Isavuconazonium Injection

WHY is this medicine prescribed?

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) in adults and children 1 year of age and older. Isavuconazonium injection is in a class of medications called azole antifungals. It works by slowing the growth of fungi that cause infection.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Isavuconazonium injection comes as a powder to be mixed with liquid and injected intravenously (into a vein). Isavuconazonium injection may also be administered through a nasogastric (NG) tube. 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.

If you have a nasogastric (NG) tube, your doctor or pharmacist will explain how to prepare isavuconazonium injection to give through an NG tube.

Isavuconazonium injection may cause serious reactions during infusion of the medication. If you experience any of the following symptoms, tell your doctor immediately: difficulty breathing or shortness of breath; chills; shaking; dizziness; feeling faint; numbness, burning, or tingling in the hands, arms, feet, or legs; or changes in your sense of touch. Your doctor may need to stop your treatment if you experience these side effects.

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

What SPECIAL PRECAUTIONS should I follow?

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.

• Some medications should not be taken with isavuconazonium injection. Other medications may cause dosing changes or extra monitoring when taken with isavuconazonium injection. Make sure you have discussed any medications you are currently taking or plan to take before starting isavuconazonium injection with your doctor and pharmacist. Before starting, stopping, or changing any medications while recieving isavuconazonium injection, please get the advice of your doctor or pharmacist.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• the following nonprescription or herbal products may interact with isavuconazonium injection: St. John's wort. You should not take this medication while receiving isavuconazonium injection.

• 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 arrhythmia (abnormal heart rate or rhythm) or other heart problems, a low level of potassium in your blood, cancer of the blood cells, or liver problems.

• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant during your treatment with isavuconazonium injection and for 28 days after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. If you become pregnant while receiving isavuconazonium injection, call your doctor. Isavuconazonium may harm the fetus.

• tell your doctor if you are breastfeeding or plan to breastfeed. Your doctor may tell you not to breastfeed during your treatment with isavuconazonium injection.

What SPECIAL DIETARY instructions should I follow?

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

What SIDE EFFECTS can this medicine cause?

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
• nausea
• vomiting
• stomach pain
• heartburn or indigestion
• decreased appetite
• redness, pain, or swelling at the injection site

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

• rash; hives; itching; swelling of the face, throat, tongue, lips, or eyes; hoarseness; difficulty breathing or swallowing; fast or irregular heartbeat; dizziness; sweating; or fainting
• peeling or blistering skin
• nausea; vomiting; yellowing of the skin or eyes; extreme tiredness; or flu-like symptoms
• 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).

What should I do in case of OVERDOSE?

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

What OTHER INFORMATION should I know?

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.