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MATULANE is a brand name for Procarbazine, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ................................................ 3 CONTRAINDICATIONS ..................................................................... 4 WARNINGS AND PRECAUTIONS.................................................... 4 ADVERSE…
Verbatim from this product's HC label. Tap a section to expand.
• hypersensitivity to procarbazine or any other component of the product. • inadequate marrow reserve as demonstrated by bone marrow aspiration. Due consideration of this possible state should be given to each patient who has leukopenia, thrombocytopenia or anemia.
WARNINGS AND PRECAUTIONS General It is recommended that Matulane (procarbazine hydrochloride) be given only by or under the supervision of a physician experienced in the use of potent antineoplastic drugs. Adequate clinical and laboratory facilities should be available for a proper monitoring of a treatment.
To minimize CNS depression and possible potentiation, barbiturates, antihistamines, narcotics, hypotensive agents or phenothiazines should be used with caution. Ethyl alcohol should not be used since there may be a disulfiram-like reaction.
g. g. ginseng) and foods known to react with momoamine oxidase inhibitors due to high tyramine content or other physiologic properties should be avoided. High tyramine content is most common in foods that are aged or fermented to increase flavor such as cheeses, yeast or meat extracts, fava or broad bean pods, smoked or pickled meat, poultry, or fish, fermented sausage (bologna, pepperoni, salami, and summer sausage) or other unfresh meat, or dried or overripe fruit.
Matulane (procarbazine hydrochloride) should be prescribed by a qualified health care professional who is experienced with cancer chemotherapy drugs. Clinically significant treatment- related toxicities include: • Long-term risk of developing acute leukemia, myelodysplasia, second cancers • Infertility • Neuropathy • MAO (monoamine oxidase) inhibition The MOPP regimen is not recommended in treating favourable prognosis CS I-II patients.
5 A further phenomenon of toxicity common to many hydrazine derivatives is hemolysis and the appearance of Heinz-Ehrlich inclusion bodies in erythrocytes. If radiation or a chemotherapeutic agent known to have marrow-depressant activity has been used, an interval of one month or longer without such therapy is recommended before starting treatment with Matulane.
The length of this interval may also be determined by evidence of bone marrow recovery based on successive bone marrow studies. Prompt cessation of therapy is recommended if any one of the following occurs: • Central nervous system signs or symptoms such as paresthesias, neuropathies or confusion.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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• Leukopenia (white blood count under 4,000). • Thrombocytopenia (platelets under 100,000). • Hypersensitivity reaction. • Stomatitis - The first small ulceration or persistent spot soreness around the oral cavity is a signal for cessation of therapy.
• Diarrhea - Frequent bowel movements or watery stools. • Hemorrhage or bleeding tendencies. Therapy may be resumed, at the discretion of the physician, after toxic side effects have cleared on clinical evaluation and appropriate laboratory studies.
Carcinogenesis and Mutagenesis Instances of new nonlymphoid malignancy, including lung cancer and acute myelocytic leukemia, have been reported in patients with Hodgkin's disease treated with procarbazine in combination with other chemotherapy and/or radiation.
The risks of secondary lung cancer from treatment appear to be multiplied by tobacco use. The International Agency for Research on Cancer (IARC) considers that there is “sufficient evidence” for the human carcinogenicity of procarbazine hydrochloride when it is given in intensive regimens which include other antineoplastic agents but that there is inadequate evidence of carcinogenicity in humans given procarbazine hydrochloride alone.
The international population-based study Hodgkin Lymphoma patients has demonstrated statistically significant risk of acute myeloid leukemia following Hodgkin lymphoma treatments over a 30-year period [Schonfeld, 2006]. One-year Hodgkin lymphoma survivors (N = 35,511) were identified within 14 population-based cancer registries in Nordic countries and North America from January 1, 1970, through December 31, 2001.
A total of 217 Hodgkin lymphoma survivors were diagnosed with AML. 9 in the < 35 and ≥ 35 age groups, respectively, which may be associated with modifications in chemotherapy. Analytical studies with detailed treatment data are required to correlate these decreases with changes in therapy and to better understand the long term risk of AML after Hodgkin’s Lymphoma.
6 The carcinogenicity of procarbazine hydrochloride in animals and mutagenicity in test systems has been reported in a number of studies (see TOXICOLOGY). Hematologic Leukopenia and thrombocytopenia have been reported in patients on Matulane therapy.
Platelets and white blood cell counts should be performed prior to each subsequent cycle. Hepatic/Renal Undue toxicity may occur if Matulane is used in patients with impairment of renal and/or hepatic function. When appropriate, hospitalization for the initial course of treatment should be considered.
The metabolism of procarbazine is dependent on hepatic transformation and renal elimination. Therefore, dosing modifications may be required in patients with compromised renal or hepatic function. Sexual Function/Reproduction Exposure to procarbazine has been reported to be an independent risk factor for acute ovarian failure and acute amenorrhea in females.
Azoospermia which can be prolonged resulting in male infertility has been reported to be associated with procarbazine when used in combination with other chemotherapeutic agents. The standard battery of fertility/reproduction studies in laboratory animals have not been carried out with procarbazine hydrochloride (see TOXICOLOGY).
Special Populations Pregnancy:
Procarbazine […]