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Cytarabine

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Cytarabine

Cytarabine

Cytarabine Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Cytarabine for Injection (Brand Names: Cytosar-U, Tarabine PFS) is used to treat certain types of leukemia (blood cancers). Cytarabine is also used to treat leukemia associated with meningitis. It is a cancer medication. This medication is available in generic form. Common side effects include nausea and vomiting (may be severe), loss of appetite, diarrhea, headache, dizziness, and pain/swelling/redness at the injection site.

Cytarabine may be given by intravenous infusion or injection, subcutaneously, or intrathecally. Dose is determined by a physician. Cytarabine may interact with digoxin. Other drugs may interact with cytarabine. Tell your doctor all prescription and over-the-counter medications and supplements you use. Cytarabine is not recommended for use during pregnancy. It may harm a fetus, especially in the first 3 months of pregnancy. It is recommended that men and women use two forms of birth control (e.g., condoms, birth control pills) while taking this medication and for some period afterwards. Consult your doctor. It is unknown if this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended.

Our Cytarabine Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Cytarabine in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have a serious side effect such as:

  • fever with nausea, vomiting, and headache;
  • problems with your vision or hearing;
  • loss of movement in any part of your body;
  • loss of bowel or bladder control;
  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • confusion, unusual thoughts or behavior;
  • trouble standing or walking,
  • seizure (convulsions);
  • pain or burning when you urinate;
  • feeling like you might pass out; or
  • feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.

Less serious side effects may include:

  • drowsiness, dizziness, weakness, memory problems;
  • constipation, diarrhea, mild nausea;
  • back pain, pain in your arms or legs;
  • headache; or
  • trouble sleeping (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Cytarabine (Cytarabine) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Cytarabine FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Expected Reactions: Because cytarabine is a bone marrow suppressant, anemia, leukopenia, thrombocytopenia, megaloblastosis, and reduced reticulocytes can be expected as a result of administration of 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 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 to 9. This is followed by a brief rise which peaks around day 12. A second and deeper fall reaches nadir at days 15 to 24. Then there is a rapid rise to above baseline in the next 10 days. Platelet depression is noticeable at day 5 with a peak depression occurring between days 12 to 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 (Ara-C) 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 to 12 hours following drug administration. Corticosteroids have been shown to be beneficial in treating or preventing this syndrome. If the symptoms of the 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 or ulceration inflammation bleeding (all sites)

Nausea and vomiting are most frequent following rapid intravenous injection.

Less Frequent Adverse Reactions
sepsis bowel necrosis
pneumonia abdominal pain
cellulitis at injection site freckling jaundice
skin ulceration conjunctivitis (may occur with rash)
urinary retention dizziness
renal dysfunction alopecia
neuritis neural toxicity anaphylaxis (See "WARNINGS" Section)
sore throat allergic edema
esophageal ulceration pruritus
esophagitis shortness of breath
chest pain urticaria
pericarditis pancreatitis headache

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 diluent containing benzyl alcohol.

Cases of cardiomyopathy with subsequent death have 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.

Read the entire FDA prescribing information for Cytarabine (Cytarabine) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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