Fanapt (Page 7 of 7)

17 PATIENT COUNSELING INFORMATION

Physicians are advised to discuss the following issues with patients for whom they prescribe FANAPT:

17.1 QT Interval Prolongation

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.

17.2 Neuroleptic Malignant Syndrome

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)].

17.3 Metabolic Changes

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)].

17.4 Orthostatic Hypotension

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)].

17.5 Interference with Cognitive and Motor Performance

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)].

17.6 Pregnancy

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)].

17.7 Nursing

Patients should be advised not to breastfeed an infant if they are taking FANAPT [see Use in Specific Populations (8.3)].

17.8 Concomitant Medication

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)].

17.9 Alcohol

Patients should be advised to avoid alcohol while taking FANAPT.

17.10 Heat Exposure and Dehydration

Patients should be advised regarding appropriate care in avoiding overheating and dehydration.

Distributed by:

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.

January 2016

PRINCIPAL DISPLAY PANEL

Iloperidone 4 mg tablet
(click image for full-size original)

FANAPT
iloperidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69189-0665(NDC:43068-104)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ILOPERIDONE (ILOPERIDONE) ILOPERIDONE 4 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
CROSPOVIDONE
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score no score
Shape ROUND (flat, beveled-edge) Size 7mm
Flavor Imprint Code 4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69189-0665-1 1 TABLET in 1 DOSE PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022192 07/01/2016
Labeler — Avera McKennan Hospital (068647668)
Establishment
Name Address ID/FEI Operations
Avera McKennan Hospital 068647668 relabel (69189-0665), repack (69189-0665)

Revised: 03/2017 Avera McKennan Hospital

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