Applies to anidulafungin: intravenous powder for solution.

Serious side effects of Anidulafungin

Along with its needed effects, anidulafungin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

Less common

• Black, tarry stools
• chills
• cough
• decreased urine
• dry mouth
• fever
• increased thirst
• irregular heartbeat
• loss of appetite
• lower back or side pain
• mood or mental changes
• muscle pain or cramps
• nausea
• numbness or tingling in the hands, feet or lips
• painful or difficult urination
• pale skin
• seizures
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Rare

• Back pain
• bleeding gums
• blood in the urine or stools
• bloody stools
• bluish color of skin
• blurred or loss of vision
• changes in skin color
• chest pain or tightness
• clay-colored stools
• constipation
• dark urine
• depression
• diarrhea
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• extra heartbeats
• fainting
• fast heartbeat
• flushed, dry skin
• flushing
• fruit-like breath odor
• headache
• hives or welts
• incoherent speech
• increased hunger
• increased urination
• irregular fast heartbeat
• irritability
• itching
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• metallic taste
• muscle spasms (tetany) or twitching
• muscle weakness
• nervousness
• pain, redness, or swelling in the arm or leg
• pain, tenderness, and swelling of foot or leg
• pinpoint red spots on the skin
• pounding in the ears
• redness of the skin
• restlessness
• skin rash
• slow heartbeat
• sore mouth or tongue
• stomach pain
• sweating
• swelling of the feet or lower legs
• swollen glands
• trembling
• unexplained weight loss
• unpleasant breath odor
• unusually warm skin
• vomiting of blood
• weakness
• weight loss
• white patches in the mouth or throat or on the tongue
• white patches with diaper rash
• yellow eyes or skin

Other side effects of Anidulafungin

Some side effects of anidulafungin 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:

Rare

• Acid or sour stomach
• belching
• bloating or swelling of the face, arms, hands, lower legs, or feet
• disturbed color perception
• double vision
• eye pain
• feeling of warmth
• feeling unusually cold
• halos around light
• indigestion
• loss of bowel control
• night blindness
• over bright appearance of lights
• rapid weight gain
• redness of the face, neck, arms, and occasionally, upper chest
• shivering
• stomach discomfort or upset
• tingling of the hands or feet
• tunnel vision
• unusual weight gain or loss

For Healthcare Professionals

Applies to anidulafungin: intravenous powder for injection.

General

The most common side effects reported during studies in patients with candidemia and other Candida infections were hypokalemia, nausea, diarrhea, vomiting, pyrexia, and insomnia. This drug was discontinued in 11.5% of patients due to side effects; the most common side effects leading to discontinuation were multi-organ failure and systemic Candida infection.

The most common side effects reported during a study in patients with esophageal candidiasis were diarrhea, pyrexia, anemia, headache, vomiting, nausea, and dyspepsia. This drug was discontinued in 9% of patients due to side effects; the most common side effect leading to discontinuation was maculopapular rash.^[Ref]

Metabolic

Very common (10% or more): Hypokalemia (up to 25%), hypomagnesemia (up to 12%)

Common (1% to 10%): Hypoglycemia, hyperglycemia, hyperkalemia, dehydration

Uncommon (0.1% to 1%): Hyperuricemia, hypocalcemia, hyponatremia, hypoalbuminemia, hypophosphatemia

Frequency not reported: Hypercalcemia, hypernatremia, hypoproteinemia^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 24%), diarrhea (up to 18%), vomiting (up to 18%)

Common (1% to 10%): Constipation, dyspepsia, abdominal pain, oral candidiasis

Uncommon (0.1% to 1%): Upper abdominal pain, dry mouth, esophageal ulcer

Frequency not reported: Increased amylase, increased lipase, fecal incontinence, gastroesophageal reflux disease, abdominal distension, stomatitis, gastroenteritis^[Ref]

Other

Very common (10% or more): Pyrexia (up to 18%), bacteremia (up to 18%), increased blood alkaline phosphatase (up to 12%), peripheral edema (up to 11%)

Common (1% to 10%): Sepsis, chest pain, flushing

Uncommon (0.1% to 1%): Hot flushes, chills, increased blood LDH

Frequency not reported: Infusion-related reaction, rigors, clostridial infection, fungemia, candidiasis, multi-organ failure, systemic Candida infection, infusion-related side effects (possibly histamine-mediated; included rash, urticaria, flushing, pruritus, bronchospasm, dyspnea, hypotension), decreased potassium, decreased magnesium, device-related infection^[Ref]

Cardiovascular

Very common (10% or more): Hypotension (up to 15%), hypertension (up to 12%), deep vein thrombosis (up to 10%)

Common (1% to 10%): ECG QT prolonged

Uncommon (0.1% to 1%): Phlebitis, superficial thrombophlebitis

Frequency not reported: ECG early transition, atrial fibrillation, bundle branch block (right), sinus arrhythmia, ventricular extrasystoles^[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 15%)

Common (1% to 10%): Confusional state, depression

Uncommon (0.1% to 1%): Anxiety, delirium, auditory hallucination

Frequency not reported: Agitation^[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (up to 15%)

Uncommon (0.1% to 1%): Hematuria^[Ref]

Respiratory

Very common (10% or more): Dyspnea (up to 12%), pleural effusion (up to 10%)

Common (1% to 10%): Cough, pneumonia, respiratory distress

Frequency not reported: Epistaxis, lower respiratory tract infection, upper respiratory tract infection, hemoptysis

Postmarketing reports: Bronchospasm^[Ref]

Hematologic

Common (1% to 10%): Anemia, increased WBC, thrombocythemia, leukocytosis, coagulopathy, thrombocytopenia, decreased platelet count

Uncommon (0.1% to 1%): Neutropenia, leukopenia, lymphangitis, decreased lymphocyte count

Frequency not reported: Prothrombin time prolonged, increased platelet count, pancytopenia, thrombocytosis, febrile neutropenia^[Ref]

Nervous system

Common (1% to 10%): Headache, convulsion

Uncommon (0.1% to 1%): Dizziness, paresthesia, central pontine myelinolysis, dysgeusia, Guillain-Barre syndrome, tremor, unilateral deafness

Frequency not reported: Seizure^[Ref]

Hepatic

Common (1% to 10%): Increased hepatic enzymes, increased ALT, increased AST, increased blood bilirubin, cholestasis, increased GGT

Uncommon (0.1% to 1%): Hepatic necrosis

Frequency not reported: Significant hepatic dysfunction, abnormal liver function tests, hepatitis, hepatic failure, increased transaminases^[Ref]

Hypersensitivity

Postmarketing reports: Anaphylactic shock, anaphylactic reaction^[Ref]

Dermatologic

Common (1% to 10%): Decubitus ulcer, rash, pruritus

Uncommon (0.1% to 1%): Urticaria, angioneurotic edema, hyperhidrosis

Frequency not reported: Maculopapular rash, erythema, increased sweating, generalized rash^[Ref]

Renal

Common (1% to 10%): Increased blood creatinine

Uncommon (0.1% to 1%): Renal failure

Frequency not reported: Increased urea^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain

Uncommon (0.1% to 1%): Myalgia, monoarthritis, increased blood creatine phosphokinase

Frequency not reported: Pain in extremity^[Ref]

Local

Uncommon (0.1% to 1%): Infusion site pain, injection site reaction^[Ref]

Ocular

Uncommon (0.1% to 1%): Altered visual depth perception

Frequency not reported: Eye pain, blurred vision, visual disturbance, periorbital edema^[Ref]