Buprenorphine (Sublocade).

Whats is Buprenorphine?

An extended-release medication, Sublocade is an injectable liquid that turns into a gel once it enters the body (called a depot). It is only available through a special distribution program called the Brixadi and Sublocade REMS.

Side Effects

Buprenorphine can cause a range of side effects, some common and others more serious. It’s important to be aware of these potential effects and to discuss any concerns with your doctor.

Common Side Effects:

• Constipation
• Headache
• Nausea and vomiting
• Dizziness
• Drowsiness and fatigue
• Sweating
• Dry mouth
• Tooth decay, dental cavities, and mouth pain
• Muscle aches and cramps
• Inability to sleep
• Fever
• Blurred vision or dilated pupils
• Tremors
• Palpitations
• Disturbance in attention
• Back pain
• Stomach pain
• Mouth numbness or redness
• Tongue pain
• Skin reactions (if using a buprenorphine patch)

Serious Side Effects:

• Respiratory distress: Slow or shallow breathing, shortness of breath. This can be life-
  threatening.
• Overdose: Symptoms include narrowing of the pupils, sleepiness or extreme drowsiness, slow or
  shallow breathing, difficulty breathing, and being unresponsive.
• Adrenal insufficiency: Nausea, vomiting, loss of appetite, weakness, or dizziness.
• Dependence and withdrawal: Buprenorphine can lead to physical and psychological dependence. Withdrawal symptoms can occur if the medication is stopped suddenly.
• Allergic reactions: Hives, rash, itching, difficulty breathing or swallowing, swelling of the face, throat, tongue, lips, or eyes.
• Liver problems: Symptoms include right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, and yellowing of the skin or eyes.
• Heart rhythm changes: Fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing.
• Low blood pressure: Dizziness, feeling faint or lightheaded, blurry vision.
• Neonatal abstinence syndrome: In newborns whose mothers took buprenorphine during pregnancy, symptoms can include irritability, seizures, uncontrollable shaking, vomiting, diarrhea, or failure to gain weight.
• Dental problems: Tooth decay, dental infections, tooth fracture, and tooth loss.
  Changes in mood or mental health: Agitation, hallucinations, confusion, depression.
• Seizures
• Decreased fertility in men and women.

Important Considerations:

The likelihood of experiencing side effects can depend on factors such as dosage, individual health conditions, and whether buprenorphine is taken with other medications or substances like alcohol. It’s crucial to take buprenorphine exactly as prescribed by your doctor. Do not stop taking buprenorphine suddenly without consulting your doctor, as this can lead to withdrawal symptoms. Inform your doctor about any other medications you are taking, including over-the-counter drugs and supplements, as they may interact with buprenorphine. Be aware that buprenorphine can cause drowsiness and dizziness, so avoid activities that require alertness, such as driving or operating heavy machinery, until you know how the medication affects you. Regular dental checkups are important while taking buprenorphine due to the risk of dental problems.

If you experience any serious side effects, seek immediate medical attention.

This is not an exhaustive list of all possible side effects. If you have any concerns or experience any unusual symptoms while taking buprenorphine, contact your doctor right away.

Black Box Warning

Sublocade does come with a black box warning. The downloadable prescription information sheet reads as follows:

WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY
See full prescribing information for complete boxed warning.

• Serious harm or death could result if administered intravenously. (5.1)
• SUBLOCADE is only available through a restricted program called the SUBLOCADE REMS Program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with the REMS requirements. (5.2)

FDA Approval

Buprenorphine was approved by the FDA for use back in 2017 as a medication-assisted treatment for opioid use disorder. The recommended use should be combined with counseling and other behavioral therapies.

Alternatives to Sublocade

Sublocade is one of 3 common medications used to treat opioid dependence. Alternatives include Methadone and Suboxone.

Off-label Use

There are only a few off-label uses of buprenorphine which include perineural anesthesia and withdrawal management in hospitalized patients dependent on heroin. However, there are also studies that are currently in progress that indicate buprenorphine may be beneficial for treating other additions such as cocaine use.

FDA Fact Sheet

Click here to download the full fact sheet.

Questions to Ask Your Doctor About Sublocade

Before starting a medication, it is important to understand the benefits, risks, and what to expect from your medication. Here are some questions you might ask your doctor:

• What are the side effects of this medication?
• Are there any alternatives I am a good candidate for this medication?
• How long do you anticipate I will need this medication?
• What can I do to increase my success with this medication?
• Will this help with pain management?