Pronunciation:

val-BEN-a-zeen

Brand Names:

• Ingrezza

Dosage Forms:

• Capsule

Warnings:

Warning: Depression and Suicidal Ideation and Behavior in Patients with Huntington's DiseaseVMAT2 inhibitors, including valbenazine, can increase the risk of depression and suicidal thoughts and behavior in patients with Huntington's disease. Anyone considering the use of valbenazine must balance the risks of depression and suicidal ideation and behavior with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidal ideation, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidal ideation and behavior and instruct them to report behaviors of concern promptly to the treating physician.Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in patient's with Huntington's disease .

Classifications:

Therapeutic—

Central Nervous System Agent

Uses of This Medicine:

Valbenazine is used to treat movement disorders, including tardive dyskinesia and chorea caused by Huntington's disease.

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.

• Apalutamide
• Boceprevir
• Bupropion
• Carbamazepine
• Ceritinib
• Clarithromycin
• Cobicistat
• Conivaptan
• Dacomitinib
• Digoxin
• Enzalutamide
• Fluoxetine
• Fosphenytoin
• Idelalisib
• Indinavir
• Isocarboxazid
• Itraconazole
• Ivosidenib
• Josamycin
• Ketoconazole
• Linezolid
• Lonafarnib
• Lopinavir
• Lumacaftor
• Methylene Blue
• Mibefradil
• Mifepristone
• Mitotane
• Nefazodone
• Nelfinavir
• Ozanimod
• Paroxetine
• Phenelzine
• Phenytoin
• Posaconazole
• Procarbazine
• Quinidine
• Rasagiline
• Ribociclib
• Rifampin
• Rifapentine
• Ritonavir
• Safinamide
• Saquinavir
• Selegiline
• St John's Wort
• Telaprevir
• Telithromycin
• Tranylcypromine
• Troleandomycin
• Tucatinib
• 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.

• Mental problems (eg, depression, nervousness, anxiety, suicidal thoughts, psychosis)—Use with caution. May make these conditions worse, especially in patients with Huntington's disease.

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 chorea caused by Huntington's disease:
    • Adults—At first, 40 milligrams (mg) once a day. Your doctor may increase your dose every 2 weeks until your dose is 80 mg once a day. Your doctor may adjust your dose to 40 or 60 mg once a day as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.
  • 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. Your doctor may adjust your dose to 40 or 60 mg once a day as needed and tolerated.
    • 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.

Do not take this medicine if you are also taking a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan®), phenelzine (Nardil®), selegiline (Eldepryl®), or tranylcypromine (Parnate®) within 14 days of each other. If you have questions, check with your doctor.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed, especially if they have a condition called Huntington's disease. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause serious allergic reaction, including angioedema, which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs.

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, including QT prolongation.

Check with your doctor right away if you have difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, seizures, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause parkinsonism (a movement disorder). Check with your doctor right away if you have difficulty swallowing, loss of balance control, mask-like face, shuffling walk, slowed movements, slurred speech, stiffness of the arms and legs, tic-like or jerky movements of the head, face, mouth, and neck, or trembling and shaking of the fingers and hands.

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

Absence of or decrease in body movement

clumsiness or unsteadiness

dizziness

drooling

inability to sit still

loss of balance control

need to keep moving

restlessness

trembling and shaking of the fingers or hands

trouble walking

Incidence not known

Difficulty swallowing

fainting

high fever

high or low blood pressure

hives or welts, itching, or red skin rash

increased sweating

irregular heartbeat recurrent

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of balance control

mask-like face

seizures

severe muscle stiffness

shuffling walk

slowed movements

slurred speech

stiffness of the arms and legs

tic-like (jerky) movements of the head, face, mouth, and neck

tiredness

trembling and shaking of the fingers and hands

trouble breathing

unusually pale skin

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

Fear or nervousness

headache

joint pain

muscle pain or stiffness

nausea

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.