Tolsura

Tolsura is a prescription medication used to treat certain fungal infections in adults. 

Tolsura belongs to a group of drugs called azole antifungal medications. This medication works by inhibiting the synthesis of ergosterol, a vital component of the fungal cell membrane. 
 
Tolsura comes in capsule form and is taken up to 3 times daily. Swallow capsules whole, with food, to ensure maximum absorption.
 
Common side effects of Tolsura include nausea, vomiting, diarrhea, swelling, rash, and headache. Tolsura can also cause dizziness, vision problems and fatigue. Do not drive or operate heavy machinery until you know how this medication affects you.

Tolsura is a prescription medication used to treat the following fungal infections in immunocompromised and non-immunocompromised adult patients:

• Blastomycosis 
• Histoplasmosis 
• Aspergillosis

Tolsura is not for use for the treatment of fungal infections of the toenails or fingernails (onychomycosis). Tolsura is not for use in place of other medicines that contain itraconazole. It is not known if Tolsura is safe and effective in children.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Tolsura. See the “Tolsura Precautions” section.

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 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

This is not a complete list of Tolsura side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
 

Tell your doctor about all the medicines you take, including prescription and non-prescription 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.

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
• ivabradine
• lomitapide
• lovastatin
• lurasidone
• methadone
• midazolam (taken by mouth)
• naloxegol
• nisoldipine
• pimozide
• quinidine
• ranolazine
• simvastatin
• ticagrelor
• 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 an enzyme in your body, called CYP2D6, breaks down (metabolizes) 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 (CYP2D inhibitor). Ask your doctor or pharmacist if you take any of these medicines.

This is not a complete list of Tolsura drug interactions. Ask your doctor or pharmacist for more information.
 

Serious side effects have been reported with Tolsura 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 for you
• 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. Talk to your doctor about all of the medications you are taking.
• 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)

• 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.

Do not take Tolsura:

• if you are allergic to itraconazole or any of the ingredients in Tolsura.

Tolsura can cause dizziness and vision problems. Do not drive or operate machinery until you know how Tolsura affects you. Tell your doctor if you get dizziness or vision problems.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Tolsura, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Tolsura, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Tolsura or to any of its ingredients
• have or had congestive heart failure
• have liver problems
• have hearing impairment
• have pre-existing nerve conditions
• have any issues with heart rhythm
• previously had an allergic to an antifungal medication
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given Tolsura, and some babies had problems if given very high doses of the medication. But in human studies, pregnant women were given this medication within the first trimester and their babies did not have any problems related to this medication. Findings on miscarriage were inconclusive. Long-term effects are not well-studied. Your doctor can help you decide if taking the medication has benefits that outweigh the possible risks.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Tolsura has been detected in human breast milk. There is not enough information on the amount of this medication in human milk, the effects on the breastfed child, or the effects on milk production. Because of the possibility for adverse reactions in nursing infants from Tolsura, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered. Talk to your doctor about the best way to feed your baby if you take Tolsura.

Take Tolsura exactly as prescribed by your doctor. Your doctor will tell you how much Tolsura to take and when to take it.

Tolsura must be taken with food. Do not chew, crush or break Tolsura capsules.

It is important to take Tolsura as your doctor has directed for as long as prescribed. Depending on the type and severity of your infection, you could be taking Tolsura for extended periods of time. Do not take Tolsura if you are allergic to itraconazole or any of the ingredients in Tolsura.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Tolsura at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.
 
The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose/dose range of Tolsura (itraconazole) for the treatment of fungal infections will depend on the type of infection. Your doctor will help determine the right dose for you.

• Blastomycosis, Histoplasmosis: 130 mg once daily. If no obvious improvement, or there is evidence of progressive fungal disease, the dose should be increased in 65 mg increments to a maximum of 260 mg/day (130 mg (2 × 65 mg capsules) twice daily). Doses above 130 mg/day should be given in two divided doses.
• Aspergillosis: 130 mg once or twice daily
• Life-threatening treatment: 130 mg three times daily for the first 3 days, then 130 mg once or twice daily depending on infection.

If you take too much Tolsura, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Tolsura at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Tolsura in a tightly closed container.
• Keep Tolsura away from light.

Keep Tolsura and all medicines out of the reach of children.

Congestive Heart Failure
TOLSURA can cause or exacerbate congestive heart failure (CHF). When itraconazole was administered intravenously to healthy human volunteers and dogs, negative inotropic effects were seen. If signs or symptoms of congestive heart failure
occur or worsen during administration of TOLSURA, reassess the benefit-risk of continuing treatment. (5.1, 6).

Drug Interactions

• Co-administration of certain drugs that are metabolized by human CYP3A4 enzymes are contraindicated with TOLSURA because plasma concentrations of such drugs are increased.
• Co-administration with colchicine, fesoterodine and solifenacin is contraindicated in subjects with varying degrees of renal or hepatic impairment.
• Co-administration with eliglustat is contraindicated in poor or intermediate metabolizers of CYP2D6 and in subjects taking strong or moderate CYP2D6 inhibitors.
• Increased plasma concentrations of some of these drugs can lead to QT prolongation and ventricular tachyarrhythmias including occurrences of torsades de pointes, a potentially fatal arrhythmia.