Ganciclovir

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• Prevention and treatment of life-threatening or sight-threatening cytomegalovirus disease (CMV) in immunocompromised patients and prevention of CMV disease in transplant recipients

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Elderly
• Children
• Haematological cytopenia
• Patients receiving radiotherapy
• Blood dyscrasias 
• Patients on low sodium diet
• Women of childbearing potential 
• Cross-hypersensitivity to other antivirals

Forms avail. in SA and covered in this monograph: inj

Infections caused by: Cytomegalovirus

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

Cytomegalovirus in immunocompromised patients

• IV: 5mg/kg, 12hrly, infused over 1hr; Treatment duration: 14 days
  Refer to cytomegalovirus: STG, Adult 2019

Cytomegalovirus retinitis

• Intravitreal (inj): 2mg, once a week
  Refer to retinitis, HIV CMV: STG, Adult 2019

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See additional prescribing points

Paed. forms avail. in SA and covered in this monograph: inj

Infections caused by: Cytomegalovirus

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

Cytomegalovirus in immunocompromised patients (additional agent required)
- Pneumonia and biopsy-proven gastrointestinal disease
- Central nervous system disease

• IV: 5mg/kg, infused over 1hr, 12hrly; Treatment duration: 7 days
  Refer to cytomegalovirus (CMV) Infection: STG, Paed. 2017

Pneumonia with confirmed cytomegalovirus disease
- In immunocompromised patients

• IV: 5mg/kg, 12hrly until oral treatment is tolerated
  Refer to pneumonia in HIV exposed or infected children: STG, Paed. 2017

Cytomegalovirus retinitis

• Intravitreal (inj): 2mg, once a week
  Refer to cytomegalovirus (CMV) infection retinitis: STG, Paed. 2017

Symptomatic congenital cytomegalovirus infections
- Unable to tolerate oral treatment

• IV: 5mg/kg, infused over 1hr, 12hrly, until able to tolerate oral treatment
  Refer to cytomegalovirus (CMV) Infection: STG, Paed. 2017

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See additional prescribing points

Pregnancy

• Caution
• The safety of ganciclovir for use in pregnant women has not been established. However, ganciclovir readily diffuses across the human placenta. In animals studies ganciclovir was associated with reproductive toxicity and teratogenicity. Therefore, ganciclovir should not be used in pregnant women unless the clinical need for treatment of the woman outweighs the potential teratogenic risk to the foetus
• Contraception in males and females: As a result of the potential for reproductive toxicity and teratogenicity, women of childbearing potential must be advised to use effective contraception during and for at least 30 days after treatment. Male patients must be advised to practice barrier contraception during and for at least 90 days following treatment with ganciclovir unless it is certain that the female partner is not at risk of pregnancy

Breastfeeding

• Caution; not recommended
• It is unknown if ganciclovir is excreted in human breast milk, but the possibility of ganciclovir being excreted in breast milk and causing serious adverse reactions in the breastfed infant cannot be excluded. Animal data indicate that ganciclovir is excreted in the milk of lactating rats. Therefore, breastfeeding must be discontinued during treatment with ganciclovir

Renal Impairment

• Caution; dose adjustment recommended

CrCl (ml/min)	Induction dose	Adult and paediatric maintenance doses
>70	No adjustment necessary	No adjustment necessary
50-69	2.5mg/kg every 12hrs	2.5mg/kg daily
25-49	2.5mg/kg daily	1.25mg/kg daily
10-24	1.25mg/kg daily	0.625mg/kg daily
<10	1.25mg/kg, 3 times/week	0.625mg/kg, 3 times/week

Hepatic Impairment

• No dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Insomnia
• Hypoaesthesia
• Paraesthesia
• Peripheral neuropathy
• Convulsion
• Dizziness
• Tremor
• Depression
• Anxiety
• Confusion
• Agitation
• Psychotic disorder
• Hallucinations
• Malaise

Cardiovascular Disorders

• Cardiac arrhythmias
• Hypotension

Respiratory Disorders

• Dyspnoea
• Cough

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting 
• Abdominal pain
• Constipation
• Flatulence
• Dysphagia
• Dyspepsia
• Abdominal distention
• Mouth ulceration
• Pancreatitis

Hepatobiliary Disorders

• Increased blood alkaline phosphatase 
• Increased aspartate aminotransferase
• Increased alanine aminotransferase 

Genitourinary Disorders

• Decreased creatinine clearance 
• Renal impairment
• Haematuria
• Renal failure
• Male infertility

Endocrine and Metabolic Disorders

• Decreased appetite
• Anorexia
• Decreased weight 

Musculoskeletal Disorders

• Back pain
• Myalgia
• Arthralgia
• Muscle spasms

Skin and Subcutaneous Tissue Disorders

• Dermatitis
• Night sweats
• Pruritus
• Alopecia
• Urticaria
• Dry skin
• Rash

Immune, Blood and Lymphatic System Disorders

• Sepsis
• Cellulitis
• Urinary tract infection
• Candida infections 
• Neutropenia
• Anaemia
• Thrombocytopenia
• Leucopenia
• Pancytopenia
• Bone marrow failure
• Agranulocytosis
• Aplastic anaemia
• Granulocytopenia
• Anaphylactic reaction

Sensory Disorders

• Macular oedema
• Dysgeusia
• Retinal detachment
• Vitreous floaters
• Eye pain
• Visual impairment
• Conjunctivitis
• Ear pain
• Deafness

• Probenecid
• Didanosine
• Imipenem
• Myelosupressive agents
• Agents associated with renal impairment 
• Zidovudine

None routine. Specific cases may require

• Renal function
• Full blood count 

Administration directions

• IV infusion: Reconsitute with 10ml water for injection; Add appropriate dose of reconstituted solution to diluent (final concentration should be <10mg/ml); Infusion rate: infuse over 1 hour; Suitable diluents: sodium chloride, 5% dextrose or ringer's lactate
• DO NOT administer as IM or IV bolus

Ganciclovir inhibits replication of herpes viruses. In cytomegalovirus (CMV) infected cells, ganciclovir is phosphorylated. The virustatic activity of ganciclovir is a result of the inhibition of viral DNA synthesis by: (1) competitive inhibition of incorporation of deoxyguanosine triphosphate into DNA by DNA polymerase, and (2) incorporation of ganciclovir triphosphate into viral DNA, causing termination of, or very limited, viral DNA elongation.

Spectrum of activity: Cytomegalovirus

Injection (per vial) 500mg

• Cymevene (Roche) originator