Patient Medication Information: uses, side effects, how to take - Voriconazole for Injection (Fresenius Kabi Canada)
Serious warnings and precautions box
What Voriconazole for Injection is used for:
- Voriconazole for Injection is used to treat certain fungal infections, specifically Aspergillus or Candida infections.
How Voriconazole for Injection works:
Voriconazole for Injection works by killing or interfering with the growth of fungi which helps stop the infection.
The ingredients in Voriconazole for Injection are:
Medicinal ingredients: voriconazole
Non-medicinal ingredients: sulphobutylether-β-cyclodextrin sodium (SBECD)
For more information, see the “To help avoid side effects and ensure proper use…” and the “Serious side effects and what to do about them” sections below. |
Voriconazole for Injection comes in the following dosage forms:
Voriconazole powder for solution, 200 mg per vial
Do not use Voriconazole for Injection if:
- You are allergic to voriconazole or any of the other ingredients of Voriconazole for Injection (see “What are the ingredients in Voriconazole for Injection?” section above).
- You are taking other medication that must not be taken with Voriconazole for Injection (see the ”Serious Drug Interactions” box below).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Voriconazole for Injection. Talk about any health conditions or problems you may have, including if you:
- have history of heart disease, or an irregular heartbeat.
- have had any drug allergies including allergic reactions to other drugs known as “azoles”.
- have or had liver problems.
- have or had kidney problems.
are pregnant or planning to become pregnant. Do not take Voriconazole for Injection while you are pregnant unless your healthcare professional tells you to do so. Use effective contraception methods if you are of childbearing age. Contact your healthcare professional right away if you become pregnant while taking Voriconazole for Injection.
- are breast-feeding or planning to breast-feed. Do not take Voriconazole for Injection during breast feeding. It is not known if Voriconazole for Injection passes in breast milk. Ask your healthcare professional for advice before taking any medicine while breast feeding.
Other warnings you should know about:
While being treated with Voriconazole for Injection:
- tell your healthcare professional immediately if you develop serious skin reactions such as rash, red skin, blistering of lips, eyes or mouth, skin peeling accompanied by fever, and skin lesions.
- avoid strong sunlight while being treated with Voriconazole for Injection. Wear protective clothing and use sunscreen. Tell your healthcare professional if your skin becomes more sensitive to the sun.
- your healthcare professional may wish to monitor the function of your liver and kidney by doing blood tests.
- Voriconazole for Injection may affect your vision (e.g. make your eyes blurry). Do not drive or perform complex tasks if you have problems with your eyes. You should not drive at night while taking Voriconazole for Injection.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious drug interactions
The following list of medicines must not be taken during your course of Voriconazole for Injection treatment:
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The following may also interact with Voriconazole for Injection:
- Cyclosporine (a medicine used in transplant patients).
- Tacrolimus (a medicine used in transplant patients).
- Tricyclic antidepressants (medicines used to treat depression).
- Antiarrhythmics (medicines that stabilize heart function, e.g. procainamide, amiodarone, quinidine, and sotalol).
- Antipsychotic drugs (medicines used to treat psychotic disorders).
- HIV protease inhibitors (medicines used to treat HIV).
- Macrolide antibiotics (medicines used to treat bacterial infections).
- Methadone (a medicine used to treat pain).
- Oral contraceptives (medicines used for birth control).
- Short-acting opiates (medicines used to treat pain, e.g. alfentanil and sufentanil).
- Long-acting opiates (medicines used to treat pain, e.g. oxycodone and fentanyl).
- Some oral anticoagulants (medicines used to prevent blood clots, e.g. warfarin and coumarin).
- Fluconazole (a medicine used for fungal infections).
- Everolimus (a medicine used for treating advanced kidney cancer and in transplant patients).
- Benzodiazepines (medicines used to treat anxiety, insomnia, and seizures, e.g. alprazolam).
- Calcium channel blockers (medicines used to treat heart conditions).
- Sulfonylureas (medicines used to treat diabetes, e.g. glyburide and glipizide).
- Letermovir (a medicine used to treat viral infections).
- Ivacaftor (a medicine used to treat cystic fibrosis).
- Corticosteroids (medicines used to treat inflammation, e.g. prednisolone, budesonide).
- Lemborexant (a medicine used to treat insomnia).
- Glasdegib (a medicine used to treat acute myeloid leukemia).
- Tretinoin (a medicine used to treat acute promyelocytic leukemia).
- Tyrosine kinase inhibitors (medicines used to treat cancer e.g. axitinib, bosutinib).
Tell your healthcare professional if you are taking non-steroidal anti-inflammatories (NSAIDS) (medicines used for treating pain and inflammation) including ibuprofen and diclofenac, as the NSAID dose may have to be adjusted.
How to take Voriconazole for Injection:
Voriconazole for Injection has been prescribed for you. Do not allow anyone else to take it. This product should only be taken under the supervision of a healthcare professional.
Usual dose:
Usual Adult Dose:
Your healthcare professional will determine your dose depending on your weight and the type of infection (or suspected infection) you have.
Always take Voriconazole for Injection exactly as directed by your healthcare professional. You should check with your healthcare professional if you are unsure. Never change the dose yourself.
Your healthcare professional will prescribe a higher dose of Voriconazole for Injection on your first day of treatment. This will help your body quickly obtain an effective blood level of the antifungal.
During the first 24 hours, you will be administered 2 doses of 6 mg/kg (12 hours apart).
After the first 24 hours:
- If you have an Aspergillus infection, you will be administered 4 mg/kg, twice a day.
- If you have a Candida infection, you will be administered 3 mg/kg or 4 mg/kg, twice a day.
If you have liver disease, your healthcare professional may prescribe a lower dose of Voriconazole for Injection.
Your healthcare professional may order periodic blood tests to monitor your liver function during Voriconazole for Injection treatment.
Continue taking Voriconazole for Injection until your healthcare professional tells you to stop. Do NOT stop treatment early because your infection may not be cured. Patients with a weakened immune system or those with difficult infections may require long term treatment to prevent the infection from returning.
Overdose:
| If you think you, or a person you are caring for, have taken too much Voriconazole for Injection, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
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Missed Dose:
If you miss taking a dose of Voriconazole for Injection, just take the next dose when it is due. Do NOT take a double dose to make up for the forgotten dose.
Possible side effects from using Voriconazole for Injection:
These are not all the possible side effects you may have when taking Voriconazole for Injection. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- fever,
- rash,
- nausea,
- vomiting,
- diarrhea,
- headache,
- swelling of the extremities (hands and feet),
- stomach pain,
- dizziness,
- itchiness,
- weakness,
- back pain,
- chest pain,
- flu-like symptoms,
- facial swelling,
- tingling,
- cough,
- hair loss,
- pain and irritation of the eyes,
- sensitivity to light and sun (photosensitivity).
Patients taking Voriconazole for Injection alone or taking Voriconazole for Injection along with corticosteroids long-term have experienced adrenal problems with symptoms of dizziness, fatigue, loss of appetite, nausea and vomiting.
Serious side effects and what to do about them
| Symptom/effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Symptom/effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom/effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| UNCOMMON | |||
| Bone and joint pain | √ | ||
| Hallucination | √ | ||
| Heart failure (heart does not pump blood as well as it should): shortness of breath, fatigue and weakness, swelling in ankles, legs and feet, cough, fluid retention, lack of appetite, nausea, rapid or irregular heartbeat, reduced ability to exercise. | √ | ||
| Hyponatremia (low levels of sodium in the blood): nausea, vomiting, confusion, weakness, fatigue, cramps, decreased consciousness, seizures. | √ | ||
| Irregular heartbeat | √ | ||
| Kidney problems: nausea, vomiting, fever, swelling of hands and feet, fatigue, thirst, dry skin, irritability, dark urine, increased or decreased urine output, rash, weight gain (from retaining fluid), loss of appetite, abnormal blood test results, drowsiness, confusion. | √ | ||
| Liver problems: yellowing of the skin, itching, feeling more tired than usual or like you have the flu, stomach pains or nausea and vomiting. | √ | ||
| Pancreatitis (inflammation of the pancreas): persistent abdominal pain and tenderness, vomiting. | √ | ||
| Peripheral neuropathy (nerve damage): burning pain, tingling, numbness, sensitivity to touch, weakness. | √ | ||
Severe Cutaneous Adverse Reactions (SCAR): severe skin reactions that may also affect other organs:
| √ | ||
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| Visual disturbances (eye problems): blurring of vision, reduced vision, colour vision change and increased sensitivity to light. | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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Storage:
Keep out of reach and sight of children.
Store at controlled room temperature, 15 °C to 30 °C.
If you want more information about Voriconazole for Injection:
- Talk to your healthcare professional;
- Find the full Product Monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website https://www.fresenius-kabi.com/en-ca/, or by calling 1-877-821-7724.
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8