FDA Approves First Treatment for Tardive Dyskinesia

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Repetitive involuntary movements typically affecting the jaw, lips, tongue, arms or legs can be caused by tardive dyskinesia, a neurological disorder. Tardive dyskinesia is often seen as a side effect in patients taking antipsychotic medications used to treat certain mental illnesses.

Previously, no medications were FDA approved to specifically treat tardive dyskinesia, making prevention key. This meant that the only way help patients with tardive dyskinesia were to change their antipsychotic medication, or stop it all together, which could be harmful to patients who required treatment.

However, there is now good news for patients suffering from Tardive Dyskinesia, the FDA just approved Ingrezza. This is the first drug approved by the FDA for this condition.

What is Ingrezza indicated for?
Ingrezza is indicated for the treatment of adults with tardive dyskinesia, a side effect of medications used to treat certain psychiatric or stomach conditions. Tardive dyskinesia can cause repetitive involuntary movements like sticking out the tongue, lip smacking, facial grimacing, movement of the arms and legs, or shallow breathing.

Tardive dyskinesia can be caused by antipsychotic drugs like chlorpromazine (Promapar, Thorazine), fluphenazine (Prolixin, Permitil), haloperidol (Haldol), perphenazine (Trilafon), prochlorperazine (Compazine, Compro, Procomp), thioridazine (Mellaril) and trifluoperazine (Stelazine). Tardive dyskinesia can also be caused by the stomach medication, metoclopramide (Reglan, Metozolv).

Ingrezza is a specialty medication, which means that it will most likely be delivered to your home by a designated specialty pharmacy rather than picking it up at your local pharmacy.

How should Ingrezza be taken?
Ingrezza will be available as a capsule in a strength of 40 mg. For the initial dose, patients should take one 40 mg capsule by mouth once daily for one week. After one week, the dose should be increased to the recommended dose of two 40 mg capsules once daily. Ingrezza can be taken with or without food.

The most common side effect associated with Ingrezza is drowsiness. Ingrezza can also cause serious side effects like heart rhythm problems.

How can I save on Ingrezza?

Manufacturer Neurocrine Biosciences has created the Inbrace Support Program to help patients afford Ingrezza. You will need your doctor to fill out the enrollment form, and then eligible patients can save up to 100% on each prescription. You can read here for more information about the Ingrezza savings program.

For more information, you can read the FDA’s press release here, or read more on Ingrezza’s website here.

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