Actiq Oral Film 600 Micrograms (Fentanyl Citrate)

Adult dose

A dose that provides adequate pain relief and minimizes adverse reactions must be established for each individual patient. 1. Dose titration 1) Initiation of treatment The initial dose of this drug for the treatment of breakthrough cancer pain is 200 ㎍. Patients should be prescribed the initial-dose titration product containing six 200 ㎍ tablets, thereby limiting the number of tablets available for home use during the titration period. Patients must not increase the dose until they have taken all of the prescribed tablets of this drug. Patients must strictly follow this initial dose, and the dose should be adjusted until a single dose of this drug provides adequate pain relief and minimizes adverse reactions when the patient experiences breakthrough cancer pain. To determine whether dose adjustment has been adequate, patients should record the doses of this drug taken for several episodes of breakthrough cancer pain and review these records with their physician. 2) Redosing for a single pain episode Until an adequate dose is reached, the patient may need to take an additional dose of this drug for a single pain episode. Redosing may begin 15 minutes after completion of the immediately preceding 1-tablet dose (30 minutes after the start of the immediately preceding 1-tablet dose). While the patient is undergoing dose titration and taking an individually determined dose as adjunctive treatment, no more than 2 tablets should be administered for each episode of breakthrough cancer pain. 3) Dose escalation If treatment with this drug for several consecutive episodes of breakthrough pain shows that more than 1 tablet is needed for each pain episode, consider increasing the dose by one dose level. It is recommended that 6 tablets be prescribed as the new dose of this drug during the initial dose-titration process. Each new dose of this drug used during the initial dose-titration period should be evaluated over several episodes of breakthrough cancer pain (usually 1～2 days) to determine whether it provides adequate efficacy with tolerable adverse reactions. Adverse reactions tend to occur more frequently during the initial dose-titration phase than after the effective dose has been determined. 4) Maximum daily dose After a successful dose has been identified (for example, treatment of each pain episode with 1 tablet), the patient's daily dose should be limited to no more than 4 tablets. If the dose exceeds 4 tablets per day, the dose of the long-acting opioid used for persistent cancer pain should be readjusted. Initial dose-titration process Start with a dose of 200 ㎍ (Do not dispense more than 6 tablets initially.) ↓ 1 - Take this drug over 15 minutes. 2 - Wait an additional 15 minutes after taking it. 3 - If needed, take a second tablet over 15 minutes. 4 - Administer this drug for several episodes of breakthrough pain. ↓ Does 1 tablet provide adequate relief? ↙ ↘ Yes No ↓ ↓ Effective dose determined Increase the dose* by one dose level * Available dose range: 200 ㎍, 400 ㎍, 600 ㎍, 800 ㎍, 1200 ㎍, 1600 ㎍. 2. Dose adjustment Long-term studies of this drug for the treatment of breakthrough cancer pain have shown that some patients require adjustment of both this drug and the dose of their regularly scheduled (at fixed time intervals) opioid analgesic to continue to obtain adequate relief of breakthrough cancer pain. In general, if treatment with this drug for several consecutive episodes of breakthrough pain shows that more than 1 tablet is needed for each pain episode, the dose should be increased. During the process of adjusting to an appropriate dose, a small quantity (6 tablets) should be prescribed at each adjustment step. If the patient experiences breakthrough cancer pain more than 4 times per day, the physician should consider increasing the dose of the opioid that the patient takes regularly for persistent cancer pain. If pain is not adequately controlled, the possibility of hyperalgesia, tolerance, and progression of the underlying disease should be considered. 3. Discontinuation of this drug Because it is not known at what dose opioid treatment can be discontinued without the sudden onset of withdrawal symptoms, gradual dose reduction is recommended for patients who need to discontinue opioid treatment.

This drug is an opioid used to treat breakthrough pain in cancer patients. Only patients who have developed a tolerance to opioids should take this drug, as it may be dangerous for those who have not been on opioids for an extended period. It should not be used for treating acute pain or postoperative pain. It must only be administered by professionals with expertise in cancer pain management. It should be stored out of reach of children as it can be fatal to them. Co-administration with narcotics, benzodiazepines, alcohol, etc., may cause severe respiratory depression or coma. Careful monitoring of the patient is required when used in conjunction with other central nervous system depressants. It is advisable not to use this drug in patients who have taken specific antidepressants known as MAO inhibitors within 14 days. Caution is required in patients with respiratory depression, chronic lung disease, head injuries, heart disease, liver or kidney diseases. This drug has the potential for various side effects; if any unusual symptoms occur, the patient should consult medical personnel immediately. Mental and physical functioning may be impaired while taking this medication, so patients should avoid driving or operating machinery. Long-term use may lead to drug dependence or abuse potential. As this drug is metabolized in the liver, it may interact with other medications; therefore, patients should inform their healthcare provider of any concomitant drugs. In cases of pregnancy or breastfeeding, consultation with a specialist is mandatory before use. Special caution is necessary for the elderly or children under 18, as safety and efficacy have not been established. In overdose situations, severe symptoms such as respiratory depression may occur, necessitating immediate emergency measures. This drug should be used only for cancer patient treatment and administered by knowledgeable healthcare professionals. During storage, maintain appropriate temperatures, avoid moisture and freezing, and do not use opened products. Unused medications should be safely disposed of out of reach of children, and unopened drugs should also be discarded appropriately. Regular oral hygiene maintenance and dental visits are recommended.

• Asthenia
• headache
• incidental injury
• hypertonicity
• pain
• fever
• abdominal pain
• chills
• back pain
• chest pain

This drug may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 15 to 30 degrees Celsius. This will help preserve the effectiveness and safety of the medication for a longer period.

Appearance

White cylindrical oral film attached to a white plastic backing, flat on the bottom and domed on the top.

Package unit

30 films (3 films/PTP pack x 10)