Cyclophosphamide for Injection USP (Marcan Pharmaceuticals): Uses, Side Effects and Dosage

WARNINGS AND PRECAUTIONS

PART III: CONSUMER INFORMATION

^Pr Cyclophosphamide for Injection USP

This leaflet is part III of a three-part "Product Monograph" published when Cyclophosphamide for Injection USP was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about Cyclophosphamide for Injection USP. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for:

Cyclophosphamide for Injection USP (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:

Cyclophosphamide for Injection USP 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

There are no nonmedicinal ingredients

What dosage forms it comes in:

Cyclophosphamide for Injection USP is available as a sterile powder for injection supplied in 50 mL and 100 mL vials.

BEFORE you use Cyclophosphamide for Injection USP 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; Cyclophosphamide for Injection USP 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.
• Cyclophosphamide for Injection USP is not recommended for use in patients under 16 years of age.

• Cyclophosphamide for Injection USP may cause

  Serious Warnings and Precautions Cyclophosphamide for Injection USP 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 Cyclophosphamide for Injection USP 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

Cyclophosphamide for Injection USP can affect depolarizing muscle relaxants such as succinylcholine.

Cyclophosphamide for Injection USP should not be given to patients with low white blood cell and platelet count.

ABOUT THIS MEDICATION

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• harm to an unborn baby. Female patients should use an effective birth control method while using Cyclophosphamide for Injection USP. Male patients should not father a child while using Cyclophosphamide for Injection USP and for at least 6 months after the last dose of Cyclophosphamide for Injection USP.
• Cyclophosphamide for Injection USP may cause sterility in both male and female patients.
• Do not breast feed while taking Cyclophosphamide for Injection USP, the drug can get into the breast milk, and therefore, into the baby.

Before and while taking Cyclophosphamide for Injection USP 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 Cyclophosphamide for Injection USP. Many medications may interact with Cyclophosphamide for Injection USP, 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

Your doctor will determine what dose of Cyclophosphamide for Injection USP is right for you and how often you should receive it.

Cyclophosphamide for Injection USP is to be given into the vein.

It is important to drink extra fluids to help prevent kidney and bladder problems.

Overdose:

Missed Dose:

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

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.

INTERACTIONS WITH THIS MEDICATION

PROPER USE OF THIS MEDICATION

If you think you, or a person you are caring for, have taken too much Cyclophosphamide for Injection USP, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

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SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM

* 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 Cyclophosphamide for Injection USP, contact your doctor or pharmacist.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice

Store at temperature 15°C - 25°C. Protect from light.

MORE INFORMATION

If you want more information about Cyclophosphamide for Injection USP:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html);

  Marcan Pharmaceuticals website www.marcanpharma.com or by calling 1-855-627-2261.

Marcan Pharmaceuticals Inc.

2 Gurdwara Road, Suite # 112

Ottawa, Ontario

Canada K2E1A2

Last revised: AUG 18, 2025

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