Cassipa

Cassipa is a prescription medication used for the maintenance treatment of opioid dependence. 

Cassipa is a single product containing 2 medications: buprenorphine and naloxone. Buprenorphine belongs to a group of drugs called partial opioid agonists. Like opioids, these have a pain relief and euphoric effect. Naloxone belongs to a group of drugs called opioid antagonists. These work to reverse the effect of opioids. Naloxone is included to prevent abuse of this medication.

This medication comes as a sublingual film (applied under the tongue) and is taken once a day, with or without food. Do not cut, chew, or swallow Cassipa film. 

Common side effects include nausea, vomiting, headache, signs and symptoms of opioid withdrawal, and constipation. Cassipa can cause dizziness and intoxication. Do not drive or operate heavy machinery until you know how Cassipa affects you.

Cassipa sublingual film is a prescription medicine used for maintenance treatment in adults who are addicted to (dependent on) opioid drugs (either prescription or illegal) as part of a complete treatment program that also includes counseling and behavioral therapy.

• Cassipa sublingual film is a controlled substance (CIII) because it contains buprenorphine, which can be a target for people who abuse prescription medicines or street drugs. Keep your Cassipa sublingual film in a safe place to protect it from theft. Never give your Cassipa sublingual film to anyone else; it can cause death or harm them. Selling or giving away this medicine is against the law.

• It is not known if Cassipa sublingual film is safe or effective in children.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Cassipa, for maintenance treatment of opioid dependence, contains 16 mg of buprenorphine and 4 mg of naloxone and is taken once daily. It should only be used after your dose has been increased to 16 mg of buprenorphine using another marketed product.

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

• Cassipa sublingual film can cause serious and life‐threatening breathing problems. Call your doctor right away or get emergency help if:
  • You feel faint, dizzy, or confused
  • Your breathing gets much slower than is normal for you

These can be signs of an overdose or other serious problems.

• Do not switch from Cassipa sublingual film to other medicines that contain buprenorphine without talking with your doctor. The amount of buprenorphine in a dose of Cassipa sublingual film is not the same as the amount of buprenorphine in other medicines that contain buprenorphine. Your doctor will prescribe a starting dose of Cassipa sublingual film that may be different than other buprenorphine containing medicines you may have been taking.

• Cassipa sublingual film contains an opioid that can cause physical dependence.

  • Do not stop taking Cassipa sublingual film without talking to your doctor. You could become sick with uncomfortable withdrawal signs and symptoms because your body has become used to this medicine.
  • Physical dependence is not the same as drug addiction.
  • Cassipa sublingual film is not for occasional or “as needed” use.

• An overdose and even death can happen if you take benzodiazepines, sedatives, tranquilizers, antidepressants, or alcohol while using Cassipa sublingual film. Ask your doctor what you should do if you are taking one of these.

• Call a doctor or get emergency help right away if you:

  • Feel sleepy and uncoordinatedo 
  • Have blurred vision
  • Have slurred speech 
  • Cannot think well or clearly
  • Have slowed reflexes and breathing
• Do not inject (“shoot‐up”) Cassipa sublingual film.
  • Injecting Cassipa sublingual film may cause life‐threatening infections and other serious health problems.o Injecting Cassipa sublingual film may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.
• In an emergency, have family members tell emergency department staff that you are physically dependent on an opioid and are being treated with Cassipa sublingual film.

Do not take Cassipa if you are allergic to buprenorphine or naloxone.

Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medication affects you. Cassipa can cause drowsiness and slow reaction times. This may happen more often in the first few weeks of treatment when your dose is being changed but can also happen if you drink alcohol or take other sedative drugs when you take Cassipa sublingual film.

You should not drink alcohol while using Cassipa sublingual film, as this can lead to loss of consciousness or even death.

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

Common side effects of Cassipa include:

• Nausea
• Vomiting
• Drug withdrawal syndrome
• Headache
• Sweating
• Numb mouth
• Constipation
• Swollen and/or painful tongue
• The inside of your mouth is more red than normal
• Intoxication (feeling lightheaded or drunk)
• Disturbance in attention
• Irregular heart beat (palpitations)
• Decrease in sleep (insomnia)
• Blurred vision
• Back pain
• Fainting
• Dizziness
• Sleepiness

This is not a complete list of Cassipa side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effect that bothers you or that does 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.

Be especially careful about taking other medicines that may make you sleepy, such as pain medicines, tranquilizers, antidepressant medicines, sleeping pills, anxiety medicines or antihistamines.

Know the medicines you take. Keep a list of them to show your doctor or pharmacist each time you get a new medicine.

Especially tell your doctor if you take:

• Other opioids (e.g., hydrocodone and codeine)
• Medications that use the enzyme CYP3A4 such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir), rifampin, carbamazepine, and phenytoin
• Selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, tricyclic antidepressants, drugs that affect the serotonin neurotransmitter system
• Monoamine Oxidase Inhibitors such as phenelzine, tranylcypromine, and linezolid
• Efavirenz
• Ritonavir
• Alcohol

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

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

If you take CASSIPA sublingual film while pregnant, your baby may have signs of opioid withdrawal at birth. Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy. Talk to your doctor if you are pregnant or plan to become pregnant.

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

Buprenorphine, can pass into your milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you take CASSIPA sublingual film. Monitor your baby for increased sleepiness and breathing problems.