Emcido (Concentrate) Instructions for Use

ATC Code

J05AB12 (Cidofovir)

Active Substance

Cidofovir (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antiviral drug

Pharmacotherapeutic Group

Systemic antiviral agents; nucleosides and nucleotides, excluding reverse transcriptase inhibitors

Pharmacological Action

Antiviral agent. It blocks the reproduction of cytomegalovirus (CMV) by disrupting the production of viral DNA.

Cidofovir is capable of improving the condition of a patient with CMV retinitis by slowing the progression of the disease.

CMV retinitis is an eye infection caused by cytomegalovirus. CMV affects the retina of the eye and can cause vision loss and ultimately lead to blindness. Patients with AIDS have a high risk of developing CMV retinitis or other forms of CMV infection, such as colitis (inflammatory bowel disease). Treatment of CMV retinitis is necessary to reduce the likelihood of developing blindness.

The safety and efficacy of cidofovir have not been demonstrated for diseases other than CMV retinitis in adults with AIDS.

Cidofovir should be used only in cases where there are no alternative treatment options.

Indications

Treatment of cytomegalovirus retinitis in adults with AIDS without renal impairment.

ICD codes

Dosage Regimen

Concentrate

Administered in a hospital setting, intravenously using an infusion pump.

Initial (induction) treatment: the recommended dose is 5 mg/kg of body weight once a week for 2 consecutive weeks.

Maintenance treatment: 2 weeks after completion of initial (induction) treatment, the recommended maintenance dose is 5 mg/kg of body weight once every 2 weeks.

In patients with impaired renal function, adjustment of the dosage regimen is required.

Adverse Reactions

Most frequently – kidney damage.

From the urinary system very common – proteinuria, increased blood creatinine concentration; common – renal failure.

From the organ of vision common – iritis, uveitis, decreased intraocular pressure.

From the organ of hearing unknown – hearing impairment.

From the digestive system very common – nausea, vomiting; common – diarrhea; unknown – pancreatitis.

From the nervous system very common – headache.

From the skin very common – alopecia, rash.

From the respiratory system common – dyspnea.

From the blood and lymphatic system : very common – neutropenia.

General reactions very common – asthenia, fever; common – chills.

When used concomitantly with probenecid, possible adverse reactions due to its action should be taken into account.

Contraindications

Hypersensitivity to cidofovir, kidney disease, hypersensitivity to probenecid (used to reduce the risk of kidney damage).

With caution

Diabetes mellitus (due to a potentially increased risk of developing decreased intraocular pressure), concomitant use with drugs that can cause impaired renal function.

Use in Pregnancy and Lactation

Cidofovir has been shown to have a teratogenic effect in animals, so it should not be used during pregnancy unless the potential benefit of therapy to the mother justifies the existing risk to the fetus.

Effective methods of contraception should be used during treatment and for 1 month after its completion.

It is not known whether Cidofovir is excreted in human breast milk. Cidofovir should not be used during breastfeeding.

Use in Renal Impairment

Contraindicated in case of impaired renal function.

Pediatric Use

Studies of cidofovir in children have not been conducted. Cidofovir should not be used in children and adolescents under 18 years of age (safety and efficacy of cidofovir use in this category of patients have not been established).

Special Precautions

Kidney damage is the main adverse reaction during treatment with cidofovir.

Renal function should be assessed before each injection.

To reduce the risk of kidney damage, the patient is administered intravenous saline before each injection, as well as oral probenecid.

During treatment, regular ophthalmological monitoring should be carried out for possible eye irritation, inflammation, or swelling.

Cidofovir causes a decrease in testicular mass and a decrease in sperm count (hypospermia) in animals. Although this was not noted in clinical studies, similar changes may occur in humans and cause infertility. During treatment and for 3 months after treatment, men should use barrier methods of contraception.
Cidofovir is not used to treat HIV infection and does not prevent the transmission of HIV infection from a patient to another person, so patients should continue to take precautions to avoid infecting other people.

Use in pediatrics

Studies of cidofovir in children have not been conducted. Cidofovir should not be used in children and adolescents under 18 years of age (safety and efficacy of cidofovir use in this category of patients have not been established).

Effect on the ability to drive vehicles and operate machinery

Cidofovir may cause short-term adverse reactions such as fatigue or weakness. This should be taken into account when used in patients whose activities require increased concentration and speed of psychomotor reactions.

Drug Interactions

An increased risk of impaired renal function is possible with the concomitant use of cidofovir with the following drugs: tenofovir, aminoglycosides, pentamidine or vancomycin, amphotericin B, foscarnet, adefovir. The use of these drugs should be discontinued at least 7 days before starting cidofovir.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.