Ruconest Generic Name & Formulations
Legal Class
Rx
General Description
C1 esterase inhibitor (recombinant) 2100 IU; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.
Pharmacological Class
C1 inhibitor.
How Supplied
Single-use vial—1
Manufacturer
Generic Availability
NO
Ruconest Indications
Indications
Treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).
Limitations of Use
Efficacy not established in HAE patients with laryngeal attacks.
Ruconest Dosage and Administration
Adult
Give by slow IV inj over 5 mins. <84kg: 50 IU/kg. ≥84kg: 4200 IU. Max 4200 IU/dose. May give second dose if attack symptoms persist; max 2 doses/24hrs.
Children
Not established.
Ruconest Contraindications
Contraindications
Allergy to rabbits or rabbit-derived products.
Ruconest Boxed Warnings
Not Applicable
Ruconest Warnings/Precautions
Warnings/Precautions
Discontinue if hypersensitivity reactions occur. Monitor patients with known risk factors for thrombotic events (eg, indwelling venous catheter, history of thrombosis, atherosclerosis, morbid obesity, immobility). Labor & delivery. Pregnancy (Cat.B). Nursing mothers.
Ruconest Pharmacokinetics
See Literature
Ruconest Interactions
Interactions
Risk of thrombotic events with concomitant oral contraceptives or certain androgens.
Ruconest Adverse Reactions
Adverse Reactions
Headache, nausea, diarrhea; thrombotic events, hypersensitivity reactions (may be severe).
Ruconest Clinical Trials
See Literature
Ruconest Note
Not Applicable
Ruconest Patient Counseling
See Literature