abatacept (Rx)

Brand and Other Names:Orencia, Orencia ClickJect
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable, IV infusion (lyophilized powder for reconstitution)

  • 250mg/vial

solution for SC injection

  • 125mg/mL prefilled syringe
  • 125mg/mL autoinjector
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Rheumatoid Arthritis

Indicated to reduce signs and symptoms of moderate-to-severe rheumatoid arthritis; 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

Dosage Forms & Strengths

injectable, IV infusion (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
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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 kg to <25 kg: 50 mg SC once weekly
    • 25 kg to <50 kg: 87.5 mg SC once weekly
    • ≥50 kg: 125 mg SC once weekly

IV administration

  • <6 years: Safety and efficacy not established
  • ≥6 years old, <75 kg: Loading dose of 10 mg/kg IV infused over 30 minutes 
  • Maintenance: Same dose repeated 2 and 4 weeks after loading dose, THEN q4Weeks
  • ≥75 kg: Administer as in adult
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Interactions

Interaction Checker

and abatacept

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            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

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            Warnings

            Contraindications

            Hypersensitivity

            Coadministration with other TNF antagonists (other biologic RA therapies not recommended)

            Active serious infections

            Cautions

            Do not give live vaccines concurrently or less than 3 months after discontinuation

            Higher risk for serious infections; discontinue if serious infections develop

            Screen for latent TB before initiating; safety unknown in pts with latent TB

            Patients should have all necessary immunizations before initiating therapy

            Increased risk of lymphoma and lung cancer reported; significance unknown; increased risk of lymphoma associated with rheumatoid arthritis

            Use caution in patients with COPD; exacerbations may occur

            Higher incidence of infections and malignancy reported in the elderly; use caution

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            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.

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            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

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            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
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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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