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Deutetrabenazine

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Warning

If you have Huntington's disease, deutetrabenazine can sometimes increase the risk of depression and suicidal thoughts/attempts. People with Huntington's disease are already more likely to have depression and suicidal thoughts/attempts. Talk with your doctor about the risks and benefits of this medication. People with Huntington's disease and depression must not use deutetrabenazine if they are not being treated for depression or if they still have symptoms of depression with medication/treatment. Tell your doctor right away if you or your family/caregivers notice that you have new/worsening symptoms of depression, sadness, loss of interest in activities you used to enjoy, suicidal thoughts/attempts, or other mental/mood/behavior changes (such as new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings).

Precautions

See also Warning section.

Before taking deutetrabenazine, tell your doctor or pharmacist if you are allergic to it; or to tetrabenazine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breast cancer, liver problems, certain heart problems (fast/slow/irregular heartbeat, QT prolongation in the EKG).

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Side Effects

See also Warning section.

Drowsiness, trouble sleeping, tiredness, dizziness, nausea, or vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Your doctor may need to adjust your dose to reduce these side effects.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: agitation/restlessness, Parkinson's disease symptoms (such as shaking/tremors, slowed movement, loss of balance).

Sometimes deutetrabenazine can cause side effects that are similar to the symptoms of worsening Huntington's disease. Your doctor may need to adjust your dose to see if these side effects are due to the drug or to the disease. Tell your doctor right away if any of these serious side effects occur: mental/mood changes (such as new/worsening depression, suicidal thoughts/attempts, problems with thinking), trouble swallowing, uncontrolled muscle movements of the face (such as lip smacking, unusual tongue movements), signs of increased prolactin hormone (such as enlarged breasts, abnormal breast milk production, decreased sexual ability, a change in menstrual cycle).

This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, signs of kidney problems (such as change in the amount of urine).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.