FLONIDA CREAM (Efudex) 5% w/v

Fluorouracil Information

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Pronunciation

flure oh YOOR a sil

 

What is this drug used for?

• It is used to treat colorectal cancer.

• It is used to treat breast cancer.

• It is used to treat stomach cancer.

• It is used to treat pancreatic cancer.

• It may be given to you for other reasons. Talk with the doctor.

Frequently reported side effects of this drug

• Lack of appetite

• Dry skin

• Hair loss

• Nail changes

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Infection

• Bleeding like vomiting blood or vomit that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding.

• Chest pain

• Shortness of breath

• Excessive weight gain

• Swelling in the arms or legs

• Abnormal heartbeat

• Dizziness

• Passing out

• Severe abdominal pain

• Severe nausea

• Vomiting

• Severe diarrhea

• Swelling of hands or feet

• Change in balance

• Severe fatigue

• Confusion

• Severe mouth irritation

• Burning or numbness feeling

• Involuntary eye movements

• Headache

• Mouth sores

• Sensitivity to lights

• Severe loss of strength and energy

• Vision changes

• Severe injection site pain, burning, edema, or redness

• Redness or irritation of palms or soles of feet

• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

 

Medication Safety Issues

 

Storage and Stability

Store intact vials at 20°C to 25°C (68°F to 77°F). Do not freeze. Protect from light. Pharmacy bulk vials should be used within 4 hours of initial entry. Syringes and solutions diluted for infusion may be stored for up to 4 hours (at room temperature) prior to administration (according to the manufacturer). Fluorouracil 50 mg/mL in NS was stable in polypropylene infusion pump syringes for 7 days when stored at 30°C (86°F) (Stiles 1996). Stability of fluorouracil 1 mg/mL or 10 mg/mL in NS or D5W in PVC bags was demonstrated for up to 14 days at 4°C (39.2°F) and 21°C (69.8°F) (Martel 1996). Stability of undiluted fluorouracil (50 mg/mL) in ethylene-vinyl acetate ambulatory pump reservoirs was demonstrated for 3 days at 4°C (39.2°F) (precipitate formed after 3 days) and for 14 days at 33°C (91.4°F) (Martel 1996). Stability of undiluted fluorouracil (50 mg/mL) in PVC ambulatory pump reservoirs was demonstrated for 5 days at 4°C (39.2°F) (precipitate formed after 5 days) and for 14 days at 33°C (91.4°F) (Martel 1996). Follow USP 797 recommendations for beyond use dates based on the level of risk for preparation.

 

Adverse Reactions

Toxicity depends on duration of treatment and/or rate of administration.

Cardiovascular: Angina pectoris, cardiac arrhythmia, cardiac failure, cerebrovascular accident, ischemic heart disease, local thrombophlebitis, myocardial infarction, vasospasm, ventricular ectopy

Central nervous system: Cerebellar syndrome (acute), confusion, disorientation, euphoria, headache

Dermatologic: Alopecia, changes in nails (including nail loss), dermatitis, hyperpigmentation (supravenous), maculopapular rash (pruritic), palmar-plantar erythrodysesthesia, skin fissure, skin photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis, xeroderma

Gastrointestinal: Anorexia, diarrhea, esophagopharyngitis, gastrointestinal hemorrhage, gastrointestinal ulcer, mesenteric ischemia (acute), nausea, stomatitis, tissue sloughing (gastrointestinal), vomiting

Hematologic & oncologic: Agranulocytosis, anemia, leukopenia (nadir: days 9 to 14; recovery by day 30), pancytopenia, thrombocytopenia

Hypersensitivity: Anaphylaxis, hypersensitivity reaction (generalized)

Ophthalmic: Lacrimal stenosis, lacrimation, nystagmus, photophobia, visual disturbance

Respiratory: Epistaxis

Rare but important or life-threatening: Dysgeusia (Syed 2016)