COVERED, ELIGIBLE PATIENTS MAY PAY AS LITTLE AS $0*
$0 Copay*
Patient Savings Card
- RxBIN: 025706
- RxPCN: IFX
- RxGRP: MP01
- ID: MAYN2023
Covered, eligible patients may pay as little as $0 for a prescription fill.*
*Restrictions and limitations apply. Please see below for Terms, Conditions, and Eligibility Criteria. Out-of-pocket costs may vary.
OUT-OF-POCKET COSTS MAY VARY.
*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 TOLSURA 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.
This is not health insurance. Subject to change. Savings card offer not valid for patients enrolled in Medicare, Medicaid, or other federal or state healthcare programs.
If patients have questions about how to use their Mayne Pharma Patient Savings Card, please have them call (888)-927-3499. Remind patients to use this card every time they refill their Mayne Pharma Patient prescription.
IMPORTANT SAFETY INFORMATION
WARNING: CONGESTIVE HEART FAILURE and DRUG INTERACTIONS
See full prescribing information for complete boxed warning.
Limitations of Use:
-
- Congestive Heart Failure
- 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 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.
TOLSURA is not indicated for the treatment of onychomycosis.
TOLSURA is NOT interchangeable or substitutable with other itraconazole products.
- Co-administration with certain drugs that are metabolized by human CYP3A4 substrates 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.
- Co-administration with eliglustat is contraindicated in subjects that are poor or intermediate CYP2D6 and in subjects taking strong or moderate CYP2D6 inhibitors.
- Increased plasma concentrations of some of these drugs due to co-administration of TOLSURA can lead to QT prolongation and ventricular tachyarrhythmias including occurrences of torsade de pointes, a potentially fatal arrhythmia.
Hypersensitivity
- TOLSURA is contraindicated in patients with known hypersensitivity to itraconazole. There is limited information regarding cross-hypersensitivity between itraconazole and other azole antifungal agents.
Warnings and Precautions
- Congestive Heart Failure: TOLSURA can cause or exacerbate congestive heart failure (CHF). For patients with evidence of ventricular dysfunction such as CHF, history or risk factors for CHF, physicians should carefully review the risks and benefits of TOLSURA therapy. These risk factors include cardiac disease such as ischemic and valvular disease; significant pulmonary disease such as chronic obstructive pulmonary disease; and renal failure and other edematous disorders.
- 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.
- Pseudoaldosteronism: Manifested by the onset of hypertension or worsening of hypertension, and abnormal laboratory findings have been reported with itraconazole use in the postmarketing setting. Monitor blood pressure and potassium levels and manage as necessary.
- 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 has been reported in patients. Discontinue treatment if hearing loss occurs.
- Hypersensitivity Reactions: TOLSURA is contraindicated in patients with a known hypersensitivity to itraconazole. Hypersensitivity reactions have been reported with the use of itraconazole. Due to the limited information regarding cross-hypersensitivity between itraconazole and other azole antifungal drugs, careful inquiry about previous hypersensitivity to other azole antifungal drugs should be made when prescribing TOLSURA. If hypersensitivity reactions to TOLSURA occurs, discontinue the drug and institute appropriate therapy.
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, impotence. To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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.
IMPORTANT SAFETY INFORMATION
WARNING: CONGESTIVE HEART FAILURE and DRUG INTERACTIONS
See full prescribing information for complete boxed warning.
Limitations of Use:
-
- Congestive Heart Failure
- 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 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.
TOLSURA is not indicated for the treatment of onychomycosis.
TOLSURA is NOT interchangeable or substitutable with other itraconazole products.
- Co-administration with certain drugs that are metabolized by human CYP3A4 substrates 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.
- Co-administration with eliglustat is contraindicated in subjects that are poor or intermediate CYP2D6 and in subjects taking strong or moderate CYP2D6 inhibitors.
- Increased plasma concentrations of some of these drugs due to co-administration of TOLSURA can lead to QT prolongation and ventricular tachyarrhythmias including occurrences of torsade de pointes, a potentially fatal arrhythmia.
Hypersensitivity
- TOLSURA is contraindicated in patients with known hypersensitivity to itraconazole. There is limited information regarding cross-hypersensitivity between itraconazole and other azole antifungal agents.
Warnings and Precautions
- Congestive Heart Failure: TOLSURA can cause or exacerbate congestive heart failure (CHF). For patients with evidence of ventricular dysfunction such as CHF, history or risk factors for CHF, physicians should carefully review the risks and benefits of TOLSURA therapy. These risk factors include cardiac disease such as ischemic and valvular disease; significant pulmonary disease such as chronic obstructive pulmonary disease; and renal failure and other edematous disorders.
- 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.
- Pseudoaldosteronism: Manifested by the onset of hypertension or worsening of hypertension, and abnormal laboratory findings have been reported with itraconazole use in the postmarketing setting. Monitor blood pressure and potassium levels and manage as necessary.
- 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 has been reported in patients. Discontinue treatment if hearing loss occurs.
- Hypersensitivity Reactions: TOLSURA is contraindicated in patients with a known hypersensitivity to itraconazole. Hypersensitivity reactions have been reported with the use of itraconazole. Due to the limited information regarding cross-hypersensitivity between itraconazole and other azole antifungal drugs, careful inquiry about previous hypersensitivity to other azole antifungal drugs should be made when prescribing TOLSURA. If hypersensitivity reactions to TOLSURA occurs, discontinue the drug and institute appropriate therapy.
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, impotence. To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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.