Dosing and uses of Arcalyst (rilonacept)
Adult dosage forms and strengths
powder for injection
- 220mg/vial
Cryopyrin Associated Periodic Syndrome
Load: 160 mg SC for 2 injections on same day at different sites (320 mg total)
Maintenance: 160 mg SC qWeek
Administration
Aseptically reconstitute lyophilized powder with 2.3 mL sterile water for injection yielding 80 mg/mL solution
Use within 3 hr of reconstitution
Inject 2 mL (160 mg) subcutaneously in sites such as abdomen, thigh, upper arm
Rotate injection sites
Do NOT administer more frequently than qweek
Other Indications & Uses
Familial Cold Autoinflammatory Syndrome & Muckle-Wells Syndrome in adults & children >12 years old
Pediatric dosage forms and strengths
powder for injection
- 220mg/vial
Cryopyrin Associated Periodic Syndrome
<12 years: safety/efficacy not established
>12 years
Load: 4.4 mg/kg SC, no more than 320 mg, delivered as 1-2 injections on same day at different sites (if 2 doses given)
Maint: 2.2 mg/kg SC qWeek, no more than 160 mg
Administration
Aseptically reconstitute lyophilized powder with 2.3 mL sterile water for injeciton yielding 80 mg/mL solution
Use within 3 hr of reconstitution
Inject 2 mL (160 mg) subcutaneously in sites such as abdomen, thigh, upper arm
Rotate injection sites
Geriatric dosage forms and strengths
Cryopyrin Associated Periodic Syndrome
Load: 160 mg SC for 2 injections on same day at different sites (320 mg total)
Maintenance: 160 mg SC qWeek
Arcalyst (rilonacept) adverse (side) effects
>10%
Injection site reactions (48%)
Infections (34-48%)
Upper respiratory tract infections (26%)
1-10%
Cough (9%)
Hypoesthesia (9%)
Sinusitis (9%)
<1%
Hypersensitivity reaction
Neutropenia
Warnings
Contraindications
Concomitant live vaccines
Active/chronic infections
Cautions
Risk of serious, life-threatening infections
- Discontinue if patient develops serious infection
- Concomitant TNFalpha or IL-1 inhibitors not recommended
Receive all necessary vaccinations before commencing therapy
Increased risk of malignancies
Do NOT administer more frequently than weekly
Pregnancy and lactation
Pregnancy category: C
Lactation: use caution; not known if excreted in breast milk
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.
