Procytox: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

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 important nonmedicinal 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 forms 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 non-prescription 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.

* 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 IT

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

REPORTING SUSPECTED 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 3 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 0701D

  Ottawa, Ontario

  K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ 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

Last revised: September 7, 2012