Consumer Information for: GANCICLOVIR FOR INJECTION

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for
  • Ganciclovir for Injection is a prescription medication that belongs to the family of drugs known as “antivirals”
  • Ganciclovir for Injection is used to treat cytomegalovirus (CMV) retinitis in people who have acquired immunodeficiency syndrome (AIDS) or in patients undergoing chemotherapy.
  • Ganciclovir for Injection is also used to prevent cytomegalovirus (CMV) disease in people who have received a solid organ transplant and are at risk of developing CMV disease.
What it does
  • Ganciclovir for Injection works by slowing the growth of CMV virus, the virus that causes CMV retinitis as well as CMV infection at other sites in the body. For most people with CMV retinitis, Ganciclovir for Injection prevents CMV from progressing (spreading) into healthy cells as quickly as it would without treatment, thereby protecting eyesight from damage due to CMV disease.
  • Ganciclovir for Injection does not cure CMV retinitis, and some people may experience progression of retinitis during or following treatment with Ganciclovir for Injection. Therefore, you must follow your doctor’s advice and have your eyes checked regularly.
When it should not be used

Do not take Ganciclovir for Injection if you have ever had a serious reaction to ganciclovir or valganciclovir. Known hypersensitivity to acyclovir or its prodrug valacyclovir.

What the medicinal ingredient is

Ganciclovir sodium

What the non-medicinal ingredients are
What dosage form it comes in

Ganciclovir for Injection is a white to off-white powder in a vial. Each vial contains the equivalent of 500 mg of an active ingredient called ganciclovir. The powder is made up by dissolving it into a liquid for injection.

Warnings and precautions

Serious Warnings and Precautions

  • Serious blood problems can occur such as low numbers of white blood cells, red blood cells or platelets.
  • Tumours have been found in laboratory animals receiving this drug, although at this time there is no similar information from human studies. The drug also has damaging effects on the reproductive system. When used in men, it may decrease the number of sperm in the semen and this may be complete and irreversible. In women, not only may there be suppression of fertility, but pregnancy during treatment is likely to lead to the birth of a malformed child.

BEFORE you use Ganciclovir for Injection talk to your doctor or pharmacist if:

  • You have, or have had low numbers of either white blood cells, red blood cells or platelets in your blood;
  • you are taking acyclovir, valganciclovir or valacyclovir;
  • you have kidney problems;
  • you are receiving hemodialysis;
  • you are taking ANY other medicines (prescription or non-prescription) including herbal or natural products.
  • you or your partner are pregnant, plan on becoming pregnant, or are breast-feeding a child, as Ganciclovir for Injection may cause birth defects in humans and should not be used during pregnancy. If there is any chance that you or your partner could become pregnant, it is very important for you to use effective contraception during and after treatment with Ganciclovir for Injection. For women, this means using barrier protection (condoms) and one additional form of contraception (birth control pills, intrauterine device) during and for at least 30 days after treatment with Ganciclovir for Injection. For men, this means using barrier protection (condoms) during for at least 90 days following treatment with Ganciclovir for Injection, unless it is certain that the female partner is not at risk of pregnancy. Women who are HIV positive should not breast feed because HIV infection can be passed to the baby via the breast milk.

This information will help your doctor and you decide whether you should use Ganciclovir for Injection and what extra care may need to be taken while you are on the medication. You should always consult your doctor or pharmacist before using other medications while on Ganciclovir for Injection.

Interactions with this medication

Tell your doctor or pharmacist about all medications that you are taking, including those you buy over the counter and herbal or natural products. Ganciclovir for Injection may change the effect of other medications.

The following drugs may need to have their dose changed when taken with Ganciclovir for Injection:

  • zidovudine
  • didanosine
  • probenecid
  • cyclosporine
  • mycophenolate mofetil

Imipenem-cilastin - talk to your doctor if you are taking imipenem-cilastin.

Convulsions have occurred in patients taking imipenem-cilastin and ganciclovir. You may discuss different options with your doctor.

Proper use of this medication

Usual Dose

For Treatment of CMV Retinitis
The initial dose is usually 5 milligrams for every kilogram that you weigh (5 mg/kg). The dose may be administered every 12 hours for 14 - 21 days.

For Maintenance Treatment of CMV Retinitis
The dose of 5 mg/kg/day may be administered once per day for 7 days or 6 mg/kg/day for 5 days.

For Prevention of CMV Retinitis in Transplant Patients
The initial dose is usually 5 milligrams for every kilogram that you weigh (5 mg/kg). The dose may be administered every 12 hours for 7 - 14 days.

If your kidney function is less than normal, your doctor may prescribe a different dose.

To assess your treatment, you may need to have regular blood tests.

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.

Side effects and what to do about them

Unwanted effects are possible with all medicines. Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Ganciclovir for Injection.

Common side effects include nausea, diarrhea, upset stomach, abdominal pain, headache, injection site soreness, cough, fever and weight loss. If these become bothersome, contact your doctor.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
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
Common
Blood Problems (see text)   ✔  
Retinal detachment*   ✔  
Serious skin reactions (exfoliative dermatitis)   ✔  

*Your doctor may recommend frequent eye examinations.

Blood problems. Ganciclovir for Injection can cause serious blood cell problems. These include reduced numbers of certain white blood cells (granulocytopenia, neutropenia, or leukopenia), reduced numbers of red blood cells (anemia). Ganciclovir for Injection may also cause increased blood creatinine. Your doctor should recommend that you have blood tests done on a regular basis.

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

How to store

Ganciclovir for Injection Sterile Powder: Store at room temperature (15 °C ‒ 30 °C), avoid excessive heat above 40 °C (104 °F).

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 (http://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

Reminder: This medicine has been prescribed only for you. Do not give it to anybody else. If you have any further questions, please ask your doctor or pharmacist.

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Fresenius Kabi Canada Ltd., at: 1-877-821-7724

This leaflet was prepared by
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8

Last revised: April 30, 2018

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