Tiglutik is used to treat amyotrophic lateral sclerosis, also known as ALS or Lou Gehrig's disease.

Tiglutik is not a cure for ALS, but it may delay progression of the disease and prolong your life.

Tiglutik may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take Tiglutik on an empty stomach, at least 1 hour before or 2 hours after a meal.

Tiglutik may also be given through a PEG feeding tube.

Read and follow all Instructions for Use. Ask your doctor or pharmacist if you need help.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

You will need frequent medical tests.

Store at room temperature away from moisture, heat, and light. Keep the liquid medicine upright and do not freeze. Throw away any unused liquid after 15 days.

You should not use Tiglutik if you are allergic to it.

Tell your doctor if you have ever had:

• liver disease.

Tiglutik may harm an unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

Ask a doctor if it is safe to breastfeed while using Tiglutik.

Not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include drowsiness, confusion, problems with thinking or memory, coma, tremors, or blue lips or fingers.

Avoid smoking. Smoking cigarettes may make Tiglutik less effective.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tiglutik may cause serious side effects. Stop using Tiglutik and call your doctor at once if you have:

• sudden chest pain, wheezing, feeling short of breath;

• dry cough, or cough with mucus;

• low white blood cell counts--fever, mouth sores, skin sores, sore throat; or

• liver problems--nausea, loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, jaundice (yellowing of the skin or eyes).

Side effects may be more likely to occur in people of Japanese descent.

Common side effects of Tiglutik may include:

• increased blood pressure;

• numbness or tingling around your mouth;

• weakness;

• dizziness;

• stomach pain, nausea; or

• breathing problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tiglutik can harm your liver, especially if you also use certain medicines for infections, birth control, high cholesterol, seizures, pain, or arthritis (including Advil).

Other drugs may affect Tiglutik, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.