देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
ICATIBANT ACETATE (UNII: 325O8467XK) (ICATIBANT - UNII:7PG89G35Q7)
GLENMARK PHARMACEUTICALS INC., USA
SUBCUTANEOUS
PRESCRIPTION DRUG
Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. None. Risk Summary Available data from published literature and the pharmacovigilance database with icatibant use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, icatibant, administered by the subcutaneous route during the period of organogenesis, did not cause structural abnormalities in rats or rabbits; however, premature birth and abortion were observed in rabbits at doses approximately 0.025 times the maximum recommended human dose (MRHD) and higher. Decreased embryofetal survival was observed in rabbits at a subcutaneous dose that was 13 times the MRHD. In a pre- and post-natal development study in rats, delayed parturition was observed at subcutaneous doses 0.5 times the MRHD and higher, which resulted in deaths of dams at doses 2 times the MRHD and hi
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. Icatibant Injection is available in cartons containing one single-dose, prefilled syringe and one 25 G Luer lock needle. NDC 68462-828-15. Icatibant Injection 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 68462-828-46. Keep out of the reach of children. Store between 2°C to 25°C (36°F to 77°F). Do not freeze. Store in carton until time of administration.
Abbreviated New Drug Application
ICATIBANT- ICATIBANT ACETATE INJECTION, SOLUTION GLENMARK PHARMACEUTICALS INC., USA ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ICATIBANT INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ICATIBANT INJECTION. ICATIBANT INJECTION, FOR SUBCUTANEOUS USE INITIAL U.S. APPROVAL: 2011 INDICATIONS AND USAGE Icatibant injection is a bradykinin B receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. (1) DOSAGE AND ADMINISTRATION • • • • DOSAGE FORMS AND STRENGTHS Injection: 10 mg per mL (3) CONTRAINDICATIONS None (4) WARNINGS AND PRECAUTIONS Laryngeal attacks: Following treatment of laryngeal attacks with icatibant injection, advise patients to seek immediate medical attention. (5.1) 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 GLENMARK PHARMACEUTICALS INC., USA AT 1 (888) 721-7115 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH USE IN SPECIFIC POPULATIONS Elderly patients demonstrate increased systemic exposure to icatibant. Differences in efficacy and safety between elderly and younger patients have not been identified. (8.5) SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 5/2022 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosing 2.2 Administration Instructions 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Laryngeal Attacks 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 2 30 mg injected subcutaneously in the abdominal area. (2.1) If response is inadequate or symptoms recur, additional injections of 30 mg may be admin पूरा दस्तावेज़ पढ़ें