Abatacept


Concise Prescribing Info
Indications/Uses
Rheumatoid arthritis.
Dosage/Direction for Use
Adult : IV As monotherapy or in combination with methotrexate or other DMARDs: Initial: <60 kg: 500 mg; 60-100 kg: 750 mg; >100 kg: 1 g. Given over 30 minutes, repeated at 2 and 4 weeks after 1st infusion, then every 4 weeks thereafter. SC 125 mg once weekly. If initiated with single IV infusion, administer 125 mg within the day of infusion followed by 125 mg once weekly.
Dosage Details
Intravenous
Rheumatoid arthritis
Adult: As monotherapy or in combination with methotrexate or other DMARDs: Initially, <60 kg: 500 mg; 60-100 kg: 750 mg; >100 kg: 1 g. Dose is given via infusion over 30 minutes, repeated at 2 and 4 weeks after 1st infusion, then every 4 weeks thereafter.

Intravenous
Juvenile idiopathic arthritis
Child: As monotherapy or in combination with methotrexate or other DMARDs: 6-17 yr <75 kg: 10 mg/kg via infusion over 30 minutes, repeated at 2 and 4 weeks after 1st infusion, then every 4 weeks thereafter; ≥75 kg Same as adult dose.

Subcutaneous
Rheumatoid arthritis
Adult: 125 mg once weekly. If initiated with single IV infusion, administer 125 mg within the day of infusion followed by 125 mg once weekly.
Reconstitution
IV infusion: Add 10 mL sterile water for inj to a vial labelled as containing 250 mg to provide a soln containing 25 mg/mL. Swirl gently to avoid foaming. Dilute further w/ NaCl 0.9% inj to a total volume of 100 mL (withdraw a volume of NaCl equal to the volume of abatacept required), w/ a final concentration of ≤10 mg/mL. Do not shake.
Contraindications
Hypersensitivity. Severe and uncontrolled infections (e.g. sepsis, active TB, hepatitis B, opportunistic infection). Lactation. Concomitant use w/ tumour necrosis factor (TNF) inhibitors and biologic immunosuppressive agents.
Special Precautions
Patient w/ COPD, history of recurrent infections, underlying conditions that may predispose to infections, or chronic, latent, or localised infections. Childn. Pregnancy. Admin of live vaccines.
Adverse Reactions
Significant: Viral reactivation (i.e. hepatitis B), exacerbation of COPD.
Nervous: Dizziness, headache, fatigue, paraesthesia, depression, anxiety, vertigo.
CV: HTN, hypotension, flushing, arrhythmias.
GI: Nausea, dyspepsia, diarrhea, mouth ulcers.
Resp: Wheezing, dyspnoea, nasopharyngitis, cough, bronchitis.
Hepatic: Abnormal liver function values.
Haematologic: Thrombocytopenia, leucopenia.
Musculoskeletal: Back pain, pain in extremities.
Ophthalmologic: Conjunctivitis.
Dermatologic: Pruritus, rash, cellulitis, alopecia, psoriasis.
Others: Inj site reactions (e.g. haematoma, erythema, itch), infusion-related reactions.
Potentially Fatal: Serious infections (e.g. pneumonia, sepsis). Rarely, hypersensitivity, anaphylaxis, or anaphylactoid reactions.
Patient Counseling Information
This drug may cause dizziness and reduced visual acuity, if affected, do not drive or operate machinery.
MonitoringParameters
Screen for hepatitis B and TB prior to initiation of therapy. Monitor CBC, ALT/AST, and creatinine before treatment. Monitor signs and symptoms of infections and hypersensitivity reaction.
Drug Interactions
May diminish the therapeutic effect of live vaccines.
Potentially Fatal: Increased risk of serious infection w/ TNF inhibitors (e.g. adalimumab, etanercept, infliximab). Enhanced toxicity w/ biologic immunosuppressive agents (e.g. anakinra, rituximab).
Lab Interference
May result in falsely elevated blood glucose w/ dehydrogenase pyrroloquinolinequinone or glucose-dye-oxidoreductase tests on the day of infusion.
Action
Description: Abatacept is a selective costimulation modulator that binds to CD80 and CD86 on antigen presenting cells, which prevents activation of CD28 T-lymphocytes found in the synovium of rheumatoid arthritis patients, thus reducing cytokine production and inflammation.
Pharmacokinetics:
Absorption: Bioavailability: Approx 79% (SC; relative to IV).
Excretion: Terminal elimination half-life: Approx 13 days (IV); approx 14 days (SC).
Storage
Store between 2-8°C. Protect from light. Do not freeze.
ATC Classification
L04AA24 - abatacept ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
References
Anon. Abatacept. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/06/2017.

Buckingham R (ed). Abatacept. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/06/2017.

Joint Formulary Committee. Abatacept. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/06/2017.

McEvoy GK, Snow EK, Miller J et al (eds). Abatacept. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 02/06/2017.

Orencia Injection, Powder, Lyophilized, For Solution (E.R. Squibb & Sons, L.L.C.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/06/2017.

Disclaimer: This information is independently developed by MIMS based on Abatacept from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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