Ganciclovir for Injection USP (Auro Pharma): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• Ganciclovir for Injection USP is a prescription

  medication that belongs to the family of drugs known as “antivirals”

• Ganciclovir for Injection USP is used to treat

  cytomegalovirus (CMV) retinitis in people who have acquired immunodeficiency syndrome (AIDS) or in patients undergoing chemotherapy.

• Ganciclovir for Injection USP 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 USP if you have ever had a serious reaction to ganciclovir, valganciclovir or to any of the non-medicinal ingredients (see “What the non-medicinal ingredients are”). Known hypersensitivity to acyclovir or its prodrug valacyclovir.

What the medicinal ingredient is:

The medicinal ingredient found in Ganciclovir for Injection USP is ganciclovir sodium.

What the non-medicinal ingredients are:

Sodium Hydroxide 80 mg, Nitrogen (quantity sufficient) and Water for Injection 3.5 mL

What dosage forms it comes in:

Ganciclovir for Injection USP 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 USP 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 nonprescription) 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 USP 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 USP. 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 USP. For men this means using barrier protection (condoms) during and for at least 90 days following treatment with Ganciclovir for Injection USP, unless it is certain that the female partner is not at risk of becoming pregnant. 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 USP 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 USP.

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 USP may change the effect of other medications.

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

• zidovudine
• didanosine
• probenecid
• cyclosporin
• mycophenolate mofetil

Imipenem-cilastin - talk to your doctor if you are taking imipenem-cilastin. Seizures have occurred in patients taking imipenem-cilastin and ganciclovir. You may discuss different options with your doctor.

PROPER USE OF THIS MEDICATION

Usual adult dose:

For Treatment of CMV Retinitis

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

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

If you think you have taken too much Ganciclovir for Injection USP, contact your 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

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 USP.

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.

*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.

Driving and using machines. Ganciclovir for Injection USP can affect your ability to drive or use machines. Avoid driving, using tools or operating machines if you have problems with your vision or other problems that might affect your ability, e.g. if you feel dizzy or tired. Talk to your doctor if you are not sure.

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

HOW TO STORE IT

Lyophilized powder: Store at room temperature 15 to 30°C. Protect from moisture.

Storage conditions for the Reconstituted solution (reconstituted with water for injection): Reconstituted solution in the vial may be stored at 15 to 30°C up to 12 hours and should not be refrigerated.

Storage conditions for Diluted solutions ( diluted with normal saline, dextrose 5% in water, Ringer's injection, lactated Ringer's injection): Stored refrigerated at 2 to 8°C in polyvinyl chloride (PVC) bags, remain physically and chemically stable for 14 days. However, because Ganciclovir for injection is reconstituted with nonbacteriostatic sterile water, it is recommended that the infusion solution be used within 24 hours of dilution to reduce the risk of bacterial contamination. The reconstituted and further diluted solutions should be stored under refrigeration. Freezing is not recommended.

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.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.

MORE INFORMATION

If you want more information about Ganciclovir 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 the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website http:// www.auropharma.ca, or by calling 1-855-648-6681.

Auro Pharma Inc.

3700 Steeles Avenue West, Suite # 402

Woodbridge, Ontario, L4L 8K8,

Canada

Date of Revision: April 20, 2018