Tiglutik

Tiglutik is a prescription medication used to treat amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. ALS is a rare disease that affects nerve cells that are responsible for controlling muscle movement. It is a progressive condition, meaning that people living with ALS experience a continuing decline in muscle strength.

Tiglutik belongs to a group of drugs called benzothiazoles. The exact way Tiglutik works is not known. It is thought that it may inhibit the release and signaling of glutamate (a neurotransmitter that may be in excess in people with ALS) and therefore reduce the damage caused by glutamate and slow the progression of ALS.

This medication comes in liquid suspension form and is taken every 12 hours, at least 1 hour before or 2 hours after a meal.

Common side effects include numbness or tingling around the mouth, weakness, nausea, decreased lung function, high blood pressure, and stomach pain.

Tiglutik is a prescription medication used to treat amyotrophic lateral sclerosis (ALS).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Tiglutik. See the “Tiglutik Precautions” section.

Common side effects of Tiglutik include:

• numbness or tingling around the mouth
• weakness
• nausea
• decreased lung function
• high blood pressure
• stomach pain

This is not a complete list of Tiglutik side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800- FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Medications that increase the activity of the CYP1A2 enzyme such as montelukast (Singulair), phenytoin (Dilantin, Phenytek), omeprazole (Prilosec, Zegerid), phenobarbital
• Medications that decrease the activity of the CYP1A2 enzyme such as zileuton (Zyflo), amiodarone (Cordarone, Pacerone), mexiletine (Mexitil), propafenone (Rythmol), verapamil (Calan, Covera, Isoptin), cimetidine (Tagamet), famotidine (Pepcid), birth control pills, acyclovir (Zovirax), ticlopidine (Ticlid), ciprofloxacin (Cipro, Proquin), and fluvoxamine (Luvox)
• Medications that are considered hepatotoxic (damaging or destructive to liver cells) such as allopurinol (Zyloprim) and methyldopa (Aldomet)

This is not a complete list of Tiglutik drug interactions. For more information, ask your doctor or pharmacist.

Serious side effects have been reported with Tiglutik including the following:

• Liver injury. Tell your healthcare provider right away if you have some or all of the following symptoms of liver injury.
  • yellowing of your skin or eyes
  • nausea
  • vomiting
  • pain in upper right abdomen
  • confusion
• Neutropenia (low white blood cell count). Tell your healthcare provider right away if you have develop a fever.
• Interstitial lung disease. Tell your healthcare provider right away if you have cough, difficulty in breathing, or notice any changes in lung function while taking this medication.

Tiglutik can cause drowsiness. Do not drive or operate heavy machinery until you know how Tiglutik affects you.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Tiglutik, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Tiglutik, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Tiglutik or to any of its ingredients
• have or have had blood disorders or anemia
• have or have had liver disease or elevated liver enzymes
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed
• use tobacco products. Cigarette smoking may cause Tiglutik to not work as well as it should.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. There are no studies of Tiglutik in pregnant women. In animal studies, pregnant animals were given this medication, and the babies showed to have developmental and functional defects. This medication may harm your unborn baby. Your doctor and you will decide if the benefits of taking this medication outweight the risks to you and your unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Tiglutik crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Tiglutik.

Take Tiglutik exactly as prescribed. Tiglutik comes in suspension form and is taken twice a day on an empty stomach at least 1 hour before or 2 hours after a meal. Alcohol may add to the drowsiness caused by this medication. If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Tiglutik at the same time.

Take this Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose of Tiglutik for the treatment of amyotrophic lateral sclerosis is 50 mg (10 mL) taken orally twice daily every 12 hours.

If you take too much Tiglutik, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Tiglutik at room temperature. Do not freeze.
• Keep away from bright light.
• Store upright.
• Use within 15 days of opening each bottle. Discard unused Tiglutik after 15 days of first opening the bottle.
• Keep this and all medicines out of the reach of children.

This page was written by Jessica Galindo, PharmD Candidate 2020 | UT Austin College of Pharmacy