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INDICATION

DHIVY is a prescription medication that contains a combination of carbidopa and levodopa for the treatment of Parkinson’s disease, Parkinson’s disease caused by infection or inflammation of the brain, or Parkinson’s disease–like symptoms that may result from carbon monoxide or manganese poisoning.

IMPORTANT SAFETY INFORMATION

DHIVY is contraindicated in patients

• Currently taking a nonselective monoamine oxidase (MAO) inhibitor (e.g., phenelzine, linezolid, and tranylcypromine) or have recently (within 2 weeks) taken a nonselective MAO inhibitor. Hypertension can occur if these drugs are used concurrently.
• With known hypersensitivity to any component of DHIVY.

Taking DHIVY may result in falling asleep while engaged in normal activities, even without warning and as late as 1 year or later after starting DHIVY. This may affect your ability to drive or operate machinery, resulting in accidents. Do not do anything that requires alertness until you know how DHIVY affects you. Tell your healthcare provider about any sleep medicines you take or if you have a sleep disorder, and discuss any episodes of drowsiness or sleepiness you experience while taking DHIVY.

Talk to your healthcare provider before you change the dose or stop taking DHIVY, as this may result in serious side effects. Call your healthcare provider immediately if you develop withdrawal symptoms such as fever, confusion, or severe muscle stiffness.

Tell your healthcare provider if you have any heart conditions, especially if you have had a heart attack or irregular heartbeats. Your heart function should be monitored during the time period your DHIVY dose is first adjusted.

Treatment with DHIVY may cause hallucinations or abnormal thoughts and behaviors. Be sure to tell your healthcare provider if you experience excessive suspicion; seeing, hearing, or feeling things that are not real; confusion; agitation; aggressive behavior; and disorganized thinking.

Treatment with DHIVY may also cause intense urges to gamble, increased sexual urges, intense urges to spend money, binge eating, and other intense urges, as well as the inability to control those urges. Uncontrolled sudden movements of the face, arms, legs, or trunk may appear or get worse during treatment with DHIVY. This may mean your dosage of DHIVY or other Parkinson’s medications needs to be adjusted.

Tell your healthcare provider if you have ever had a peptic ulcer or glaucoma, as treatment with DHIVY may worsen these conditions. DHIVY also may cause abnormal blood or urine test results.

Some patients taking DHIVY may experience depression or suicidal thoughts. Tell your healthcare provider if you have thoughts of suicide.

The most common side effects that may appear with DHIVY include uncontrolled sudden movements and nausea.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using DHIVY with certain other medicines, including MAO inhibitors, isoniazid, iron supplements, medicines for high blood pressure or those that increase or decrease dopamine levels, or metoclopramide, may cause serious side effects.

Notify your healthcare provider if you become pregnant or intend to become pregnant during DHIVY therapy or if you intend to breastfeed or are breastfeeding an infant.

Please see full Prescribing Information.