  • etanercept (Enbrel);

  • golimumab (Simponi);

  • infliximab (Remicade);

  • rituximab (Rituxan); or

  • tocilizumab (Actemra).

This list is not complete. Other drugs may interact with abatacept, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Uses for Abatacept

Rheumatoid Arthritis

Used to manage the signs and symptoms of rheumatoid arthritis, to induce a major clinical response, to improve physical function, and to inhibit progression of structural damage associated with the disease in adults with moderate to severe active rheumatoid arthritis.1 2 3 4 5 Can be used alone or with other DMARDs other than tumor necrosis factor (TNF) blocking agents.1

Do not use concomitantly with TNF blocking agents (e.g., adalimumab, certolizumab pegol, etanercept, infliximab); concomitant use with other biologic antirheumatic drugs (e.g., anakinra) not recommended.1 (See Infectious Complications under Cautions and see Specific Drugs and Laboratory Tests under Interactions.)

Juvenile Arthritis

Management of the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in children.1 7 Can be use alone or with methotrexate.1

Do not use concomitantly with TNF blocking agents (e.g., adalimumab, certolizumab pegol, etanercept, infliximab); concomitant use with other biologic antirheumatic drugs (e.g., anakinra) not recommended.1 (See Infectious Complications under Cautions and see Specific Drugs and Laboratory Tests under Interactions.)

Abatacept Dosage and Administration

Administration

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.1

Administer by IV infusion.1

Administer with an in-line, sterile, nonpyrogenic, low-protein-binding filter with a pore diameter ≤1.2 mcm.1

Consult manufacturer’s labeling for additional information on reconstitution, dilution, and administration.1

Reconstitution

Reconstitute the appropriate number of vials containing 250 mg of abatacept lyophilized powder with 10 mL of sterile water for injection to provide a solution containing 25 mg/mL.1

Use only the silicone-free disposable syringe provided by the manufacturer and an 18–21 gauge needle.1 If a siliconized syringe is inadvertently used, translucent particles may develop and solution should be discarded.1

Direct sterile water for injection toward the side of the vial during reconstitution; swirl gently to minimize foaming.1 Do not shake.1 Upon dissolution, insert a vented needle into the vial to dissipate foam.1 Must be diluted further before IV administration.1

Dilution

Remove the volume of diluent equal to the total required volume of reconstituted abatacept solution from a 100 mL bag of 0.9% sodium chloride injection.1

Using same silicone-free disposable syringe used for reconstitution, slowly add reconstituted abatacept to the bag to a total volume of 100 mL; mix gently.1

Rate of Administration

Infuse over 30 minutes.1

Dosage

Dosage is based on patient’s weight.1

Pediatric Patients

Juvenile Arthritis IV

Children 6–17 years of age weighing <75 kg: 10 mg/kg at 0, 2, and 4 weeks, then every 4 weeks.1

Children 6–17 years of age weighing ≥75 kg: Use adult dosage.1

Adults

Rheumatoid Arthritis IV

Adults weighing <60 kg: 500 mg at 0, 2, and 4 weeks, then every 4 weeks.1

Adults weighing 60–100 kg: 750 mg at 0, 2, and 4 weeks, then every 4 weeks.1

Adults weighing >100 kg: 1 g at 0, 2, and 4 weeks, then every 4 weeks.1

Prescribing Limits

Pediatric Patients

Juvenile Arthritis IV

Children 6–17 years of age weighing ≥75 kg: Maximum dose is 1 g.1

Special Populations

No special population dosage recommendations at this time.1

Administration

IV: Infuse over 30 minutes. Administer through a 0.2 to 1.2 micron low protein-binding filter

SubQ: Allow prefilled syringe and autoinjector to warm to room temperature (for 30 to 60 minutes and 30 minutes, respectively) prior to administration. Inject into the front of the thigh (preferred), abdomen (except for 2-inch area around the navel), or the outer area of the upper arms (if administered by a caregiver). Rotate injection sites (≥1 inch apart); do not administer into tender, bruised, red, or hard skin.

Orencia Interactions

Tell your doctor about all prescription, nonprescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially:

  • Kineret (anakinra)
  • Humira (adalimumab)
  • Cimzia (certolizumab)
  • Enbrel (etanercept)
  • Simponi (golimumab)
  • Remicade (infliximab)
  • Tysabri (natalizumab)
  • Rituxan (rituximab)
  • Actemra (tocilizumab)

What is the dosage for abatacept?

For adult patients, abatacept is infused over 30 minutes or injected under the skin. Patients weighing < 60 kg should receive a 500 mg dose, weighing 60-100 kg a 750 mg dose and weighing >100 kg a 1000 mg dose. The initial dose of abatacept is followed by additional doses two and four weeks after the first infusion with further doses every four weeks thereafter. Alternatively, adults may receive 125 mg by subcutaneous injection one day after the initial weight-based dose and then 125 mg by subcutaneous injection once weekly.

Patients 6 to 17 years old weighing less than 75 kg should receive a 10 mg/kg infusion initially. Pediatric patients weighing more than 75 kg should receive the adult infusion doses. The initial dose of abatacept is followed by additional doses two and four weeks after the first infusion with further doses every four weeks thereafter.

What else should I know about abatacept?

What preparations of abatacept are available?

Powder for Injection: 250 mg. Prefilled Syringe: 125 mg/ml.

How should I keep abatacept stored?

Abatacept should be refrigerated between 2 C - 8 C (36 F - 46 F).

Side effects

Because clinical trials are conducted under widely varying and controlled conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not predict the rates observed in a broader patient population in clinical practice.

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to abatacept in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

Clinical Studies Experience In Adult RA Patients Treated With Intravenous ORENCIA

The data described herein reflect exposure to ORENCIA administered intravenously in patients with active RA in placebo-controlled studies (1955 patients with ORENCIA, 989 with placebo). The studies had either a double-blind, placebo-controlled period of 6 months (258 patients with ORENCIA, 133 with placebo) or 1 year (1697 patients with ORENCIA, 856 with placebo). A subset of these patients received concomitant biologic DMARD therapy, such as a TNF blocking agent (204 patients with ORENCIA, 134 with placebo).

The majority of patients in RA clinical studies received one or more of the following concomitant medications with ORENCIA: methotrexate, nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, TNF blocking agents, azathioprine, chloroquine, gold, hydroxychloroquine, leflunomide, sulfasalazine, and anakinra.

The most serious adverse reactions were serious infections and malignancies.

The most commonly reported adverse events (occurring in ≥ 10% of patients treated with ORENCIA) were headache, upper respiratory tract infection, nasopharyngitis, and nausea.

The adverse events most frequently resulting in clinical intervention (interruption or discontinuation of ORENCIA) were due to infection. The most frequently reported infections resulting in dose interruption were upper respiratory tract infection (1.0%), bronchitis (0.7%), and herpes zoster (0.7%). The most frequent infections resulting in discontinuation were pneumonia (0.2%), localized infection (0.2%), and bronchitis (0.1%).

Infections

In the placebo-controlled trials, infections were reported in 54% of ORENCIA-treated patients and 48% of placebo-treated patients. The most commonly reported infections (reported in 5%-13% of patients) were upper respiratory tract infection, nasopharyngitis, sinusitis, urinary tract infection, influenza, and bronchitis. Other infections reported in fewer than 5% of patients at a higher frequency ( > 0.5%) with ORENCIA compared to placebo, were rhinitis, herpes simplex, and pneumonia [see WARNINGS AND PRECAUTIONS].

Serious infections were reported in 3.0% of patients treated with ORENCIA and 1.9% of patients treated with placebo. The most common (0.2%-0.5%) serious infections reported with ORENCIA were pneumonia, cellulitis, urinary tract infection, bronchitis, diverticulitis, and acute pyelonephritis [see WARNINGS AND PRECAUTIONS].

Malignancies

In the placebo-controlled portions of the clinical trials (1955 patients treated with ORENCIA for a median of 12 months), the overall frequencies of malignancies were similar in the ORENCIA and placebo-treated patients (1.3% and 1.1%, respectively). However, more cases of lung cancer were observed in ORENCIA-treated patients (4, 0.2%) than placebo-treated patients (0). In the cumulative ORENCIA clinical trials (placebo-controlled and uncontrolled, open-label) a total of 8 cases of lung cancer (0.21 cases per 100 patient-years) and 4 lymphomas (0.10 cases per 100 patient-years) were observed in 2688 patients (3827 patient-years). The rate observed for lymphoma is approximately 3.5-fold higher than expected in an age- and gender-matched general population based on the National Cancer Institute's Surveillance, Epidemiology, and End Results Database. Patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. Other malignancies included skin, breast, bile duct, bladder, cervical, endometrial, lymphoma, melanoma, myelodysplastic syndrome, ovarian, prostate, renal, thyroid, and uterine cancers [see WARNINGS AND PRECAUTIONS]. The potential role of ORENCIA in the development of malignancies in humans is unknown.

Infusion-Related Reactions And Hypersensitivity Reactions

Acute infusion-related events (adverse reactions occurring within 1 hour of the start of the infusion) in Studies III, IV, and V [see Clinical Studies] were more common in the ORENCIA-treated patients than the placebo patients (9% for ORENCIA, 6% for placebo). The most frequently reported events (1%-2%) were dizziness, headache, and hypertension.

Acute infusion-related events that were reported in > 0.1% and ≤ 1% of patients treated with ORENCIA included cardiopulmonary symptoms, such as hypotension, increased blood pressure, and dyspnea; other symptoms included nausea, flushing, urticaria, cough, hypersensitivity, pruritus, rash, and wheezing. Most of these reactions were mild (68%) to moderate (28%). Fewer than 1% of ORENCIA-treated patients discontinued due to an acute infusion-related event. In controlled trials, 6 ORENCIA-treated patients compared to 2 placebo-treated patients discontinued study treatment due to acute infusion-related events.

In clinical trials of 2688 adult RA patients treated with intravenous ORENCIA, there were two cases ( < 0.1%) of anaphylaxis or anaphylactoid reactions. Other reactions potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, each occurred in less than 0.9% of ORENCIA-treated patients and generally occurred within 24 hours of ORENCIA infusion. Appropriate medical support measures for the treatment of hypersensitivity reactions should be available for immediate use in the event of a reaction [see WARNINGS AND PRECAUTIONS].

Adverse Reactions In Patients With COPD

In Study V [see Clinical Studies], there were 37 patients with chronic obstructive pulmonary disease (COPD) who were treated with ORENCIA and 17 COPD patients who were treated with placebo. The COPD patients treated with ORENCIA developed adverse events more frequently than those treated with placebo (97% vs 88%, respectively). Respiratory disorders occurred more frequently in ORENCIA-treated patients compared to placebo-treated patients (43% vs 24%, respectively) including COPD exacerbation, cough, rhonchi, and dyspnea. A greater percentage of ORENCIA-treated patients developed a serious adverse event compared to placebo-treated patients (27% vs 6%), including COPD exacerbation (3 of 37 patients [8%]) and pneumonia (1 of 37 patients [3%]) [see WARNINGS AND PRECAUTIONS].

Other Adverse Reactions

Adverse events occurring in 3% or more of patients and at least 1% more frequently in ORENCIA-treated patients during placebo-controlled RA studies are summarized in Table 3.

Table 3: Adverse Events Occurring in 3% or More of Patients and at Least 1% More Frequently in ORENCIA-Treated Patients During Placebo-Controlled RA Studies

Adverse Event (Preferred Term) ORENCIA
(n=1955)a Percentage
Placebo
(n=989)b Percentage
Headache 18 13
Nasopharyngitis 12 9
Dizziness 9 7
Cough 8 7
Back pain 7 6
Hypertension 7 4
Dyspepsia 6 4
Urinary tract infection 6 5
Rash 4 3
Pain in extremity 3 2
a Includes 204 patients on concomitant biologic DMARDs (adalimumab, anakinra, etanercept, or infliximab).
b Includes 134 patients on concomitant biologic DMARDs (adalimumab, anakinra, etanercept, or infliximab).

Immunogenicity

Antibodies directed against the entire abatacept molecule or to the CTLA-4 portion of abatacept were assessed by ELISA assays in RA patients for up to 2 years following repeated treatment with ORENCIA. Thirty-four of 1993 (1.7%) patients developed binding antibodies to the entire abatacept molecule or to the CTLA-4 portion of abatacept. Because trough levels of abatacept can interfere with assay results, a subset analysis was performed. In this analysis it was observed that 9 of 154 (5.8%) patients that had discontinued treatment with ORENCIA for over 56 days developed antibodies.

Samples with confirmed binding activity to CTLA-4 were assessed for the presence of neutralizing antibodies in a cell-based luciferase reporter assay. Six of 9 (67%) evaluable patients were shown to possess neutralizing antibodies. However, the development of neutralizing antibodies may be underreported due to lack of assay sensitivity.

No correlation of antibody development to clinical response or adverse events was observed.

The data reflect the percentage of patients whose test results were positive for antibodies to abatacept in specific assays. The observed incidence of antibody (including neutralizing antibody) positivity in an assay is highly dependent on several factors, including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medication, and underlying disease. For these reasons, comparison of the incidence of antibodies to abatacept with the incidence of antibodies to other products may be misleading.

Clinical Experience In Methotrexate-Naive Patients

Study VI was an active-controlled clinical trial in methotrexate-naive patients [see Clinical Studies]. The safety experience in these patients was consistent with Studies I-V.

Clinical Studies Experience In Adult RA Patients Treated With Subcutaneous ORENCIA

Study SC-1 was a randomized, double-blind, double-dummy, non-inferiority study that compared the efficacy and safety of abatacept administered subcutaneously (SC) and intravenously (IV) in 1457 subjects with rheumatoid arthritis, receiving background methotrexate, and experiencing an inadequate response to methotrexate (MTX-IR) [see Clinical Studies]. The safety experience and immunogenicity for ORENCIA administered subcutaneously was consistent with intravenous Studies I-VI. Due to the route of administration, injection site reactions and immunogenicity were evaluated in Study SC-1 and two other smaller studies discussed in the sections below.

Injection Site Reactions In Adult RA Patients Treated With Subcutaneous ORENCIA

Study SC-1 compared the safety of abatacept including injection site reactions following subcutaneous or intravenous administration. The overall frequency of injection site reactions was 2.6% (19/736) and 2.5% (18/721) for the subcutaneous abatacept group and the intravenous abatacept group (subcutaneous placebo), respectively. All these injection site reactions (including hematoma, pruritus, and erythema) were mild (83%) to moderate (17%) in severity, and none necessitated drug discontinuation.

Immunogenicity In Adult RA Patients Treated With Subcutaneous ORENCIA

Study SC-1 compared the immunogenicity to abatacept following subcutaneous or intravenous administration. The overall immunogenicity frequency to abatacept was 1.1% (8/725) and 2.3% (16/710) for the subcutaneous and intravenous groups, respectively. The rate is consistent with previous experience, and there was no correlation of immunogenicity with effects on pharmacokinetics, safety, or efficacy.

Immunogenicity And Safety Of Subcutaneous ORENCIA Administration As Monotherapy Without An Intravenous Loading Dose

Study SC-2 was conducted to determine the effect of monotherapy use of ORENCIA on immunogenicity following subcutaneous administration without an intravenous load in 100 RA patients, who had not previously received abatacept or other CTLA4Ig, who received either subcutaneous ORENCIA plus methotrexate (n=51) or subcutaneous ORENCIA monotherapy (n=49). No patients in either group developed anti-product antibodies after 4 months of treatment. The safety observed in this study was consistent with that observed in the other subcutaneous studies.

Immunogenicity And Safety Of Subcutaneous ORENCIA Upon Withdrawal (Three Months) And Restart Of Treatment

Study SC-3 in the subcutaneous program was conducted to investigate the effect of withdrawal (three months) and restart of ORENCIA subcutaneous treatment on immunogenicity in RA patients treated concomitantly with methotrexate. One hundred sixty-seven patients were enrolled in the first 3-month treatment period and responders (n=120) were randomized to either subcutaneous ORENCIA or placebo for the second 3-month period (withdrawal period). Patients from this period then received open-label ORENCIA treatment in the final 3-month period of the study (period 3). At the end of the withdrawal period, 0/38 patients who continued to receive subcutaneous ORENCIA developed anti-product antibodies compared to 7/73 (9.6%) of patients who had subcutaneous ORENCIA withdrawn during this period. Half of the patients receiving subcutaneous placebo during the withdrawal period received a single intravenous infusion of ORENCIA at the start of period 3 and half received intravenous placebo. At the end of period 3, when all patients again received subcutaneous ORENCIA, the immunogenicity rates were 1/38 (2.6%) in the group receiving subcutaneous ORENCIA throughout, and 2/73 (2.7%) in the group that had received placebo during the withdrawal period. Upon reinitiating therapy, there were no injection reactions and no differences in response to therapy in patients who were withdrawn from subcutaneous therapy for up to 3 months relative to those who remained on subcutaneous therapy, whether therapy was reintroduced with or without an intravenous loading dose. The safety observed in this study was consistent with that observed in the other studies.

Clinical Studies Experience In Juvenile Idiopathic Arthritis Patients Treated With Intravenous ORENCIA

In general, the adverse events in pediatric patients were similar in frequency and type to those seen in adult patients [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS].

Study JIA-1 was a three-part study including an open-label extension that assessed the safety and efficacy of intravenous ORENCIA in 190 pediatric patients, 6 to 17 years of age, with polyarticular juvenile idiopathic arthritis. Overall frequency of adverse events in the 4-month, lead-in, open-label period of the study was 70%; infections occurred at a frequency of 36% [see Clinical Studies]. The most common infections were upper respiratory tract infection and nasopharyngitis. The infections resolved without sequelae, and the types of infections were consistent with those commonly seen in outpatient pediatric populations. Other events that occurred at a prevalence of at least 5% were headache, nausea, diarrhea, cough, pyrexia, and abdominal pain.

A total of 6 serious adverse events (acute lymphocytic leukemia, ovarian cyst, varicella infection, disease flare [2], and joint wear) were reported during the initial 4 months of treatment with ORENCIA.

Of the 190 patients with juvenile idiopathic arthritis treated with ORENCIA in clinical trials, there was one case of a hypersensitivity reaction (0.5%). During Periods A, B, and C, acute infusion-related reactions occurred at a frequency of 4%, 2%, and 3%, respectively, and were consistent with the types of events reported in adults.

Upon continued treatment in the open-label extension period, the types of adverse events were similar in frequency and type to those seen in adult patients, except for a single patient diagnosed with multiple sclerosis while on open-label treatment.

Immunogenicity

Antibodies directed against the entire abatacept molecule or to the CTLA-4 portion of abatacept were assessed by ELISA assays in patients with juvenile idiopathic arthritis following repeated treatment with ORENCIA throughout the open-label period. For patients who were withdrawn from therapy for up to 6 months during the double-blind period, the rate of antibody formation to the CTLA-4 portion of the molecule was 41% (22/54), while for those who remained on therapy the rate was 13% (7/54). Twenty of these patients had samples that could be tested for antibodies with neutralizing activity; of these, 8 (40%) patients were shown to possess neutralizing antibodies.

The presence of antibodies was generally transient and titers were low. The presence of antibodies was not associated with adverse events, changes in efficacy, or an effect on serum concentrations of abatacept. For patients who were withdrawn from ORENCIA during the double-blind period for up to 6 months, no serious acute infusion-related events were observed upon re-initiation of ORENCIA therapy.

Clinical Studies Experience In Juvenile Idiopathic Arthritis Patients Treated With Subcutaneous ORENCIA

Study JIA-2 was an open-label study with a 4-month short-term period and a long-term extension period that assessed the pharmacokinetics (PK), safety, and efficacy of subcutaneous ORENCIA in 205 pediatric patients, 2 to 17 years of age with juvenile idiopathic arthritis. The safety experience and immunogenicity for ORENCIA administered subcutaneously were consistent with the intravenous Study JIA-1.

There were no reported cases of hypersensitivity reactions. Local injection-site reactions occurred at a frequency of 4.4%.

Clinical Studies Experience In Adult PsA Patients

The safety of ORENCIA was evaluated in 594 patients with psoriatic arthritis (341 patients on ORENCIA and 253 patients on placebo), in two randomized, double-blind, placebo-controlled trials. Of the 341 patients who received ORENCIA, 128 patients received intravenous ORENCIA (PsA-I) and 213 patients received subcutaneous ORENCIA (PsA-II). The safety profile was comparable between studies PsA-I and PsA-II and consistent with the safety profile in rheumatoid arthritis [see WARNINGS AND PRECAUTIONS, Clinical Studies Experience in Adult RA Patients Treated with Intravenous ORENCIA and Clinical Studies Experience in Adult RA Patients Treated with Subcutaneous ORENCIA].

Postmarketing Experience

Adverse reactions have been reported during the postapproval use of ORENCIA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to ORENCIA. Based on the postmarketing experience in adult RA patients, the following adverse reaction has been identified during postapproval use with ORENCIA.

  • Vasculitis (including cutaneous vasculitis and leukocytoclastic vasculitis)

Side Effects of Abatacept

Abatacept can cause serious side effects. See "Precautions" section.

Common side effects of abatacept include:

  • headache
  • upper respiratory tract infection
  • sore throat
  • nausea

In children and adolescents, other side effects may include:

  • diarrhea
  • cough
  • fever
  • abdominal pain

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of abatacept. For more information, ask your healthcare provider or pharmacist.

Abatacept Precautions

Abatacept can cause serious side effects including:

  • infections. Abatacept can make you more likely to get infections or make the infection that you have get worse. Some patients have died from these infections. Call your healthcare provider right away if you have any symptoms of an infection. Symptoms of an infection may include:
    • fever
    • feel very tired
    • have a cough
    • have flu-like symptoms
    • warm, red, or painful skin
  • allergic reactions. Allergic reactions can happen to people who use abatacept. Call your healthcare provider or go to the emergency room right away if you have any symptoms of an allergic reaction. Symptoms of an allergic reaction may include:
    • hives
    • swollen face, eyelids, lips, or tongue
    • trouble breathing
  • hepatitis B infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use abatacept. Your healthcare provider may do a blood test before you start treatment with abatacept.
  • vaccinations. You should not receive abatacept with certain types of vaccines (live vaccines). Abatacept may also cause some vaccinations to be less effective. Talk with your healthcare provider about your vaccination plans.
  • breathing problems in patients with chronic obstructive pulmonary Disease (COPD). Some people may get certain respiratory problems more often if you receive abatacept and have COPD. Symptoms of respiratory problems include:
    • COPD that becomes worse
    • cough
    • trouble breathing
  • cancer (malignancies). Certain kinds of cancer have been reported in people using abatacept. It is not known if abatacept increases your chance of getting certain kinds of cancer.

You should not receive abatacept if you are allergic to any of its ingredients.

You should not have any vaccinations while you are using abatacept or for 3 months after you stop using abatacept without talking to your doctor.

Inform MD

Before you use abatacept, tell your healthcare provider if you:

  • are allergic to abatacept or to any of its ingredients
  • have any kind of infection even if it is small (such as an open cut or sore), or an infection that is in your whole body (such as the flu). If you have an infection when taking abatacept, you may have a higher chance of getting serious side effects.
  • have an infection that will not go away or an infection that keeps coming back.
  • are allergic to abatacept or any of the ingredients in abatacept. 
  • have or have had inflammation of your liver due to an infection (viral hepatitis). Before you use abatacept, your healthcare provider may examine you for hepatitis.
  • have had a lung infection called tuberculosis (TB), a positive skin test for TB, or you recently have been in close contact with someone who has had TB. Before you use abatacept, your healthcare provider may examine you for TB or perform a skin test. Symptoms of TB may include:
    • a cough that does not go away
    • weight loss
    • fever
    • night sweats
  • are scheduled to have surgery.
  • recently received a vaccination or are scheduled for a vaccination. If you are receiving abatacept, and for 3 months after you stop receiving abatacept, you should not receive live vaccines.
  • have a history of a breathing problem called chronic obstructive pulmonary disease (COPD).
  • have diabetes and use a blood glucose monitor to check your blood sugar (blood glucose) levels. Abatacept for intravenous infusion (given through a needle placed in a vein) contains maltose, a type of sugar that can give false high blood sugar readings with certain types of blood glucose monitors, on the day of abatacept infusion. Your doctor may tell you to use a different way to monitor your blood sugar levels.
  • Abatacept for subcutaneous injection (injected under the skin) does not contain maltose. You do not need to change your blood sugar monitoring if you are taking abatacept subcutaneously.
  • have any other medical conditions.
  • are pregnant or planning to become pregnant.
  • are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Abatacept and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Abatacept falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Bristol-Myers Squibb Company has a registry for pregnant women exposed to abatacept. The purpose of this registry is to check the health of the pregnant mother and her child. Women are encouraged to call the registry themselves or ask their doctors to contact the registry for them by calling 1-877-311-8972.

Abatacept and Lactation

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if abatacept passes into your breast milk. You and your healthcare provider should decide if you will use abatacept or breastfeed. You should not do both.

Abatacept Dosage

Your doctor will determine the best abatacept dosage for you based on your age and weight, your medical conditions, as well as other medications you take. Abatacept is given by infusion into a vein (IV) at your doctor's office or another medical facility, or by subcutaneous injection (under the skin).

What happens if i miss a dose (orencia)?

Call your doctor for instructions if you miss your abatacept dose.

Precautions

-Safety and efficacy in pediatric patients below 6 years of age have not been established.
-Safety and efficacy for uses other than juvenile idiopathic arthritis have not been established.

Consult WARNINGS section for additional precautions.

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