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Details for: PROCYTOX

Company: BAXTER CORPORATION

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02241795PROCYTOX TAB 25MGCYCLOPHOSPHAMIDE25 MGTABLETORAL
02241796PROCYTOX TAB 50MGCYCLOPHOSPHAMIDE50 MGTABLETORAL
02241797PROCYTOXCYCLOPHOSPHAMIDE200 MG / VIALPOWDER FOR SOLUTIONINTRAVENOUS
02241798PROCYTOXCYCLOPHOSPHAMIDE500 MG / VIALPOWDER FOR SOLUTIONINTRAVENOUS
02241799PROCYTOXCYCLOPHOSPHAMIDE1000 MG / VIALPOWDER FOR SOLUTIONINTRAVENOUS
02241800PROCYTOXCYCLOPHOSPHAMIDE2000 MG / VIALPOWDER FOR SOLUTIONINTRAVENOUS
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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

PROCYTOX (Cyclophosphamide) can be used alone or in combination with other medication to treat:

  • Malignant lymphomas
  • Multiple Myelomas
  • Leukemias
  • Mycosis Fungoides (Advanced disease)
  • Neuroblastoma (in patients with disseminated disease, Stage IV)
  • Carcinoma of the Breast (Stages II-IV)
  • Retinoblastoma (St.Jude Stages II-IV)
  • Malignant neoplasms of the lung
What it does

Cyclophosphamide interferes with the growth of cancer cells by slowing their growth and spread in the body. Cyclophosphamide may also affect the growth of normal body cells. This could lead to undesirable side effects.

When it should not be used

PROCYTOX should not be used if you have:

  • allergy to Cyclophosphamide
  • obstruction to urine flow manifested as difficulty with urination
  • severe suppression of bone marrow function
  • severe kidney problems
  • severe liver problems
  • active infection/suppressed immune system
What the medicinal ingredient is

Cyclophosphamide

What the non-medicinal ingredients are

Tablets: Calcium carbonate, Dibasic Calcium phosphate, Cellulose, Gelatin, Glycerin, Lactose, Magnesium stearate, Polyethylene glycol, Polysorbate, Povidone, Silicon dioxide, Starch (Corn), Sucrose, Talc, Titanium dioxide, Wax.
Injection: There are no nonmedicinal ingredients

What dosage form it comes in

PROCYTOX is available as a sterile powder for injection supplied in 20 mL, 50 mL, 75 mL, and 100 mL vials. It is also available as 25 mg and 50 mg tablets.

Warnings and precautions

Serious Warnings and Precautions

PROCYTOX should only be used under supervision of a doctor who is experienced in the use of anti-cancer drugs. Serious side effects that may occur with PROCYTOX include:

  • Causing other types of cancers with long term use;
  • Cardiac toxicity;
  • Severe QT/QTc prolongation (disturbances in heart rhythm);
  • Lung injury;
  • Liver injury;
  • Increased kidney and bladder injury;
  • Serious allergic reaction;
  • Vaccine induced infection when used in patients who have received live-vaccine
PROCYTOX can affect depolarizing muscle relaxants such as succinylcholine.
PROCYTOX should not be given to patients with low white blood cell and platelet count.

BEFORE you use PROCYTOX talk to your doctor or pharmacist if:

  • You have any of the following conditions:
    • Previously received radiation therapy;
    • QT/QTc prolongation or family history of QT/QTc prolongation;
    • Electrolyte problems or conditions that could lead to electrolyte disturbances;
    • Cancer that has spread to the brain;
    • Low white blood cell count;
    • Low platelet count;
    • Low red blood cell count;
    • Cancer that has spread to the bone marrow;
    • Liver problems;
    • Kidney problems;
    • Difficulty urinating:
    • Cystitis (bladder infection);
    • Active infections;
    • Abnormal serum creatinine;
  • You have had surgery in the previous 10 days, or have any upcoming surgery, including dental surgery; PROCYTOX may prevent normal wound healing.
  • You are going to receive any vaccine.
  • You are pregnant or likely to become pregnant or are nursing a baby.
  • You are male and are likely to father a child.
  • You have any allergies to this drug or its ingredients, including lactose or have lactose intolerance. PROCYTOX tablet contains lactose.
  • PROCYTOX is not recommended for use in patients under 16 years of age.
  • PROCYTOX may cause harm to an unborn baby. Female patients should use an effective birth control method while using PROCYTOX. Male patients should not father a child while using PROCYTOX and for at least 6 months after the last dose of PROCYTOX.
  • PROCYTOX may cause sterility in both male and female patients.
  • Do not breast feed while taking PROCYTOX, the drug can get into the breast milk, and therefore, into the baby.
Interactions with this medication

Before and while taking PROCYTOX you should tell your doctor or pharmacist about your other prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. This list shows some of the drugs (and their common use) and some procedures that may interact with PROCYTOX. Many medications may interact with PROCYTOX, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

  • Alcohol
  • Antibiotics (eg. ciprofloxacin, metronidazole, rifampin, chloramphenicol, sulfonamides)
  • Anticoagulants such as warfarin (Coumadin)
  • Antidepressants (eg. St. John’s wort, bupropion)
  • Anti-fungals (fluconazole, itraconazole)
  • Cimetidine (for acid reduction)
  • Corticosteroids such as prednisone
  • Medications to aid in the management of selected chronic alcohol patients (disulfiram)
  • Medications to treat rheumatoid arthritis (etanercept, indomethacin)
  • Lovastatin (for high cholesterol)
  • Medications to treat gout (allopurinol)
  • Medications to treat seizures (eg. phenytoin, carbamazepine, phenobarbital)
  • Medications to treat high blood pressure such as ACE inhibitors and thiazide diuretics (e.g. hydrochlorothiazide)
  • Medications to treat heart problems and abnormal heart rhythm (eg. amiodarone, digoxin, prasugrel, verapamil)
  • Medications to prevent vomiting (eg. aprepitant, ondansetron)
  • Medications to stimulate the bone marrow (eg. G-CSF, GM-CSF)
  • Medications to treat cancers (e.g. busulfan, tamoxifen)
  • Medications that modulate immune system (eg. cyclosporine, azathioprine, methotrexate)
  • Sedatives (eg. chloral hydrate, benzodiazepines)
  • Medications to treat diabetes (sulfonylureas)
  • Medications to treat HIV (protease inhibitors, zidovudine)
  • Vaccines, especially live-vaccines
  • Previous irradiation of the cardiac region
Proper use of this medication

Your doctor will determine what dose of PROCYTOX is right for you and how often you should receive it. PROCYTOX tablet is to be taken by mouth.
PROCYTOX injection is to be given into the vein. It is important to drink extra fluids to help prevent kidney and bladder problems.
Do not eat grapefruit or drink grapefruit juice while taking PROCYTOX.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you miss your scheduled treatment, contact your doctor or nurse as soon as possible to schedule your next treatment.

Side effects and what to do about them

Cyclophosphamide can sometimes cause side effects such as blood problems, loss of hair, and problems with the bladder. Also, because of the way the drug acts on the body, there is a chance that it might cause other unwanted effects that may not occur until months or years later. These may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and talk with your doctor or pharmacist
Common
Anemia   ✔  
Blood in Urine   ✔  
Central Nervous System Troubles*   ✔  
Fever or fever with low white cell count   ✔  
Infection   ✔  
Kidney problems   ✔  
Liver problems   ✔  
Loss of Appetite   ✔  
Loss of Hair ✔    
Low platelet count   ✔  
Low white cell count   ✔  
Nausea/ Vomiting   ✔  
Urinary problems   ✔  
Vein inflammation   ✔  
Uncommon
Diarrhea   ✔  
Fatigue ✔    
Heart troubles   ✔  
Low blood pressure   ✔  
Malaise ✔    
Mouth inflammation   ✔  
Papular rash   ✔  
Peripheral neuropathy**   ✔  
Skin inflammation   ✔  

* For example Dizziness, Confusion, Convulsions, Headache ** For example, numbness of the hands and feet.

This is not a complete list of side effects. For any unexpected effects while taking PROCYTOX, contact your doctor or pharmacist.

How to store

Store at temperature 15 oC – 25 o C. Protect from direct light.

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

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, Baxter Corporation, at:

1-800-387-8399

This leaflet was prepared by Baxter Corporation.

Last revised: September 7, 2012

Date modified: