SAPHRIS (Page 9 of 10)

16 HOW SUPPLIED/STORAGE AND HANDLING

SAPHRIS (asenapine) sublingual tablets are supplied as:

2.5 mg Tablets, black cherry flavor

Round, white to off-white sublingual tablets, with a hexagon on one side.

Child-resistant packaging

Box of 60 6 blisters with 10 tablets NDC 0456-2402-60

Hospital Unit Dose

Box of 100 10 blisters with 10 tablets NDC 0456-2402-63

5 mg Tablets, black cherry flavor

Round, white to off-white sublingual tablets, with “5” on one side within a circle.

Child-resistant packaging

Box of 60 6 blisters with 10 tablets NDC 0456-2405-60

Hospital Unit Dose

Box of 100 10 blisters with 10 tablets NDC 0456-2405-63

10 mg Tablets, black cherry flavor

Round, white to off-white sublingual tablets, with “10” on one side within a circle.

Child-resistant packaging

Box of 60 6 blisters with 10 tablets NDC 0456-2410-60

Hospital Unit Dose

Box of 100 10 blisters with 10 tablets NDC 0456-2410-63

Storage

Store at 20 º C to 25 º C (68 º F to 77 º F) ; excursions permitted between 15 º C and 30 º C (59 º F and 86 º F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling ( Instructions for Use ).

Dosage and Administration

Counsel patients on proper sublingual administration of SAPHRIS and advise them to read the FDA-approved patient labeling (Instructions for Use). When initiating treatment with SAPHRIS, provide dosage escalation instructions [see Dosage and Administration ( 2)].

Hypersensitivity Reactions

Counsel patients on the signs and symptoms of a serious allergic reaction (e.g., difficulty breathing, itching, swelling of the face, tongue or throat, feeling lightheaded etc.) and to seek immediate emergency assistance if they develop any of these signs and symptoms [see Contraindications ( 4), Warnings and Precautions ( 5.6) and Adverse Reactions ( 6)].

Application Site Reactions

Inform patients that application site reactions, primarily in the sublingual area, including oral ulcers, blisters, peeling/sloughing and inflammation have been reported. Instruct patients to monitor for these reactions [see Adverse Reactions ( 6.2)] . Inform patients that numbness or tingling of the mouth or throat may occur directly after administration of SAPHRIS and usually resolves within 1 hour [ see Adverse R eactions ( 6.1) ].

Neuroleptic Malignant Syndrome

Counsel patients about a potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) that has been reported in association with administration of antipsychotic drugs. Patients should contact their health care provider or report to the emergency room if they experience the following signs and symptoms of NMS, including 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)].

Tardive Dyskinesia

Counsel patients on the signs and symptoms of tardive dyskinesia and to contact their health care provider if these abnormal movements occur [ see Warnings and Precautions ( 5.4) ] .

Metabolic Changes ( Hyperglycemia and Diabetes Mellitus , Dyslipidemia, and Weight Gain)

Educate patients about the risk of metabolic changes, how to recognize symptoms of hyperglycemia (high blood sugar) and diabetes mellitus, and the need for specific monitoring, including blood glucose, lipids, and weight [see Warnings and Precautions ( 5.5)].

Orthostatic Hypotension

Educate patients about the risk of orthostatic hypotension (symptoms include feeling dizzy or lightheaded upon standing) especially early in treatment, and also at times of re-initiating treatment or increases in dose [ see Warnings and Precautions ( 5.7) ].

Leukopenia/Neutropenia

Advise patients with a pre-existing low WBC or a history of drug induced leukopenia/neutropenia they should have their CBC monitored while taking SAPHRIS [s ee Warnings and Precautions ( 5.9)].

H yperprolactinemia

Counsel patients on the signs and symptoms of hyperprolactinemia and to contact their health care provider if these abnormalities occur [ see Warnings and Precautions ( 5.11) ] .

Interference with Cognitive and Motor Performance

Caution patients about performing activities requiring mental alertness, such as operating hazardous machinery or operating a motor vehicle, until they are reasonably certain that SAPHRIS therapy does not affect them adversely [see Warnings and Precautions ( 5.13)].

Heat Exposure and Dehydration

Counsel patients regarding appropriate care in avoiding overheating and dehydration [see Warnings and Precautions ( 5.14)].

Concomitant Medication s

Advise patients to inform their health care provider if they are taking, or plan to take, any prescription or over-the-counter medications since there is a potential for interactions [see Drug Interactions ( 7.1)].

Pregnancy

Advise patients that SAPHRIS may cause fetal harm as well as extrapyramidal and/or withdrawal symptoms in a neonate. Advise patients to notify their healthcare provider with a known or suspected pregnancy [see Use in Specific Populations ( 8.1)].

Pregnancy Registry

Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to SAPHRIS during pregnancy [see Use in Specific Populations ( 8.1)].

Distributed by:
Allergan USA, Inc.,
Madison, NJ 07940

© 2021 N. V. Organon; used by AbbVie under license.
© 2021 AbbVie. All rights reserved.

The trademarks SAPHRIS, SAPHRIS & Star Design, and Star Design are used by AbbVie under license from N. V. Organon.

v1.0USPI2402

INSTRUCTIONS FOR USE

SAPHRIS® (asenapine)

sublingual tablets

Read these Instructions for Use before you start using SAPHRIS and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or your treatment.

IMPORTANT:

  • For sublingu al (under your tongue) use only
  • Do not remove tablet until ready to administer.
  • Use dry hands when handling tablet.

Your SAPHRIS tablets

Tablet Pack

Directions for Taking your SAPHRIS Tablet s :

Step 1. Firmly press and hold thumb button, then pull out the tablet pack (see Figure A). Do not push tablet through the tablet pack. Do not cut or tear the tablet pack.

case

Figure A

Step 2. Peel back the colored tab (see Figure B).

Figure b

Figure B

Step 3. Gently remove the tablet (see Figure C). Do not split, cut or crush the tablet.

Figure c

Figure C

Step 4. Place the whole tablet under tongue and allow it to dissolve completely (see Figure D).

Figure d

Figure D

Do not chew or swallow the tablet.

Do not eat or drink for 10 minutes (See Figure E).

Figure e

Figure E

Step 5. Slide the tablet pack back into case until it clicks (see Figure F).

Figure f

Figure F

Stor ing SAPHRIS tablets :

Store SAPHRIS tablets at room temperature between 68°F to 77°F (20°C to 25°C).

These Instructions for Use have been approved by the U.S. Food and Drug Administration.

Distributed by:
Allergan USA, Inc.,
Madison, NJ 07940

© 2021 N. V. Organon; used by AbbVie under license.
© 2021 AbbVie. All rights reserved.

The trademarks SAPHRIS, SAPHRIS & Star Design, and Star Design are used by AbbVie under license from N. V. Organon.

Revised: October 2021

v1.0IFU2402

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