Ganciclovir parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Powder for infusion containing ganciclovir.
Drugs List
Therapeutic Indications
Uses
Prevention of CMV disease: Pre-emptive therapy
Prevention of CMV disease: Universal prophylaxis
Treatment of CMV disease in immunocompromised patients
Treatment of Cytomegalovirus (CMV) disease in immunocompromised patients aged 12 years and older.
Prevention of Cytomegalovirus (CMV) disease using pre-emptive therapy in patients with drug-induced immunosuppression in patients aged 12 years and older.
Prevention of Cytomegalovirus (CMV) disease using universal prophylaxis in patients with drug-induced immunosuppression.
Unlicensed Uses
Treatment of congenital cytomegalovirus infection of the CNS in neonates
Congenital Cytomegalovirus (CMV) infection of the CNS in neonates.
Dosage
Adults
Prevention of CMV disease
Universal Prophylaxis
5mg/kg given as an intravenous infusion over one hour, once a day on seven days per week
or
6mg/kg given as an intravenous infusion over one hour, once a day on five days per week.
The duration of prophylaxis should be based on the risk of CMV disease and local treatment guidelines should be consulted.
Pre-emptive therapy
Initial dose: 5mg/kg infused at a constant rate over one hour every 12 hours for seven to fourteen days.
Maintenance therapy: 5mg/kg given as an intravenous infusion over one hour, once daily on seven days per week
or
6mg/kg given as an intravenous infusion over one hour, once a day on five days per week
The duration of maintenance therapy should be based on the risk of CMV disease and local treatment guidelines should be consulted.
Treatment of CMV infection
Initial dose: 5mg/kg infused at a constant rate over one hour every 12 hours for fourteen to twenty one days.
Maintenance dose:
5mg/kg given as an intravenous infusion over one hour once a day on seven days per week.
or
6mg/kg as an intravenous infusion over one hour once a day on five days per week.
Treatment of disease progression Any patient in whom the CMV disease progresses, either while on maintenance treatment or because treatment with ganciclovir has been withdrawn, may be re-treated using the treatment regimen.
Children
Prevention of CMV disease
Universal Prophylaxis
Child 16 to 18 years
(See Dosage; Adult)
Child Birth to 16 years
Dose mg = 3 x Body Surface Area (BSA) x Creatinine Clearance (See Mostellar BSA formula and Schwartz Creatinine Clearance formula)
Prevention of CMV disease
Pre-emptive therapy
Child 12 to 18 years
(See Dosage; Adult)
Note that ganciclovir is unlicensed for the treatment of CMV children under 12 years old.
Treatment of CMV infection
Child 12 to 18 years
Initial dose: 5mg/kg infused at a constant rate over one hour every 12 hours for fourteen to twenty one days.
Maintenance dose:
5mg/kg given as an intravenous infusion over one hour once a day on seven days per week.
or
6mg/kg as an intravenous infusion over one hour once a day on five days per week.
Neonates
Congenital cytomegalovirus infection of the CNS (unlicensed)
6mg/kg every 12 hours by intravenous infusion for six weeks.
Patients with Renal Impairment
For adults and children over 12 years dosed as mg/kg with renal impairment the dose should be modified according to creatinine clearance.
Creatinine clearance greater than or equal to 70ml/minute
Initial dose: 5mg/kg every 12 hours.
Maintenance dose: 5mg/kg/day.
Creatinine clearance 50 to 69ml/minute
Initial dose: 2.5mg/kg every 12 hours
Maintenance dose: 2.5mg/kg/day.
Creatinine clearance 25 to 49ml/minute
Initial dose: 2.5mg/kg daily.
Maintenance dose: 1.25mg/kg/day.
Creatinine clearance 10 to 24ml/minute
Initial dose: 1.25mg/kg daily.
Maintenance dose: 625 microgram/kg/day.
Creatinine clearance less than 10ml/minute
Initial dose: 1.25mg/kg three times a week after haemodialysis.
Maintenance dose: 625 microgram/kg three times a week after haemodialysis.
For children from birth to 16 years of age with renal impairment receiving a prophylactic dose calculated by 3 x BSA x Creatinine Clearance no further adjustment is required.
Administration
For intravenous infusion following reconstitution.
Contraindications
Absolute neutrophil count below 0.5 x 10 to the power of 9 / L
Haemoglobin concentration below 8g / dL
Platelet count below 25 x 10 to the power of 9 / L
Breastfeeding
Pregnancy
Precautions and Warnings
Children under 18 years
Concurrent radiotherapy
Females of childbearing potential
History of cytopenic reaction
Cytopenia
Renal impairment - creatinine clearance below 70ml/min
Reduce dose in patients with renal impairment
Advise ability to drive/operate machinery may be affected by side effects
Concurrent radiotherapy may increase risk of serious adverse effects
Avoid contact of powder with skin and mucous membranes
Avoid contact of prepared solution with skin and mucous membranes
Staff: Not to be handled by pregnant staff
Monitor blood counts regularly
Consider treatment with blood growth factors if severe cytopenias develop
Consider dose interruption if patient develops severe cytopenias
Not licensed for all indications in all age groups
May cause impaired fertility
Female: Contraception required during and for 1 month after treatment
Male: Use barrier contraception during and for 3 months after treatment
Ganciclovir should be used with extreme caution in children and adolescents due to the potential for long term carcinogenicity and reproductive toxicity. The benefits of treatment should outweigh the risks.
Pregnancy and Lactation
Pregnancy
Ganciclovir is contraindicated in pregnancy.
The safety of ganciclovir use in human pregnancy has not been established. Ganciclovir readily diffuses across the human placenta. Ganciclovir should be considered to be teratogenic and carcinogenic in humans, and capable of causing birth defects and cancers.
Animal studies have shown ganciclovir to be embryotoxic, mutagenic, teratogenic, spermatogenic, carcinogenic and a female fertility suppressant. Foetal birth defects included cleft palate, anophthalmia/microphthalmia and aplastic kidneys and pancreas.
It is also likely that a temporary or permanent inhibition of spermatogenesis may occur with treatment.
Schaefer(2015) concludes that inadvertent use during the first trimester, a detailed ultrasound examination should be offered.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Ganciclovir is contraindicated in breastfeeding women.
It is not know if ganciclovir is excreted in human breast milk. Due to the potential adverse effects in the nursing infant, breastfeeding must be discontinued whilst on therapy.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Side Effects
Abdominal distension
Abdominal pain
Abnormal thinking
Abnormal vision
Agitation
Agranulocytosis
Alopecia
Anaemia
Anaphylactic reaction
Anaphylactoid reaction
Anorexia
Anxiety
Aplastic anaemia
Arrhythmias
Arthralgia
Asthenia
Back pain
Bone marrow depression
Candidiasis (mouth or throat)
Cellulitis
Chest pain
Chills
Confusion
Conjunctivitis
Constipation
Convulsions
Cough
Deafness
Decrease in creatinine clearance
Decreased appetite
Depression
Dermatitis
Diarrhoea
Dizziness
Dry skin
Dysgeusia
Dyspepsia
Dysphagia
Dyspnoea
Ear pain
Eye pain
Fatigue
Flatulence
Granulocytopenia
Haematuria
Hallucinations
Headache
Hepatic impairment
Hypersensitivity reactions
Hypoaesthesia
Hypotension
Increase in alkaline phosphatase
Increase in serum ALT/AST
Infertility
Influenza
Injection site reactions
Insomnia
Leucopenia
Macular oedema
Malaise
Mouth ulcers
Muscle spasm
Myalgia
Nausea
Neutropenia
Night sweats
Pain
Pancreatitis
Pancytopenia
Paraesthesia
Peripheral neuropathy
Pruritus
Psychotic reactions
Pyrexia
Rash
Renal failure
Renal impairment
Retinal detachment
Sepsis
Serum creatinine increased
Thrombocytopenia
Tremor
Upper respiratory tract infection
Urinary tract infections
Urticaria
Vitreous disorder
Vomiting
Weight loss
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: July 2018
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Cymevene Powder for Infusion. Roche Products Ltd. Revised May 2018.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 16 July 2018
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.