Home » Drug Information » FDA-Approved Drugs » 2002
Medical Areas: Nephrology/Urology | Pharmacology/Toxicology
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Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Bristol-Myers Squibb, Baxter Healthcare
Approval Status: Approved March 2002
Treatment Area: Bladder complications caused by Ifex (ifosfamide)
Mesnex Tablets are approved for use as a detoxifying agent to
inhibit the hemorrhagic cystitis induced by Ifex (ifosfamide). This
condition involves bladder problems, such as irritation due to
blood being in the urine. Ifex is an antineoplastic drug used for
treatment of testicular cancer. Along with Ifex, Mesnex Injection
was approved for use in 1988.
Mesnex Tablets are to be used in a dosing regimen with Ifex and
Mesnex Injection. If only using Mesnex Injection, the dosing
regimen lasts eight hours. With the addition of Mesnex Tablets, it
is reduced to six hours. Tablets also allow for quicker
administration that can easily be done if not at home.
Approval of Mesnex Tablets is supported by two clinical studies
with over 100 cancer subjects receiving Ifex. Trials compared three
intravenous doses of Mesnex to an initial intravenous dose followed
by two oral doses for the prevention of hemorrhagic cystitis
induced by treatment with Ifex. Both dosing regimens successfully
reduced incidences of grade three or four hematuria, the primary
efficacy endpoint.
Mesnex Tablets are given orally two and six hours after the
co-administartion of Ifex and Mesnex Injection. Mesnex should only
be prescribed along with Ifex.
Adverse effects associated with the use of Mesnex may include
(but are not limited to) the following:
- Nausea
- Vomiting
- Fatigue
- Constipation
- Leukopenia
- Anemia
- Asthenia
Because Mesnex is used in combination with Ifex, it is difficult
to distinguish the adverse reactions which may be due to Mesnex
from those caused by Ifex.
Mesnex (mesna) was developed as a prophylactic agent to reduce
the risk of hemorrhagic cystitis induced by Ifex (ifosfamide).
Mesna is rapidly oxidized to its major metabolite, mesna disulfide,
which then remains in the intravascular compartment and is rapidly
eliminated by the kidneys. In the kidney, mesna disulfide is
reduced to mesna, which reacts with the urotoxic ifosfamide
metabolites, resulting in their detoxification. (From Mesnex
Prescribing Information)