General

High Alert Medication: This medication bears a heightened risk of causing significant patient harm when it is used in error.

Pronunciation
FEN-ta-nil


Trade Name(s)

• Onsolis

Controlled Substance Schedule
II

Pregnancy Category
Category C

Ther. class.
opioid analgesics

Pharm. class.
opioid agonists

Indications

Management of breakthrough pain in cancer patients B 18 yr already receiving opioids and tolerant to opioids for their underlying persistent cancer pain (60 mg/day of oral morphine or equivalent).

Action

Binds to opioid receptors in the CNS, altering the response to and perception of pain

Therapeutic Effect(s):
Decrease in severity of breakthrough pain

Pharmacokinetics

Absorption: Well absorbed following buccal administration

Distribution: Rapidly distributes to body tissues and fluids, readily penetrates CNS ; crosses the placenta and enters breast milk

Metabolism and Excretion: Mostly metabolized in the liver and intestinal mucosa via the the CYP3A4 enzyme system; inactive metabolites are excreted in urine; < 7% excreted unchanged in urine

Half-life: 14 hr

TIME/ACTION PROFILE (analgesia)

ROUTE	ONSET	PEAK	DURATION
Buccal	15–30 min	1 hr	2–6 hr

Contraindication/Precautions

Contraindicated in:

• Hypersensitivity to fentanyl or other components of the buccal system

• Opioid non-tolerant patients

• Acute/postoperative pain, including headache/migraine, dental pain, or ER use

• Concurrent use of MAO inhibitors

• Lactation: Avoid use during breastfeeding; may cause infant sedation and/or respiratory depression.

Use Cautiously in:

• Severe renal/hepatic impairment

• Chronic obstructive pulmonary disease or preexisting medical conditions predisposing hypoventilation

• History of substance abuse

• Geri: Elderly patients may be more sensitive to the effects of opioids; consider age-related decrease in hepatic and cardiovascular function, concurrent illnesses and medications

• OB: Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Chronic maternal treatment with opioids during pregnancy may result in neonatal abstinence syndrome.

• Pedi: Safety and effectiveness in children <18 yr not established

Exercise Extreme Caution in:
Patients susceptible to intracranial effects of CO₂ retention including those with increased intracranial pressure, head injuries or impaired consciousness

Adverse Reactions/Side Effects

Opioid side effects increase with increased dosage

CNS: dizziness, drowsiness..

Resp: RESPIRATORY DEPRESSION, dyspnea.

GI: nausea, vomiting.

F and E: dehydration.

*CAPITALS indicates life-threatening.
*italic indicates most frequent.

Interactions

Drug-Drug

• Concurrent use of CYP3A4 inhibitors including ritonavir , ketoconazole , itraconazole , fluconazole clarithromycin , erythromycin ,, nefazodone , diltiazem , verapamil, amprenavir , nelfinavir , fosamprenavir ↑ levels and risk of opioid toxicity; careful monitoring during initiation, dose changes or discontinuation of the inhibitor is recommended and dose changes may be necessary

• Concurrent use with CYP3A4 inducers including barbiturates , carbamazepine , efavirenz , corticosteroids , modafinil , nevirapine , oxcarbazepine , phenobarbital , phenytoin , pioglitazone , rifabutin , rifampin or troglitazone may ↓ fentanyl levels and analgesia; if inducers are discontinued or dosage decreased, patients should be monitored for signs of opioid toxicity and necessary dose adjustments made

• CNS depressants including other opioids , sedative/hypnotics, general anesthetics , phenothiazines , skeletal muscle relaxants , sedating antihistamines and alcohol may ↑ CNS depression, hypoventilation and hypotension

• Should not be used within 14 days of MAO inhibitors (may result in severe and unpredictable reactions)

Drug-Natural Products
St. John's wort is an inducer of CYP3A4; concurrent use may ↓ levels and analgesia; if inducers are discontinued or dosage decreased, patients should be monitored for signs of opioid toxicity and necessary dosage adjustments made

Drug-Food
Grapefuit juice is a moderate inhibitor of CYP3A4 enzyme system; concurrent use may ↑ levels and the risk of CNS and respiratory depression. Careful monitoring and dose adjustment may be necessary

Route/Dosage

• Buccal (Adults): 200 mcg initially, then titrate using 200 mcg increments (up to a maximum of four 200 mcg films or a single 1200 mcg film) to adequate analgesia without undue side effects (not to exceed one dose per episode; no more than four doses per day; separate by at least 2 hours).

Availability

• Buccal soluble film: Buccal soluble film 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1200 mcg

Assessment

• Monitor type, location, and intensity of pain before and 1 hr after administration of buccal fentanyl

• Assess blood pressure, pulse, and respirations before and periodically during administration. If respiratory rate is <10 min, assess level of sedation. Physical stimulation may be sufficient to prevent hypoventilation. Subsequent doses may need to be decreased. Patients tolerant to opioid analgesics are usually tolerant to the respiratory depressant effects also

• Monitor for application site reactions (paresthesia, ulceration, bleeding, pain, ulcer, irritation). Reactions are usually self-limited and rarely require discontinuation

Lab Test Considerations

• May cause anemia, neutropenia, thrombocytopenia, and leukopenia

» May cause hypokalemia, hypoalbuminemia, hypercalcemia, hypomagnesemia, and hyponatremia

Toxicity and Overdose

• If an opioid antagonist is required to reverse respiratory depression or coma, naloxone (Narcan) is the antidote. Dilute the 0.4-mg ampule of naloxone in 10 mL of 0.9% NaCl and administer 0.5 mL (0.02 mg) by direct IV push every 2 min. For patients weighing <40 kg, dilute 0.1 mg of naloxone in 10 mL of 0.9% NaCl for a concentration of 10 mcg/mL and administer 0.5 mcg every 2 min. Use extreme caution when titrating dose in patients physically dependent on opioid analgesics to avoid withdrawal, seizures, and severe pain. Duration of respiratory depression may be longer than duration of opioid antagonist, requiring repeated doses

Potential Nursing Diagnoses

• Acute pain (Indications)

• Risk for injury (Adverse Reaction)

Implementation

• High Alert: Accidental overdosage of opioid analgesics has resulted in fatalities. Before administering, clarify all ambiguous orders; have second practitioner independently check original order and dose calculations

• Patients considered opioid-tolerant are those who are taking B60 mg of oral morphine/day, at least 25 mcg transdermal fentanyl/hr, 30 mg of oxycodone/day, 8 mg of hydromorphone/day or an equianalgesic dose of another opioid for B1 wk

» High Alert: Dose may be lethal to a child; keep out of reach of children.

» Do not substitute fentanyl buccal soluble film(Onsolis) for fentanyl buccal (Fentora) or fentanyl oral transmucosal (Actiq); doses are not equivalent

• Available only through FOCUS, a restricted distribution program. Only prescribers and pharmacies registered in the program and patients enrolled in the program have access. Program provides education, counseling, and facilitated distribution of the medication. To enroll in the FOCUS Program call 1–877–4ONSOLIS or visit www.OnsolisFocus.com

• Dose must be started with one 200 mcg film; do not convert patients on a mcg/mcg basis. If adequate relief is not achieved with one 200 mcg film, titrate using multiples of the 200 mcg film to provide adequate relief while minimizing side effects. Do not use more than 4 of the 200 mcg films simultaneously. Do not place on top of each other; use both sides of the mouth. If adequate pain relief is not achieved after 800 mcg (four 200 mcg films) and patient tolerated 800 mcg dose, treat next episode with one 1200 mcg film. Do not use doses above 1200 mcg

» Single doses should be separated by at least 2 hrs. Use fentanyl buccal film only once per breakthrough pain episode; do not redose. Other rescue medications may be used as directed

» Once a successful dose has been established, if more than 4 breakthrough pain episodes/day occur, re-evaluate opioid dose for persistent pain

• Buccal: Use tongue to wet inside of cheek or rinse mouth with water to wet area for placement of film. Open package immediately prior to use. Place entire film near tip of dry finger with pink side facing up and hold in place. Place pink side of film against inside of cheek. Press and hold film in place for 5 seconds. Film should stay in place on its own after this period. May consume liquids after 5 min. Do not cut or tear film prior to use. Film should dissolve within 15–30 min after application. Do not manipulate with tongue or fingers; avoid eating food until film has dissolved

» If film is chewed or swallowed, lower peak concentration and lower bioavailability may result

» To dispose of unneeded films, open foil packets, drop films into toilet and flush

Patient/Family Teaching

• Instruct patient to take fentanyl buccal film exactly as directed. Do not take more often than prescribed, keep out of reach of children, protect it from being stolen, and do not share with others, even if they have the same symptoms. Explain FOCUS Program to patient and caregiver, including receipt of medication via a traceable courier and need of adult signature upon delivery. Advise patient to review Medication Guide each time fentanyl buccal film is dispensed; new information may be available. Advise patient to notify health care professional if breakthrough pain is not alleviated or worsens

• Caution patient to make position changes slowly to minimize orthostatic hypotension

• Medication causes dizziness and drowsiness. Advise patient to call for assistance during ambulation and transfer, and to avoid driving or other activities requiring alertness until response to medication is known

• Instruct patient to avoid concurrent use of alcohol or other CNS depressants, such as sleep aids

• Advise patient to notify health care professional if sores on gums or inside cheek become a problem

• Instruct patient to consult health care professional before taking Rx, OTC, or herbal products

• Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding

Evaluation/Desired Outcomes

Decrease in severity of pain during episodes of breakthrough pain in patients receiving long-acting opioids

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