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Cytovene Side Effects

Generic Name: ganciclovir

Note: This document contains side effect information about ganciclovir. Some of the dosage forms listed on this page may not apply to the brand name Cytovene.

In Summary

Common side effects of Cytovene include: severe neutropenia, severe thrombocytopenia, anemia, leukopenia, neutropenia, and decreased creatinine clearance. Other side effects include: severe anemia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to ganciclovir: capsule, powder for solution, solution

Along with its needed effects, ganciclovir (the active ingredient contained in Cytovene) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Medicines like ganciclovir can sometimes cause serious side effects such as blood problems; these are described below. Discuss these possible effects with your doctor.

Check with your doctor immediately if any of the following side effects occur while taking ganciclovir:

More Common

For oral capsules and injection into the vein only

Less Common

For oral capsules and injection into the vein only

  • Mood or other mental changes
  • nervousness
  • pain at place of injection
  • skin rash
  • tremor
  • unusual tiredness and weakness

For injection into the eye only

  • Decreased vision or any change in vision

Some side effects of ganciclovir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less Common

For Healthcare Professionals

Applies to ganciclovir: intravenous powder for injection, intravenous solution, oral capsule

General

The most commonly reported adverse events have included pyrexia, diarrhea, leukopenia, nausea, anemia, asthenia, headache, cough, dyspnea, abdominal pain, decreased appetite, and increased creatinine.[Ref]

Hematologic

Very common (10% or more): Leukopenia (up to 41%), anemia (up to 26%), neutropenia (up to 26%)

Common (1% to 10%): Thrombocytopenia, lymphadenopathy

Uncommon (0.1% to 1%): Bone marrow failure

Frequency not reported: Pancytopenia

Postmarketing reports: Hemolytic anemia, agranulocytosis, granulocytopenia[Ref]

During clinical trials for the treatment of CMV retinitis, neutropenia with absolute neutrophil count (ANC) less than 500, between 500 and 749, and 750 to less than 1000 mcL, was reported in 25%, 14%, and 26% of patients, respectively. Anemia with hemoglobin less than 6.5, between 6.5 and less than 8, and 8 to less than 9.5 g/dL was reported in 5%, 16%, and 26% of patients, respectively.

During clinical trials among transplant recipients receiving this drug for CMV prevention, neutropenia with absolute neutrophil count (ANC) less than 500, between 500 and 1000 mcL, and total ANC of 1000 mcL or less was reported in 4%, 3% and 7% of heart transplant recipients and 12%, 29%, and 41% of bone marrow transplant recipients, respectively. Thrombocytopenia with platelet counts less than 25,000 and between 25,000 and 50,000 mcL were reported in 3% and 5% and 32% and 25% of heart and bone marrow recipients, respectively. Total platelet count of 50,000 mcL or less was reported in 8% and 57% of heart and bone marrow recipients, respectively.[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 44%), vomiting 13%

Common (1% to 10%): Nausea, abdominal pain, constipation, flatulence, esophageal candidiasis, dysphagia, dyspepsia

Uncommon (0.1% to 1%): Mouth ulceration, abdominal distention, pancreatitis

Frequency not reported: Gastrointestinal perforation, eructation, dry mouth, pancreatitis

Postmarketing reports: Intestinal ulcer[Ref]

Renal

Very common (10% or more): Elevated serum creatinine

Frequency not reported: Kidney failure, abnormal renal function, pleural effusion

Postmarketing reports: Renal tubular disorder, hemolytic uremic syndrome[Ref]

Elevated serum creatinine between greater than 1.5 and less than 2.5 mg/dL was reported in 14% of patients receiving 5 mg/kg/day for treatment of CMV retinitis; 2% experienced elevated serum creatinine of 2.5 mg/dL or greater.

Elevated serum creatinine between greater than 1.5 and less than 2.5 mg/dL was reported in 58%, 50%, and 43% of patients receiving this drug for CMV prevention in heart, and 2 bone marrow trials, respectively; 18%, 20%, and 0% experienced serum creatinine levels of 2.5 mg/dL or higher.[Ref]

Genitourinary

Frequency not reported: Urinary tract infection, urinary frequency, hematuria

Postmarketing reports: Testicular hypertrophy[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity

Postmarketing reports: Anaphylactic reaction, allergic reaction[Ref]

Ocular

Very common (10% or more): Retinal detachment (11%)

Common (1% to 10%): Eye hemorrhage, macular edema, vitreous floaters, eye pain

Frequency not reported: Visual impairment, vitreous disorders, eye pain, conjunctivitis

Postmarketing reports: Cataracts, dry eyes[Ref]

Retinal detachment has been observed both before and after initiation of therapy in patients with CMV retinitis; its relationship to therapy is unknown.[Ref]

Cardiovascular

Very common (10% or more): Tachycardia (16%), hypotension (11%)

Frequency not reported: Arrhythmias, chest pain, hypertension, phlebitis, vasodilation

Postmarketing reports: Cardiac arrest, conduction disorder, torsade de pointes, ventricular tachycardia, peripheral ischemia[Ref]

Cases of ventricular tachycardia associated with ganciclovir infusions in patients with AIDS have been reported, although it is known that HIV infection is associated with myocarditis, decreased left ventricular function, and in some cases, nonsustained ventricular tachycardia.[Ref]

Dermatologic

Very common (10% or more): Hyperhidrosis (12%)

Common (1% to 10%): Pruritus, dermatitis, night sweats

Frequency not reported: Cellulitis, alopecia, dry skin, urticaria, rash, photosensitivity reaction

Postmarketing reports: Exfoliative dermatitis, Stevens-Johnson syndrome[Ref]

Hepatic

Common (1% to 10%): Increased alkaline phosphatase

Frequency not reported: Abnormal hepatic function tests, increased transaminases

Postmarketing reports: Cholelithiasis, cholestasis, hepatic failure, hepatitis[Ref]

Nervous system

Very common (10% or more): Headache (15%)

Common (1% to 10%): Peripheral neuropathy, tremor, dizziness, paresthesia, hypoesthesia, seizures, dysgeusia

Frequency not reported: Somnolence

Postmarketing reports: Dysesthesia, dysphasia, extrapyramidal disorder, facial paralysis, amnesia, anosmia, myelopathy, cerebrovascular accident, third cranial nerve paralysis, aphasia, encephalopathy, intracranial hypertension, facial palsy[Ref]

Endocrine

Postmarketing reports: Inappropriate antidiuretic hormone secretion, infertility[Ref]

Local

Common (1% to 10%): Catheter infection, catheter sepsis, injection site inflammation,

other catheter related events

Frequency not reported: Injection site inflammation[Ref]

Metabolic

Very common (10% or more): Decreased appetite (14%), decreased blood magnesium (11%)

Common (1% to 10%): Decreased weight, anorexia

Frequency not reported: Hypocalcemia, hypokalemia, hyperglycemia

Postmarketing reports: Acidosis, hypercalcemia, hyponatremia, increased blood triglycerides[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, myalgia, back pain, muscle spasms

Frequency not reported: Leg cramps, myasthenia

Postmarketing reports: Arthritis, rhabdomyolysis[Ref]

Respiratory

Very common (10% or more): Cough (16%)

Common (1% to 10%): Pneumocystis carinii pneumonia, sinus congestion, rhinitis, dyspnea

Frequency not reported: Upper respiratory infection

Postmarketing reports: Bronchospasm, pulmonary fibrosis[Ref]

Other

Very common (10% or more): Pyrexia (up to 48%)

Common (1% to 10%): Chills

Uncommon (0.1% to 1%): Deafness

Frequency not reported: Tinnitus, ear pain, fatigue, pain, malaise, asthenia, multiple organ failure

Postmarketing reports: Congenital anomaly, loss of sense of smell[Ref]

Immunologic

Very common (10% or more): Sepsis (15%), infection (13%)

Common (1% to 10%): Mycobacterium avium complex

Frequency not reported: Candida infections, influenza

Postmarketing reports: Vasculitis[Ref]

References

1. "Product Information. Cytovene (ganciclovir)." Genentech, South San Francisco, CA.

2. Sulecki M, Rosenfeld CS, Przepiorka D, et al "Treatment of ganciclovir-induced neutropenia with recombinant human GM-CSF." Am J Med 90 (1991): 401-2

3. Tomonari A, Takahashi S, Ooi J, et al. "Preemptive therapy with ganciclovir 5 mg/kg once daily for cytomegalovirus infection after unrelated cord blood transplantation." Bone Marrow Transplant (2007):

4. Reischig T, Jindra P, Mares J, et al. "Valacyclovir for Cytomegalovirus Prophylaxis Reduces the Risk of Acute Renal Allograft Rejection." Transplantation 79 (2005): 317-324

5. Wiltshire H, Paya CV, Pescovitz MD, et al. "Pharmacodynamics of Oral Ganciclovir and Valganciclovir in Solid Organ Transplant Recipients." Transplantation 79 (2005): 1477-1483

6. Slifkin M, Doron S, Snydman DR "Viral prophylaxis in organ transplant patients." Drugs 64 (2004): 2763-92

7. Whitely RJ "Ganciclovir: have we established clinical value in the treatment of cytomegalovirus infections?" Ann Intern Med 108 (1988): 452-4

8. Hayashi K, Mori J, Saito H, Hayashi T "Antiviral targets of a chromene derivative from Sargassum micracanthum in the replication of human cytomegalovirus." Biol Pharm Bull 29 (2006): 1843-7

9. Asano-Mori Y, Kanda Y, Oshima K, et al. "Pharmacokinetics of ganciclovir in haematopoietic stem cell transplantation recipients with or without renal impairment." J Antimicrob Chemother 57 (2006): 1004-7

10. SOCA Reseach Group, et al "Mortality in patients with the acquired immunodeficiency syndrome treated with either foscarnet or ganciclovir for cytomegalovirus retinitis." N Engl J Med 326 (1992): 213-20

11. Goodrich JM, Mori M, Gleaves CA, et al "Early treatment with ganciclovir to prevent cytomegalovirus disease after allogeneic bone marrow transplantation." N Engl J Med 325 (1991): 1601-7

12. Salzberger B, Bowden RA, Hackman RC, Davis C, Boeckh M "Neutropenia in allogeneic marrow transplant recipients receiving ganciclovir for prevention of cytomegalovirus disease: risk factor and outcome." Blood 90 (1997): 2502-8

13. Schmidt GM, Horak DA, Niland JC, et al "A randomized, controlled trial of prophylactic ganciclovir for cytomegalovirus pulmonary infection in recipients of allogeneic bone marrow transplants." N Engl J Med 324 (1991): 1005-12

14. Takami A, Mochizuki K, Ito S, et al. "Safety and efficacy of foscarnet for preemptive therapy against cytomegalovirus reactivation after unrelated cord blood transplantation." Transplant Proc 39 (2007): 237-9

15. Taegtmeyer AB, Halil O, Bell AD, Carby M, Cummins D, Banner NR "Neutrophil dysplasia (acquired pseudo-pelger anomaly) caused by ganciclovir." Transplantation 80 (2005): 127-30

16. Keven K, Basu A, Tan HP, et al. "Cytomegalovirus prophylaxis using oral ganciclovir or valganciclovir in kidney and pancreas-kidney transplantation under antibody preconditioning." Transplant Proc 36 (2004): 3107-12

17. Faulds D, Heel RC "Ganciclovir: a review of its antiviral activity, pharmacokinetic properties and therapeutic efficacy in cytomegalovirus infections." Drugs 39 (1990): 597-638

18. Reed EC, Wolford JL, Kopecky KJ, et al "Ganciclovir for the treatment of cytomegalovirus gastroenteritis in bone marrow transplant patients." Ann Intern Med 112 (1990): 505-10

19. Cochrane AB "Antiviral dosing and efficacy for prophylaxis of cytomegalovirus disease in solid organ transplant recipients." Am J Health Syst Pharm 63(19 Suppl 5) (2006): S17-21

20. Jabs DA "The ganciclovir implant plus oral ganciclovir versus parenteral cidofovir for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome: The ganciclovir cidofovir cytomegalovirus retinitis trial." Am J Ophthalmol 131 (2001): 457-67

21. Figge HL, Bailie GR, Briceland LL, Kowalsky SF "Possible ganciclovir-induced hepatotoxicity in patients with aids." Clin Pharm 11 (1992): 432-4

22. Izzedine H, Launay-Vacher V, Deray G "Antiviral drug-induced nephrotoxicity." Am J Kidney Dis 45 (2005): 804-17

23. Cochereau-Massin I, Lehoang P, Lautier-Frau M, et al "Efficacy and tolerance of intravitreal ganciclovir in cytomegalovirus retinitis in aids." Ophthalmology 98 (1991): 1348-55

24. Cohen AJ, Weiser B, Afzal Q, Fuhrer J "Ventricular tachycardia in two patients with aids receiving ganciclovir (DHPG)." AIDS 4 (1990): 807-9

25. Marcollo Pini A, Kerl K, Kamarachev J, French LE, Hofbauer GF "Interstitial granulomatous drug reaction following intravenous ganciclovir." Br J Dermatol 158 (2008): 1391-3

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29. Davis CL, Springmeyer S, Gmerek BJ "Central nervous system side effects of ganciclovir." N Engl J Med 322 (1990): 933-4

30. Georgiev OP, Lal SM, Gupta N, Ross G "Ganciclovir-associated hypercalcemia in a renal transplant patient." Int J Artif Organs 21 (1998): 702-4

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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