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Actiq

"Nov. 29, 2012 (Chicago) -- For cancer patients undergoing chemotherapy who have found their complaints of general mental fogginess and haziness dismissed by their doctors as not being a real medical condition, vindication has arrived.

"...

Actiq

Actiq

Actiq Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Actiq (oral transmucosal fentanyl citrate) treats "breakthrough" cancer pain that is not controlled by other medicines. This medication is not for short-term pain relief. It is a narcotic pain medicine. This medication is available in generic form. Common side effects include dry mouth, headache, dizziness, weakness, anxiety, nausea, vomiting, or constipation.

The initial dose of Actiq to treat episodes of breakthrough cancer pain is always 200 mcg. The Actiq unit should be consumed over 15 minutes. The dose may be increased under a physician's supervision until pain relief is achieved. Tell your doctor all medications you are taking. It is not known whether Actiq is harmful a fetus. This medication could cause addiction or withdrawal symptoms in a newborn if the mother uses it during pregnancy. This medication can pass into breast milk and may cause sleepiness or breathing problems in a nursing baby. Actiq may also cause addiction and withdrawal symptoms in a nursing infant. Consult your doctor before breast-feeding. Actiq may be habit-forming. Do not stop using Actiq suddenly, or you could have withdrawal symptoms.

Our Actiq (oral transmucosal fentanyl citrate) 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Actiq in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using fentanyl citrate and call your doctor at once if you have any of these serious side effects:

  • shallow breathing, slow heart rate;
  • extreme sleepiness; or
  • feeling light-headed, fainting.

Less serious side effects may include:

  • dry mouth;
  • headache, dizziness, weakness, anxiety; or
  • nausea, vomiting, or constipation.

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 Actiq (Fentanyl Citrate) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Actiq FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Studies Experience

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 adverse reactions seen with ACTIQ are typical opioid side effects. Frequently, these adverse reactions will cease or decrease in intensity with continued use of ACTIQ, as the patient is titrated to the proper dose. Expect opioid side effects and manage them accordingly.

The most serious adverse reactions associated with all opioids including ACTIQ 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 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. Adverse reactions are included regardless of causality or severity.

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.

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. The goal of titration in these trials was to find the dose of ACTIQ that provided adequate analgesia with acceptable side effects (successful dose). Patients were titrated from a low dose to a successful dose in a manner similar to current titration dosing guidelines. Table 1 lists, by dose groups, adverse reactions with an overall frequency of 1% or greater that occurred during titration and are commonly associated with opioid administration or are of particular clinical interest. 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)

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
  ThinkingAbnormal 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
* Any Dose = A patient who experienced the same adverse event at multiple doses was only counted once.

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

Cardiovascular: Migraine

Digestive: Diarrhea, dyspepsia, flatulence

Metabolic and Nutritional: Peripheral edema, dehydration

Nervous: Hypesthesia

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: Flu syndrome, abscess, bone pain

Cardiovascular: Deep thrombophlebitis, hypertension, hypotension

Digestive: Anorexia, eructation, esophageal stenosis, 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 and are commonly associated with opioid administration or are of particular clinical interest. 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)

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
* Any Dose = A patient who experienced the same adverse event at multiple doses was only counted once.

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, migraine, 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

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, injection site pain, 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

Adverse reactions are reported voluntarily from a population of uncertain size, and, therefore, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of the reporting, or (3) strength of causal connection to ACTIQ.

The following adverse reactions have been identified during postapproval use of ACTIQ (which contains approximately 2 grams of sugar per unit):

Digestive: Dental decay of varying severity including dental caries, tooth loss, and gum line erosion.

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

Read the entire FDA prescribing information for Actiq (Fentanyl Citrate) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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