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Cresemba (Generic Isavuconazonium)

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Why is this medication prescribed?

Isavuconazonium is a medication prescribed primarily for the treatment of invasive aspergillosis and invasive mucormycosis in patients who are unable to tolerate or have failed other therapies. These are serious fungal infections that can affect immunocompromised individuals, such as those undergoing chemotherapy, organ transplantation, or with severe immunodeficiency conditions.

How should this medicine be used?

Here’s how Isavuconazonium should typically be used:

  • Dosage: The typical adult dosage of Isavuconazonium sulfate is 372 mg (equivalent to 200 mg isavuconazole) administered orally, once daily, preferably with food.
  • Duration: The duration of treatment varies depending on the severity and type of fungal infection, as well as the patient’s response to therapy. Treatment may continue for weeks to months.
  • Administration: Isavuconazonium should be taken with a full meal or nutritional supplement to maximize absorption.
  • Special Considerations:
    • Renal Impairment: Dosing adjustments may be necessary in patients with moderate to severe renal impairment.
    • Hepatic Impairment: No dosage adjustment is necessary for patients with mild to moderate hepatic impairment, but caution is advised in severe hepatic impairment.
    • Drug Interactions: Isavuconazonium can interact with several medications, so it’s important to review the patient’s current medications to avoid potentially harmful interactions.
  • Monitoring: Patients receiving Isavuconazonium should be monitored for signs of adverse effects and for therapeutic response.
  • Adherence: It’s crucial to take Isavuconazonium as prescribed and to complete the full course of treatment unless otherwise directed by a healthcare provider.

Always follow the specific instructions provided by the healthcare provider or pharmacist regarding the use of Isavuconazonium, as individual circumstances may vary. This medication requires a prescription and should not be used without medical supervision.

Other uses for this medicine

  • Empirical Therapy: Isavuconazonium may be considered for empirical antifungal therapy in patients with persistent fever and neutropenia who are at high risk for invasive fungal infections.
  • Off-label Uses: In some cases, healthcare providers may consider using Isavuconazonium off-label for other types of fungal infections or in specific patient populations where it might be deemed appropriate based on clinical judgment.

What special precautions should I follow?

Special Precautions:

  • Liver Function: Isavuconazonium can cause hepatotoxicity (liver damage). Therefore, it should be used with caution in patients with pre-existing liver disease or elevated liver enzymes. Liver function tests should be monitored regularly during treatment.
  • Renal Function: Dosing adjustments are necessary in patients with moderate to severe renal impairment. Isavuconazonium is excreted mainly through the kidneys, so renal function should be assessed before starting treatment and monitored throughout.
  • Cardiovascular Effects: Isavuconazonium may prolong the QT interval on electrocardiogram (ECG), which can lead to serious arrhythmias. It should be used cautiously in patients with a history of QT prolongation, electrolyte abnormalities (such as hypokalemia or hypomagnesemia), or concurrent use of other medications that prolong the QT interval.
  • Drug Interactions: Isavuconazonium interacts with several medications, including CYP3A4 inhibitors and inducers, which can affect its metabolism and efficacy. It’s essential to review all medications the patient is taking to avoid interactions that could reduce efficacy or increase the risk of adverse effects.
  • Pregnancy and Breastfeeding: The safety of Isavuconazonium during pregnancy has not been established. It should only be used if the potential benefits outweigh the risks to the fetus. It is also unknown whether Isavuconazonium passes into breast milk, so breastfeeding is not recommended during treatment.
  • Allergic Reactions: Patients with known hypersensitivity to Isavuconazonium or any component of the formulation should not use this medication.
  • Monitoring: Regular monitoring of liver function, renal function, electrolytes, and ECG may be necessary during treatment with Isavuconazonium to detect and manage potential adverse effects promptly.

As with any prescription medication, Isavuconazonium should only be used under the supervision of a healthcare provider who can assess individual risk factors and tailor treatment accordingly.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Isavuconazonium. However, taking Isavuconazonium with a full meal or nutritional supplement is recommended to enhance absorption. This can also help minimize potential gastrointestinal side effects.

What should I do if I forget a dose?

If you forget to take a dose of Isavuconazonium, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double up on doses to make up for a missed one.

What side effects can this medication cause?

Isavuconazonium can cause several side effects, ranging from mild to severe. It’s essential to be aware of these potential side effects and to promptly inform your healthcare provider if you experience any concerning symptoms. Here are some of the common side effects associated with Isavuconazonium:

  • Gastrointestinal Effects:
    • Nausea
    • Vomiting
    • Diarrhea
    • Abdominal pain
    • Constipation
  • Liver Effects:
    • Elevated liver enzymes (AST, ALT)
    • Hepatotoxicity (rare, but can occur)
  • Electrolyte Imbalances:
    • Hypokalemia (low potassium levels)
    • Hypomagnesemia (low magnesium levels)
  • Cardiovascular Effects:
    • Prolongation of the QT interval on ECG (can lead to arrhythmias)
  • Hematologic Effects:
    • Anemia
    • Decreased white blood cell count (neutropenia)
    • Decreased platelet count (thrombocytopenia)
  • Renal Effects:
    • Acute kidney injury (rare)
  • Allergic Reactions:
    • Rash
    • Itching
    • Swelling (especially of the face/tongue/throat)
    • Severe allergic reactions (anaphylaxis)
  • Other Common Side Effects:
    • Headache
    • Fatigue
    • Fever
    • Insomnia

It’s important to note that not all individuals will experience these side effects, and some may experience different or additional side effects. If you notice any new or worsening symptoms while taking Isavuconazonium, especially signs of liver problems (such as yellowing of the eyes or skin, dark urine, persistent nausea or vomiting), severe allergic reactions, or irregular heartbeats, seek medical attention immediately.

Your healthcare provider will monitor you for side effects during treatment with Isavuconazonium and may adjust your treatment regimen if necessary to minimize these effects while ensuring effective management of your fungal infection.

What should I know about storage and disposal of this medication?

Storage and Disposal of Isavuconazonium:

Storage:

  • Room Temperature: Store Isavuconazonium tablets at room temperature between 20-25°C (68-77°F).
  • Keep Container Closed: Keep the medication in its original container, tightly closed, and protect it from moisture.
  • Avoid Heat and Light: Store away from excessive heat and direct light.
  • Keep Out of Reach of Children: Store Isavuconazonium in a secure place where children and pets cannot access it.

Disposal:

  • Unused Medication: Dispose of any unused Isavuconazonium properly according to local regulations or guidelines. Do not flush medications down the toilet or pour them into a drain unless instructed to do so.
  • Medication Take-Back Programs: Check with your pharmacist or local waste disposal company about medication take-back programs in your area.
  • Throwing Away Containers: After removing the tablets, dispose of the empty container as per local regulations.

In case of emergency/overdose

  • Seek Immediate Medical Help: If you suspect an overdose of Isavuconazonium, or if someone has accidentally ingested it, call emergency services (911 in the US) or a poison control center immediately.
  • Symptoms of Overdose: Symptoms of overdose may include nausea, vomiting, diarrhea, dizziness, and potential worsening of other side effects. It’s important to seek medical attention even if symptoms seem mild.

What other information should I know?

  • Follow Prescription: Take Isavuconazonium exactly as prescribed by your healthcare provider. Do not change your dose or stop taking the medication without consulting them first, even if you feel better.
  • Regular Monitoring: Your healthcare provider may perform regular blood tests to monitor liver function, kidney function, and other parameters during treatment with Isavuconazonium.
  • Drug Interactions: Inform your healthcare provider about all other medications, supplements, or herbal products you are taking, as Isavuconazonium can interact with certain medications.
  • Allergic Reactions: If you have a known allergy to Isavuconazonium or any of its components, inform your healthcare provider before starting treatment.
  • Pregnancy/Breastfeeding: Discuss the risks and benefits of Isavuconazonium if you are pregnant, planning to become pregnant, or breastfeeding.
  • Storage Conditions: Always store medications in a cool, dry place away from direct sunlight and out of the reach of children.

Following these guidelines will help ensure the safe and effective use of Isavuconazonium. If you have any questions or concerns about your medication, do not hesitate to consult your healthcare provider or pharmacist for clarification.

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