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
- 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
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
- Administer without a loading dose
IV administration
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (11)
- 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.).
- 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.
- 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.
- etanercept
abatacept, etanercept. Mechanism: pharmacodynamic synergism. Contraindicated. Increased risk of serious infection.
- 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.
- 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)
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 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
- Withdrawing a 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 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 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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Orencia subcutaneous - | 87.5 mg/0.7 mL solution |  | |
| Orencia subcutaneous - | 50 mg/0.4 mL solution |  | |
| Orencia subcutaneous - | 125 mg/mL solution |  | |
| Orencia ClickJect subcutaneous - | 125 mg/mL syringe |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
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.Do not have immunizations/vaccinations during or within 3 months after treatment with abatacept without the consent of your doctor. 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 August 2021. Copyright(c) 2021 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.
Formulary
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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.
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