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Cresemba Side Effects

Generic Name: isavuconazonium

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

In Summary

Common side effects of Cresemba include: dyspnea, increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase, and increased serum bilirubin. Other side effects include: hypotension. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to isavuconazonium: oral capsule

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

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking isavuconazonium:

More common:
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody urine
  • blurred vision
  • chest pain
  • confusion
  • convulsions
  • decreased frequency or amount of urine
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast or irregular heartbeat
  • loss of appetite
  • lower back or side pain
  • muscle pain or cramps
  • muscle spasms (tetany) or twitching
  • numbness or tingling in the hands, feet, or lips
  • seizures
  • severe nausea or vomiting
  • sweating
  • tightness in the chest
  • tingling of the hands or feet
  • trembling
  • trouble breathing
  • unusual tiredness or weakness
Less common or rare:
  • Cough or hoarseness
  • dark urine
  • fever with or without chills
  • hives, itching, or rash
  • irritation
  • joint pain, stiffness, or swelling
  • light-colored stools
  • red, swollen skin
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomach pain
  • unusual bleeding or bruising
  • upper right abdominal or stomach pain
  • yellow eyes and skin
Incidence not known:
  • Blistering, peeling, or loosening of the skin
  • chills
  • diarrhea
  • red skin lesions, often with a purple center
  • red, irritated eyes

Minor Side Effects

Some of the side effects that can occur with isavuconazonium 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:
  • Acid or sour stomach
  • anxiety
  • back pain
  • headache
  • heartburn or indigestion
  • seeing, hearing, or feeling things that are not there
  • stomach discomfort or upset
  • trouble sleeping
  • unusual excitement, nervousness, or restlessness
Less common or rare:
  • Continuing ringing or buzzing or other unexplained noise in the ears
  • decreased vision
  • eye pain
  • feeling of constant movement of self or surroundings
  • hair loss or thinning of the hair
  • hearing loss
  • sensation of spinning

For Healthcare Professionals

Applies to isavuconazonium: intravenous powder for injection, oral capsule

General

The most common side effects were nausea, vomiting, diarrhea, headache, elevated liver chemistry tests, hypokalemia, constipation, dyspnea, cough, peripheral edema, and back pain. Serious side effects were reported in 55% of patients. Therapy was permanently discontinued due to side effects in 14% of patients; confusional state, acute renal failure, increased blood bilirubin, convulsion, dyspnea, epilepsy, respiratory failure, and vomiting led to permanent discontinuation most often.[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 27.6%), vomiting (up to 25%), diarrhea (up to 23.7%), abdominal pain (16.7%), constipation (up to 14%)
Common (1% to 10%): Dyspepsia
Frequency not reported: Abdominal distension, gastritis, gingivitis, stomatitis

Metabolic

Very common (10% or more): Hypokalemia (up to 19.1%)
Common (1% to 10%): Decreased appetite, hypomagnesemia
Frequency not reported: Hypoalbuminemia, hypoglycemia, hyponatremia[Ref]

Hepatic

Elevated liver transaminases (ALT or AST) greater than 3 times the upper limit of normal (3 x ULN) and greater than 10 x ULN were reported in 4.4% and 1.2% of patients, respectively.[Ref]

Very common (10% or more): Elevated liver chemistry/laboratory tests (includes increased ALT, AST, blood alkaline phosphatase, blood bilirubin, GGT; up to 17.1%)
Common (1% to 10%): Elevated liver transaminases (ALT or AST)
Frequency not reported: Cholecystitis, cholelithiasis, hepatitis, hepatomegaly, hepatic failure, cholestasis[Ref]

Respiratory

Very common (10% or more): Dyspnea (up to 17.1%), cough (12%)
Common (1% to 10%): Acute respiratory failure
Frequency not reported: Bronchospasm, tachypnea[Ref]

Nervous system

Very common (10% or more): Headache (up to 17%)
Frequency not reported: Convulsion, epilepsy, dysgeusia, encephalopathy, hypoesthesia, migraine, peripheral neuropathy, paresthesia, somnolence, stupor, syncope, tremor, tinnitus, vertigo[Ref]

Other

Very common (10% or more): Peripheral edema (up to 15.2%), fatigue (10.5%)
Common (1% to 10%): Chest pain
Frequency not reported: Infusion-related reactions (including hypotension, dyspnea, chills, dizziness, paresthesia, hypoesthesia), catheter thrombosis, malaise, chills, fall[Ref]

Psychiatric

Very common (10% or more): Insomnia (10.5%)
Common (1% to 10%): Delirium (includes agitation, confusional state, delirium, disorientation, mental status changes), anxiety
Frequency not reported: Confusion, hallucination, depression[Ref]

Renal

Very common (10% or more): Renal failure (10.1%)
Frequency not reported: Acute renal failure[Ref]

Musculoskeletal

Very common (10% or more): Back pain (up to 10.1%)
Frequency not reported: Myositis, bone pain, neck pain[Ref]

Cardiovascular

Common (1% to 10%): Hypotension
Frequency not reported: Atrial fibrillation, atrial flutter, bradycardia, reduced QT interval on ECG, palpitations, supraventricular extrasystoles, supraventricular tachycardia, ventricular extrasystoles, cardiac arrest, thrombophlebitis[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus
Frequency not reported: Alopecia, dermatitis, exfoliative dermatitis, erythema, petechiae, urticaria[Ref]

Local

Common (1% to 10%): Injection site reaction[Ref]

Hematologic

Frequency not reported: Agranulocytosis, leukopenia, pancytopenia[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity[Ref]

Genitourinary

Frequency not reported: Hematuria, proteinuria[Ref]

Ocular

Frequency not reported: Optic neuropathy[Ref]

References

1. "Product Information. Cresemba (isavuconazonium)." Astellas Pharma US, Inc, Deerfield, IL.

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

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