KALBITOR- ecallantide injection, solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

Ecallantide (UNII: 5Q6TZN2HNM) (Ecallantide - UNII:5Q6TZN2HNM)

제공처:

Takeda Pharmaceuticals America, Inc.

INN (국제 이름):

ECALLANTIDE

구성:

ECALLANTIDE 10 mg in 1 mL

관리 경로:

SUBCUTANEOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

KALBITOR® (ecallantide) is indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older. Do not administer KALBITOR to a patient who has known clinical hypersensitivity to KALBITOR. [see Warnings and Precautions (5.1) ]. Risk Summary The available data from the pharmacovigilance database for Kalbitor have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In an animal reproduction study, increased early fetal deaths resulting in decreased live fetuses were observed in rats following treatment during the period of organogenesis at an intravenous dose approximately 1.6 times the maximum recommended human dose (MRHD) in the presence of maternal toxicity. There were no effects on embryofetal survival or structural abnormalities in rats and rabbits following treatment during the period of organogenesis with intravenous doses up to approximately 1.1 and 6 times the MRHD, respectively, or rats treated with subcutaneous doses up to 2.4 times the MRHD. In a pre- and post-natal development study with rats, there were no effects on pup survival and development with subcutaneous doses up to approximately 2.7 times the MRHD. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryofetal development study with rats, ecallantide administered by the intravenous route during the period of organogenesis from gestation days 7 to 17 at a dose approximately 1.6 times the MRHD (on a mg/m2 basis at a maternal intravenous dose of 15 mg/kg/day) caused increased numbers of early resorptions and percentages of resorbed conceptuses per litter resulting in decreased numbers of live fetuses in the presence of mild maternal toxicity. No effects on embryofetal survival or structural abnormalities were observed in rats with intravenous doses up to approximately 1.1 times the MRHD (on a mg/m2 basis with maternal intravenous dose of 10 mg/kg/day). In an embryofetal development study with rats, ecallantide administered by the subcutaneous route during the period of organogenesis from gestation days 7 to 17 at doses up to approximately 2.4 times the MRHD (on an AUC basis with maternal subcutaneous doses up to 20 mg/kg/day) had no effects on embryofetal survival or structural abnormalities. In an embryofetal development study with rabbits, ecallantide administered by the intravenous route during the period of organogenesis from gestation days 7 to 19 at doses up to approximately 6 times the MRHD (on an AUC basis with maternal intravenous doses up to 5 mg/kg/day in rabbits) had no effects on embryofetal survival or structural abnormalities. In a pre- and post-natal development study with rats, ecallantide administered by the subcutaneous route from gestation day 7 through lactation day 20 at doses up to approximately 2.7 times the MRHD (on a mg/m2 basis with maternal subcutaneous doses up to 25 mg/kg/day) had no effects on pup survival and behavioral or physical development. Risk Summary There are no data on the presence of ecallantide in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for KALBITOR and any potential adverse effects on the breastfed child from KALBITOR or from the underlying maternal condition. The safety and effectiveness of KALBITOR have been established in patients 12 to 17 years of age. The efficacy of KALBITOR in the 12-15 year age group is extrapolated from efficacy in patients 16 years of age and older with support from population pharmacokinetic analyses showing similar drug exposure levels in adults and adolescents [see Clinical Pharmacology (12.3) and Clinical Studies (14)] . The safety profile observed in pediatric patients 12-17 years of age was similar to the adverse reactions observed in the overall clinical trial population [see Adverse Reactions (6.1)] . Safety and effectiveness of KALBITOR in patients less than 12 years of age have not been established. Clinical trials of KALBITOR did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

제품 요약:

KALBITOR (ecallantide) is supplied as three 10 mg/mL single-use vials packaged in a carton. Each vial contains 10 mg of ecallantide. Each vial contains a slight overfill. KALBITOR should be kept refrigerated (2°C to 8°C/36°F to 46°F). Vials removed from refrigeration should be stored below 86°F/30°C and used within 14 days or returned to refrigeration until use. Protect vials from light until use. Do not use beyond the expiration date.

승인 상태:

Biologic Licensing Application

환자 정보 전단

KALBITOR- ECALLANTIDE INJECTION, SOLUTION
Takeda Pharmaceuticals America, Inc.
----------
MEDICATION GUIDE
KALBITOR® (KAL-bi-tor)
(ecallantide)
Read this Medication Guide before you start receiving KALBITOR and
before each treatment. There may
be new information. This Medication Guide does not take the place of
talking to your doctor about your
medical condition or your treatment.
What is the most important information that I should know about
KALBITOR?
Serious allergic reactions may happen in some people who receive
KALBITOR. These allergic reactions
can be life-threatening and usually happen within 1 hour after
receiving KALBITOR.
•
KALBITOR should be given to you by a doctor or nurse in a healthcare
setting where serious
allergic reactions and hereditary angioedema (HAE) can be treated.
•
Symptoms of a serious allergic reaction to KALBITOR can be similar to
the symptoms of HAE,
the condition that you are being treated for. Your doctor or nurse
should watch you for any signs
of a serious allergic reaction after treatment with KALBITOR.
•
Tell your doctor or nurse right away if you have any of these symptoms
of a serious allergic
reaction during or after treatment with KALBITOR:
•
wheezing, shortness of breath, cough, chest tightness, or trouble
breathing
•
dizziness, fainting, fast or weak heartbeat, or feeling nervous
•
reddening of the face, itching, hives, or feeling warm
•
swelling of the throat or tongue, throat tightness, hoarse voice, or
trouble swallowing
•
runny nose, nasal congestion, or sneezing
What is KALBITOR?
KALBITOR is a prescription medicine used to treat sudden attacks of
hereditary angioedema (HAE) in
people 12 years of age and older.
KALBITOR is not a cure for HAE.
It is not known if KALBITOR is safe and effective in children under 12
years of age.
Who should not receive KALBITOR?
Do not receive KALBITOR if you are allergic to KALBITOR.
What should I tell my doctor before I receive KALBITOR?
Before receiving KALBITOR, tell your doctor if you:
•
have ever had an allergic r

제품 특성 요약

KALBITOR- ECALLANTIDE INJECTION, SOLUTION
TAKEDA PHARMACEUTICALS AMERICA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KALBITOR SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR KALBITOR.
KALBITOR (ECALLANTIDE) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2009
WARNING: ANAPHYLAXIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
ANAPHYLAXIS HAS BEEN REPORTED AFTER ADMINISTRATION OF KALBITOR .
BECAUSE OF THE RISK
OF ANAPHYLAXIS, KALBITOR SHOULD ONLY BE ADMINISTERED BY A HEALTHCARE
PROFESSIONAL
WITH APPROPRIATE MEDICAL SUPPORT TO MANAGE ANAPHYLAXIS AND HEREDITARY
ANGIOEDEMA.
HEALTHCARE PROFESSIONALS SHOULD BE AWARE OF THE SIMILARITY OF SYMPTOMS
BETWEEN
HYPERSENSITIVITY REACTIONS AND HEREDITARY ANGIOEDEMA AND PATIENTS
SHOULD BE
MONITORED CLOSELY. DO NOT ADMINISTER KALBITOR TO PATIENTS WITH KNOWN
CLINICAL
HYPERSENSITIVITY TO KALBITOR [_SEE CONTRAINDICATIONS (4), WARNINGS AND
PRECAUTIONS_
_(5.1), AND ADVERSE REACTIONS (6)_].
INDICATIONS AND USAGE
KALBITOR is a plasma kallikrein inhibitor indicated for treatment of
acute attacks of hereditary angioedema
(HAE) in patients 12 years of age and older. (1)
DOSAGE AND ADMINISTRATION
30 mg (3 mL), administered subcutaneously in three 10 mg (1 mL)
injections. If an attack persists, an
additional dose of 30 mg may be administered within a 24 hour period.
(2.1)
KALBITOR should only be administered by a healthcare professional with
appropriate medical support to
manage anaphylaxis and hereditary angioedema. (2.2).
DOSAGE FORMS AND STRENGTHS
Single use glass vial containing 10 mg/mL of ecallantide as a solution
for injection. (3)
CONTRAINDICATIONS
Do not administer KALBITOR to a patient who has known clinical
hypersensitivity to KALBITOR. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions Including Anaphylaxis: Anaphylaxis has
occurred in 4% of treated patients.
Administer KALBITOR in a setting equipped to manage anaphylaxis and
hereditary angioedema. Given the
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