Sublocade

Sublocade is a prescription medication used for the maintenance treatment of moderate to severe opioid addiction in adults.

Sublocade belongs to a group of drugs called opioid antagonists. These work by preventing withdrawal symptoms when someone stops taking opioid medications.

This medication is available in an injectable form to be given directly under the skin (subcutaneously) by a healthcare professional.

Common side effects of Sublocade include constipation, headache, and nausea.

Sublocade can also affect mental or physical abilities. Do not drive or operate heavy machinery until you know how Sublocade affects you.

Sublocade is a prescription medicine used to treat adults with moderate-to-severe addiction (dependence) to opioid drugs (prescription or illegal) who:

• have received treatment with an oral transmucosal (used under the tongue or inside the cheek) buprenorphine‐containing medicine for 7 days and 
• are taking a dose that controls withdrawal symptoms for at least seven days.
• Sublocade is part of a complete treatment plan that should include counseling. It is not known if Sublocade is safe or effective in children.
• Sublocade is a controlled substance (CIII) because it contains buprenorphine that can be a target for people who abuse prescription medicines or street drugs. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Sublocade. See the “Sublocade Precautions” section.

Common side effects of Sublocade include the following:

• constipation
• headache
• nausea
• itching or pain at the injection site
• vomiting
• liver injury
• tiredness

This is not a complete list of Sublocade side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St John's wort
• medications that could lead to serotonin syndrome such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), desvenlafaxine (Pristiq), nefazodone (Serzone), paroxetine (Paxil, Pexeva), sertraline (Zoloft), venlafaxine (Effexor), trimipramine (Surmontil), isocarboxazid (Marplan), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil), and linezolid (Zyvox)
• monoamine oxidase inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil). tranylcypromine (Parnate), selegiline (Emsam, Eldepryl, Zelapar), and rasagiline (Azilect)
• muscle relaxant medications including baclofen (Lioresal), carisoprodol (Somadril), cyclobenzaprine (Flexeril), methocarbamol (Robaxin), tizanidine (Zanaflex), gabapentin (Neurontin), andpregabalin (Lyrica)
• diuretics such as acetazolamide (Diamox), amiloride (Midamor), bumetanide (Bumex), chlorothiazide (Diuril), chlorthalidone (Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide, HCTZ), metolazone (Zaroxolyn), torsemide (Demadex), andtriamterene (Dyrenium, Dyazide, Maxzide)
• anticholinergics such as glycopyrrolate (Cuvposa, Robinul), trospium (Sanctura), oxybutynin (Anturol, Gelnique, Oxytrol, Ditropan), solifenacin (Vesicare), dicyclomine (Bentyl), propantheline (Pro-Banthine), and atropine (Atropen, Sal-Tropine)

This is not a complete list of Sublocade drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Sublocade including the following:

• respiratory problems. You have a higher risk of death and coma from respiratory problems if you take Suboxone with other medicines that cause respiratory problems, such as benzodiazepines including diazepam (Valium(, alprazolam (Xanax), clonazepam (Klonopin), lorazepam (Ativan), and zolpidem (Ambien).
• hypersensitivity (severe allergic reaction). Tell your healthcare provider about any signs or symptoms of hypersensitivity, which include the following chest pain, rash, difficulty breathing or swallowing, or swelling of the face or mouth
• dependency or abuse.
• opioid withdrawal. Symptoms of opioid withdrawal may include shaking, excessive sweating, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting, and muscle aches
• a decline in liver function. Tell your healthcare provider about any signs or symptoms of liver damage, including loss of appetite, weight loss, nausea, vomiting, feeling tired, stomach pain, dark urine, light-colored stools, fever, rash, and yellowing of the skin or the whites of the eyes.
• neonatal opioid withdrawal syndrome (NOWS). NOWS is a treatable outcome of the long-term use of opioids when used during pregnancy.
• adrenal insufficiency. Tell your healthcare provider if you have any symptoms of adrenal insufficiency, including nausea, vomiting, anorexia, fatigue, weakness, and dizziness.

Sublocade can affect mental or physical abilities. Do not drive or operate heavy machinery until you know how Sublocade affects you.

Do not take Sublocade if you are allergic to Sublocade or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Sublocade, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Sublocade, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Sublocade or to any of its ingredients
• have or have had adrenal problems such as Addison's disease
• have liver problems
• have heart problems
• have any lung problems or trouble breathing
• have any head or brain injury problems
• have a history of alcoholism
• drink large amounts of alcohol
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. There is a risk of neonatal opioid withdrawal syndrome (NOWS). NOWS is a treatable outcome of the long-term use of opioids when used during pregnancy. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Sublocade has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Sublocade, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered. Advise breastfeeding women who take Sublocade to monitor their baby for an increase in drowsiness and any difficulty with breathing.

Sublocade comes in an injectable form that is given once a month just under the skin (subcutaneously) by a healthcare professional.

If you miss a dose of Sublocade, talk to your healthcare provider immediately. If a Sublocade dose is missed, you could become sick and have withdrawal symptoms because your body has become used to the medicine. Physical dependence is not the same as drug addiction. Your doctor can tell you more about the differences between physical dependence and drug addiction. To have fewer withdrawal symptoms, ask your doctor how to stop using Suboxone the right way.

The recommended initial dose of Sublocade for the treatment of opioid addiction is 300 mg once a month for 2 months. After 2 months, the recommended maintenance dose of Sublocade for the maintenance treatment of opioid addiction is 100 mg once monthly. 

If Sublocade is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep all appointments with your doctor.
• Do not try to mess with or attempt to remove the drug that is deposited under the skin.

RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION

• Serious harm or death could result if administered intravenously.

SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY

• 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.