ICATIBANT injection, solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

ICATIBANT ACETATE (UNII: 325O8467XK) (ICATIBANT - UNII:7PG89G35Q7)

थमां उपलब्ध:

Teva Pharmaceuticals USA, Inc.

प्रशासन का मार्ग:

SUBCUTANEOUS

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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

उत्पाद समीक्षा:

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 0093-3066-34. 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 0093-3066-93. Store between 2° to 25°C (36° to 77°F). Do not freeze. Store in carton until time of administration. Keep this and all medications out of the reach of children.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

ICATIBANT- ICATIBANT INJECTION, SOLUTION
TEVA PHARMACEUTICALS USA, INC.
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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)
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)
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, 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 TEVA AT 1-888-838-2872
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: 10/2022
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 CONTRAIN