Mechlorethamine Side Effects

Some side effects of mechlorethamine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to mechlorethamine: injectable powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking mechlorethamine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• pain, burning, irritation, or skin changes where the injection was given;

• severe vomiting for longer than 24 hours, or coughing up blood;

• fever, chills, weakness, flu symptoms, sores in your mouth and throat;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• hearing problems, ringing in your ears; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• dizziness, spinning sensation;

• nausea, diarrhea; or

• temporary hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to mechlorethamine: injectable powder for injection

Hematologic

Hematologic side effects are usually dose related. Depression of formed elements in the circulating blood has is a dose-limiting effect. At recommended dosages, the drug will generally produce a lymphocytopenia within 24 hours after the first injection, and significant granulocytopenia will occur within 6 to 8 days, and last for 10 days to 3 weeks. Agranulocytosis has been reported infrequently.

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 recommended dosage, especially in patients with widespread disease and debilitation, and in patients previously treated with other antineoplastic agents or x-ray. Persistent pancytopenia has been reported. Hemorrhagic complications due to hyperheparinemia has been reported rarely. Erythrocyte and hemoglobin levels may decline during the first 2 weeks after therapy, but rarely significantly. Depression of the hematopoietic system may be found over 50 days after the initiation of therapy.

Hemolytic anemia associated with such diseases as the lymphomas and chronic lymphocytic leukemia may be precipitated by treatment with alkylating agents including mechlorethamine.

Recovery from leukopenia is complete in most cases within 2 weeks of the maximum reduction.

When the drug is administered by the intracavitary route, bone marrow depression is generally milder.

Gastrointestinal

Gastrointestinal side effects including nausea and vomiting are dose-limiting. Anorexia and diarrhea have also been reported. The aggressive use of serotonin antagonist based antiemetic premedication is recommended.

Nausea and vomiting usually occur 1 to 2 hours after dosage administration. 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 may help control severe nausea and vomiting. When the drug is administered by the intracavitary route, the acute side effects such as nausea and vomiting are usually mild.

Dermatologic

Further treatment should be discontinued during the acute phase of herpes zoster to avoid progression to generalized herpes zoster.

Dermatologic side effects including macropapular skin eruptions, erythema multiforme, and alopecia have been reported. Herpes zoster is a common complicating infection in patients with lymphomas. Eczematous contact dermatitis has been reported in patients receiving topical therapy (for mycosis fungoides). Topical therapy resulting in hyperpigmentation and a delayed hypersensitivity (rarely) has also been reported.

Local

High concentration and prolonged contact with the drug should be avoided. This is particularly important in cases of elevated pressure in the antebrachial vein (e.g., in mediastinal tumor compression from severe vena cava syndrome).

If leakage of the drug is obvious, first the drug should be aspirated from the extravasation site if possible, then rapid 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. Some clinicians have recommended the use of 2 mL of thiosulfate for each 1 mL of mechlorethamine estimated to have extravasated.

Local side effects including thrombosis and thrombophlebitis may result from direct contact of the drug with the intima of the injected vein. Extravasation of the drug into subcutaneous tissues has been reported to have resulted in a painful inflammation. The area usually becomes indurated and sloughing may occur. Discoloration of the vein has also been reported.

Hypersensitivity

Hypersensitivity side effects including anaphylaxis have been reported.

Oncologic

Oncologic side effects including various chromosomal abnormalities have been reported in association with nitrogen mustard therapy. Therapy with alkylating agents may be associated with an increased incidence of a second malignancy, especially when such therapy is combined with other antineoplastic agents or radiation therapy.

Cardiovascular

Cardiovascular side effects including transient cardiac irregularities have been reported when the drug has been administered by intrapericardial injection.

Nervous system

Neurotoxicity increased with increasing age and dosage, and in patients receiving concurrent procarbazine or cyclophosphamide.

Nervous system side effects have been reported in one study. In this study, 14 of 21 neurologically evaluable patients developed neurotoxicity an average of 4 days after treatment. Confusion and disorientation (in 6 of the patients), headache (6), hallucinations (4), lethargy (4), tremors (3), paraplegia (1), seizure (1), and vertigo (1) were observed.

Other

Pain occurs rarely with intrapleural use but is common with intraperitoneal injection and is often associated with nausea, vomiting and diarrhea of 2 to 3 days duration. In earlier studies using higher than currently recommended dosages, severe irreversible hearing loss has been reported. Using currently recommended dosages, a case of reversible ototoxicity has been reported.

Other side effects including hypocalcemia, pain, jaundice, vertigo, weakness, drowsiness, tinnitus, diminished hearing, metallic taste and temporary aphasia have been reported.

Hepatic

Hepatic side effects including hepatotoxicity have been reported.

Ocular

Ocular side effects including lacrimation have been reported.

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