What is the recommended dosing for Nucynta (tapentadol) in a patient with Chronic Kidney Disease (CKD) stage 3, characterized by Impaired Renal Function?

From the Guidelines

For patients with CKD stage 3, Nucynta (tapentadol) dosing should start at the lower end of the recommended range and be titrated slowly, with a maximum daily dose of 500 mg for ER formulations or 600 mg for IR formulations, as tapentadol is primarily metabolized by the liver and has minimal renal elimination 1.

Key Considerations

• Nucynta (tapentadol) is an opioid that binds to the mu-opioid receptor and inhibits norepinephrine reuptake, available as ER and IR formulations for treatment of moderate to severe pain and neuropathic pain.
• Typical doses start at 50 to 100 mg orally every 4 hours as needed, with a maximal daily dose of 500 mg per day for ER formulations or 600 mg per day for IR formulations due to lack of published data regarding higher doses 1.
• Lower doses are recommended for patients with moderate hepatic impairment, and tapentadol should be avoided in patients with severe hepatic or renal impairment.
• Since tapentadol is primarily metabolized by the liver through glucuronidation, with minimal renal elimination of unchanged drug (less than 5%), it is a safer option compared to opioids that rely heavily on renal excretion.

Dosing Recommendations

• For Nucynta immediate-release, the standard dosing is 50-100 mg every 4-6 hours as needed for pain, with a maximum daily dose of 600 mg.
• For Nucynta ER (extended-release), the typical starting dose is 50-100 mg twice daily, with a maximum daily dose of 500 mg.
• It is essential to start at the lower end of the dosing range and titrate slowly while monitoring for side effects such as nausea, dizziness, constipation, and respiratory depression, especially in patients with CKD stage 3.

Monitoring and Precautions

• Patients with CKD stage 3 should be closely monitored for signs of opioid toxicity, such as respiratory depression, and for other side effects like nausea, dizziness, and constipation.
• Tapentadol should be used with caution or avoided in patients taking other serotonergic or monoamine oxidase inhibitors (MAOI)-like medications due to the risk of serotonin syndrome 1.

From the FDA Drug Label

Use of NUCYNTA tablets in patients with severe renal impairment (creatinine clearance less than 30 mL/minute) is not recommended. No dosage adjustment is recommended in patients with mild or moderate renal impairment (creatinine clearance 30-90 mL/minute) [see Warnings and Precautions (5.17), Clinical Pharmacology (12.3)].

The recommended dosing for Nucynta (tapentadol) in a patient with Chronic Kidney Disease (CKD) stage 3 is to use the standard dosing, as no dosage adjustment is recommended in patients with mild or moderate renal impairment (creatinine clearance 30-90 mL/minute) 2.

• Initiate treatment with NUCYNTA tablets at a dose of 50 mg, 75 mg, or 100 mg every 4 to 6 hours depending upon pain intensity.
• Subsequent dosing is 50 mg, 75 mg, or 100 mg every 4 to 6 hours and should be adjusted to maintain adequate analgesia with acceptable tolerability.
• Daily doses greater than 700 mg on the first day of therapy and 600 mg on subsequent days have not been studied and are, therefore, not recommended.
• Monitor closely for signs of central nervous system and respiratory depression.

From the Research

Dosing Recommendations for Nucynta (Tapentadol) in CKD Stage 3

• The recommended dosing for Nucynta (tapentadol) in patients with Chronic Kidney Disease (CKD) stage 3 is not explicitly stated in the provided studies 3, 4, 5, 6, 7.
• However, it is known that tapentadol has no active metabolites, which makes it useful in patients with hepatic and renal failure 4.
• The studies provided do not offer specific guidance on dosing adjustments for tapentadol in patients with CKD stage 3, but they do highlight the importance of careful consideration of renal function when prescribing medications that are renally eliminated 7.
• In general, it is recommended to exercise caution when using tapentadol in patients with impaired renal function, and to monitor for signs of toxicity or adverse effects 4, 5.
• The dosing regimens for tapentadol in patients with normal renal function are well established, with recommended doses ranging from 50-100 mg every 4-6 hours for immediate-release formulations 5.
• However, in patients with CKD stage 3, the dosing regimen may need to be adjusted to account for decreased renal function, although the exact adjustments are not specified in the provided studies.