METHYLENE BLUE injection

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Zydus Pharmaceuticals USA Inc.

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Methylene blue injection is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials [see Clinical Studies (14.1)] . Clinical Studies information is approved for PROVEPHARM SAS's Provayblue® (Methylene blue solution, intravenous). However, due to PROVEPHARM SAS's marketing exclusivity rights, this drug product is not labeled with that information. Methylene blue 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 Methylene blue 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 methylene blue 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 methylene blue [see Clinical Pharmacology (12.3)] . The safety and effectiveness of methylene blue for the treatment of acquired methemoglobinemia have been established in pediatric patients. Use of methylene blue is supported by two retrospective case series that included 2 pediatric patients treated with methylene blue 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)] . The retrospective case series included 3 patients age 65 years and over treated with methylene blue injection (or a bioequivalent formulation) and 5 treated with another methylene blue class product. The efficacy outcomes were consistent across adult and elderly patients in both case series [see Clinical Studies (14)] . Methylene blue 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)]. Clinical Studies information is approved for PROVEPHARM SAS's Provayblue® (Methylene blue solution, intravenous). However, due to PROVEPHARM SAS's marketing exclusivity rights, this drug product is not labeled with that information. Methylene blue concentrations increased in subjects with renal impairment (eGFR 15 to 89 mL/min/1.73 m2 ) significantly [see Clinical Pharmacology (12.3)]. Adjust methylene blue 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 methylene blue.

Prehľad produktov:

Methylene blue injection, USP is supplied in 10 mL and 2 mL single-dose vials. Each 10 mL vial contains 50 mg of methylene blue, USP as a clear dark blue solution. Each 2 mL vial contains 10 mg of methylene blue, USP as a clear dark blue solution. A box contains five vials. Box of 5 vials of 50 mg/10 mL (0.5%): NDC 70710-1838-5 Box of 5 vials of 10 mg/2 mL (0.5%): NDC 70710-1837-5 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 vial in the original package to protect from light.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

METHYLENE BLUE- METHYLENE BLUE INJECTION
ZYDUS PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHYLENE BLUE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
METHYLENE BLUE
INJECTION.
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._
METHYLENE BLUE MAY CAUSE SERIOUS OR FATAL SEROTONERGIC SYNDROME WHEN
USED IN
COMBINATION WITH SEROTONERGIC DRUGS AND OPIOIDS. AVOID CONCOMITANT USE
OF METHYLENE
BLUE WITH SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIS), SEROTONIN
AND NOREPINEPHRINE
REUPTAKE INHIBITORS (SNRIS), MONOAMINE OXIDASE INHIBITORS (MAOIS) AND
OPIOIDS. (5.1,
7.1)
RECENT MAJOR CHANGES
Boxed Warning
11/2023
Warnings and Precautions (5)11/2023
INDICATIONS AND USAGE
Methylene blue is an oxidation-reduction agent indicated for the
treatment of pediatric and adult patients
with acquired methemoglobinemia. This indication is approved under
accelerated approval. Continued
approval for this indication may be contingent upon verification of
clinical benefit in subsequent trials. (1,
14)
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) (0.5%) single-dose vial. (3)
10 mg/2 mL (5 mg/mL) (0.5%) single-dose vial. (3)
CONTRAINDICATIONS
Methylene blue 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 allergi