Is Sublocade (buprenorphine) safe for patients with liver cirrhosis?

From the Guidelines

Sublocade should be used with extreme caution in patients with liver cirrhosis, and alternative treatments may be safer due to the potential for increased risk of adverse effects 1. When considering the use of Sublocade in patients with liver cirrhosis, it is essential to understand the liver's role in metabolizing opioids and the potential for increased side effects in patients with liver dysfunction.

• The liver is responsible for the metabolism of opioids, and liver dysfunction can lead to increased side effects, including hepatic encephalopathy 1.
• Opioids such as morphine, oxycodone, and hydromorphone have different metabolic characteristics, and their use in patients with liver cirrhosis requires careful consideration of their pharmacokinetics 1.
• Fentanyl, which is metabolized by cytochromes and does not produce toxic metabolites, may be a safer option for pain management in patients with liver cirrhosis 1.
• The EASL recommends the use of paracetamol, morphine, and hydromorphone for pain control, while NSAIDs, tramadol, codeine, and oxycodone should be avoided in patients with end-stage liver disease 1.
• For patients with moderate to severe hepatic impairment, a lower dose of Sublocade may be necessary, and close monitoring for signs of opioid toxicity is essential 1.
• Before initiating Sublocade, liver function tests should be obtained, and regular monitoring should continue throughout treatment 1.
• Consultation with both addiction medicine and hepatology specialists is strongly recommended to develop an individualized treatment plan for patients with liver cirrhosis 1.

From the FDA Drug Label

Buprenorphine hydrochloride should be administered with caution in the elderly, debilitated patients, in children and those with severe impairment of hepatic, pulmonary, or renal function; Because buprenorphine is metabolized by the liver, the activity of buprenorphine may be increased and/or extended in those individuals with impaired hepatic function or those receiving other agents known to decrease hepatic clearance

Sublocade (buprenorphine) administration in patients with liver cirrhosis requires caution.

• The drug label warns that buprenorphine should be administered with caution in patients with severe impairment of hepatic function.
• Impaired hepatic function may increase and/or extend the activity of buprenorphine.
• Therefore, caution is advised when administering Sublocade to patients with liver cirrhosis 2.

From the Research

Sublocade for Patients with Liver Cirrhosis

There are no direct research papers on the use of Sublocade for patients with liver cirrhosis. However, we can look at the available evidence on opioid therapy and liver cirrhosis:

• Opioid therapy in patients with liver cirrhosis requires careful consideration of the pharmacokinetic properties of the applied drugs, as liver cirrhosis can affect the metabolism and clearance of these drugs 3.
• The bioavailability of drugs with a high first-pass effect, such as buprenorphine, can increase in patients with liver cirrhosis, while the clearance of these drugs can decrease 3.
• Studies on the effect of liver cirrhosis on the systemic availability of naltrexone, an opioid antagonist, have shown that liver cirrhosis can alter the pharmacokinetics of this drug, leading to increased serum levels of naltrexone and its active metabolite, 6 beta-naltrexol 4.
• Exercise and physical activity have been shown to be beneficial for patients with liver cirrhosis, improving muscle mass, cardiopulmonary function, and nutritional status, but the safety and efficacy of exercise in patients with decompensated cirrhosis are not well established 5, 6.
• The management of cirrhosis typically involves a multifaceted approach, including directed counseling, laboratory testing, and ultrasound monitoring, with treatment goals focused on preventing cirrhosis, decompensation, and death 7.

Key Considerations

• Patients with liver cirrhosis may require adjusted doses of opioid medications due to altered pharmacokinetics 3.
• The use of Sublocade, a buprenorphine-based medication, in patients with liver cirrhosis may require careful monitoring and dose adjustment due to the potential for increased bioavailability and decreased clearance 3.
• Further research is needed to fully understand the safety and efficacy of Sublocade in patients with liver cirrhosis.