Bicavir Tablet 450 mg (Cidofovir Hydrochloride)

Adult dosage

Treatment of CMV retinitis in patients with AIDS Adult patients Induction therapy For patients with active CMV retinitis, take 900mg per dose twice daily with food for 21 days. Maintenance therapy After induction therapy, or for patients with inactive CMV retinitis, take 900mg once daily with food. If retinitis worsens, repeat induction therapy. Prevention of CMV disease in transplant recipients Adult patients For kidney transplant recipients, start taking the medicine within 10 days after transplantation and take 900mg once daily through day 200. For recipients of solid organ transplants other than kidney transplants, start taking the medicine within 10 days after transplantation and take 900mg once daily through day 100. Dosage and administration in special populations Adults with renal impairment Serum creatinine clearance should be monitored carefully in patients with renal impairment, and the dose should be adjusted according to creatinine clearance. CrCl(ml/min) | Induction dose | Maintenance/prophylactic dose ≥60 | 900mg per dose twice daily | 900mg per dose once daily 40-59 | 450mg per dose twice daily | 450mg per dose once daily 25-39 | 450mg per dose once daily | 450mg per dose every other day 10-24 | 450mg per dose every other day | 450mg per dose twice weekly *Creatinine clearance is calculated from serum creatinine using the following formula. Female creatinine clearance = 0.85 x male creatinine clearance Patients on dialysis This medicine cannot be used in patients on dialysis (ClCR<10ml/min); use of intravenous ganciclovir is recommended, and the dose should be adjusted according to the current prescribing information for intravenous ganciclovir.

Children's dosage

Treatment of CMV retinitis in patients with AIDS Pediatric patients The safety and efficacy of this drug for the treatment of CMV retinitis have not been established in adequate and well-controlled clinical studies in pediatric patients. Prevention of CMV disease in solid organ transplant recipients Pediatric patients For pediatric patients aged 4 months or older who have undergone solid organ transplantation and are at risk of developing CMV disease, the recommended daily dose of this drug is calculated using the following formula based on body surface area (BSA) and creatinine clearance (CrCL) calculated using the Schwartz formula (CrCLS). Pediatric dose (mg) = 7 × BSA × CrCLS (Refer to the Mosteller BSA formula and the Schwartz creatinine clearance formula.) If the calculated Schwartz creatinine clearance exceeds 150mL/min/1.73m2, 150mL/min/1.73m2 should be used in the formula. k=0.45*(under 2 years of age) k=0.55 (boys: 2 years to under 13 years; girls: 2 years to under 16 years) k=0.7 (boys: 13 years-16 years) For patients over 16 years of age, refer to the adult dosage. - The k values provided are based on the Jaffe method for measuring serum creatinine; adjustment may be needed when an enzymatic method is used. -* A lower k value may be required for appropriate subpopulations. Pediatric kidney transplant recipients should start taking this drug within 10 days after transplantation and take the recommended dose (7×BSA×CrCLS) once daily through day 200. Pediatric recipients of solid organ transplants other than kidney transplants should start taking this drug within 10 days after transplantation and take the recommended dose (7×BSA×CrCLS) once daily through day 100. All calculated doses should be rounded to the nearest multiple of 25mg, taking into account the dose that can actually be administered. If the calculated dose exceeds 900mg, the maximum dose of this drug, 900mg, should be administered. Valcyte powder for oral solution is convenient for administering doses calculated using the above formula; however, the 450mg tablet may be taken if the calculated dose is within 10% of the 450mg tablet dose (405mg-495mg) and the patient can swallow tablets. It is recommended that serum creatinine levels be monitored regularly and that the dose be adjusted as appropriate during the prophylaxis period, taking into account changes in renal function and body weight.

This drug quickly converts to ganciclovir in the body and acts as such. Women who may become pregnant must use effective contraception while taking this medication, and men must use physical contraception for at least 90 days during and after taking the drug. This drug should not be administered to patients with very low levels of white blood cells, platelets, or hemoglobin, and blood tests should be conducted prior to administration to confirm these conditions. Adverse effects such as cytopenia or bone marrow suppression may occur, so blood counts should be monitored regularly, and if abnormalities are detected, medical consultation should be sought immediately. Patients with impaired kidney function may be affected in drug excretion; hence, dose adjustments may be necessary based on renal function tests. This medication may affect the central nervous system, causing dizziness, confusion, or seizures; caution is needed when performing hazardous tasks such as driving or operating machinery. Pregnant or breastfeeding women should generally not use this drug, and when nursing, careful consideration should be given to discontinuing either the medication or breastfeeding. Safety and efficacy data are lacking for children, especially infants under 4 months, so caution is advised in use. Elderly patients are at higher risk of renal function decline, and kidney function should be assessed before and after administration, with dose adjustments made accordingly while being alert for adverse reactions. This drug may interact with other medications, thus patients should inform healthcare providers of any other medications they are taking, especially immunosuppressants or antiviral agents, as side effects may increase when taken concurrently. In cases of overdose, there is a risk of severe bone marrow suppression and nephrotoxicity; therefore, it is critical to strictly adhere to the prescribed dosage and regimen, and to seek medical help immediately in the event of overdose. This medication should not be divided or powdered for use, and care should be taken to prevent any fragments from contacting the skin or mucous membranes while handling. For storage, keep this medication in a tightly sealed container, away from children, and dispose of expired medication properly.

• Diarrhea
• Neutropenia
• Fever
• Oral Candidiasis
• Headache
• Fatigue
• Nausea
• Injection Site Reaction
• Phlebitis
• Thrombophlebitis

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is important to store it at room temperature, between 1 and 30 degrees Celsius, to maintain its efficacy.

Appearance

Brown, double-convex, film-coated tablet

Package unit

20 tablets/blister[/box]