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Cytarabine (Cytarabine) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Expected Reactions

Because cytarabine is a bone marrow suppressant, anemia, leukopenia, thrombocytopenia, megaloblastosis and reduced reticulocytes can be expected as a result of administration with cytarabine. The severity of these reactions are dose and schedule dependent. Cellular changes in the morphology of bone marrow and peripheral smears can be expected.

Following 5-day constant infusions or acute injections of 50 mg/m2 to 600 mg/m2, white cell depression follows a biphasic course. Regardless of initial count, dosage level, or schedule, there is an initial fall starting the first 24 hours with a nadir at days 7-9. This is followed by a brief rise which peaks around the twelfth day. A second and deeper fall reaches nadir at days 15-24. Then there is a rapid rise to above baseline in the next 10 days. Platelet depression is noticeable at 5 days with a peak depression occurring between days 12-15. Thereupon, a rapid rise to above baseline occurs in the next 10 days.

Infectious Complications

Infection

Viral, bacterial, fungal, parasitic or saprophytic infections, in any location in the body may be associated with the use of cytarabine alone or in combination with other immunosuppressive agents following immunosuppressant doses that affect cellular or humoral immunity. These infections may be mild, but can be severe and at times fatal.

The Cytarabine Syndrome

A cytarabine syndrome has been described by Castleberry. It is characterized by fever, myalgia, bone pain, occasionally chest pain, maculopapular rash, conjunctivitis and malaise. It usually occurs 6-12 hours following drug administration. Corticosteroids have been shown to be beneficial in treating or preventing the syndrome. If the symptoms of this syndrome are deemed treatable, corticosteroids should be contemplated as well as continuation of therapy with cytarabine.

Most Frequent Adverse Reactions

Anorexia, hepatic dysfunction, nausea, fever, vomiting, rash, diarrhea, thrombophlebitis, oral and anal inflammation or ulceration, bleeding (all sites). Nausea and vomiting are most frequent following rapid intravenous injection.

Less Frequent Adverse Reactions

Sepsis, abdominal pain, pneumonia, freckling, cellulitis at injection site, jaundice, skin ulceration, conjunctivitis (may occur with rash), urinary retention, dizziness, renal dysfunction, alopecia, neuritis, anaphylaxis (see WARNINGS), neural toxicity, allergic edema, sore throat, pruritus, esophageal ulceration, shortness of breath, esophagitis, urticaria, chest pain, pericarditis, headache, bowel necrosis, pancreatitis.

Experimental Doses

Severe and at times fatal CNS, GI and pulmonary toxicity (different from that seen with conventional therapy regimens of cytarabine) has been reported following some experimental dose schedules of cytarabine. These reactions include reversible corneal toxicity and hemorrhagic conjunctivitis, which may be prevented or diminished by prophylaxis with a local corticosteroid eye drop; cerebral and cerebellar dysfunction, including personality changes, somnolence and coma, usually reversible; severe gastrointestinal ulceration, including pneumatosis cystoides intestinalis leading to peritonitis; sepsis and liver abscess; pulmonary edema, liver damage with increased hyperbilirubinemia; bowel necrosis; and necrotizing colitis. Rarely, severe skin rash, leading to desquamation has been reported. Complete alopecia is more commonly seen with experimental high dose therapy than with standard cytarabine treatment programs. If experimental high dose therapy is used, do not use a cytarabine injection containing benzyl alcohol.

Cases of cardiomyopathy with subsequent death has been reported following experimental high dose therapy with cytarabine in combination with cyclophosphamide when used for bone marrow transplant preparation. This cardiac toxicity may be schedule dependent.

A syndrome of sudden respiratory distress, rapidly progressing to pulmonary edema and radiographically pronounced cardiomegaly has been reported following experimental high dose therapy with cytarabine used for the treatment of relapsed leukemia from one institution in 16/72 patients. The outcome of this syndrome can be fatal.

Two patients with adult acute non-lymphocytic leukemia developed peripheral motor and sensory neuropathies after consolidation with high-dose cytarabine, daunorubicin, and asparaginase. Patients treated with high-dose cytarabine should be observed for neuropathy since dose schedule alterations may be needed to avoid irreversible neurologic disorders.

Ten patients treated with experimental intermediate doses of cytarabine (1 g/m2) with and without other chemotherapeutic agents (meta-AMSA, daunorubicin, etoposide) at various dose regimens developed a diffuse interstitial pneumonitis without clear cause that may have been related to the cytarabine.

Two cases of pancreatitis have been reported following experimental doses of cytarabine and numerous other drugs. Cytarabine could have been the causative agent.



REPORTS OF SUSPECTED CYTARABINE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Cytarabine. The information is not vetted and should not be considered as verified clinical evidence.

Possible Cytarabine side effects / adverse reactions in 55 year old female

Reported by a physician from Japan on 2011-10-03

Patient: 55 year old female weighing 43.3 kg (95.3 pounds)

Reactions: Septic Shock

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Doxorubicin Hydrochloride
    Dosage: 30 mg/m2 x 1/4 week
    Start date: 2011-07-20
    End date: 2011-09-06

Etoposide
    Dosage: 100 mg/m2, x 1 / 4week
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2011-07-28
    End date: 2011-07-30

KW-0761
    Dosage: 1.0 mg/kg, x 1 / 2week
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2011-07-14
    End date: 2011-08-17

Prednisolone
    Dosage: 40 mg/m2, x 1 / 4week
    Administration route: Oral
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2011-07-13
    End date: 2011-08-18

Vindesine Sulfate
    Dosage: 2.4 mg/m2, x 1 / 4week
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2011-07-28
    End date: 2011-07-28

Doxorubicin Hydrochloride
    Dosage: 40 mg/m2 x 1/4week
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2011-07-13
    End date: 2011-08-18

Methotrexate Sodium
    Dosage: 15 mg, 1 / 8week
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2011-08-16

Cyclophosphamide
    Dosage: 350 mg/m2, x 1 /4week
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2011-07-13
    End date: 2011-08-18

Prednisolone
    Dosage: 40 mg/m2, x 1 / 4week
    Administration route: Oral
    Start date: 2011-07-28
    End date: 2011-07-30

Ranimustine
    Dosage: 60 mg/m2, x 1 / 4week
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2011-07-20
    End date: 2011-09-06

Prednisolone Sodium Succinate INJ
    Dosage: 10 mg, x 1 / 8week
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2011-08-16

Cytarabine
    Dosage: 40 mg, x 1 / 8week
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2011-08-16

Vincristine Sulfate
    Dosage: 1 mg/m2, x 1 / 4week
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2011-07-13
    End date: 2011-08-18

Prednisolone
    Dosage: 40 mg/m2, x 1 / 4week
    Administration route: Oral
    Start date: 2011-07-20
    End date: 2011-09-06

Carboplatin
    Dosage: 250 mg/m2, x 1 / 4week
    Indication: Adult T-Cell Lymphoma/leukaemia
    Start date: 2011-07-28
    End date: 2011-07-28

Other drugs received by patient: Solu-Medrol; Levothyroxine Sodium; Prepenon; Amizet; Potassium Phosphate Dibasic; Neoparen No.2; Funguard; Intrafat; NEO-Mercazole TAB; Sodium Bicarbonate; Pasil; Famotidine



Possible Cytarabine side effects / adverse reactions in 34 year old female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2011-10-03

Patient: 34 year old female weighing 65.5 kg (144.1 pounds)

Reactions: Drug Interaction, Sinus Tachycardia, Sinoatrial Block, Sinus Bradycardia

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Noxafil
    Dosage: 400 mg milligram(s), 1 day, oral
    Administration route: Oral
    Indication: Hepatosplenic Candidiasis
    Start date: 2007-10-19
    End date: 2008-01-25

Etoposide
    Indication: Product Used FOR Unknown Indication

Acyclovir
    Dosage: 200 mg milligram(s), oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Ondansetron
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-01-22
    End date: 2008-01-25

Vogalene
    Indication: Product Used FOR Unknown Indication

Allopurinol
    Dosage: 100 mg milligram(s), oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Cytarabine
    Indication: Product Used FOR Unknown Indication

Pantoloc /01263204/)
    Dosage: 40 mg milligram(s)
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-01-22
    End date: 2008-01-25

Potassium Chloride
    Dosage: 750 mg milligram(s), oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Cytarabine side effects / adverse reactions in 54 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-03

Patient: 54 year old male

Reactions: Fungal Infection, Pyrexia, Neutropenia, Septic Shock

Adverse event resulted in: death

Suspect drug(s):
Cytarabine
    Dosage: 30 mg, unk

Idarubicin HCL
    Dosage: unk ukn, unk

Hydrocortisone
    Dosage: 12.5 mg, unk

Methotrexate
    Dosage: 12.5 mg, unk

Etoposide
    Dosage: unk ukn, unk

Other drugs received by patient: Amphotericin B



See index of all Cytarabine side effect reports >>

Drug label data at the top of this Page last updated: 2006-05-15

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