ONMEL® (itraconazole)

200-mg tablets

Effectively treats onychomycosis1

The ONMEL Advantage

  • Once-daily dosing with one 200-mg tablet1
  • Proprietary Meltrex® technology to improve bioavailability2,4
  • Has no A/B-rated substitute
  • Patient and disease state educational support
  • Savings Program support for patient co-pays to offset patient out-of-pocket costs see eligibility requirements for more details

Only ONMEL delivers the efficacy of itraconazole in one 200-mg, once-daily tablet1

One ONMEL tablet has efficacy comparable to two 100-mg, once-daily itraconazole capsules.1,5

Proven efficacy in clinical trial

Take a look at the results from a large-scale, randomized controlled trial for onychomycosis.

Phase 3 trial1

  • Randomized, multicenter, parallel-group, active-and placebo-controlled, evaluator-blinded trial
  • Treatments once daily in the morning after a full meal

Primary endpoint1

  • Complete cure = clinical cure + mycological cure of the toenail at week 52 (40 weeks after treatment)
  • Clinical cure: no evidence of onychomycosis in target nail; normal nail unit without subungual hyperkeratosis or onycholysis
  • Mycological cure: negative KOH and negative culture

Secondary endpoint5

  • Clinical improvement, defined as Investigator’s Global Assessment (IGA) Score of either 0 or 1
  • Mycological cure

ONMEL® (itraconazole)

Once-daily dosing with one 200-mg tablet for your patients

The power of itraconazole enhanced with proprietary Meltrex® technology2

Melt-extrusion technology allows for 200 mg of itraconazole in a single tablet. This dosing provides:

  • Increased bioavailability4
  • Steady and consistent GI absorption2

Help patients save on their prescription

ONMEL® (itraconazole)

200-mg tablets

ONMEL Co-Pay Savings Program

Eligible patients can receive great savings on their ONMEL prescriptions at participating pharmacies. Please see full terms and conditions on savings offer printout.

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Indications and Usage

ONMEL is a prescription medicine used to treat fungal infections of the toenails.
It is not known if ONMEL is safe and effective in children under the age of 18.

Important Safety Information for ONMEL

ONMEL can cause serious life-threatening side effects, including:

1. Heart Failure. Do not take ONMEL if you have had heart failure, including congestive heart failure. Stop taking ONMEL 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 phlegm
  • fast heartbeat
  • waking up at night more than normal for you

2. Serious cardiovascular effects. Do not take ONMEL if you also take the following medicines:

  • cisapride (Propulsid®)
  • felodipine, nisoldipine (Lexxel®, Plendil®, Sular®)
  • pimozide (Orap®)
  • triazolam (Halcion®)
  • quinidine (Quinidine Gluconate, Quinidine Sulfate)
  • lovastatin (Mevacor®, Advicor®, Altoprev®)
  • dofetilide (Tikosyn®)
  • simvastatin (Zocor®, Simcor®, Vytorin®)
  • levomethadyl (Oralaam®)
  • methadone (Dolophine®)
  • midazolam (Versed®)
  • ergot alkaloids (Migranal®, Ergonovine®, Cafergot®, Methergine®, Dihydroergotamine Mesylate, Methylergonovine)
  • This is not a complete list of medicines that can interact with ONMEL.
  • The product names used herein are for identification purposes only. All product names, trademarks and registered trademarks are the property of their respective owners.
  • Before taking ONMEL, tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
  • Talk to your doctor or pharmacist before you start any new medicine. They can tell you if it is safe to take ONMEL with your other medicines.
    • Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

Who should not take ONMEL?

Do not take ONMEL if you:

  • have or had heart failure, including congestive heart failure.
  • take certain medicines.
  • are taking fentanyl. Taking fentanyl, a strong opioid narcotic pain medicine with ONMEL could cause serious breathing problems that can lead to death.
  • are pregnant or plan to become pregnant. ONMEL can harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breast-feeding or plan to breast-feed. ONMEL can pass into your breastmilk and may harm your baby.
  • have ever had an allergic reaction to itraconazole or any of the other ingredients in ONMEL. Ask your doctor or pharmacist for a list of these ingredients.

What are the possible side effects of ONMEL?

ONMEL can cause serious side effects, including:

  • liver failure and death. Stop taking ONMEL and call your doctor right away if you have symptoms of liver failure including:
    • unusually tired
    • lose your appetite
    • nausea
    • abdominal pain
    • vomiting
    • yellow change in the color of your skin or eyes
    • dark colored urine
    • pale stools (bowel movements)
  • nerve damage (neuropathy). Call your doctor right away if you have tingling or numbness in your hands or feet. You may need to stop taking ONMEL if this happens.
  • hearing loss. Hearing loss can happen for a short time or permanently in some people who take ONMEL with other medications. Stop taking ONMEL and call your doctor right away if you have any changes in your hearing.

Common side effects of ONMEL include:

  • increased liver enzyme in blood test results
  • upper respiratory infection or cold
    (runny nose, cough, and sneeze)
  • urinary tract infection (burning and painful urination)
  • stomach pain
  • diarrhea
  • nausea
  • headache
  • tiredness
  • throat pain
  • back pain

These are not all of the possible side effects of ONMEL. Tell your doctor if you have any side effect that bothers you or that does not go away. For more information, ask your doctor.

Thank you for visiting ONMEL.com

Sebela is committed to advancing treatment in antifungal therapy.
For other information, please contact:

Sebela Pharmaceuticals Inc.
645 Hembree Parkway, Suite I
Roswell, GA 30076
Toll free: 844-SEBELA1

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References: 1. ONMEL [package insert]. Greensboro, NC: Merz Pharmaceuticals, LLC; 2012. 2. Data on file. Roswell, GA. Sebela Pharmaceuticals Inc. 3. Rodgers P, Bassler M. Treating onychomycosis. Am Fam Physician. 2001;63:663-672. 4. Breitenbach J. Melt extrusion: from process to drug delivery technology. Eur J Pharm Biopharm. 2002;54(2):107-117. 5. Maddin S, Quiring J, Bulger L. Randomized, placebo-controlled, phase 3 study of itraconazole for the treatment of oncyhomycosis. J Drugs Dermatol. 2013;12(7):758-763.