abatacept (Rx)

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

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 250mg/vial

solution for SC injection

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

Rheumatoid Arthritis

Indicated for moderately to severely active rheumatoid arthritis (RA) in adults

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
  • If IV loading dose is used, administer first SC injection within 1 day of infusion
  • 125 mg SC qWeek
  • 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

Graft versus Host Disease

Indicated for the prophylaxis of acute graft versus host disease (aGvHD), in combination with a calcineurin inhibitor and methotrexate, in adults undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor

Day -1 (day before transplantation): 10 mg/kg IV (up to 1,000 mg) IV, followed by

Days 5, 14, and 28 (after transplantation): 10 mg/kg IV (up to 1,000 mg) IV

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

Dosing Considerations

Before initiating

  • Update vaccinations in accordance with current vaccination guidelines
  • Screen for viral hepatitis in accordance with published guidelines
  • Tuberculosis (TB)
    • Screen for TB infection with a tuberculin skin test
    • Not studied in patients with a positive TB screen, and safety in individuals with latent TB infection is unknown
    • Patients testing positive in TB screening should be treated by standard medical practice before therapy

Limitations of use

  • Use with other potent immunosuppressants (eg, biologic disease modifying antirheumatic drugs [bDMARDS], Janus kinas [JAK] inhibitors)

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
    • Administer without a loading dose

IV administration

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

Graft versus Host Disease

Indicated for the prophylaxis of acute graft versus host disease (aGvHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients aged ≥2 years undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor

<2 years: Safety and efficacy not established

2 to <6 years

  • Day -1 (day before transplantation): 15 mg/kg IV, followed by
  • Days 5, 14, and 28 (after transplantation): 12 mg/kg IV

≥6 years

  • Day -1 (day before transplantation): 10 mg/kg IV (up to 1,000 mg) IV, followed by
  • Days 5, 14, and 28 (after transplantation): 10 mg/kg IV (up to 1,000 mg) IV

Dosing Considerations

Before initiating

  • Update vaccinations in accordance with current vaccination guidelines
  • Screen for viral hepatitis in accordance with published guidelines
  • Tuberculosis (TB)
    • Screen for TB infection with a tuberculin skin test
    • Not studied in patients with a positive TB screen, and safety in individuals with latent TB infection is unknown
    • Patients testing positive in TB screening should be treated by standard medical practice before therapy

Limitations of use

  • Use with other potent immunosuppressants (eg, biologic disease modifying antirheumatic drugs [bDMARDS], Janus kinas [JAK] inhibitors)
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Interactions

Interaction Checker

and abatacept

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     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Contraindicated (1)

            • upadacitinib

              abatacept, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Contraindicated.

            Serious - Use Alternative (17)

            • adalimumab

              abatacept, adalimumab. Mechanism: pharmacodynamic synergism. Contraindicated. Increased risk of serious infection.

            • adenovirus types 4 and 7 live, oral

              abatacept decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.

            • anakinra

              abatacept, anakinra. Mechanism: unspecified interaction mechanism. Contraindicated. Concomitant use not recommended (in mfr. info.).

            • axicabtagene ciloleucel

              abatacept, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • baricitinib

              baricitinib, abatacept. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.

            • brexucabtagene autoleucel

              abatacept, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • certolizumab pegol

              abatacept and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid combination because of an increased risk of serious infection.

            • ciltacabtagene autoleucel

              abatacept, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • etanercept

              abatacept, etanercept. Mechanism: pharmacodynamic synergism. Contraindicated. Increased risk of serious infection.

            • idecabtagene vicleucel

              abatacept, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • infliximab

              abatacept, infliximab. Mechanism: pharmacodynamic synergism. Contraindicated. Increased risk of serious infection.

            • influenza virus vaccine quadrivalent, adjuvanted

              abatacept decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

            • influenza virus vaccine trivalent, adjuvanted

              abatacept decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

            • lisocabtagene maraleucel

              abatacept, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • tisagenlecleucel

              abatacept, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • tocilizumab

              abatacept, tocilizumab. Mechanism: unspecified interaction mechanism. Contraindicated. Concomitant use not recommended (in mfr. info.).

            • tofacitinib

              abatacept, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            Monitor Closely (17)

            • belatacept

              belatacept and abatacept both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

            • cholera vaccine

              abatacept decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

            • dengue vaccine

              abatacept decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

            • denosumab

              abatacept, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

            • fingolimod

              abatacept increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • hydroxyurea

              hydroxyurea, abatacept. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of immunosuppression.

            • isavuconazonium sulfate

              abatacept and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.

            • meningococcal group B vaccine

              abatacept decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.

            • ocrelizumab

              abatacept and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with immunosuppessants is expected to increase the risk of immunosuppression.

            • ofatumumab SC

              ofatumumab SC, abatacept. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

            • olaparib

              abatacept and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.

            • ozanimod

              ozanimod, abatacept. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration with immunosuppressive therapies may increase the risk of additive immune effects during therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs in order to avoid unintended additive immunosuppressive effects.

            • ponesimod

              ponesimod and abatacept both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

            • siponimod

              siponimod and abatacept both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

            • sipuleucel-T

              abatacept decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

            • trastuzumab

              trastuzumab, abatacept. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

            • trastuzumab deruxtecan

              trastuzumab deruxtecan, abatacept. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

            Minor (0)

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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

              Postmarketing Reports

              New or worsening psoriasis

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              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

              Cytomegalovirus (CMV) and Epstein-Barr virus (EBV) reactivation

              • CMV and EBV reactivation reported in aGVHD prophylaxis after hematopoietic cell transplant (HSCT)
              • Post-transplant lymphoproliferative disorder (PTLD) occurred in patients who received drug for aGVHD prophylaxis during unrelated HSCT; all the PTLD events were associated with Epstein-Barr virus (EBV) infection; monitor patients for EBV reactivation in accordance with institutional practices; provide prophylaxis for EBV infection for 6 months post-transplantation to prevent EBV-associated PTLD
              • Cytomegalovirus (CMV) invasive disease reported in patients who received therapy for aGVHD prophylaxis during unrelated HSCT; monitor patients for CMV infection/reactivation for 6 months post-transplant regardless of results of donor and recipient pre-transplant CMV serology; consider prophylaxis for CMV infection/reactivation
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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; however, there are clinical considerations for administering live vaccines to infants exposed to the drug while in utero

              In reproductive toxicology studies in rats and rabbits, no fetal malformations were observed with intravenous administration during organogenesis at doses that produced exposures approximately 29 times the exposure at the maximum recommended human dose (MRHD) of 10 mg/kg/month on an AUC basis; however, in a pre-and postnatal development study in rats, therapy altered immune function in female rats at 11 times the MRHD on an AUC basis

              It is unknown if abatacept can cross the placenta into the fetus when a woman is treated during pregnancy; the drug is an immunomodulatory agent; it is unknown if immune response of an infant who was exposed in utero to abatacept and subsequently administered a live vaccine is impacted; risks and benefits should be considered prior to vaccinating such infants

              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 Compatibility

              0.9% NaCl

              IV Preparation

              Reconstitution

              • 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
              • If lyophilized powder is accidently reconstituted using a siliconized syringe, solution may develop a few translucent particles (discard any solutions prepared using siliconized syringes
              • If silicone-free disposable syringe is dropped or becomes contaminated, use a new silicone-free disposable syringe; obtain new silicone-free syringes, contact BristolMyers Squibb at 1-800-ORENCIA
              • Gently swirl vial to minimize foam formation, until contents are completely dissolved; do not shake; avoid prolonged or vigorous agitation
              • Once completely dissolve, vent vial with a needle to dissipate any foam that may be present
              • Visually inspect the reconstituted solution (the solution should be clear and colorless to pale yellow); discard if opaque particles, discoloration, or other foreign particles are present

              Dilution

              • Withdraw volume of 0.9% NaCl equal to calculated dose volume; final concentration of infusion ≤10 mg/mL
              • Slowly add 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 with a sterile, nonpyrogenic, low-protein-binding filter (0.2-1.2 micron)

              RA or PJIA: Infuse IV over 30 min

              aGvHD: Infuse IV over 60 min

              Finish infusion within 24 hr of reconstitution

              Do not administer with any other drugs

              SC Administration

              Prefilled syringes and autoinjectors are intended for SC use only and are not for IV infusion

              Remove prefilled syringe or autoinjector from refrigerator and equilibrate to room temperature before administration

              Inspect visually for particulate matter and discoloration prior to administration; discard if particulate matter or discoloration observed; solution 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

              Unused vials (lyophilized powder)

              • Refrigerate at 2-8°C (36-46°F); protect from light by storing in original package until time of use

              Dilute solutions

              • Store at room temperature or refrigerated for up to 24 hr

              Prefilled syringes or autoinjectors

              • 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

              BRAND FORM. UNIT PRICE PILL IMAGE
              Orencia ClickJect subcutaneous
              -
              125 mg/mL syringe
              Orencia subcutaneous
              -
              87.5 mg/0.7 mL solution
              Orencia subcutaneous
              -
              50 mg/0.4 mL solution
              Orencia subcutaneous
              -
              125 mg/mL solution

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              abatacept subcutaneous

              ABATACEPT - SUBCUTANEOUS INJECTION

              (a-BAT-a-sept)

              COMMON BRAND NAME(S): Orencia

              USES: This medication is used to treat rheumatoid arthritis, a condition in which the body's own defense system (immune system) attacks healthy tissue. This leads to swelling in the joints, which causes pain and makes it harder to move. Abatacept works by weakening your immune system. This effect helps to slow down joint damage and reduce joint pain and swelling so you can move better. This medication is also used to treat other types of arthritis (such as juvenile idiopathic arthritis, psoriatic arthritis).

              HOW TO USE: Read the Patient Information Leaflet and Instructions for Use provided by your pharmacist before you start receiving abatacept and each time you get a treatment. If you have any questions, ask your doctor or pharmacist.This drug is given by injection under the skin of your thigh, abdomen, or upper arm as directed by your doctor, usually once a week. Your doctor may direct you to first receive abatacept by injection into a vein (loading dose) before starting treatment with this form of the medication. If you are switching from regularly scheduled injections into a vein, carefully follow your doctor's directions for when to start using this medication (usually instead of the next scheduled dose).The dosage is based on your medical condition and response to treatment. In children, the dosage is also based on weight.Remove this medication from the refrigerator and leave it at room temperature for 30 to 60 minutes before injecting. Do not warm up this medication any other way. For example, do not heat it in the microwave or place it in hot water.If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into any areas of skin that are sore, bruised, red, scaly, or hard.Learn how to store and discard medical supplies safely.Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar to keep track of when you need to receive the next dose.Tell your doctor if your symptoms do not get better or if they get worse.

              SIDE EFFECTS: Headache, nausea, or cold symptoms such as stuffy head/nose may occur. Pain, irritation, or swelling at/near the injection site may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Because abatacept works by weakening the immune system, it may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).Rarely, patients using abatacept have developed cancer (such as lymphoma, lung/skin cancer). Tell your doctor right away if you develop symptoms such as unusual lumps/growths/skin changes, swollen glands, night sweats, unexplained weight loss, shortness of breath, wheezing.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before using abatacept, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: cancer, chronic obstructive pulmonary disease-COPD, current/recent/returning infection (such as tuberculosis, hepatitis), immune system disorder (such as HIV infection, bone marrow disorder).Abatacept can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using abatacept before having any immunizations/vaccinations. Certain types of vaccines (live vaccines) should not be given during or within 3 months after the last dose of this medication. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).Children using this medication should have all recommended vaccinations before starting treatment with abatacept. Ask the child's doctor for details.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: anakinra, rituximab, TNF blocking agents (such as adalimumab, etanercept, infliximab).

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

              NOTES: Do not share this medication with others.Lab and/or medical tests (such as tuberculosis skin test, test for hepatitis B virus, skin exams) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

              MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

              STORAGE: Store in the refrigerator away from light. Do not freeze. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

              MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

              Information last revised December 2021. Copyright(c) 2022 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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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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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.