Mycamine
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Mycamine
Mycamine Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Mycamine (micafungin sodium) is used to treat infections caused by the Candida fungus, and is also used to prevent Candida fungal infections in stem cell transplant patients. It is an antifungal medication. Common side effects include nausea, vomiting, diarrhea, headache, trouble sleeping, or irritation at the site of injection.
Dosing of Mycamine ranges from 50 mg to 150 mg depending on the condition being treated, taken once daily. Mycamine may interact with sirolimus, itraconazole, or nifedipine. Tell your doctor all medications and supplements you use. Mycamine should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Mycamine (micafungin sodium) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Mycamine in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Mycamine (Micafungin Sodium) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Mycamine Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: signs of infection (e.g., persistent sore throat, pain during urination), chills, fever, dark urine, persistent nausea/vomiting, stomach/abdominal pain, yellowing of eyes/skin, easy bleeding/bruising, unusual fatigue, fast/pounding heartbeat, change in the amount of urine.
A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Mycamine (Micafungin Sodium)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Mycamine FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
General
Possible histamine-mediated symptoms have been reported with Mycamine, including rash, pruritus, facial swelling, and vasodilatation.
Injection site reactions, including phlebitis and thrombophlebitis have been reported, at Mycamine doses of 50-150 mg/day. These reactions tended to occur more often in patients receiving Mycamine via peripheral intravenous administration.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of Mycamine cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does provide a basis for identifying adverse events that appear to be related to drug use and for approximating rates.
Candidemia and Other Candida Infections
In a randomized, double-blind study for treatment of candidemia and other Candida infections, treatment emergent adverse events occurred in 183/200 (91.5%), 187/202 (92.6%) and 171/193 (88.6%) patients in the Mycamine 100 mg/day, Mycamine 150mg/day, and caspofungin (70/50mg/day) treatment groups, respectively. Treatment emergent adverse events occurring in ≥ 5% of the patients in any treatment study groups are shown in Table 2.
Table 2. *Treatment Emergent Adverse Events in Patients with
Candidemia and Other Candida Infections
| MedDRA v 5.0 System Organ Class Preferred Term† |
Micafungin 100 mg (n = 200) |
Micafungin 150 mg (n = 202) |
Caspofungin‡ (n = 193) |
| All Systems, Any Adverse Event | 183 (91.5) | 187 (92.6) | 171 (88.6) |
| Gastrointestinal Disorders | 81 (40.5) | 89 (44.1) | 76 (39.4) |
| Diarrhea NOS | 15 (7.5) | 26 (12.9) | 14 (7.3) |
| Nausea | 19 (9.5) | 15 (7.4) | 20 (10.4) |
| Vomiting NOS | 18 (9) | 15 (7.4) | 16 (8.3) |
| Abdominal Pain NOS | 5 (2.5) | 4 (2) | 10 (5.2) |
| Metabolism and Nutrition Disorders | 77 (38.5) | 83 (41.1) | 73 (37.8) |
| Hypokalemia | 28 (14) | 34 (16.8) | 28 (14.5) |
| Hypomagnesaemia | 11 (5.5) | 17 (8.4) | 14 (7.3) |
| Hypoglycemia NOS | 12 (6) | 14 (6.9) | 9 (4.7) |
| Hypernatremia | 8 (4) | 13 (6.4) | 8 (4.1) |
| Hyperkalemia | 10 (5) | 8 (4) | 5 (2.6) |
| Infections and Infestations | 67 (33.5) | 81 (40.1) | 59 (30.6) |
| Bacteremia | 10 (5) | 18 (8.9) | 11 (5.7) |
| Septic Shock | 15 (7.5) | 9 (4.5) | 9 (4.7) |
| Sepsis NOS | 11 (5.5) | 10 (5) | 11 (5.7) |
| Pneumonia NOS | 3 (1.5) | 11 (5.4) | 4 (2.1) |
| General Disorders/Administration Site Conditions | 59 (29.5) | 56 (27.7) | 51 (26.4) |
| Pyrexia | 14 (7) | 22 (10.9) | 15 (7.8) |
| Edema Peripheral | 11 (5.5) | 12 (5.9) | 14 (7.3) |
| Vascular Disorders | 43 (21.5) | 47 (23.3) | 36 (18.7) |
| Hypotension NOS | 20 (10) | 12 (5.9) | 15 (7.8) |
| Hypertension NOS | 6 (3) | 10 (5) | 12 (6.2) |
| Investigations | 36(18) | 49 (24.3) | 37 (19.2) |
| Blood Alkaline Phosphatase NOS Increased | 11 (5.5) | 16 (7.9) | 8 (4.1) |
| Blood/Lymphatic System Disorders | 38 (19) | 45 (22.3) | 37 (19.2) |
| Thrombocytopenia | 8 (4) | 8 (4) | 11 (5.7) |
| Anemia NOS | 5 (2.5) | 6 (3) | 13 (6.7) |
| Anemia NOS Aggravated | 4 (2) | 10 (5) | 5 (2.6) |
| Cardiac Disorders | 35 (17.5) | 48 (23.8) | 36 (18.7%) |
| Tachycardia NOS | 6 (3) | 7 (3.5) | 13 (6.7%) |
| BradycardiaNOS | 5 (2.5) | 10 (5) | 8 (4.1%) |
| Atrial Fibrillation | 5 (2.5) | 10 (5) | 0 |
| Nervous System Disorders | 21 (10.5) | 42 (20.8) | 32 (16.6) |
| Headache NOS | 4 (2) | 10 (5) | 11 (5.7) |
| Skin/Subcutaneous Tissue Disorders | 26 (13) | 34 (16.8) | 33 (17.1) |
| Decubitus Ulcer | 9 (4.5) | 12 (5.9) | 9 (4.7) |
| Psychiatric Disorders | 31 (15.5) | 27 (13.4) | 33 (17.1) |
| Insomnia | 11 (5.5) | 8 (4) | 16 (8.3) |
| Patient base: all randomized patients who received at least
1 dose of trial drug Common: ≥ 5% in any treatment arm. * During IV treatment + 3 days † Within a system organ class patients may experience more than 1 adverse event. ‡ 70 mg loading dose on day 1 followed by 50 mg/day thereafter (caspofungin) |
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In a second, supportive, randomized, double-blind study for treatment of candidemia and other Candida infections, treatment emergent adverse events occurred in 245/264 (92.8%) and 250/265 (94.3%) patients in the Mycamine (100 mg/day) and AmBisome (3 mg/kg/day) treatment groups, respectively. The most common treatment emergent adverse events occurring in ≥ 5% of the Mycamine-treated patients at least 16 years of age were: pyrexia (15.2% vs. 17%); hypokalemia (16.7% vs. 20.8%); nausea (9.5% vs. 8.3%); diarrhea (10.6% vs. 11.3%) and vomiting (12.9% vs. 9.4%), in the Mycamine and AmBisome treatment groups, respectively. Other important treatment emergent adverse events that occurred at < 5% frequency were abnormal liver function tests (4.2% vs. 3%); increased aspartate aminotransferase (2.7% vs. 1.9%), and increased blood alkaline phosphatase (3% vs. 2.3%), in the Mycamine and AmBisome treatment groups, respectively.
Esophageal Candidiasis
In a randomized, double-blind study for treatment of esophageal candidiasis, a total of 202/260 (77.7%) patients who received Mycamine 150 mg/day and 186/258 (72.1%) patients who received intravenous fluconazole 200 mg/day experienced an adverse event. Treatment emergent adverse events resulting in discontinuation were reported in 17 (6.5%) Mycamine treated patients; and in 12 (4.7%) fluconazole treated patients. Treatment emergent adverse events occurring in ≥ 5% of the patients in either treatment group are shown in Table 3.
Table 3. *Treatment Emergent Adverse Events in Patients with
Esophageal Candidiasis
| Adverse Events† (MedDRA System Organ Class and Preferred Term) |
Mycamine 150 mg/day n (%) |
Fluconazole 200 mg/day n (%) |
| Number of Patients | 260 | 258 |
| All Systems, Any Adverse Event | 202 (77.7) | 186 (72.1) |
| Gastrointestinal Disorders | 84 (32.3) | 93 (36) |
| Diarrhea NOS | 27 (10.4) | 29 (11.2) |
| Nausea | 20 (7.7) | 23 (8.9) |
| Vomiting NOS | 17 (6.5) | 17 (6.6) |
| Abdominal Pain NOS | 10 (3.8) | 15 (5.8) |
| General Disorders/Administration Site Conditions | 52 (20) | 45 (17.4) |
| Pyrexia | 34 (13.1) | 21 (8.1) |
| Nervous System Disorders | 42 (16.2) | 40 (15.5) |
| Headache NOS | 22 (8.5) | 20 (7.8) |
| Blood/Lymphatic System Disorders | 38 (14.6) | 43 (16.7) |
| Anemia NOS | 8 (3.1) | 16 (6.2) |
| Vascular Disorders | 54 (20.8) | 21 (8.1) |
| Phlebitis NOS | 49 (18.8) | 13 (5) |
| Skin and Subcutaneous Tissue Disorders | 36 (13.8) | 26 (10.1) |
| Rash NOS | 14 (5.4) | 6 (2.3) |
| Psychiatric Disorders | 20 (7.7) | 21 (8.1) |
| Insomnia | 9 (3.5) | 13 (5) |
| Patient base: all randomized patients who received at least
1 dose of trial drug Common: ≥ 5% in either treatment arm. * During treatment + 3 days. † Within a system organ class patients may experience more than 1 adverse event. |
||
Prophylaxis of Candida Infections in Hematopoietic Stem Cell Transplant Recipients
A double-blind study was conducted in a total of 882 patients scheduled to undergo an autologous or allogeneic hematopoietic stem cell transplant. The median duration of treatment was 18 days (range 1 to 51 days) in both treatment arms.
All patients who received Mycamine (425) and all patients who received fluconazole (457) experienced at least one adverse event during the study. Treatment emergent adverse events resulting in Mycamine discontinuation were reported in 18 (4.2%) patients; while those resulting in fluconazole discontinuation were reported in 33 (7.2%). Treatment emergent adverse events occurring in ≥ 15% of the patients in either treatment group are shown in Table 4.
Table 4. *Treatment Emergent Adverse Events During Prophylaxis
of Candida Infection in Hematopoietic Stem Cell Transplant Recipients
| Adverse Events† (MedDRA System Organ Class and Preferred Term) |
Mycamine 50 mg/day n (%) |
Fluconazole 400 mg/day n (%) |
| Number of Patients | 425 | 457 |
| All Systems, Any Adverse Events | 425 (100) | 457 (100) |
| Gastrointestinal Disorders | 421 (99.1) | 449 (98.2) |
| Diarrhea NOS | 302 (71.1) | 348 (76.1) |
| Nausea | 296 (69.6) | 309 (67.6) |
| Vomiting NOS | 281 (66.1) | 307 (67.2) |
| Constipation | 129 (30.4) | 143 (31.3) |
| Dyspepsia | 104 (24.5) | 122 (26.7) |
| Abdominal Pain NOS | 115 (27.1) | 107 (23.4) |
| General Disorders/Administration Site Conditions | 410 (96.5) | 440 (96.3) |
| Mucosal Inflammation NOS | 322 (75.8) | 360 (78.8) |
| Pyrexia | 191 (44.9) | 218 (47.7) |
| Fatigue | 126 (29.6) | 145 (31.7) |
| Rigors | 112 (26.4) | 118 (25.8) |
| Edema Peripheral | 88 (20.7) | 100 (21.9) |
| Blood and Lymphatic System Disorders | 408 (96) | 429 (93.9) |
| Neutropenia | 320 (75.3) | 327 (71.6) |
| Thrombocytopenia | 307 (72.2) | 304 (66.5) |
| Anemia NOS | 151 (35.5) | 173 (37.9) |
| Febrile Neutropenia | 155 (36.5) | 166 (36.3) |
| Metabolism and Nutrition Disorders | 385 (90.6) | 428 (93.7) |
| Hypomagnesaemia | 214 (50.4) | 256 (56) |
| Hypokalemia | 209 (49.2) | 232 (50.8) |
| Anorexia | 116 (27.3) | 121 (26.5) |
| Appetite Decreased NOS | 87 (20.5) | 93 (20.4) |
| Fluid Overload | 74 (17.4) | 96 (21) |
| Hyperglycemia NOS | 68 (16) | 92 (20.1) |
| Hypocalcemia | 72 (16.9) | 82 (17.9) |
| Fluid Retention | 69 (16.2) | 66 (14.4) |
| Respiratory, Thoracic and Mediastinal Disorders | 291 (68.5) | 336 (73.5) |
| Cough | 98 (23.1) | 112 (24.5) |
| Epistaxis | 49 (11.5) | 84 (18.4) |
| Dyspnea NOS | 54 (12.7) | 64 (14) |
| Skin and Subcutaneous Tissue Disorders | 290 (68.2) | 316 (69.1) |
| Rash NOS | 110 (25.9) | 102 (22.3) |
| Pruritus NOS | 75 (17.6) | 87 (19.) |
| Erythema | 48 (11.3) | 71 (15.5) |
| Nervous System Disorders | 261 (61.4) | 268 (58.6) |
| Headache NOS | 179 (42.1) | 165 (36.1) |
| Dizziness | 55 (12.9) | 83 (18.2) |
| Psychiatric Disorders | 257 (60.5) | 249 (54.5) |
| Insomnia | 152 (35.8) | 146 (31.9) |
| Anxiety | 95 (22.4) | 92 (20.1) |
| Vascular Disorders | 224 (52.7) | 267 (58.4) |
| Hypertension NOS | 91 (21.4) | 113 (24.7) |
| Hypotension NOS | 79 (18.6) | 89 (19.5) |
| Flushing | 47 (11.1) | 70 (15.3) |
| Infections and Infestations | 178 (41.9) | 208 (45.5) |
| Bacteremia | 66 (15.5) | 86 (18.8) |
| Cardiac Disorders | 147 (34.6) | 162 (35.4) |
| Tachycardia NOS | 105 (24.7) | 102 (22.3) |
| Patient base: all randomized patients who received at least
1 dose of trial drug Common: ≥ 15% in either treatment arm. * During treatment + 3 days † Within a system organ class patients may experience more than 1 adverse event. |
||
Overall Mycamine Safety Experience in Clinical Trials
The overall safety of Mycamine was assessed in 3083 patients and 501 volunteers in 41 clinical studies, including the invasive candidiasis, esophageal candidiasis and prophylaxis studies, who received single or multiple doses of Mycamine, ranging from 12.5 mg to ≥ 150 mg/day. Treatment emergent adverse events which occurred in ≥ 5% of all patients who received Mycamine in these trials are shown in Table 5.
Overall, 2810 of 3083 (91.1%) patients who received Mycamine experienced an adverse event.
Clinically significant adverse events regardless of causality or incidence which occurred in these trials are listed below:
- Blood and lymphatic system disorders: coagulopathy, febrile neutropenia, hemolysis, hemolyric anemia, pancytopenia, thrombotic thrombocytopenia purpura
- Cardiac disorders: arrhythmia, atrial fibrillation, cardiac arrest, cyanosis, hypotension, myocardial infarction, tachycardia
- Gastrointestinal disorders: abdominal pain upper, dyspepsia
- General disorders and administration site conditions: injection site thrombosis
- Hepatobiliary disorders: hepatocellular damage, hepatomegaly, jaundice, hepatic failure
- Infections and infestations: infection, pneumonia, sepsis
- Metabolism and nutrition disorders: acidosis, anorexia, hyponatremia
- Musculoskeletal, connective tissue and bone disorders: arthralgia
- Nervous system disorders: convulsions, encephalopathy, intracranial hemorrhage
- Psychiatric disorders: delirium
- Renal and urinary disorders: anuria, hemoglobinuria, oliguria, renal failure acute, renal tubular necrosis
- Respiratory, thoracic and mediastinal disorders: apnea, dyspnea, hypoxia, pulmonary embolism
- Skin and subcutaneous tissue disorders: erythema multiforme, skin necrosis, urticaria
- Vascular disorders: deep venous thrombosis, hypertension
Table 5. *Treatment Emergent Adverse Events in Patients Who
Received Mycamine in Clinical Trials
| Adverse Events† (MedDRA System Organ Class and Preferred Term) |
Mycamine n (%) |
| Number of Patients | 3083 |
| AD Systems, Any Adverse Event | 2810 (91.1) |
| Gastrointestinal Disorders | 1764 (57.2) |
| Diarrhea NOS | 718 (23.3) |
| Nausea | 679 (22) |
| Vomiting NOS | 669 (21.7) |
| Constipation | 341 (11.1) |
| Abdominal Pain | 300 (9.7) |
| Dyspepsia | 176 (5.7) |
| General Disorders/Administration Site Conditions | 1407 (45.6) |
| Pyrexia | 618 (20) |
| Mucosal Inflammation NOS | 438 (14.2) |
| Rigors | 281 (9.1) |
| Edema Peripheral | 209 (6.8) |
| Fatigue | 198 (6.4) |
| Metabolism and Nutrition Disorders | 1316 (42.7) |
| Hypokalemia | 556 (18) |
| Hypomagnesemia | 409 (13.3) |
| Hypocalcemia | 201 (6.5) |
| Anorexia | 190 (6.2) |
| Hyperglycemia NOS | 173 (5.6) |
| Fluid Overload | 155 (5) |
| Infections and Infestations | 1227 (39.8) |
| Bacteremia | 185 (6) |
| Sepsis NOS | 156 (5.1) |
| Respiratory, Thoracic and Mediastinal Disorders | 1108 (35.9) |
| Cough | 251 (8.1) |
| Dyspnea NOS | 182 (5.9) |
| Epistaxis | 172 (5.6) |
| Blood and Lymphatic System Disorders | 1047 (34) |
| Thrombocytopenia | 474 (15.4) |
| Neutropenia | 436 (14.1) |
| Anemia NOS | 302 (9.8) |
| Febrile Neutropenia | 187 (6.1) |
| Investigations | 989 (32.1) |
| Aspartate Aminotransferase Increased | 172 (5.6) |
| Blood Alkaline Phosphatase NOS Increased | 168 (5.4) |
| Alanine Aminotransferase Increased | 165 (5.4) |
| Skin and Subcutaneous Tissue Disorders | 940 (30.5) |
| Rash NOS | 269 (8.7) |
| Pruritus NOS | 187 (6.1) |
| Nervous System Disorders | 889 (28.8) |
| Headache NOS | 489 (15.9) |
| Psychiatric Disorders | 727 (23.6) |
| Insomnia | 303 (9.8) |
| Anxiety | 198 (6.4) |
| Vascular Disorders | 867 (28.1) |
| Hypotension NOS | 279 (9.1) |
| Hypertension NOS | 214 (6.9) |
| Phlebitis NOS | 172 (5.6) |
| Musculoskeletal and Connective Tissue Disorders | 579 (18.8) |
| Back Pain | 166 (5.4) |
| Cardiac Disorders | 563 (18.3) |
| Tachycardia NOS | 231 (7.5) |
| Patient base: all randomized patients who received at least
1 dose of trial drug Common: Incidence of adverse event ≥ 5%. * During treatment + 3 days † Within a system organ class patients may experience more than 1 adverse event |
|
Postmarketing Adverse Reactions
The following adverse reactions have been identified during the post-approval use of micafungin sodium for injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency. A causal relationship to micafungin sodium for injection could not be excluded for these adverse reactions, which included:
- Blood and lymphatic system disorders: white blood cell count decreased, hemolytic anemia, disseminated intravascular coagulation
- Hepatobiliary disorders: hyperbilirubinemia, hepatic function abnormal, hepatic disorder, hepatocellular damage
- Renal and urinary disorders: acute renal failure and renal impairment
- Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome, toxic epidermal necrolysis
- Vascular disorders: shock
Read the entire FDA prescribing information for Mycamine (Micafungin Sodium) »
Additional Mycamine Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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