Details for: MATULANE
Company: LEADIANT BIOSCIENCES, INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 00012750 | MATULANE | PROCARBAZINE (PROCARBAZINE HYDROCHLORIDE) | 50 MG | CAPSULE | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Matulane is used to treat Stage III and IV Hodgkin’s disease in combination with certain cancer drugs. Matulane is used as part of the MOPP regimen (nitrogen mustard, vincristine, procarbazine, prednisone).
What it does
Matulane is thought to work by killing rapidly dividing cells, such as cancer cells.
When it should not be used
- allergic to procarbazine hydrochloride or any of the other ingredients in Matulane.
- have low blood cell counts (bone marrow depression).
What the medicinal ingredient is
Procarbazine hydrochloride.
What the non-medicinal ingredients are
Cornstarch, gelatin, mannitol, methylparaben, potassium sorbate, propylparaben, quinoline yellow WS, sunset yellow FCF, talc, and titanium dioxide.
What dosage form it comes in
Matulane is available in capsules. Each capsule contains 50 mg of procarbazine as procarbazine hydrochloride.
Warnings and precautions
Serious Warnings and Precautions
Matulane should be prescribed and managed by a doctor experienced in the use of anti-cancer drugs.
Serious side effects with the use of Matulane include:
- long-term risk of acute leukemia (blood cancer), myelodysplasia (a decrease of the production of blood cell), and developing another type of cancer
- infertility
- neuropathy (nerve damage)
- Monoamine oxidase (MAO) inhibition
The MOPP regimen is not recommended to treat early stages of Hodgkin’s disease.
Before you use Matulane talk to your doctor if any of the following applies to you:
- if you have or have experienced a sensitivity or allergic reaction to Matulane or any component of the product.
- if you have low blood cell counts due to bone marrow problems.
- if you have kidney or liver disease.
- if you are pregnant or planning to be pregnant, and if you are breastfeeding.
Matulane may cause sterility in men and menopause in women
Matulane may damage sperm and may harm your baby if used during pregnancy. Effective birth control methods must be used while taking Matulane.
Do not smoke, as Matulane may increase the risk of developing lung cancer in patients who smoke.
Interactions with this medication
Tell your doctor about other medications or dietary supplements that you are taking as your dose may need to be changed. Check with your doctor or pharmacist before you start taking any new drugs or dietary supplements. Matulane in combination with barbiturates, antihistamines, narcotics, hypotensive agents or phenothiazines may cause CNS depression (slowing of normal brain function) and increase the effect of these medications. Matulane can interfere with the absorption of digoxin. The effects of antidiabetics and levodopa may be enhanced by Matulane use. Sensitivity to Matulane can be increased when used with carbamazepine. Matulane also exhibits monoamine oxidase inhibitory activity. Dietary supplements (e.g. ginseng) and foods known to react with momoamine oxidase inhibitors should be avoided. Sympathomimetic drugs (such as cold remedies) and tricyclic antidepressant drugs may interact with Matulane to cause a rise in blood pressure.
Alcohol may interact with Matulane, causing flushing, headache or sweating. Do not drink alcohol, alcohol-free or reduced-alcohol beer or wine while being treated with Matulane.
Avoid certain foods which have a substance called tyramine as it may interact with Matulane. Typical reactions include headache, flushed face, palpitations, nausea and vomiting or a rise in blood pressure. Do not eat foods that have a high tyramine content (most common in foods that are aged or fermented to increase their 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 any dried or overripe fruit. Do not eat or drink large amounts of caffeine-containing food or beverages, such as chocolate, coffee, tea, or cola.
Talk to your doctor about tyramine containing foods for a complete list.
Proper use of this medication
Your doctor will determine the length of your treatment based on your treatment goals, the medicines you receive, and how your body responds to those medicines.
Matulane is usually given in cycles that include rest periods between treatments. The rest periods give your body a chance to build healthy cells and regain your strength before the next treatment.
It is important to take Matulane exactly as directed by your doctor. Make sure you understand the directions.
Do not open or crush capsules. Do not take Matulane if the capsule is broken.
Overdose
Do not take more than the prescribed dose (see Missed Dose below). Symptoms of overdose may occur as nausea, vomiting, diarrhea, low blood pressure, tremors, convulsions, and coma. Contact your Poison Control Center for information and management information.
Missed Dose
If you miss a dose of Matulane, take it as soon as you can if it is within 12 hours of the missed dose. If it is over 12 hours since your missed dose, skip the missed dose and go back to your usual dosing times. Call your doctor to ask about making up the missed dose.
Side effects and what to do about them
In dealing with cancer drugs, adverse effects are not only common but are to be expected and actually serve as a guideline to dosage and duration of administration.
The most serious adverse effects are associated with changes in blood cell counts and a variety of neurological effects such as headache, flushing of the face, palpitations, and rise in blood pressure.
The most common reported adverse effects are nausea and vomiting. Changes in blood cell counts occur frequently.
The following side effects have also been reported: infection or reduced ability to fight infection, excessive bleeding, blood clots, liver function changes, coma, convulsions (seizures), headache, nerve or reflex problems, low or high blood pressure, chest pain, heart damage, vision changes, cough, lung infection and lung damage, skin reactions (sometimes serious), allergic reactions, urinary disturbances, pain, weakness, depression, nervousness, nightmares, fever, sweating, chills, and hallucinations.
Check with your doctor immediately if any of these side effects occur:
- Central nervous system signs or symptoms such as tingling, numbness or confusion
- Reduced white blood cell count
- Reduced platelet count
- Allergic reactions
- The first small ulceration or persistent spot soreness around the mouth
- Diarrhea- frequent bowel movements or watery stools
- Excessive or abnormal bleeding
Second cancers and male and female reproductive effects have been reported in patients with Hodgkin's disease treated with Matulane in combination with other cancer drugs and/or radiation.
| Symptom / effect | Talk with your doctor or pharmacist only if severe | Talk with your doctor or pharmacist in all cases |
|---|---|---|
| Common | ||
| Reduced white blood cell count | ✔ | |
| Infection or reduced ability to fight infection | ✔ | |
| Reduced platelet count | ✔ | |
| Excessive or abnormal bleeding | ✔ | |
| Uncommon | ||
| Central nervous system signs or symptoms such as tingling, numbness or confusion | ✔ | |
| Allergic reactions | ✔ | |
| The first small ulceration or persistent spot soreness around the mouth | ✔ | |
| Diarrhea- frequent bowel movements or watery stools | ✔ | |
| Blood clots | ✔ | |
| Liver function changes | ✔ | |
| Coma | ✔ | |
| Convulsions (seizures) | ✔ | |
| Low or high blood pressure | ✔ | |
| Chest pain (posible heart damage) | ✔ | |
| Vision changes | ✔ | |
| Lung infection (possible lung damage) | ✔ | |
| Skin reactions | ✔ | |
| Urinary disturbances | ✔ | |
| Hallucinations | ✔ | |
This is not a complete list of side effects. For any unexpected effects while taking Matulane, contact your doctor or pharmacist.
How to store
Keep out of the reach of children. Store away from heat and direct light. Store at 15" - 30"C. Protect from light. Do not store in the bathroom, near the kitchen sink, or in other damp places.
Reporting side effects
To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:
By toll-free telephone: 866-234-2345
By toll-free fax: 866-678-6789
Online: www.healthcanada.gc.ca/medeffect
By email: CanadaVigilance@hc-sc.gc.ca
By regular mail:
Canada Vigilance National Office
Marketed Health Products Safety and Effectiveness Information Bureau
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Leadiant Biosciences, Inc. at: 1-800-447-0169.
This leaflet was prepared by Leadiant Biosciences, Inc.
Last revised: August 9, 2017.