Valbenazine

Before taking valbenazine,

• tell your doctor and pharmacist if you are allergic to valbenazine, any other medications, or any of the ingredients in valbenazine capsules. Ask your pharmacist for a list of the ingredients.
• tell your doctor if you are taking the following medications or have stopped taking them within the last two weeks: monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate). Your doctor will probably tell you not to take valbenazine if you are taking one of these medications.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: carbamazepine (Equetro, Tegretol, Teril), clarithromycin (Biaxin, in Prevpac), digoxin (Lanoxin), fluoxetine (Prozac, Sarafem, Selfemra, others), itraconazole (Onmel, Sporanox), ketoconazole (Nizoral), paroxetine (Brisdelle, Paxil, Pexeva), phenytoin (Dilantin, Phenytek), quinidine (in Nuedexta), and rifampin (Rifadin, Rimactane, in Rifamate, in Rifater). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor what herbal products you are taking, especially St. John's wort.
• tell your doctor if you have recently had a heart attack or if you have or have ever had long QT syndrome (condition that increases the risk of developing an irregular heartbeat that may cause fainting or sudden death); another type of irregular heart beat or heart rhythm problem; heart failure; or liver or kidney disease.
• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking valbenazine, call your doctor.
• tell your doctor if you are breast-feeding or plan to breastfeed. Do not breastfeed while taking valbenazine and for 5 days after the final dose.
• you should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

• Ingrezza^®

Oral Administration

May take with or without food

Also see Dosage Modifications

Storage

Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)

Do not breast-feed while using this medicine and for at least 5 days after your last dose.

Other drugs may interact with valbenazine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Take valbenazine 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.

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

You may take valbenazine with or without food.

Dosing

The dose of valbenazine 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 valbenazine. 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 valbenazine, 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.

The mechanism of action of valbenazine in the treatment of tardive dyskinesia is unknown, 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. Valbenazine and its active metabolite have no appreciable binding affinity for VMAT1 or dopaminergic, serotonergic, adrenergic, histaminergic or muscarinic receptors.

Absorption

High-fat meals decrease Cmax by 47% and AUC by 13%.

Distribution

Vd: 92 L

Metabolism

Metabolism: Extensively metabolized by hydrolysis to form active metabolite ([+]-α-HTBZ) and by oxidative metabolism, primarily by CYP3A4/5, to form monooxidized valbenazine and other minor metabolites. The active metabolite is further metabolized in part by CYP2D6.

Excretion

Urine (~60%, primarily as inactive metabolites); feces (~30%, primarily as inactive metabolites)

Time to Peak

Valbenazine: 0.5 to 1 hours; Active metabolite: 4 to 8 hours

Half-Life Elimination

15 to 22 hours (valbenazine and active metabolite)

Protein Binding

Valbenazine: >99%; Active metabolite: ~64%

Refer to adult dosing.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience fatigue, loss of strength or energy, dry mouth, or constipation. Have patient report immediately to prescriber difficulty focusing, blurred vision, difficult urination, tachycardia, abnormal heartbeat, or passing out (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.