Isavuconazonium Injection

Isavuconazonium injection is used to treat serious fungal infections such as invasive aspergillosis (a fungal infection that begins in the lungs and spreads through the bloodstream to other organs) and invasive mucormycosis (a fungal infection that usually begins in the sinuses, brain, or lungs). Isavuconazonium injection is in a class of medications called azole antifungals. It works by slowing the growth of fungi that cause infection.

Isavuconazonium injection comes as a powder to be mixed with liquid and injected intravenously (into a vein). It is usually given over at least 1 hour every 8 hours for the first six doses and then once a day. The length of your treatment depends on your general health, the type of infection that you have, and how well you respond to the medication. You may receive isavuconazonium injection in a hospital or you may administer the medication at home. If you will be receiving isavuconazonium injection at home, your healthcare provider will show you how to use the medication. Be sure that you understand these directions, and ask your healthcare provider if you have any questions.

You may experience a reaction while you receive a dose of isavuconazonium injection. Tell your doctor immediately if you experience any of these symptoms while you receive isavuconazonium injection: dizziness, difficulty breathing, chills, change in your sense of touch, or numbness or tingling of the skin. Your doctor may stop the infusion until your symptoms improve.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving isavuconazonium injection,

• tell your doctor and pharmacist if you are allergic to isavuconazonium, fluconazole (Diflucan), itraconazole (Sporanox, Tolsura), ketoconazole, posaconazole (Noxafil), voriconazole (Vfend), any other medications, or any of the ingredients in isavuconazonium injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor if you are taking carbamazepine (Carbatrol, Tegretol), ketoconazole (Nizoral), phenobarbital, rifampin (Rifadin, Rifamate), ritonavir (Norvir, in Kaletra), or St. John's wort. Your doctor will probably tell you not to use isavuconazonium injection if you are taking one or more of these medications.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: atorvastatin (Lipitor, in Caduet), bupropion (Aplenzin, Forfivo XL, Wellbutrin, in Contrave), cyclosporine (Gengraf, Neoral, Sandimmune), digoxin (Lanoxin), midazolam, mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Astagraf, Prograf). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with isavuconazonium, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you or anyone in your family has or has ever had short QT syndrome (condition that increases the risk of irregular heartbeat, dizziness, fainting, or sudden death). Your doctor will probably tell you not to receive isavuconazonium injection.

• tell your doctor if you have or have ever had an irregular heartbeat, low blood levels of potassium, other heart problems, or liver problems.

• tell your doctor if you are pregnant or plan to become pregnant. You should use birth control to prevent pregnancy during your treatment with isavuconazonium injection and for 28 days after your final dose. Talk to your doctor about types of birth control that will work for you. If you become pregnant while receiving isavuconazonium injection, call your doctor. Isavuconazonium may harm the fetus.

• tell your doctor if you are breastfeeding.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while receiving this medication.

• Isavuconazonium injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • diarrhea

  • constipation

  • headache

  • back pain

  • cough

  • difficulty falling asleep or staying asleep

  • anxiety

  • agitation

  • confusion

  • decreased appetite

• Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

  • rash; itching; hives; swelling of your face, mouth, tongue, or throat; chest pain; fast heartbeat; dizziness or fainting; sweating; or difficulty breathing or swallowing

  • peeling or blistering skin

  • yellowing of the skin or eyes, pain in the upper right part of the stomach, nausea, vomiting, itching, extreme tiredness, or flu-like symptoms

  • irregular heartbeat

  • swelling of the hands, feet, arms or legs

• Isavuconazonium injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

• If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• headache

• dizziness

• pain, burning, or tingling in the hands or feet

• drowsiness

• difficulty focusing

• change in sense of taste

• dry mouth

• numbness in the mouth

• diarrhea

• vomiting

• sudden reddening of the face, neck, or upper chest

• anxiety

• restlessness

• pounding or fast heartbeat

• eye sensitivity to light

• joint pain

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to isavuconazonium injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.