Medical Editor: John P. Cunha, DO, FACOEP
Onsolis (fentanyl buccal) Soluble Film is a narcotic (opioid) pain medicine used to treat "breakthrough" cancer pain that is not controlled by other medicines. Onsolis is taken together with other non-fentanyl narcotic pain medicine that is used around the clock. Onsolis is not for treating pain that is not cancer-related. The brand name Onsolis is discontinued, but generic versions may be available. Common side effects of Onsolis (fentanyl buccal) include nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, headache, feeling weak or tired, swelling in your hands or feet, or pain or mouth sores where the medicine was placed.
All patients MUST begin treatment using one 200 mcg dose of Onsolis film. Onsolis may interact with other narcotics, sedatives, tranquilizers, sleeping pills, muscle relaxers, other medicines that can make you sleepy or slow your breathing, dexamethasone, imatinib, isoniazid, St. John's wort, antibiotics, antifungals, antidepressants, heart or blood pressure medications, HIV medications, or seizure medications. Tell your doctor all medications and supplements you use. Before using Onsolis, tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, Onsolis should be used only when prescribed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Using it near the expected delivery date may harm the fetus. Tell the doctor if you notice symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea. This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking this medication.
Our Onsolis (fentanyl buccal) Soluble Film Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
SLIDESHOW
Skin Cancer Symptoms, Types, Images See SlideshowGet emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Like other opioid medications, fentanyl can slow or stop your breathing. If your breathing gets too weak, death may occur.
Your caregivers will watch for any of these side effects, which may clear up within minutes after stopping the fentanyl infusion or decreasing the dose:
- weak or shallow breathing;
- fast or slow heart rate;
- stiff muscles; or
- severe weakness, feeling light-headed or fainting.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Common side effects may include:
- slowed breathing;
- slow heart rate;
- muscle stiffness;
- dizziness, vision problems;
- nausea, vomiting;
- itching, sweating; or
- high blood pressure (confusion, anxiety, pounding in your neck or ears).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Onsolis (Fentanyl Buccal Soluble Film)
SIDE EFFECTS
Clinical Studies Experience
The safety of Onsolis has been evaluated in 306 opioid tolerant patients with breakthrough cancer pain in the efficacy study and an open-label safety study. The mean duration of therapy was 115 days, with 32 patients treated for more than 1 year.
The adverse reactions seen with Onsolis are typical opioid side effects in a population with cancer. Frequently, opioid-associated adverse reactions will cease or decrease in intensity with continued use of Onsolis. Expect opioid side effects and manage them accordingly.
The most serious adverse reactions associated with all opioids including Onsolis are respiratory depression (potentially leading to apnea or respiratory arrest), circulatory depression, hypotension, and shock. Follow all patients for symptoms of respiratory depression.
Because the clinical trials of Onsolis were designed to evaluate safety and efficacy in treating patients with breakthrough pain associated with cancer, all patients were also taking concomitant opioids, such as sustained-release morphine, sustained-release oxycodone or transdermal fentanyl, for their persistent cancer pain. The adverse event data presented here reflect the actual percentage of patients experiencing each adverse event among patients who received Onsolis for breakthrough cancer pain along with a concomitant opioid for persistent cancer pain. There has been no attempt to correct for concomitant use of other opioids, duration of Onsolis therapy, or cancer-related symptoms. Adverse reactions are included regardless of severity.
Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Table 1 lists, by maximum dose received, adverse reactions with an overall frequency of 5% or greater that occurred during titration. The ability to assign a dose-response relationship to these adverse reactions is limited by the titration schedules used in these studies. Adverse reactions are listed in descending order of frequency within each body system.
Table 1 : Adverse Reactions Which Occurred During
Titration at a Frequency of ≥ 5%
| System Organ Class, Preferred Term, n (%) | Onsolis Dose (mcg) | Total (N=306) |
|||||
| 200 (N=303) |
400 (N=257) |
600 (N=207) |
800 (N=138) |
1200 (N=79) |
> 1200 (N=9) |
||
| Gastrointestinal Disorders | |||||||
| Nausea | 16 (5) | 12 (5) | 6 (3) | 5 (4) | 4 (5) | 0 | 42 (14) |
| Vomiting | 7(2) | 9 (4) | 8 (4) | 2 (1) | 0 | 0 | 26 (8) |
| Nervous System Disorders | |||||||
| Dizziness | 5 (2) | 5 (2) | 6 (3) | 2 (1) | 4 (5) | 0 | 22 (7) |
| Somnolence | 6 (2) | 2 (1) | 4 (2) | 2 (1) | 4 (5) | 1 (11) | 17 (6) |
Table 2 lists, by successful dose, adverse reactions with an overall frequency of ≥ 5% that occurred during long-term treatment (i.e., the double-blind or open-label maintenance periods).
Table 2 : Adverse Reactions Which Occurred During
Long-Term Treatment at a Frequency of ≥ 5%
| System Organ Class, Preferred Term, n (%) | Onsolis Dose (mcg) | Total (N=213) |
|||||
| 200 (N=23) |
400 (N=59) |
600 (N=79) |
800 (N=91) |
1200 (N=81) |
> 1200 (N=28) |
||
| Gastrointestinal | |||||||
| Nausea | 2 (9) | 6 (10) | 8 (10) | 12(13) | 26 (32) | 4 (14) | 56 (26) |
| Vomiting | 1 (4) | 5 (8) | 9 (11) | 8 (9) | 23 (28) | 3 (11) | 45 (21) |
| Constipation | 2 (9) | 4 (7) | 4 (5) | 4 (4) | 6 (7) | 4 (14) | 23(11) |
| Diarrhea | 1 (4) | 1 (2) | 4 (5) | 4 (4) | 10 (12) | 0 | 19 (9) |
| Dry mouth | 1 (4) | 4 (7) | 3 (4) | 2 (2) | 3 (4) | 1 (4) | 14 (7) |
| Abdominal pain | 0 | 0 | 3 (4) | 1 (1) | 7 (9) | 1 (4) | 11 (5) |
| General/administration site | |||||||
| Asthenia | 0 | 6 (10) | 3 (4) | 8 (9) | 7 (9) | 4 (14) | 28 (13) |
| Fatigue | 2 (9) | 6 (10) | 1 (1) | 7 (8) | 7 (9) | 3 (11) | 25(12) |
| Investigations | |||||||
| Weight decreased | 3 (13) | 0 | 2 (3) | 5 (5) | 5 (6) | 1 (4) | 15 (7) |
| Metabolism/nutrition | |||||||
| Dehydration | 1 (4) | 4 (7) | 6 (8) | 5 (5) | 10 (12) | 3 (11) | 28 (13) |
| Decreased appetite | 0 | 4 (7) | 4 (5) | 6 (7) | 2 (2) | 2 (7) | 18 (8) |
| Anorexia | 2 (9) | 1 (2) | 3 (4) | 4 (4) | 6 (7) | 1 (4) | 17 (8) |
| Nervous system | |||||||
| Dizziness | 2 (9) | 4 (7) | 2 (3) | 3 (3) | 10 (12) | 2 (7) | 23(11) |
| Headache | 2 (9) | 1 (2) | 3 (4) | 9 (10) | 7 (9) | 0 | 20 (9) |
| Somnolence | 2 (9) | 0 | 4 (5) | 2 (2) | 3 (4) | 3 (11) | 14 (7) |
| Psychiatric | |||||||
| Confusional state | 1 (4) | 0 | 4 (5) | 4 (4) | 6 (7) | 4 (14) | 18 (8) |
| Depression | 0 | 3 (5) | 1 (1) | 4 (4) | 7 (9) | 3 (11) | 18 (8) |
| Insomnia | 0 | 2 (3) | 2 (3) | 3 (3) | 4 (5) | 2 (7) | 12 (6) |
| Anxiety | 1 (4) | 1 (2) | 2 (3) | 3 (3) | 3 (4) | 1 (4) | 11 (5) |
| Respiratory | |||||||
| Dyspnea | 3 (13) | 4 (7) | 3 (4) | 8 (9) | 6 (7) | 3 (11) | 26 (12) |
| Cough | 1 (4) | 0 | 3 (4) | 5 (5) | 6 (7) | 1 (4) | 15 (7) |
| Vascular | |||||||
| Hypotension | 0 | 3 (5) | 3 (4) | 1 (1) | 3 (4) | 1 (4) | 11 (5) |
In a mucositis study, a group of patients (n=7) with Grade 1 oral mucositis and a matched group of control patients (n=7) without oral mucositis were included in a clinical trial designed to support the safety of Onsolis. The adverse event profile was similar in both subsets of patients. There was no evidence that Onsolis caused or worsened oral mucosal irritation or pain in either study group.
The duration of exposure to Onsolis varied greatly, and included open-label and double-blind studies. The adverse reactions listed below represent those that were reported by ≥ 1% of patients from two clinical trials (the titration and posttitration periods) while receiving Onsolis. Events are classified by system organ class.
Cardiac disorders: tachycardia
Eye disorders: vision blurred, diplopia
Gastrointestinal disorders: nausea, vomiting, constipation, diarrhea, dry mouth, abdominal pain, dyspepsia, dysphagia, abdominal distension, intestinal obstruction, flatulence
General disorders and administration site conditions: asthenia, fatigue, malaise
Injury, poisoning and procedural complications: fall, contusion
Investigations: weight decreased, blood pressure increased
Metabolism and nutrition disorders: dehydration, decreased appetite, anorexia
Nervous system disorders: dizziness, somnolence, headache, lethargy, amnesia, sedation
Psychiatric disorders: confusional state, depression, insomnia, anxiety, hallucination, agitation, mental status changes
Renal and urinary disorders: urinary retention
Respiratory, thoracic and mediastinal disorders: dyspnea, cough
Skin and subcutaneous tissue disorders: pruritus, rash
Vascular disorders: hypotension, hot flush, deep vein thrombosis, hypertension
Read the entire FDA prescribing information for Onsolis (Fentanyl Buccal Soluble Film)
Read the Onsolis User Reviews »
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