abatacept (Rx)

>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

Contraindications

Hypersensitivity

Coadministration with other TNF antagonists (other biologic RA therapies not recommended)

Active serious infections

Cautions

Do not give live vaccines concurrently or less than 3 months after discontinuation

Higher risk for serious infections; discontinue if serious infections develop

Screen for latent TB before initiating; safety unknown in pts with latent TB

Patients should have all necessary immunizations before initiating therapy

Increased risk of lymphoma and lung cancer reported; significance unknown; increased risk of lymphoma associated with rheumatoid arthritis

Use caution in patients with COPD; exacerbations may occur

Higher incidence of infections and malignancy reported in the elderly; use caution

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.

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

IV Preparation

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 (discard any siliconized syringes accidentally used)

Dilute further to 100 mL as follows by withdrawing a volume of 0.9% NaCl equal to the combined volume of the reconstituted vials; final concentration of infusion ≥10 mg/mL

Slowly add the 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 ClickJect autoinjector are intended for SC use only and are not for IV infusion

Remove prefilled syringe or autoinjector from refrigerator and allow to come to room temperature before administering

Inspect visually for particulate matter and discoloration prior to administration; do not use if particulate matter or discoloration observed

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

injectable, IV infusion (lyophilized powder)

• Refrigerate at 2-8°C (36-46°F); protect from light by storing in original package until time of use
• Fully diluted solution may be stored at room temperature or refrigerated for up to 24 hr

solution for SC injection

• 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