Cymevene®

Cymevene®

Active ingredient(s): ganciclovir

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Consumer Medicine Information (CMI)

This leaflet provides important information about using Cymevene. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Cymevene.

Where to find information in this leaflet:

1. Why am I using Cymevene?
2. What should I know before I use Cymevene?
3. What if I am taking other medicines?
4. How do I use Cymevene?
5. What should I know while using Cymevene?
6. Are there any side effects?
7. Product details

1. Why am I using Cymevene?

Cymevene contains the active ingredient ganciclovir. Cymevene belongs to a class of medicines used to treat viral infections. It works by stopping certain viruses from growing in the body.

CYMEVENE acts against a certain type of herpes virus called cytomegalovirus or CMV. CMV causes infections mainly in people with poor immunity. Poor immunity can be caused by HIV/AIDS or some transplant medications.

Cymevene is used to control CMV eye infections in AIDS patients and in other patients who have poor immunity, which if left untreated can cause blindness

CYMEVENE is not a cure for CMV eye infections and is not effective against any underlying HIV-infection.

CYMEVENE may also be used to treat CMV lung infections in bone marrow transplant patients or in prevention of CMV infection and disease in patients following bone marrow or solid organ transplantation.

Ask your doctor if you have any questions about why CYMEVENE has been prescribed for you.

Your doctor, however, may have prescribed CYMEVENE for another purpose.

CYMEVENE is not addictive.

This medicine is available only with a doctor’s prescription

2. What should I know before I use Cymevene?

Warnings

Animal and other laboratory studies have shown CYMEVENE has caused infertility, birth defects and cancer. It is possible that these effects may also occur in humans.

Do not use Cymevene if:

• you are allergic to ganciclovir, or any of the ingredients listed at the end of this leaflet.
• Always check the ingredients to make sure you can use this medicine.
• you have had an allergic reaction to CYMEVENE or Vitrasert^® implant, or other drugs from the same family: valganciclovir (Valcyte^®); aciclovir (e.g. Zovirax^®, Acyclo-V^®, Acihexal^®, Lovir^® or Zyclir^®); valaciclovir (e.g. Valtrex^®, Zelitrex^®, Xerebid^®, Valnir^®)
  Some of the symptoms of an allergic reaction may include: shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin.
• you have very low blood counts for platelets (which help clotting) or neutrophils (a type of white blood cell which defends against infection) or haemoglobin (a substance that carries oxygen in the blood)
• you are pregnant.
• you are breast-feeding or intend to breast-feed.
• the package is torn or shows signs of tampering
• the expiry date (EXP) printed on the pack has passed.
  If you take this medicine after the expiry date has passed, it may not work as well.

Check with your doctor if you:

• have any other medical conditions including:
• a history of low blood counts for platelets (thrombocytopenia), neutrophils (neutropenia) or red blood cells/haemoglobin (anaemia)
• you have or previously have had poor kidney function
• are less than 12 years of age.

There is very little information available on the use of CYMEVENE in children less than 12 years and safety and effectiveness in children has not been proven. Children that take CYMEVENE, when grown-up, have an increased risk of cancer and, also, adverse effects when trying to have children of their own. Therefore, CYMEVENE should only be used if these risks are outweighed by the benefits of treatment.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Your baby may absorb this medicine in the womb and therefore there is a high likelihood of harm to the baby.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

CYMEVENE may pass into breast milk and therefore there is a possibility that the breast-fed baby may be affected.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with CYMEVENE. These medicines include:

• probenecid (e.g. Benemid^®)
• zidovudine (AZT, Retrovir^®, Combivir^®)
• didanosine (ddI or Videx^®)
• imipenem/cilastatin (Primaxin^®)
• medicines for the treatment of cancer
• other medicines for the treatment of HIV or HIV-related infections
• mycophenolate mofetil (CellCept^®), a medicine used to prevent rejection of transplanted organs
• other medicines used to prevent rejection of transplanted organs

These medicines may be affected by CYMEVENE, or may affect how well it works. You may need to receive different amounts of your medicine, or you may need to receive different medicines. Your doctor will advise you.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Cymevene.

4. How do I use Cymevene?

How Cymevene is given

• CYMEVENE is added to an infusion bag and given as a ‘drip’ into a vein, usually over a period of one hour.
• Your doctor will decide what dose of CYMEVENE you will receive. This depends on how serious your infection is as well as your kidney function.

When Cymevene is given

• CYMEVENE is usually given once or twice a day.

If you have been given too much Cymevene

If you think that you have been too much Cymevene, you may need urgent medical attention especially if you develop serious side effects listed in section 6.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Cymevene?

Things you should do

Call your doctor straight away if you:

• if you become pregnant while receiving CYMEVENE
• develop any of the serious side effects listed in section 6.

Remind any doctor, dentist or pharmacist you visit that you are using Cymevene.

If you are a sexually active woman or man

• If you are a sexually active man, you should use condoms during and for at least 90 days following treatment with CYMEVENE unless it is certain that your female partner is not at risk of pregnancy.
• If you are a woman who could become pregnant and you are not using contraception, you must use a reliable form of contraception during CYMEVENE therapy, and for at least 30 days after stopping CYMEVENE, unless you are not sexually active.

Things you should not do

• Do not take any other medicines whether they require a prescription or not, without first telling your doctor or consulting a pharmacist.

You must see your doctor regularly

• See your doctor regularly so that your CMV disease, blood cell counts, and any other potential side effects may be monitored carefully.

If blood cell counts are low then this may reduce your ability to fight infection, or for your blood to clot efficiently. If left undetected these effects on blood cells may contribute to death or serious illness.

• If you have a CMV eye infection, you must also see your doctor regularly to monitor the condition of your retina (part of the eye).

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Cymevene affects you.

Cymevene may cause dizziness, confusion or seizures (fits) in some people and therefore may affect alertness. Make sure you know how you react to CYMEVENE before you drive a car or operate machinery or do anything else that could be dangerous if you are drowsy, dizzy or not alert.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

• CYMEVENE vials and infusion bags will be stored in the pharmacy or on the ward.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects	What to do
pain loss of feeling or tingling itching skin rash difficulty in swallowing cough nervousness or feeling anxious confusion headache fluid buildup indigestion shortness of breath	Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

a deterioration or worsening of your eyesight even if you are receiving CYMEVENE bruising or purple spots any sign of infection such as fever, chills, sore throat or mouth ulcers rapid or irregular heartbeat or sudden fevers tiredness severe allergic reactions causing swelling, rash or itching severe blisters and bleeding in the lips eyes, mouth, nose and genitals pain or inflammation in your chest, stomach or intestines bleeding (haemorrhage) collapse, numbness or weakness of the arms or legs, headache, dizziness and confusion, visual disturbance, difficulty swallowing, slurred speech and loss of speech pain, swelling or joint stiffness seizures (fits) change in the amount of urine you pass

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Many unwanted effects commonly reported in people with HIV appear to be related to their medical condition. The following list are unwanted effects seen in people receiving intravenous CYMEVENE which may or may not be caused by their medication.

Side effects related to existing medical conditions

Side effects which may or may not be caused by Cymevene	What to do
low white blood cell counts anaemia (low red blood cell counts) diarrhoea nausea and/or vomiting feeling of weakness weight loss low blood platelet count other infections injection site soreness or redness.	Maintain regular doctor visits for monitoring of your medical condition especially during treatment with CYVEMENE.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What Cymevene contains

Active ingredient (main ingredient)	Ganciclovir Each 10 mL CYMEVENE vial contains: 543 mg of ganciclovir sodium equivalent to 500 mg of ganciclovir
Other ingredients (inactive ingredients)	There are no other ingredients in CYMEVENE vials
Potential allergens	CYMEVENE does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes

Do not take this medicine if you are allergic to any of these ingredients.

What Cymevene looks like

CYMEVENE is available as a freeze-dried powder in clear glass vials. It will be made up into an infusion bag before being given to you. (Aust R 10047).

Who distributes Cymevene

Pharmaco (Australia) Ltd
Level 13, 465 Victoria Avenue
Chatswood NSW 2067
Australia

This leaflet was prepared in Nov 2022.