Patient Medication Information: uses, side effects, how to take - Apo-Voriconazole
Serious Warnings and Precautions
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. |
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What is APO-VORICONAZOLE used for?
- APO-VORICONAZOLE is used to treat certain fungal infections, specifically Aspergillus or Candida infections.
How does APO-VORICONAZOLE work?
APO-VORICONAZOLE works by killing or interfering with the growth of fungi which helps stop the infection.
What are the ingredients in APO-VORICONAZOLE?
Medicinal ingredients: Voriconazole
Non-medicinal ingredients: Croscarmellose sodium, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
APO-VORICONAZOLE comes in the following dosage forms:
Voriconazole tablets, 50 mg and 200 mg
Do not use APO-VORICONAZOLE if:
- You are allergic to voriconazole or any of the other ingredients of APO-VORICONAZOLE (see Non-medicinal ingredients)
- You are taking other medication that must not be taken with APO-VORICONAZOLE (see the following may interact with this medication)
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-VORICONAZOLE. 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
- think you have galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, please check with your healthcare professional before starting to take APO-VORICONAZOLE tablets since they contain lactose monohydrate
are pregnant: Do not take APO-VORICONAZOLE 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 APO-VORICONAZOLE.
- are breast-feeding: do not take APO-VORICONAZOLE during breast feeding. It is not known if voriconazole 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 APO-VORICONAZOLE:
- 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 APO-VORICONAZOLE. 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.
- APO-VORICONAZOLE 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 APO-VORICONAZOLE.
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 APO-VORICONAZOLE treatment:
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The following may interact with APO-VORICONAZOLE:
- 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 such as procainamide, amiodarone, quinidine, 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 (medicine used to treat pain)
- Oral contraceptives (medicines used for birth control)
- Short-acting opiates (medicines used to treat pain, e.g. alfentanil, sufentanil)
- Long-acting opiates (medicines used to treat pain, e.g. oxycodone, fentanyl)
- Some oral anticoagulants (medicines used to prevent blood clots, e.g. warfarin, coumarin)
- Fluconazole (medicine used for fungal infections)
- Everolimus (medicine used for treating advanced kidney cancer and in transplant patients)
- Benzodiazepines (medicine used to treat anxiety, insomnia and seizures, e.g. midazolam, alprazolam)
- Calcium channel blockers (medicines used to treat heart conditions)
- Sulfonylureas (medicine used to treat diabetes, e.g. glyburide, glipizide)
- Letermovir (medicine used to treat viral infections)
- Ivacaftor (medicine used to treat cystic fibrosis)
- Corticosteroids (medicine used to treat inflammation, e.g. prednisolone, budesonide)
- Lemborexant (medicine used to treat insomnia)
Tell your healthcare professional if you are taking non-steroidal anti-inflammatories (NSAIDS) (used for treating pain and inflammation) including ibuprofen and diclofenac, as the NSAID dose may have to be adjusted.
How to take APO-VORICONAZOLE:
APO-VORICONAZOLE 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 APO-VORICONAZOLE 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 APO-VORICONAZOLE on your first day of treatment. This will help your body quickly obtain an effective blood level of the antifungal.
APO-VORICONAZOLE Tablets:
| Infection | First 24 hours (2 doses 12 hours apart) | After the first 24 hours | ||||||||
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| 40 kg or more | Less than 40 kg | 40 kg or more | Less than 40 kg | |||||||
| Aspergillus | 400 mg | 200 mg | 200 mg twice a day | 100 mg twice a day | ||||||
| Candida | 400 mg | |||||||||
APO-VORICONAZOLE tablets must be taken at least one hour before or two hours after a meal. Swallow the tablet whole with some water.
If you have liver disease, your healthcare professional may prescribe a lower dose of APO-VORICONAZOLE.
Your healthcare professional may order periodic blood tests to monitor your liver function during APO-VORICONAZOLE treatment.
Continue taking APO-VORICONAZOLE 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 APO-VORICONAZOLE, |
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| contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Take your bottle of APO-VORICONAZOLE with you.
Missed Dose:
If you miss taking a dose of APO-VORICONAZOLE, just take the next dose when it is due. Do NOT take a double dose to make up for the forgotten dose.
What are possible side effects from using APO-VORICONAZOLE?
These are not all the possible side effects you may have when taking APO-VORICONAZOLE. 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 APO-VORICONAZOLE alone or taking APO-VORICONAZOLE 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 | |
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| Only if severe | In all cases | ||
| UNCOMMON | |||
| 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 | √ | ||
| Irregular heartbeat | √ | ||
| Visual disturbances (eye problems): blurring of vision, reduced vision, colour vision change and increased sensitivity to light | √ | ||
Severe Cutaneous Adverse Reactions (SCAR): severe skin reactions that may also affect other organs:
| √ | ||
| Liver problems: yellowing of the skin, itching, feeling more tired than usual or like you have the flu, stomach pains or | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| nausea and vomiting | |||
| 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 | √ | ||
| Peripheral neuropathy (nerve damage): burning pain, tingling, numbness, sensitivity to touch, weakness | √ | ||
| Hyponatremia (low levels of sodium in the blood): nausea, vomiting, confusion, weakness, fatigue, cramps, decreased consciousness, seizures | √ | ||
| Pancreatitis (inflammation of the pancreas): persistent abdominal pain and tenderness, vomiting | √ | ||
| Bone and joint pain | √ | ||
| Hallucination | √ | ||
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:
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| NOTE: Contact your health 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 APO-VORICONAZOLE tablets at controlled room temperature (15°C to 30°C). Do not use after the expiry date stated on the label.
If you want more information about APO-VORICONAZOLE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.