RYLAZE (asparaginase erwinia chrysanthemi- recombinant-rywn injection

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

ASPARAGINASE (UNII: G4FQ3CKY5R) (ASPARAGINASE - UNII:G4FQ3CKY5R)

Доступна с:

Jazz Pharmaceuticals, Inc.

Администрация маршрут:

INTRAMUSCULAR

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

RYLAZE is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli -derived asparaginase. RYLAZE is contraindicated in patients with: Risk Summary Based on findings from animal reproduction studies, RYLAZE can cause fetal harm when administered to a pregnant woman. There are no available data on RYLAZE use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproductive and developmental toxicity studies, intramuscular administration of asparaginase Erwinia chrysanthemi to pregnant rats and rabbits during organogenesis resulted in structural abnormalities and embryo-fetal mortality (see Data ) at exposures below those in patients at the recommended human dose. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. Data Animal Data Animal reproductive and developmental toxicity studies have not been conducted with RYLAZE. In embryofetal development studies, asparaginase Erwinia chrysanthemi was administered intramuscularly every other day during the period of organogenesis to pregnant rats (at 3, 6, or 12 mg/m2 ) and rabbits (at 0.12, 0.30, or 0.48 mg/m2 ). In rats given 12 mg/m2 (approximately 0.48 times the maximum recommended human dose), maternal toxicity of decreased body weight gain was observed, as was a fetal finding of increased incidence of partially undescended thymic tissue. In rabbits, maternal toxicity consisting of decreased body weight was observed at 0.48 mg/m2 (approximately 0.02 times the maximum recommended human dose). Increased post-implantation loss, a decrease in the number of live fetuses, and gross abnormalities (e.g., absent kidney, absent accessory lung lobe, additional subclavian artery, and delayed ossification) were observed at doses of ≥ 0.12 mg/m2 (approximately 0.005 times the maximum recommended human dose). Risk Summary There are no data on the presence of asparaginase erwinia chrysanthemi (recombinant)-rywn in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for adverse reactions in the breastfed child, advise women not to breastfeed during treatment with RYLAZE and for 1 week after the last dose. RYLAZE can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)] . Pregnancy Testing Pregnancy testing is recommended in females of reproductive potential prior to initiating RYLAZE. Contraception Advise females of reproductive potential to use effective non-hormonal contraceptive methods during treatment with RYLAZE and for 3 months after the last dose. The safety and effectiveness of RYLAZE in the treatment of ALL and LBL have been established in pediatric patients 1 month to < 17 years who have developed hypersensitivity to a long-acting E. coli -derived asparaginase. Use of RYLAZE in these age groups is supported by evidence from an adequate and well-controlled study in adults and pediatric patients. The trial included 139 pediatric patients, including 2 infants (1 month to < 2 years), 99 children (2 years to < 12 years old), and 38 adolescents (12 years to < 17 years old). There were no clinically meaningful differences in safety or nadir serum asparaginase activity across age groups. The safety and effectiveness of RYLAZE have not been established in pediatric patients younger than 1 month of age. Clinical studies of RYLAZE did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger patients.

Обзор продуктов:

RYLAZE (asparaginase erwinia chrysanthemi (recombinant)-rywn) injection is supplied as a sterile, clear to opalescent, colorless to slightly yellow, preservative-free solution in single-dose vials. Each single-dose vial (NDC 68727-900-01) contains 10 mg/0.5 mL asparaginase erwinia chrysanthemi (recombinant)-rywn. Each carton of RYLAZE (NDC 68727-900-03) contains 3 single-dose vials. Store RYLAZE vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not shake or freeze.

Статус Авторизация:

Biologic Licensing Application

Характеристики продукта

RYLAZE- ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN INJECTION
JAZZ PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RYLAZE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RYLAZE.
RYLAZE (ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN)
INJECTION, FOR
INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 2021
RECENT MAJOR CHANGES
Contraindications (4) 4/2024
Warnings and Precautions (5.5) 4/2024
INDICATIONS AND USAGE
RYLAZE is an asparagine specific enzyme indicated as a component of a
multi-agent chemotherapeutic
regimen for the treatment of acute lymphoblastic leukemia (ALL) and
lymphoblastic lymphoma (LBL) in
adult and pediatric patients 1 month or older who have developed
hypersensitivity to _E. coli_-derived
asparaginase. (1)
DOSAGE AND ADMINISTRATION
There are two RYLAZE regimens that can be used to replace a
long-acting asparaginase product. The
recommended dosages of RYLAZE are:
WHEN ADMINISTERED EVERY 48 HOURS
•
WHEN ADMINISTERED MONDAY/WEDNESDAY/FRIDAY
•
DOSAGE FORMS AND STRENGTHS
Injection: 10 mg/0.5 mL solution in a single-dose vial. (3)
CONTRAINDICATIONS
RYLAZE is contraindicated in patients with:
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•
•
•
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WARNINGS AND PRECAUTIONS
•
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ADVERSE REACTIONS
Most common adverse reactions (incidence > 20%) are abnormal liver
test, nausea, musculoskeletal pain,
infection, fatigue, headache, febrile neutropenia, pyrexia,
hemorrhage, stomatitis, abdominal pain,
decreased appetite, drug hypersensitivity, hyperglycemia, diarrhea,
pancreatitis, and hypokalemia. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT JAZZ PHARMACEUTICALS
IRELAND LIMITED AT
®
25 mg/m intramuscularly every 48 hours;
2
25 mg/m intramuscularly on Monday morning and Wednesday morning and 50
mg/m
intramuscularly on Friday afternoon. (2.1)
2
2
History of serious hypersensitivity reactions to RYLAZE, including
anaphylaxis. (4)
History of serious pancreatitis during previous L-asparaginase
therapy. (4)
History o