"The US Food and Drug Administration (FDA) has approved pimavanserin tablets (Nuplazid, Acadia Pharmaceuticals) for the treatment of hallucinations and delusions associated with psychosis in Parkinson's disease (PD).
Patients should be instructed to take TASMAR only as prescribed.
TASMAR should not be used by patients until there has been a complete discussion of the risks and the patient has provided written acknowledgement that the risks have been explained (see Patient Acknowledgement Of Risks section). Inform patients about clinical signs and symptoms that suggest the onset of hepatic injury (persistent nausea, fatigue, lethargy, anorexia, jaundice, dark urine, pruritus, and right upper quadrant tenderness) (see WARNINGS). If symptoms of hepatic failure occur, patients should be advised to contact their physician immediately.
Inform patients of the need to have regular blood tests to monitor liver enzymes.
Advise patients that sleepiness or drowsiness may occur and that they should not drive a car or operate other complex machinery until they have gained sufficient experience on TASMAR to gauge whether or not it adversely affects their mental and/or motor performance. Advise patients to exercise caution while driving, operating machines, or working at heights during treatment with TASMAR. Because of the possible additive sedative effects, caution should also be used when patients are taking other CNS depressants in combination with TASMAR. Inform patients that nausea may occur, especially at the initiation of treatment with TASMAR.
Inform patients that hallucinations and other psychotic-like behavior may occur.
Advise patients that they may develop postural (orthostatic) hypotension with or without symptoms such as dizziness, nausea, syncope, and sometimes sweating. Advise patients to rise slowly, especially after long periods of sitting or lying down. Hypotension may be more likely when patients first start treatment with TASMAR.
Instruct patients and caregivers to report intense urges to gamble, increased sexual urges, increase in spending money, binge eating, and other intense urges as well as the inability to control these urges to the prescriber while taking TASMAR.
Although TASMAR has not been shown to be teratogenic in animals, it is always given in conjunction with levodopa/carbidopa, which is known to cause visceral and skeletal malformations in the rabbit. Accordingly, patients should be advised to notify their physicians if they become pregnant or intend to become pregnant during therapy (see PRECAUTIONS: Pregnancy).
Tolcapone is excreted into maternal milk in rats. Because of the possibility that tolcapone may be excreted into human milk, advise patients to notify their physicians if they intend to breastfeed or are breastfeeding an infant.
Patient Acknowledgement Of Risks Associated With Tasmar Treatment
The following is important information that patients should know about TASMAR.
- TASMAR should not be used until you and your doctor (insert physician name here: _________________________) have had a complete discussion about the risks and benefits associated with the use of TASMAR.
- Reports of potentially life-threatening cases of severe hepatocellular injury, including fulminant liver failure resulting in death, have been reported in association with use of TASMAR.
- There are no laboratory tests that will predict in advance which patients are at an increased risk for liver failure or death from liver failure.
- Patients should have the recommended liver blood tests before treatment with TASMAR is begun and periodically for the first 6 months of therapy. After the first six months, periodic liver blood tests should be performed as directed by your physician. If the dose of TASMAR is to be increased, the liver blood tests should be checked before increasing the dose and repeated periodically as described earlier. Liver blood tests may help detect if liver failure has occurred but they may do so only after significant damage, that may not go away, has already occurred.
- Patients must immediately report any unusual symptoms to their physician and be especially aware of persistent nausea, fatigue, lethargy, decreased appetite, jaundice (yellowing of skin or the whites of the eyes), dark urine, itchiness or right-sided abdominal pain.
The above points of information, possibly along with other information, have been explained to me and I have been able to ask my physician questions and discuss risks and benefits associated with TASMAR treatment.
Patient or Patient Caregiver Signature: _______________________________________________________
Date : _________________
NOTE TO PHYSICIAN: It is strongly recommended that you retain a signed copy of this form with the patient's medical records.
Supply Of Patient Acknowledgement Forms
A supply of Patient Acknowledgement forms is available, free of charge, from your local Valeant representative, or may be obtained at www.Tasmar.com or by calling 1-800-556-1937. Permission to use the above Patient Acknowledgement form by photocopy reproduction is also hereby granted by Valeant Pharmaceuticals North America.
Last reviewed on RxList: 5/24/2013
This monograph has been modified to include the generic and brand name in many instances.
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