Nucynta ER (Page 9 of 10)

16 HOW SUPPLIED/STORAGE AND HANDLING

NUCYNTA ER tablets are available in the following strengths and packages:

50 mg extended-release tablets are white oblong-shaped with a black print “OMJ 50” on one side and are available in bottles of 60 with child-resistant closure

55700-796-60

100 mg extended-release tablets are light-blue oblong-shaped with a black print “OMJ 100” on one side and are available in bottles of 60 with child-resistant closure

55700-797-60

150 mg extended-release tablets are blue-green oblong-shaped with a black print “OMJ 150” on one side and are available in bottles of 60 with child-resistant closure

200 mg extended-release tablets are blue oblong-shaped with a depression in the middle running lengthwise on each side and with a black print “OMJ 200” on one side, and are available in bottles of 60 with child- resistant closure

250 mg extended-release tablets are dark blue oblong-shaped with a depression in the middle running lengthwise on each side and with a white print “OMJ 250” on one side, and are available in bottles of 60 with child-resistant closure

Storage and Handling

Store at 20°C — 25°C (68°F — 77°F); excursions permitted to 15° C — 30°C (59° F — 86°F) [see USP Controlled Room Temperature].
Protect from moisture.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Addiction, Abuse, and Misuse

Inform patients that the use of NUCYNTA ER, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose or death [see Warnings and Precautions (5.1)]. Instruct patients not to share NUCYNTA ER with others and to take steps to protect NUCYNTA ER from theft or misuse.

Life-threatening Respiratory Depression

Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting NUCYNTA ER or when the dosage is increased, and that it can occur even at recommended dosages [see Warnings and Precautions (5.3)]. Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.

Accidental Ingestion

Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see Warnings and Precautions (5.3)]. Instruct patients to take steps to store NUCYNTA ER securely and to dispose of unused NUCYNTA ER by flushing the tablets down the toilet.

Interactions with Benzodiazepines and other CNS Depressants

Inform patients and caregivers that potentially fatal additive effects may occur if NUCYNTA ER is used with benzodiazepines or other CNS depressants, including and not to use these concomitantly unless supervised by a health care provider [see Warnings and Precautions (5.5), Drug Interactions (7)].

Serotonin Syndrome

Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications [see Warnings and Precautions [5.7], Drug Interactions (7).

MAOI Interaction

Inform patients not to take NUCYNTA ER while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking NUCYNTA ER [see Warnings and Precautions (5.7)].

Adrenal Insufficiency

Inform patients that opioids could cause adrenal insufficiency, a potentially life- threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms [see Warnings and Precautions (5.8)].

Seizures

Inform patients that NUCYNTA ER could cause seizures if they are at risk for seizures or have epilepsy. Patients should be advised to stop taking NUCYNTA ER if they have a seizure while taking NUCYNTA ER and call their healthcare provider right away [see Warnings and Precautions (5.12)].

Important Administration Instructions

Instruct patients how to properly take NUCYNTA ER, including the following:

• Using NUCYNTA ER exactly as prescribed to reduce the risk of life-threatening adverse reactions (e.g., respiratory depression) [see Dosage and Administration (2)]
• Swallowing NUCYNTA ER tablets whole [see Dosage and Administration (2.1)]
• To take each tablet with enough water to ensure complete swallowing immediately after placing in mouth [see Dosage and Administration (2.1)]
• Not cutting, crushing, chewing, or dissolving the tablets [see Dosage and Administration (2.1)]
• Not discontinuing NUCYNTA ER without first discussing the need for a tapering regimen with the prescriber [see Dosage and Administration (2.5)]

Hypotension

Inform patients that NUCYNTA ER may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) [see Warnings and Precautions (5.9)].

Anaphylaxis

Inform patients that anaphylaxis has been reported with ingredients contained in NUCYNTA ER. Advise patients how to recognize such a reaction and when to seek medical attention [see Contraindications (4), Adverse Reactions (6.2)].

Pregnancy

Neonatal Opioid Withdrawal Syndrome

Inform female patients of reproductive potential that prolonged use of NUCYNTA ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)].

Embryo-Fetal Toxicity

Advise female patients that NUCYNTA ER can cause fetal harm and to inform the prescriber if they are pregnant or plan to become pregnant [see Use in Specific Populations (8.1)].

Lactation

Advise patients that breastfeeding is not recommended during treatment with NUCYNTA ER [see Use in Specific Populations (8.2)]

Infertility

Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible [see Use in Specific Populations (8.3)].

Driving or Operating Heavy Machinery

Inform patients that NUCYNTA ER may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication.

Constipation

Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention.

Disposal of Unused NUCYNTA ER

Advise patients to flush the unused tablets down the toilet when NUCYNTA ER is no longer needed.

Distributed by: Collegium Pharmaceutical, Inc., Stoughton, MA 02072

U.S. Patent Nos. 6071970, 7994364, 8075872, 8114383, 8309060, 8420056, 8536130, and RE39593.

NUCX-011-C.7

Revised: November 2018

Medication Guide NUCYNTA® ER (new-SINN-tah E-R) (tapentadol) extended-release oral tablets, CII
This Medication Guide has been approved by the U.S. Food and Drug Administration			NUCX-012-C.1 Revised: 12/2016
NUCYNTA ER is: A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them. Also used to manage pain from damaged nerves (neuropathic pain) that happens with diabetes and is severe enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them. A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death. Not used to treat pain that is not around-the-clock pain.
Important information about NUCYNTA ER: Get emergency help right away if you take too much NUCYNTA ER (overdose). When you first start taking NUCYNTA ER, when your dose is changed, or if you take too much (overdose), serious or life threatening breathing problems that can lead to death may occur. Taking NUCYNTA ER with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. Never give anyone your NUCYNTA ER. They could die from taking it. Store NUCYNTA ER away from children and in a safe place to prevent stealing or abuse. Selling or giving away NUCYNTA ER is against the law.
Do not take NUCYNTA ER if you have:
	severe asthma, trouble breathing, or other lung problems. a bowel blockage or have narrowing of the stomach or intestines.
Before taking NUCYNTA ER, tell your healthcare provider if you have a history of:
head injury, seizures problems urinating		liver, kidney, thyroid problems pancreas or gallbladder problems
abuse of street or prescription drugs, alcohol addiction, or mental health problems.
Tell your healthcare provider if you are: pregnant or planning to become pregnant. Prolonged use of NUCYNTA ER during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. breastfeeding. Not recommended during treatment with NUCYNTA ER. It may harm your baby. taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking NUCYNTA ER with certain other medicines can cause serious side effects.
When taking NUCYNTA ER: Do not change your dose. Take NUCYNTA ER exactly as prescribed by your healthcare provider. Use the lowest effective dose for the shortest time needed. Take your prescribed dose every 12 hours, at the same time every day. Do not take more than your prescribed dose in 24 hours. If you miss a dose, take your next dose at your usual time. Swallow NUCYNTA ER whole. Do not cut, break, chew, crush, dissolve, snort, or inject NUCYNTA ER because this may cause you to overdose and die. Call your healthcare provider if the dose you are taking does not control your pain. Do not stop taking NUCYNTA ER without talking to your healthcare provider. After you stop taking NUCYNTA ER, flush any unused tablets down the toilet.
While taking NUCYNTA ER DO NOT: Drive or operate heavy machinery until you know how NUCYNTA ER affects you. NUCYNTA ER can make you sleepy, dizzy, or lightheaded. Drink alcohol, or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with NUCYNTA ER may cause you to overdose and die.
The possible side effects of NUCYNTA ER are: constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help if you have: trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion. agitation, hallucinations, coma, feeling overheated, or heavy sweating. These are not all the possible side effects of NUCYNTA ER. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov Distributed by: Collegium Pharmaceutical, Inc., 100 Technology Center Drive Suite 300, Stoughton, MA, 02072, www.collegiumpharma.com or call 1-855-331-5615.