A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Matulane Indications, Dosage, Storage, Stability - Procarbazine
Matulane Indications, Dosage, Storage, Stability - Procarbazine
INDICATIONS
Matulane is indicated for use in combination with other anticancer drugs
for the treatment of Stage III and IV Hodgkin's disease. Matulane is used
as party of the MOPP (nitrogen mustard, vincristine, procarbazine, prednisone)
regimen.
DOSAGE AND ADMINISTRATION
The following doses are for administration of the drug as a single agent.
When used in combination with other anticancer drugs, the Matulane dose
should be appropriately reduced, e.g., in the MOPP regimen, the Matulane
dose is 100 mg/m2 daily for 14 days. All dosages are based
on the patient's actual weight. However, the estimated lean body mass
(dry weight) is used if the patient is obese or if there has been a spurious
weight gain due to edema, ascites or other forms of abnormal fluid retention.
Adults: To minimize the nausea and vomiting experienced
by a high percentage of patients beginning Matulane therapy, single or
divided doses of 2 to 4 mg/kg/day for the first week are recommended.
Daily dosage should then be maintained at 4 to 6 mg/kg/day until maximum
response is obtained or until the white blood count falls below 4000/mm³
or the platelets fall below 100,000/mm³. When maximum response is obtained,
the dose may be maintained at 1 to 2 mg/kg/day. Upon evidence of hematologic
or other toxicity (see PRECAUTIONS
section), the drug should be discontinued until there has been satisfactory
recovery. After toxic side effects have subsided, therapy may then be
resumed at the discretion of the physician, based on clinical evaluation
and appropriate laboratory studies, at a dosage of 1 to 2 mg/kg/day.
Pediatric Patients: Very close clinical monitoring is mandatory.
Undue toxicity, evidenced by tremors, coma and convulsions, has occurred
in a few cases. Dosage, therefore, should be individualized. The following
dosage schedule is provided as a guideline only.
Fifty (50) mg per square meter of body surface per day is recommended
for the first week. Dosage should then be maintained at 100 mg per square
meter of body surface per day until maximum response is obtained or until
leukopenia or thrombocytopenia occurs. When maximum response is attained,
the dose may be maintained at 50 mg per square meter of body surface per
day. Upon evidence of hematologic or other toxicity (see PRECAUTIONS
section), the drug should be discontinued until there has been satisfactory
recovery, based on clinical evaluation and appropriate laboratory tests.
After toxic side effects have subsided, therapy may then be resumed.
Procedures for proper handling and disposal of anticancer drugs should
be considered. Several guidelines on this subject have been published.1-6
There is no general agreement that all of the procedures recommended in
the guidelines are necessary or appropriate.
HOW SUPPLIED
Capsules, ivory, containing the equivalent of 50 mg procarbazine as the
hydrochloride, bottles of 100 (NDC 0004-0053-01). Imprint on capsules:
MATULANE® ROCHE.
REFERENCES
1. Recommendations for the safe handling of parenteral
antineoplastic drugs. Washington DC: U.S. Government Printing Office NIH
Publication No. 83-2621.
2. AMA Council Report. Guidelines for handling parenteral
antineoplastics. JAMA. Mar 15, 1985; 253:1590-1592.
3. National Study Commission on Cytotoxic Exposure: Recommendations
for handling cytotoxic agents. Available from Louis P. Jeffrey, ScD, Director
of Pharmacy Services, Rhode Island Hospital, 591 Eddy Street, Providence,
Rhode Island 02902.
4. Clinical Oncological Society of Australia: Guidelines
and recommendations for safe handling of antineoplastic agents. Med
J Aust. Apr 30, 1983; 1: 426-428.
5. Jones RB, Frank R, Mass T: Safe handling of chemotherapeutic
agents: a report from the Mount Sinai Medical Center. CA. Sept-Oct
1983; 33:258-263.
6. ASHP technical assistance bulletin on handling cytotoxic
drugs in hospitals. Am J Hosp Pharm. Jan 1985; 42:131-137.
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