Why TIGLUTIK now?

Why start treatment with TIGLUTIK now?

As soon as ALS is diagnosed, it’s important to do everything possible to fight the condition. TIGLUTIK can help. TIGLUTIK’s main ingredient is riluzole. Riluzole has been used in the treatment of ALS for more than 20 years to help slow the progression of disease. It can be started as early as diagnosis and continued throughout the course of treatment, because of its liquid form.

TIGLUTIK is easy-to-swallow

Unlike riluzole tablets, which are often crushed and altered to enable swallowing, TIGLUTIK is designed to be delivered reliably and simply. Because it’s a liquid, TIGLUTIK can be swallowed in its original form.

Formulated specifically to address swallowing problems in people living with ALS

Many people living with ALS experience swallowing problems at some point—making it difficult to take some types of medicine. That’s the reason that TIGLUTIK was developed. It provides an alternative to riluzole tablets in an easy-to-swallow liquid, ensuring that the medicine prescribed can be taken.

TIGLUTIK is made to deliver reliable, everyday dosing

Slows disease progression

Riluzole, the active ingredient in TIGLUTIK, has been thoroughly studied and used by people living with ALS worldwide.

Clinical outcomes were based on time to tracheostomy or death.

Riluzole was studied in 2 large clinical trials

  • Combined, more than 1,100 people living with ALS participated in these placebo-controlled trials (placebo is also known as a sugar pill), which showed that riluzole is an effective treatment for ALS
  • Progression of the disease was slowed in people who took riluzole
  • People who took riluzole lived up to 3 months longer than those who did not

Studies were conducted using riluzole tablets, which contain the same active ingredient as TIGLUTIK.

Delivers the full intended dose of the medicine

TIGLUTIK delivers the full intended treatment dose—and the full effect of the medicine your doctor intended

  • Unlike crushed riluzole tablets, which often get mixed with food like yogurt or applesauce, and may be delivered incompletely, TIGLUTIK is designed to be delivered simply and completely

Helps reduce the need to stop treatment or crush riluzole tablets

Since TIGLUTIK is designed to be taken as early as diagnosis and throughout your treatment course, there’s no need to change what you’re doing based on swallowing ability. It’s one less thing that has to be considered along the ALS treatment journey.

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Important Information

Riluzole, the main ingredient in TIGLUTIK, has been used in patients for more than 20 years.

TIGLUTIK should not be used by anyone who has a history of severe hypersensitivity to riluzole or any of its components

Riluzole was evaluated for safety in 2 clinical studies

  • Participants in the trial were randomized to receive either riluzole 50 mg tablets twice daily, or placebo
  • Combined, there were over 313 people with ALS who received riluzole
  • The most common adverse reactions in trial participants taking riluzole that occurred more frequently (greater than 5%) vs those taking placebo were:
    • Numbness/tingling around the mouth
    • Weakness
    • Nausea
    • Dizziness
    • Decreased lung function
    • Abdominal/stomach pain

The most common adverse reactions that led to discontinuation of riluzole were nausea, abdominal pain, constipation, and elevated alanine aminotransferase (ALT), an enzyme normally present in the liver and heart.

How to take TIGLUTIK

TIGLUTIK is easy to take and/or administer. TIGLUTIK should be taken orally, twice daily, once in the morning and once in the evening.

Follow these instructions

STEP 1: Gently shake the TIGLUTIK bottle for at least 30 seconds, continually rotating it 180°, so that the contents appear uniform, before use.

STEP 2: Remove the tip of the syringe and insert the syringe into the opening of the TIGLUTIK bottle.

STEP 3: Turn the bottle upside down and slowly pull the plunger on the syringe to withdraw 10 mL of TIGLUTIK.

STEP 4: Check to ensure the dose is correct and place the tip of the syringe in the center of the mouth, while completely pressing down on the plunger. Swallow all of the contents in the syringe.

STEP 5: Rotate the bottle right-side up and remove the syringe. Wash the syringe with water only and safely store TIGLUTIK.

Refer to the TIGLUTIK Instructions for Use for complete instructions.

TIGLUTIK co-pay support is available*

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*ELIGIBILITY AND RESTRICTIONS
Offer is valid for each prescription fill for commercially insured patients where TIGLUTIK is covered. Offer is valid for patients age 18 and older. Medicare, Medicaid, TRICARE, or other patients of other federal or state programs are not eligible. ITF Pharma reserves the right to rescind, revoke, or amend this offer without notice. Offer good only in the USA, including Puerto Rico, at participating retail pharmacies. Void if prohibited by law, taxed, or restricted. This offer has no cash value and may not be used in combination with any other discount, coupon, rebate, free trial, or similar offer for the specified product. Maximum savings limit applies; patient out-of-pocket expense may vary.

TIGLUTIK co-pay support is available*

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Indication

TIGLUTIK (riluzole) is a prescription medicine for the treatment of amyotrophic lateral sclerosis (ALS).

Important Safety Information

  • You should not take TIGLUTIK if you are allergic to any of its ingredients.
  • TIGLUTIK can cause liver injury, including death. Your doctor should do blood tests to check your liver function before and during your treatment and may stop treatment with TIGLUTIK if liver function is not normal. Contact your doctor immediately if you have unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine.
  • Call your doctor immediately if you have a fever, cough, or difficulty in breathing while taking TIGLUTIK.
  • If you miss or skip a dose of TIGLUTIK, do not take any extra dose to make up for those you missed, but take your prescribed dose at the next regularly scheduled time.
  • The most common side effects of TIGLUTIK that occurred during medical studies were numbness/tingling around the mouth, weakness, nausea, decreased lung function, high blood pressure, and abdominal pain. If any side effects become troublesome, contact your doctor.
  • Be sure to tell your doctor and pharmacist about all other health conditions you have and all medicines you are taking, including nonprescription products and vitamins. If you have questions, please talk to your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-332-1088.

Please click here for the Full Prescribing Information.