INSTANT ACCESS AND SUPPORT

with the Mayne Pharma Patient Savings Program

BOTH COVERED AND DENIED, INSURED, ELIGIBLE PATIENTS MAY PAY AS LITTLE AS $0*

Savings Card

OUT OF POCKET COSTS MAY VARY.

COMMERCIALLY-INSURED PATIENTS

  • Coverage

    INSURANCE COVERAGE

    $0 COPAY*

  • No Coverage

    INSURANCE DENIED

    $0 COPAY*

If patients have questions about how to use their Mayne Pharma Patient Savings Card, please have them call (347)-442-7919. Remind patients to use this card every time they refill their Mayne Pharma Patient prescription.

Phone Icon

ANY QUESTIONS?
CALL CUSTOMER CARE AT:+1 800 344 8661

*Restrictions and limitations apply. Terms, conditions and eligibility criteria are included with the Mayne Pharma Patient Savings Card and can be accessed at the following address: https://www.maynepharma.com/legal/co-pay-card/.


Is TOSURA covered by your patient’s insurer? If it is not on the insurer’s prescription drug formulary or if the plan requires prior authorization, complete this form and send it to your patient’s insurer to request coverage of TOLSURA.

Traingle Marker

TOLSURA — RIGHT ON TARGET

Learn about TOLSURA’s efficacy

Suba Technology Triangle Graphic

Indications and Important
Safety Information

BOXED WARNING
WARNING: CONGESTIVE HEART FAILURE and DRUG INTERACTIONS

  • » 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 and risk of continuing treatment.

  • » 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, which may also increase or prolong both the pharmacologic effects and/or adverse reactions to these drugs.
  • Co-administration with colchicine, fesoterodine and solifenacin is contraindicated in subjects with varying degrees of renal or hepatic impairment, and
  • Co-administration with eligustat is contraindicated in subjects taking strong or moderate CYP2D6 inhibitors.
  • Increased plasma concentrations of some of these drugs caused by co-administration with TOLSURA can lead to QT prolongation and/or ventricular tachyarrhythmias, including occurrences of torsades de pointes, a potentially fatal arrhythmia.

Indications and Usage

TOLSURA is an azole antifungal indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised adult patients:

  • Blastomycosis, pulmonary and extrapulmonary
  • Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and
  • Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy

Limitations of Use:

TOLSURA is not indicated for the treatment of onychomycosis.

TOLSURA is NOT interchangeable or substitutable with other itraconazole products.

Contraindications

Co-administration with certain drugs that either affect metabolism of itraconazole or whose metabolism is affected by itraconazole Hypersensitivity to itraconazole

Warnings and Precautions

  • Hepatotoxicity: Serious hepatotoxicity, including liver failure and death, were reported with the use of itraconazole. Discontinue treatment if signs of liver dysfunction occur
  • Cardiac Dysrhythmias: Life-threatening cardiac dysrhythmias and/or sudden death have occurred in patients using certain drugs that are metabolized by human CYP450 enzymes concomitantly with oral itraconazole and/or other CYP3A4 inhibitors.
  • Peripheral Neuropathy: This has been reported in patients on long-term therapy with itraconazole. Monitor and promptly evaluate neurologic symptoms
  • Hearing loss: Reversible or permanent hearing loss has been reported in patients. Discontinue treatment if hearing loss occurs

Adverse Reactions

Most common adverse reactions (incidence ≥ 1%) are nausea, rash, vomiting, edema, headache, diarrhea, fatigue, fever, pruritus, hypertension, abnormal hepatic function, abdominal pain, dizziness, hypokalemia, anorexia, malaise, decreased libido, somnolence, albuminuria, and impotence.

To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For more information, please see full Prescribing Information and Patient Information Leaflet.

plus icon minus icon

Indications and Important
Safety Information

BOXED WARNING
WARNING: CONGESTIVE HEART FAILURE and DRUG INTERACTIONS

  • » 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 and risk of continuing treatment.

  • » 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, which may also increase or prolong both the pharmacologic effects and/or adverse reactions to these drugs.
  • Co-administration with colchicine, fesoterodine and solifenacin is contraindicated in subjects with varying degrees of renal or hepatic impairment, and
  • Co-administration with eligustat is contraindicated in subjects taking strong or moderate CYP2D6 inhibitors.
  • Increased plasma concentrations of some of these drugs caused by co-administration with TOLSURA can lead to QT prolongation and/or ventricular tachyarrhythmias, including occurrences of torsades de pointes, a potentially fatal arrhythmia.

Indications and Usage

TOLSURA is an azole antifungal indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised adult patients:

  • Blastomycosis, pulmonary and extrapulmonary
  • Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and
  • Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy

Limitations of Use:

TOLSURA is not indicated for the treatment of onychomycosis.

TOLSURA is NOT interchangeable or substitutable with other itraconazole products.

Contraindications

Co-administration with certain drugs that either affect metabolism of itraconazole or whose metabolism is affected by itraconazole Hypersensitivity to itraconazole

Warnings and Precautions

  • Hepatotoxicity: Serious hepatotoxicity, including liver failure and death, were reported with the use of itraconazole. Discontinue treatment if signs of liver dysfunction occur
  • Cardiac Dysrhythmias: Life-threatening cardiac dysrhythmias and/or sudden death have occurred in patients using certain drugs that are metabolized by human CYP450 enzymes concomitantly with oral itraconazole and/or other CYP3A4 inhibitors.
  • Peripheral Neuropathy: This has been reported in patients on long-term therapy with itraconazole. Monitor and promptly evaluate neurologic symptoms
  • Hearing loss: Reversible or permanent hearing loss has been reported in patients. Discontinue treatment if hearing loss occurs

Adverse Reactions

Most common adverse reactions (incidence ≥ 1%) are nausea, rash, vomiting, edema, headache, diarrhea, fatigue, fever, pruritus, hypertension, abnormal hepatic function, abdominal pain, dizziness, hypokalemia, anorexia, malaise, decreased libido, somnolence, albuminuria, and impotence.

To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For more information, please see full Prescribing Information and Patient Information Leaflet.