WARNINGS
MUSTARGENRegistered trademark of Ovation Pharmaceuticals (Mechlorethamine HCl) should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.
This drug is HIGHLY TOXIC and both powder and solution must be handled and administered with care. Inhalation of dust or vapors and contact with skin or mucous membranes, especially those of the eyes, must be avoided. Avoid exposure during pregnancy. Due to the toxic properties of mechlorethamine (e.g., corrosivity, carcinogenicity, mutagenicity, teratogenicity), special handling procedures should be reviewed prior to handling and followed diligently.
Extravasation of the drug into subcutaneous tissues results in a painful inflammation. The area usually becomes indurated and sloughing may occur. If leakage of drug is obvious, prompt infiltration of the area with sterile isotonic sodium thiosulfate (1/6 molar) and application of an ice compress for 6 to 12 hours may minimize the local reaction. For a 1/6 molar solution of sodium thiosulfate, use 4.14 g of sodium thiosulfate per 100 mL of Sterile Water for Injection or 2.64 g of anhydrous sodium thiosulfate per 100 mL or dilute 4 mL of Sodium Thiosulfate Injection (10%) with 6 mL of Sterile Water for Injection.
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MUSTARGEN SUMMARY
TRITURATION OF
MUSTARGEN®
(Mechlorethamine HCl for Injection)
MUSTARGEN, an antineoplastic nitrogen mustard also known as HN2 hydrochloride, is a nitrogen analog of sulfur mustard.
Before using MUSTARGEN see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, DOSAGE AND ADMINISTRATION, and HOW SUPPLIED, Special Handling.
MUSTARGEN, administered intravenously, is indicated for the palliative treatment of Hodgkin's disease (Stages III and IV), lymphosarcoma, chronic myelocytic or chronic lymphocytic leukemia, polycythemia vera, mycosis fungoides, and bronchogenic carcinoma.
MUSTARGEN, administered intrapleurally, intraperitoneally, or intrapericardially, is indicated for the palliative treatment of metastatic carcinoma resulting in effusion.
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NEWS HIGHLIGHTS
Published Studies Related to Mustargen (Mechlorethamine)
Tetracycline compared with mechlorethamine in the treatment of malignant pleural effusions. A randomized trial. [1994.08]
Pleural sclerosis after tube thoracostomy was performed in 40 patients with malignant pleural effusions. The patients were randomly allocated to intrapleural therapy with tetracycline or mechlorethamine...
Comparison of total nodal irradiation versus combined sequence of mantle irradiation with mechlorethamine, vincristine, procarbazine, and prednisone in clinical stages I and II Hodgkin's disease: experience of the European Organization for Research and Treatment of Cancer. [1988]
The H5 study of supradiaphragmatic Hodgkin's disease in clinical stages I-II consisted of two controlled trials adapted to patients considered to have either favorable or unfavorable characteristics, based on prognostic factors identified in two former studies by the European Organization for Research and Treatment of Cancer...
Mechlorethamine, procarbazine and prednisone for the treatment of resistant lymphoma in dogs. [2009.03]
Forty-one dogs with resistant lymphoma were treated with a modified MOPP (mechlorethamine, vincristine, procarbazine and prednisone) protocol (MPP [mechlorethamine, procarbazine and prednisone] administered on a 21-day cycle, shortened from the 28-day MOPP cycle)... Minimal toxicity was observed with the MPP protocol, suggesting that further dose intensification or addition of another chemotherapeutic agent would be possible.
Stability of the nitrogen mustard mechlorethamine in novel formulations for dermatological use. [2008.10.01]
Long term stability measurements were made for the nitrogen mustard mechlorethamine HCl at a concentration of 0.02% in six topical formulations: Aquaphor ointment, Transcutol, Labrasol, 10% Transcutol in Aquaphor, 10% Transcutol in Labrasol, and Aquaphilic ointment... Four BHT-stabilized Transcutol and Labrasol formulations gave assays in ranges of 92-99% at the end of 4 weeks, 77-98% at the end of 12 weeks, and 38-93% at the end of 41 weeks.
Mycosis fungoides in a lung transplant recipient with advanced ciclosporin nephropathy: management with mechlorethamine and subsequent renal transplantation. [2008]
Posttransplant cutaneous T cell lymphomas are rare and have been reported to have a poor prognosis. We report the case of a follicular mycosis fungoides in a lung transplant recipient who was successfully treated with topical mechlorethamine, prior to subsequent renal transplantation.
Clinical Trials Related to Mustargen (Mechlorethamine)
An Open Label Six Month Study to Evaluate the Safety and Efficacy of Nitrogen Mustard (NM) 0.04% Ointment Formulation in Patients With Stage I or IIA Mycosis Fungoides (MF) Who Have Completed an Initial 12 Month Treatment With Nitrogen Mustard 0.02% But Without a Complete Response [Enrolling by invitation]
To evaluate the efficacy of topical application of NM 0. 04% in a propylene glycol ointment
(PG)in patients with stage I or IIA MF previously treated with NM 0. 02% in a PG or AP
ointment who did not achieve a complete response.
Phase II Trial of the Histone-Deacetylase Inhibitor ITF2357 Followed by Mechlorethamine in Relapsed/Refractory Hodgkin's Lymphoma Patients [Recruiting]
This is a single-center, open label, phase II study aimed at testing the activity of
multiple cycles of ITF2357 followed by Mechlorethamine administered to patients with
relapsed/refractory Hodgkin's lymphoma.
Patients will receive a maximum of twelve 3-week cycles of ITF2357 followed by
Mechlorethamine according to the following schema:
- ITF2357, 50 mg every 6 hours, per os, days 1 - 3
- Mechlorethamine, 6 mg/sqm, intravenously , day 4
Study therapy will be administered every 21 days as long as there is no evidence of
progressive disease or unacceptable adverse events or patient's request to discontinue
treatment occurs, but in any case for a maximum of 12 cycles.
Decision regarding the continuation of ITF2357/Mechlorethamine therapy will be made on
(i)the basis of tumor reassessment following cycles 2, 6, 9, and 12 and (ii) the occurrence
of toxicity. Tumor response will be evaluated according to the International Working Group
response criteria HL.
Treatment will be administrated on an outpatient basis and patients will be followed
regularly with physical and laboratory tests, as specified in the protocol; in case of
hospitalisation, the treatment will be continued or interrupted according to the
Investigators' decision.
The study will accrue 23 patients evaluable for efficacy and the anticipated duration of the
study is about 24 months.
Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides [Recruiting]
This study will evaluate the efficacy, tolerability and safety of the topical application of
nitrogen mustard (NM) ointment formulations in patients with stage I or IIA mycosis
fungoides (MF).
Furosemide Inhalation in Dyspnea of Mustard Gas Exposed Patients [Completed]
to assess the efficacy of inhaled furosemide in mustard gas exposed patients with acute
respiratory failure
Helium:Oxygen Noninvasive Positive Pressure Ventilation in Patients Exposed to Sulfur Mustard [Completed]
to assess the effect of Heliox with Noninvasive positive pressure ventilation to decrease
dyspnea and improve physiologic and respiratory measures in patients with a previous exposure
to Sulfur Mustard gas.
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Page last updated: 2009-10-20
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