Consumer medicine information

1. Why am I using Cymevene?

Cymevene contains the active ingredient ganciclovir. Cymevene is used to act against a certain type of herpes virus called cytomegalovirus or CMV. Cymevene is used to control CMV eye infections in AIDS patients, in treatment of CMV lung infections and in prevention of CMV infection and disease in patients following bone marrow or solid organ transplantation.
For more information, see Section 1. Why am I using Cymevene? in the full CMI.

2. What should I know before I use Cymevene?

Do not use if you have ever had an allergic reaction to ganciclovir or any of the ingredients listed at the end of the CMI.
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.
For more information, see Section 2. What should I know before I use Cymevene? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Cymevene and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Cymevene?

• CYMEVENE is added to an infusion bag and given as a 'drip' into a vein, usually over a period of one hour.

• CYMEVENE is usually given once or twice a day at a dose determined by your doctor in consideration of your kidney function and severity of your infection.

5. What should I know while using Cymevene?

6. Are there any side effects?

Many unwanted effects commonly reported in people with HIV appear related to their medical condition. See your doctor regularly so that your CMV disease, blood cell counts and any other potential side effects may be monitored carefully.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Ganciclovir.

2 Qualitative and Quantitative Composition

Each Cymevene vial contains 500 mg of ganciclovir (as ganciclovir sodium 543 mg equivalent to ganciclovir 500 mg and sodium 43 mg (2 mEq) ganciclovir sodium).
After reconstitution with 10 mL of water for injections, each mL provides 50 mg of ganciclovir.
There are no excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Sterile lyophilised powder for intravenous infusion.
Ganciclovir, when formulated as monosodium salt in the intravenous (IV) dosage form, is a white to off-white lyophilised powder. The lyophilised powder has an aqueous solubility of greater than 50 mg/mL at 25°C. At physiological pH, ganciclovir sodium exists as the un-ionized form.

4 Clinical Particulars

4.9 Overdose

Toxic manifestations seen in animals given very high single IV doses of Cymevene (500 mg/kg) included emesis, hypersalivation, anorexia, bloody diarrhoea, inactivity, cytopenia, elevated liver function test results, elevated serum urea, testicular atrophy, and death.
Reports of overdoses with IV ganciclovir, some with fatal outcomes, have been received from clinical trials and during post-marketing experience. In some of these cases no adverse events were reported. The majority of patients experienced one or more of the following adverse events.
Haematological toxicity. Myelosuppression including pancytopenia, bone marrow failure, leukopenia, neutropenia, granulocytopenia.
Hepatotoxicity. Hepatitis, liver function disorder.
Renal toxicity. Worsening of haematuria in a patient with pre-existing renal impairment, acute renal failure, elevated creatinine.
Gastrointestinal toxicity. Abdominal pain, diarrhoea, vomiting.
Neurotoxicity. Generalised tremor, seizure.
In patients who have received an overdose of Cymevene, dialysis and hydration may be of benefit in reducing drug plasma levels. The use of haematopoietic growth factors should be considered.
Treatment of overdose should consist of general supportive measures.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Carcinogenicity. In animal studies ganciclovir was found to be mutagenic, teratogenic, aspermatogenic and carcinogenic. Cymevene should therefore be considered a potential teratogen and carcinogen in humans with the potential to cause birth defects and cancers. It is also considered likely that Cymevene causes temporary or permanent inhibition of spermatogenesis (see Section 4.6 Fertility, Pregnancy and Lactation; Section 4.8 Adverse Effects (Undesirable Effects)).
In an 18 month study, ganciclovir was carcinogenic in the mouse after oral doses of 20 mg/kg/day and 1000 mg/kg/day. All ganciclovir induced tumours were of epithelial or vascular origin, except for histiocytic sarcoma of the liver. Epithelial tumours involved a wide variety of tissues. No carcinogenic effects occurred at 1 mg/kg/day. Based on data on plasma drug concentrations, exposure of humans to ganciclovir would be greater than exposure of mice in the above study at 20 mg/kg. Thus, Cymevene should be considered a potential carcinogen in humans.
Genotoxicity. Ganciclovir caused point mutations and chromosomal damage in mammalian cells in vitro and in vivo. Ganciclovir was clastogenic in the mouse micronucleus assay. Ganciclovir was not mutagenic in the Ames Salmonella assay.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Ganciclovir is a synthetic nucleoside analogue of guanine. Its chemical name is 9-(1,3-dihydroxy-2-propoxymethyl) guanine. Ganciclovir has also been referred to as DHPG. Ganciclovir has a molecular formula of C₉H₁₃N₅O₄ and a molecular weight of 255.2.
Ganciclovir is a polar hydrophilic compound with a solubility of 2.6 mg/mL in water at 25°C (Hydrated Phase II polymorph) and an n-octanol/water partition coefficient of 0.022. The solubility of ganciclovir is independent of the crystalline phase composition. Ganciclovir has two dissociation constants: pKa₁ = 2.2 and pKa₂ = 9.4.
CAS number. 82410-32-0.

7 Medicine Schedule (Poisons Standard)

Schedule 4. Prescription Only Medicine.

Summary Table of Changes

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