Caspofungin Side Effects

Some side effects of caspofungin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to caspofungin: intravenous powder for injection

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

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

• pain, swelling, or vein irritation around the IV needle;

• fever, chills, body aches, flu symptoms;

• swelling in your hands or feet;

• weakness, muscle cramps, pounding or uneven heart beats; or

• nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects include:

• vomiting, diarrhea;

• mild skin rash or itching;

• headache;

• dizziness, feeling light-headed; or

• flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to caspofungin: intravenous powder for injection

Gastrointestinal

Gastrointestinal side effects have included diarrhea (up to 27%), vomiting (up to 17%), nausea (up to 15%), and abdominal pain (up to 9%). Anorexia, abdominal distension, upper abdominal pain, constipation, and dyspepsia have been reported in less than 5% of patients. Pancreatitis has been reported during postmarketing experience.

Other

Other side effects have included fever (up to 40%), infusion-related adverse reactions (defined as a systemic event, such as flushing, fever, chills, hypotension, hypertension, tachycardia, dyspnea, tachypnea, rash, or anaphylaxis; up to 35%), chills (up to 23%), septic shock (up to 14%), aspergillosis (13%), peripheral edema (up to 11%), sepsis (up to 7%), mucosal inflammation (up to 6%), flu-like illness, malaise, pain, and warm sensation. Asthenia, fatigue, edema, flushing, and bacteremia have been reported in less than 5% of patients. Swelling has been reported during postmarketing experience.

Metabolic

Metabolic side effects have included decreased blood potassium (up to 23%), increased blood alkaline phosphatase (up to 22%), hypokalemia (up to 10%), decreased blood albumin (up to 8.6%), decreased blood magnesium (up to 7%), increased blood glucose (6%), decreased total serum protein (3.1%), and elevated serum calcium (1.1%). Decreased appetite, fluid overload, hypomagnesemia, hypercalcemia, and hyperglycemia have been reported in less than 5% of patients.

Hematologic

Hematological side effects have included decreased hemoglobin (up to 21%), decreased hematocrit (up to 18%), decreased white blood cell count (up to 12%), anemia (up to 11%), eosinophilia (2.3% to 3.2%), decreased platelets (1.5% to 3.1%), and hypoalbuminemia (common). Thrombocytopenia, coagulopathy, febrile neutropenia, and neutropenia have been reported in less than 5% of patients.

A 68-year-old male experienced reversible severe thrombocytopenia coincident with caspofungin therapy. He was admitted for shortness of breath, coughing, abdominal pain, and intermittent fever, which had persisted for 10 days. Two blood cultures obtained on admission revealed Candida albicans. He was given caspofungin 70 mg for 1 day, then 50 mg per day. One week after receiving caspofungin therapy, his platelet count dropped precipitously from 136 x 10(3)/mm3 to 24 x 10(3)/mm3, reaching a nadir at 3 x 10(3)/mm3 in 2 days. Caspofungin was discontinued, and his platelet count returned to a level above 150 x 10(3)/mm3 within 10 days.

Respiratory

Respiratory side effects have included respiratory failure (up to 20%), cough (up to 11%), pneumonia (up to 11%), pleural effusion (9%), dyspnea (up to 9%), and rales (7%). Tachypnea, epistaxis, and hypoxia have been reported in less than 5% of patients. Pulmonary edema, adult respiratory distress syndrome, and pulmonary infiltrates have been reported infrequently.

Cardiovascular

Cardiovascular side effects have included hypotension (up to 20%), tachycardia (up to 8%), and hypertension (up to 6%). Arrhythmia, atrial fibrillation, bradycardia, cardiac arrest, and myocardial infarction have been reported in less than 5% of patients.

Hepatic

Reported elevations in ALT and AST were accompanied by the use of cyclosporine in some of the patients enrolled in the clinical trials.

Hepatic side effects have included elevations in ALT (up to 18%), AST (up to 17%), blood bilirubin (up to 13%), and conjugated bilirubin (up to 8%). Hepatic failure, hepatomegaly, hepatotoxicity, hyperbilirubinemia, and jaundice have been reported in less than 5% of patients. Isolated cases of clinically significant hepatic dysfunction and hepatitis have also been reported. Hepatic necrosis has been reported during postmarketing experience.

Local

Local side effects have included phlebitis (up to 25%), thrombophlebitis (11.3% to 15.7%), and infused vein complications (1.5% to 12%). Infusion site pain, infusion site pruritus, and infusion site swelling have been reported in less than 5% of patients.

Dermatologic

Dermatological side effects have included rash (up to 23%), pruritus (up to 7%), decubitus ulcer (up to 5%), erythema (up to 5%), induration (3.1%), and sweating (1.3%). Petechiae, skin lesion, and urticaria have been reported in less than 5% of patients. At least one case of toxic epidermal necrolysis has been reported. Erythema multiforme, Stevens-Johnson syndrome, and skin exfoliation have been reported during postmarketing experience.

Nervous system

Nervous system side effects have included headache (up to 15%) and paresthesia (1.3% to 3.1%). Convulsion, dizziness, somnolence, and tremor have been reported in less than 5% of patients.

Renal

Renal side effects have included increased blood creatinine (up to 11%), increased blood urea nitrogen (up to 9%), nephrotoxicity (3%), and renal failure (less than 5%). Clinical renal events, regardless of causality, have been reported in 13% of patients. Clinically significant renal dysfunction has been reported during postmarketing experience.

Hypersensitivity

Hypersensitivity side effects have included anaphylaxis and possible histamine-mediated symptoms (including reports of rash, facial swelling, angioedema, pruritus, sensation of warmth, or bronchospasm).

Genitourinary

Genitourinary side effects have included urine positive for red blood cells (10%) and an increase in urine white blood cells (7.7%), protein (1.2% to 4.9%), and red blood cells (1.1% to 3.8%). Urinary tract infection and hematuria have been reported in less than 5% of patients.

Psychiatric

Psychiatric side effects have included anxiety, confusional state, depression, and insomnia in less than 5% of patients.

Musculoskeletal

Musculoskeletal side effects have included myalgia (3.1%) and musculoskeletal pain (1.3%). Arthralgia, back pain, and pain in extremity have been reported in less than 5% of patients.

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