Mycamine Side Effects

Generic name: micafungin

Note: This document contains side effect information about micafungin. Some of the dosage forms listed on this page may not apply to the brand name Mycamine.

Some side effects of Mycamine 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 micafungin: intravenous powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking micafungin (the active ingredient contained in Mycamine) hives; difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

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

• pale skin, dark colored urine, confusion or weakness;

• upper stomach pain, itching, clay-colored stools, jaundice (yellowing of the skin or eyes);

• fever, chills, body aches, flu symptoms;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• urinating less than usual or not at all;

• drowsiness, mood changes, increased thirst, loss of appetite, nausea and vomiting;

• swelling, weight gain, feeling short of breath;

• uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects of micafungin may include:

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

• mild nausea, vomiting, or stomach pain;

• diarrhea, constipation, indigestion;

• headache;

• sleep problems (insomnia);

• mild itching or skin rash; or

• pain, swelling, or tenderness where the medicine was injected.

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 micafungin: intravenous powder for injection

General

The overall safety of micafungin (the active ingredient contained in Mycamine) was assessed in 41 clinical studies. Overall, 91.1% of patients treated with micafungin reported a side effect, including gastrointestinal disorders (57.2%); general disorders and administration site conditions (45.6%); metabolism and nutrition disorders (42.7%); infections and infestations (39.8%); respiratory, thoracic, and mediastinal disorders (35.9%); blood and lymphatic system disorders (34%); investigations (32.1%); skin and subcutaneous tissue disorders (30.5%); nervous system disorders (28.8%); vascular disorders (28.1%); psychiatric disorders (23.6%); musculoskeletal and connective tissue disorders (18.8%); and cardiac disorders (18.3%).

During a study for treatment of candidemia and other Candida infections, treatment emergent side effects were reported in 91.5% and 92.6% of patients treated with micafungin 100 mg/day and micafungin 150 mg/day, respectively. During another study, 92.8% of patients treated with micafungin 100 mg/day reported treatment emergent side effects.

During a study for treatment of esophageal candidiasis, 77.7% of patients treated with micafungin 150 mg/day reported a side effect. Discontinuation due to treatment emergent side effects was reported in 6.5% of patients treated with micafungin.

During a study for prophylaxis of Candida infections in hematopoietic stem cell transplant recipients, all patients (n=425) reported at least one side effect. Discontinuation due to treatment emergent side effects was reported in 4.2% of patients treated with micafungin.

Gastrointestinal

Gastrointestinal side effects have included diarrhea NOS (up to 23.3%), nausea (up to 22%), vomiting NOS (up to 21.7%), constipation (11.1%), abdominal pain NOS (up to 9.7%), dyspepsia (5.7%), upper abdominal pain, and hiccups. Diarrhea NOS (71.1%), nausea (69.6%), vomiting NOS (66.1%), constipation (30.4%), abdominal pain NOS (27.1%), and dyspepsia (24.5%) have been reported in hematopoietic stem cell transplant recipients. At least one case of acute pancreatitis has also been reported.

A 73-year-old male presented with upper abdominal tenderness after 3 weeks of treatment with micafungin (150 mg per day) for pulmonary aspergillosis accompanied by Mycobacterium avium complex infection. Laboratory findings, magnetic resonance imaging, and upper abdominal tenderness were consistent with acute pancreatitis. After stopping all drugs, his symptoms improved with bowel rest and parenteral nutrition.

Other

Other side effects have included pyrexia (up to 20%), mucosal inflammation NOS (14.2%), rigors (9.1%), bacteremia (up to 8.9%), septic shock (up to 7.5%), peripheral edema (up to 6.8%), fatigue (6.4%), sepsis NOS (up to 5.5%), infection, and fever. Mucosal inflammation NOS (75.8%), pyrexia (44.9%), fatigue (29.6%), rigors (26.4%), peripheral edema (20.7%), bacteremia (15.5%), and flushing (11.1%) have been reported in hematopoietic stem cell transplant recipients.

Cardiovascular

Cardiovascular side effects have included phlebitis NOS (up to 18.8%), hypotension NOS (up to 10%), tachycardia NOS (up to 7.5%), hypertension NOS (up to 6.9%), bradycardia NOS (up to 5%), atrial fibrillation (up to 5%), arrhythmia, cardiac arrest, cyanosis, myocardial infarction, and deep venous thrombosis. Tachycardia NOS (24.7%), hypertension NOS (21.4%), and hypotension NOS (18.6%) have been reported in hematopoietic stem cell transplant recipients. Shock has been reported during postmarketing experience.

Metabolic

Metabolic side effects have included hypokalemia (up to 18%), hypomagnesemia (up to 13.3%), hypoglycemia NOS (up to 6.9%), hypocalcemia (6.5%), hyponatremia (up to 6.4%), anorexia (up to 6.2%), hyperglycemia NOS (5.6%), hyperkalemia (up to 5%), fluid overload (5%), acidosis, and hypophosphatemia. Hypomagnesemia (50.4%), hypokalemia (49.2%), anorexia (27.3%), decreased appetite NOS (20.5%), fluid overload (17.4%), hypocalcemia (16.9%), fluid retention (16.2%), and hyperglycemia NOS (16%) have been reported in hematopoietic stem cell transplant recipients.

Hematologic

Hematologic side effects have included thrombocytopenia (up to 15.4%), neutropenia (up to 14.1%), anemia NOS (up to 9.8%), febrile neutropenia (up to 6.1%), aggravated anemia NOS (up to 5%), leukopenia, acute intravascular hemolysis, hemoglobinuria, hemolysis, hemolytic anemia, coagulopathy, pancytopenia, and thrombotic thrombocytopenic purpura. Neutropenia (75.3%), thrombocytopenia (72.2%), febrile neutropenia (36.5%), and anemia NOS (35.5%) have been reported in hematopoietic stem cell transplant recipients. Decreased white blood cell count, hemolytic anemia, and disseminated intravascular coagulation have been reported during postmarketing experience.

Hepatic

Hepatic side effects have included increased blood alkaline phosphatase NOS (up to 7.9%), increased aspartate aminotransferase (up to 5.6%), increased alanine aminotransferase (5.4%), and abnormal liver function tests (up to 4.2%). Hepatitis, hyperbilirubinemia, hepatocellular damage, hepatomegaly, jaundice, hepatic failure, and worsening hepatic failure have been reported. Hyperbilirubinemia, abnormal hepatic function, hepatic disorder, and hepatocellular damage have been reported during postmarketing experience.

Hypersensitivity

Hypersensitivity side effects have included possible histamine-mediated symptoms, including rash, pruritus, facial swelling, and vasodilatation. Serious hypersensitivity (anaphylaxis and anaphylactoid) reactions (including shock) have been reported.

Dermatologic

Dermatologic side effects have included rash NOS (up to 8.7%), pruritus (up to 6.1%), decubitus ulcer (up to 5.9%), erythema multiforme, skin necrosis, and urticaria. Rash NOS (25.9%), pruritus NOS (17.6%), and erythema (11.3%) have been reported in hematopoietic stem cell transplant recipients. Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported during postmarketing experience.

Nervous system

Nervous system side effects have included headache NOS (up to 15.9%), insomnia (up to 9.8%), dysgeusia, somnolence, dizziness, convulsions, encephalopathy, and intracranial hemorrhage. Headache NOS (42.1%), insomnia (35.8%), and dizziness (12.9%) have been reported in hematopoietic stem cell transplant recipients.

Respiratory

Respiratory side effects have included cough (8.1%), dyspnea NOS (up to 5.9%), epistaxis (5.6%), pneumonia (up to 5.4%), apnea, hypoxia, and pulmonary embolism. Cough (23.1%), dyspnea NOS (12.7%), and epistaxis (11.5%) have been reported in hematopoietic stem cell transplant recipients.

Psychiatric

Psychiatric side effects have included anxiety (6.4%) and delirium. Anxiety (22.4%) has been reported in hematopoietic stem cell transplant recipients.

Renal

In controlled trials, the incidence of drug-related renal adverse events was 0.4%.

Renal side effects have included elevations in BUN and serum creatinine, anuria, oliguria, renal tubular necrosis, hemoglobinuria, and acute renal failure. Renal impairment and acute renal failure have been reported during postmarketing experience.

Local

Local side effects have included injection site reactions (including phlebitis and thrombophlebitis) and injection site thrombosis.

Injection site reactions have been reported with doses of 50 to 150 mg per day. These reactions occurred more often with peripheral intravenous administration.

Musculoskeletal

Musculoskeletal side effects have included back pain (5.4%) and arthralgia.

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