Specifically Developed for People Living with ALS Who Have Difficulty Swallowing

TIGLUTIK® (riluzole) is the only formulation of riluzole indicated for both oral and PEG tube administration

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.

Understanding treatment for ALS

Riluzole is a treatment that doctors have been prescribing for patients with ALS since its FDA approval more than 20 years ago.
  • The American Academy of Neurology Practice Guidelines include a recommendation for the use of riluzole to slow disease progression in patients with ALS

Riluzole was studied in 2 large clinical trials.

  • Combined, more than 1,100 people with ALS participated in these placebo-controlled trials, which showed that riluzole is an effective treatment for ALS*
  • Progression of the disease was slowed in people who took riluzole vs a sugar pill (also known as a placebo)†
  • 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® (riluzole).

†Clinical outcomes were based on time to tracheostomy or death.

Until recently, riluzole has only been available in a tablet form, which may present challenges if swallowing problems develop or if the patient has a PEG tube.

Challenges with crushed tablets

At some point, many people living with ALS experience swallowing problems, also known as dysphagia (pronounced “dis-FAY-ja”). Sometimes, it’s not easy to tell if you or someone you’re caring for is having swallowing problems. Some people living with ALS have reported having no swallowing issues, even when medical imaging results showed that issues existed.

When there is a swallowing problem, choosing to crush tablets may:

  • Increase the chance of choking
  • Increase the chance of particles entering the lungs (also known as aspiration)
  • Prevent you from getting the full effect of your medicine, especially when mixed with food like yogurt or applesauce

What if there were an easy-to-swallow form of riluzole?

Important Safety Information (cont)

  • 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.

Specifically developed for people living with ALS

Easy to swallow

Same medication as riluzole tablets

Lessens the risk of choking

Helps reduce the need to stop treatment or crush riluzole tablets based on swallowing ability or having a PEG tube

Starting therapy

If you and your doctor decide that TIGLUTIK® (riluzole) is the right therapy for you, it’s important to begin treatment as early as possible and stay with it through your treatment course.

In 2 clinical studies with more than 1,100 people with ALS, progression was slowed in those who took riluzole vs a sugar pill.*

*Studies were conducted using riluzole tablets, which contain the same active ingredient as TIGLUTIK.
Why TIGLUTIK now?
  • With TIGLUTIK, you get the reliability and effectiveness of riluzole in an easy-to-swallow liquid
  • TIGLUTIK delivers the full intended treatment dose—and the full effect your doctor intended

Important Safety Information (cont)

  • 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.

How to take TIGLUTIK orally

TIGLUTIK is easy to administer
  • TIGLUTIK should be taken twice daily, once in the morning and once in the evening

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

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 oral syringe in your mouth and aim the tip toward the inside of your cheek. Slowly push the plunger all the way in until the oral syringe is empty while completely pressing down on the plunger. Swallow all of the contents in the syringe.

STEP 5

Wash the syringe with water only after each use. After it is dried and reassembled, put the tip cap back on the syringe and store in a clean, dry place.

How to take TIGLUTIK® (riluzole) through a PEG tube

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

Using a catheter-tip syringe, flush the PEG tube with 1 ounce (30 mL) of water.

STEP 5

Place the oral syringe provided (containing the 10 mL of TIGLUTIK) into the PEG tube right away. Slowly push down the plunger until the oral syringe is empty.

STEP 6

Using a catheter-tip syringe, flush the PEG tube again with 1 ounce (30 mL) of water.

STEP 7

Remove the plunger from the oral syringe barrel. Rinse the oral syringe barrel, plunger, and syringe tip cap with water.

When the oral syringe barrel, plunger, and syringe tip cap are dry, put the plunger back into the oral syringe barrel and put the syringe tip cap on the syringe tip. Do not throw away the oral syringe. Keep this oral syringe for use with this bottle of TIGLUTIK .

Treatment tips:

  • TIGLUTIK syringes are reusable – use again with the same bottle
  • After opening the TIGLUTIK bottle, use within
  • 15 days – dispose of any TIGLUTIK that is not used within 15 days of opening the bottle
  • Do not use TIGLUTIK after the expiration date on the bottle
  • Open a new bottle of TIGLUTIK when ready to give first dose
  • Keep bottle tightly closed between each use
  • Keep TIGLUTIK and all medicines out of the reach of children
  • IMPORTANT: do not mix with food or crushed tablets

Important Safety Information (cont)

  • 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.

Helping you get your medication

ITF Pharma, the maker of TIGLUTIK® (riluzole), is dedicated to providing support and services for those impacted by ALS

  • TIGLUTIK copay support helps ensure that people get financial assistance in accessing the treatment they need
    • Eligible patients pay no more than $50 per filled prescription of TIGLUTIK

Eligibility and Restrictions

Offer is valid for each prescription fill for commercially insured patients where TIGLUTIK is covered. Offer is valid for patients aged 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 is only available through Anovo Specialty Pharmacy. Pharmacists are available at (844) 763-1198 24 hours a day, 7 days a week, to answer your questions.
Your first TIGLUTIK prescription

An Anovo representative will call you or your caregiver after your doctor submits your prescription. The Caller ID will be AnovoRx Group: (901) 201 5470.

You or your caregiver must speak with the Anovo team to activate your prescription. Anovo will research your insurance benefits, obtain authorization and fill your prescription in time for your scheduled delivery.

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.

Support that helps you stay connected

ITF Pharma, the maker of TIGLUTIK® (riluzole), wants to help you stay connected to the latest news in ALS and treatment updates.
Connecting to empowering ALS communities
It’s important to find other people who know how you feel and can offer emotional support to help you along your treatment journey. There are many ways to connect and find hope.
Visit these national online communities for immediate support

Get encouragement, guidance, and advice from:

  • The ALS Association website at alsa.org
  • An ALS online forum for patients and caregivers at alsforums.com
  • The Motor Neurone Disease Association at mndassociation.org and/or an online forum at mndforum.com
  • The International Alliance of ALS/MND (motor neurone disease) Associations at alsmndalliance.org
Visit local chapters

Connect with other caregivers

Being a caregiver requires a loving commitment to the person being cared for and special understanding of his or her changing needs. But there is also a need to take care of yourself and your other family obligations. Learn how to manage by connecting to ALS caregiver communities

  • Visit the ALS Association website at alsa.org or the Motor Neurone Disease Association at mndassociation.org to find numerous, helpful online resources that focus on supporting caregivers
  • Talk with other caregivers at local ALS Association chapter meetings to share strategies, hear stories, and understand even more about what it takes when a loved one is living with ALS

Ask Your Doctor if TIGLUTIK® (riluzole) Is Right for You

The only formulation of riluzole indicated for both oral and PEG tube administration

  • Patients eligible for copay support pay no more than $50 per filled prescription of TIGLUTIK*
Visit TIGLUTIK.com to learn more

TIGLUTIK is only available through Anovo Specialty Pharmacy.

Anovo pharmacists are available at (844) 763-1198, 24 hours a day, 7 days a week, to answer your questions.

Important Safety Information

    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.
ITF Pharma Corporate Office
850 Cassatt Road, Suite 350,
Berwyn, PA 19312
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