Isavuconazonium (Intravenous)

Overview

By killing the yeast or fungus that is causing the infection, Isavuconazonium injections tackle serious infections, including invasive mucormycosis and invasive aspergillosis. It should only be administered by a qualified physician or other healthcare professional.

It may be more familiar to people under the US brand name Cresemba. It belongs to a group of medicines known as antifungals, which work by destroying the fungal cells to stop infection. It is supplied as a powder for mixing into a solution for intravenous injections.

Conditions Treated

  • Severe fungal infections eg invasive mucormycosis and invasive aspergillosis

Type Of Medicine

  • Antifungal

Side Effects

All medicines can cause unwanted side effects alongside their desired functions. Not all of the following side effects may appear, but some side effects may require medical attention if they do.

Patients who notice any of the following side effects should contact their physician as soon as possible:

  • Blurred vision

Other side effects may be present that do not typically require medical assistance. They may disappear over the course of treatment, as the body adjusts to the effects of Isavuconazonium. Concerned patients should consult their physician or pharmacist to discuss ways to prevent or reduce side effects, if they become persistent or particularly bothersome.

  • Trouble sleeping

Some patients may experience other side effects not listed in this guide. Patients who notice other side effects should check with their physician. New side effects can also be reported to the FDA by calling 1-800-FDA-1088.

Dosage

Nurses or other medical professionals will administer Isavuconazonium injections, typically in a hospital or other clinical setting. Isavuconazonium is given via a needle, which is normally inserted into one of the veins on the patient's arm. It must be injected slowly using an IV tube, which needs to stay inserted and stable for around an hour.

Isavuconazonium is provided with a patient information leaflet, which should be handed to the patient. The patient should read the information carefully and raise any questions with their physician before the procedure begins.

When treating invasive aspergillosis, a typical dose for adults over the age of 18 is a 372mg IV loading dose, followed by a 372mg IV maintenance dose once a day for the duration of treatment, until the patient's condition improves.

Isavuconazonium is supplied as a powder, which should be prepared in solution as Isavuconazonium sulfate. A 372mg dose of Isavuconazonium sulfate is equivalent to 200mg of Isavuconazonium. Maintenance doses should start around 12 to 24 hours after the loading dose.

When treating invasive mucormycosis, a typical dose for adults is a 372mg IV loading dose, followed by a 372mg IV maintenance dose, once a day.

Major drug interactions

Some medications should never be used together, as they are known to cause interactions. Other medicines can be used together, even if there is a risk of interactions. A physician should evaluate the risks and may make adjustments to the doses or frequency of use of one or more medicines to counteract the risks.

Patients should always fully inform their physician about all medicines and substances they are taking, including prescription and over the counter medications, vitamins, supplements and herbal remedies. The following list of substances represents significant known interactions with Isavuconazonium. It is not all-inclusive.

Using any of the following medicines at the same time as Isavuconazonium is not typically recommended. A physician may choose to take precautions and still prescribe them together.

  • Boceprevir

The following medicines are not recommended for use at the same time as Isavuconazonium, but a physician may, in some cases, decide to prescribe them together. If they are used, the physician may choose to alter the doses or frequency of use of one or both of the medicines.

  • Digoxin

The following medicines have been known to cause some interactions with Isavuconazonium, but taking both of them at the same time may still be the best course of treatment, as determined by a patient's physician. Again, a physician may wish to adjust the frequency of use or dosages to reduce the risk of interactions.

  • Bupropion

Some medicines may cause interactions when used at the same time as a patient eating or drinking certain types of food. Using tobacco products or alcohol may also trigger interactions with some medications. Patients should always be honest with their physician about their intake of food, drinks and other substances so the doctor can make adjustments to reduce the risk of interactions or provide special advice. The following interactions are known to be significant. This should not be considered as an all-inclusive list.

  • Grapefruit juice

Patients who have other medical issues may also experience problems during treatment with Isavuconazonium. Patients should provide a full medical history, including any history of:

  • Liver disease, which may require close monitoring as Isavuconazonium can exacerbate the condition

Warnings

While a patient is taking Isavuconazonium, their physician should regularly review their progress. They should assess whether the infection is retreating and check for any side effects. They may take some blood tests to look for potential side effects.

Isavuconazonium should never be used together with phenobarbital (Luminal®), carbamazepine (Tegretol®), rifampin (Rifadin®, Rimactane®), St John's wort, ketoconazole (Nizoral®) or ritonavir (Norvir®), as these are known to trigger severe interactions.

Patients who are pregnant or planning to start a family should tell their physician before accepting any treatment. Patients who believe they may have become pregnant during the course of treatment should consult their physician immediately.

Patients who experience tenderness or pain in their upper stomach area, dark urine, pale stools, vomiting, nausea, a loss of appetite or yellowing skin or eyes should seek medical attention urgently. These could be the symptoms of a developing liver problem.

Isavuconazonium has also been known to trigger a severe allergic reaction, known as infusion related reaction. It requires urgent medical attention and can be life-threatening. Patients who experience dizziness, chills, breathing difficulties, numbness, tingling, chest tightness, changes in their sense of touch, faintness or lightheadedness should contact their physician right away.

Isavuconazonium can also trigger anaphylactic shock (a severe allergic reaction) in some patients. Anaphylaxis requires immediate medical assistance and can be life-threatening. Patients who notice itching, a rash, swallowing or breathing difficulties or swelling of their face, mouth or hands should seek medical help immediately.

Severe skin reactions can also be triggered by Isavuconazonium. Patients who have peeling, blistering or loose skin, red lesions, a severe rash or acne, ulcers or sores, chills or a fever should check with their physician immediately.

Patients should never take other medicines unless they have first been checked with their physician while taking Isavuconazonium. That includes over the counter medicines, vitamins and herbal supplements.

Storage

Patients will not be asked to store Isavuconazonium as it should be stored and administered only in a hospital or other clinical setting. Healthcare professionals should store Isavuconazonium for IV in either its unreconstituted vials between 36F and 46F in a refrigerator, or in a reconstituted solution below 25C for up to one hour before being prepared as the patient infusion solution.

Once diluted in solution for infusion, it should be fully used within six hours of dilution at room temperature (between 68F and 77F) or refrigerated between 36F and 36F immediately after dilution and completed within 24 hours. Isavuconazonium solution should never be frozen.

Summary

Isavuconazonium belongs to a group of medications that fight infections that are caused by fungus. Isavuconazonium, in particular, is used to kill specific types of fungus, including invasive mucormycosis and invasive aspergillosis. Isavuconazonium may also be prescribed for other reasons. It is given intravenously slowly over the course of an hour, before being followed up with repeat doses at regular intervals.

Isavuconazonium is usually injected into patients in a hospital or clinic. If Isavuconazonium has been given to a patient to use at home, they should carefully read all the preparation material and ensure they understand the usage instructions, asking any questions with their healthcare professional. Patients should use an in-line filter while injecting Isavuconazonium. It looks like a clear liquid with white particles, but patients should always check for signs of decay, including other particles or discoloration. If they notice any differences, they should not use the vial.

Isavuconazonium should never be used by patients who have the genetic heart condition known as Short QT Syndrome. Many drugs may interact with Isavuconazonium if used together, including some over the counter and prescription medicines. Patients should always fully inform their physician about their history of other conditions and any other medicines they may be taking, including herbal remedies and vitamins. A physician can then decide whether to make any adjustments.

Patients should receive Isavuconazonium over regular intervals to keep the dose in the body at a constant level. They should continue to receive the medicine until the prescribed amount is completely finished, even if they start to feel better. Stopping treatment early may result in the infection returning.