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Isavuconazonium

Generic name: isavuconazonium [EYE-sa-vue-KOE-na-ZOE-nee-um]

Brand name: Cresemba
Forms of dosage: intravenous powder for injection (372 mg), oral capsule (186 mg).
Drug class: Azole antifungals

What is Isavuconazonium (I.C.A.Z.)?

Isavuconazonium can be used to treat certain types of fungal infections (aspergillosis and mucormycosis). This medication guide does not list all possible uses of isavuconazonium.

Side effects of Isavuconazonium

If you experience symptoms of an allergic reaction, such as hives, difficulty breathing, swelling on your face or in your throat, or a severe reaction to the skin (fever or sore throat with burning eyes, skin rash, blistering or peeling skin, or red or purple rash), seek emergency medical attention.

Some side effects can occur during injection. You should tell your carer if you experience any of the following: dizziness, lightheadedness, difficulty breathing, chilling, numbness or tingling, or changes in your sensation.

Isavuconazonium may cause serious side effects. If you experience:

  • If you have liver problems, they may include fatigue, nausea, stomach pain, dark urine or stools (clay-coloured), itching, or jaundice.
  • Low sodium level: leg cramps, constipation, irregular heartbeats, increased thirst, increased urination or numbness, muscle weakness, or a limp feeling.

Isavuconazonium side effects include:

  • Nausea, vomiting, diarrhea, constipation;
  • You may experience swelling in your arms or legs.
  • Headache, back pain;
  • Shortness of breath.
  • Low potassium
  • Abnormal liver function tests

There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.

Similar/related drugs

Itraconazole, Voriconazole, Amphotericin B, Posaconazole, Sporanox, and Cresemba

Warnings

"You should not use isavuconazonium if you suffer from a genetic heart rhythm disorder known as short-QT syndrome."

Inform your doctor of all the medications you are taking, as well as any new ones. Some drugs are not to be taken together, and others can cause drug interactions.

Before you take this drug

If you are allergic or have any of the following:

  • A genetic heart rhythm disorder known as short QT syndrome

Many drugs can cause harmful interactions. Isavuconazonium and some drugs shouldn't be taken together. If you are also taking

  • Carbamazepine;
  • Ketoconazole;
  • Phenobarbital;
  • Rifampin;
  • Ritonavir at high doses;
  • John's wort

Tell your doctor about any of the following:

  • Liver disease
  • A heart rhythm disorder,
  • History of allergic reactions to antifungal medicines such as fluconazole or itraconazole.

This medicine may harm an unborn child. Prevent pregnancy by using effective contraception while taking this medication and for at least 28 days following your last dose. As soon as you become pregnant, notify your physician immediately.

Breastfeeding is not recommended while using isavuconazonium.Anyone younger than 18 is not allowed to use isavuconazonium.

How to take Isavuconazonium?

Learn all of the instructions or guides that come with your medication and follow them exactly. Sometimes, your doctor will change the dose. You must take the medication exactly as prescribed. Isavuconazonium is taken orally. Isavuconazonium is given by infusion. Your healthcare provider may give you your first dose and teach you how to use the medication properly. Take the capsules with or without food. Do not open, crush, chew, or break the capsule. Swallow it whole.

Isavuconazonium must be diluted with a liquid first (diluent) and then in an IV bag. Please read and follow all instructions for use that come with your medication. If you don't understand the instructions, ask your doctor or pharmacist. Please read and follow all instructions included with your medication. If you don't understand them, seek guidance from your healthcare provider or pharmacist. Only make an injection when it is time to give it. If the color of your medicine has changed or if it contains particles, do not use it. For new medication, call your pharmacist. Your liver will require frequent blood tests.

You should not stop taking isavuconazonium without your doctor's permission. Keep the capsules at room temperature, away from heat and moisture. Do not put capsules in a daily pill organizer or daily pill box.

Keep unused vials inside the refrigerator. Keep the vial at room temperature after mixing the diluent. Then, dilute it further in an IV bag. Once the final solution is mixed, the IV bag should be kept at room temperature for 6 hours and then used within 24 hours. Do not freeze.

Only use a needle or syringe once, and then store them in a "sharps container" that is puncture-proof. Be sure to follow local or state laws on how to properly dispose of the container. Keep the container out of reach of pets and children.

Isavuconazonium dosing information

Adult dose for Aspergillosis: Invasive:

Loading dose: 372 mg IV every 8 hours orally for 6 doses.
Maintenance Dose: 372 mg IV, orally or intravenously, once per day.
Comments:
Isavuconazonium sulfate, the prodrug for isavuconazole, is 372 mg. This is 200 mg of isavuconazole.
Maintenance doses can be given 12–24 hours after the loading dose.
Uses: Treatment of invasive aspergillosis and invasive mucormycosis

Adult dose for mucormycosis (invasive):

Loading dose: 372 mg IV every 8 hours or orally for 6 doses in 48 hours
Maintenance Dose: 372 mg IV, orally or intravenously, once per day.
Comments:
Isavuconazonium sulfate, the prodrug for isavuconazole, is 372 mg. This is 200 mg of isavuconazole.
Maintenance doses can be given 12–24 hours after the loading dose.
Uses: Treatment of invasive aspergillosis, invasive mucormycosis

What happens if I miss the dose?

If you miss a dosage, call your doctor to get instructions.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

Overdose symptoms include dizziness and drowsiness. They may also include hot flashes, headaches, joint pains, anxiety, restlessness, tingling or numbness, difficulty concentrating, dryness of mouth, altered taste, numbness around the mouth or in your mouth, diarrhea or vomiting, or fast or pounding pulses.

What should be avoided?

If your doctor prescribes any restrictions regarding food, beverage, or activity, follow their instructions.

Interaction with other drug

It is sometimes not safe to take certain medications together. Some drugs may affect the blood levels of drugs that you are taking, which can increase side effects and make them less effective.

Inform your doctor of all the medications you are taking. Isavuconazonium can be affected by many drugs, including:

  • Digoxin;
  • Medicine to prevent organ rejection (cyclosporine; sirolimus; tacrolimus)

This list does not include all drugs that may interact with isavuconazonium. This includes over-the-counter and prescription medicines, vitamins, and herbal products. This list does not include all possible drug interactions.

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

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