abatacept

Reduction of signs and symptoms, progression of structural damage in adults with moderate to severe rheumatoid arthritis (RA) alone or with disease-modifying antirheumatic drugs (DMARDs) other than JAK inhibitors or biologic DMARDs (e.g., TNF antagonists). Treatment of active adult psoriatic arthritis. Treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in pts 2 yrs and older. Prophylaxis of acute graft-versus-host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pts 2 yrs of age and older undergoing hematopoietic stem cell transplantation (HSCT). Note: Do not use with anakinra or tumor necrosis factor [TNF] antagonists.

Precautions ⬆ ⬇

Contraindications: Hypersensitivity to abatacept. Cautions: Chronic, latent, or localized infection; conditions predisposing to infections (diabetes, indwelling catheters, renal failure, open wounds); COPD (higher incidence of adverse effects); elderly, hx recurrent infections.

Action ⬆ ⬇

Inhibits T-cell (T-lymphocyte) activation (binds to CD80 and CD86 on antigen-presenting cells (APCs); blocks CD28 interaction between APCs and T-cells). Activated T-cells are found in synovium of rheumatoid arthritic patients. Therapeutic Effect: Induces positive clinical response in adult pts with moderate to severely active RA or juvenile idiopathic arthritis.

Pharmacokinetics ⬆ ⬇

Higher clearance with increasing body weight. Age, gender do not affect clearance. Half-life: 8–25 days.

Lifespan Considerations ⬆ ⬇

Pregnancy/Lactation: Crosses placenta; unknown if distributed in breast milk. Children: Safety and efficacy not established in pts younger than 6 yrs. Elderly: May have increased risk of serious infection and malignancy

Interactions ⬆ ⬇

DRUG: Anakinra, anti-TNF agents, baricitinib, pimecrolimus, rituximab, tacrolimus (topical), tocilizumab may increase adverse effects. May decrease therapeutic effect of BCG (intravesical), vaccines (live). May increase concentration/effects of belimumab, natalizumab, tofacitinib, vaccines (live). HERBAL: Echinacea may decrease concentration/effect. FOOD: None known. LAB VALUES: None significant.

Availability ⬆ ⬇

IV Injection, Powder for Reconstitution: 250 mg. SQ Injection, Solution: 50 mg/0.4 mL, 87.5 mg/0.7 mL, 125 mg/mL single-dose prefilled syringe.

Administration/Handling ⬆ ⬇

Reconstitution

Reconstitute each vial with 10 mL Sterile Water for Injection using the silicone-free syringe provided with each vial and an 18- to 21-gauge needle.
Rotate solution gently to prevent foaming until powder is completely dissolved.
From a 100-mL 0.9% NaCl infusion bag, withdraw and discard an amount equal to the volume of the reconstituted vials (for 2 vials remove 20 mL, for 3 vials remove 30 mL, for 4 vials remove 40 mL), resulting in final volume of 100 mL.
Slowly add the reconstituted solution from each vial into the infusion bag using the same syringe provided with each vial.
Concentration in the infusion bag will be 10 mg/mL or less abatacept. Rate of administration
Infuse over 30 min (60 min for aGVHD prophylaxis) using a 0.2 to 1.2 micron low protein-binding filter.

Storage

Store vials, prefilled syringes in refrigerator.
Any reconstitution that has been prepared by using siliconized syringes will develop translucent particles and must be discarded.
Solution should appear clear and colorless to pale yellow. Discard if solution is discolored or contains precipitate.
Solution is stable for up to 24 hrs after reconstitution.
Reconstituted solution may be stored at room temperature or refrigerated.

Allow syringe to warm to room temperature (30–60 min).
Inject in front of thigh, outer areas of upper arms, or abdomen.
Avoid areas that are tender, bruised, red, scaly, or hard.
Do not rub injection site.
Rotate injection sites.

Indications/Routes/Dosage ⬆ ⬇

Note: Discontinue in pts developing serious infection.

Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA)

IV: ADULTS, ELDERLY WEIGHING 101 KG OR MORE: 1 g (4 vials) given as a 30-min infusion. Following initial therapy, give at 2 wks and 4 wks after first infusion, then q4wks thereafter. WEIGHING 60–100 KG: 750 mg (3 vials) given as a 30-min infusion. Following initial therapy, give at 2 wks and 4 wks after first infusion, then q4wks thereafter. WEIGHING 59 KG OR LESS: 500 mg (2 vials) given as a 30-min infusion. Following initial therapy, give at 2 wks and 4 wks after first infusion, then q4wks thereafter.

SQ: (RA): Following a single IV infusion, 125 mg given within 24 hrs of infusion, then 125 mg once a week (SQ administration may be initiated without an IV loading dose). (PsA): Give without an IV loading dose. 125 mg once weekly. Transitioning from IV to SQ: Give 1st SQ dose instead of next scheduled IV dose.

Juvenile Idiopathic Arthritis

Note: Dose based on body weight at each administration.

IV: CHILDREN 6 YRS AND OLDER, WEIGHING LESS THAN 75 KG: 10 mg/kg. CHILDREN WEIGHING 75–100 KG: 750 mg. WEIGHING MORE THAN 100 KG: 1,000 mg. Following initial therapy, give 2 wks and 4 wks after first infusion, then q4wks thereafter.

SQ: CHILDREN 2 YRS AND OLDER, ADOLESCENTS WEIGHING 50 KG OR MORE: 125 mg once weekly. WEIGHING 25–49 KG: 87.5 mg once weekly. WEIGHING 10–24 KG: 50 mg once weekly.

aGVHD

IV: ADULTS, CHILDREN 6 YRS AND OLDER: 10 mg/kg (maximum: 1,000 mg) on day before transplant, then on days 5, 14, and 28 after transplant. CHILDREN 2–5 YRS: 15 mg/kg on day before transplant, then 12 mg/kg on days 5, 14, and 28 after transplant.

Dosage Adjustment for Toxicity

Discontinue in pts developing a serious infection.

Dosage in Renal/Hepatic Impairment

No dose adjustment.

Side Effects ⬆ ⬇

Frequent (18%): Headache. Occasional (9%–6%): Dizziness, cough, back pain, hypertension, nausea.

Adverse Effects/Toxic Reactions ⬆ ⬇

Upper respiratory tract infection, nasopharyngitis, sinusitis, UTI, influenza, bronchitis occur in 5% of pts. Serious infections, including pneumonia, cellulitis, diverticulitis, acute pyelonephritis, occur in 3% of pts. Hypersensitivity reaction (rash, urticaria, hypotension, dyspnea) occurs rarely. May increase risk of malignancies.

Nursing Considerations ⬆ ⬇

BASELINE ASSESSMENT Assess onset, type, location, duration of pain/inflammation. Inspect appearance of affected joint for immobility, deformities, skin condition. Screen for latent TB infection prior to initiating therapy. INTERVENTION/EVALUATION Assess for therapeutic response: relief of pain, stiffness, swelling; increased joint mobility; reduced joint tenderness; improved grip strength. Monitor for hypersensitivity reaction. Diligently screen for infection. PATIENT/FAMILY TEACHING
Notify physician if infection, hypersensitivity reaction, infusion-related reaction occurs.
Do not receive live vaccines during treatment or within 3 mos of its discontinuation.
COPD pts must report worsening of respiratory symptoms.

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Information ⬇

Classification ⬆ ⬇

Uses ⬆ ⬇