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mechlorethamine hydrochloride

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Overview

What is Mustargen?

MUSTARGEN, an antineoplastic nitrogen mustard also known as HN2 hydrochloride, is a nitrogen analog of sulfur mustard. It is a light yellow brown, crystalline, hygroscopic powder that is very soluble in water and also soluble in alcohol. Mechlorethamine hydrochloride is designated chemically as 2-chloro- -(2-chloroethyl)- -methylethanamine hydrochloride. The molecular weight is 192.52 and the melting point is 108-111°C. The empirical formula is C H Cl N•HCl, and the structural formula is: CH N(CH CH Cl) •HCl.

Trituration of MUSTARGEN is a sterile, light yellow brown crystalline powder for injection by the intravenous or intracavitary routes after dissolution. Each vial of MUSTARGEN contains 10 mg of mechlorethamine hydrochloride triturated with sodium chloride q.s. 100 mg. When dissolved with 10 mL Sterile Water for Injection or 0.9% Sodium Chloride Injection, the resulting solution has a pH of 3-5 at a concentration of 1 mg mechlorethamine HCl per mL.



What does Mustargen look like?



What are the available doses of Mustargen?

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What should I talk to my health care provider before I take Mustargen?

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How should I use Mustargen?

Before using MUSTARGEN see , , , , , and .

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.

Not for oral administration

Intravenous Administration:

The margin of safety in therapy with

is narrow and considerable care must be exercised in the matter of

dosage.

Within a few minutes after intravenous injection, MUSTARGEN undergoes chemical transformation, combines with reactive compounds, and is no longer present in its active form in the blood stream. Subsequent courses should not be given until the patient has recovered hematologically from the previous course; this is best determined by repeated studies of the peripheral blood elements awaiting their return to normal levels. It is often possible to give repeated courses of MUSTARGEN as early as three weeks after treatment.

Preparation of Solution for Intravenous Administration:

HIGHLY TOXIC

Each vial of MUSTARGEN contains 10 mg of mechlorethamine hydrochloride triturated with sodium chloride q.s. 100 mg. In neutral or alkaline aqueous solution it undergoes rapid chemical transformation and is highly unstable. Although solutions prepared according to instructions are acidic and do not decompose as rapidly, they should be prepared immediately before each injection since they will decompose on standing. When reconstituted, MUSTARGEN is a clear colorless solution.

Using a sterile 10 mL syringe, inject 10 mL of Sterile Water for Injection or 10 mL of 0.9% Sodium Chloride Injection into a vial of MUSTARGEN. With the needle (syringe attached) still in the rubber stopper, shake the vial several times to dissolve the drug completely. The resultant solution contains 1 mg of mechlorethamine hydrochloride per mL.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Special Handling:

Several other guidelines for proper handling and disposal of antineoplastic drugs have been published and should be considered. -

Accidental Contact Measures:

Technique for Intravenous Administration:

Dispose of any remaining solution after neutralization

Intracavitary Administration:

The technique and the dose used by any of these routes varies. Therefore, if MUSTARGEN is given by the intracavitary route, the published articles concerning such use should be consulted. MUSTARGEN

As a general guide, reference is made especially to the techniques of Weisberger et al. , - Intracavitary use is indicated in the presence of pleural, peritoneal, or pericardial effusion due to metastatic tumors. Local therapy with nitrogen mustard is used only when malignant cells are demonstrated in the effusion. Intracavitary injection is not recommended when the accumulated fluid is chylous in nature, since results are likely to be poor.

Paracentesis is first performed with most of the fluid being removed from the pleural or peritoneal cavity. The intracavitary use of MUSTARGEN may exert at least some of its effect through production of a chemical poudrage. Therefore, the removal of excess fluid allows the drug to more easily contact the peritoneal and pleural linings. For intrapleural or intrapericardial injection nitrogen mustard is introduced directly through the thoracentesis needle. For intraperitoneal injection it is given through a rubber catheter inserted into the trocar used for paracentesis or through a No. 18 gauge needle inserted at another site. This drug should be injected slowly, with frequent aspiration to ensure that a free flow of fluid is present. If fluid cannot be aspirated, pain and necrosis due to injection of solution outside the cavity may occur. , - Free flow of fluid also is necessary to prevent injection into a loculated pocket and to ensure adequate dissemination of nitrogen mustard.

The usual dose of nitrogen mustard for intracavitary injection is 0.4 mg/kg of body weight, though 0.2 mg/kg (or 10 to 20 mg) has been used by the intrapericardial route. , - The solution is prepared, as previously described for intravenous injection, by adding 10 mL of Sterile Water for Injection or 10 mL of 0.9% Sodium Chloride Injection to the vial containing 10 mg of mechlorethamine hydrochloride. (Amounts of diluent of 50 to 100 mL of normal saline have also been used. , ) The position of the patient should be changed every 5 to 10 minutes for an hour after injection to obtain more uniform distribution of the drug throughout the serous cavity. The remaining fluid may be removed from the pleural or peritoneal cavity by paracentesis 24 to 36 hours later. The patient should be followed carefully by clinical and x-ray examination to detect reaccumulation of fluid.

Pain occurs rarely with intrapleural use; it is common with intraperitoneal injection and is often associated with nausea, vomiting, and diarrhea of 2 to 3 days duration. Transient cardiac irregularities may occur with intrapericardial injection. Death, possibly accelerated by nitrogen mustard, has been reported following the use of this agent by the intracavitary route. Although absorption of MUSTARGEN when given by the intracavitary route is probably not complete because of its rapid deactivation by body fluids, the systemic effect is unpredictable. The acute side effects such as nausea and vomiting are usually mild. Bone marrow depression is generally milder than when the drug is given intravenously. Care should be taken to avoid use by the intracavitary route when other agents which may suppress bone marrow function are being used systemically.

Neutralization of Equipment and Unused Solution:


What interacts with Mustargen?

The use of MUSTARGEN is contraindicated in the presence of known infectious diseases and in patients who have had previous anaphylactic reactions to MUSTARGEN.



What are the warnings of Mustargen?

Cyclobenzaprine HCl may enhance the effects of alcohol, barbiturates, and other CNS depressants.

As nitrogen mustard therapy may contribute to extensive and rapid development of amyloidosis, it should be used only if foci of acute and chronic suppurative inflammation are absent.

Usage in Pregnancy:


What are the precautions of Mustargen?

General:

HIGHLY TOXIC

Because of the toxicity of MUSTARGEN, and the unpleasant side effects following its use, the potential risk and discomfort from the use of this drug in patients with inoperable neoplasms or in the terminal stage of the disease must be balanced against the limited gain obtainable. These gains will vary with the nature and the status of the disease under treatment. The routine use of MUSTARGEN in all cases of widely disseminated neoplasms is to be discouraged.

The use of MUSTARGEN in patients with leukopenia, thrombocytopenia, and anemia, due to invasion of the bone marrow by tumor carries a greater risk. In such patients a good response to treatment with disappearance of the tumor from the bone marrow may be associated with improvement of bone marrow function. However, in the absence of a good response or in patients who have been previously treated with chemotherapeutic agents, hematopoiesis may be further compromised, and leukopenia, thrombocytopenia and anemia may become more severe and lead to the demise of the patient.

Tumors of bone and nervous tissue have responded poorly to therapy. Results are unpredictable in disseminated and malignant tumors of different types.

Precautions must be observed with the use of MUSTARGEN and x-ray therapy or other chemotherapy in alternating courses. Hematopoietic function is characteristically depressed by either form of therapy, and neither MUSTARGEN following x-ray therapy nor x-ray therapy subsequent to the drug should be given until bone marrow function has recovered. In particular, irradiation of such areas as sternum, ribs, and vertebrae shortly after a course of nitrogen mustard may lead to hematologic complications.

MUSTARGEN has been reported to have immunosuppressive activity. Therefore, it should be borne in mind that use of the drug may predispose the patient to bacterial, viral or fungal infection.

Hyperuricemia may develop during therapy with MUSTARGEN. The problem of urate precipitation should be anticipated, particularly in the treatment of the lymphomas, and adequate methods for control of hyperuricemia should be instituted and careful attention directed toward adequate fluid intake before treatment.

Since drug toxicity, especially sensitivity to bone marrow failure, seems to be more common in chronic lymphatic leukemia than in other conditions, the drug should be given in this condition with great caution, if at all.

Extreme caution must be used in exceeding the average recommended dose.

Laboratory Tests:

Carcinogenesis, Mutagenesis, Impairment of Fertility:

The International Agency for Research on Cancer has judged that mechlorethamine is a probable carcinogen in humans. This is supported by limited evidence of carcinogenicity in humans and sufficient evidence of carcinogenicity in animals. Young-adult female RF mice were injected intravenously with four doses of 2.4 mg/kg of mechlorethamine (0.1% solution) at 2-week intervals with observations for up to 2 years. An increased incidence of thymic lymphomas and pulmonary adenomas was observed. Painting mechlorethamine on the skin of mice for periods up to 33 weeks resulted in squamous cell tumors in 9 of 33 mice.

Mechlorethamine induced mutations in the Ames test, in , and . Mechlorethamine caused chromosome aberrations in a variety of plant and mammalian cells. Dominant lethal mutations were produced in ICR/Ha Swiss mice.

Mechlorethamine impaired fertility in the rat at a daily dose of 500 mg/kg intravenously for two weeks.

Pregnancy:

Nursing Mothers:

Pediatric Use:

Geriatric Use:


What are the side effects of Mustargen?

Clinical use of

usually is accompanied by toxic manifestations

Local Toxicity:

Systemic Toxicity

General:

MUSTARGEN is given preferably at night in case sedation for side effects is required. Nausea and vomiting usually occur 1 to 3 hours after use of the drug. Emesis may disappear in the first 8 hours, but nausea may persist for 24 hours. Nausea and vomiting may be so severe as to precipitate vascular accidents in patients with a hemorrhagic tendency. Premedication with antiemetics, in addition to sedatives, may help control severe nausea and vomiting. Anorexia, weakness and diarrhea may also occur.

Hematologic:

Integumentary:

Reproductive:

To report suspected adverse reactions, contact Recordati Rare Diseases Inc. at 1-888-575-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


What should I look out for while using Mustargen?

The use of MUSTARGEN is contraindicated in the presence of known infectious diseases and in patients who have had previous anaphylactic reactions to MUSTARGEN.

Before using

an accurate histologic diagnosis of the disease, a knowledge of its natural course, and an

adequate clinical history are important. The hematologic status of the patient must first be determined. It is essential to understand the hazards and therapeutic effects to be expected. Careful clinical judgment must be exercised in selecting patients. If the indication for its use is not clear, the drug should not be used.

As nitrogen mustard therapy may contribute to extensive and rapid development of amyloidosis, it should be used only if foci of acute and chronic suppurative inflammation are absent.

Usage in Pregnancy:


What might happen if I take too much Mustargen?

With total doses exceeding 0.4 mg/kg of body weight for a single course, severe leukopenia, anemia, thrombocytopenia and a hemorrhagic diathesis with subsequent delayed bleeding may develop. Death may follow. The only treatment in instances of excessive dosage appears to be repeated blood product transfusions, antibiotic treatment of complicating infections and general supportive measures.

The intravenous LD of MUSTARGEN is 2 mg/kg and 1.6 mg/kg in the mouse and rat, respectively. The oral LD for mechlorethamine hydrochloride is 20 mg/kg and 10 mg/kg in the mouse and rat, respectively.


How should I store and handle Mustargen?

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Preserve in tight, light-resistant containers as defined in the USP.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Preserve in tight, light-resistant containers as defined in the USP.Trituration of MUSTARGEN is a light yellow brown crystalline powder, each vial containing 10 mg of mechlorethamine hydrochloride with sodium chloride q.s. 100 mg, and is supplied in treatment sets of 4 vials. NDC 55292-911-51 Storage Trituration of MUSTARGEN is a light yellow brown crystalline powder, each vial containing 10 mg of mechlorethamine hydrochloride with sodium chloride q.s. 100 mg, and is supplied in treatment sets of 4 vials. NDC 55292-911-51 Storage Trituration of MUSTARGEN is a light yellow brown crystalline powder, each vial containing 10 mg of mechlorethamine hydrochloride with sodium chloride q.s. 100 mg, and is supplied in treatment sets of 4 vials. NDC 55292-911-51 Storage


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Mechlorethamine, a biologic alkylating agent, has a cytotoxic action which inhibits rapidly proliferating cells.

Non-Clinical Toxicology
The use of MUSTARGEN is contraindicated in the presence of known infectious diseases and in patients who have had previous anaphylactic reactions to MUSTARGEN.

Before using

an accurate histologic diagnosis of the disease, a knowledge of its natural course, and an

adequate clinical history are important. The hematologic status of the patient must first be determined. It is essential to understand the hazards and therapeutic effects to be expected. Careful clinical judgment must be exercised in selecting patients. If the indication for its use is not clear, the drug should not be used.

As nitrogen mustard therapy may contribute to extensive and rapid development of amyloidosis, it should be used only if foci of acute and chronic suppurative inflammation are absent.

Usage in Pregnancy:

Aminoglutethimide

Amphotericin B Injection and Potassium-depleting agents

Antibiotics

Anticholinesterases

Anticoagulants, Oral

Antidiabetics

Antitubercular Drugs

Cholestyramine

Cyclosporine

Dexamethasone Suppression Test (DST)

Digitalis Glycosides

Ephedrine

Estrogens, Including Oral Contraceptives









Ketoconazole

Nonsteroidal Anti-Inflammatory Agents (NSAIDS)

Phenytoin

Skin Tests

Thalidomide





General:

HIGHLY TOXIC

Because of the toxicity of MUSTARGEN, and the unpleasant side effects following its use, the potential risk and discomfort from the use of this drug in patients with inoperable neoplasms or in the terminal stage of the disease must be balanced against the limited gain obtainable. These gains will vary with the nature and the status of the disease under treatment. The routine use of MUSTARGEN in all cases of widely disseminated neoplasms is to be discouraged.

The use of MUSTARGEN in patients with leukopenia, thrombocytopenia, and anemia, due to invasion of the bone marrow by tumor carries a greater risk. In such patients a good response to treatment with disappearance of the tumor from the bone marrow may be associated with improvement of bone marrow function. However, in the absence of a good response or in patients who have been previously treated with chemotherapeutic agents, hematopoiesis may be further compromised, and leukopenia, thrombocytopenia and anemia may become more severe and lead to the demise of the patient.

Tumors of bone and nervous tissue have responded poorly to therapy. Results are unpredictable in disseminated and malignant tumors of different types.

Precautions must be observed with the use of MUSTARGEN and x-ray therapy or other chemotherapy in alternating courses. Hematopoietic function is characteristically depressed by either form of therapy, and neither MUSTARGEN following x-ray therapy nor x-ray therapy subsequent to the drug should be given until bone marrow function has recovered. In particular, irradiation of such areas as sternum, ribs, and vertebrae shortly after a course of nitrogen mustard may lead to hematologic complications.

MUSTARGEN has been reported to have immunosuppressive activity. Therefore, it should be borne in mind that use of the drug may predispose the patient to bacterial, viral or fungal infection.

Hyperuricemia may develop during therapy with MUSTARGEN. The problem of urate precipitation should be anticipated, particularly in the treatment of the lymphomas, and adequate methods for control of hyperuricemia should be instituted and careful attention directed toward adequate fluid intake before treatment.

Since drug toxicity, especially sensitivity to bone marrow failure, seems to be more common in chronic lymphatic leukemia than in other conditions, the drug should be given in this condition with great caution, if at all.

Extreme caution must be used in exceeding the average recommended dose.

Laboratory Tests:

Carcinogenesis, Mutagenesis, Impairment of Fertility:

The International Agency for Research on Cancer has judged that mechlorethamine is a probable carcinogen in humans. This is supported by limited evidence of carcinogenicity in humans and sufficient evidence of carcinogenicity in animals. Young-adult female RF mice were injected intravenously with four doses of 2.4 mg/kg of mechlorethamine (0.1% solution) at 2-week intervals with observations for up to 2 years. An increased incidence of thymic lymphomas and pulmonary adenomas was observed. Painting mechlorethamine on the skin of mice for periods up to 33 weeks resulted in squamous cell tumors in 9 of 33 mice.

Mechlorethamine induced mutations in the Ames test, in , and . Mechlorethamine caused chromosome aberrations in a variety of plant and mammalian cells. Dominant lethal mutations were produced in ICR/Ha Swiss mice.

Mechlorethamine impaired fertility in the rat at a daily dose of 500 mg/kg intravenously for two weeks.

Pregnancy:

Nursing Mothers:

Pediatric Use:

Geriatric Use:

Clinical use of

usually is accompanied by toxic manifestations

Local Toxicity:

Systemic Toxicity

General:

MUSTARGEN is given preferably at night in case sedation for side effects is required. Nausea and vomiting usually occur 1 to 3 hours after use of the drug. Emesis may disappear in the first 8 hours, but nausea may persist for 24 hours. Nausea and vomiting may be so severe as to precipitate vascular accidents in patients with a hemorrhagic tendency. Premedication with antiemetics, in addition to sedatives, may help control severe nausea and vomiting. Anorexia, weakness and diarrhea may also occur.

Hematologic:

Integumentary:

Reproductive:

To report suspected adverse reactions, contact Recordati Rare Diseases Inc. at 1-888-575-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Tips

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Interactions

Interactions

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