Ingrezza

What is Ingrezza?

Ingrezza is a prescription medicine used to treat adults with movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).
It is not known if Ingrezza is safe and effective in children.

Description

INGREZZA contains valbenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, present as valbenazine tosylate salt, with the chemical name, L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl ester, 4-methylbenzenesulfonate (1:2). Valbenazine tosylate is slightly soluble in water. Its molecular formula is C38H54N2O10S2, and its molecular weight is 762.97 g/mol (ditosylate salt) with the following structure:

The molecular formula of valbenazine free base is C24H38N2O4 and its molecular weight is 418.57.

INGREZZA capsules are intended for oral administration only. Each capsule contains 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The capsules contain the following inactive ingredients: hypromellose, isomalt, magnesium stearate, pregelatinized starch, and silicified microcrystalline cellulose. The capsule shells contain candurin silver fine, FD&C Blue#1, FD&C Red#40, and gelatin.

Mechanism of Action

The mechanism of action of valbenazine in the treatment of tardive dyskinesia is unclear, but is thought to be mediated through the reversible inhibition of vesicular monoamine transporter 2 (VMAT2), a transporter that regulates monoamine uptake from the cytoplasm to the synaptic vesicle for storage and release.

Who should not take Ingrezza?

Do not take Ingrezza if you:

• are allergic to valbenazine, or any of the ingredients in Ingrezza. See the end of this Patient Information leaflet for a complete list of ingredients in Ingrezza.

What should I tell my healthcare provider before taking Ingrezza?

Before taking Ingrezza, tell your healthcare provider about all of your medical conditions including if you:

• 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. Ingrezza may harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Ingrezza passes into your breast milk. Do not breastfeed during treatment with Ingrezza and for 5 days after the final dose. Talk to your healthcare provider about the best way to feed your baby during treatment with Ingrezza.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
Taking Ingrezza with certain other medicines may cause serious side effects. Do not start any new medicines while taking Ingrezza without talking to your healthcare provider first.

How should I take Ingrezza?

• Take Ingrezza exactly as your healthcare provider tells you to. Your healthcare provider will tell you how much Ingrezza to take and when to take it.
• Do not stop taking Ingrezza without talking to your healthcare provider first.
• Ingrezza can be taken with or without food.
• If you take too much Ingrezza, call your poison control center at 1-800-222-1222.

What are the possible side effects of Ingrezza?

Ingrezza may cause serious side effects, including:

• 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.

• Parkinson-like symptoms. Symptoms include:
  • shaking,
  • body stiffness,
  • trouble moving or walking, or keeping your balance

The most common side effect of Ingrezza is sleepiness (somnolence).
Other common side effects include:

• changes in balance (balance problems, dizziness) or an increased risk of falls
• headache
• feelings of restlessness
• dry mouth
• constipation
• blurred vision

These are not all of the possible side effects of Ingrezza. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Ingrezza

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Ingrezza for a condition for which it was not prescribed. Do not give Ingrezza to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Ingrezza that is written for healthcare professionals.

How should I store Ingrezza?

• 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.

What are the ingredients in Ingrezza?

Active ingredient: valbenazine
Inactive ingredients: 40 mg Size 1 capsule: colloidal silicon dioxide, magnesium stearate, mannitol, and pregelatinized starch;
40 mg Size 2 capsule, 80 mg capsule: hypromellose, isomalt, magnesium stearate, pregelatinized starch, and silicified microcrystalline cellulose.
The capsule shells contain candurin silver fine, FD&C Blue#1, FD&C Red#40, and gelatin.

Label

• PRINCIPAL DISPLAY PANEL

  NDC 70370-2040-1
  INGREZZA
  (valbenazine) capsules
  40 mg
  30 Capsules
  Rx Only

  

  

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL