PROVAYBLUE- methylene blue injection

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

METHYLENE BLUE (UNII: T42P99266K) (METHYLENE BLUE CATION - UNII:ZMZ79891ZH)

から入手可能:

American Regent, Inc.

INN（国際名）:

METHYLENE BLUE

構図:

METHYLENE BLUE 5 mg in 1 mL

投与経路:

INTRAVENOUS

処方タイプ:

PRESCRIPTION DRUG

適応症:

PROVAYBLUE is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. PROVAYBLUE is contraindicated in the following conditions: - Severe hypersensitivity reactions to methylene blue or any other thiazine dye [see Warnings and Precautions (5.2)] . - Patients with glucose-6-phosphate dehydrogenase deficiency (G6PD) due to the risk of hemolytic anemia [see Warnings and Precautions (5.3, 5.4)]. Risk Summary PROVAYBLUE may cause fetal harm when administered to a pregnant woman. Intra-amniotic injection of pregnant women with a methylene blue class product during the second trimester was associated with neonatal intestinal atresia and fetal death. Methylene blue produced adverse developmental outcomes in rats and rabbits when administered orally during organogenesis at doses at least 32 and 16 times, respectively, the clinical dose of 1 mg/kg (see Data) . 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 2-4% and 15-20%, respectively. Clinical Considerations Fetal/neonatal adverse reactions Intra-amniotic injection of a methylene blue class product hours to days prior to birth can result hyperbilirubinemia, hemolytic anemia, skin staining, methemoglobinemia, respiratory distress and photosensitivity in the newborn. Following administration of PROVAYBLUE to a pregnant woman at term, observe the newborn for these adverse reactions and institute supportive care. Data Animal Data Methylene blue was administered orally to pregnant rats at doses of 50 to 350 mg/kg/day, during the period of organogenesis. Maternal and embryofetal toxicities were observed at all doses of methylene blue and were most evident at the 200 and 350 mg/kg/day doses. Maternal toxicity consisted of increased spleen weight. Embryo-fetal toxicities included reduced fetal weight, post-implantation loss, edema, and malformations including enlarged lateral ventricles. The dose of 200 mg/kg (1200 mg/m2 ) in rats is approximately 32 times a clinical dose of 1 mg/kg based on body surface area. Methylene blue was administered orally to pregnant rabbits at doses of 50, 100, or 150 mg/kg/day, during the period of organogenesis. Maternal death was observed at the methylene blue dose of 100 mg/kg. Embryofetal toxicities included spontaneous abortion at all dose levels and a malformation (umbilical hernia) at the 100 and 150 mg/kg/day doses. The dose of 50 mg/kg (600 mg/m2 ) in rabbits is approximately 16 times a clinical dose of 1 mg/kg based on body surface area. Risk Summary There is no information regarding the presence of methylene blue in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions including genotoxicity, discontinue breast-feeding during and for up to 8 days after treatment with PROVAYBLUE [see Clinical Pharmacology (12.3)] . The safety and effectiveness of PROVAYBLUE for the treatment of acquired methemoglobinemia have been established in pediatric patients. Use of PROVAYBLUE is supported by two retrospective case series that included 2 pediatric patients treated with PROVAYBLUE and 12 treated with another methylene blue class product. The case series included pediatric patients in the following age groups: 3 neonates (less than 1 month), 4 infants (1 month up to less than 2 years), 4 children (2 years up to less than 12 years), and 3 adolescents (12 years to less than 17 years). The efficacy outcomes were consistent across pediatric and adult patients in both case series [see Clinical Studies (14)]. Clinical studies of PROVAYBLUE did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. PROVAYBLUE is known to be substantially excreted by the kidney, so the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, treatment of methemoglobinemia in these patients should use the lowest number of doses needed to achieve a response [see Dosage and Administration (2)] . Methylene blue concentrations increased in subjects with renal impairment (eGFR 15 to 89 mL/min/1.73m2 ) significantly [see Clinical Pharmacology (12.3)] . Adjust PROVAYBLUE dosage in patients with moderate or severe renal impairment (eGFR 15 to 59 mL/min/1.73 m2 ) [see Dosage and Administration (2.2)] . No dose adjustment is recommended in patients with mild renal impairment (eGFR 60 – 89 mL/min/1.73 m2 ). Methylene blue is extensively metabolized in the liver. Monitor patients with any hepatic impairment for toxicities and potential drug interactions for an extended period of time following treatment with PROVAYBLUE.

製品概要:

PROVAYBLUE (methylene blue) injection, USP : is supplied in 10 mL and 2 mL single-dose ampules or single-dose vials. Each 10 mL ampule and vial contains 50 mg of methylene blue as a clear dark blue solution. Each 2 mL ampule and vial contains 10 mg of methylene blue as a clear dark blue solution. A box contains five ampules or vials. Box of 5 ampules of 50 mg/10 mL: NDC 0517-0374-05 Box of 5 ampules of 10 mg/2 mL: NDC 0517-0125-05 Box of 5 vials of 50 mg/10 mL: NDC 0517-0381-05 Box of 5 vials of 10 mg/2 mL: NDC 0517-0371-05 Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature] Any unused product or waste material should be disposed of in accordance with local practice. Do not refrigerate or freeze . Keep the ampule or the vial in the original package to protect from light.

認証ステータス:

New Drug Application

製品の特徴

PROVAYBLUE- METHYLENE BLUE INJECTION
AMERICAN REGENT, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
(PROVAYBLUE) SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR (PROVAYBLUE).
PROVAYBLUE (METHYLENE BLUE) INJECTION, USP FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2016
WARNING: SEROTONIN SYNDROME WITH CONCOMITANT USE OF SEROTONERGIC
DRUGS AND OPIOIDS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
PROVAYBLUE MAY CAUSE SERIOUS OR FATAL SEROTONERGIC SYNDROME WHEN USED
IN
COMBINATION WITH SEROTONERGIC DRUGS AND OPIOIDS. AVOID CONCOMITANT USE
OF
PROVAYBLUE WITH SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIS),
SEROTONIN
NOREPINEPHRINE REUPTAKE INHIBITORS (SNRIS), MONOAMINE OXIDASE
INHIBITORS (MAOIS) AND
OPIOIDS. (_5.1, 7.1_)
RECENT MAJOR CHANGES
Boxed Warning 11/2023
Indications and Usage (1) 01/2024
Warnings and Precautions (5) 11/2023
INDICATIONS AND USAGE
PROVAYBLUE (methylene blue) is an oxidation-reduction agent indicated
for the treatment of pediatric and
adult patients with acquired methemoglobinemia. (1)
DOSAGE AND ADMINISTRATION
Administer 1 mg/kg intravenously over 5-30 minutes. (2.1)
If methemoglobin level remains above 30% or if clinical symptoms
persist, give a repeat dose of up to 1
mg/kg one hour after the first dose. (2.1)
Administer a single dose of 1 mg/kg in patients with moderate or
severe renal impairment. (2.2)
DOSAGE FORMS AND STRENGTHS
50 mg/10 mL (5 mg/mL) single-dose ampule. (3)
10 mg/2 mL (5 mg/mL) single-dose ampule. (3)
50 mg/10 mL (5 mg/mL) single-dose vial. (3)
10 mg/2 mL (5 mg/mL) single-dose vial. (3)
CONTRAINDICATIONS
PROVAYBLUE is contraindicated in the following conditions (4):
Severe hypersensitivity to methylene blue
Patients with glucose-6-phosphate dehydrogenase deficiency (G6PD) due
to the risk of hemolytic
anemia
WARNINGS AND PRECAUTIONS
Hypersensitivity: If severe or life threatening allergic reaction
occurs, discontinue PROVAYBLUE, treat
the allergic reaction, and monitor until