Onsolis

Serious side effects have been reported oral, topical, inhalational, and injectable forms of fentanyl. See the “Fentanyl Precautions” section.

Common side effects of fentanyl include the following:

• Drowsiness
• Nausea
• Stomach pain
• Vomiting
• Constipation
• Gas
• Heartburn
• Loss of appetite
• Weight loss
• Difficulty urinating
• Weakness
• Headache
• Vision changes
• Anxiety
• Depression
• Hallucinations
• Changes in thinking or dreams
• Dry mouth
• Difficulty sleeping
• Sweating
• Reddening of the face, neck, or chest
• Swelling of the extremities
• Hives, rash, and itching

Irritation at the site of application may also occur after administration of oral, topical, and inhalational forms of fentanyl.

This is not a complete list of fentanyl 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.

Grapefruit and grapefruit juice may interact with fentanyl and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

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

If fentanyl 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.

Onsolis is a buccal soluble film with a white side and a pink side. The pink side contains a bioadhesive polymer and the active ingredient. Each strength is marked on the white side of the film with an identifying number. Onsolis is available in 200 mcg, 400 mcg, 600 mcg, 800 mcg, and 1200 mcg strengths [see How Supplied (16.3) and Storage and Handling (16.1)].

Fentanyl is metabolized mainly via the human CYP3A4 isoenzyme system; therefore potential interactions may occur when Onsolis is given concurrently with agents that affect CYP3A4 activity.

The concomitant use of Onsolis with CYP3A4 inhibitors (e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, telithromycin, aprepitant, diltiazem, erythromycin, fluconazole, grapefruit juice, verapamil, or cimetidine) may result in a potentially dangerous increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. Patients receiving Onsolis who begin therapy with, or increase the dose of, CYP3A4 inhibitors should be carefully monitored for signs of opioid toxicity over an extended period of time. Dosage increase should be done conservatively [see Warnings and Precautions (5.4)].

The concomitant use of Onsolis with CYP3A4 inducers (e.g., barbiturates, carbamazepine, efavirenz, glucocorticoids, modafinil, nevirapine, oxcarbazepine, phenobarbital, phenytoin, pioglitazone, rifabutin, rifampin, St. John's wort, or troglitazone) may result in a decrease in fentanyl plasma concentrations, which could decrease the efficacy of Onsolis. Patients receiving Onsolis who stop therapy with, or decrease the dose of, CYP3A4 inducers should be monitored for signs of increased Onsolis activity and the dose of Onsolis should be adjusted accordingly.

Clinical Presentation

The manifestations of Onsolis overdosage are expected to be similar in nature to intravenous fentanyl and other opioids, and are an extension of its pharmacological actions with the most serious significant effect being hypoventilation [see Clinical Pharmacology – Pharmacodynamics (12.2)].

Immediate Management

Immediate management of opioid overdose includes removal of the Onsolis film, if still in the mouth, ensuring a patent airway, physical and verbal stimulation of the patient, and assessment of level of consciousness, ventilatory and circulatory status.

Treatment of Overdosage (Accidental Ingestion) in the Opioid NON-Tolerant Person

Provide ventilatory support, obtain intravenous access, and employ naloxone or other opioid antagonists as clinically indicated. The duration of respiratory depression following overdose may be longer than the effects of the opioid antagonist’s action (e.g., the half-life of naloxone ranges from 30 to 81 minutes) and repeated administration may be necessary. Consult the package insert of the individual opioid antagonist for details about such use.

Treatment of Overdose in Opioid Tolerant Patients

Provide ventilatory support and obtain intravenous access as clinically indicated. Judicious use of naloxone or another opioid antagonist may be warranted in some instances, but it is associated with the risk of precipitating an acute withdrawal syndrome.

General Considerations for Overdose

Management of severe Onsolis overdose includes: securing a patent airway, assisting or controlling ventilation, establishing intravenous access, and GI decontamination by lavage and/or activated charcoal, once the patient’s airway is secure. In the presence of hypoventilation or apnea, assist or control ventilation, and administer oxygen as indicated.

Although muscle rigidity interfering with respiration has not been seen following the use of Onsolis, this is possible with fentanyl and other opioids. If it occurs, manage by the use of assisted or controlled ventilation, by the administration of an opioid antagonist, and, as a final alternative, by the administration of a neuromuscular blocking agent.

The efficacy of Onsolis was investigated in a clinical trial in opioid tolerant adult patients experiencing breakthrough cancer pain. Breakthrough cancer pain was defined as a transient flare of moderate-to-severe pain occurring in patients with cancer experiencing persistent cancer pain otherwise controlled with maintenance doses of opioid medications including at least 60 mg morphine/day, 50 mcg transdermal fentanyl/hour, or an equianalgesic dose of another opioid for 1 week or longer. All patients were on stable doses of either long-acting oral opioids or transdermal fentanyl for their persistent cancer pain.

A double-blind, placebo controlled, crossover study was performed in patients with cancer to evaluate the effectiveness of Onsolis for the treatment of breakthrough cancer pain. Open-label titration identified a successful dose of Onsolis, within the range of 200 to 1200 mcg. A “successful” dose was defined as a dose in which a patient obtained adequate analgesia with tolerable side effects. Table 6 presents the successful dose for both the double-blind efficacy and open-label safety studies. In the double-blind efficacy study, patients who identified a successful dose were randomized to a sequence of nine treatments; six with the successful dose of Onsolis and three with placebo. Of the patients who entered the study, 54 percent acheived a successful dose during the titration phase and 4 percent withdrew for lack of effective pain relief. The final titrated dose of Onsolis for breakthrough cancer pain was not predicted from the daily maintenance dose of opioid used to manage the persistent cancer pain and, therefore, the dose was determined by titration starting at 200 mcg.

                                              Table 6

The primary outcome measure, the mean sum of pain intensity differences at 30 minutes (SPID30) for Onsolis-treated episodes was statistically significantly higher than for placebo-treated episodes (see Figure 2).

See FDA-Approved patient labeling(Medication Guide).

Patient/Caregiver Instructions

• Before initiating treatment with Onsolis, explain the statements below to patients and/or caregivers. Instruct patients to read the Medication Guide each time Onsolis is dispensed because new information may be available.
• TIRF REMS Access Program
  • Outpatients must be enrolled in the TIRF REMS Access program before they can receive Onsolis.
  • Allow patients the opportunity to ask questions and discuss any concerns regarding Onsolis or the TIRF REMS Access program.
  • As a component of the TIRF REMS Access program, prescribers must review the contents of the Onsolis Medication Guide with every patient before initiating treatment with Onsolis.
  • Advise the patient that Onsolis is available only from pharmacies that are enrolled in the TIRF REMS Access Program, and provide them with the telephone number and website for information on how to obtain the drug.
  • Patient must sign the Patient-Prescriber Agreement to acknowledge that they understand the risks of Onsolis.
  • Advise patients that they may be requested to participate in a survey to evaluate the effectiveness of the TIRF REMS Access Program.
• Instruct patients and their caregivers that Onsolis contains medicine in an amount which can be fatal in children, in individuals for whom it is not prescribed, and in those who are not opioid tolerant. Patients and their caregivers must be instructed to keep Onsolis out of the reach of children. Patients and members of their household must be instructed to dispose of any unneeded films remaining from a prescription as soon as possible [see How Supplied (16.3) and Storage and Handling (16.1)].
• Instruct patients not to take Onsolis for acute pain, postoperative pain, pain from injuries, headache, migraine, or any other short-term pain, even if they have taken other opioid analgesics for these conditions.
• Instruct patients on the meaning of opioid tolerance and Onsolis is only to be used as a supplemental pain medication for patients with pain requiring regular opioids, who have developed tolerance to the opioid medication and who need additional opioid treatment of breakthrough pain episodes.
• Instruct that if they are not taking an opioid medication on a regular around-the-clock basis, they must not take Onsolis.
• Instruct patients NOT to share Onsolis and that sharing Onsolis with anyone else could result in the other individual’s death due to overdose.
• Advise patients that Onsolis contains fentanyl, which is a pain medication similar to hydromorphone, methadone, morphine, oxycodone, and oxymorphone.
• Instruct patients that they must wait at least 2 hours before treating a new episode of breakthrough pain with Onsolis.
• Advise patients that the active ingredient in Onsolis, fentanyl, is a drug that some people abuse. Onsolis is to be taken only by the patient for whom it was prescribed, and protected from theft or misuse in the work or home environments.
• Instruct patients to talk to their doctor if breakthrough pain is not alleviated or worsens after taking Onsolis.
• Instruct patients to use Onsolis exactly as prescribed by their doctor and not to take Onsolis more often than prescribed.
• Caution patients that Onsolis can affect a person’s ability to perform activities that require a high level of attention (such as driving or using heavy machinery). Warn patients taking Onsolis of these dangers and counsel accordingly.
• Warn patients not to combine Onsolis with alcohol, sleep aids, or tranquilizers except by order of the prescribing physician, because dangerous additive effects may occur resulting in serious injury or death.
• Inform female patients that if they become pregnant or plan to become pregnant during treatment with Onsolis to ask their doctor about the effects that Onsolis (or any medicine) may have on them and their unborn child.
• Physicians and dispensing pharmacists must specifically question patients or caregivers about the presence of children in the home (on a full time or visiting basis) and counsel them regarding the dangers to children from inadvertent exposure.

Disposal of Unneeded Onsolis Films

Patients and members of their household must be instructed on the safe disposal of any unneeded films remaining from a prescription as soon as they are no longer needed.

To dispose of the unneeded Onsolis films:

1. Remove the Onsolis film from its foil package.
2. Drop the Onsolis film into the toilet.
3. Repeat steps 1 and 2 for each Onsolis film. Flush the toilet after all unneeded films have been put into the toilet.

Do not flush the Onsolis foil packages or cartons down the toilet [see How Supplied (16.3) and Storage and Handling (16.1)].

Detailed instructions for the proper storage, administration, disposal, and important instructions for managing an overdose of Onsolis are provided in the Medication Guide. Encourage patients to read this information in its entirety and give them an opportunity to have their questions answered.

In the event that a caregiver requires additional assistance in disposing of excess unneeded films that remain in the home after a patient has expired, instruct them to call Meda Pharmaceuticals Inc. at 1-800-526-3840 or seek assistance from their local Drug Enforcement Agency (DEA) office.

IN-500012-02                            Rev. 12/11

Medication Guide

Onsolis® (on sol is) CII
(fentanyl buccal soluble film)

200 mcg, 400 mcg, 600 mcg, 800 mcg, 1200 mcg

IMPORTANT:

Do not use Onsolis unless you are regularly using another opioid pain medicine around-the-clock for your constant cancer pain and your body is used to this medicine (this means that you are opioid tolerant).

Keep Onsolis in a safe place away from children.

Get emergency medical help right away if:

• a child takes Onsolis. Onsolis can cause an overdose and death in any child who takes it.
• an adult who has not been prescribed Onsolis uses it.
• an adult who is not already taking opioids around-the-clock, uses Onsolis.

These are medical emergencies that can cause death. If possible, try to remove Onsolis from the mouth.

Read this Medication Guide completely before you start using Onsolis, and each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment. Be sure to share this information with members of your household and other caregivers.

What is the most important information I should know about Onsolis?

Onsolis can cause life-threatening breathing problems which can lead to death.

1. Do not use Onsolis if you are not opioid tolerant.

2. If you stop taking your around-the-clock opioid pain medicine for your constant cancer pain, you must stop using Onsolis. You may no longer be opioid tolerant. Talk to your healthcare provider about how to treat your pain.

3. Use Onsolis exactly as prescribed by your healthcare provider.

• You must not take more than 1 dose of Onsolis for each episode of breakthrough cancer pain.
• You must wait 2 hours before treating a new episode of breakthrough pain with Onsolis. See the Medication Guide section “How should I use Onsolis?” and the Patient Instructions for Use at the end of this Medication Guide for detailed information about how to use Onsolis the right way.

4. Do not switch from Onsolis to other medicines that contain fentanyl without talking with your healthcare provider. The amount of fentanyl in a dose of Onsolis is not the same as the amount of fentanyl in other medicines that contain fentanyl. Your healthcare provider will prescribe a starting dose of Onsolis that may be different than other fentanyl containing medicines you may have been taking.

5. Do not use Onsolis for short-term pain that you would expect to go away in a few days, such as:

• pain after surgery
• headache or migraine
• dental pain

6. Never give Onsolis to anyone else, even if they have the same symptoms you have. It may harm them or even cause death.

Onsolis is a federally controlled substance (CII) because it is a strong opioid (narcotic) pain medicine that can be misused by people who abuse prescription medicines or street drugs.

• Prevent theft, misuse or abuse. Keep Onsolis in a safe place to protect it from being stolen. Onsolis can be a target for people who abuse opioid (narcotic) medicines or street drugs.
• Selling or giving away this medicine is against the law.

7. Onsolis is available only through a program called the Transmucosal Immediate Release Fentanyl) (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access program. To receive Onsolis, you must:

• talk to your healthcare provider
• understand the benefits and risks of Onsolis
• agree to all of the instructions
• sign the Patient-Prescriber Agreement form

What is Onsolis?

• Onsolis is a prescription medicine that contains fentanyl.
• Onsolis is used to manage breakthrough pain in adults with cancer (18 years of age and older) who are already routinely taking other opioid pain medicines around-the-clock for their constant cancer pain.
• Onsolis is started only after you have been taking another opioid pain medicine and your body is used to it (you are opioid tolerant). Do not use Onsolis if you are not opioid tolerant.
• Onsolis contains fentanyl in a small film (about the size of a dime or nickel) that sticks to the inside of your cheek.
• You must stay under your healthcare provider’s care while using Onsolis.

Onsolis is only:

• available through the TIRF REMS Access program
• given to people who are opioid tolerant

It is not known if Onsolis is safe and effective in children under the age of 18 years.

Who should not use Onsolis?

Do Not Use Onsolis:

• if you are not opioid tolerant. Opioid tolerant means that you are already taking other opioid pain medicine around-the-clock for your constant cancer pain, and your body is used to these medicines.
• for a short-term pain that you would expect to go away in a few days, such as:
  • pain from surgery,
  • headache or migraine
  • dental pain
• if you are allergic to any of the ingredients in Onsolis. See near the end of this Medication Guide (before PATIENT INSTRUCTIONS FOR USE) for a complete list of ingredients in Onsolis.

What should I tell my healthcare provider before starting Onsolis?

Before using Onsolis, tell your healthcare provider if you:

• have trouble breathing or lung problems such as asthma, wheezing or shortness of breath
• have or had a head injury or brain problem
• have liver or kidney problems
• have seizures
• have a slow heart rate or other heart problems
• have low blood pressure
• have mental health problems such as major depression, schizophrenia, or hallucinations (seeing or hearing things that are not real)
• have a past or present drinking problem (alcoholism) or a family history of drinking problems
• have a past or present drug abuse or addiction problem, or a family history of a drug abuse problem or addiction problem
• have any other medical conditions
• are pregnant or plan to become pregnant. Onsolis may cause serious harm to your unborn baby.
• are breastfeeding or plan to breastfeed. Onsolis passes through your breast milk. It can cause serious harm to your baby. You should not use Onsolis while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may cause serious or life-threatening side effects when taken with Onsolis. Sometimes the doses of certain medicines and Onsolis may need to be changed if used together.

• Do not take any medicine while using Onsolis until you have talked with your healthcare provider. Your healthcare provider will tell you if it is safe to take other medicines while you are using Onsolis.
• Be very careful about taking other medicines that make you sleepy, such as other pain medicines, anti-depressants, sleeping pills, anti-anxiety medicines, antihistamines, or tranquilizer.

Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

How should I use Onsolis?

Before you can begin to use Onsolis:

• Your healthcare provider will explain the TIRF REMS Access program to you.
• You will sign the TIRF REMS Access Patient-Prescriber Agreement Form.
• Onsolis is only available at pharmacies that are part of the TIRF REMS Access program. Your healthcare provider will let you know the pharmacies where you can have your Onsolis prescription filled.

Use Onsolis:

• Use Onsolis exactly as prescribed by your healthcare provider. Do not use Onsolis more often than prescribed.
• Your healthcare provider will change the dose until you and your healthcare provider find the right dose for you. Do not change your dose of Onsolis yourself.
• Do not chew or swallow Onsolis.
• You must not take a dose of Onsolis more than 1 time for each episode of breakthrough cancer pain.
• You must wait at least 2 hours between doses before treating a new episode of breakthrough cancer pain with Onsolis.
• It is important for you to keep taking your around-the-clock opioid pain medicine while using Onsolis.
• Talk to your healthcare provider if your dose of Onsolis does not relieve your breakthrough cancer pain. Your healthcare provider will decide if your dose of Onsolis needs to be changed.
• You must not use Onsolis for more than four episodes of breakthrough cancer pain in one day. Talk to your healthcare provider if you have more than four episodes of breakthrough pain each day. The dose of the around-the-clock opioid pain medicine for your constant pain may need to be changed.
• If you use too much Onsolis or overdose, you or your caregiver should call for emergency medical help or have someone take you to the nearest hospital emergency room right away.

What should I avoid while using Onsolis?

• Do not drive, operate machinery, or do other dangerous activities until you know how Onsolis affects you. Onsolis can make you sleepy. Ask your healthcare provider when it is okay to do these activities.
• Do not drink alcohol while using Onsolis. It can increase your chance of having dangerous side effects.

What are the possible side effects of Onsolis?

Onsolis can cause serious side effects including:

1.Breathing problems that can become life-threatening. See “What is the most important information I should know about Onsolis?”

• You or a family member should call your healthcare provider or get emergency medical help right away if you: :
  • have trouble breathing
  • have drowsiness with slowed breathing
  • have slow, shallow breathing (little chest movement with breathing)
  • feel faint, dizzy, confused, or have other unusual symptoms

These can be a sign that you have used too much Onsolis or the dose is too high for you. These symptoms may lead to serious problems or death if not treated right away. If you have any of these symptoms, do not use any more Onsolis until you have talked to your healthcare provider.

2. Decreased blood pressure. This can make you feel dizzy if you get up too fast from sitting or lying down.

3. Physical dependence. Do not stop using Onsolis or any other opioid without talking to your healthcare provider. You could become sick with uncomfortable withdrawal symptoms because your body has become used to these medicines. Physical dependency is not the same as drug addiction.

4. A chance of abuse or addiction with Onsolis. The chance is higher if you have ever been addicted to or abused other medicines, street drugs, or alcohol, or have a history of mental health problems.

The most common side effects of Onsolis are:

• nausea
• vomiting
• dizziness
• loss of too much body fluid (dehydration)
• shortness of breath
• sleepiness

Constipation (not often enough or hard bowel movements) is a very common side effect of pain medicines (opioids) including Onsolis and is unlikely to go away without treatment. Talk to your healthcare provider about dietary changes, and the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while taking Onsolis.

Talk with your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of Onsolis. For more information, ask your healthcare provider or pharmacist.

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

How should I store Onsolis?

• Always keep Onsolis in a safe place away from children and from anyone for whom it has not been prescribed. Protect Onsolis from theft.
• Store Onsolis at room temperature, 59°F to 86°F (15°C to 30°C) until ready to use.
• Do not freeze Onsolis.
• Keep Onsolis dry.

How should I dispose of unopened Onsolis films when they are no longer needed?

• Dispose of any unopened Onsolis films as soon as you no longer need them:
  1. Remove the Onsolis film from its foil package.
  2. Drop the Onsolis film into the toilet.
  3. Repeat steps 1 and 2 for each Onsolis film. Flush the toilet after all unneeded films have been put into the toilet.
• Do not flush the Onsolis foil packages or cartons down the toilet.
• If you need help with disposal of Onsolis, call Meda Pharmaceuticals Inc. at 1 800 526 3840 or call your local Drug Enforcement Agency (DEA) office.

General information about the safe and effective use of Onsolis.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Use Onsolis only for the purpose for which it was prescribed. Do not give Onsolis to other people, even if they have the same symptoms you have.

Onsolis can harm other people and can even cause death.

Sharing Onsolis is against the law.

This Medication Guide summarizes the most important information about Onsolis. For more information talk with your healthcare provider or pharmacist. You can ask your pharmacist or healthcare provider for information about Onsolis that is written for healthcare professionals.

For more information about the TIRF REMS Access program, go to www.TIRFREMSaccess.com or call 1-866-822-1483.

What are the ingredients in Onsolis?

Active ingredient:fentanyl citrate

Inactive ingredients:carboxymethylcellulose, citric acid, hydroxyethyl cellulose, hydroxypropyl cellulose, methylparaben, monobasic sodium phosphate, peppermint oil, polycarbophil, propylene glycol, propylparaben, red iron oxide, sodium benzoate, sodium hydroxide, sodium saccharin, titanium dioxide, tribasic sodium phosphate, vitamin E acetate, and water.

Patient Instructions for Use

Before you use Onsolis, it is important that you read the Medication Guide and these Patient Instructions for Use. Be sure that your read, understand, and follow these Patient Instructions for Use so that you use Onsolis the right way. Ask your healthcare provider or pharmacist if you have any questions about the right way to use Onsolis.

Onsolis comes in a foil package. Do not open the package until ready to use. Once opened, use the entire Onsolis film right away.

To open an Onsolis package:

1. With the back side of the foil package facing you, cut along arrows with scissors.(See figure A)
2. Repeat step above to open the other side of the package.
3. Separate the layers of the foil package and remove the Onsolis film. (See figure B)

• Do not chew or swallow Onsolis. If you do, you will likely get less relief for your breakthrough cancer pain.
• Do not cut or tear the Onsolis film.
• To correctly use Onsolis (see figures below):
• Use your tongue to wet the inside of your cheek or, if needed, rinse your mouth with water to wet the area in your mouth where you will place Onsolis.
• Hold the Onsolis film in place on a clean, dry finger with the pink side facing up (see figure C)
• Carefully place the Onsolis film inside your mouth with the pink side against the inside of your moistened cheek. (see figure D)
• With your finger, press the Onsolis film against your cheek. Hold it there for 5 seconds.
• Take your finger away from the Onsolis film. It will stick to the inside of your cheek.
• Leave the film in place until it dissolves – usually within 15 to 30 minutes after you apply it.
• You may drink liquids after 5 minutes.
• If your doctor tells you to use more than one Onsolis film at the same time for your breakthrough cancer pain, do not put the films on top of each other. Onsolis films may be placed on either side of your mouth.
• Avoid touching or moving the film while it dissolves.
• Do not eat any food until after the film dissolves.

If you can not use Onsolis this way, talk with your healthcare provider about other choices to treat your breakthrough cancer pain.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured by Aveva Drug Delivery Systems (a Nitto Denko Company), Miramar, Florida, 33025 USA

Marketed under license from BioDelivery Sciences International Inc., Raleigh, North Carolina, 27607 USA

by Meda Pharmaceuticals Inc., Somerset, New Jersey, 08873 USA

IS-500012-01            Rev. 12/11

© 2011 Meda Pharmaceuticals Inc.

U.S Patents 6,159,498; 7,579,019

MEDA PHARMACEUTICALS is a registered trademark of Meda AB. Onsolis is a
registered trademark of Meda Pharmaceuticals Inc.
Meda Pharmaceuticals®
Meda Pharmaceuticals Inc.
Somerset, New Jersey 08873-4120

Package Label - Principal Display Panel - Individual Pouch, 200 mcg Film

Rx Only            NDC 0037-5200-01
Quantity: 1 film
Onsolis™ CII
fentanyl buccal soluble film
200 mcg
fentanyl base

WARNING: Only for patients regularly
taking around-the-clock opioid therapy.
Keep in a safe place away from children.
Can be harmful or fatal to someone for
whom it was not prescribed.

Use immediately after opening.
For buccal administration only. Do not chew or swallow.
Dosing must be at least 2 hours apart.

Store at 20-25°C (68-77°F) with excursions permitted
between 15-30°C (59-86°F) until ready to use.

Package Label - Principal Display Panel - Individual Pouch, 400 mcg Film

Rx Only            NDC 0037-5400-01
Quantity: 1 film
Onsolis™ CII
fentanyl buccal soluble film
400 mcg
fentanyl base

WARNING: Only for patients regularly
taking around-the-clock opioid therapy.
Keep in a safe place away from children.
Can be harmful or fatal to someone for
whom it was not prescribed.

Use immediately after opening.
For buccal administration only. Do not chew or swallow.
Dosing must be at least 2 hours apart.
Maximum 1 film per episode.

Store at 20-25°C (68-77°F) with excursions permitted
between 15-30°C (59-86°F) until ready to use.

Package Label - Principal Display Panel - Individual Pouch, 600 mcg Film

Rx Only            NDC 0037-5600-01
Quantity: 1 film
Onsolis™ CII
fentanyl buccal soluble film
600 mcg
fentanyl base

WARNING: Only for patients regularly
taking around-the-clock opioid therapy.
Keep in a safe place away from children.
Can be harmful or fatal to someone for
whom it was not prescribed.

Use immediately after opening.
For buccal administration only. Do not chew or swallow.
Dosing must be at least 2 hours apart.
Maximum 1 film per episode.

Store at 20-25°C (68-77°F) with excursions permitted
between 15-30°C (59-86°F) until ready to use.

Package Label - Principal Display Panel - Individual Pouch, 800 mcg Film

Rx Only            NDC 0037-5800-01
Quantity: 1 film
Onsolis™ CII
fentanyl buccal soluble film
800 mcg
fentanyl base

WARNING: Only for patients regularly
taking around-the-clock opioid therapy.
Keep in a safe place away from children.
Can be harmful or fatal to someone for
whom it was not prescribed.

Use immediately after opening.
For buccal administration only. Do not chew or swallow.
Dosing must be at least 2 hours apart.
Maximum 1 film per episode.

Store at 20-25°C (68-77°F) with excursions permitted
between 15-30°C (59-86°F) until ready to use.

Package Label - Principal Display Panel - Individual Pouch, 1200 mcg Film

Rx Only            NDC 0037-5120-01
Quantity: 1 film
Onsolis™ CII
fentanyl buccal soluble film
1200 mcg
fentanyl base

WARNING: Only for patients regularly
taking around-the-clock opioid therapy.
Keep in a safe place away from children.
Can be harmful or fatal to someone for
whom it was not prescribed.

Use immediately after opening.
For buccal administration only. Do not chew or swallow.
Dosing must be at least 2 hours apart.
Maximum 1 film per episode.

Store at 20-25°C (68-77°F) with excursions permitted
between 15-30°C (59-86°F) until ready to use.

Since Onsolis is used on an as needed basis, you are not likely to miss a dose. Do not take extra medicine to make up the missed dose.

Applies to fentanyl: film, lozenge/troche, spray, tablet

Other dosage forms:

• injection injectable, injection solution
• nasal spray
• transdermal patch device assisted, transdermal patch extended release

Along with its needed effects, fentanyl (the active ingredient contained in Onsolis) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking fentanyl:

• Black, tarry stools
• blurred vision
• chest pain
• confusion
• convulsions
• cough
• decreased urine
• difficult or labored breathing
• dizziness
• dry mouth
• fainting
• fever or chills
• increased thirst
• irregular heartbeat
• lightheadedness
• loss of appetite
• lower back or side pain
• mood changes
• muscle pain or cramps
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• painful or difficult urination
• pale skin
• pounding in the ears
• rapid breathing
• sneezing
• sore throat
• sunken eyes
• swelling of the hands, ankles, feet, or lower legs
• tightness in the chest
• troubled breathing with exertion
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• wrinkled skin

• Abdominal or stomach pain
• change in walking and balance
• clumsiness or unsteadiness
• decreased awareness or responsiveness
• decreased frequency of urination
• headache
• muscle twitching or jerking
• pounding in the ears
• rhythmic movement of the muscles
• seeing, hearing, or feeling things that are not there
• seizures
• severe constipation
• severe sleepiness
• shakiness in the legs, arms, hands, or feet
• slow or fast heartbeat
• thinking abnormalities
• trembling or shaking of the hands or feet

Get emergency help immediately if any of the following symptoms of overdose occur while taking fentanyl:

• Extremely shallow or slow breathing

Some side effects of fentanyl may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back pain
• diarrhea
• difficulty having a bowel movement (stool)
• difficulty with moving
• discouragement
• feeling sad or empty
• irritability
• lack or loss of strength
• loss of interest or pleasure
• muscle stiffness
• pain in the joints
• sleepiness or unusual drowsiness
• tiredness
• trouble concentrating
• trouble sleeping
• weight loss

• Changes in vision
• excessive muscle tone
• feeling of constant movement of self or surroundings
• feeling of warmth or heat
• flushing or redness of the skin, especially on the face and neck
• irritation, pain, or sores at the site of application
• itching skin
• muscle tension or tightness
• rash
• sensation of spinning
• sweating

• Tooth pain
• trouble with gums
• trouble with teeth