TARGINIQ ER (Page 2 of 11)

2.3 Titration and Maintenance of Therapy

Individually titrate TARGINIQ ER to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving TARGINIQ ER to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, and misuse [see Warnings and Precautions (5.1)]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy, periodically reassess the continued need for the use of opioid analgesics.

Patients who experience breakthrough pain may require a dosage adjustment of TARGINIQ ER or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the TARGINIQ ER dose.

As a guideline, the dose of TARGINIQ ER can be up-titrated from the current dose by increasing the dose 10 mg/5 mg q12h every 1 to 2 days as needed based on efficacy, safety, and tolerability. The total daily dose of TARGINIQ ER should not exceed 80 mg/40 mg (40 mg/20 mg q12h).

The highest total daily dose of TARGINIQ ER studied in the main clinical program is 80 mg/40 mg (40 mg/20 mg twice daily). Total daily doses above 80 mg/40 mg have not been studied sufficiently to ensure patient safety and may be associated with symptoms of opioid withdrawal or decreased analgesia.

If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

There are no well-controlled clinical studies evaluating the safety and efficacy with dosing more frequently than every 12 hours.

2.4 Dosage Modifications with Concomitant Use of Central Nervous System Depressants

If the patient is currently taking a central nervous system (CNS) depressant and the decision is made to begin TARGINIQ ER, start with one-third to one-half the recommended starting dosage of TARGINIQ ER, consider using a lower dosage of the concomitant CNS depressant, and monitor patients for signs of respiratory depression, sedation, and hypotension [see Warnings and Precautions (5.4), Drug Interactions (7)].

2.5 Dosage Modifications in Patients with Mild Hepatic Impairment

TARGINIQ ER is contraindicated in patients with moderate and severe hepatic impairment. When administering TARGINIQ ER to patients with mild hepatic impairment, reduce the dose to one-third to one-half the usual starting dose followed by careful dose titration. Monitor for signs of respiratory depression, sedation, and hypotension [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

2.6 Dosage Modifications in Patients with Renal Impairment

When administering TARGINIQ ER to patients with renal impairment, reduce the initial dose to one-half the usual starting dose followed by careful dose titration. Monitor for signs of respiratory depression, sedation, and hypotension [see Use in Specific Populations (8.8), Clinical Pharmacology (12.3)].

2.7 Discontinuation of TARGINIQ ER

When the patient no longer requires therapy with TARGINIQ ER, taper the dose gradually by 25% to 50 % every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue TARGINIQ ER [see Warnings and Precautions (5.12), Drug Abuse and Dependence (9.3)].

Table 3 presents a suggested taper schedule that was used in a clinical trial to discontinue patients from TARGINIQ ER:

Table 3. Suggested Taper Schedule
* 30 mg/15 mg dose was achieved by administering a 20 mg/10 mg + a 10 mg/5 mg tablet
Patient’s Dose of TARGINIQ ER Taper Dose (mg/mg)
Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Day 8 Day 9 Day 10
10 mg/5 mg q12h AM 10/5 10/5
PM
20 mg/10 mg q12h AM 20/10 20/10 10/5 10/5 10/5 10/5
PM 10/5 10/5 10/5 10/5
30 mg/15 mg q12h* AM 20/10 20/10 20/10 20/10 10/5 10/5 10/5 10/5
PM 20/10 20/10 10/5 10/5 10/5 10/5
40 mg/20 mg q12h AM 30/15 30/15 20/10 20/10 20/10 20/10 10/5 10/5 10/5 10/5
PM 30/15 30/15 20/10 20/10 10/5 10/5 10/5 10/5

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