What is Cidofovir Tillomed used for?

Cidofovir is indicated for the treatment of CMV retinitis in adults with acquired immunodeficiency syndrome (AIDS) and without renal dysfunction. It should be used only when other medicinal products are considered unsuitable.

What is the active ingredient in Cidofovir Tillomed?

Cidofovirum (Cidofovirum dihydricum)

What pharmaceutical form is Cidofovir Tillomed available in?

Cidofovir Tillomed: Koncentrat do sporządzania roztworu do infuzji 75 mg/ml (dożylna)

Is Cidofovir Tillomed OTC or prescription only?

Cidofovir Tillomed requires a doctor's prescription.

What are the side effects of Cidofovir Tillomed?

The table below lists the adverse reactions identified through clinical trials or post-marketing surveillance by system organ class (SOC) and frequency. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000) or not known (cannot be estimated from the available data). Advers

Who should NOT take Cidofovir Tillomed?

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Cidofovir administration is contraindicated in patients unable to receive probenecid or other sulfa containing medication (see section 4.4 Prevention of nephrotoxicity). Cidofovir is contraindicated in patients with renal insufficiency (see section 4.2). Concomitant administration of cidofovir and other potentially nephrotoxic agents is contraindicated (see section 4.4). Direct intraocul

Does Cidofovir Tillomed interact with other medications?

There is a risk that concomitant treatment of cidofovir with products containing tenofovir disoproxil fumarate may give rise to a pharmacodynamic interaction and increase the risk of Fanconi syndrome (see section 4.4). Probenecid increases the AUC of zidovudine. Patients receiving both medicinal products should be closely monitored for zidovudine induced haematological toxicity. For other nucleoside reverse transcriptase inhibitors (NRTI) administered concomitantly with probene

Can Cidofovir Tillomed be used during pregnancy?

Women of childbearing potential/Contraception in males and females: Due to the genotoxic potential of cidofovir (see section 5.3), women of childbearing potential should use effective contraceptive measures while being treated with cidofovir and for six months following completion of treatment. Men are recommended to use effective contraceptive measures and to not father a child while receiving cidofovir and for three months following completion of treatment. Pregnancy: There are no data from th

What ATC class does Cidofovir Tillomed belong to?

Cidofovir Tillomed: ATC J05AB12. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Cidofovir Tillomed

This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.

Pharmacotherapeutic group: Antivirals for systemic use, nucleosides and nucleotides excluding reverse transcriptase inhibitors, ATC code: J05AB12 General Cidofovir is a cytidine analogue with in vitro and in vivo activity against human cytomegalovirus (HCMV).‍‍‍‍‍ HCMV strains resistant to ganciclovir may still be susceptible to cidofovir. Mechanism of action Cidofovir suppresses HCMV replication by selective inhibition of viral DNA synthesis. Biochemical data support selective inhibition of HSV-1, HSV-2 and HCMV DNA polymerases by cidofovir diphosphate, the active intracellular metabolite of cidofovir. Cidofovir diphosphate inhibits these viral polymerases at concentrations that are 8- to 600- fold lower than those needed to inhibit human cellular DNA polymerases alpha, beta, and gamma. Incorporation of cidofovir into viral DNA results in reductions in the rate of viral DNA synthesis. Cidofovir enters cells by fluid-phase endocytosis and is phosphorylated to cidofovir monophosphate and subsequently to cidofovir diphosphate. Prolonged antiviral effects of cidofovir are related to the half-lives of its metabolites; cidofovir diphosphate persists inside cells with a half-life of 17-65 hours and a cidofovir phosphate-choline adduct has a half-life of 87 hours. Antiviral activity Cidofovir is active in vitro against HCMV, a member of the herpesviridae family. Antiviral activity is seen at concentrations significantly below those which cause cell death. The in vitro sensitivity to cidofovir is shown in the following table: Cidofovir inhibition of virus multiplication in cell culture Virus IC 50 (μM) wild-type CMV isolates 0.7 (± 0.6) ganciclovir-resistant CMV isolates 7.5 (± 4.3) foscarnet-resistant CMV isolates 0.59 (± 0.07) In vivo activity against HCMV was confirmed with controlled clinical studies of cidofovir for the treatment of CMV retinitis in patients with AIDS, which demonstrated statistically significant delays in time to CMV retinitis progression for patients on cidofovir when compared to control patients. The median times to retinitis progression in the two efficacy studies (GS-93-106 and GS-93-105), were 120 days and not reached for the treatment arms vs. 22 days and 21 days for the untreated (deferred treatment) arms, respectively. In study GS-93-107 conducted in patients who had relapsed after treatment with other agents, the median time to retinitis progression was 115 days. Viral resistance Following in vitro selection of ganciclovir-resistant HCMV isolates, cross-resistance between ganciclovir and cidofovir was seen with ganciclovir-selected mutations in the HCMV DNA polymerase gene but not with mutations in the UL97 gene. No cross-resistance between foscarnet and cidofovir was seen with foscarnet-selected mutants. Cidofovir-selected mutants had a mutation in the DNA polymerase gene and were cross-resistant to ganciclovir, but susceptible to foscarnet.

⚠️ Warnings

Method of preparation and administration Cidofovir 75 mg/ml Concentrate for Solution for Infusion vials should be visually inspected for particulate matter and discolouration prior to administration. With a syringe, transfer under aseptic conditions the appropriate dose of cidofovir from the vial to an infusion bag containing 100 ml 0.9% (normal) saline solution, and mix thoroughly.‍‍‍‍‍ The entire volume should be infused intravenously into the patient at a constant rate over a period of 1 hour by use of a standard infusion pump. It should be administered by health care professionals adequately experienced in the care of AIDS patients. The chemical and physical stability of Cidofovir 75 mg/ml Concentrate for Solution for Infusion admixed with saline has been demonstrated in glass bottles, in infusion bags composed of either polyvinyl chloride (PVC) or ethylene/propylene copolymer, and in PVC based vented IV administration sets. Other types of IV set tubing and infusion bags have not been studied. Compatibility with Ringer's Solution, Lactated Ringer's Solution or bacteriostatic infusion fluids has not been evaluated. Handling and disposal Adequate precautions including the use of appropriate safety equipment are recommended for the preparation, administration and disposal of cidofovir. The preparation of cidofovir reconstituted solution should be done in a laminar flow biological safety cabinet. Personnel preparing the reconstituted solution should wear surgical gloves, safety glasses and a closed front surgical-type gown with knit cuffs. If cidofovir contacts the skin, wash membranes and flush thoroughly with water. Excess cidofovir and all other materials used in the admixture preparation and administration should be placed in a leak-proof, puncture-proof container for disposal. Any unused product or waste material should be disposed of in accordance with local requirements. Obtaining probenecid Probenecid is not supplied with cidofovir and should be obtained via the Marketing Authorisation Holder of probenecid. However, in case of difficulty in obtaining probenecid the local representative of the Marketing Authorisation Holder of Cidofovir 75 mg/ml Concentrate for Solution for Infusion should be contacted for information (see also sections 4.2 and 4.4).

Cidofovir Tillomed

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