VALCYTE ® Valganciclovir

VALCYTE ® is a drug based on Valganciclovir

THERAPEUTIC GROUP: Antivirals for systemic use

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications VALCYTE ® Valganciclovir

VALCYTE ® is a drug indicated for the initial and maintenance treatment of cytomegalovirus (CMV) retinitis in AIDS patients.

Valgancivlovir has also been shown to be effective in preventing CMV infections in transplanted patients.

Mechanism of action VALCYTE ® Valganciclovir

VALCYTE ® is a medicinal product based on Valganciclovir, a molecule obtained through the esterification of Gancilovir with L-Valine, and used in the clinical setting in the treatment and prevention of infectious diseases supported by CMV especially in immunocompromised patients.

Valganciclovir, taken orally, is rapidly absorbed by the intestinal mucosa and metabolized in Ganciclovir directly at the enteric and hepatic level, effectively distributing itself in various tissues and biological compartments.

In these the Ganciclovir easily permeates the plasma membranes of the host cells, being first phosphorylated by viral kinases and only subsequently by cellular enzymes in a triphosphate molecule which competes actively with deoxyguanosine in the synthesis of viral DNA.

More precisely, replacing deoxyguanosine, Ganciclovir triphosphate inhibits the enzyme Dna viral polymerase, thus blocking the processes of viral replication and limiting the spread of the virus as well as the symptomatology in place.

Once its activity is over, the oral Vanganciclovir taken in the form of Ganciclovir is eliminated mainly through glomerular filtration and active tubular secretion.

Studies carried out and clinical efficacy

VALGANCICLOVIR AND TRANSPLANTATION OF STEM CELLS

Int J Hematol. 2012 Jul; 96 (1): 94-100.

Study demonstrating how preventive administration of Valganciclovir may be effective in preventing CMV infection in patients requiring hematopoietic stem cell transplantation. However, in some cases neutropenia has occurred, fortunately not severe.

THE VALGANCICLOVIR IN THE TREATMENT OF CMV CONGENITAL INFECTIONS

No To Hattatsu. 2012 Jan; 44 (1): 55-9.

Experimental study that tests the efficacy of Valganciclovir in the treatment of congenital CMV infection, demonstrating how this therapy can reduce, in some cases completely eliminating the presence of viral DNA in biological samples.

VALGANCICLOVIR AND SARCOMA OF KAPOSI

J Infect Dis. 2011 Apr 15; 203 (8): 1082-6.

Pilot study that unravels the potential therapeutic role of Valganciclovir in the treatment of Kaposi's Sarcoma, in patients with important immunodeficiency.

Method of use and dosage

VALCYTE ®

450 mg coated tablets of Valganciclovir hydrochloride;

Powder for oral solution of 50 mg of Valganciclovir per ml of reconstituted solution.

Given the selectivity of the therapeutic indications and the complexity of the therapeutic scheme, dosages and timing of recruitment must necessarily be defined by a specialist doctor in the treatment of infectious diseases taking into account the overall health status of the patient and the severity of his / her clinical picture.

In any case, in order to optimize the absorption of the drug, limiting the potential side effects, it would be advisable to take the drug preferably on a full stomach.

Warnings VALCYTE ® Valganciclovir

Therapy with VALCYTE ® must necessarily be preceded by a careful medical examination aimed at assessing the possible presence of absolute contraindications rather than conditions incompatible with Valganciclovir-based therapy.

Particular caution should in fact be reserved for patients suffering from renal and hepatic diseases, given the increased risk of pharmacokinetic alterations affecting Valganciclovir, such as to further compromise the safety and efficacy of the therapy itself.

It would also be advisable for the doctor to periodically monitor the overall health status of the patient undergoing therapy with VALCYTE ®, paying particular attention to the renal and hepatic function as well as to the hematology in some cases characterized by leukopenia, anemia and thrombocytopenia. severe to require suspension of therapy.

PREGNANCY AND BREASTFEEDING

The use of VALCYTE ® is strictly contraindicated during pregnancy and in the subsequent period of breastfeeding, given the numerous studies, many of which are experimental, which demonstrate the teratogenic and mutagenic potential of Valganciclovir.

For this reason it would be advisable to use contraceptives, preferably a barrier one, in the three months following Valganciclovir therapy.

Interactions

The patient on VALCYTE ® therapy should pay particular attention to the simultaneous intake of active ingredients such as imipenem-cilastatin, probenecid, zidovudine, mycophenolate mofetil, haematotoxic and cytotoxic drugs due to the increased risk of particularly serious adverse reactions, such as to seriously compromise the state of patient health.

Contraindications VALCYTE ® Valganciclovir

VALCYTE ® is contraindicated in patients who are hypersensitive to the active ingredient, to structurally related molecules and to one of its excipients.

The use of Valganciclovir is strongly contraindicated in pregnancy and during breastfeeding.

Undesirable effects - Side effects

Therapy with VALCYTE ® could lead to the onset of numerous side effects such as:

Changes in renal function;
Changes in liver function;
Neurological symptoms such as convulsions, insomnia, headache, dizziness and peripheral neuropathies;
Retinal detachment:
Haematological changes with neutropenia, leukopenia, anemia and thrombocytopenia;
Nausea, diarrhea, vomiting and abdominal cramps;
Anorexia;
Arthralgia, muscle pain and muscle cramps;
Urinary tract infections.

Fortunately, rarer are side effects such as psychotic disorders, hypotension, pancreatitis and deafness.