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Abatacept

Medically reviewed by Drugs.com. Last updated on Aug 26, 2020.

Pronunciation

(ab a TA sept)

Index Terms

  • BMS-188667
  • CTLA-4Ig

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Auto-injector, Subcutaneous [preservative free]:

Orencia ClickJect: 125 mg/mL (1 mL)

Solution Prefilled Syringe, Subcutaneous [preservative free]:

Orencia: 50 mg/0.4 mL (0.4 mL); 87.5 mg/0.7 mL (0.7 mL); 125 mg/mL (1 mL)

Solution Reconstituted, Intravenous [preservative free]:

Orencia: 250 mg (1 ea)

Brand Names: U.S.

  • Orencia
  • Orencia ClickJect

Pharmacologic Category

  • Antirheumatic, Disease Modifying
  • Selective T-Cell Costimulation Blocker

Pharmacology

Selective costimulation modulator; inhibits T-cell (T-lymphocyte) activation by binding to CD80 and CD86 on antigen presenting cells (APC), thus blocking the required CD28 interaction between APCs and T cells. Activated T lymphocytes are found in the synovium of rheumatoid arthritis patients.

Distribution

Vss: Rheumatoid arthritis: IV: 0.07 L/kg (range: 0.02 to 0.13 L/kg).

Half-Life Elimination

Rheumatoid arthritis (RA): IV: 13.1 days (range: 8 to 25 days).

Clearance: Note: Clearance increases with increasing body weight.

Children 6 to 17 years: Juvenile idiopathic arthritis: 0.4 mL/hour/kg (0.2 to 1.12 mL/hour/kg).

Adults: RA: 0.22 mL/hour/kg (0.13 to 0.47 mL/hour/kg).

Use: Labeled Indications

Juvenile idiopathic arthritis: Treatment of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ≥2 years of age; may be used as monotherapy or in combination with methotrexate.

Psoriatic arthritis: Treatment of active psoriatic arthritis in adults.

Rheumatoid arthritis: Treatment of moderately to severely active adult rheumatoid arthritis; may be used as monotherapy or in combination with other disease-modifying antirheumatic drugs (DMARDs).

Note: Abatacept should not be used in combination with other potent immunosuppressants (eg, biologic DMARDs, Janus kinase inhibitors).

Contraindications

There are no contraindications listed within the manufacturer's US labeling.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to abatacept or any component of the formulation; patients with, or at risk of sepsis syndrome (eg, immunocompromised, HIV positive)

Dosing: Adult

Psoriatic arthritis (PsA):

IV: Dosing is according to body weight. Following the initial IV infusion (using the weight-based dosing), repeat IV infusion (using the same weight-based dosing) at 2 weeks and 4 weeks after the initial infusion, and every 4 weeks thereafter.

<60 kg: 500 mg

60 to 100 kg: 750 mg

>100 kg: 1,000 mg

SubQ: 125 mg once weekly. Note: Administer without an IV loading dose.

If transitioning from IV therapy to SubQ therapy, administer the first SubQ dose instead of the next scheduled IV dose.

Rheumatoid arthritis (RA):

IV: Dosing is according to body weight. Following the initial IV infusion (using the weight-based dosing), repeat IV infusion (using the same weight-based dosing) at 2 weeks and 4 weeks after the initial infusion, and every 4 weeks thereafter.

<60 kg: 500 mg

60 to 100 kg: 750 mg

>100 kg: 1,000 mg

SubQ: 125 mg once weekly. Note: SubQ dosing may be initiated with or without an IV loading dose.

If initiating with an IV loading dose, administer the initial IV infusion (using the weight-based dosing), then administer 125 mg subcutaneously within 24 hours of the infusion, followed by 125 mg subcutaneously once weekly thereafter.

If transitioning from IV therapy to SubQ therapy, administer the first SubQ dose instead of the next scheduled IV dose.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing. Due to potential for higher rates of infections and malignancies, use caution.

Dosing: Pediatric

Note: Dosing presented in mg/kg and fixed mg; use extra precaution to ensure dosing units.

Juvenile idiopathic arthritis: Note: Dosing varies by route of administration (IV or SubQ); use extra precaution.

IV: Children ≥6 years and Adolescents: Note: Dose is based on body weight at each dose administration. Following the initial IV infusion, repeat IV dose at 2 weeks and 4 weeks after the initial infusion, and every 4 weeks thereafter.

Patient weight:

<75 kg: IV: 10 mg/kg.

75 to 100 kg: IV: 750 mg.

>100 kg: IV: 1,000 mg.

SubQ: Children ≥2 years and Adolescents: Note: Administer without an IV loading dose and use the following weight-based dosing. The autoinjector for subcutaneous injection has not been studied in patients under 18 years of age.

Patient weight:

10 to <25 kg: SubQ: 50 mg once weekly.

≥25 to <50 kg: SubQ: 87.5 mg once weekly.

≥50 kg: SubQ: 125 mg once weekly.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing adjustment for toxicity: Children ≥2 years and Adolescents: Discontinue in patients who develop serious infection.

Dosing: Adjustment for Toxicity

Discontinue in patients who develop a serious infection.

Reconstitution

IV: Reconstitute each vial with 10 mL SWFI using the provided silicone-free disposable syringe (discard solutions accidentally reconstituted with siliconized syringe as they may develop translucent particles) and an 18- to 21-gauge needle. Inject SWFI down the side of the vial to avoid foaming; gently swirl without shaking until contents dissolved. The reconstituted solution contains 25 mg/mL abatacept. Further dilute (using a silicone-free syringe) in 100 mL NS to a final concentration of ≤10 mg/mL. Prior to adding abatacept to the 100 mL bag, the manufacturer recommends withdrawing a volume of NS equal to the abatacept volume required, resulting in a final volume of 100 mL. Mix gently; do not shake.

SubQ: Allow prefilled syringe to reach room temperature prior to administration by removing from refrigerator 30 to 60 minutes prior to administration.

Administration

Do not administer if solution is discolored or contains particulate matter.

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 full amount 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.

Storage

Prefilled syringe: Store at 2°C to 8°C (36°F to 46°F); do not freeze. Protect from light.

Powder for injection: Prior to reconstitution, store at 2°C to 8°C (36°F to 46°F); do not freeze. Protect from light. After dilution in NS, may be stored for up to 24 hours at room temperature or refrigerated at 2°C to 8°C (36°F to 46°F). Must be used within 24 hours of reconstitution.

Drug Interactions

Anti-TNF Agents: May enhance the immunosuppressive effect of Abatacept. Avoid combination

BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

Belimumab: May enhance the immunosuppressive effect of Biologic Disease-Modifying Antirheumatic Drugs (DMARDs). Avoid combination

Biologic Disease-Modifying Antirheumatic Drugs (DMARDs): May enhance the immunosuppressive effect of other Biologic Disease-Modifying Antirheumatic Drugs (DMARDs). Avoid combination

Cladribine: May enhance the immunosuppressive effect of Immunosuppressants. Avoid combination

Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy

Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy

Echinacea: May diminish the therapeutic effect of Immunosuppressants. Management: Consider avoiding Echinacea in patients receiving therapeutic immunosuppressants. If coadministered, monitor for reduced efficacy of the immunosuppressant during concomitant use. Consider therapy modification

Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification

Inebilizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy

Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification

Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination

Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Management: Avoid use of immunosuppressants (including systemic corticosteroids) prior to initiation of nivolumab. Use of immunosuppressants after administration of nivolumab (eg, for immune-related toxicity) is unlikely to affect nivolumab efficacy. Consider therapy modification

Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy

Ozanimod: Immunosuppressants may enhance the immunosuppressive effect of Ozanimod. Monitor therapy

Pidotimod: Immunosuppressants may diminish the therapeutic effect of Pidotimod. Monitor therapy

Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Management: Consider avoiding concomitant use of roflumilast and immunosuppressants as recommended by the Canadian product monograph. Inhaled or short-term corticosteroids are unlikely to be problematic. Consider therapy modification

Siponimod: Immunosuppressants may enhance the immunosuppressive effect of Siponimod. Monitor therapy

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Management: Evaluate patients to see if it is medically appropriate to reduce or discontinue therapy with immunosuppressants prior to initiating sipuleucel-T therapy. Consider therapy modification

Smallpox and Monkeypox Vaccine (Live): Immunosuppressants may diminish the therapeutic effect of Smallpox and Monkeypox Vaccine (Live). Monitor therapy

Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Talimogene Laherparepvec: Immunosuppressants may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk for disseminated herpetic infection may be increased. Avoid combination

Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy

Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated less than 2 weeks before starting or during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification

Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Avoid combination

Test Interactions

Contains maltose; may result in falsely elevated blood glucose levels with dehydrogenase pyrroloquinolinequinone or glucose-dye-oxidoreductase testing methods on the day of infusion. Glucose monitoring methods which utilize glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase, or glucose hexokinase are recommended.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Gastrointestinal: Nausea (≥10%)

Genitourinary: Urinary tract infection (5% to 13%)

Immunologic: Antibody development (2% to 41%; neutralizing: 40% to 67%)

Infection: Infection (54%; serious infection: 3%), influenza (5% to 13%)

Nervous system: Headache (18%)

Respiratory: Bronchitis (5% to 13%), nasopharyngitis (5% to 13%), sinusitis (5% to 13%), upper respiratory tract infection (5% to 13%)

1% to 10%:

Cardiovascular: Flushing (≤1%), hypertension (7%), hypotension (≤1%)

Dermatologic: Pruritus (≤1%), skin rash (4%), urticaria (≤1%)

Gastrointestinal: Dyspepsia (6%)

Hypersensitivity: Hypersensitivity reaction (≤1%)

Immunologic: Immunogenicity (1% to 2%)

Infection: Herpes simplex infection (<5%)

Local: Injection site reaction (4%)

Nervous system: Dizziness (9%)

Neuromuscular & skeletal: Back pain (7%), limb pain (3%)

Respiratory: Cough (8%), dyspnea (≤1%), pneumonia (<5%), rhinitis (<5%), wheezing (≤1%)

Miscellaneous: Infusion related reaction (≤9%)

<1%:

Dermatologic: Cellulitis

Gastrointestinal: Diverticulitis of the gastrointestinal tract

Hematologic & oncologic: Malignant lymphoma, malignant neoplasm of lung

Hypersensitivity: Anaphylaxis

Renal: Pyelonephritis

Frequency not defined:

Genitourinary: Malignant neoplasm of cervix

Hematologic & oncologic: Endometrial carcinoma, malignant melanoma, malignant neoplasm of bladder, malignant neoplasm of breast, malignant neoplasm of kidney, malignant neoplasm of ovary, malignant neoplasm of prostate, malignant neoplasm of skin, malignant neoplasm of the bile duct, malignant neoplasm of thyroid, malignant neoplasm of uterus, myelodysplastic syndrome

Postmarketing:

Cardiovascular: Hypersensitivity angiitis, vasculitis

Dermatologic: Exacerbation of psoriasis, psoriasis

Hematologic & oncologic: Basal cell carcinoma of skin, squamous cell carcinoma of skin

Hypersensitivity: Angioedema

Infection: Sepsis

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Rare cases of hypersensitivity, anaphylaxis, or anaphylactoid reactions, including fatalities, have been reported with IV administration; may occur with first infusion. Some reactions (angioedema, hypotension, urticaria, dyspnea) occurred within 24 hours of infusion, but may also have a delayed onset. Discontinue treatment if anaphylaxis or other serious allergic reaction occurs; medication for the treatment of hypersensitivity reactions should be available for immediate use.

• Infections: Serious and potentially fatal infections (including tuberculosis and sepsis) have been reported, particularly in patients receiving concomitant immunosuppressive therapy. Rheumatoid arthritis (RA) patients receiving a concomitant tumor necrosis factor (TNF) antagonist experienced an even higher rate of serious infection; monitor for signs and symptoms of infection when transitioning from TNF-blocking agents to abatacept. Caution should be exercised when considering the use in any patient with a history of new/recurrent infections, with conditions that predispose them to infections, or with chronic, latent, or localized infections. Patients who develop a new infection while undergoing treatment should be monitored closely. If a patient develops a serious infection, therapy should be discontinued.

• Malignancy: Use may affect defenses against malignancies (via T-cell inhibition); impact on the development and course of malignancies is not fully defined. As compared to the general population, an increased risk of lymphoma and lung cancer has been noted in clinical trials; however, RA has been previously associated with an increased rate of lymphoma. Malignancies, including skin cancer, have been reported with abatacept therapy; periodic skin examinations are recommended.

Disease-related concerns:

• Chronic obstructive pulmonary disease: Use caution with chronic obstructive pulmonary disease (COPD); higher incidences of adverse effects (COPD exacerbation, cough, rhonchi, dyspnea) have been observed; monitor closely.

Special populations:

• Elderly: Use with caution, higher incidences of infection and malignancy were observed in the elderly.

• Tuberculosis-positive patients: Safety has not been established in tuberculosis-positive patients; screen patients for latent tuberculosis infection prior to initiating therapy. Treat patients testing positive according to standard therapy prior to initiating abatacept.

Dosage form specific issues:

• Maltose: Powder for injection may contain maltose, which may result in falsely-elevated serum glucose readings on the day of infusion.

Other warnings/precautions:

• Hepatitis screening: Patients should be screened for viral hepatitis prior to use; antirheumatic therapy may cause reactivation of hepatitis B.

• Immunizations: Patients should be brought up to date with all immunizations before initiating therapy. Live vaccines should not be given concurrently or within 3 months of discontinuation of therapy; there is no data available concerning secondary transmission of live vaccines in patients receiving therapy.

Monitoring Parameters

Signs and symptoms of infection, signs and symptoms of hypersensitivity reaction; hepatitis and tuberculosis screening prior to therapy initiation; periodic skin examinations.

Reproductive Considerations

Until additional data are available related to use in pregnancy, it is recommended to discontinue use and switch to a safer medication prior to conception unless no other pregnancy compatible medication is able to control maternal disease (Götestam Skorpen 2016).

Pregnancy Considerations

Information related to the use of abatacept in pregnancy is limited (Kumar 2015).

A pregnancy registry has been established to monitor outcomes of women exposed to abatacept during pregnancy (1-877-311-8972).

Patient Education

What is this drug used for?

• It is used to treat some types of arthritis.

• It may be given to you for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness or headache

• Signs of a common cold

• Nose or throat irritation

• Upset stomach

• Stomach pain or diarrhea

• Back pain

• Irritation where this drug is used

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal

• High or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight

• Feeling very tired or weak

• Flu-like signs

• Warm, red, or painful skin or sores on the body

• A skin lump or growth

• Change in color or size of a mole

• Swollen gland, night sweats, shortness of breath, or weight loss without trying

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Frequently Asked Questions