Last update Aug. 6, 2020

Ganciclovir

Low Risk

Moderately safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.

Synthetic nucleoside which is analogue of guanine, structurally very closed related to acyclovir.
Indicated for the treatment and prevention of Cytomegalovirus (CMV) in immunocompromised patients.
Oral or intravenous administration once or twice a day. Also, topical ophthalmic use for the treatment of herpetic keratitis.

At latest update no published data on excretion into breast milk were found.

Its pharmacokinetic data do not allow a good prediction of excretion in breast milk, since while the low molecular weight and its almost zero protein binding would facilitate it, its high volume of distribution would prevent it.

In any ay, its low oral bioavailability (< 10%: Anderson 1995, Jacobson 1987) hinders the passage from ingested milk towards the infant’s plasma, except in preterm babies and immediate neonatal period, which may show an increased intestinal permeability.

In addition to this, it is used in newborns and premature infants who are affected with CMV infection (Mahler 2014, Lombardi 2012, Oulu 2012, Alarcón 2011).

OPHTHALMIC USE:
The small dose and poor plasma absorption of most topical ophthalmic preparations make it unlikely that a significant amount will pass into breast milk.
Ophthalmic administration of 5 drops daily supposes a maximum daily dose of 0.375 mg, more than 2,000 times lower than oral or intravenous doses (Hale 2019).
Topical ophthalmic use of ganciclovir is compatible with breastfeeding.


See below the information of this related product:

Alternatives

  • Letermovir (Moderately safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)

Suggestions made at e-lactancia are done by APILAM team, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Ganciclovir is also known as


Ganciclovir in other languages or writings:

Groups

Ganciclovir belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Ganciclovir in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 2.6 - 8.8 %
Molecular weight 256 daltons
Protein Binding 1 - 2 %
VD 0.5 - 0.9 l/Kg
pKa 10.16 -
Tmax 1 - 2.9 hours
T1/2 iv: 2.5 - 4.5. Oral: 4 - 5.7 hours

References

  1. Mehler K, Oberthuer A, Lang-Roth R, Kribs A. High rate of symptomatic cytomegalovirus infection in extremely low gestational age preterm infants of 22-24 weeks' gestation after transmission via breast milk. Neonatology. 2014 Abstract
  2. Okulu E, Akin IM, Atasay B, Ciftçi E, Arsan S, Türmen T. Severe postnatal cytomegalovirus infection with multisystem involvement in an extremely low birth weight infant. J Perinatol. 2012 Abstract
  3. Lombardi G, Garofoli F, Manzoni P, Stronati M. Breast milk-acquired cytomegalovirus infection in very low birth weight infants. J Matern Fetal Neonatal Med. 2012 Abstract Full text (link to original source) Full text (in our servers)
  4. Alarcón Allen A, Baquero-Artigao F; Grupo de estudio de la infección por citomegalovirus de la Sociedad Española de Infectología Pediátrica. [Review and guidelines on the prevention, diagnosis and treatment of post-natal cytomegalovirus infection]. An Pediatr (Barc). 2011 Abstract
  5. Anderson RD, Griffy KG, Jung D, Dorr A, Hulse JD, Smith RB. Ganciclovir absolute bioavailability and steady-state pharmacokinetics after oral administration of two 3000-mg/d dosing regimens in human immunodeficiency virus- and cytomegalovirus-seropositive patients. Clin Ther. 1995 Abstract
  6. Spector SA, Busch DF, Follansbee S, Squires K, Lalezari JP, Jacobson MA, Connor JD, Jung D, Shadman A, Mastre B, et al. Pharmacokinetic, safety, and antiviral profiles of oral ganciclovir in persons infected with human immunodeficiency virus: a phase I/II study. AIDS Clinical Trials Group, and Cytomegalovirus Cooperative Study Group. J Infect Dis. 1995 Abstract
  7. Trang JM, Kidd L, Gruber W, Storch G, Demmler G, Jacobs R, Dankner W, Starr S, Pass R, Stagno S, et al. Linear single-dose pharmacokinetics of ganciclovir in newborns with congenital cytomegalovirus infections. NIAID Collaborative Antiviral Study Group. Clin Pharmacol Ther. 1993 Abstract
  8. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Full text (link to original source)
  9. Sommadossi JP, Bevan R, Ling T, Lee F, Mastre B, Chaplin MD, Nerenberg C, Koretz S, Buhles WC Jr. Clinical pharmacokinetics of ganciclovir in patients with normal and impaired renal function. Rev Infect Dis. 1988 Abstract
  10. Jacobson MA, de Miranda P, Cederberg DM, Burnette T, Cobb E, Brodie HR, Mills J. Human pharmacokinetics and tolerance of oral ganciclovir. Antimicrob Agents Chemother. 1987 Abstract

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