Patient Medication Information: uses, side effects, how to take - Apo-Posaconazole
Serious Warnings and Precautions
Drug Interactions: Taking APO-POSACONAZOLE with other medicines can cause serious side effects.
Do NOT take APO-POSACONAZOLE if you are taking any of the following:
- ergot alkaloids, used to treat migraines
- cisapride, used to treat stomach problems
- pimozide, used to treat mental health problems
- quinidine, used to treat irregular heartbeat
- terfenadine and astemizole, used to treat allergies
- certain statin medicines that lower cholesterol, such as atorvastatin, lovastatin, simvastatin
- sirolimus, used in transplant patients
Avoid taking APO-POSACONAZOLE with any of the following:
- cimetidine, used to treat stomach problems
- rifabutin, an antibiotic used to treat bacterial infections including tuberculosis
- phenytoin, used to prevent seizures
If you are taking APO-POSACONAZOLE with any of the following your healthcare professional may have to reduce your dose and monitor you closely:
- cyclosporine or tacrolimus, used in transplant patients
- vinca alkaloids, including vincristine, used to treat cancer
- venetoclax, used to treat cancer
- midazolam, used as a sedative to help you sleep
- calcium channel blockers, used to treat high blood pressure
- Heart Problems: APO-POSACONAZOLE can cause serious heart problems including problems with your heart rhythm. Tell a healthcare professional immediately if you have any of the following symptoms while you are being treated with APO-POSACONAZOLE:
- very slow, fast or irregular heartbeat
- shortness of breath
- light-headedness
- fainting
- Liver Problems (including Liver Failure): APO-POSACONAZOLE can cause serious liver problems including liver failure. Your healthcare professional will do blood tests to see how well your liver is working before you start treatment with APO-POSACONAZOLE and while you are being treated. Tell a healthcare professional immediately if you have any of the following symptoms while you are being treated with APO-POSACONAZOLE:
- dark colored urine
- pale stools
- yellowing of the skin and eyes
- abdominal pain
- nausea and vomiting
What is APO-POSACONAZOLE used for?
APO-POSACONAZOLE Delayed-Release Tablets are used:
- to prevent fungal infections caused by the fungi Aspergillus and Candida in patients whose immune systems may be weakened due to other medicines or diseases.
- to treat fungal infections caused by Aspergillus that have not improved during treatment with the anti-fungal medicines amphotericin B or itraconazole or in patients who cannot tolerate these medicines.
- APO-POSACONAZOLE Delayed-Release Tablets can be used in patients 13 years of age and older.
How does APO-POSACONAZOLE work?
APO-POSACONAZOLE belongs to a group of medicines called triazole antifungal agents. APO-POSACONAZOLE works by killing or stopping the growth of some types of fungi that can cause infections in humans.
What are the ingredients in APO-POSACONAZOLE?
Medicinal ingredients: Posaconazole
Non-medicinal ingredients: Colloidal silicon dioxide, croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
APO-POSACONAZOLE comes in the following dosage forms:
APO-POSACONAZOLE Delayed-Release Tablets: 100 mg
Do not use APO-POSACONAZOLE if:
- you are hypersensitive (allergic) to posaconazole or to any of the other ingredients in APO-POSACONAZOLE (see What are the ingredients in APO-POSACONAZOLE? section).
you are taking any of the following medicines:
- ergot alkaloids, used to treat migraines
- cisapride, used to treat stomach problems
- pimozide, used to treat mental health problems
- quinidine, used to treat irregular heartbeat
- terfenadine and astemizole, used to treat allergies
- certain statin medicines that lower cholesterol, such as atorvastatin, lovastatin, simvastatin
- sirolimus, used in transplant patients
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-POSACONAZOLE. Talk about any health conditions or problems you may have, including if you:
- have had an allergic reaction to other antifungal medicines such as ketoconazole, fluconazole, itraconazole or voriconazole.
- are taking certain medicines that suppress your immune system such as cyclosporine and tacrolimus. Serious side effects that have been fatal, have happened in patients taking cyclosporine in combination with APO-POSACONAZOLE. Your healthcare professional may adjust your dose of these immune suppressants and monitor their blood levels if you are taking them with APO-POSACONAZOLE.
are taking certain medicines used to treat cancer such as venetoclax and vincristine. Toxicity from vincristine has happened in patients taking it in combination with APO-POSACONAZOLE This has caused serious side effects such as:
- Damage to nervous tissue
- Seizures
- Numbness, pain and weakness in hand and feet due to damage to nerves
- Muscles cramps, nausea, vomiting and confusion due to water retention in body
- Blockage of the intestine (abdominal pain).
- have or have had liver problems.
- have kidney problems.
- have a history of heart problems, including heart failure, an irregular heartbeat, a slow heartbeat or a genetic condition called “congenital or acquired QT prolongation”.
- have problems with your electrolytes (low levels of potassium, magnesium or calcium in your blood).
- suffer from excessive vomiting or diarrhea.
are breastfeeding. Do not breastfeed while being treated with APO-POSACONAZOLE
- unless you have discussed the risks and benefits with your healthcare professional.
- are pregnant or planning on becoming pregnant. Do not use APO-POSACONAZOLE during pregnancy unless you have discussed the risks and benefits with your healthcare professional. If you are a woman who could become pregnant, you must use effective birth control while you are being treated with APO-POSACONAZOLE. Tell your healthcare professional immediately if you become pregnant while being treated with APO-POSACONAZOLE.
Other warnings you should know about:
Blood tests: APO-POSACONAZOLE can cause abnormal blood test results. Your healthcare professional may ask you to have blood tests while you are being treated with APO-POSACONAZOLE.
Driving and using machines: Do not drive or operate machinery if you experience sleepiness or blurred vision.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines. The following medicines must not be taken with APO-POSACONAZOLE:
- cisapride, used to treat stomach problems
- pimozide, used to treat mental health problems
- quinidine, used to treat irregular heartbeat
- ergot alkaloids, used to treat migraines
- terfenadine and astemizole, used to treat allergies
- certain statin medicines that lower cholesterol, such as atorvastatin, lovastatin, simvastatin
- sirolimus, used in transplant patients
The following may interact with APO-POSACONAZOLE:
- rifabutin or rifampin, antibiotics used to treat bacterial infections like tuberculosis
- phenytoin, used to prevent seizures
- efavirenz, fosamprenavir, atazanavir and atazanavir/ritonavir, used to treat HIV infection
- vinca alkaloids, including vincristine, used to treat cancer
- venetoclax, used to treat cancer
- cyclosporine and tacrolimus, used in transplant patients
- midazolam, used as a sedative to help you sleep
- statins, used to treat high cholesterol
- calcium channel blockers, used to treat high blood pressure
- digoxin, used to treat heart failure
How to take APO-POSACONAZOLE:
- APO-POSACONAZOLE must only be used as directed by your healthcare professional.
- Your healthcare professional will decide how long you are to be treated with APO-POSACONAZOLE and your dose depending on your condition and how you respond to treatment.
- Do not stop treatment early because your infection may not be fully cured. Even if you feel well, your immune system may still be weakened and you may still need treatment to prevent an infection.
- Do not switch between APO-POSACONAZOLE Delayed-Release Tablets and Posaconazole Oral Suspension without talking to your healthcare professional. The dosing is different for the 2 formulations.
If you are being treated with APO-POSACONAZOLE Delayed-Release Tablets:
APO-POSACONAZOLE Delayed-Release Tablets can be taken with or without food.
- APO-POSACONAZOLE Delayed-Release Tablets must be swallowed whole. Use plenty of water if you have some difficulty swallowing.
- Do not crush, chew, break, or dissolve the tablets.
Usual dose:
APO-POSACONAZOLE Delayed-Release Tablets:
- Take 300 mg (three 100 mg tablets) twice on the first day.
- After the first day take 300 mg (three 100 mg tablets) once a day.
Overdose:
Take your bottle of APO-POSACONAZOLE with you.
If you think you, or a person you are caring for, have taken too much APO-POSACONAZOLE, 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.
Missed dose:
If you miss taking a dose of APO-POSACONAZOLE, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not take a double dose to make up for the forgotten dose.
What are possible side effects from using APO-POSACONAZOLE?
These are not all the possible side effects you may have when taking APO-POSACONAZOLE. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- diarrhea
- gas
- nausea, vomiting
- stomach pain
- loss of appetite
- abnormal taste in the mouth
- dry mouth
- swelling in the mouth
- headache
- dizziness
- numbness or tingling
- sleepiness, tiredness
- weakness
- rash
- cough, shortness of breath
Serious side effects and what to do about them
| 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 | ||
| COMMON | |||
| Anemia (low red blood cells): shortness of breath, feeling very tired, pale skin, fast heartbeat, loss of energy, or weakness. | ✓ | ||
| Neutropenia (low white blood cells): infections (fever, chills, sore throat, mouth sores), weakness, fatigue, aches and pains, and flu-like symptoms. | ✓ | ||
| Thrombocytopenia (low blood platelets): bruising or bleeding for longer than usual if you hurt yourself, fatigue and weakness, nosebleeds, tiny red spots on the skin. | ✓ | ||
| Electrolyte imbalance (low levels of potassium, magnesium or calcium in your blood): weakness, fatigue, muscle cramps. | ✓ | ||
| Edema: swelling of the hands or feet. | ✓ | ||
| UNCOMMON | |||
| Heart problems: very slow, fast or irregular heartbeat, shortness of breath, light-headedness, fainting. | ✓ | ||
| RARE | |||
| Allergic reaction: severe skin blistering, peeling, rash, swollen lips, mouth and throat, difficulty in breathing. | ✓ | ||
| Liver problems (including liver failure): dark colored urine, pale stools, yellowing of the skin and eyes, abdominal pain, nausea, vomiting. | ✓ | ||
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 (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 health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Keep out of the reach and sight of children. Do not use this product after the expiry date stated on the label.
Store at room temperature 15°C to 30°C. Protect from moisture.
If you want more information about APO-POSACONAZOLE:
- 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.