a-BAT-a-cept

Therapeutic Classification: antirheumatics (DMARDs)

Pharmacologic Classification: fusion proteins

• Moderate to severely active rheumatoid arthritis in adults (as monotherapy or in combination with other disease modifying antirheumatic drugs, other than tumor-necrosis factor (TNF) inhibitors.
• Moderate to severely active polyarticular juvenile idiopathic arthritis (as monotherapy or in combination with methotrexate).
• Active psoriatic arthritis.
• Prophylaxis of acute graft versus host disease in patients undergoing hematopoietic stem cell transplantation from a matched or 1 allele-mismatched unrelated-donor (in combination with a calcineurin inhibitor and methotrexate).

• Inhibits T-cell activation (and the inflammatory process) by binding to specific receptors.

• Decreased progression of rheumatoid arthritis, juvenile idiopathic arthritis, and psoriatic arthritis.
• Improved survival and graft versus host disease-free survival in patients undergoing hematopoietic stem cell transplantation.

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-life: 13 days.

(improvement in symptoms)

Contraindicated in:

• Hypersensitivity
• Concurrent use of TNF inhibitors or anakinra.

Use Cautiously in:

• Chronic obstructive pulmonary disease (↑ risk of exacerbations and other adverse events)
• OB: Safety not established in pregnancy
• Lactation: Safety not established in breastfeeding
• Pedi: Safety and effectiveness not established in children <18 yr (rheumatoid arthritis) or 2 yr (all other indications)
• Geri: ↑risk of adverse reactions in older adults.

Neuro: headache, dizziness.
Misc: infection (including cytomegalovirus and Epstein-Barr virus reactivation), (INCLUDING ANAPHYLAXIS) HYPERSENSITIVITY REACTIONS , infusion-related events, MALIGNANCY.

Drug-Drug:

• Concurrent use with TNF antagonists may ↑ risk and severity of infections.
• May ↑ risk of adverse reactions and ↓ effectiveness of live-virus vaccines.

Rheumatoid Arthritis

• IV (Adults >100 kg): 1000 mg initially; repeat dose at 2 wk and 4 wk after initial dose, then every 4 wk thereafter.
• IV (Adults 60–100 kg): 750 mg initially; repeat dose at 2 wk and 4 wk after initial dose, then every 4 wk thereafter.
• IV (Adults <60 kg): 500 mg initially; repeat dose at 2 wk and 4 wk after initial dose, then every 4 wk thereafter.
• SC (Adults): Treatment may be initiated with or without a single IV dose (according to weight-based dosing guidelines above); then give 125 mg SUBQ within 1 day; then give 125 mg SUBQ once weekly; if patient does not receive IV dose, initiate once weekly SUBQ injections; if transitioning from IV therapy, administer next scheduled dose as SUBQ injection.

Juvenile Idiopathic Arthritis

• IV (Children 6 yr and >100 kg): 1000 mg initially; repeat dose at 2 wk and 4 wk after initial dose, then every 4 wk thereafter.
• IV (Children 6 yr and 75–100 kg): 750 mg initially; repeat dose at 2 wk and 4 wk after initial dose, then every 4 wk thereafter.
• IV (Children 6 yr and <75 kg): 10 mg/kg initially; repeat dose at 2 wk and 4 wk after initial dose, then every 4 wk thereafter.
• SC (Children 2 yr and 50 kg): 125 mg once weekly.
• SC (Children 2 yr and 25–<50 kg): 87.5 mg once weekly.
• SC (Children 2 yr and 10–<25 kg): 50 mg once weekly.

Psoriatic Arthritis

• IV (Adults >100 kg): 1000 mg initially; repeat dose at 2 wk and 4 wk after initial dose, then every 4 wk thereafter.
• IV (Adults 60–100 kg): 750 mg initially; repeat dose at 2 wk and 4 wk after initial dose, then every 4 wk thereafter.
• IV (Adults <60 kg): 500 mg initially; repeat dose at 2 wk and 4 wk after initial dose, then every 4 wk thereafter.
• SC (Adults): 125 mg once weekly.
• SC (Children 2 yr and 50 kg): 125 mg once weekly.
• SC (Children 2 yr and 25–<50 kg): 87.5 mg once weekly.
• SC (Children 2 yr and 10–<25 kg): 50 mg once weekly.

Prophylaxis of Acute Graft Versus Host Disease

• IV (Adults and Children 6 yr): 10 mg/kg (max dose = 1000 mg) on the day before transplantation; repeat dose on Days 5, 14, and 28 after transplantation.
• IV (Children 2–<6 yr): 15 mg/kg on the day before transplantation, then 12 mg/kg on Days 5, 14, and 28 after transplantation.

• Lyophilized powder for IV administration: 250 mg/vial;
• Solution for SUBQ administration (prefilled syringes): 50 mg/0.4 mL; 87.5 mg/0.7 mL; 125 mg/mL;
• Solution for SUBQ administration (prefilled ClickJect autoinjector): 125 mg/mL;

• Assess range of motion, degree of swelling, and pain in affected joints before and periodically during therapy.
• Assess for infusion-related reaction (dizziness, headache, hypertension) and signs of allergic reaction (hypotension, urticaria, dyspnea). Infusion-related reactions usually occur within 1 hr of start of infusion. Keep epinephrine, an antihistamine, and resuscitation equipment close by in case of an anaphylactic reaction.
• Assess for latent tuberculosis with a tuberculin skin test. If positive, tuberculosis should be treated prior to abatacept therapy.
• Assess health status at each session. Monitor patients who develop a new infection while taking abatacept closely. Discontinue therapy in patients who develop a serious infection or sepsis. Do not initiate therapy in patients with active infections.
• Monitor for signs and symptoms of hypersensitivity reactions (angioedema) during therapy. Make sure oxygen and supportive measures are available. If reactions occur, discontinue abatacept permanently.

• Prescreen patient for viral hepatitis prior to therapy; may reactivate hepatitis. If test is positive, do not start abatacept.
  • Patients receiving IV abatacept may record false positive blood glucose due to maltose in injection; discuss with health care professional.
  • Monitor patient for Epstein-Barr virus and cytomegalovirus infection or reactivation for 6 mo post-transplant. Consider prophylaxis for 6 mo post-transplant.

• Do not confuse Orencia with Oracea.
• Prophylaxis of Acute Graft Versus Host Disease: Before administering abatacept, administer recommended antiviral prophylactic treatment for Epstein-Barr virus reactivation; continue for 6 mo following hematopoietic stem cell transplantation. Consider prophylactic antivirals for cytomegalovirus infection/reactivation during treatment and for 6 mo following hematopoietic stem cell transplantation.
• SC: Remove prefilled syringe from refrigerator and allow to reach room temperature for 30–60 min; do not use other methods to warm solution. Leave needle cover on during warming. Inspect solution; do not administer solutions that are discolored, contain particulate matter, are expired, or do not have the correct amount of fluid in syringe. Front of thigh is the preferred site; abdomen (except for 2 inches from navel) or upper arm, if administered by caregiver, may also be used. Pinch skin and inject at a 45° angle. Do not rub injection site. Rotate each injection at least 1 inch from last injection; avoid areas where skin is tender, bruised, red, or hard or contains scars or stretch marks. ClickJect autoinjector should not be used with children <18 yr.

IV Administration:

• Intermittent Infusion: Reconstitution: Reconstitute each vial with 10 mL of sterile water for injection, using ONLY SILICONE-FREE DISPOSABLE SYRINGE PROVIDED WITH EACH VIAL and an 18–21-gauge needle for a concentration of 25 mg/mL. Discard solutions prepared using siliconized syringes. Additional silicone-free syringes are available from manufacturer. Direct stream of sterile water to side of vial. Rotate vial by gently swirling to minimize foaming. Do no shake. Upon dissolution, vent vial to dissipate foam. Solution should be clear and colorless to pale yellow. Do not use solutions that are discolored or contain particulate matter. Further dilute solution to 100 mL of 0.9% NaCl by withdrawing volume of abatacept solution from 100 mL infusion bag or bottle. Slowly add reconstituted solution using the same SILICONE-FREE DISPOSABLE SYRINGE PROVIDED WITH EACH VIAL. Mix gently. 5, 7.5, or 10 mg/mL depending on whether 2, 3, or 4 vials were used. Discard unused portion of vial. Infusion must be completed within 24 hr of reconstitution. Diluted solution may be stored at room temperature or refrigerated before use.
• Rate: Administer over 30 min with a sterile nonpyrogenic, low-protein-binding filter with a 0.2–1.2-micron pore size.
  • For prophylaxis of acute graft versus host disease: Administer over 60 min with a sterile nonpyrogenic, low-protein-binding filter with a 0.2–1.2 micron pore size.
• Y-Site Incompatibility: Do not infuse in same infusion line as other agents.

• Instruct patient on purpose of abatacept. Advise patient to read the Orencia Patient Information leaflet prior to each session. Provide an opportunity for patient to ask questions. If a dose is missed, ask health care professional when to schedule next dose.
• Advise patient not to receive live vaccines during or 3 mo following therapy. Advise patients and parents that adults and children should complete immunizations to date before initiation of abatacept.
• Advise patient that methotrexate, analgesics, NSAIDs, corticosteroids, and salicylates may be continued during therapy.
• Instruct patient that abatacept should not be taken with TNF antagonists; may increase risk for infections.
• Instruct patient to notify health care professional if signs and symptoms of upper respiratory or other infections or hypersensitivity reactions occur. Therapy may need to be discontinued if serious infection occurs.
• Inform patient of increased risk of malignancies, including skin cancer. Advise patient to examine skin regularly for new or changes in lesions. Notify health care professional if changes in skin are seen.
• Advise patient to notify health care professional if pregnancy is planned or suspected. Caution patient to avoid breastfeeding during therapy.

• Reduction in symptoms of rheumatoid arthritis, juvenile idiopathic arthritis, and psoriatic arthritis.
• Improved survival and acute graft versus host disease-free survival in patients undergoing hematopoietic stem cell transplantation.

Orencia