A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Valcyte Indications, Dosage, Storage, Stability - valganciclovir
Valcyte Indications, Dosage, Storage, Stability - valganciclovir
INDICATIONS
AND USES
Valcyte tablets are indicated for the treatment of cytomegalovirus (CMV) retinitis
in patients with acquired immunodeficiency syndrome (AIDS) (see CLINICAL TRIALS
).
DOSAGE AND ADMINISTRATION
Strict adherence to dosage recommendations is essential to avoid overdose.
Valcyte tablets cannot be substituted for Cytovene capsules on a one-to-one
basis.
Valcyte tablets are administered orally, and should be taken with food (see
CLINICAL PHARMACOLOGY : Absorption ). After oral administration, valganciclovir
is rapidly and extensively converted into ganciclovir. The bioavailability of
ganciclovir from Valcyte tablets is significantly higher than from ganciclovir
capsules. Therefore the dosage and administration of Valcyte tablets as described
below should be closely followed (see PRECAUTIONS : General and OVERDOSAGE ).
For the Treatment of CMV Retinitis in Patients With Normal Renal Function
|
Induction:
For patients with active CMV retinitis, the recommended dosage is 900
mg (two 450 mg tablets)
twice a day for 21 days with food.
Maintenance:
Following induction treatment, or in patients with inactive CMV retinitis,
the recommended dosage
is 900 mg (two 450 mg tablets) once daily with food.
|
Renal Impairment
Serum creatinine or creatinine clearance levels should be monitored carefully.
Dosage adjustment is required according to creatinine clearance as shown in
the table below (see PRECAUTIONS : General and CLINICAL PHARMACOLOGY : Special
Populations : Renal Impairment ). Increased monitoring for cytopenias
may be warranted in patients with renal impairment (see PRECAUTIONS : Laboratory
Testing ).
Table 9. Dose Modifications for Patients with
Impaired Renal Function
| CrCl * (mL/min) |
Induction Dose |
Maintenance Dose |
| ≥ 60 |
900 mg twice daily |
900 mg once daily |
| 40 - 59 |
450 mg twice daily |
450 mg once daily |
| 25 - 39 |
450 mg once daily |
450 mg every 2 days |
| 10 - 24 |
450 mg every 2 days |
450 mg twice weekly |
*An estimated creatinine clearance can be related to
serum creatinine by the following formulas:
For males = (140 - age [years]) × (body weight [kg])
(72)
× (serum creatinine [mg/dL])
For females = 0.85 × male value |
Hemodialysis Patients
Valcyte should not be prescribed to patients receiving hemodialysis (see CLINICAL
PHARMACOLOGY: Special Populations : Hemodialysis and PRECAUTIONS : General
).
Handling and Disposal
Caution should be exercised in the handling of Valcyte tablets. Tablets should
not be broken or crushed. Since valganciclovir is considered a potential teratogen
and carcinogen in humans, caution should be observed in handling broken tablets
(see WARNINGS : Teratogenesis, Carcinogenesis and Mutagenesis ). Avoid direct
contact of broken or crushed tablets with skin or mucous membranes. If such
contact occurs, wash thoroughly with soap and water, and rinse eyes thoroughly
with plain water.
Because ganciclovir shares some of the properties of antitumor agents (ie,
carcinogenicity and mutagenicity), consideration should be given to handling
and disposal according to guidelines issued for antineoplastic drugs. Several
guidelines on this subject have been published (see REFERENCES ).
There is no general agreement that all of the procedures recommended in the
guidelines are necessary or appropriate.
HOW SUPPLIED
Valcyte (valganciclovir HCl tablets) is available as 450 mg pink convex oval
tablets with "VGC" on one side and "450" on the other side. Each tablet contains
valganciclovir HCl equivalent to 450 mg valganciclovir. Valcyte is supplied
in bottles of 60 tablets (NDC 0004-0038-22).
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See
USP controlled room temperature].
REFERENCES
- Recommendations for the Safe Handling of Cytotoxic Drugs. US Department
of Health and Human Services, National Institutes of Health, Bethesda, MD,
September 1992. NIH Publication No. 92-2621
- American Society of Hospital Pharmacists technical assistance bulletin on
handling cytotoxic and hazardous drugs. Am J Hosp Pharm. 1990; 47:1033-1049
- Controlling Occupational Exposures to Hazardous Drugs. US Department of
Labor. Occupational Health and Safety Administration. OSHA Technical Manual.
Section VI - Chapter 2, January 20, 1999
Cytovene is a registered trademark of Syntex (U.S.A.) LLC.
Valcyte tablets are manufactured by Patheon Inc., Mississauga, Ontario, Canada
L5N 7K9
Rx only
Distributed by:
Roche Pharmaceuticals
Roche Laboratories Inc.
340 Kingsland Street
Nutley, New Jersey 07110-1199
Mar 2001
Copyright © 2001 by Roche Laboratories Inc. All rights reserved.
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