Actiq

Name: Actiq

Fentanyl Dosage

Fentanyl (as Duragesic) comes in five strengths, which deliver fentanyl at different rates: 12 micrograms per hour (mcg/h), 25 mcg/h, 50 mcg/h, 75 mcg/h, and 100 mcg/h.

Use only as directed — never put more than one patch on at a time.

Fentanyl Overdose

If you overdose on fentanyl, call 9-1-1 or get emergency help right away.

Overdose symptoms include:

  • Difficulty breathing
  • Extreme sleepiness or fatigue
  • Difficulty thinking, talking, or walking
  • Contracted pupils
  • Faintness and dizziness
  • Confusion
  • Coma

Commonly used brand name(s)

In the U.S.

  • Abstral
  • Actiq
  • Fentora
  • Onsolis
  • Subsys

Available Dosage Forms:

  • Spray
  • Tablet
  • Lozenge/Troche
  • Film

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For Actiq

Fentanyl is used to treat severe pain in cancer patients. It is used for breakthrough cancer pain, which are flares of pain that “break through” after a routine pain medicine has been used. Fentanyl belongs to the group of medicines called narcotic analgesics. It is only used in patients who are already taking narcotic analgesics.

Fentanyl acts in the central nervous system (CNS) to relieve pain. Some of its side effects are also caused by actions in the CNS. When a narcotic is used for a long time, it may become habit-forming or cause mental or physical dependence. However, people who have continuous pain should not let the fear of dependence keep them from using narcotics to relieve pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. Withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before the medicine is stopped completely. Talk to your doctor about the benefits of this medicine and how to prevent withdrawal side effects.

This medicine is available only with your doctor's prescription. The Abstral®, Actiq®, Fentora®, Onsolis®, and Subsys® products are only available under a restricted distribution program. You will have to read and sign papers that explain how the medicine is used when you pick up your prescription.

Precautions While Using Actiq

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Do not use this medicine for minor aches and pains (eg, headaches, migraines) or after surgery or injuries.

Do not use this medicine if you have taken a monoamine oxidase (MAOI) inhibitor (eg, isocarboxazid phenelzine, selegiline, tranylcypromine, Eldepryl®, Marplan®, Nardil®, or Parnate®) in the past 2 weeks.

Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Fentanyl is a medicine that can harm or cause death to a child. Patients and caregivers should keep this medicine out of the reach of children. Carefully dispose of any partially used units or unused medicine properly.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. This effect may last for a few days after you stop using this medicine. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, benzodiazepines, other prescription pain medicine or narcotics, barbiturates or seizure medicines, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. Check with your doctor before taking any of the medicines listed above while you are using this medicine.

Fentanyl may cause some people to become drowsy, confused, or dizzy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert. Check with your doctor if you have confusion or drowsiness that is severe enough to interfere with your daily activities.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may tell you to take laxatives, drink fluids, or increase the amount of fiber in your diet. Follow the directions carefully. Constipation that continues can lead to more serious problems.

If you have been using this medicine regularly for several weeks or more, do not suddenly stop using it without checking with your doctor. You may be directed to gradually reduce the amount you are using before stopping it completely to lessen the chance of withdrawal side effects.

Using too much fentanyl, or taking too much of another narcotic with fentanyl, may cause an overdose. If this occurs, get emergency help right away. An overdose can cause severe breathing problems (breathing may even stop), unconsciousness, and death. Serious signs of an overdose include very slow breathing (fewer than 8 breaths each minute) and drowsiness that is so severe you are not able to answer when spoken to, or if asleep, cannot be awakened.

The Actiq® product contains sugar and may increase your chance for tooth decay. Schedule regular dentist visits if you are using Actiq®.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using too much of this medicine may cause reduced infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

What do I need to tell my doctor BEFORE I take Actiq?

  • If you have an allergy to Actiq or any part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
  • If you have any of these health problems: Kidney disease or liver disease.
  • If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking Actiq within 14 days of those drugs can cause very bad high blood pressure.
  • If you are taking any of these drugs: Linezolid or methylene blue.
  • If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.
  • If you are breast-feeding. Do not breast-feed while you take this medicine.

This is not a list of all drugs or health problems that interact with Actiq (fentanyl lozenge).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Adverse Reactions

The following serious adverse reactions are described, or described in greater detail, in other sections:

• Life-Threatening Respiratory Depression [see Warnings and Precautions (5.1)] • Interactions with Benzodiazepines and Other CNS Depressants [see Warnings and Precautions (5.4)] • Addiction, Abuse, and Misuse [see Warnings and Precautions (5.6)] • Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.8)] • Serotonin Syndrome [see Warnings and Precautions (5.10)] • Adrenal Insufficiency [see Warnings and Precautions (5.11)] • Severe Hypotension [see Warnings and Precautions (5.12)] • Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.14)] • Seizures [see Warnings and Precautions (5.15)]

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction 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.

The safety of Actiq has been evaluated in 257 opioid-tolerant chronic cancer pain patients. The duration of Actiq use varied during the open-label study. Some patients were followed for over 21 months. The average duration of therapy in the open-label study was 129 days.

The most serious adverse reactions associated with Actiq are respiratory depression (potentially leading to apnea or respiratory arrest), circulatory depression, hypotension, and shock.

Because the clinical trials of Actiq were designed to evaluate safety and efficacy in treating breakthrough cancer pain, all patients were also taking concomitant opioids, such as sustained-release morphine or transdermal fentanyl, for their persistent cancer pain. The adverse event data presented here reflect the actual percentage of patients experiencing each adverse effect among patients who received Actiq 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 Actiq therapy, or cancer-related symptoms.

Three short-term clinical trials with similar titration schemes were conducted in 257 patients with malignancy and breakthrough cancer pain. Data are available for 254 of these patients. Table 1 lists, by dose groups, adverse reactions with an overall frequency of 1% or greater that occurred during titration. The ability to assign a dose-response relationship to these adverse reactions is limited by the titration schemes used in these studies. Adverse reactions are listed in descending order of frequency within each body system.

Table 1. Percent of Patients with Specific Adverse Events Commonly Associated with Opioid Administration or of Particular Clinical Interest Which Occurred During Titration (Events in 1% or More of Patients)
* Any Dose = A patient who experienced the same adverse event at multiple doses was only counted once.

Dose Group

Percentage of Patients Reporting Event

200-

600 mcg

(n=230)

800-

1400 mcg (n=138)

1600

mcg

(n=54)

>1600

mcg

(n=41)

Any

Dose*

(n=254)

Body As A Whole

Asthenia

6

4

0

7

9

Headache

3

4

6

5

6

Accidental Injury

1

1

4

0

2

Digestive

Nausea

14

15

11

22

23

Vomiting

7

6

6

15

12

Constipation

1

4

2

0

4

Nervous

Dizziness

10

16

6

15

17

Somnolence

9

9

11

20

17

Confusion

1

6

2

0

4

Anxiety

3

0

2

0

3

Abnormal Gait

0

1

4

0

2

Dry Mouth

1

1

2

0

2

Nervousness

1

1

0

0

2

Vasodilatation

2

0

2

0

2

Hallucinations

0

1

2

2

1

Insomnia

0

1

2

0

1

Thinking Abnormal

0

1

2

0

1

Vertigo

1

0

0

0

1

Respiratory

Dyspnea

2

3

6

5

4

Skin

Pruritus

1

0

0

5

2

Rash

1

1

0

2

2

Sweating

1

1

2

2

2

Special Senses

Abnormal Vision

1

0

2

0

2

The following adverse reactions not reflected in Table 1 occurred during titration with an overall frequency of 1% or greater and are listed in descending order of frequency within each body system.

Body as a Whole: Pain, fever, abdominal pain, chills, back pain, chest pain, infection

Digestive: Diarrhea, dyspepsia, flatulence

Metabolic and Nutritional: Peripheral edema, dehydration

Nervous: Hypesthesia, migraine

Respiratory: Pharyngitis, cough increased

The following reactions occurred during titration with an overall frequency of less than 1% and are listed in descending order of frequency within each body system.

Body as a Whole: bone pain

Cardiovascular: Deep thrombophlebitis, hypertension, hypotension

Digestive: Anorexia, eructation, fecal impaction, gum hemorrhage, mouth ulceration, oral moniliasis

Hemic and Lymphatic: Anemia, leukopenia

Metabolic and Nutritional: Edema, hypercalcemia, weight loss

Musculoskeletal: Myalgia, pathological fracture, myasthenia

Nervous: Abnormal dreams, urinary retention, agitation, amnesia, emotional lability, euphoria, incoordination, libido decreased, neuropathy, paresthesia, speech disorder

Respiratory: Hemoptysis, pleural effusion, rhinitis, asthma, hiccup, pneumonia, respiratory insufficiency, sputum increased

Skin and Appendages: Alopecia, exfoliative dermatitis

Special Senses: Taste perversion

Urogenital: Vaginal hemorrhage, dysuria, hematuria, urinary incontinence, urinary tract infection

A long-term extension study was conducted in 156 patients with malignancy and breakthrough cancer pain who were treated for an average of 129 days. Data are available for 152 of these patients. Table 2 lists by dose groups, adverse reactions with an overall frequency of 1% or greater that occurred during the long-term extension study. Adverse reactions are listed in descending order of frequency within each body system.

Table 2. Percent of Patients with Adverse Events Commonly Associated with Opioid Administration or of Particular Clinical Interest Which Occurred During Long Term Treatment (Events in 1% or More of Patients)
* Any Dose = A patient who experienced the same adverse event at multiple doses was only counted once.

Dose Group

Percentage of Patients Reporting Event

200-

600 mcg

(n=98)

800-

1400 mcg

(n=83)

1600

mcg

(n=53)

>1600

mcg

(n=27)

Any

Dose*

(n=152)

Body As A Whole

Asthenia

25

30

17

15

38

Headache

12

17

13

4

20

Accidental Injury

4

6

4

7

9

Hypertonia

2

2

2

0

3

Digestive

Nausea

31

36

25

26

45

Vomiting

21

28

15

7

31

Constipation

14

11

13

4

20

Intestinal Obstruction

0

2

4

0

3

Cardiovascular

Hypertension

1

1

0

0

1

Nervous

Dizziness

12

10

9

0

16

Anxiety

9

8

8

7

15

Somnolence

8

13

8

7

15

Confusion

2

5

13

7

10

Depression

9

4

2

7

9

Insomnia

5

1

8

4

7

Abnormal Gait

5

1

0

0

4

Dry Mouth

3

1

2

4

4

Nervousness

2

2

0

4

3

Stupor

4

1

0

0

3

Vasodilatation

1

1

4

0

3

Thinking Abnormal

2

1

0

0

2

Abnormal Dreams

1

1

0

0

1

Convulsion

0

1

2

0

1

Myoclonus

0

0

4

0

1

Tremor

0

1

2

0

1

Vertigo

0

0

4

0

1

Respiratory

Dyspnea

15

16

8

7

22

Skin

Rash

3

5

8

4

8

Sweating

3

2

2

0

4

Pruritus

2

0

2

0

2

Special Senses

Abnormal Vision

2

2

0

0

3

Urogenital

Urinary Retention

1

2

0

0

2

The following reactions not reflected in Table 2 occurred with an overall frequency of 1% or greater in the long-term extension study and are listed in descending order of frequency within each body system.

Body as a Whole: Pain, fever, back pain, abdominal pain, chest pain, flu syndrome, chills, infection, abdomen enlarged, bone pain, ascites, sepsis, neck pain, viral infection, fungal infection, cachexia, cellulitis, malaise, pelvic pain

Cardiovascular: Deep thrombophlebitis, palpitation, vascular disorder

Digestive: Diarrhea, anorexia, dyspepsia, dysphagia, oral moniliasis, mouth ulceration, rectal disorder, stomatitis, flatulence, gastrointestinal hemorrhage, gingivitis, jaundice, periodontal abscess, eructation, glossitis, rectal hemorrhage

Hemic and Lymphatic: Anemia, leukopenia, thrombocytopenia, ecchymosis, lymphadenopathy, lymphedema, pancytopenia

Metabolic and Nutritional: Peripheral edema, edema, dehydration, weight loss, hyperglycemia, hypokalemia, hypercalcemia, hypomagnesemia

Musculoskeletal: Myalgia, pathological fracture, joint disorder, leg cramps, arthralgia, bone disorder

  Nervous: Hypesthesia, paresthesia, hypokinesia, neuropathy, speech disorder, migraine

Respiratory: Cough increased, pharyngitis, pneumonia, rhinitis, sinusitis, bronchitis, epistaxis, asthma, hemoptysis, sputum increased

  Skin and Appendages: Skin ulcer, alopecia   Special Senses: Tinnitus, conjunctivitis, ear disorder, taste perversion

Urogenital: Urinary tract infection, urinary incontinence, breast pain, dysuria, hematuria, scrotal edema, hydronephrosis, kidney failure, urinary urgency, urination impaired, breast neoplasm, vaginal hemorrhage, vaginitis

The following reactions occurred with a frequency of less than 1% in the long-term extension study and are listed in descending order of frequency within each body system.

Body as a Whole: Allergic reaction, cyst, face edema, flank pain, granuloma, bacterial infection, mucous membrane disorder, neck rigidity

Cardiovascular: Angina pectoris, hemorrhage, hypotension, peripheral vascular disorder, postural hypotension, tachycardia

Digestive: Cheilitis, esophagitis, fecal incontinence, gastroenteritis, gastrointestinal disorder, gum hemorrhage, hemorrhage of colon, hepatorenal syndrome, liver tenderness, tooth caries, tooth disorder

  Hemic and Lymphatic: Bleeding time increased

Metabolic and Nutritional: Acidosis, generalized edema, hypocalcemia, hypoglycemia, hyponatremia, hypoproteinemia, thirst

Musculoskeletal: Arthritis, muscle atrophy, myopathy, synovitis, tendon disorder

Nervous: Acute brain syndrome, agitation, cerebral ischemia, facial paralysis, foot drop, hallucinations, hemiplegia, miosis, subdural hematoma

Respiratory: Hiccup, hyperventilation, lung disorder, pneumothorax, respiratory failure, voice alteration

Skin and Appendages: Herpes zoster, maculopapular rash, skin discoloration, urticaria, vesiculobullous rash

Special Senses: Ear pain, eye hemorrhage, lacrimation disorder, partial permanent deafness, partial transitory deafness

Urogenital: Kidney pain, nocturia, oliguria, polyuria, pyelonephritis

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Actiq. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Digestive:

- Dental decay: Dental decay, including dental caries, tooth loss, and gum line erosion.

Nervous System Disorders:

- Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Endocrine Disorders:

- Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

- Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids.

Immune System Disorders:

- Anaphylaxis: Anaphylaxis has been reported with ingredients contained in Actiq.

General Disorders and Administration Site Conditions: Application site reactions including irritation, pain, and ulcer, and drug withdrawal syndrome.

Actiq Usage

Take Actiq exactly as prescribed.

This medication comes in a lozenge form. 

Instructions for use of lozenges:

Place Actiq in your mouth between your cheeks and gums and actively suck on the medicine. Move the lozenge around in your mouth, especially along the inside of your cheeks. Twirl the handle often. Finish the Actiq unit completely in 15 minutes to get the most relief. If you finish Actiq too quickly, you will swallow more of the medicine and get less relief. Do not bite or chew Actiq. You will get less relief for your breakthrough cancer pain.

Actiq Dosage

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

  • the condition being treated
  • how you respond to this medication
  • your weight
  • your age

The recommended dose/dose range of Actiq (fentanyl) lozenge for the treatment of breakthrough cancer pain is 200 mcg to 1600 mcg. The lozenge should be consumed over 15 minutes. Actiq is only indicated for patients who are already taking around-the-clock opioid medications. The dose of Actiq is titrated based on your response to the medication and the dose may be repeated once in 30 minutes if additional pain relief is needed. Wait at least 4 hours before treating another episode of pain.

 

Other Requirements

  • Store Actiq at room temperature.
  • Keep this and all medicines out of the reach of children.
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