Hycamtin (topotecan hydrochloride) for Injection should
be administered under the supervision of a physician
experienced in the use of cancer
chemotherapeutic agents. Appropriate management of complications
is possible only when adequate diagnostic and treatment
facilities are readily available.
Therapy with Hycamtin should not be given to patients
with baseline neutrophil counts of less than 1500 cells/mm3.
to monitor the occurrence of bone
which may be severe and result in infection
and death, frequent
blood cell counts should be performed on all patients receiving
Hycamtin (topotecan hydrochloride) is a semi-synthetic derivative
of camptothecin and is an anti-tumor drug
with topoisomerase I-inhibitory activity.
Hycamtin (topotecan hydrochloride) for Injection is supplied as
a sterile lyophilized, buffered, light
yellow to greenish powder
available in single-dose vials. Each vial
contains topotecan hydrochloride
equivalent to 4 mg
of topotecan as free base. The reconstituted solution
ranges in color from yellow
to yellow-green and is intended for administration
by intravenous infusion.
Inactive ingredients are mannitol, 48 mg, and tartaric acid,
20 mg. Hydrochloric acid
and sodium hydroxide
may be used to adjust the pH. The solution pH
ranges from 2.5 to 3.5.
The chemical name
for topotecan hydrochloride
is (S)-10-[(dimethylamino) methyl]-4-ethyl-4,9-dihydroxy-1H-pyrano[3',
4': 6,7] indolizino [1,2-b] quinoline-3,14-(4H,12H)-dione
It has the molecular formula
C23H23N3O5HCl and a
molecular weight of 457.9.
It is soluble in water
and melts with decomposition
at 213° to 218°C.