Dosing and uses of Orencia, Orencia ClickJect (abatacept)
Adult dosage forms and strengths
injectable, IV infusion (lyophilized powder)
- 250mg/vial
solution for SC injection
- 125mg/mL prefilled syringe
- 125mg/mL autoinjector
Rheumatoid Arthritis
Indicated to reduce signs and symptoms of moderate-to-severe rheumatoid arthritis; may be used as monotherapy or in combination with other DMARDs except TNF antagonists
<60 kg: 500 mg IV infusion
60-100 kg: 750 mg IV infusion
>100 kg: 1 g IV infusion
Maintenance: Above dose repeated q2Weeks X2, then q4Weeks
subcutaneous injection
- SC administration may be initiated with or without an IV loading dose
- IV Loading dose: Administer a single IV infusion (see IV infusion weight-based dosing)
- Maintenance dose: 125 mg SC qWeek (first dose within a day following IV loading dose)
- Patients unable to receive IV infusion may initiate weekly SC injections without loading dose
- Transitioning from IV to SC: Administer first SC dose instead of 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
Pediatric dosage forms and strengths
injectable, IV infusion (lyophilized powder)
- 250mg/vial
Juvenile Idiopathic Arthritis
<6 years: Safety and efficacy not established
≥6 years old, <75 kg: Loading dose of 10 mg/kg IV infusion
Maintenance: Same dose repeated 2 and 4 weeks later, THEN q4Weeks
≥75 kg: Administer as in adult
Orencia, Orencia ClickJect (abatacept) adverse (side) 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
Warnings
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 mth 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
Children should have all necessary immunizations before starting drug
Active infections, COPD (high occurrence of respiratory d/o)
Pregnancy and lactation
Pregnancy category: C
Lactation: not known whether excreted in breast milk, discontinue drug or do not nurse
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 of Orencia, Orencia ClickJect (abatacept)
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 Preparation
Reconstitute each vial contents in 10 mL SWI using ONLY the silicone-free disposable syringe supplied to obtain a 25 mg/mL solution. (Discard if siliconized syringes are 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
Slowly add the reconstituted solution from each vial into the infusion bag or bottle using the same disposable syringe
Gently mix
Discard any unused portion immediately. discarded
IV Administration
Infuse over 30 min using a sterile, non-pyrogenic, low-protein-binding filter (0.2-1.2 micron)
Do not use if any discoloration or particulate matter present
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
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
