Physicians are advised to discuss the following issues with patients for whom they prescribe FANAPT:
Patients should be advised to consult their physician immediately if they feel faint, lose consciousness or have heart palpitations. Patients should be counseled not to take FANAPT with other drugs that cause QT interval prolongation [see Warnings and Precautions (5.2)]. Patients should be told to inform physicians that they are taking FANAPT before any new drug is taken.
Patients and caregivers should be counseled that a potentially fatal symptom complex sometimes referred to as NMS has been reported in association with administration of antipsychotic drugs, including FANAPT. Signs and symptoms of NMS include hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia) [see Warnings and Precautions (5.3)].
Patients should be aware of the symptoms of hyperglycemia (high blood sugar) and diabetes mellitus. Patients who are diagnosed with diabetes, those with risk factors for diabetes, or those who develop these symptoms during treatment should have their blood glucose monitored at the beginning of and periodically during treatment. Patients should be counseled that weight gain has occurred during treatment with FANAPT. Clinical monitoring of weight is recommended. [see Warnings and Precautions (5.5)].
Patients should be advised of the risk of orthostatic hypotension, particularly at the time of initiating treatment, re-initiating treatment, or increasing the dose [see Warnings and Precautions (5.7)].
Because FANAPT may have the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that FANAPT therapy does not affect them adversely [see Warnings and Precautions (5.14)].
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy with FANAPT [see Use in Specific Populations (8.1)].
Patients should be advised not to breastfeed an infant if they are taking FANAPT [see Use in Specific Populations (8.3)].
Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions [see Drug Interactions (7)].
Patients should be advised to avoid alcohol while taking FANAPT.
Patients should be advised regarding appropriate care in avoiding overheating and dehydration.
Vanda Pharmaceuticals Inc.
Washington, D.C. 20037 USA
Vanda and Fanapt® are registered trademarks of Vanda Pharmaceuticals Inc. in the United States and other countries.
| FANAPT |
|Labeler — Avera McKennan Hospital (068647668)|
|Avera McKennan Hospital||068647668||relabel (69189-0665), repack (69189-0665)|
Revised: 03/2017 Avera McKennan Hospital
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