SAJAZIR 30 mg/3mL
ICATIBANT · INJECTION · Cycle Pharmaceuticals Ltd-Uk
SAJAZIR is a injection containing icatibant at 30 mg/3mL, taken subcutaneous. Manufactured by Cycle Pharmaceuticals Ltd-Uk.
Key Facts
- Brand Name
- SAJAZIR
- Generic Name
- ICATIBANT
- NDC Code (Product)
70709-013- Manufacturer
- Cycle Pharmaceuticals Ltd-Uk
- Strength
- 30 mg/3mL
- Dosage Form
- INJECTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- ANDA212446
- Marketing Start
- 06/03/2021
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE SAJAZIR (icatibant) injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. SAJAZIR (icatibant) injection is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 30 mg injected subcutaneously in the abdominal area. ( 2.1 ) If response is inadequate or symptoms recur, additional injections of 30 mg may be administered at intervals of at least 6 hours. ( 2.1 ) Do not administer more than 3 injections in 24 hours. ( 2.1 ) Patients may self-administer upon recognition of an HAE attack. ( 2.2 ) 2.1 Recommended Dosing The recommended dose of SAJAZIR is 30 mg administered by subcutaneous (SC) injection in the abdominal area. Additional doses may be administered at intervals of at least 6 hours if response is inadequate or if symptoms recur. No more than 3 doses may be administered in any 24 hour period. 2.2 Administration Instructions SAJAZIR should be inspected visually for particulate matter and discoloration prior to administration. The drug solution should be clear and colorless. Do not administer if the product contains particulates or is discolored. Attach the provided 25 gauge needle to the syringe hub and screw on securely. Do not use a different needle. Disinfect the injection site and administer SAJAZIR by subcutaneous injection over at least 30 seconds. Patients may self-administer SAJAZIR upon recognition of…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
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.
Adverse Reactions
6 ADVERSE REACTIONS The most commonly reported adverse reactions were injection site reactions, which occurred in almost all patients (97%) in clinical trials. Other common adverse reactions occurring in greater than 1% of patients included pyrexia, transaminase increase, dizziness, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals Ltd at 1-800-836-4380 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience The safety of icatibant was evaluated in three controlled trials that included 223 patients who received icatibant injection 30 mg (n=113), placebo (n=75), or comparator (n=38). The mean age at study entry was 38 years (range 18 to 83 years), 64% were female, and 95% were white. The data described below represent adverse reactions observed from the two placebo-controlled trials, consisting of 77 patients who received icatibant injection at a dose of 30 mg SC, and 75 who received placebo. The most frequently reported adverse reactions (occurring in greater than 1% of patients and at a higher rate with icatibant injection versus placebo) are shown in Table 1. Because clinical trials are conducted under widely varying co…
Frequently Asked Questions
What is SAJAZIR used for?
SAJAZIR contains ICATIBANT. It is a injection taken subcutaneous. Consult your doctor for specific uses.
Is SAJAZIR a controlled substance?
SAJAZIR is not classified as a controlled substance by the DEA.
What is the generic name for SAJAZIR?
The generic name for SAJAZIR is ICATIBANT. There are 8 other brand versions of ICATIBANT.
What is the NDC code for SAJAZIR 30 mg/3mL?
The NDC (National Drug Code) for SAJAZIR 30 mg/3mL is 70709-013, listed by Cycle Pharmaceuticals Ltd-Uk.