matulane
Matulane (Procarbazine Hydrochloride) is a medication used to treat Brain Neoplasms, Hodgkin Disease, Lung Neoplasms, Non-Hodgkin Lymphoma.
Procarbazine Hydrochloride · by Leadiant Biosci Inc
Key facts
- Active ingredient
- Procarbazine Hydrochloride
- Form
- Capsule
- Strength
- Procarbazine Hydrochloride EQ 50MG Base
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- brain neoplasms, hodgkin disease, lung neoplasms
- Manufacturer
- Leadiant Biosci Inc
- FDA application
- NDA016785
- FDA boxed warning
- Yes — see the boxed warning
What is Matulane?
From the FDA label:Matulane (procarbazine hydrochloride), a hydrazine derivative antineoplastic agent, is available as capsules containing the equivalent of 50 mg procarbazine as the hydrochloride. Each capsule also contains cornstarch, mannitol and talc. Gelatin capsule shells contain titanium dioxide, FD&C Yellow No. 6 and D&C Yellow No. 10. Chemically, procarbazine hydrochloride is N ‑isopropyl-∝-(2‑methylhydrazino)‑ p ‑toluamide monohydrochloride. It is a white to pale yellow crystalline powder which is soluble but unstable in water or aqueous solutions. The molecular weight of procarbazine hydrochloride is 257.76 and the structural formula is: chemical structure
How to use
The following doses are for administration of the drug as a single agent. When used in combination with other anticancer drugs, the Matulane dose should be appropriately reduced, eg, in the MOPP regimen, the Matulane dose is 100 mg/m2 daily for 14 days. All dosages are based on the patient's actual weight. However, the estimated lean body mass (dry weight) is used if the patient is obese or if there has been a spurious weight gain due to edema, ascites or other forms of abnormal fluid retention. Adults: To minimize the nausea and vomiting experienced by a high percentage of patients beginning Matulane therapy, single or divided doses of 2 to 4 mg/kg/day for the first week are recommended. Daily dosage should then be maintained at 4 to 6 mg/kg/day until maximum response is obtained or until the white blood count falls below 4000/cmm or the platelets fall below 100,000/ cmm. When maximum response is obtained, the dose may be maintained at 1 to 2 mg/kg/day. Upon evidence of hematologic or other toxicity (see PRECAUTIONS section), the drug should be discontinued until there has been satisfactory recovery. After toxic side effects have subsided, therapy may then be resumed at the discretion of the physician, based on clinical evaluation and appropriate laboratory studies, at a dosage of 1 to 2 mg/kg/day. Pediatric Patients: Very close clinical monitoring is mandatory. Undue…
Side effects
Leukopenia, anemia and thrombopenia occur frequently. Nausea and vomiting are the most commonly reported side effects. Other adverse reactions are: Hematologic Pancytopenia; eosinophilia; hemolytic anemia; bleeding tendencies such as petechiae, purpura, epistaxis and hemoptysis. Gastrointestinal Hepatic dysfunction, jaundice, stomatitis, hematemesis, melena, diarrhea, dysphagia, anorexia, abdominal pain, constipation, dry mouth. Neurologic Coma, convulsions, neuropathy, ataxia, paresthesia, nystagmus, diminished reflexes, falling, foot drop, headache, dizziness, unsteadiness. Cardiovascular Hypotension, tachycardia, syncope. Ophthalmic Retinal hemorrhage, papilledema, photophobia, diplopia, inability to focus. Respiratory Pneumonitis, pleural effusion, cough. Dermatologic Herpes, dermatitis, pruritus, alopecia, hyperpigmentation, rash, urticaria, flushing. Allergic Generalized allergic reactions. Genitourinary Hematuria, urinary frequency, nocturia. Musculoskeletal Pain, including myalgia and arthralgia; tremors. Psychiatric Hallucinations, depression, apprehension, nervousness, confusion, nightmares. Endocrine Gynecomastia in prepubertal and early pubertal boys. Miscellaneous Intercurrent infections, hearing loss, pyrexia, diaphoresis, lethargy, weakness, fatigue, edema, chills, insomnia, slurred speech, hoarseness, drowsiness. Second nonlymphoid malignancies (including lung…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
It is recommended that MATULANE 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 to patients for proper monitoring of treatment.
Warnings
Important safety information
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 an Antabuse (disulfiram)-like reaction. Because Matulane exhibits some monoamine oxidase inhibitory activity, sympathomimetic drugs, tricyclic antidepressant drugs (eg, amitriptyline HCI, imipramine HCI) and other drugs and foods with known high tyramine content, such as wine, yogurt, ripe cheese and bananas, should be avoided. A further phenomenon of toxicity common to many hydrazine derivatives is hemolysis and the appearance of Heinz‑Ehrlich inclusion bodies in erythrocytes. Pregnancy Teratogenic Effects Procarbazine hydrochloride can cause fetal harm when administered to a pregnant woman. While there are no adequate and well‑controlled studies with procarbazine hydrochloride in pregnant women, there are case reports of malformations in the offspring of women who were exposed to procarbazine hydrochloride in combination with other antineoplastic agents during pregnancy. Matulane should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant. Procarbazine hydrochloride is teratogenic in the rat when given at doses approximately 4 to 13 times the maximum recommended human therapeutic dose of 6 mg/kg/day. Nonteratogenic Effects Procarbazine hydrochloride has not been adequately studied in animals for its effects on peri- and postnatal development. However, neurogenic tumors were noted in the offspring of rats given intravenous injections of 125 mg/kg of procarbazine hydrochloride on day 22 of gestation. Compounds which inhibit DNA, RNA and protein synthesis might be expected to have adverse effects on peri- and postnatal development. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis The carcinogenicity of procarbazine hydrochloride in mice, rats and monkeys has been reported in a considerable number of studies. Instances of a second 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. Mutagenesis Procarbazine hydrochloride has been shown to be mutagenic in a variety of bacterial and mammalian test systems. Impairment of Fertility Azoospermia and antifertility effects associated with procarbazine hydrochloride administration in combination with other chemotherapeutic agents for treating Hodgkin's disease have been reported in human clinical studies. Since these patients received multicombination therapy, it is difficult to determine to what extent procarbazine hydrochloride alone was involved in the male germcell damage. The usual Segment I fertility/reproduction studies in laboratory animals have not been carried out with procarbazine hydrochloride. However, compounds which inhibit DNA, RNA and/or protein synthesis might be expected to have adverse effects on gametogenesis. Unscheduled DNA synthesis in the testis of rabbits and decreased fertility in male mice treated with procarbazine hydrochloride have been reported.
Who should not take Matulane
Matulane is contraindicated in patients with known hypersensitivity to the drug or 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.
Overdose — what happens if you take too much
The major manifestations of overdosage with Matulane would be anticipated to be nausea, vomiting, enteritis, diarrhea, hypotension, tremors, convulsions and coma. Treatment should consist of either the administration of an emetic or gastric lavage. General supportive measures such as intravenous fluids are advised. Since the major toxicity of procarbazine hydrochloride is hematologic and hepatic, patients should have frequent complete blood counts and liver function tests throughout their period of recovery and for a minimum of two weeks thereafter. Should abnormalities appear in any of these determinations, appropriate measures for correction and stabilization should be immediately undertaken. The estimated mean lethal dose of procarbazine hydrochloride in laboratory animals varied from approximately 150 mg/kg in rabbits to 1300 mg/kg in mice.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
See WARNINGS section. No cross-resistance with other chemotherapeutic agents, radiotherapy or steroids has been demonstrated.
May treat (source: NIH RxClass)
Dosage forms
Capsule
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- What does Matulane treat?
- Matulane (Procarbazine Hydrochloride) may be used to treat brain neoplasms, hodgkin disease, lung neoplasms, non-hodgkin lymphoma, melanoma, multiple myeloma, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Matulane?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Matulane. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Matulane?
- Matulane is marketed by Leadiant Biosci Inc. You can see Leadiant Biosci Inc's full profile, rating, and other products on pharmaranks.
- Is Matulane a brand-name or generic drug?
- Matulane is a brand-name product with the active ingredient Procarbazine Hydrochloride.
- Is Matulane available over the counter?
- No. Matulane is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Matulane come in?
- Matulane is currently marketed as capsule, per the FDA's National Drug Code Directory.
- Is Matulane FDA-registered?
- Matulane is on record with the U.S. FDA under application number NDA016785. You can verify this on its official FDA label.
- Is Matulane safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Matulane. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Matulane?
- Matulane's side effects are taken directly from its FDA label. From the label: Leukopenia, anemia and thrombopenia occur frequently. Nausea and vomiting are the most commonly reported side effects. Other adverse reactions are: Hematologic Pancytopenia; eosinophilia; hemolytic anemia; bleeding tendencies such as petechiae, purpura, epistaxis and hemoptysis.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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