DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Mustargen (Mechlorethamine Hydrochloride (Nitrogen Mustard)) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Clinical use of MUSTARGEN usually is accompanied by toxic manifestations.

Local Toxicity: Thrombosis and thrombophlebitis may result from direct contact of the drug with the intima of the injected vein. Avoid high concentration and prolonged contact with the drug, especially in cases of elevated pressure in the antebrachial vein (e.g., in mediastinal tumor compression from severe vena cava syndrome).

Systemic Toxicity
General: Hypersensitivity reactions, including anaphylaxis, have been reported. Nausea, vomiting and depression of formed elements in the circulating blood are dose-limiting side effects and usually occur with the use of full doses of MUSTARGEN. Jaundice, alopecia, vertigo, tinnitus and diminished hearing may occur infrequently. Rarely, hemolytic anemia associated with such diseases as the lymphomas and chronic lymphocytic leukemia may be precipitated by treatment with alkylating agents including MUSTARGEN. Also, various chromosomal abnormalities have been reported in association with nitrogen mustard therapy.

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: The usual course of MUSTARGEN (total dose of 0.4 mg/kg either given as a single intravenous dose or divided into two or four daily doses of 0.2 or 0.1 mg/kg, respectively) generally produces a lymphocytopenia within 24 hours after the first injection; significant granulocytopenia occurs within 6 to 8 days and lasts for 10 days to 3 weeks. Agranulocytosis appears to be relatively infrequent and recovery from leukopenia in most cases is complete within two weeks of the maximum reduction. Thrombocytopenia is variable but the time course of the appearance and recovery from reduced platelet counts generally parallels the sequence of granulocyte levels. In some cases severe thrombocytopenia may lead to bleeding from the gums and gastrointestinal tract, petechiae, and small subcutaneous hemorrhages; these symptoms appear to be transient and in most cases disappear with return to a normal platelet count. However, a severe and even uncontrollable depression of the hematopoietic system occasionally may follow the usual dose of MUSTARGEN, particularly in patients with widespread disease and debility and in patients previously treated with other antineoplastic agents or x-ray. Persistent pancytopenia has been reported. In rare instances, hemorrhagic complications may be due to hyperheparinemia. Erythrocyte and hemoglobin levels may decline during the first 2 weeks after therapy but rarely significantly. Depression of the hematopoietic system may be found up to 50 days or more after starting therapy.

Integumentary: Occasionally, a maculopapular skin eruption occurs, but this may be idiosyncratic and does not necessarily recur with subsequent courses of the drug. Erythema multiforme has been observed. Herpes zoster, a common complicating infection in patients with lymphomas, may first appear after therapy is instituted and on occasion may be precipitated by treatment. Further treatment should be discontinued during the acute phase of this illness to avoid progression to generalized herpes zoster.

Reproductive: Since the gonads are susceptible to MUSTARGEN, treatment may be followed by delayed catamenia, oligomenorrhea, or temporary or permanent amenorrhea. Impaired spermatogenesis, azoospermia, and total germinal aplasia have been reported in male patients treated with alkylating agents, especially in combination with other drugs. In some instances spermatogenesis may return in patients in remission, but this may occur only several years after intensive chemotherapy has been discontinued. Patients should be warned of the potential risk to their reproductive capacity.

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.



REPORTS OF SUSPECTED MUSTARGEN SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Mustargen. The information is not vetted and should not be considered as verified clinical evidence.

Possible Mustargen side effects / adverse reactions in 40 year old male

Reported by a physician from Japan on 2011-10-06

Patient: 40 year old male

Reactions: Renal Disorder, Bone Marrow Failure, Mucous Membrane Disorder

Suspect drug(s):
Methotrexate Sodium
    Indication: Immunodeficiency

Methotrexate
    Indication: Hodgkin's Disease

Cyclosporine
    Indication: Immunodeficiency

Prednisone
    Indication: Hodgkin's Disease

Procarbazine Hydrochloride
    Indication: Immunodeficiency

Procarbazine Hydrochloride
    Indication: Hodgkin's Disease

Etoposide
    Indication: Immunodeficiency

Mustargen
    Indication: Diffuse Large B-Cell Lymphoma

Mustargen
    Indication: Hodgkin's Disease

Adriamycin PFS
    Indication: Hodgkin's Disease

Mustargen
    Indication: Immunodeficiency

Methotrexate Sodium
    Indication: Diffuse Large B-Cell Lymphoma

Cyclosporine
    Indication: Hodgkin's Disease

Oncovin
    Indication: Diffuse Large B-Cell Lymphoma

Prednisone
    Indication: Immunodeficiency

Adriamycin PFS
    Indication: Immunodeficiency

Etoposide
    Indication: Diffuse Large B-Cell Lymphoma

Oncovin
    Indication: Immunodeficiency

Cyclophosphamide
    Indication: Diffuse Large B-Cell Lymphoma

Oncovin
    Indication: Hodgkin's Disease

Adriamycin PFS
    Indication: Diffuse Large B-Cell Lymphoma

Procarbazine Hydrochloride
    Indication: Diffuse Large B-Cell Lymphoma

Etoposide
    Indication: Hodgkin's Disease

Prednisone
    Indication: Diffuse Large B-Cell Lymphoma



Possible Mustargen side effects / adverse reactions in 13 year old female

Reported by a physician from Italy on 2011-11-02

Patient: 13 year old female

Reactions: Mucosal Inflammation, Vomiting, Barrett's Oesophagus, Metaplasia, Oesophageal Stenosis

Suspect drug(s):
Bleomycin Sulfate
    Dosage: 6 courses
    Indication: Hodgkin's Disease Stage III

Oncovin
    Dosage: 6 courses
    Indication: Hodgkin's Disease Stage III

Prednisone TAB
    Dosage: 6 courses
    Indication: Hodgkin's Disease Stage III

Vinblastine Sulfate
    Dosage: 6 courses
    Indication: Hodgkin's Disease Stage III

Dacarbazine
    Dosage: 6 courses
    Indication: Hodgkin's Disease Stage III

Procarbazine Hydrochloride
    Dosage: 6 courses
    Indication: Hodgkin's Disease Stage III

Adriamycin PFS
    Dosage: 6 courses
    Indication: Hodgkin's Disease Stage III

Mustargen
    Dosage: 6 courses
    Indication: Hodgkin's Disease Stage III



Possible Mustargen side effects / adverse reactions in 42 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-31

Patient: 42 year old female

Reactions: Atrial Septal Defect, Fatigue, Hypoxia, Breast Cancer in Situ, Fibrosis, Exercise Tolerance Decreased

Suspect drug(s):
Mustargen

Other drugs received by patient: Thyroid TAB; Lexapro (Escitalopram Ocalate); Calcium/vitamin D (Lekovit CA); Levothyroxine Sodium



See index of all Mustargen side effect reports >>

Drug label data at the top of this Page last updated: 2013-02-02

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017