ICATIBANT injection

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

icatibant acetate (UNII: 325O8467XK) (icatibant - UNII:7PG89G35Q7)

제공처:

Slayback Pharma LLC

관리 경로:

SUBCUTANEOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 injection 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

제품 요약:

Icatibant injection is supplied as a sterile, clear colorless solution in single-use, 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 with natural rubber latex. Icatibant injection is available in cartons containing one single-use, prefilled syringe and one 25 G Luer lock needle.  NDC 71225-114-01. Icatibant injection is also available in a pack containing 3 cartons; each carton contains one single-use, prefilled syringe and one 25 G Luer lock needle.  NDC 71225-114-02. Keep out of the reach of children. Store between 2 to 25° C (36 to 77° F). Do not freeze. Store in carton until time of administration.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

ICATIBANT - ICATIBANT INJECTION
SLAYBACK PHARMA LLC
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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 B2 receptor antagonist indicated
for treatment of acute attacks of hereditary angioedema
(HAE) in adults 18 years of age and older. (1) (1)
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)
DOSAGE FORMS AND STRENGTHS
Injection: 10 mg per mL (3) (3)
CONTRAINDICATIONS
None (4) (4)
WARNINGS AND PRECAUTIONS
• Laryngeal attacks: Following treatment of laryngeal attacks with
icatibant injection, advise patients to seek immediate
medical attention. (5.1) (5)
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 SLAYBACK PHARMA AT
1-844-566-2505 OR FDA AT 1-800-
FDA-1088 OR WWW.FDA.GOV/MEDWATCH (6)
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) (8)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 6/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS & USAGE
2 DOSAGE & ADMINISTRATION
2.1 Recommended Dosing
2.2 Administration Instructions
3 DOSAGE FORMS & STRENGTHS