Cymevene (Ganciclovir)
Antiviral agent for the treatment and prevention of cytomegalovirus (CMV) infections
Cymevene contains the active substance ganciclovir, a potent antiviral medication used to treat and prevent cytomegalovirus (CMV) infections in immunocompromised patients. It is administered as an intravenous infusion in hospital settings and requires careful monitoring of blood counts throughout the course of treatment. This guide covers indications, dosage, side effects, drug interactions, and important safety information based on current EMA, FDA, and WHO guidelines.
Quick Facts
Key Takeaways
- Cymevene (ganciclovir) is a prescription-only antiviral used to treat and prevent cytomegalovirus (CMV) infections in immunocompromised patients, including organ transplant recipients and those with HIV/AIDS.
- It is administered exclusively by intravenous infusion over at least 1 hour and must never be given as a rapid or bolus injection due to the risk of toxicity from elevated plasma levels.
- Bone marrow suppression (neutropenia, anemia, thrombocytopenia) is the most significant side effect; regular blood count monitoring is mandatory, particularly during the first two weeks of treatment.
- Cymevene is teratogenic and may impair fertility; effective contraception is required during treatment and for 30 days (women) or 90 days (men) after the last dose.
- Multiple drug interactions exist, particularly with other myelosuppressive agents and nephrotoxic drugs; dose adjustment may be needed in patients with impaired kidney function.
What Is Cymevene and What Is It Used For?
Cymevene contains the active substance ganciclovir, a synthetic nucleoside analogue of 2'-deoxyguanosine. It belongs to the class of antiviral medications specifically designed to combat herpes viruses, with particular effectiveness against cytomegalovirus (CMV). Ganciclovir works by inhibiting viral DNA replication: once inside infected cells, it is phosphorylated to its active triphosphate form, which then competitively inhibits viral DNA polymerase and is incorporated into the growing viral DNA chain, causing premature chain termination.
CMV is a member of the herpesvirus family and is extremely common worldwide, with seroprevalence ranging from 40% to over 90% depending on geographic region and socioeconomic factors. In healthy individuals with intact immune systems, CMV infection typically causes no symptoms or only a mild, self-limiting illness resembling mononucleosis. However, the virus remains latent in the body after primary infection and can reactivate when the immune system becomes compromised.
Primary Indications
Cymevene is indicated for the following conditions in adults and adolescents aged 12 years and older:
- Treatment of CMV disease: Including CMV retinitis (infection of the retina that can cause blindness), CMV pneumonitis (lung infection), CMV gastrointestinal disease (esophagitis, colitis), and CMV hepatitis in immunocompromised patients.
- Prevention of CMV disease: In patients undergoing solid organ transplantation or bone marrow transplantation who are at risk of CMV reactivation.
- CMV prophylaxis during chemotherapy: For patients receiving immunosuppressive therapy that places them at elevated risk of CMV reactivation.
In children from birth to 12 years of age, Cymevene may be used for the prevention of CMV disease following organ transplantation or during immunosuppressive treatment, though safety and efficacy data are more limited in this population.
Understanding CMV Disease
Cytomegalovirus can affect virtually any organ system in the body. In immunocompromised patients, the most clinically significant manifestations include CMV retinitis, which if untreated can lead to permanent vision loss. CMV pneumonitis carries a high mortality rate, particularly in bone marrow transplant recipients. Gastrointestinal CMV disease can present as severe esophagitis, gastritis, or colitis with symptoms including painful swallowing, abdominal pain, diarrhea, and gastrointestinal bleeding.
The populations most vulnerable to serious CMV disease include patients with advanced HIV infection (particularly those with CD4 counts below 50 cells/microlitre), solid organ transplant recipients (especially during the first 3-6 months after transplantation when immunosuppression is most intense), haematopoietic stem cell transplant (HSCT) recipients, and patients receiving potent immunosuppressive chemotherapy for malignancies. Early detection and treatment with ganciclovir can be life-saving in these clinical scenarios.
What Should You Know Before Taking Cymevene?
Contraindications
Cymevene must not be used in the following situations:
- Hypersensitivity: Known allergy to ganciclovir, valganciclovir, or any of the excipients in the formulation. Cross-sensitivity may also exist with aciclovir, valaciclovir, penciclovir, and famciclovir, as these drugs share structural similarities.
- Breastfeeding: Ganciclovir is excreted in breast milk and could cause serious adverse effects in the nursing infant. Women must stop breastfeeding before initiating Cymevene therapy.
Cymevene can cause severe bone marrow suppression resulting in dangerously low blood cell counts. Your doctor will perform blood tests before starting treatment and regularly throughout therapy. Seek immediate medical attention if you develop signs of infection (fever, sore throat), unusual bleeding or bruising, or extreme fatigue.
Warnings and Precautions
Discuss the following with your healthcare provider before starting Cymevene treatment:
- History of blood disorders: If you have previously experienced low white blood cell counts (neutropenia), low red blood cell counts (anemia), or low platelet counts (thrombocytopenia) from any cause, particularly drug-induced cytopenias, you may be at higher risk of haematological toxicity with ganciclovir.
- Kidney impairment: Ganciclovir is primarily eliminated through the kidneys. Patients with reduced kidney function require dose adjustments and more frequent blood monitoring to prevent drug accumulation and increased toxicity.
- Cross-allergy with other antivirals: If you have experienced allergic reactions to aciclovir, valaciclovir, penciclovir, or famciclovir, inform your doctor as cross-reactivity may occur.
- Concurrent radiation therapy: The combination of ganciclovir with radiation therapy may increase the risk of bone marrow suppression.
During treatment, your doctor will order regular blood tests to monitor your complete blood count (CBC). During the first two weeks, these tests will be performed frequently (typically every 2-3 days). After this initial period, blood monitoring will continue at less frequent intervals (weekly or every two weeks), depending on your clinical response and blood count stability.
Pregnancy and Breastfeeding
Pregnancy: Cymevene should not be used during pregnancy unless the potential benefit to the mother clearly outweighs the potential risk to the foetus. Animal studies have demonstrated teratogenic effects (birth defects) and embryotoxicity. If ganciclovir is deemed essential, the patient must be fully informed of the potential hazard to the unborn child. If pregnancy occurs during treatment, the patient should contact their doctor immediately.
Women of childbearing potential must use effective contraception during treatment with Cymevene and for at least 30 days after the last dose. Men must use barrier contraception (condoms) during treatment and for at least 90 days after the last dose, as ganciclovir may be present in seminal fluid.
Breastfeeding: Cymevene is contraindicated during breastfeeding. Ganciclovir may pass into breast milk, and the potential for serious adverse reactions in the nursing infant means breastfeeding must be discontinued before starting treatment.
Fertility: Ganciclovir may temporarily or permanently impair male fertility. Animal studies have shown inhibition of spermatogenesis and testicular atrophy at doses comparable to those used in humans. Men who wish to father children in the future should discuss sperm banking with their healthcare provider before starting treatment. The effect on female fertility has not been fully established.
Driving and Operating Machinery
Cymevene may cause side effects that can impair your ability to drive or operate machinery safely. Drowsiness, dizziness, confusion, tremor, ataxia (loss of balance), and seizures have been reported during treatment. If you experience any of these symptoms, do not drive or use heavy machinery until the effects have resolved. Discuss with your healthcare provider if these symptoms persist.
Sodium Content
Each 500 mg vial of Cymevene contains 43 mg of sodium, equivalent to approximately 2% of the WHO recommended maximum daily intake of 2 g sodium for adults. This should be taken into consideration for patients on a controlled sodium diet.
Children and Adolescents
Safety and efficacy data for the treatment of established CMV disease in children under 12 years are limited. For CMV prophylaxis in neonates, infants, and children, Cymevene may be used with careful monitoring, including frequent blood count assessments. Blood disorders (particularly neutropenia and thrombocytopenia) appear to be more common in paediatric populations, especially in neonates and infants. The dose in children may be calculated based on body weight or body surface area, and kidney function must be carefully assessed.
How Does Cymevene Interact with Other Drugs?
Ganciclovir undergoes minimal hepatic metabolism and is primarily excreted unchanged by the kidneys through glomerular filtration and active tubular secretion. This means that drugs which inhibit renal tubular secretion or reduce glomerular filtration can increase ganciclovir plasma levels, potentially increasing the risk of toxicity. Conversely, ganciclovir can affect the clearance of other renally eliminated drugs.
It is essential to inform your healthcare provider about all medications you are currently taking, have recently taken, or might take, including prescription drugs, over-the-counter medications, and herbal supplements. The following table summarises the most important drug interactions with Cymevene.
Major Interactions
| Drug | Category | Interaction Effect | Clinical Action |
|---|---|---|---|
| Imipenem/cilastatin | Antibiotic | Increased risk of seizures when used together | Avoid combination unless benefits outweigh risks; close neurological monitoring |
| Zidovudine | Antiretroviral (HIV) | Additive bone marrow suppression (severe neutropenia, anemia) | Avoid concurrent use if possible; frequent CBC monitoring if combined |
| Didanosine | Antiretroviral (HIV) | Increased didanosine plasma levels (up to 111% increase) | Monitor for didanosine toxicity (pancreatitis, peripheral neuropathy) |
| Mycophenolate mofetil | Immunosuppressant | Mutual increase in plasma concentrations; enhanced myelosuppression | Monitor blood counts closely; dose adjustment may be necessary |
| Ciclosporin / Tacrolimus | Immunosuppressant | Increased nephrotoxicity risk; potential additive myelosuppression | Monitor renal function and blood counts; adjust doses as needed |
| Trimethoprim/sulfamethoxazole | Antibiotic | Additive bone marrow suppression (neutropenia) | Monitor blood counts closely; consider alternative antibiotics if possible |
Other Notable Interactions
| Drug | Category | Interaction Effect | Clinical Action |
|---|---|---|---|
| Probenecid | Uricosuric (gout) | Reduced renal clearance of ganciclovir (up to 22% increase in AUC) | Monitor for ganciclovir toxicity; consider dose reduction |
| Tenofovir | Antiretroviral (HIV/HBV) | Both drugs compete for renal tubular secretion; increased levels of both drugs | Monitor renal function and CBC; adjust doses as needed |
| Pentamidine | Antiparasitic | Additive nephrotoxicity and myelosuppression | Monitor renal function and blood counts; avoid if possible |
| Flucytosine / Amphotericin B | Antifungal | Additive nephrotoxicity and myelosuppression | Monitor renal function and blood counts closely |
| Dapsone | Antibiotic | Additive myelosuppression | Monitor blood counts; dose adjustments may be required |
| Vincristine / Vinblastine / Doxorubicin | Cytotoxic chemotherapy | Enhanced bone marrow toxicity | Monitor blood counts carefully; may need to delay or reduce chemotherapy |
| Hydroxyurea | Antineoplastic | Additive myelosuppression | Frequent CBC monitoring; dose adjustments as needed |
This list is not exhaustive. Always inform your doctor or pharmacist about all medications you are taking. Particular caution is required when combining Cymevene with any drug that has myelosuppressive (bone marrow-suppressing) or nephrotoxic (kidney-damaging) properties, as additive toxicity may occur.
What Is the Correct Dosage of Cymevene?
Cymevene must only be administered by healthcare professionals in a clinical setting. The powder is reconstituted with water for injections and then further diluted with a compatible intravenous fluid before administration as an intravenous infusion over at least one hour. The infusion concentration must not exceed 10 mg/ml. It must never be given as a rapid bolus injection, as this can lead to dangerously high plasma levels and increased toxicity. Intramuscular and subcutaneous injection are also prohibited due to the high pH of the solution (approximately 11), which can cause severe tissue irritation.
Adults
Treatment of CMV Disease (Induction Phase)
Dose: 5 mg/kg body weight, administered intravenously every 12 hours (twice daily)
Duration: 14 to 21 days, depending on clinical response and the site and severity of infection
Note: If clinical symptoms do not improve or worsen during induction therapy, the course may be extended, but the risk of bone marrow suppression increases with prolonged treatment.
Maintenance Therapy (after induction)
Dose: 5 mg/kg body weight, administered intravenously once daily, 7 days per week; or 6 mg/kg once daily, 5 days per week
Duration: As determined by the treating physician; maintenance therapy may be continued indefinitely in patients with AIDS-related CMV retinitis, or for a defined period following organ transplantation
CMV Prophylaxis (Prevention)
Dose: 5 mg/kg body weight, administered intravenously once daily, 7 days per week; or 6 mg/kg once daily, 5 days per week
Duration: Typically continued for the first 100 days post-transplant, or as directed by the transplant team. Duration depends on the degree and duration of immunosuppression.
Children
For children from birth through adolescence, the dose is calculated based on body weight and may also take into account body surface area and height. Dose adjustments for kidney function follow the same principles as for adults, but with age-appropriate creatinine clearance calculations. Regular blood count monitoring is especially critical in neonates and infants, as haematological side effects tend to be more common in this population.
The treating physician will determine the exact dose, frequency, and duration of treatment for paediatric patients based on the indication, the child's weight, kidney function, and clinical response.
Dose Adjustment for Kidney Impairment
Since ganciclovir is almost entirely eliminated by the kidneys, dose reduction is essential in patients with impaired renal function. The dose is adjusted based on creatinine clearance (CrCl), and blood counts must be monitored more frequently in these patients.
| Creatinine Clearance (ml/min) | Induction Dose | Maintenance Dose |
|---|---|---|
| ≥ 70 | 5 mg/kg every 12 hours | 5 mg/kg once daily |
| 50 – 69 | 2.5 mg/kg every 12 hours | 2.5 mg/kg once daily |
| 25 – 49 | 2.5 mg/kg once daily | 1.25 mg/kg once daily |
| 10 – 24 | 1.25 mg/kg once daily | 0.625 mg/kg once daily |
| < 10 | 1.25 mg/kg 3 times per week (after dialysis) | 0.625 mg/kg 3 times per week (after dialysis) |
Elderly Patients
There are no specific dose recommendations for elderly patients beyond those based on renal function. Since kidney function typically declines with age, elderly patients are more likely to require dose reductions. Careful monitoring of creatinine clearance and blood counts is especially important in this population.
Missed Dose
Since Cymevene is administered by healthcare professionals in a hospital or clinical setting, missed doses are unusual. However, if an infusion is delayed or missed, it should be given as soon as possible. The prescribing physician will determine whether adjustments to the treatment schedule are necessary. Do not double the dose to compensate for a missed infusion.
Overdose
Ganciclovir overdose can cause serious and potentially life-threatening effects. Symptoms may include: severe bone marrow suppression (very low blood counts), kidney impairment or failure, seizures, abdominal pain, diarrhea, nausea and vomiting, tremor, and blood in the urine (haematuria). If overdose is suspected, contact emergency services immediately. Haemodialysis can reduce ganciclovir plasma levels by approximately 50% and may be considered in severe cases.
What Are the Side Effects of Cymevene?
Like all medicines, Cymevene can cause side effects, although not everyone experiences them. Some side effects can be serious and require immediate medical attention. It is important to be aware of potential adverse effects so that they can be reported to your healthcare team promptly. Your doctor will be monitoring your blood counts and organ function throughout treatment to detect problems early.
Contact your doctor or nurse immediately if you experience: signs of severe infection (high fever, chills, severe sore throat), unusual bleeding or bruising, blood in urine or stool, severe abdominal pain spreading to the back, seizures or convulsions, difficulty breathing, skin rash with swelling of the face or throat, or hallucinations. These may require urgent treatment or discontinuation of Cymevene.
Side Effects by Frequency
Very Common (affects more than 1 in 10 people)
- Neutropenia – low white blood cell count, increasing infection risk
- Anemia – low red blood cell count, causing fatigue and shortness of breath
- Oral candidiasis (thrush)
- Upper respiratory tract infection (sinusitis, tonsillitis)
- Loss of appetite
- Headache
- Cough
- Shortness of breath (dyspnea)
- Diarrhea
- Nausea and vomiting
- Abdominal pain
- Eczema / dermatitis
- Fatigue
- Fever
Common (affects up to 1 in 10 people)
- Sepsis (blood poisoning) – potentially life-threatening
- Thrombocytopenia – low platelet count, increased bleeding risk
- Pancytopenia – severely reduced levels of all blood cells
- Pancreatitis – severe abdominal pain spreading to back
- Seizures / convulsions
- Influenza-like illness
- Urinary tract infection
- Skin and soft tissue infection (cellulitis)
- Weight loss
- Depression, anxiety, confusion
- Insomnia
- Peripheral neuropathy (numbness, tingling in hands and feet)
- Taste disturbances
- Conjunctivitis, eye pain, visual disturbances
- Ear pain
- Low blood pressure (hypotension)
- Difficulty swallowing (dysphagia)
- Constipation, flatulence, abdominal distension
- Mouth ulcers
- Abnormal liver function tests
- Night sweats, pruritus (itching), skin rash
- Hair loss (alopecia)
- Back pain, joint or muscle pain, muscle cramps
- Abnormal kidney function tests
- Injection site reactions (inflammation, pain, swelling)
- Chills, malaise (general feeling of being unwell)
Uncommon (affects up to 1 in 100 people)
- Bone marrow failure
- Hallucinations – seeing or hearing things that are not real
- Kidney impairment
- Abnormal thoughts, feeling disconnected from reality
- Agitation
- Tremor
- Deafness
- Cardiac arrhythmia (irregular heartbeat)
- Urticaria (hives), dry skin
- Haematuria (blood in the urine)
- Male infertility
- Chest pain
Rare (affects up to 1 in 1,000 people)
- Severe allergic reaction (anaphylaxis) – may include swelling of the face, lips, tongue or throat, difficulty breathing or swallowing, itchy rash, and a drop in blood pressure
Side Effects in Children
Low blood cell counts (particularly neutropenia and thrombocytopenia) are more common in children than in adults, especially in neonates and infants. For this reason, blood counts must be monitored more frequently in paediatric patients receiving Cymevene. Parents and caregivers should be informed about the signs and symptoms of bone marrow suppression (fever, unusual bruising or bleeding, pallor, fatigue) and instructed to report them immediately to the healthcare team.
Reporting Side Effects
If you experience any side effects, including those not listed here, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through your national adverse drug reaction reporting system. By reporting side effects, you help provide more information on the safety of this medicine and contribute to ongoing pharmacovigilance.
How Should You Store Cymevene?
Keep Cymevene out of the sight and reach of children. Do not use this medicine after the expiry date printed on the carton and vial label. The expiry date refers to the last day of that month.
Unopened Vials
The dry powder in sealed vials has no special storage temperature requirements and can be stored at room temperature. Keep the vials in the original packaging to protect from light. Do not use beyond the stated expiry date.
After Reconstitution
Once the powder has been dissolved in water for injections, the resulting concentrate has demonstrated chemical and physical stability for 12 hours at 25°C. The reconstituted solution must not be refrigerated or frozen. From a microbiological standpoint, the reconstituted concentrate should ideally be used immediately. If not used immediately, the user is responsible for ensuring appropriate storage conditions.
After Dilution in Infusion Fluids
Once further diluted in compatible intravenous fluids (0.9% sodium chloride, 5% glucose, Ringer's solution, or Ringer's lactate solution), the diluted infusion solution has demonstrated chemical and physical stability for 24 hours at 2-8°C. It must not be frozen. From a microbiological perspective, the diluted solution should be used immediately unless reconstitution and dilution were performed under validated aseptic conditions.
Do not throw away any medicines via wastewater or household waste. Cymevene is a hazardous pharmaceutical product and should be disposed of according to local requirements for cytotoxic/antiviral waste. Healthcare facilities have established protocols for the safe disposal of such products. Ask your pharmacist how to properly dispose of medicines you no longer use.
What Does Cymevene Contain?
Active substance: Ganciclovir. Each glass vial contains 500 mg of ganciclovir as ganciclovir sodium. After reconstitution of the powder with 10 ml of water for injections, each 1 ml of concentrate contains 50 mg of ganciclovir.
Other ingredients (excipients): Sodium hydroxide and hydrochloric acid (used to adjust the pH of the solution). No preservatives, antimicrobial agents, or other additives are present.
Appearance and Pack Sizes
Cymevene is a white to off-white lyophilised powder for concentrate for solution for infusion. It is supplied in single-dose glass vials with a rubber stopper and aluminium seal with a flip-off cap. After reconstitution, the solution ranges from colourless to pale yellow and should be essentially free from visible particles.
Cymevene is available in packs of 1 or 5 vials. Not all pack sizes may be marketed in all countries.
Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany. This medicine is authorised in the European Economic Area under the name Cymevene in Austria, Belgium, Croatia, Czech Republic, Denmark, Finland, Hungary, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, and the United Kingdom. In Germany it is marketed as Cymeven i.v., in France as Cymevan, and in Italy as Citovirax.
Frequently Asked Questions About Cymevene
Cymevene (ganciclovir) is given as an intravenous infusion in hospital settings, while valganciclovir (marketed as Valcyte) is the oral prodrug of ganciclovir that can be taken as tablets at home. Valganciclovir is converted to ganciclovir in the body after absorption. In many clinical scenarios, patients may start with IV ganciclovir (Cymevene) for initial treatment and then transition to oral valganciclovir for maintenance therapy or prophylaxis when their condition stabilises. The choice between the two depends on the severity of disease, the patient's ability to take oral medications, and the clinical context.
The elimination half-life of ganciclovir after intravenous administration is approximately 2.5 to 3.6 hours in patients with normal kidney function. This means the drug is substantially cleared from the body within 12-18 hours of the last dose. However, in patients with impaired kidney function, the half-life can be significantly prolonged (up to 28 hours or more when creatinine clearance is below 10 ml/min), which is why dose adjustments are necessary. The intracellular half-life of the active triphosphate form is longer (approximately 18 hours), which allows for once-daily dosing during maintenance therapy.
Yes, CMV can develop resistance to ganciclovir, though this is relatively uncommon. Resistance typically develops through mutations in the UL97 gene (which encodes the viral kinase responsible for the initial phosphorylation of ganciclovir) or, less commonly, in the UL54 gene (which encodes the viral DNA polymerase). Risk factors for resistance development include prolonged exposure to subtherapeutic drug levels, high viral loads, and profound immunosuppression. If resistance is suspected (e.g., rising viral load despite adequate treatment), your doctor may order genotypic resistance testing and consider alternative antiviral agents such as foscarnet or cidofovir.
Cymevene is widely used in kidney transplant patients for both CMV prophylaxis and treatment. However, particular care is needed because transplant patients are already on immunosuppressive medications (such as mycophenolate mofetil, ciclosporin, or tacrolimus) that can interact with ganciclovir and increase the risk of side effects, particularly bone marrow suppression and nephrotoxicity. Dose adjustments based on the transplanted kidney's function are essential, and blood counts and renal function must be monitored closely. The transplant team will determine the optimal dosing strategy based on the patient's CMV risk profile and overall clinical status.
Regular monitoring during Cymevene treatment includes: complete blood count (CBC) with differential, initially every 2-3 days during the first two weeks, then at least weekly thereafter; serum creatinine and estimated glomerular filtration rate (eGFR) to assess kidney function; CMV viral load (by PCR) to assess treatment response; liver function tests; and ophthalmological examinations in patients being treated for CMV retinitis. If neutrophil counts fall below 500 cells/microlitre or platelet counts fall below 25,000 cells/microlitre, treatment may need to be interrupted until counts recover. Growth factors (G-CSF) may be used to support neutrophil recovery in some cases.
All information in this article is based on the approved Summary of Product Characteristics (SmPC) for Cymevene as registered with the European Medicines Agency (EMA), the FDA prescribing information, WHO Essential Medicines List recommendations, ECIL (European Conference on Infections in Leukaemia) guidelines for CMV management in immunocompromised patients, and peer-reviewed studies published in journals including The Lancet Infectious Diseases, Clinical Infectious Diseases, and the Journal of Antimicrobial Chemotherapy. All medical claims follow the GRADE evidence framework and are reviewed by board-certified infectious disease physicians and clinical pharmacologists.
References
- European Medicines Agency (EMA). Cymevene – Summary of Product Characteristics (SmPC). CHEPLAPHARM Arzneimittel GmbH. Last updated 2021.
- Kotton CN, Kumar D, Caliendo AM, et al. The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid-Organ Transplantation. Transplantation. 2018;102(6):900-931. doi:10.1097/TP.0000000000002191
- Ljungman P, de la Camara R, Robin C, et al. Guidelines for the management of cytomegalovirus infection in patients with haematological malignancies and after stem cell transplantation from the 2017 European Conference on Infections in Leukaemia (ECIL 7). Lancet Infect Dis. 2019;19(8):e260-e272. doi:10.1016/S1473-3099(19)30107-0
- Razonable RR, Humar A. Cytomegalovirus in solid organ transplant recipients – Guidelines of the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019;33(9):e13512. doi:10.1111/ctr.13512
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List (2023). Geneva: WHO; 2023.
- Kimberlin DW, Jester PM, Sanchez PJ, et al. Valganciclovir for Symptomatic Congenital Cytomegalovirus Disease. N Engl J Med. 2015;372(10):933-943. doi:10.1056/NEJMoa1404599
- British National Formulary (BNF). Ganciclovir. National Institute for Health and Care Excellence (NICE). Updated 2025.
- Paya C, Humar A, Dominguez E, et al. Efficacy and safety of valganciclovir vs. oral ganciclovir for prevention of cytomegalovirus disease in solid organ transplant recipients. Am J Transplant. 2004;4(4):611-620. doi:10.1111/j.1600-6143.2004.00382.x
Editorial Team
This article was written by the iMedic Medical Editorial Team, comprising licensed physicians specialising in infectious disease, clinical pharmacology, and transplant medicine. All content has been reviewed according to international medical standards and the GRADE evidence framework.
iMedic Medical Editorial Team – specialists in clinical pharmacology, infectious disease, and antiviral therapy with documented academic backgrounds and clinical experience.
iMedic Medical Review Board – independent panel of medical experts who review all content according to EMA, FDA, and WHO guidelines.
Conflict of interest: None. iMedic is an independent medical information resource with no commercial funding, pharmaceutical sponsorship, or advertising revenue.
Evidence standard: All clinical information is based on Level 1A evidence (systematic reviews and meta-analyses of randomised controlled trials) where available, supplemented by regulatory-approved product information (EMA SmPC, FDA label) and current international clinical practice guidelines (ECIL, AST-IDCOP).