Cytovene

[Guest guest]

http://www.stanford.edu/~thanatos/ganciclovir.html

CYTOVENE

General description

Cytovene is the name for the drug ganciclovir, or ganciclovir sodium, put

out by Roche Laboratories. Ganciclovir is a synthetic guanine derivative and

an active antiviral agent for cytomegalovirus (CMV) infections. It is

available in two forms: Cytovene-IV is found as a sterile lyophilized powder

for use with intravenous administration. Each vial contains 500 mg of

ganciclovir, which can be reconstituted with 10 mL of sterile water for

injection (see usage). Cytovene is the capsular form available in 250 mg and

500 mg dosages.

Mechanism

Ganciclovir acts to inhibit CMV replication. It is phosphorylated to

ganciclovir triphosphate in the body by cellular kinases whereupon the drug

enters the infected cells where it persists for days. Ganciclovir

triphosphate then inhibits DNA synthesis by competitively inhibiting DNA

polymerases and incorporating itself into the viral DNA, terminating viral

DNA elongation.

Indications

Cytovene-IV is indicated for treating immunocompromised patients infected

with CMV. This includes patients already infected with HIV. It is also

indicated as a preventive agent for transplant recipients at risk for CMV

infection.

Cytovene capsules are indicated for prevention of CMV infection in organ

transplant recipients and for patients with advanced HIV infection at risk

for CMV infection. Capsules are also indicated as alternative treatment to

Cytovene-IV intravenous administration for maintaining treatment for CMV

retinitis and for cases where the benefit of avoiding intravenous

administration outweighs the risk of more rapid progression of disease

course.

Usage/Dosage

preparation

Reconstitute Cytovene-IV by adding 10 mL of sterile water to the ganciclovir

vial. Shake the vial to dissolve the drug and inspect the solution for

particles or discoloration (vial should be discarded if particulate matter

or discoloration is observed). Reconstituted solution should be stable at

room temperature for 12 hours. For IV infusion, concentrations greater than

10 mg/mL are not recommended.

CMV retinitis

induction treatment: recommended initial dosage for normal renal function

patients is 5mg/kg intravenously at a constant rate over 1 your every 12

hours for 14 to 21 days.

maintenance treatment: following induction treatment, Cytovene-IV can be

given intravenously at 5 mg/kg in a constant rate IV infusion over 1 hour

daily, 7 days per week or 6 mg/kg once daily, 5 days a week. Or Cytovene

capsules can be used at 1000 mg tid with food. Alternatively, a dosage of

500 mg 6 times daily every 3 hours with food during waking hours can be

used. if CMV retinitis progresses, reinduction treatment is recommended.

Preventing CMV disease in patients with advanced HIV disease and normal

renal function

recommended prophylactic treatment is Cytovene capsules at 1000 mg tid with

food.

Preventing CMV in Transplant recipients with normal renal function

Cytovene-IV can be used initially at at 5 mg/kg every 12 hours for 7 to 14

days followed by 5 mg/kg once daily7 days per week or 6 mg/kg once daily, 5

days per week. Cytovene capsules can be used at 1000 mg tid with food.

Duration of treatment for either form is dependent on the degree and

duration of immunosuppression

With Renal impairment

Dosing for patients receiving hemodialysis treatment should not exceed 1.25

mg/kg 3 times per week. Treatment should be administered shortly following

hemodialysis. Dosage should be adjusted as according to the following

tables:

Creatine Clearance* (mL/min> Cytovene-IV induction Dose Dosing Interval

(hrs) Cytovene-IV maintenance Dose (mg/kg) Dosing Interval (hrs)

>70 5.0 12 5.0 24

50-69 2.5 12 2.5 24

25-49 2.5 24 1.25 24

10-24 1.25 24 0.625 24

<10 1.25 3 times per week, following hemodialysis 0.625 3 times per week,

following hemodialysis

Creatine Clearance* (mL/min) Cytovene Capsule Dosages

>70 1000 mg tid or 500 mg q3h, 6x/day

50-69 1500 mg qd or 500 mg tid

25-49 1000 mg qd or 500 mg bid

10-24 500 mg qd

<10 500 mg 3 times per week, following hemodialysis

*Creatine Clearance can be calculated in the following manner:

For males = ((140-age[yrs])(body wt.[kg]))/((72)(serum creatine[mg/mL]))

For females = 0.85 x male value

Precautions

Overdose can lead to toxicity. The major elimination pathway for ganciclovir

is renal, so adequate hydration should be performed following IV

administration. Cytovene-IV should not be administered by rapid or bolus

intravenous injection or by intramuscular or subcutaneous injection.

Cytovene has potential negative interactions with didanosine, zidovudine,

probenecid, imipenem-cilastatin, and potentially drugs that inhibit

replication of rapidly dividing cell populations. Ganciclovir is a potential

long term carcinogen, teratogen, and source of reproductive impairment.

Contraindications

Cytovene should be used with caution in patients with a history of cytopenic

drug reactions. Although it has not been tested in humans yet, it has been

found that Cytovene caused reversible infertility in animals at lower doses

and irreversible infertility in animals at higher doses. Since it is a

teratogen, men and women should practice effective contraception during and

90 days following treatment with Cytovene or Cytovene-IV.

Potential Adverse Effects

Abdominal pain, nausea, flatulence, pneumonia, paresthesia, and rash are the

most frequently observed effects in clinical trials, but occur with equal or

greater frequency than placebo controlled subjects.

[Guest guest]

Thanks for the info Kay. Sounds dreadful, which is how I feel!

Lovette