Patient Medication Information: uses, side effects, how to take - Cytovene

ABOUT THIS MEDICATION

What the medication is used for:

CYTOVENE is a prescription medication that belongs to the family of drugs known as “antivirals”
CYTOVENE is used to treat cytomegalovirus (CMV) retinitis in people who have acquired immunodeficiency syndrome (AIDS) or in patients undergoing chemotherapy.
CYTOVENE 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:

CYTOVENE 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, CYTOVENE prevents CMV from progressing (spreading) into healthy cells as quickly as it would without treatment, thereby protecting eyesight from damage due to CMV disease.
CYTOVENE does not cure CMV retinitis, and some people may experience progression of retinitis during or following treatment with CYTOVENE. Therefore, you must follow your doctor’s advice and have your eyes checked regularly.

When it should not be used:

Do not take CYTOVENE 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:

ganciclovir

What the non-medicinal ingredients are:

hydrochloric acid and sodium hydroxide.

What dosage forms it comes in:

CYTOVENE 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

BEFORE you use CYTOVENE 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 CYTOVENE 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 CYTOVENE. 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 CYTOVENE. For men this means using barrier protection (condoms) during and for at least 90 days following treatment with CYTOVENE, 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 CYTOVENE 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 CYTOVENE.

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.

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. CYTOVENE may change the effect of other medications.

The following drugs may need to have their dose changed when taken with CYTOVENE:

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:

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 CYTOVENE.

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 with your doctor or pharmacist		Stop taking drug and call your doctor or pharmacist
Symptom / effect	Only if severe	In all cases
Common	Blood Problems (see text)		✓
	Retinal detachment*		✓
	Serious skin reactions (exfoliative dermatitis)		✓

*Your doctor may recommend frequent eye examinations.

Blood problems. CYTOVENE 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). CYTOVENE may also cause increased blood creatinine. Your doctor should recommend that you have blood tests done on a regular basis.

Driving and using machines . CYTOVENE 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 CYTOVENE, contact your doctor or pharmacist.

HOW TO STORE IT

CYTOVENE Sterile Powder: Store at room temperature (15-30°C), avoid excessive heat above 40°C (104°F).

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.

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:

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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 19808C
  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

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 found at:

Health Canada website (http://hc-sc.gc.ca/index-eng.php) or by calling 1-855 788-3153.

Last revised: July 20, 2018

CYTOVENE^®is a registered trade-mark of CHEPLAPHARM Arzneimittel GmbH.

All other trade-marks are the property of their respective owners.

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24, 17489 Greifswald, Germany

Rx or OTC	Prescription (Rx)?
DIN	02162695
Schedule(s)	PRESCRIPTION
Active ingredient(s)	Ganciclovir (ganciclovir sodium) 500 MG
Dosage form(s)	Powder For Solution
Route(s) of administration	Intravenous
Drug class (WHO ATC)	J Antiinfectives for systemic use J05 Antivirals for systemic use J05A Direct acting antivirals J05AB Nucleosides and nucleotides excl. reverse transcriptase inhibitors J05AB06 Ganciclovir
Company	CHEPLAPHARM ARZNEIMITTEL GMBH
Current status	Marketed
Current status date	August 9, 2019

Cytovene: Uses, Side Effects and Dosage