Ingrezza

Ingrezza is a prescription medication used to treat tardive dyskinesia (uncontrollable movement of the face, tongue, or other body parts) in adults. Ingrezza belongs to a group of drugs called vesicular monoamine transporter 2 (VMAT2) inhibitors. They work by changing the activity of certain natural substances in the brain.

This medication comes in capsule form and is taken once daily, with or without food.

Common side effects of Ingrezza include sleepiness, balance problems and dizziness. Do not drive or operate heavy machinery until you know how Ingrezza affects you.

Ingrezza is a prescription medication used to treat tardive dyskinesia (uncontrollable movement of the face, tongue, or other body parts) in adults.

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

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

Common side effects of Ingrezza include the following:

• Sleepiness
• Changes in balance (balance problems, dizziness) or an increased risk of falls
• Dry mouth
• Headache
• Constipation
• Feeling of restlessness
• Blurred vision

These are not all of the possible side effects of Ingrezza. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away. 

You may report side effects to 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:

• Monoamine oxidase inhibitors such as
  • isocarboxazid (Marplan)
  • phenelzine (Nardil)
  • tranylcypromine (Parnate)
  • selegiline (Emsam, Eldepryl, Zelapar)
  • rasagiline (Azilect)
• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone
• medications that block a protein in the body (CYP2D6) such as quinidine (Qualaquin), fluoxetine (Prozac, Sarafem), amitriptyline (Elavil, Amitril, Amitid), and paroxetine (Paxil)
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St John's wort
• digoxin (Lanoxin). Co-administration of Ingrezza with digoxin may increase digoxin levels. Digoxin concentrations should be monitored.

This is not a complete list of Ingrezza drug interactions. Ask your doctor or pharmacist for more information.

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

• Sleepiness (somnolence). Do not drive, operate heavy machinery, or do other dangerous activities until you know how Ingrezza affects you.
• Heart rhythm problems (QT prolongation). Ingrezza may cause a heart problem known as QT prolongation. 
  Symptoms of QT prolongation may include:
  • Fast, slow, or irregular heartbeat
  • Shortness of breath
  • Dizziness or fainting

Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you faint.

Ingrezza can cause dizziness and blurred vision. Do not drive or operate heavy machinery until you know how Ingrezza affects you.

Do not take Ingrezza if you:

• are allergic to Ingrezza or to any of its ingredients
• have liver problems 
• have heart disease that is not stable, have heart failure or recently had a heart attack 
• have an irregular heart rhythm or heartbeat (QT prolongation, heart arrhythmia) 
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

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 Ingrezza, there are no specific foods that you must exclude from your diet when receiving this medication.

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

• are allergic to Ingrezza or to any of its ingredients
• have liver problems 
• have heart disease that is not stable, have heart failure or recently had a heart attack 
• have an irregular heart rhythm or heartbeat (QT prolongation, heart arrhythmia) 
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

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 planning to become pregnant. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or planning to breastfeed.

It is not known if Ingrezza 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 Ingrezza.

Take Ingrezza exactly as prescribed.

Ingrezza comes in capsule form and is taken once daily with or without food.

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 Ingrezza at the same time.

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:

• other medical conditions you have including your liver function
• other medications you are taking
• how you respond to this medication

Your doctor will probably start you on a low dose of Ingrezza (40mg) and may increase your dose once one week later (to 80mg).

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

• Store Ingrezza at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Ingrezza and all medicines out of the reach of children.