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.

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.

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.

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 Cassipa, there are no specific foods that you must exclude from your diet when receiving this medication.

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

• Have liver or kidney problems
• Have trouble breathing or lung problems
• Have an enlarged prostate gland (men)
• Have a head injury or brain problem
• Have problems urinating
• Have a curve in your spine that affects your breathing
• Have gallbladder problems
• Have adrenal gland problems
• Have Addison’s disease
• Have low thyroid (hypothyroidism)
• Have a history of alcoholism
• Have mental problems such as hallucinations (seeing or hearing things that are not there)
• Have any other medical condition
• 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.

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.

• Always take Cassipa sublingual film exactly as your doctor tells you.
• Do not take Cassipa sublingual film more often than prescribed by your doctor.
• Take Cassipa sublingual film 1 time a day.
• When taking a dose of Cassipa sublingual film, it should only be placed under the tongue (sublingual administration).
• Cassipa sublingual film must be taken whole. Do not cut, chew, or swallow Cassipa sublingual film.
• Your doctor should show you how to take Cassipa sublingual film the right way.
• Each Cassipa sublingual film comes in a sealed child‐resistant foil pouch. Do not open the foil pouch until you are ready to use it.

Taking Cassipa sublingual film: 

• To open your Cassipa sublingual film foil pouch, fold along the dotted line.

• Tear down at slit or cut with scissors along the arrow.

• Before taking Cassipa sublingual film, rinse your mouth with a small amount of room temperature water. This helps the film dissolve more easily.

• Hold the film between two fingers by the outside edges.

• Place the Cassipa sublingual film under your tongue, close to the base; either to the left or right of the center.

• Keep the film in place until it has completely dissolved. Cassipa sublingual film should not be moved after placement.

• While Cassipa sublingual film is dissolving, do not chew or swallow the film because the medicine will not work as well.

• Talking while the film is dissolving can affect how well the medicine in Cassipa sublingual film is absorbed.

• Do not eat or drink until Cassipa sublingual film is completely dissolved.

• If you miss a dose of Cassipa sublingual film, take your medicine when you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses at the same time. If you are not sure about your dosing, call your doctor.

• Do not stop taking Cassipa sublingual film suddenly. 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 Cassipa sublingual film the right way.

• If you take too much Cassipa sublingual film or overdose, call Poison Control or get emergency medical help right away.

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.

If you take too much Cassipa, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store Cassipa sublingual film at room temperature between 68°F to 77°F (20°C to 25°C).

Keep Cassipa sublingual film in a safe place, out of the sight and reach of children.

How should I dispose of unused Cassipa sublingual film?

• Dispose of unused Cassipa sublingual film as soon as you no longer need them.

• Unused films should be removed from the foil pouch and flushed down the toilet.

• Do not flush the Cassipa sublingual film foil pouch down the toilet. If you need help with disposal of Cassipa sublingual film, call 1-888-838-2872.

This page was written by Emily Interrante, PharmD Candidate 2020 | UT Austin College of Pharmacy