Details for: CYTOVENE
Company: CHEPLAPHARM ARZNEIMITTEL GMBH
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02162695 | CYTOVENE | GANCICLOVIR (GANCICLOVIR SODIUM) | 500 MG / VIAL | POWDER FOR SOLUTION | INTRAVENOUS |
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
- 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 nonmedicinal 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 form 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
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 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.
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.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| 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
CYTOVENE Sterile Powder: Store at room temperature (15-30°C), avoid excessive heat above 40°C (104°F).
Reporting 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:
- 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 (hc-sc.gc.ca/index-eng.php) or by calling 1-855 788-3153.
This leaflet was prepared by CHEPLAPHARM Arzneimittel GmbH
Last revised: July 20, 2018
© Copyright 1999 – 2018, CHEPLAPHARM Arzneimittel GmbH
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