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Isavuconazonium (Intravenous route)

Pronunciation:

eye-sa-vue-koe-na-ZOE-nee-um SUL-fate

Brand Names:

  • Cresemba

Dosage Forms:

  • Powder for Solution

Classifications:

Therapeutic

Antifungal

Chemical

Isavuconazonium

Uses of This Medicine:

Isavuconazonium injection is used to treat serious fungal or yeast infections, such as invasive aspergillosis and invasive mucormycosis. This medicine works by killing the fungus or yeast and preventing its growth.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children

Appropriate studies have not been performed on the relationship of age to the effects of isavuconazonium injection in the pediatric population. Safety and efficacy have not been established.

Older adults

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of isavuconazonium injection in the elderly.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Other medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Atazanavir
  • Boceprevir
  • Carbamazepine
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Delavirdine
  • Efavirenz
  • Enzalutamide
  • Fosphenytoin
  • Idelalisib
  • Imatinib
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Mephobarbital
  • Mitotane
  • Nefazodone
  • Nelfinavir
  • Oxcarbazepine
  • Phenobarbital
  • Phenytoin
  • Posaconazole
  • Primidone
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Ritonavir
  • Saquinavir
  • St John's Wort
  • Telaprevir
  • Telithromycin
  • Tipranavir
  • Voriconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Atorvastatin
  • Cyclosporine
  • Digoxin
  • Lopinavir
  • Midazolam
  • Quinidine
  • Sirolimus
  • Tacrolimus

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Bupropion

Other interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Heart rhythm problem (eg, familial short QT syndrome) Should not be used in patients with this condition.
  • Liver disease Use with caution. May make this condition worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for at least 1 hour.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Precautions While Using This Medicine:

It is important that your doctor check your progress after treatment. This is to make sure that the infection is cleared up completely, and to allow your doctor to check for any unwanted effects. Blood tests may be needed to check for unwanted effects.

Do not use this medicine together with carbamazepine (Tegretol®), ketoconazole (Nizoral®), phenobarbital (Luminal®), rifampin (Rifadin®, Rimactane®), ritonavir (Norvir®), or St. John's wort. Using these medicines together may cause unwanted effects.

Make sure your doctor knows if you are pregnant or planning to get pregnant before you start using this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause a serious allergic reaction called infusion related reaction. This can be life-threatening and requires immediate medical attention. Tell your doctor right away if you start to have chills, dizziness, trouble breathing, chest tightness, numbness or tingling, change in sense of touch, or lightheadedness or faintness while you are receiving this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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 or nurse immediately if any of the following side effects occur:

More common
Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
bloating or swelling of the face, arms, hands, lower legs, or feet
bloody urine
blurred vision
chest pain
confusion
convulsions
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
tightness in the chest
tingling of the hands or feet
trembling
trouble breathing
unusual tiredness or weakness
Less common or rare
Cough or hoarseness
dark urine
fever with or without chills
hives, itching, or rash
irritation
joint pain, stiffness, or swelling
light-colored stools
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
chills
diarrhea
red skin lesions, often with a purple center
red, irritated eyes

Some side effects 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
trouble sleeping
unusual excitement, nervousness, or restlessness
Less common or rare
Continuing ringing or buzzing or other unexplained noise in the ears
decreased vision
eye pain
feeling of constant movement of self or surroundings
hair loss or thinning of the hair
hearing loss
sensation of spinning

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 9/15/2016
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