Mycamine Side Effects

Generic Name: micafungin

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

Not all side effects for Mycamine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to micafungin: intravenous powder for solution

In addition to its needed effects, some unwanted effects may be caused by micafungin (the active ingredient contained in Mycamine). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking micafungin, check with your doctor or nurse immediately:

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
  • shortness of breath
  • 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
  • convulsions
  • 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
  • blistering, peeling, or loosening of the skin
  • bruising
  • diarrhea
  • fast, weak pulse
  • general body swelling
  • hives
  • hostility or irritability
  • itching
  • joint pain
  • lightheadedness
  • 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
  • vomiting of blood
  • yellow eyes or skin

Some of the side effects that can occur with micafungin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Cold sweats
  • cool, pale skin
  • depression
  • flushing
  • increased hunger
  • nightmares
  • slurred speech
  • 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
  • injection site pain
  • sleepiness or unusual drowsiness
  • stomach discomfort or upset
  • unusual excitement, nervousness, or restlessness

For Healthcare Professionals

Applies to micafungin: intravenous powder for injection

General

Overall, 91% of patients treated with micafungin (the active ingredient contained in Mycamine) reported at least one side effect.

Candidemia and other Candida infections: During one study, treatment-emergent side effects were reported in 92% and 93% of patients treated with micafungin 100 mg/day and micafungin 150 mg/day, respectively. These included gastrointestinal disorders (up to 44%), metabolism and nutrition disorders (up to 41%), general disorders/administration site conditions (up to 30%), investigations (up to 24%), and cardiac disorders (up to 24%). During another study, 93% of patients treated with micafungin 100 mg/day reported treatment-emergent side effects.

Esophageal candidiasis: During one study, 78% of patients treated with micafungin 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%). Micafungin was discontinued due to side effects in 7% of patients.

Prophylaxis of Candida infections in hematopoietic stem cell transplant (HSCT) recipients: During one study, all adult patients who received micafungin (n=382) reported at least one 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%). Micafungin was discontinued due to side effects in 4% of patients.

Gastrointestinal

Very common (10% or more): Diarrhea (up to 77%), nausea (up to 71%), vomiting (up to 66%), abdominal pain (26%)
Rare (less than 0.1%): Acute pancreatitis (at least 1 case)
Frequency not reported: Constipation, dyspepsia, upper abdominal pain, hiccups

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 13%), 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 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 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.

Hematologic

Very common (10% or more): Neutropenia (75%), thrombocytopenia (75%)
Common (1% to 10%): Coagulopathy (less than 5%), pancytopenia (less than 5%), thrombotic thrombocytopenic purpura (less than 5%)
Frequency not reported: Anemia, febrile neutropenia, aggravated anemia, leukopenia, acute intravascular hemolysis, hemoglobinuria, hemolysis, hemolytic anemia, decreased white blood cell count
Postmarketing reports: Disseminated intravascular coagulation

Neutropenia and thrombocytopenia were reported during the study for prophylaxis of Candida infections in HSCT recipients.

Nervous system

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

Very common (10% or more): Headache (up to 44%)
Common (1% to 10%): Convulsions (less than 5%), encephalopathy (less than 5%), intracranial hemorrhage (less than 5%)
Frequency not reported: Dysgeusia, somnolence, dizziness

Psychiatric

Very common (10% or more): Insomnia (37%), anxiety (22%)
Common (1% to 10%): Delirium (less than 5%)

Insomnia and anxiety were reported during the study for prophylaxis of Candida infections in HSCT recipients.

Cardiovascular

Tachycardia was reported during the study for prophylaxis of Candida infections in HSCT recipients.

Phlebitis was reported during the study for esophageal candidiasis.

Atrial fibrillation was reported during the studies for candidemia and other Candida infections.

Very common (10% or more): Tachycardia (26%), phlebitis (19%)
Common (1% to 10%): Atrial fibrillation (up to 5%), cardiac arrest (less than 5%), myocardial infarction (less than 5%), pericardial effusion (less than 5%)
Frequency not reported: Arrhythmia, cyanosis, deep venous thrombosis, hypertension, hypotension, bradycardia
Postmarketing reports: Shock

Dermatologic

Very common (10% or more): Rash (up to 25%)
Common (1% to 10%): Urticaria (less than 5%)
Frequency not reported: Pruritus, decubitus ulcer, erythema multiforme, skin necrosis, erythema
Postmarketing reports: Stevens-Johnson syndrome, toxic epidermal necrolysis

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

Other

Pyrexia was reported during the study for esophageal candidiasis (13%) and the studies for candidemia and other Candida infections (up to 11%).

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

Very common (10% or more): Pyrexia (up to 13%)
Common (1% to 10%): Infusion reaction (possible histamine-mediated symptoms including rash, pruritus, facial swelling, vasodilatation; less than 5%), injection site thrombosis (less than 5%)
Frequency not reported: Mucosal inflammation, infection, fever, injection site reactions (including phlebitis and thrombophlebitis) , fatigue, rigors, peripheral edema, bacteremia, flushing, septic shock, sepsis

Hepatic

Increased blood alkaline phosphatase, abnormal liver function tests, and increased aspartate aminotransferase were reported during the studies for candidemia and other Candida infections.

Common (1% to 10%): Increased blood alkaline phosphatase (up to 8%), hepatocellular damage (less than 5%), hepatomegaly (less than 5%), jaundice (less than 5%), hepatic failure (less than 5%), abnormal liver function tests (4%), increased aspartate aminotransferase (3%)
Frequency not reported: Hepatitis, hyperbilirubinemia, worsening hepatic failure, abnormal hepatic function, increased alanine aminotransferase
Postmarketing reports: Hepatic disorder

Metabolic

Common (1% to 10%): Hypoglycemia (up to 7%), hypernatremia (up to 6%), hyperkalemia (up to 5%)
Frequency not reported: Acidosis, hypophosphatemia, hypomagnesemia, hypokalemia, anorexia, decreased appetite, fluid overload, hypocalcemia, fluid retention, hyperglycemia

Hypoglycemia, hypernatremia, and hyperkalemia were reported during the studies for candidemia and other Candida infections.

Hypersensitivity

Common (1% to 10%): Hypersensitivity (less than 5%), anaphylactic reaction (less than 5%)
Frequency not reported: Possible histamine-mediated symptoms (including rash, pruritus, facial swelling, vasodilatation), serious hypersensitivity (anaphylaxis and anaphylactoid) reactions (including shock)

Renal

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

Frequency not reported: Elevations in BUN and serum creatinine, anuria, oliguria, renal tubular necrosis, hemoglobinuria, acute renal failure
Postmarketing reports: Renal impairment

Respiratory

Frequency not reported: Cough, dyspnea, epistaxis, pneumonia, apnea, hypoxia, pulmonary embolism

Musculoskeletal

Frequency not reported: Back pain, arthralgia

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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