Isavuconazonium Sulfate

Isavuconazonium Sulfate is a prescription medication used to treat Invasive Aspergillosis and Invasive Mucormycosis.

• Isavuconazonium Sulfate is available under the following different brand names: Cresemba, Isavuconazole

Adult dosage

Capsule

• 186mg isavuconazonium sulfate (equivalent to 100mg isavuconazole)

Injection, lyophilized powder for reconstitution 

• 372mg isavuconazonium sulfate (equivalent to 200mg isavuconazole)

Invasive Aspergillosis

Adult dosage

• Initial: 372 mg orally/IV every 8 hours x 6 doses (48 hours)
• Maintenance: 372 mg orally/IV once daily

Invasive Mucormycosis

Adult dosage

• Initial: 372 mg orally/IV every 8 hours x 6 doses (48 hours)
• Maintenance: 372 mg orally/IV once daily

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”.

Common side effects of Isavuconazonium Sulfate include:

• nausea, 
• vomiting, 
• diarrhea, 
• constipation, 
• swelling in the arms or legs, 
• headache, 
• back pain, 
• cough, 
• shortness of breath, 
• low potassium, and 
• abnormal liver function tests 

Serious side effects of Isavuconazonium Sulfate include:

• hives, 
• difficulty breathing, 
• swelling in your face or throat, 
• fever, 
• sore throat, 
• burning eyes, 
• skin pain, 
• red or purple skin rash with blistering and peeling, 
• dizziness, 
• lightheadedness, 
• chilled, 
• numbness or tingling, 
• changes in the sense of touch, 
• loss of appetite, 
• stomach pain (upper right side), 
• tiredness, 
• itching, 
• dark urine, 
• clay-colored stools, 
• yellowing of the skin or eyes (jaundice), 
• leg cramps, 
• constipation, 
• irregular heartbeats, 
• fluttering in the chest, 
• increased thirst or urination, 
• muscle weakness, and 
• limp feeling 

Rare side effects of Isavuconazonium Sulfate include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Isavuconazonium Sulfate has severe interactions with at least 47 other drugs. 
• Isavuconazonium Sulfate has serious interactions with the following drugs:
  • bosutinib
  • dienogest/estradiol valerate
  • drospirenone 
  • ethinylestradiol 
  • levonorgestrel oral
  • levonorgestrel oral/ethinylestradiol/ferrous bisglycinate
  • venetoclax  
• Isavuconazonium Sulfate has moderate interactions with at least 307 other drugs.
• Isavuconazonium Sulfate has minor interactions with at least 16 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• Hypersensitivity
• Coadministration with strong CYP3A4 inhibitors or inducers
• Familial short QT syndrome; isavuconazole shortens the QTc interval in a concentration-related manner

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Isavuconazonium Sulfate?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Isavuconazonium Sulfate?”

Cautions

• Hepatic adverse drug reactions (e.g., elevated ALT, AST, alkaline phosphatase, total bilirubin) reported; the elevations in liver-related laboratory tests were generally reversible and did not require discontinuation of drug; cases of more severe hepatic adverse drug reactions, including hepatitis, cholestasis, or hepatic failure including death, have been reported in patients with serious underlying medical conditions (e.g., hematologic malignancy) during treatment with azole antifungal agents
• Infusion-related reactions, including hypotension, dyspnea, chills, dizziness, paresthesia, and hypoesthesia, were reported; discontinue the infusion if these reaction occur
• May cause fetal harm when administered to a pregnant woman
• Anaphylactic reactions, with fatal outcome, reported during treatment; symptoms including dyspnea, hypotension, generalized erythema with flushing, and urticaria reported often soon after initiation of treatment
• Severe skin reactions
  • Severe skin reactions, such as Stevens-Johnson syndrome, reported during treatment with other azole antifungal agents
  • Discontinue therapy if a patient develops anaphylactic or severe cutaneous adverse reaction and initiate supportive treatment as needed
  • There is no information regarding cross-sensitivity between this drug and other azole antifungal agents though cross-sensitivity between other triazole agents has been reported
  • When prescribing to patients with hypersensitivity to other azoles, monitor for signs and symptoms of hypersensitivity reactions
• Drug interaction overview
  • Isavuconazole is a sensitive CYP3A4 substrate, moderate CYP3A4 inhibitor, mild P-gp inhibitor, and a mild organic cation transporter 2 (OCT2) inhibitor
  • CYP3A4 inhibitors or inducers may alter the plasma concentrations of isavuconazole
  • Caution with other drugs that cause short QT syndrome (e.g., cenobamate, rufinamide)

Pregnancy and Lactation

• Based on findings from animal studies, fetal harm may occur when administered to pregnant women
• No human data available on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes
• Contraception
  • Advise female patients of reproductive potential to use effective contraception during treatment and for 28 days after the final dose
  • Isavuconazole was present in the milk of lactating rats following IV administration. Thus, drugs may be present in human milk. Therefore, breastfeeding should be discontinued during treatment.