MESNA injection, solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

MESNA (UNII: NR7O1405Q9) (2-MERCAPTOETHANESULFONIC ACID - UNII:VHD28S0H7F)

Beschikbaar vanaf:

Baxter Healthcare Corporation

INN (Algemene Internationale Benaming):

MESNA

Samenstelling:

MESNA 100 mg in 1 mL

Toedieningsweg:

INTRAVENOUS

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Mesna is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. Limitation of Use: Mesna is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia. Mesna is contraindicated in patients known to be hypersensitive to mesna or to any of the excipients [see Warnings and Precautions (5.1)] . Risk Summary Mesna is used in combination with ifosfamide or other cytotoxic agents. Ifosfamide can cause fetal harm when administered to a pregnant woman. Refer to the ifosfamide prescribing information for more information on use during pregnancy. Mesna injection contains the preservative benzyl alcohol. Because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely [see Warnings and Precautions (5.3) and Use in Specific Populations (8.4)]. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies

Product samenvatting:

Mesna injection 100 mg/mL If mesna is co-administered with ifosfamide, refer to the ifosfamide prescribing information for safe handling instructions. MESNEX (mesna) tablets

Autorisatie-status:

New Drug Application

Productkenmerken

MESNA- MESNA INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MESNA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR MESNA.
MESNEX (MESNA) TABLETS, FOR ORAL USE
MESNA INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1988
RECENT MAJOR CHANGES
Warnings and Precautions, Benzyl Alcohol Toxicity (5.3) 12/2018
INDICATIONS AND USAGE
Mesna is a cytoprotective agent indicated as a prophylactic agent in
reducing the incidence of ifosfamide-induced
hemorrhagic cystitis. (1)
Limitation of Use:
Mesna is not indicated to reduce the risk of hematuria due to other
pathological conditions such as thrombocytopenia. (1)
DOSAGE AND ADMINISTRATION
Mesna may be given on a fractionated dosing schedule of three bolus
intravenous injections or a single bolus injection
followed by two oral administrations of MESNEX tablets as outlined
below. The dosing schedule should be repeated on
each day that ifosfamide is administered. When the dosage of
ifosfamide is adjusted, the ratio of mesna to ifosfamide
should be maintained. (2)
Intravenous Dosing Schedule:
0 Hours
4 Hours
8 Hours
Ifosfamide
1.2 g/m
--
--
Mesna injection
240 mg/m
240 mg/m
240 mg/m
Intravenous and Oral Dosing Schedule:
0 Hours
2 Hours
6 Hours
Ifosfamide
1.2 g/m
--
--
Mesna injection
240 mg/m
--
--
MESNEX tablets
--
480 mg/m
480 mg/m
Maintain sufficient urinary output, as required for ifosfamide
treatment, and monitor urine for the presence of hematuria.
(2.3)
DOSAGE FORMS AND STRENGTHS
•
•
CONTRAINDICATIONS
Known hypersensitivity to mesna or to any of the excipients in mesna,
including benzyl alcohol. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
The most common adverse reactions (> 10%) when mesna is given with
ifosfamide are nausea, vomiting, constipation,
leukopenia, fatigue, fever, anorexia, thrombocytopenia, anemia,
granulocytopenia, diarrhea, asthenia, abdominal pain,
headache, alopecia, and somnolence. (6.1)
To report S