TIGLUTIK is for People Who Have Difficulty Swallowing

Swallowing requires many nerves and muscles to work together so food and beverages can move from the mouth to the stomach.  ALS often affects the nerves and muscles that help us swallow. In many people, ALS causes a medical condition called dysphagia. Dysphagia means difficulty in eating. It is the sensation of abnormal swallowing.

Symptoms of Dysphagia

  • Choking or coughing while swallowing
  • Bringing food back up (regurgitation)
  • Being hoarse
  • Having frequent heartburn
  • Being unable to swallow
  • Pain while swallowing
  • Sensation of food getting stuck in throat
  • Gagging when swallowing

One of the biggest fears that people with ALS have is choking. Dysphagia doesn’t happen overnight. Often, people with ALS don’t notice they have difficulty swallowing.  They automatically adjust to the small day-to-day changes that occur to the nerves and muscles that control swallowing.  Dysphagia is very common in ALS and affects about 85% of people. 

Dysphagia is more common in patients with bulbar onset ALS. However, many people with limb onset ALS also develop dysphagia. Patients should not delay telling their doctor if they are having difficulty swallowing. Sometimes, caregivers will notice that patients are having difficulty swallowing before patients realize it.

Dysphagia is Common in ALS

Bulbar Onset

Chart - Bulbar Onset

Limb Onset

Chart - Limb Onset

Combined*

Chart - Combined Bulbar and Limb Onset

* Weighted average
Adapted from Onesti E. Frontiers in Neurology 2017;8:94.

The PILL-5 is a validated questionnaire that can help identify people who have difficulty swallowing pills. It consists of 5 questions and is easy to take and score. Results from the PILL-5 is not equivalent to a clinical swallowing evaluation or instrumental assessment – only your doctors can determine this.

Click here for a copy of the PILL-5 assessment tool. After you print out the PILL-5, complete the 5 questions before your doctor’s appointment. Take the completed PILL-5 to your appointment and discuss the results with your doctor.

Click here for information to Ask Your Doctor if TIGLUTIK is Right for you.

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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.

Intended for U.S. Residents Only

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