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.

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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.

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