Summary

Commonly reported side effects of isavuconazonium include: dyspnea, increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase, and increased serum bilirubin. Other side effects include: hypotension. Continue reading for a comprehensive list of adverse effects.

Applies to isavuconazonium: oral capsule. Other dosage forms:

• intravenous powder for solution

Serious side effects of Isavuconazonium

Along with its needed effects, isavuconazonium 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 immediately if any of the following side effects occur while taking isavuconazonium:

More common

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody urine
• blurred vision
• chest pain or tightness
• confusion
• 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
• tingling of the hands or feet
• trembling
• trouble breathing
• unusual tiredness or weakness

Less common or rare

• Black, tarry stools
• chills
• cough or hoarseness
• dark urine
• fever with or without chills
• hives, itching, or rash
• irritation
• joint pain, stiffness, or swelling
• light-colored stools
• painful or difficult urination
• 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
• diarrhea
• red skin lesions, often with a purple center
• red, irritated eyes

Other side effects of Isavuconazonium

Some side effects of isavuconazonium 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

• 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

• Burning, numbness, tingling, or painful sensations
• continuing ringing or buzzing or other unexplained noise in the ears
• decreased vision
• eye pain
• feeling of constant movement of self or surroundings
• hearing loss
• loss or thinning of the hair
• sensation of spinning
• unsteadiness or awkwardness
• weakness in arms, hands, legs, or feet

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, back pain, abdominal pain, injection site reaction, and rash. 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

Uncommon (0.1% to 1%): Abdominal distension

Frequency not reported: Gastritis, gingivitis, stomatitis^[Ref]

Metabolic

Very common (10% or more): Hypokalemia (up to 19.1%)

Common (1% to 10%): Decreased appetite, hypomagnesemia

Uncommon (0.1% to 1%): Hypoalbuminemia, hypoglycemia, malnutrition

Frequency not reported: Hyponatremia^[Ref]

Hepatic

Very common (10% or more): Elevated liver chemistry/laboratory tests (includes increased ALT, increased AST, increased blood alkaline phosphatase, increased blood bilirubin, increased blood lactate dehydrogenase, increased GGT, increased hepatic enzyme, abnormal hepatic function, hyperbilirubinemia, abnormal liver function test, increased transaminases; up to 17.1%)

Common (1% to 10%): Elevated liver transaminases (ALT or AST)

Uncommon (0.1% to 1%): Hepatitis, hepatomegaly

Frequency not reported: Cholecystitis, cholelithiasis, hepatic failure, cholestasis^[Ref]

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]

Respiratory

Very common (10% or more): Dyspnea (up to 17.1%), cough (12%)

Common (1% to 10%): Acute respiratory failure

Uncommon (0.1% to 1%): Bronchospasm, tachypnea, hemoptysis, epistaxis^[Ref]

Nervous system

Very common (10% or more): Headache (up to 17%)

Common (1% to 10%): Somnolence

Uncommon (0.1% to 1%): Convulsion, syncope, dizziness, paresthesia, encephalopathy, presyncope, peripheral neuropathy, dysgeusia, vertigo

Frequency not reported: Epilepsy, hypoesthesia, migraine, stupor, tremor, tinnitus^[Ref]

Other

Very common (10% or more): Peripheral edema (up to 15.2%), fatigue (10.5%)

Common (1% to 10%): Chest pain

Uncommon (0.1% to 1%): Malaise, asthenia

Frequency not reported: Infusion-related reactions (including hypotension, dyspnea, chills, dizziness, paresthesia, hypoesthesia), catheter thrombosis, 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

Uncommon (0.1% to 1%): Depression

Frequency not reported: Confusion, hallucination^[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, thrombophlebitis

Uncommon (0.1% to 1%): Atrial fibrillation, atrial flutter, bradycardia, reduced QT interval on ECG/shortened ECG QT, palpitations, supraventricular extrasystoles, supraventricular tachycardia, tachycardia, ventricular extrasystoles, circulatory collapse

Frequency not reported: Cardiac arrest^[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus

Uncommon (0.1% to 1%): Alopecia, dermatitis, petechiae, drug eruption

Frequency not reported: Exfoliative dermatitis, erythema, urticaria^[Ref]

Local

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

Hematologic

Uncommon (0.1% to 1%): Neutropenia, thrombocytopenia, leukopenia, pancytopenia, anemia

Frequency not reported: Agranulocytosis^[Ref]

Hypersensitivity

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

Genitourinary

Frequency not reported: Hematuria, proteinuria^[Ref]

Ocular

Frequency not reported: Optic neuropathy^[Ref]