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Valganciclovir (Tablets) Instructions for Use

ATC Code

J05AB14 (Valganciclovir)

Active Substance

Valganciclovir (Rec.INN WHO registered)

Clinical-Pharmacological Group

Antiviral drug

Pharmacotherapeutic Group

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

Pharmacological Action

Antiviral agent, the L-valyl ester of ganciclovir. It is a prodrug of ganciclovir. After oral administration, it is rapidly transformed into ganciclovir with the participation of intestinal and hepatic esterases.

Ganciclovir is a synthetic analog of guanine. Inside the cell, ganciclovir is sequentially metabolized to the monophosphate form by cellular deoxyguanosine kinase, and then to the active ganciclovir triphosphate. Acting as a substrate and being incorporated into DNA, ganciclovir triphosphate competitively inhibits the synthesis of viral DNA. This leads to the suppression of DNA synthesis by inhibiting DNA chain elongation. Ganciclovir inhibits viral DNA polymerase more effectively than cellular polymerase.

Valganciclovir is active against human cytomegalovirus, Herpes simplex types 1 and 2, Varicella zoster, Epstein-Barr virus, and hepatitis B virus.

Pharmacokinetics

After oral administration, it is rapidly absorbed from the gastrointestinal tract and is converted to ganciclovir in the intestinal wall and liver. The absolute bioavailability of ganciclovir after its conversion from valganciclovir is approximately 60%. The binding of ganciclovir to plasma proteins is 1-2%.

It is mainly excreted by the kidneys.

After administration of valganciclovir, the terminal T1/2 of ganciclovir is about 4.2 hours.

Indications

Treatment of cytomegalovirus retinitis in AIDS.

Prevention of CMV infection after organ transplantation in at-risk patients.

ICD codes

ICD-10 code Indication
B20.2 Human immunodeficiency virus [HIV] disease resulting in cytomegaloviral disease
B25.8 Other cytomegaloviral diseases
Z29.8 Other specified prophylactic measures
Z94 Presence of transplanted organs and tissues
ICD-11 code Indication
1C62.Z Human immunodeficiency virus [HIV] disease without mention of associated disease or condition, clinical stage unspecified
1D82.Y Other specified cytomegaloviral disease
QB63.Z Presence of transplanted organ or tissue, unspecified
QC05.Z Prophylactic measures, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Take tablets orally with food to improve bioavailability.

For induction treatment of cytomegalovirus retinitis in adult patients, the recommended dose is 900 mg taken twice daily for 21 days.

For maintenance treatment following induction, the recommended dose is 900 mg taken once daily.

For prevention of CMV disease in adult kidney, heart, or kidney-pancreas transplant recipients, the recommended dose is 900 mg taken once daily, starting within 10 days of transplantation and continuing until 100 days post-transplant.

For prevention of CMV disease in adult liver transplant recipients, the recommended dose is 900 mg taken once daily, starting within 10 days of transplantation and continuing until 100 days post-transplant.

Adjust the dosage in all patients with impaired renal function; calculate the creatinine clearance and refer to specific dosage reduction tables.

For patients with end-stage renal disease (CrCl less than 10 mL/min) on hemodialysis, use a reduced dose of 450 mg approximately after each hemodialysis session; this dose is only recommended for patients already on maintenance therapy.

Do not use for induction in patients on hemodialysis due to inadequate systemic exposure.

Monitor complete blood count frequently, particularly for neutropenia and thrombocytopenia; dosage interruption or reduction may be required.

Ensure adequate hydration during administration.

Adverse Reactions

From the digestive system: diarrhea, nausea, vomiting, abdominal pain, constipation, upper abdominal pain, dyspepsia, bloating, ascites, impaired liver function.

From the hematopoietic system: neutropenia, anemia, thrombocytopenia, leukopenia; pancytopenia, bone marrow suppression, aplastic anemia; potentially life-threatening bleeding associated with the development of thrombocytopenia.

Infectious complications: oral candidiasis, pharyngitis/nasopharyngitis, sinusitis, upper respiratory tract infections, influenza, pneumonia, bronchitis, pneumocystis pneumonia, urinary tract infections.

From the nervous system: headache, insomnia, peripheral neuropathy, paresthesia, tremor, dizziness (excluding vertigo), depression, seizures, psychotic disorders, hallucinations, confusion, agitation.

From the skin and subcutaneous tissue: dermatitis, night sweats, itching, acne.

From the respiratory system: cough, shortness of breath, productive cough, nasal discharge, pleural effusion.

From the sensory organs: retinal detachment, blurred vision.

From the musculoskeletal system: back pain, arthralgia, muscle cramps, limb pain.

From the urinary system: renal failure, dysuria, decreased creatinine clearance.

From the immune system: transplant rejection reaction.

From metabolism: anorexia, cachexia, decreased appetite, dehydration, weight loss.

From the cardiovascular system: arterial hypotension, arterial hypertension.

From laboratory parameters: hyperkalemia, hypokalemia, hypomagnesemia, hyperglycemia, hypophosphatemia, hypocalcemia, hypercreatininemia.

Postoperative complications: postoperative complications, postoperative pain, postoperative wound infection, increased frequency of drainage need, poor postoperative wound healing.

General disorders: fever, fatigue, lower limb edema, pain, edema, peripheral edema, weakness, hypersensitivity reactions to valganciclovir.

Contraindications

Absolute neutrophil count <500/µL, platelet count <25,000/µL; hemoglobin level <80 g/L; creatinine clearance <10 mL/min; pregnancy, breastfeeding period; children under 12 years of age; hypersensitivity to valganciclovir, ganciclovir.

With caution

Renal failure, elderly patients (safety and efficacy not established).

Due to the similar chemical structure of valganciclovir, acyclovir, and valacyclovir, cross-sensitivity reactions to these substances are possible.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and breastfeeding.

Use in Renal Impairment

Patients with impaired renal function and patients on hemodialysis require dosage adjustment.

Pediatric Use

Contraindicated in children under 12 years of age.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

Due to the similar chemical structure of valganciclovir, acyclovir, and valacyclovir, cross-sensitivity reactions to these drugs are possible.

Use with caution in elderly patients (the safety and efficacy of the drug have not been established).

Experimental animal studies have revealed mutagenic, teratogenic, aspermatogenic, and carcinogenic effects of ganciclovir. Valganciclovir should be considered a potential human teratogen and carcinogen, the use of which may cause congenital malformations and cancer. Furthermore, it is likely that Valganciclovir may temporarily or irreversibly suppress spermatogenesis.

Treatment should not be started if the absolute neutrophil count is less than 500 cells/µL or the platelet count is less than 25,000 cells/µL, or if hemoglobin is below 80 g/L.

During treatment, it is recommended to regularly monitor the complete blood count and platelets. Patients with severe leukopenia, neutropenia, anemia and/or thrombocytopenia are recommended to be prescribed hematopoietic growth factors and/or to discontinue valganciclovir.

Concomitant use of valganciclovir and imipenem/cilastatin should be avoided unless the potential benefits of treatment outweigh the possible risk.

Since both zidovudine and ganciclovir can cause neutropenia and anemia, some patients may experience intolerance when taking valganciclovir and zidovudine concomitantly at full doses.

Due to the possible increase in plasma concentrations of didanosine in the presence of ganciclovir, patients should be carefully monitored for symptoms of didanosine toxicity.

Effect on ability to drive vehicles and operate machinery

During treatment with valganciclovir and/or ganciclovir, seizures, sedative effects, dizziness, ataxia, and/or confusion may occur, which may adversely affect activities requiring increased concentration, including driving vehicles and operating machinery.

Drug Interactions

Valganciclovir is converted to ganciclovir, therefore interactions characteristic of ganciclovir can be expected with the use of valganciclovir.

Concomitant use of valganciclovir with other drugs that have myelosuppressive or nephrotoxic effects may enhance their toxic effects.

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Aurobindo Pharma, Ltd. (India)

Manufactured By

Aurobindo Pharma, Ltd. (India)

Labeled By

AUROBINDO PHARMA, Ltd. (India)

Or

ROZLEKS PHARM, LLC (Russia)

Dosage Form

Bottle Rx Icon Valganciclovir Film-coated tablets, 450 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets pink, biconvex, oval, with the inscription "H" embossed on one side and "96" on the other; the core is white or almost white on the cross-section.

1 tab.
Valganciclovir hydrochloride 496.36 mg,
   Equivalent to valganciclovir content 450 mg

Excipients: microcrystalline cellulose 108.44 mg, crospovidone (type B) – 19.2 mg, povidone (K-30) – 12.8 mg, magnesium stearate – 3.2 mg.

Film coating composition Opadry pink YS-1-14519A: hypromellose (3 cP) – 31.71%, hypromellose (6 cP) – 31.71%, titanium dioxide – 25.92%, macrogol-400 – 8%, polysorbate-80 – 1%, iron oxide red dye – 1.66%) – 16 mg.

10 pcs. – Al/Al blisters (3) – cardboard packs.

Marketing Authorization Holder

Hetero Labs, Limited (India)

Manufactured By

Makiz-Pharma, LLC (Russia)

Dosage Form

Bottle Rx Icon Valganciclovir Film-coated tablets, 450 mg: 60 or 120 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets pink with a slight brownish or grayish tint, oval, biconvex, with engraving "J" on one side and "156" on the other.

1 tab.
Valganciclovir hydrochloride 496.3 mg,
   Equivalent to valganciclovir content 450 mg

Excipients: microcrystalline cellulose – 109.35 mg, crospovidone – 19.35 mg, povidone K30 – 12 mg, stearic acid – 8 mg.

Coating composition: Opadry pink 15B24005 19.35 mg (hypromellose (3 cP) 31.71%, hypromellose (6 cP) 31.71%, titanium dioxide 25.92%, macrogol 400 8%, iron oxide red 1.66%, polysorbate 80 1%).

60 pcs. – polyethylene bottles (1) – cardboard packs.
60 pcs. – polyethylene jars (1) – cardboard packs.
120 pcs. – polyethylene jars (1) – cardboard packs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle Rx Icon Valganciclovir Film-coated tablets, 450 mg: 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 180, 200, or 300 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from pink to light pink, oval, biconvex; the cross-section shows a white or almost white core.

1 tab.
Valganciclovir hydrochloride 496.36 mg,
   Equivalent to valganciclovir content 450 mg

Excipients: microcrystalline cellulose (MCC-101) – 86.1 mg, crospovidone – 25.6 mg, povidone K25 – 25.6 mg, magnesium stearate – 6.4 mg.

Coating composition Opadry II 85F240012 Pink – 16 mg, incl.: polyvinyl alcohol – 6.4 mg, macrogol 3350 – 3.232 mg, iron oxide red dye – 0.064 mg, iron oxide yellow dye – 0.035 mg, talc – 2.368 mg, titanium dioxide – 3.901 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
20 pcs. – contour cell packs (4) – cardboard packs.
20 pcs. – contour cell packs (5) – cardboard packs.
20 pcs. – contour cell packs (6) – cardboard packs.
20 pcs. – contour cell packs (10) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
30 pcs. – contour cell packs (2) – cardboard packs.
30 pcs. – contour cell packs (3) – cardboard packs.
30 pcs. – contour cell packs (4) – cardboard packs.
30 pcs. – contour cell packs (5) – cardboard packs.
30 pcs. – contour cell packs (6) – cardboard packs.
30 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.

Marketing Authorization Holder

Irvin 2, LLC (Russia)

Manufactured By

ZiO-Health CJSC (Russia)

Dosage Form

Bottle Rx Icon Valganciclovir Film-coated tablets, 450 mg: 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets pink, oval, biconvex, with a logo "Z" on one side; core from white to almost white.

1 tab.
Valganciclovir (as valganciclovir hydrochloride) 450 mg

Excipients: microcrystalline cellulose – 47.8 mg, povidone K-30 – 23.9 mg, crospovidone – 23.9 mg, stearic acid – 6 mg.

Film coating composition Opadry pink 15B24005 – 18 mg (hypromellose – 11.4156 mg, titanium dioxide – 4.6656 mg, macrogol 400 – 1.44 mg, iron oxide red dye – 0.2988 mg, polysorbate 80 – 0.18 mg).

60 pcs. – jars (1) – cardboard packs.

Marketing Authorization Holder

MBA-Group, LLC (Russia)

Manufactured By

Amedart LLC (Russia)

Or

PharmVILAR NPO, LLC (Russia)

Dosage Form

Bottle Rx Icon Valganciclovir Film-coated tablets, 450 mg: 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, oval, biconvex.

1 tab.
Valganciclovir hydrochloride 496.3 mg,
   Equivalent to valganciclovir content 450 mg

Excipients: microcrystalline cellulose – 47.8 mg, povidone K30 – 23.9 mg, crospovidone – 23.9 mg, stearic acid – 6 mg.

Film coating composition: Opadry® AMB II white 88A180040 (polyvinyl alcohol (E1203) – 37%, talc (E553b) – 31%, titanium dioxide (E171) – 25%, glycerol monocaprylocaprate (type 1) – 4%, sodium lauryl sulfate – 3%) – 18 mg.

60 pcs. – polyethylene jars (1) – cardboard packs.

Marketing Authorization Holder

PSK Pharma, LLC (Russia)

Dosage Form

Bottle Rx Icon Valganciclovir Film-coated tablets, 450 mg: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets brownish-pink, biconvex, oblong in shape, with a score on one side.

1 tab.
Valganciclovir (as valganciclovir hydrochloride) 450 mg (506.28 mg*)

* accounting for a 2% overage.

Excipients: microcrystalline cellulose (type 102) – 74.81 mg, crospovidone – 24.46 mg, povidone K30 – 20 mg, stearic acid – 6.67 mg, colloidal silicon dioxide – 7.78 mg.

Shell composition Opadry brown 15B565000 (hypromellose (hydroxypropyl methylcellulose) – 12.69 mg, titanium dioxide – 5.18 mg, macrogol (polyethylene glycol) – 1.6 mg, iron oxide red dye – 0.33 mg, polysorbate 80 – 0.2 mg) – 20 mg.

10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (9) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Form

Bottle Rx Icon Valganciclovir Canon Film-coated tablets, 450 mg: 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow with a brownish tint, round, biconvex; on the cross-section – almost white in color.

1 tab.
Valganciclovir hydrochloride 496.3 mg,
   Equivalent to valganciclovir content 450 mg

Excipients: colloidal silicon dioxide – 9 mg, crospovidone – 18 mg, magnesium stearate – 3 mg, povidone K-30 – 12 mg, stearic acid – 3 mg, microcrystalline cellulose type 101 – 58.7 mg.

Shell composition Opadry II 85F32410 yellow – 18 mg, incl.: polyvinyl alcohol – 7.2 mg, macrogol (polyethylene glycol) – 3.636 mg, talc – 2.664 mg, titanium dioxide – 4.23 mg, iron oxide yellow dye – 0.27 mg.

60 pcs. – polyethylene jars (1) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.

Marketing Authorization Holder

Advanced Pharma, LLC (Russia)

Dosage Form

Bottle Rx Icon Valganciclovir-Advanced Film-coated tablets, 450 mg: 10, 20, 30, 40, 60, or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets

Valganciclovir 450 mg

10 pcs. – jars – cardboard packs (10 pcs.) – By prescription
10 pcs. – blisters – cardboard packs (10 pcs.) – By prescription
10 pcs. – blisters (10 pcs.) – cardboard packs (100 pcs.) – By prescription
10 pcs. – blisters (2 pcs.) – cardboard packs (20 pcs.) – By prescription
10 pcs. – blisters (3 pcs.) – cardboard packs (30 pcs.) – By prescription
10 pcs. – blisters (4 pcs.) – cardboard packs (40 pcs.) – By prescription
10 pcs. – blisters (5 pcs.) – cardboard packs (50 pcs.) – By prescription
10 pcs. – blisters (6 pcs.) – cardboard packs (60 pcs.) – By prescription
100 pcs. – jars – cardboard packs (100 pcs.) – By prescription
20 pcs. – jars – cardboard packs (20 pcs.) – By prescription
30 pcs. – jars – cardboard packs (30 pcs.) – By prescription
40 pcs. – jars – cardboard packs (40 pcs.) – By prescription
50 pcs. – jars – cardboard packs (50 pcs.) – By prescription
60 pcs. – jars – cardboard packs (60 pcs.) – By prescription

Marketing Authorization Holder

Pharmasintez-Tyumen, LLC (Russia)

Dosage Form

Bottle Rx Icon Valganciclovir-FS Film-coated tablets, 450 mg: 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets brownish-pink, biconvex oblong, with a score on one side; on the cross-section the core is from white to almost white.

1 tab.
Valganciclovir hydrochloride 506.28 mg
   Equivalent to valganciclovir content 450 mg

Excipients: microcrystalline cellulose (type 102) – 74.81 mg, crospovidone XL-10 – 24.46 mg, povidone K-30 – 20 mg, stearic acid PALMAC 90-18 – 6.67 mg, colloidal silicon dioxide – 7.78 mg.

Film shell composition: ready-made film coating (hypromellose – 12.69 mg, titanium dioxide – 5.18 mg, polyethylene glycol – 1.6 mg, iron oxide red dye – 0.33 mg, polysorbate 80 – 0.2 mg) – 20 mg.

10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (9) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Teva Czech Industries, s.r.o. (Czech Republic)

Dosage Form

Bottle Rx Icon Valganciclovir-Teva Film-coated tablets, 450 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets pink, oval, biconvex, with a bevel and engraving “93” on one side and “5465” on the other.

1 tab.
Valganciclovir hydrochloride 496.3 mg,
   Equivalent to valganciclovir content 450 mg

Excipients: microcrystalline cellulose (type 112) – 70 mg, mannitol – 86.23 mg, colloidal silicon dioxide – 3.4 mg, crospovidone (type A) – 10.05 mg, magnesium stearate – 4.02 mg.

Shell composition Opadry II 32K54870 pink – 26.8 mg (hypromellose 15 cP / HPMC 2910 (E464) – 10.72 mg, lactose monohydrate – 6.7 mg, titanium dioxide (E171) – 6.218 mg, triacetin (E1518) – 2.948 mg, iron oxide red dye (E172) – 0.214 mg).

10 pcs. – blisters (3) – cardboard packs×.
10 pcs. – blisters (6) – cardboard packs×.
30 pcs. – polyethylene jars (1) – cardboard packs×.
60 pcs. – polyethylene jars (1) – cardboard packs×.

× protective stickers may additionally be applied.

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