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

Summary

Common side effects of Mycamine include: febrile neutropenia, abdominal pain, diarrhea, fever, headache, increased serum alanine aminotransferase, nausea, neutropenia, phlebitis, pruritus, skin rash, thrombocytopenia, and vomiting. Other side effects include: abnormal hepatic function tests. Continue reading for a comprehensive list of adverse effects.

Applies to micafungin: intravenous powder for solution.

Serious side effects of Mycamine

Along with its needed effects, micafungin (the active ingredient contained in Mycamine) 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 micafungin:

More common

• Black, tarry, stools
• cough
• decreased frequency or amount of urine
• fast, pounding, or irregular heartbeat or pulse
• fever or chills
• increased thirst
• loss of appetite
• lower back or side pain
• nausea or vomiting
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• swelling of the face, fingers, or lower legs
• trouble breathing
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• weight gain

Less common

• Bone pain
• changes in skin color, pain, tenderness, or swelling of the foot or leg
• chest pain
• drowsiness
• mood or mental changes
• muscle pain or cramps
• muscle spasms or twitching
• numbness or tingling in the hands, feet, or lips
• seizures
• swollen glands
• trembling

Rare

• Abdominal or stomach cramps
• blurred vision
• dizziness
• headache
• nervousness
• pounding in the ears
• slow or fast heartbeat
• weakness or heaviness of the legs

Incidence not known

• Agitation
• back, leg, or stomach pain
• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• blistering, peeling, or loosening of the skin
• bloody urine
• bruising
• dark urine
• diarrhea
• fast, weak pulse
• feeling faint, dizzy, or lightheaded
• flushing or redness of the skin, especially on the face and neck
• general body swelling
• hives or itching
• hostility or irritability
• joint pain
• light-colored stools
• nosebleeds
• persistent bleeding or oozing from puncture sites, mouth, or nose
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• skin rash or redness
• sweating
• vomiting of blood
• yellow eyes or skin

Other side effects of Mycamine

Some side effects of micafungin 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:

More common

• Cold sweats
• cool, pale skin
• depression
• increased hunger
• nightmares
• slurred speech
• trouble sleeping
• welts

Less common

• Bluish color
• feeling unusually cold or shivering

Rare

• Belching
• change in taste
• confusion as to time, place, or person
• difficulty having a bowel movement (stool)
• hallucinations
• heartburn
• hiccups
• sleepiness or unusual drowsiness
• stomach discomfort or upset
• unusual excitement, nervousness, or restlessness

For Healthcare Professionals

Applies to micafungin: intravenous powder for injection.

General

In clinical trials with this drug, 91% of adult patients reported at least 1 side effect.

Candidemia and other Candida infections: During 1 study, side effects were reported in 92% of patients treated with 100 mg/day. These included gastrointestinal disorders (41%), metabolism and nutrition disorders (39%), general disorders/administration site conditions (30%), investigations (18%), and cardiac disorders (18%). During another study, 93% of patients treated with 100 mg/day reported side effects, including nausea, diarrhea, vomiting, abnormal liver tests, increased AST, and increased blood alkaline phosphatase.

Esophageal candidiasis: During 1 study, 78% of patients treated with 150 mg/day reported a side effect. These included gastrointestinal disorders (32%), vascular disorders (21%), general disorders/administration site conditions (20%), nervous system disorders (16%), and skin and subcutaneous tissue disorders (14%). This drug was discontinued due to side effects in 7% of patients.

Prophylaxis of Candida infections in hematopoietic stem cell transplant (HSCT) recipients: During 1 study, all adult patients who received this drug (n=382) reported at least 1 side effect. These included gastrointestinal disorders (99%), blood and lymphatic system disorders (96%), skin and subcutaneous tissue disorders (67%), nervous system disorders (65%), psychiatric disorders (61%), and cardiac disorders (35%). This drug was discontinued due to side effects in 4% of patients.^[Ref]

Gastrointestinal

Diarrhea was reported during the study for prophylaxis of Candida infections in HSCT recipients (77%), the studies for candidemia and other Candida infections (up to 11%), and the study for esophageal candidiasis (10%).

Nausea was reported during the study for prophylaxis of Candida infections in HSCT recipients (71%), the studies for candidemia and other Candida infections (up to 10%), and the study for esophageal candidiasis (8%).

Vomiting was reported during the study for prophylaxis of Candida infections in HSCT recipients (66%), the studies for candidemia and other Candida infections (up to 13%), and the study for esophageal candidiasis (7%).

Abdominal pain (26%) was reported during the study for prophylaxis of Candida infections in HSCT recipients.

A 73-year-old male presented with upper abdominal tenderness after 3 weeks of treatment with this drug (150 mg/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.^[Ref]

Very common (10% or more): Diarrhea (up to 77%), nausea (up to 71%), vomiting (up to 66%), abdominal pain (up to 26%), constipation (up to 11.1%)

Uncommon (0.1% to 1%): Dyspepsia

Frequency not reported: Upper abdominal pain, hiccups, acute pancreatitis^[Ref]

Hematologic

Neutropenia (75%) and thrombocytopenia (75%) were reported during the study for prophylaxis of Candida infections in HSCT recipients.^[Ref]

Very common (10% or more): Neutropenia (up to 75%), thrombocytopenia (up to 75%)

Common (1% to 10%): Anemia, leukopenia, febrile neutropenia

Uncommon (0.1% to 1%): Pancytopenia, eosinophilia, hypoalbuminemia

Rare (0.01% to 0.1%): Hemolysis, hemolytic anemia

Frequency not reported: Coagulopathy, thrombotic thrombocytopenic purpura, aggravated anemia, acute intravascular hemolysis

Postmarketing reports: Disseminated intravascular coagulation, decreased WBC count, hemolytic anemia, intravascular hemolysis^[Ref]

Nervous system

Very common (10% or more): Headache (up to 44%)

Uncommon (0.1% to 1%): Dysgeusia, somnolence, dizziness, tremor

Frequency not reported: Convulsions, encephalopathy, intracranial hemorrhage^[Ref]

Headache was reported during the study for prophylaxis of Candida infections in HSCT recipients (44%) and the study for esophageal candidiasis (9%).^[Ref]

Psychiatric

Insomnia (37%) and anxiety (22%) were reported during the study for prophylaxis of Candida infections in HSCT recipients.^[Ref]

Very common (10% or more): Insomnia (up to 37%), anxiety (up to 22%)

Uncommon (0.1% to 1%): Confusion

Frequency not reported: Delirium^[Ref]

Cardiovascular

Tachycardia (26%) was reported during the study for prophylaxis of Candida infections in HSCT recipients.

Phlebitis (19%) was reported during the study for esophageal candidiasis.

Atrial fibrillation (3%) was reported during the studies for candidemia and other Candida infections.^[Ref]

Very common (10% or more): Tachycardia (up to 26%), phlebitis (up to 19%)

Common (1% to 10%): Atrial fibrillation, hypertension, hypotension

Uncommon (0.1% to 1%): Palpitations, bradycardia

Frequency not reported: Cardiac arrest, myocardial infarction, pericardial effusion, arrhythmia, cyanosis, deep venous thrombosis

Postmarketing reports: Shock^[Ref]

Dermatologic

Very common (10% or more): Rash (up to 25%)

Common (1% to 10%): Pruritus

Uncommon (0.1% to 1%): Urticaria, erythema

Frequency not reported: Toxic skin eruption, erythema multiforme, decubitus ulcer, skin necrosis

Postmarketing reports: Stevens-Johnson syndrome, toxic epidermal necrolysis^[Ref]

Rash was reported during the study for prophylaxis of Candida infections in HSCT recipients (25%) and the study for esophageal candidiasis (5%).^[Ref]

Other

Very common (10% or more): Pyrexia (up to 20%), mucosal inflammation (up to 14.2%)

Common (1% to 10%): Rigors, peripheral edema, fatigue, bacteremia, sepsis

Uncommon (0.1% to 1%): Flushing, increased blood lactate dehydrogenase

Frequency not reported: Infusion reaction (possible histamine-mediated symptoms including rash, pruritus, facial swelling, vasodilatation), infection, fever, septic shock^[Ref]

Pyrexia (13%) was reported during the study for esophageal candidiasis.^[Ref]

Metabolic

Very common (10% or more): Hypomagnesemia (up to 18%), hypokalemia (up to 13.3%)

Common (1% to 10%): Hypoglycemia, hypernatremia, hyperkalemia, hypocalcemia, anorexia, hyperglycemia, fluid overload

Uncommon (0.1% to 1%): Hyponatremia, hypophosphatemia

Frequency not reported: Acidosis, decreased appetite, fluid retention^[Ref]

Hypoglycemia (6%), hyperkalemia (5%), and hypernatremia (4%) were reported during the studies for candidemia and other Candida infections.^[Ref]

Hepatic

Increased blood alkaline phosphatase (6%), abnormal liver tests (4%), and increased AST (3%) were reported during the studies for candidemia and other Candida infections.^[Ref]

Common (1% to 10%): Increased blood alkaline phosphatase, abnormal liver tests/liver function test abnormal, increased AST, increased ALT, increased blood bilirubin (including hyperbilirubinemia)

Uncommon (0.1% to 1%): Hepatomegaly, jaundice, hepatic failure, increased GGT, cholestasis, hepatitis

Frequency not reported: Hepatocellular damage (including fatal cases), increased hepatic enzyme, increased transaminases, worsening hepatic failure

Postmarketing reports: Hepatic disorder, hyperbilirubinemia, abnormal hepatic function, hepatocellular damage^[Ref]

Respiratory

Common (1% to 10%): Cough, dyspnea, epistaxis

Frequency not reported: Pneumonia, apnea, hypoxia, pulmonary embolism^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain

Frequency not reported: Arthralgia^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity, anaphylactic/anaphylactoid reaction

Frequency not reported: Possible histamine-mediated symptoms (including rash, pruritus, facial swelling, vasodilatation), serious hypersensitivity (anaphylaxis and anaphylactoid) reactions (including shock)

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

Renal

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

Uncommon (0.1% to 1%): Increased blood creatinine, increased blood urea, aggravated renal failure

Frequency not reported: Elevations in BUN and serum creatinine, anuria, oliguria, renal tubular necrosis

Postmarketing reports: Renal impairment, acute renal failure^[Ref]

Local

Uncommon (0.1% to 1%): Injection site thrombosis, infusion site inflammation, injection site pain

Frequency not reported: Injection site reactions (including phlebitis, thrombophlebitis)^[Ref]

Injection site reactions have been reported with doses of 50 to 150 mg per day. These reactions occurred more often with peripheral IV administration.^[Ref]

Endocrine

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

Genitourinary

Frequency not reported: Hemoglobinuria