WHAT IS TOLSURA?
WHAT IS TOLSURA?
TOLSURA with SUBA® is a prescription medicine that is used to treat the following fungal infections in adults1:
-
HISTOPLASMOSIS
-
BLASTOMYCOSIS
-
ASPERGILLOSIS
TOLSURA with Suba®
TOLSURA capsules contain itraconazole.TOLSURA is NOT interchangeable with other itraconazole products because they are different dosages. Follow the specific dosing for TOLSURA1.
TOLSURA should not be used to treat fungal infections of the toenails or fingernails (which are called onychomycosis)1.
Depending on the type and severity of your infection, you may need to take TOLSURA for extended periods of time. It is important that you stay on the medication as prescribed by your doctor.
CHALLENGES WITH CONVENTIONAL ITRACONAZOLE
Itraconazole has been used for several decades for the treatment of fungal infections.
TRADITIONAL ITRACONAZOLE
HOWEVER, THE STANDARD VERSIONS OF ITRACONAZOLE HAVE SOME CHALLENGES:
The medicine has to be taken in very specific ways (with a high-fat meal and an acidic drink) in order to be effective2,3.
The amount of drug absorbed by different patients (and so how effective it is) varies a great deal4.
Stomach acid is needed for patients to absorb the drug, but then the medicine precipitates in the basic environment of the small intestine, leading to poor absorption2.
THESE CHALLENGES MAY LEAD TO REDUCED EFFICACY OF THE MEDICATION.
HOW CAN TOLSURA HELP ME?
TOLSURA HAS BEEN UNIQUELY DESIGNED IN WAYS THAT MAKE IT DIFFERENT FROM ANY OTHER STANDARD ITRACONAZOLE FORMULATION.
TOLSURA comes in a smaller capsule size than conventional itraconazole, making it easier to swallow for daily dosing1.
With TOLSURA, the amount of drug that your body absorbs does not significantly change if you also take antacid medication, or whether you take TOLSURA with a meal1.
TOLSURA releases its drug in the upper small intestine—not the stomach—which may lead to better absorption of the medication in your body5.
LEARN ABOUT FUNGAL INFECTIONS
INDICATIONS AND IMPORTANT SAFETY INFORMATION
TOLSURA is a prescription medicine used to treat the following fungal infections in adults: blastomycosis, histoplasmosis, and aspergillosis.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT TOLSURA?
TOLSURA CAN CAUSE SERIOUS SIDE EFFECTS, INCLUDING:
- Congestive heart failure. TOLSURA can cause congestive heart failure or make congestive heart failure that you already have worse. Stop taking TOLSURA and call your doctor right away if you have any of these symptoms of congestive heart failure:
- shortness of breath
- swelling of your feet, ankles, or legs
- sudden weight gain
- increased tiredness
- coughing up white or pink mucus (phlegm)
- fast heartbeat
- waking up at night more
- than normal
- Heart problems and other serious medical problems. Serious medical problems that affect the heart and other parts of your body can happen if you take TOLSURA with certain other medicines.
- Do not take TOLSURA if you take any of the following medicines:
- avanafil
- disopyramide
- dofetilide
- dronedarone
- eplerenone
- ergot alkaloids (such as dihydroergotamine or ergotamine)
- felodipine
- irinotecan
- isavuconazonium
- simvastatin
- ticagrelor
- ivabradine
- lomitapide
- lovastatin
- lurasidone
- methadone
- midazolam (taken by mouth)
- naloxegol
- nisoldipine
- pimozide
- quinidine
- ranolazine
- triazolam
- Do not take TOLSURA if you have kidney or liver problems and take any of the following medicines:
- colchicine
- fesoterodine
- solifenacin
- Do not take TOLSURA:
- If you have been told that enzymes in your body, called CYP2D6 or CYP3A4, break down (metabolize) certain medicines in your body too slowly.
- If you are taking the medicine eliglustat and are also taking a medicine that slows the rate that your body breaks down (metabolizes) certain other medicines (CYP2D6 inhibitor). Ask your doctor or pharmacist if you take any of these medicines.
These are not complete lists of medicines that can interact with TOLSURA. TOLSURA may affect the way other medicines work, and other medicines may affect how TOLSURA works. You can ask your pharmacist for a list of medicines that interact with TOLSURA.
Before you start taking TOLSURA, tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Before you start any new medicine, ask your doctor or pharmacist if it is safe to take it with TOLSURA or within 2 weeks after stopping treatment with TOLSURA.
- Liver problems. TOLSURA can cause serious liver problems, which may be severe and lead to death. Stop taking TOLSURA and call your doctor right away if you have any of these symptoms of liver problems:
- unusual fatigue
- loss of appetite
- nausea or vomiting
- your skin or the white part of your eyes turn yellow (jaundice)
- dark (tea-colored) urine
- light-colored stools (bowel movement)
Do not take TOLSURA:
- if you are allergic to itraconazole or any of the ingredients in TOLSURA. Please see the end of the Patient Information leaflet for a complete list of ingredients in TOLSURA.
Before taking TOLSURA, tell your doctor about all of your medical conditions, including if you:
- have heart problems.
- have lung problems.
- have kidney problems.
- have liver problems.
- have had an allergic reaction to a medicine used to treat a fungal infection.
- are pregnant or plan to become pregnant. It is not known if
- TOLSURA will harm your unborn baby. Tell your doctor if you become pregnant during treatment with TOLSURA.
- are breastfeeding or plan to breastfeed. TOLSURA can pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take TOLSURA.
Before you start taking TOLSURA, tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:
- a medicine to treat high blood pressure or certain other heart problems called a calcium channel blocker.
- a medicine to reduce acid in your stomach called a proton pump inhibitor, such as omeprazole.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF TOLSURA?
TOLSURA may cause serious side effects, including:
- See “What is the most important information I should know about TOLSURA?”
- Nerve problems (neuropathy). Nerve problems have happened in some people who have taken TOLSURA for longer than 3 months. Call your doctor right away if you have tingling or numbness in your hands or feet. Your doctor may stop your treatment with TOLSURA if you have nerve problems.
- Hearing loss. Hearing loss can happen in some people who take TOLSURA. Hearing loss usually improves when treatment with TOLSURA is stopped, but hearing loss has been permanent in some people. Call your doctor if you have any changes in your hearing.
The most common side effects of TOLSURA include:
- nausea
- rash
- vomiting
- swelling
- headache
- diarrhea
- fatigue
- fever
- itching
- high blood pressure
- abnormal liver blood tests
- stomach pain
- dizziness
- low blood potassium levels
- loss of appetite
- general feeling of discomfort
- decreased sex drive
- sleepiness
- elevated levels of a type of protein, called albumin, in your urine
- erectile dysfunction
These are not all the possible side effects of TOLSURA.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or call Mayne Pharma at 1-844-825-8500.
REFERENCES:
- Tolsura® Product Information. Mayne Pharma. Greenville, NC. 7/2020.
- Brouwers J, Geboers S, Mohls R, et al. Gastrointestinal behavior of itraconazole in humans – Part 1: Supersaturation from a solid dispersion and a cyclodextrinbased solution. International Journal of Pharmaceutics. 2017; 525: 211-217.
- Sporanox® capsule Product Information. Ortho-McNeil-Janssen Pharmaceuticals, Inc. Raritan, NJ.
- Poirier JM, Berlioz F, Isnard F, Cheymol G. Marked intra- and inter-patient variability of itraconazole steady state plasma concentrations. Thérapie. 1996;51:163-167.
- Data on File. Mayne Pharma, Inc. 2017.
INDICATIONS AND IMPORTANT SAFETY INFORMATION
TOLSURA is a prescription medicine used to treat the following fungal infections in adults: blastomycosis, histoplasmosis, and aspergillosis.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT TOLSURA?
TOLSURA CAN CAUSE SERIOUS SIDE EFFECTS, INCLUDING:
- Congestive heart failure. TOLSURA can cause congestive heart failure or make congestive heart failure that you already have worse. Stop taking TOLSURA and call your doctor right away if you have any of these symptoms of congestive heart failure:
- shortness of breath
- swelling of your feet, ankles, or legs
- sudden weight gain
- increased tiredness
- coughing up white or pink mucus (phlegm)
- fast heartbeat
- waking up at night more
- than normal
- Heart problems and other serious medical problems. Serious medical problems that affect the heart and other parts of your body can happen if you take TOLSURA with certain other medicines.
- Do not take TOLSURA if you take any of the following medicines:
- avanafil
- disopyramide
- dofetilide
- dronedarone
- eplerenone
- ergot alkaloids (such as dihydroergotamine or ergotamine)
- felodipine
- irinotecan
- isavuconazonium
- simvastatin
- ticagrelor
- ivabradine
- lomitapide
- lovastatin
- lurasidone
- methadone
- midazolam (taken by mouth)
- naloxegol
- nisoldipine
- pimozide
- quinidine
- ranolazine
- triazolam
- Do not take TOLSURA if you have kidney or liver problems and take any of the following medicines:
- colchicine
- fesoterodine
- solifenacin
- Do not take TOLSURA:
- If you have been told that enzymes in your body, called CYP2D6 or CYP3A4, break down (metabolize) certain medicines in your body too slowly.
- If you are taking the medicine eliglustat and are also taking a medicine that slows the rate that your body breaks down (metabolizes) certain other medicines (CYP2D6 inhibitor). Ask your doctor or pharmacist if you take any of these medicines.
These are not complete lists of medicines that can interact with TOLSURA. TOLSURA may affect the way other medicines work, and other medicines may affect how TOLSURA works. You can ask your pharmacist for a list of medicines that interact with TOLSURA.
Before you start taking TOLSURA, tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Before you start any new medicine, ask your doctor or pharmacist if it is safe to take it with TOLSURA or within 2 weeks after stopping treatment with TOLSURA.
- Liver problems. TOLSURA can cause serious liver problems, which may be severe and lead to death. Stop taking TOLSURA and call your doctor right away if you have any of these symptoms of liver problems:
- unusual fatigue
- loss of appetite
- nausea or vomiting
- your skin or the white part of your eyes turn yellow (jaundice)
- dark (tea-colored) urine
- light-colored stools (bowel movement)
Do not take TOLSURA:
- if you are allergic to itraconazole or any of the ingredients in TOLSURA. Please see the end of the Patient Information leaflet for a complete list of ingredients in TOLSURA.
Before taking TOLSURA, tell your doctor about all of your medical conditions, including if you:
- have heart problems.
- have lung problems.
- have kidney problems.
- have liver problems.
- have had an allergic reaction to a medicine used to treat a fungal infection.
- are pregnant or plan to become pregnant. It is not known if
- TOLSURA will harm your unborn baby. Tell your doctor if you become pregnant during treatment with TOLSURA.
- are breastfeeding or plan to breastfeed. TOLSURA can pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take TOLSURA.
Before you start taking TOLSURA, tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:
- a medicine to treat high blood pressure or certain other heart problems called a calcium channel blocker.
- a medicine to reduce acid in your stomach called a proton pump inhibitor, such as omeprazole.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF TOLSURA?
TOLSURA may cause serious side effects, including:
- See “What is the most important information I should know about TOLSURA?”
- Nerve problems (neuropathy). Nerve problems have happened in some people who have taken TOLSURA for longer than 3 months. Call your doctor right away if you have tingling or numbness in your hands or feet. Your doctor may stop your treatment with TOLSURA if you have nerve problems.
- Hearing loss. Hearing loss can happen in some people who take TOLSURA. Hearing loss usually improves when treatment with TOLSURA is stopped, but hearing loss has been permanent in some people. Call your doctor if you have any changes in your hearing.
The most common side effects of TOLSURA include:
- nausea
- rash
- vomiting
- swelling
- headache
- diarrhea
- fatigue
- fever
- itching
- high blood pressure
- abnormal liver blood tests
- stomach pain
- dizziness
- low blood potassium levels
- loss of appetite
- general feeling of discomfort
- decreased sex drive
- sleepiness
- elevated levels of a type of protein, called albumin, in your urine
- erectile dysfunction
These are not all the possible side effects of TOLSURA.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or call Mayne Pharma at 1-844-825-8500.