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Valbenazine (Oral route)

Pronunciation:

val-BEN-a-zeen

Brand Names:

  • Ingrezza

Dosage Forms:

  • Capsule

Classifications:

Therapeutic—

Central Nervous System Agent

Uses of This Medicine:

Valbenazine is used to treat adults with tardive dyskinesia (a movement disorder).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of valbenazine in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of valbenazine in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Boceprevir
  • Bupropion
  • Carbamazepine
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Digoxin
  • Enzalutamide
  • Fluoxetine
  • Fosphenytoin
  • Furazolidone
  • Idelalisib
  • Indinavir
  • Iproniazid
  • Isocarboxazid
  • Itraconazole
  • Ketoconazole
  • Linezolid
  • Lopinavir
  • Lumacaftor
  • Methylene Blue
  • Mitotane
  • Moclobemide
  • Nefazodone
  • Nelfinavir
  • Nialamide
  • Paroxetine
  • Phenelzine
  • Phenytoin
  • Posaconazole
  • Procarbazine
  • Quinidine
  • Rasagiline
  • Rifampin
  • Ritonavir
  • Safinamide
  • Saquinavir
  • Selegiline
  • St John's Wort
  • Telaprevir
  • Telithromycin
  • Terbinafine
  • Tranylcypromine
  • Voriconazole

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Heart rhythm problems (eg, arrhythmia, congenital long QT syndrome)—May increase risk for more serious side effects.
  • Liver disease, moderate or severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with patient information leaflet Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules):
    • For tardive dyskinesia:
      • Adults—At first, 40 milligrams (mg) once a day. After 1 week, your doctor may increase your dose to 80 mg once a day.
      • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine may cause some people to become sleepy or drowsy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that requires you to be alert.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common
Dizziness
inability to sit still
need to keep moving
restlessness
trouble walking
Incidence not known
Fainting
irregular heartbeat recurrent

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Blurred vision
decrease in the frequency of urination
decrease in urine volume
difficulty having a bowel movement (stool)
difficulty in passing urine (dribbling)
dry mouth
painful urination
sleepiness or unusual drowsiness
Less common
Difficulty in moving
fear or nervousness
headache
muscle pain or stiffness
nausea
pain in the joints
trouble sleeping
vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 9/4/2017
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