Details for: MAR-CIDOFOVIR
Company: MARCAN PHARMACEUTICALS INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02473925 | MAR-CIDOFOVIR | CIDOFOVIR (CIDOFOVIR DIHYDRATE) | 375 MG / 5 ML | SOLUTION | INTRAVENOUS |
Summary Reports
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
Mar-Cidofovir is used to treat an eye infection called CMV (cytomegalovirus) retinitis in patients with
AIDS (Acquired Immunodeficiency Syndrome).
CMV retinitis is an eye infection caused by a virus. CMV attacks the retina of the eye and may cause loss
of vision, and eventually lead to blindness. Patients with AIDS are at high risk of developing CMV
retinitis. Treatment for CMV retinitis is necessary to reduce the potential for blindness.
Mar-Cidofovir will not cure CMV retinitis but may improve your condition by delaying progression of
the disease.
What it does
Mar-Cidofovir is an antiviral medicine. It stops CMV from multiplying.
When it should not be used
- you ever had kidney disease.
- you are currently taking other medicine that can harm your kidneys.
- you are allergic to cidofovir or any other ingredients of this medicine. See “What are the ingredients in Mar-Cidofovir, above.
- you cannot take probenecid because of a serious allergy to probenecid or to other sulphacontaining medications.
What the medicinal ingredient is
cidofovir as the dehydrat
What the non-medicinal ingredients are
water for injection, sodium hydroxide, hydrochloric acid.
What dosage form it comes in
Solution for Injection 75 mg /mL (375 mg / Vial).
Warnings and precautions
Serious Warnings and Precautions
- Mar-Cidofovir may cause problems with your kidneys. Talk to your doctor if you suspect that you are having kidney issues. See “Serious side effects and what to do about them”, below.
- To avoid serious or fatal kidney problems, you will be given Probenecid and fluids with each dose of Mar-Cidofovir. See “How to take Mar-Cidofovir”, below.
- Your doctor will request blood and urine tests before each dose of Mar-Cidofovir.
- You should not take Mar-Cidofovir if you are taking any other medicines that may cause kidney problems. Talk to your healthcare professional about any other medicines that you are taking.
- Mar-Cidofovir may affect your blood cell count. Your doctor will order blood tests to monitor this.
- Mar-Cidofovir should only be used to treat CMV Retinitis (cytomegalovirus) if you have AIDS (Acquired Immunodeficiency Syndrome). See “What is Mar-Cidofovir used for?”, below.
- Mar-Cidofovir may cause cancer, birth defects or infertility. Talk to your doctor if you plan to have children.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Mar-Cidofovir. Talk about any health conditions or problems you may have, including if you:
- Are pregnant or planning to become pregnant. Mar-Cidofovir may cause birth defects. Tell your doctor if you become pregnant while taking Mar-Cidofovir.
- Are breastfeeding or plan to breastfeed. It is not known if Mar-Cidofovir passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take Mar- Cidofovir.
Other warnings you should know about:
Male Patients
Using Mar-Cidofovir may cause birth defects or infertility. Talk your doctor if you are expecting
a child or plan to have children. Male patients should practice barrier contraceptive methods
(condom) while taking Mar-Cidofovir and for 3 months afterwards.
Eyesight
Mar-Cidofovir may affect your eyesight. Be sure to schedule regular eye exams while taking
Mar-Cidofovir.
Kidney Health
Mar-Cidofovir may cause kidney problems. Your doctor may ask for blood and urine tests to
monitor your kidney health. This will help your doctor determine your dose.
Tell your healthcare professional about all the medicines you take, including any drugs,
vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
- paracetamol
- acyclovir
- angiotensin-converting enzyme inhibitors
- aminosalicylic acid
- barbiturates
- benzodiazepines
- bumetanide
- clofibrate
- methotrexate
- famotidine
- furosemide,
- nonsteroidal anti-inflammatory agents
- theophylline
- zidovudine
Proper use of this medication
How to take Mar-Cidofovir
Mar-Cidofovir will be given by a healthcare professional. To reduce possible kidney damage, you
will be given another medicine called probenecid with each dose.
Be sure to eat food and drink lots of fluids on days that you receive Mar-Cidofovir.
Your doctor may prescribe other medication to help manage the side effects of your treatment.
Usual dose
Your doctor will determine how much Mar-Cidofovir to give you based on your test results and body
weight.
You will receive Mar-Cidofovir once weekly for the first two weeks and once every 2 weeks afterwards.
Overdose
Side effects and what to do about them
The most common side effects of Cidofovir include:
- Lack of energy
If any of these side effects affect you severely, please tell your doctor or pharmacist immediately.
| Symptom/effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| VERY COMMON | |||
| Rash, weakness/fatigue, fever, hair loss, nausea, vomiting, headache | ✔ | ||
| changes in blood or urine tests results | ✔ | ||
| COMMON | |||
| diarrhea and chills. | ✔ | ||
| Any pain, redness or itching of the eye or changes in your vision, reduced pressure in the eyes, difficult or laboured breathing, shortness of breath, inflammation of the pancreas and hearing impairment | ✔ | ||
| Kidney problems which may include symptoms such as: changes in urine output or colour, blood in the urine, weight gain (from retaining fluid), confusion, swelling of the eyes, hands, legs, and feet. | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
The storage condition recommended for Mar-Cidofovir injection 75 mg/ml is “Store at 15°-
25°C (59° - 77°F).”
Keep out of reach and sight of children.
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 (www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) 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.
More information
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website www.marcanpharma.com, or by calling 1-855-627-2261 .
This leaflet was prepared by
Marcan Pharmaceuticals Inc. 77 Auriga Drive, Unit # 4, Ottawa, Ontario, K2E 7Z7.
Last Revised <13-03-2018>