SAJAZIR
These highlights do not include all the information needed to use SAJAZIR™ (icatibant) safely and effectively. See full prescribing information for SAJAZIR™.SAJAZIR™ (icatibant) injection, for subcutaneous useInitial U.S. Approval: 2011
1756aca0-21a1-4898-8d6c-9666738db45c
HUMAN PRESCRIPTION DRUG LABEL
Sep 7, 2023
Cycle Pharmaceuticals Ltd-Uk
DUNS: 218215530
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ICATIBANT
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (5)
Drug Labeling Information
DRUG INTERACTIONS SECTION
7 DRUG INTERACTIONS
7.1 ACE Inhibitors
Icatibant is a bradykinin B2 receptor antagonist and thereby has the potential to have a pharmacodynamic interaction with ACE inhibitors where icatibant may attenuate the antihypertensive effect of ACE inhibitors. Clinical trials to date have excluded subjects taking ACE inhibitors.
HOW SUPPLIED SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
SAJAZIR (icatibant) injection is supplied as a single-dose, prefilled syringe for subcutaneous administration. Each syringe delivers 3 mL of a sterile solution of icatibant 30 mg (as icatibant acetate). Each glass syringe has a bromobutyl plunger stopper, which is not made of latex natural rubber.
SAJAZIR is available in cartons containing one single-dose, prefilled syringe and one 25 G Luer lock needle. NDC 70709-013-01.
SAJAZIR is also available in a pack containing 3 cartons; each carton contains one single-dose, prefilled syringe and one 25 G Luer lock needle. NDC 70709-013-03.
16.2 Storage and Handling
Keep out of the reach of children.
Store between 2 - 25° C (36 - 77° F).
Do not freeze.
Store in carton until time of administration.