Dosing & Uses
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 250mg/vial
solution for SC injection
- 125mg/mL prefilled syringe
- 125mg/mL autoinjector
Moderate-to-Severe Rheumatoid Arthritis
Indicated to reduce signs and symptoms; may be used as monotherapy or in combination with other DMARDs except TNF antagonists
IV infusion
- <60 kg: 500 mg
- 60-100 kg: 750 mg
- >100 kg: 1000 mg
- Maintenance: Above dose repeated q2Weeks X2, then q4Weeks
SC injection
- SC administration may be initiated with or without an IV loading dose
- IV Loading dose: Administer a single IV infusion (see IV infusion weight-based dosing)
- Maintenance dose: 125 mg SC qWeek (first dose within a day following IV loading dose)
- Patients unable to receive IV infusion may initiate weekly SC injections without loading dose
- Transitioning from IV to SC: Administer first SC dose instead of scheduled IV dose
Psoriatic Arthritis
Indicated for adults with active psoriatic arthritis; may be used with or without nonbiologic DMARDs
IV infusion
- <60 kg: 500 mg
- 60-100 kg: 750 mg
- >100 kg: 1000 mg
- Maintenance: Above dose repeated q2Weeks X2, then q4Weeks
SC injection
- 125 mg SC qWeek without the need for an IV loading dose
- Switching from IV to SC: Administer the first SC dose instead of the next scheduled IV dose
Diabetes Mellitus Type 1 (Orphan)
Orphan designation for treatment of type 1 diabetes mellitus in patients with residual beta cell function
Orphan sponsor
- Orban Biotech LLC; 64 Aspinwall Avenue; Brookline, MA 02446-6495
Giant Cell Arteritis (Orphan)
Orphan designation for giant cell arteritis
Sponsor
- Bristol-Myers Squibb; P.O. Box 5326; Princeton, New Jersey 08543
Graft versus Host Disease (Orphan)
Orphan designation for prevention of graft versus host disease
Sponsor
- Bristol-Myers Squibb; P.O. Box 5326; Princeton, New Jersey 08543
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 250mg/vial
solution for SC injection
- 125mg/mL prefilled syringe
- Note: autoinjector has not been studied in patients aged <18 yr
Juvenile Idiopathic Arthritis
Indicated for reducing signs and symptoms in patients aged ≥2 years with moderately to severely active polyarticular juvenile idiopathic arthritis (JIA); may be used as monotherapy or concomitantly with methotrexate
SC administration
- <2 years: Safety and efficacy not established
-
≥2 years
- 10 to <25 kg: 50 mg SC once weekly
- 25 to <50 kg: 87.5 mg SC once weekly
- ≥50 kg: 125 mg SC once weekly
IV administration
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Adverse Effects
>10%
Headache (18%)
Nasopharyngitis (12%)
Nausea (>10%)
Infection (54% for adults & 36% for children)
1-10%
Dizziness (9%)
Cough (8%)
Back pain (7%)
Hypertension (7%)
Dyspepsia (6%)
Urinary Tract Infection (6%)
Rash (4%)
Pain in extremety (3%)
< 1%
Acute lymphocytic leukemia
Anaphylaxis
Cellulitis
COPD exacerbation
Disease flare
Diverticulitis
Dyspnea
Flushing
Hypersensitivity
Hypotension
Joint wear
Lung cancer
Lymphoma
Malignancies
Ovarian cyst
Pruitus
Pyelonephritis
Rhonchi
Urticaria
Varicella infection
Wheezing
Frequency Not Defined
Nausea
Abdominal pain
Diarrhea
Postmarketing Reports
New or worsening psoriasis
Warnings
Contraindications
None listed by the manufacturer
Cautions
Appropriate medical support measures for treatment of hypersensitivity reactions should be available for immediate use in event of reaction; if an anaphylactic or other serious allergic reaction occurs, stop administration immediately; institute appropriate therapy; permanently discontinue therapy
Higher risk for serious infections; concomitant use with a TNF antagonist can also increase risk of infections and serious infections; concurrent therapy with another TNF antagonist not recommended; discontinue if serious infections develop
Serious infections, including sepsis and pneumonia, reported; 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; a higher rate of serious infections has been observed in adult RA patients treated with concurrent TNF antagonists
Healthcare providers should exercise caution when considering therapy 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 should be monitored closely; administration should be discontinued if a patient develops a serious infection
Antirheumatic therapies have been associated with hepatitis B reactivation; screening for viral hepatitis should be performed in accordance with published guidelines before starting therapy
Prior to initiating therapy, patients should be screened for latent tuberculosis (TB) infection with a tuberculin skin test; therapy has not been studied in patients with a positive TB screen; safety of therapy in individuals with latent TB infection is unknown; patients testing positive in TB screening should be treated by standard medical practice prior to therapy
Prior to initiating therapy, update vaccinations in accordance with current vaccination guidelines; treated patients may receive current non-live vaccines; live vaccines should not be given concurrently or within 3 months after discontinuation; no data are available on secondary transmission of infection from persons receiving live vaccines to patients receiving therapy; based on mechanism of action, therapy may blunt effectiveness of some immunizations
Increased risk of lymphoma and lung cancer reported; significance unknown; increased risk of lymphoma associated with rheumatoid arthritis
Patients receiving therapy for RA reported to develop adverse events more frequently, including COPD exacerbations, cough, rhonchi, and dyspnea; therapy in patients with COPD should be undertaken with caution and such patients should be monitored for worsening of their respiratory status
The possibility exists for drugs inhibiting T cell activation, to affect host defenses against infections and malignancies since T cells mediate cellular immune responses; there have been reports of malignancies, including skin cancer in patients receiving therapy; periodic skin examinations are recommended for all treated patients, particularly those with risk factors for skin cancer
Higher incidence of infections and malignancy reported in the elderly; use caution
Pregnancy & Lactation
Pregnancy
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to therapy during pregnancy; healthcare professionals are encouraged to register patients and pregnant women are encouraged to enroll themselves by calling 1-877-311-8972
There are no adequate and well-controlled studies of use in pregnant women; data in pregnant women are insufficient to inform on drug-associated risk
Lactation
There is no information regarding presence of abatacept in human milk, effects on breastfed infant, or effects on milk production; however, abatacept was present in the milk of lactating rats dosed with abatacept.
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Chimeric protein that inhibits T-lymphocyte activation
Pharmacokinetics
Half-life, Terminal: 13 days
Peak Plasma: 295 mcg/mL
Vd: 0.07 L/kg
Clearance: 0.22 mL/hr/kg
Administration
IV Preparation
Reconstitute each vial contents with 10 mL sterile water for injection using ONLY the silicone-free disposable syringe supplied to obtain a 25 mg/mL solution (discard any siliconized syringes accidentally used)
Dilute further to 100 mL as follows by withdrawing a volume of 0.9% NaCl equal to the combined volume of the reconstituted vials; final concentration of infusion ≥10 mg/mL
Slowly add the reconstituted solution from each vial into the infusion bag or bottle using the same disposable syringe
Gently mix; avoid shaking infusion bag or bottle
Discard any unused portion immediately
Do not use if any discoloration or particulate matter present
IV Administration
Infuse IV over 30 min using a sterile, nonpyrogenic, low-protein-binding filter (0.2-1.2 micron)
Finish infusion within 24 hr of reconstitution
Do not administer with any other drugs
SC Administration
Prefilled syringes and ClickJect autoinjector are intended for SC use only and are not for IV infusion
Remove prefilled syringe or autoinjector from refrigerator and allow to come to room temperature before administering
Inspect visually for particulate matter and discoloration prior to administration; do not use if particulate matter or discoloration observed
Should appear clear and colorless to pale yellow
Inject full amount SC (ie, 1 mL)
Rotate injection site between abdomen (except for 2-inch area around navel), thigh, or outer area of upper arms (if administered by care giver)
May use same thigh for weekly injections, as long as each injection is at leat 1-inch away from the last area injected
Do not inject into areas where the skin is tender, bruised, red, or hard
Storage
injectable, IV infusion (lyophilized powder)
- Refrigerate at 2-8°C (36-46°F); protect from light by storing in original package until time of use
- Fully diluted solution may be stored at room temperature or refrigerated for up to 24 hr
solution for SC injection
- Refrigerate at 2-8°C (36-46°F); protect from light by storing in original package until time of use
- Do not allow prefilled syringe or autoinjector to freeze
Images
Patient Handout
Formulary
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