Isavuconazonium (Oral)

Overview

When patients develop fungal infections, various parts of the body can be affected. For example, invasive mucormycosis commonly affects the brain and oral cavity but can also occur in the lungs, skin, gastrointestinal tract and other organs. Similarly, invasive aspergillosis can present in a number of areas, with patients experiencing infections of the sinuses, eyes, ears and nails as a result of this type of fungi. More seriously, these fungal infections can also affect major organs and may be life-threatening if they are not treated appropriately.

Although anyone can develop a fungal infection, patients may be more likely to develop these infections if they have underlying health problems. Invasive aspergillosis is more common in patients with chronic pulmonary obstructive disorder (COPD) or tuberculosis, whilst invasive mucormycosis is more commonly found in patients who are immunocompromised and suffering with illnesses such as diabetes mellitus, kidney failure, cancer and HIV or AIDS.

When patients first present with symptoms, doctors may run specific tests in order to confirm whether their infection has been caused by a bacteria, fungus or virus. In many cases, a biopsy is needed in order to confirm the presence of fungal infections and to determine what type of fungus is affecting the patient.

Following this, Isavuconazonium may be used to treat the infection. Isavuconazonium is a prodrug of Isavuconazole and becomes active once it has been metabolized in the patient's body. As an antifungal agent, this medication will not be effective if used to treat infections which are viral or bacterial in nature.

When used to treat fungal infections, however, Isavuconazonium can be extremely effective. The medication inhibits a specific enzyme, known as lanosterol 14 alpha-demethylase, which normally converts lanosterol to ergosterol. When this enzyme is inhibited, the amount of ergosterol in the body is reduced and the amount of lanosterol is increased. This compromises the cell's structure of the fungal membrane and allows the body to destroy the cell. As a result, the patient's infection is resolved.

Whilst Isavuconazonium may be administered intravenously if the patient is suffering from a life-threatening infection, it is more commonly prescribed in oral form. Although oral Isavuconazonium can be used to treat serious and severe infections, it can also be used to successfully resolve mild or moderate fungal infections.

Conditions Treated

  • Fungal infections

Type Of Medicine

  • Antifungal agent

Side Effects

When patients take Isavuconazonium to resolve an infection, they may exhibit some side effects. These may be more likely to occur when they first start taking the medication and may diminish over time. For example, the following side effects may occur when patients first start using Isavuconazonium:

  • Sour or acid stomach
  • Eye pain
  • Anxiety
  • Decreased vision
  • Back pain
  • Continuing buzzing or ringing or other unexplained noise in the ear
  • Headache
  • Unusual nervousness, restlessness or excitement
  • Indigestion or heartburn
  • Feeling, hearing or seeing things that are not there
  • Trouble sleeping
  • Stomach upset or discomfort
  • Feeling of constant movement of surroundings or self
  • Thinning of the hair or hair loss
  • Hearing loss
  • Sensation of spinning

If the above side effects are reduced over time, are not severe and are not prolonged, they may not require medical attention. However, if patients are concerned about the presence of side effects, they should seek medical advice.

Furthermore, patients will need to obtain immediate medical advice if they develop the following symptoms whilst taking Isavuconazonium:

  • Swelling or bloating of the hands, arms face, feet or lower legs
  • Bloody urine
  • Tightness in the chest
  • Blurred vision
  • Sweating
  • Chest pain
  • Severe nausea and vomiting
  • Confusion
  • Seizures
  • Convulsions
  • Tingling or numbness in the feet, hands or lips
  • Decreased amount or frequency of urine
  • Lightheadedness, faintness or dizziness when getting up suddenly from a sitting or lying position
  • Irregular or fast heartbeat
  • Dark urine
  • Loss of appetite
  • Hoarseness or cough
  • Pain in the lower back or side
  • Muscle cramps or pain
  • Trouble breathing
  • Muscle twitching or spasms (tetany)
  • Unusual weakness or tiredness
  • Tingling of the feet or hands
  • Fever with or without chills
  • Trembling
  • Rash, itching or hives
  • Irritation
  • Unusual bruising or bleeding
  • Joint swelling, stiffness or pain
  • Stomach pain
  • Light-colored stools
  • Sore throat
  • Ulcers, sores or white spots in the mouth or on the lips
  • Swollen, red skin
  • Pain in the stomach or upper right abdomen
  • Yellowing of the skin or eyes
  • Chills
  • Loosening, peeling or blistering of the skin
  • Irritated, red eyes
  • Diarrhea
  • Red skin lesions, may have a purple center

Patients should also seek medical advice if they experience any other side effects whilst they are using Isavuconazonium. If patients experience any side effects which are not listed above, they can also report them to the Food and Drug Administration on 1-800-FDA-1088.

Dosage

When Isavuconazonium is prescribed in oral form, patients are usually advised to take two capsules every eight hours, for six doses (48hours). Following this, patients are generally instructed to take two capsules per day. Typically, each capsule contains 186mg of Isavuconazonium. However, the patient's dose may be modified if their physician feels it is appropriate.

When Isavuconazonium is prescribed as a capsule, patients should swallow the capsule whole and should not attempt to break it, open it or crush it.

Patients should continue to take Isavuconazonium for the full course of treatment, even if their symptoms have resolved. If patients stop taking Isavuconazonium too early, their infection may return and may be more difficult to treat. Often, patients will need to continue taking Isavuconazonium until their physician advises them to stop.

If patients forget to take a dose of Isavuconazonium, they should take it as soon as they remember to do so. However, if their next dose of medication is due soon, they should skip the missed dose. Patients should not attempt to take an extra or double dose of Isavuconazonium, even if they have missed a previous dose of medication.

If patients are unsure how or when to take Isavuconazonium, they should contact their physician or pharmacist for advice.

Potential Drug Interactions:

Although some medications can be used at the same time, it is not safe to use certain medicines alongside one another. Due to this, Isavuconazonium should not be prescribed if the patient is taking any of the following:

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

Similarly, the use of Isavuconazonium is not usually advisable if the patient is taking or using any of the following medications:

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

If patients are prescribed Isavuconazonium alongside one of the drugs listed above, their physician may alter their dose in order to prevent an interaction occurring.

When patients take Isavuconazonium alongside the follow medicine, it may increase their risk of side effects:

  • Bupropion

However, the patient's doctor may be able to provide guidance regarding the reduction of side effects or may be able to prescribe additional medication to combat severe side effects.

As well as interacting with other prescription medicines, Isavuconazonium could interact with other substances, such as foods, drinks, over-the-counter medicines, supplements and/or vitamins. Due to this patients should not consume the following when taking Isavuconazonium:

  • Grapefruit, grapefruit juice or any food or drink containing grapefruit

Patients should also inform their physician if they are taking any over-the-counter medicines, supplements or vitamins before they start taking Isavuconazonium. Similarly, patients should obtain medical advice before they use any new medicines, supplements or vitamins once they have started taking Isavuconazonium.

Warnings

If the patient has any existing health problems or a medical history containing certain conditions, it may affect their treatment with Isavuconazonium. Patients should disclose any existing conditions to their doctor before they start using this medicine. The following conditions may be particularly relevant if treatment with Isavuconazonium is being considered:

  • Liver disease
  • Heart rhythm problems

Isavuconazonium is normally only prescribed to adult patients who are over the age of 18 years. The safety of Isavuconazonium has not been specifically tested on the pediatric population and, therefore, this medication is not normally prescribed to children or infants.

When patients are taking Isavuconazonium, they may need to have regular blood tests and check-ups. This enables their physician to confirm that the medication is working and that it is not having any unwanted effects on the patient.

In some cases, patients may need to take Isavuconazonium for several months in order for their infection to be fully resolved. If symptoms do not improve whilst the patient is taking Isavuconazonium or if they worsen, patients should contact their physician for advice.

Patients could develop a liver problem whilst taking Isavuconazonium and must obtain medical attention if they develop the following symptoms:

  • Loss of appetite
  • Yellowing of the skin or eyes
  • Nausea or vomiting
  • Dark urine
  • Pale stools
  • Tenderness or pain in the upper stomach

When patients are taking Isavuconazonium, they could develop a serious skin reaction. If patients experience the following symptoms whilst taking this medicine, they must obtain immediate medical advice:

  • Loosening, blistering or peeling of the skin
  • Severe acne or skin rash
  • Red skin lesions
  • Ulcers or sores on the skin
  • Chills or fever

Isavuconazonium should not normally be prescribed to patients who are pregnant. Isavuconazonium has been classed as a category C drug by the Food and Drug Administration in relation to pregnancy and may cause harm and/or development delays to an unborn fetus.

If patients are pregnant or are planning to become pregnant, they must inform their physician before they start using Isavuconazonium. If patients become pregnant whilst taking Isavuconazonium, they should inform their doctor immediately.

Studies have suggested that Isavuconazonium can be excreted in breast milk and, due to this, patients are advised not to breastfeed whilst taking this medicine or for some time afterwards. Patients should obtain medical advice before they resume breastfeeding after they have taken Isavuconazonium, particularly as they may have taken this medication for a long period of time.

Before taking Isavuconazonium, patients should tell their doctor if they have any known allergies or if they have ever experienced a serious allergic reaction before. This includes allergies to medicines, foods, animals, dyes and/or preservatives. In some cases, Isavuconazonium can cause serious allergic reactions, including anaphylaxis. The symptoms of this type of reaction may include:

  • Rash on the skin
  • Itching
  • Hoarseness
  • Difficulty breathing
  • Hives
  • Shortness of breath
  • Difficulty swallowing
  • Swelling of the face, hands and/or mouth

If patients exhibit the above symptoms whilst taking Isavuconazonium, they must obtain immediate medical help. A serious allergic reaction is life-threatening and requires emergency medical treatment.

Storage

When patients are prescribed Isavuconazonium, they are usually advised to take the medication on a daily and on-going basis. Due to this, patients will need to store their medication at home. However, when keeping Isavuconazonium at home, patients should use a secure location and should prevent children and/or pets from gaining access to the medication.

Patients should adhere to the manufacturer's instructions or medication guidelines when storing Isavuconazonium at home. In most cases, Isavuconazonium capsules can be kept at room temperature but will need to be kept away from heat, moisture and light. If Isavuconazonium capsules are packaged in a blister pack, they should be left in the packaging and only removed as needed.

If patients are advised to stop taking Isavuconazonium capsules or if the medication reaches its expiry date, patients will need to dispose of it carefully. It is not safe to throw Isavuconazonium capsules out with regular household waste as they may pose a risk to other people. In order to dispose of medication, patients should contact their physician's office or pharmacist and make use of a specialist medicine disposal service.

Summary

As fungal infections can affect almost any part of the body, Isavuconazonium is a commonly-prescribed medication. If the infection is fairly mild, Isavuconazonium can be used to treat the patient's condition in a relatively short space of time. However, fungal infections can be difficult to treat and some patients may require weeks or months of treatment with Isavuconazonium in order to fully resolve the infection.

Whilst Isavuconazonium may need to be taken for a long period of time in order to rid the patient's body of infection, it should be effective in resolving the patient's symptoms far more quickly. Although patients may be given additional medication to reduce their symptoms, Isavuconazonium should be successful in minimizing the patient's symptoms once it begins to take effect.

As Isavuconazonium is only effective in treating fungal infections, patients may undergo a biopsy before this medication is prescribed to them. Once the infection has been confirmed as fungal in nature, Isavuconazonium can be used to treat the patient's symptoms and to rid their body of the infection.