Patient Medication Information: uses, side effects, how to take - Auro-Voriconazole

Serious warnings and precautions box

Some medications should not be taken during Auro-Voriconazole treatment (see the “Serious Drug Interactions” box below).
Auro-Voriconazole may cause irregular heartbeat and rarely cardiac arrest (when the heart suddenly stops beating) and death.
Auro-Voriconazole may cause problems with your vision.
Auro-Voriconazole may cause liver problems.
Auro-Voriconazole may cause severe skin reactions.
Auro-Voriconazole may cause harm to the fetus (unborn baby) in pregnant women.
Auro-Voriconazole may cause changes to the appearance of your teeth and pain affecting your joints, bones, or muscles.

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.

What Auro-Voriconazole is used for:

Auro-Voriconazole is used to treat certain fungal infections, specifically Aspergillus or Candida infections.

How Auro-Voriconazole works:

Auro-Voriconazole works by killing or interfering with the growth of fungi which helps stop the infection.

The ingredients in Auro-Voriconazole are:

Medicinal ingredient: voriconazole.

Non-medicinal ingredients: Croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, maize starch, povidone, pregelatinized starch silica colloidal anhydrous, titanium dioxide and triacetin.

Auro-Voriconazole comes in the following dosage forms:

Voriconazole tablets: 50 mg and 200 mg.

Do not use Auro-Voriconazole if:

You are allergic to voriconazole or any of the other ingredients of Auro-Voriconazole (see the “What are the ingredients in Auro-Voriconazole?” section above).
You are taking other medication that must not be taken with Auro-Voriconazole (see the “Serious Drug Interactions” box below).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Auro-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 Auro-Voriconazole tablets since they contain lactose monohydrate.
are pregnant or planning to become pregnant. Do not take Auro-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 Auro-Voriconazole.
are breast-feeding or planning to breast-feed. Do not take Auro-Voriconazole during breast feeding. It is not known if Auro-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 Auro-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 Auro-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.
Auro-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
Auro-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 Auro-Voriconazole treatment:

Pimozide (a medicine for treating mental illness).
Quinidine (a medicine for irregular heartbeat).
Rifampin (a medicine for treating tuberculosis).
Carbamazepine (a medicine used to treat seizures).
Long acting barbiturates (medicines for severe insomnia and seizures, e.g., phenobarbital).
Sirolimus (a medicine used in transplant patients).
Rifabutin (a medicine for fungal infections).
Ergot Alkaloids: dihydroergotamine (a medicine for migraines).
Ritonavir (doses of 400 mg twice daily or higher) and efavirenz (doses of 400 mg once daily or higher) (medicines for the treatment of HIV).
Naloxegol (a medicine used to treat constipation caused by opioid use).
Ivabradine (a medicine used to treat heart failure).
St John’s Wort (Hypericum perforatum).
Venetoclax (a medicine used to treat leukemia and lymphoma).
Eszopiclone, if you are 65 years of age or older (a medicine used to treat insomnia).
Lovastatin or simvastatin (medicines used to treat high cholesterol levels).
Triazolam (a medicine used to treat insomnia).
Tolvaptan (a medicine used to treat low sodium levels).
Finerenone (a medicine used to slow the worsening of kidney damage and to lower the risk of dying from heart or blood vessel disease, having a heart attack, and being hospitalized for heart failure).
Eplerenone (a medicine used to lower high blood pressure, prevent heart failure from getting worse, and to reduce of death and the risk of being hospitalized due to heart failure.
Lurasidone (a medicine used to schizophrenia and bipolar disorder).
Midazolam (a medicine used to treat anxiety and cause drowsiness or sleepiness).

The following may also interact with Auro-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, e.g., such as 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 (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 (medicine 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 (medicine 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 (a medicine used to treat cancer, e.g., axitinib and 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 Auro-Voriconazole:

Auro-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 Auro-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 Auro-Voriconazole on your first day of treatment. This will help your body quickly obtain an effective blood level of the antifungal.

Auro-Voriconazole Tablets:

Infection Type

First 24 hours

After the first 24 hours

40 kg or more

Less than 40 kg

40 kg or more

Less than 40 kg

Aspergillus

400 mg twice a day

(two 200 mg tablets every 12 hours)

200 mg twice a day

(one 200 mg tablet every 12 hours)

200 mg twice a day

(one 200 mg tablet every 12 hours)

100 mg twice a day

(two 50 mg tablets every 12 hours)

Candida

Auro-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 Auro-Voriconazole.

Your healthcare professional may order periodic blood tests to monitor your liver function during Auro-Voriconazole treatment.

Continue taking Auro-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 Auro-Voriconazole, 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 symptoms.

Take your box of Auro-Voriconazole tablets with you.

Missed Dose:

If you miss taking a dose of Auro-Voriconazole, 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 Auro-Voriconazole:

These are not all the possible side effects you may have when taking Auro-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 Auro-Voriconazole alone or taking Auro-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
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
UNCOMMON
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: Skin peeling, scaling, or blistering (with or without pus) which may also affect your eyes, mouth, nose or genitals, itching, severe rash, bumps under the skin, skin pain, skin color changes (redness, yellowing, purplish). Swelling and redness of eyes or face. Flu-like feeling, fever, chills, body aches, swollen glands, cough. Shortness of breath, chest pain or discomfort.			√
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:

Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html?utm_campaign=not-applicable&utm_medium=vanity-url&utm_source=canada-ca_Canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

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.

Storage:

Store Auro-Voriconazole tablets at room temperature (15°C to 30°C). Do not use after the expiry date stated on the label.
Keep out of reach and sight of children.

If you want more information about Auro-Voriconazole:

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
(https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug- product-database.html); the manufacturer’s website http://www.auropharma.ca or by calling 1-855-648-6681.

Auro-Voriconazole: Uses, Side Effects and Dosage