Amitiza

AMITIZA- lubiprostone capsule, gelatin coated
Carilion Materials Management

1 INDICATIONS AND USAGE

1.1 Chronic Idiopathic Constipation

Amitiza is indicated for the treatment of chronic idiopathic constipation in adults. ®

1.2 Opioid-induced Constipation

Amitiza is indicated for the treatment of opioid -induced constipation (OIC) in adults with chronic non-cancer pain.

Limitations of Use:

Effectiveness of Amitiza in the treatment of opioid -induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established. [see Clinical Studies ( )] 14.2

1.3 Irritable Bowel Syndrome with Constipation

Amitiza is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in women ≥ 18 years old.

2 DOSAGE AND ADMINISTRATION

Take Amitiza orally with food and water. Swallow capsules whole and do not break apart or chew. Physicians and patients should periodically assess the need for continued therapy.

2.1 Chronic Idiopathic Constipation and Opioid-induced Constipation

The recommended dose is 24 mcg twice daily orally with food and water.

Dosage in patients with hepatic impairment

For patients with moderately impaired hepatic function (Child-Pugh Class B), the recommended starting dose is 16 mcg twice daily. For patients with severely impaired hepatic function (Child-Pugh Class C), the recommended starting dose is 8 mcg twice daily. If this dose is tolerated and an adequate response has not been obtained after an appropriate interval, doses can then be escalated to full dosing with appropriate monitoring of patient response and . [see Use in Specific Populations ( ) 8.7 Clinical Pharmacology ( )] 12.3

2.2 Irritable Bowel Syndrome with Constipation

The recommended dose is 8 mcg twice daily orally with food and water.

Dosage in patients with hepatic impairment

For patients with severely impaired hepatic function (Child-Pugh Class C), the recommended starting dose is 8 mcg once daily. If this dose is tolerated and an adequate response has not been obtained after an appropriate interval, doses can then be escalated to full dosing with appropriate monitoring of patient response. Dosage adjustment is not required for patients with moderately impaired hepatic function (Child-Pugh Class B) . [see Use in Specific Populations ( ) and Clinical Pharmacology ( )] 8.712.3

3 DOSAGE FORMS AND STRENGTHS

Amitiza is available as an oval, gelatin capsule containing 8 mcg or 24 mcg of lubiprostone.

8 mcg capsules are pink and are printed with “SPI” on one side
24 mcg capsules are orange and are printed with “SPI” on one side

4 CONTRAINDICATIONS

Amitiza is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.

5 WARNINGS AND PRECAUTIONS

5.1 Nausea

Patients taking Amitiza may experience nausea. Concomitant administration of food with Amitiza may reduce symptoms of nausea [see ]. Adverse Reactions ( ) 6.1

5.2 Diarrhea

Amitiza should not be prescribed to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment. Patients should be instructed to discontinue Amitiza and inform their physician if severe diarrhea occurs [see ]. Adverse Reactions ( ) 6.1

5.3 Dyspnea

In clinical trials, dyspnea was reported by 3%, 1%, and < 1% of the treated CIC, OIC, and IBS-C populations receiving Amitiza, respectively, compared to 0%, 1%, and < 1% of placebo-treated patients. There have been postmarketing reports of dyspnea when using Amitiza 24 mcg twice daily. Some patients have discontinued treatment because of dyspnea. These events have usually been described as a sensation of chest tightness and difficulty taking in a breath, and generally have an acute onset within 30–60 minutes after taking the first dose. They generally resolve within a few hours after taking the dose, but recurrence has been frequently reported with subsequent doses.

5.4 Bowel Obstruction

In patients with symptoms suggestive of mechanical gastrointestinal obstruction, perform a thorough evaluation to confirm the absence of an obstruction prior to initiating therapy with Amitiza.

6 ADVERSE REACTIONS

The following adverse reactions are described below and elsewhere in labeling:

Nausea [see Warnings and Precautions ( )] 5.1
Diarrhea [see Warnings and Precautions ( )] 5.2
Dyspnea [see Warnings and Precautions ( )] 5.3

6.1 Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

During clinical development of Amitiza for CIC, OIC, and IBS-C, 1234 patients were treated with Amitiza for 6 months and 524 patients were treated for 1 year (not mutually exclusive).

Chronic Idiopathic Constipation

The data described below reflect exposure to Amitiza 24 mcg twice daily in 1113 patients with chronic idiopathic constipation over 3- or 4-week, 6-month, and 12-month treatment periods; and from 316 patients receiving placebo over short-term exposure (≤ 4 weeks). The placebo population (N = 316) had a mean age of 47.8 (range 21–81) years; was 87.3% female; 80.7% Caucasian, 10.1% African American, 7.3% Hispanic, 0.9% Asian; and 11.7% elderly (≥ 65 years of age). Of those patients treated with Amitiza 24 mcg twice daily (N=1113), the mean age was 50.3 (range 19-86) years; 86.9% were female; 86.1% Caucasian, 7.6% African American, 4.7% Hispanic, 1.0% Asian; and 16.7% elderly (≥ 65 years of age). Table 1 presents data for the adverse reactions that occurred in at least 1% of patients who received Amitiza 24 mcg twice daily and that occurred more frequently with study drug than placebo. Adverse reactions in dose-finding, efficacy, and long-term clinical studies:

*
Includes only those events associated with treatment (possibly, probably, or definitely related, as assessed by the investigator).
This term combines “abdominal tenderness,” “abdominal rigidity,” “gastrointestinal discomfort,” “stomach discomfort”, and “abdominal discomfort.”

Table 1: Percent of Patients with Adverse Reactions (Chronic Idiopathic Constipation)

System/Adverse Reaction *

Placebo N = 316 %

Amitiza 24 mcg Twice Daily N = 1113 %

Gastrointestinal disorders

Nausea

3

29

Diarrhea

1

12

Abdominal pain

3

8

Abdominal distension

2

6

Flatulence

2

6

Vomiting

0

3

Loose stools

0

3

Abdominal discomfort

1

3

Dyspepsia

< 1

2

Dry mouth

< 1

1

Nervous system disorders

Headache

5

11

Dizziness

1

3

General disorders and site administration conditions

Edema

< 1

3

Fatigue

1

2

Chest discomfort/pain

0

2

Respiratory, thoracic, and mediastinal disorders

Dyspnea

0

2

The most common adverse reactions (incidence > 4%) in CIC were nausea, diarrhea, headache, abdominal pain, abdominal distension, and flatulence.

Approximately 29% of patients who received Amitiza 24 mcg twice daily experienced nausea; 4% of patients had severe nausea and 9% of patients discontinued treatment due to nausea. The rate of nausea associated with Amitiza 24 mcg twice daily was lower among male (8%) and elderly (19%) patients. No patients in the clinical studies were hospitalized due to nausea. Nausea:

Approximately 12% of patients who received Amitiza 24 mcg twice daily experienced diarrhea; 2% of patients had severe diarrhea and 2% of patients discontinued treatment due to diarrhea. Diarrhea:

No serious adverse reactions of electrolyte imbalance were reported in clinical studies, and no clinically significant changes were seen in serum electrolyte levels in patients receiving Amitiza. Electrolytes:

The following adverse reactions (assessed by investigator as probably or definitely related to treatment) occurred in less than 1% of patients receiving Amitiza 24 mcg twice daily in clinical studies, occurred in at least two patients, and occurred more frequently in patients receiving study drug than those receiving placebo: fecal incontinence, muscle cramp, defecation urgency, frequent bowel movements, hyperhidrosis, pharyngolaryngeal pain, intestinal functional disorder, anxiety, cold sweat, constipation, cough, dysgeusia, eructation, influenza, joint swelling, myalgia, pain, syncope, tremor, decreased appetite. Less common adverse reactions:

Opioid -induced Constipation

The data described below reflect exposure to Amitiza 24 mcg twice daily in 860 patients with OIC for up to 12 months and from 632 patients receiving placebo twice daily for up to 12 weeks. The total population (N = 1492) had a mean age of 50.4 (range 20–89) years; was 62.7% female; 82.7% Caucasian, 14.2% African American, 0.8% American Indian/Alaska Native, 0.8% Asian; 5.2% were of Hispanic ethnicity; and 8.8% were elderly (≥ 65 years of age). Table 2 presents data for the adverse reactions that occurred in at least 1% of patients who received Amitiza 24 mcg twice daily and that occurred more frequently with study drug than placebo. Adverse reactions in efficacy and long-term clinical studies:

*
Includes only those events associated with treatment (possibly, probably, or definitely related, as assessed by the investigator).
This term combines “abdominal tenderness,” “abdominal rigidity,” “gastrointestinal discomfort,” “stomach discomfort”, and “abdominal discomfort.”

Table 2: Percent of Patients with Adverse Reactions (OIC Studies)

System/Adverse Reaction *

Placebo N = 632 %

Amitiza 24 mcg Twice Daily N = 860 %

Gastrointestinal disorders

Nausea

5

11

Diarrhea

2

8

Abdominal pain

1

4

Flatulence

3

4

Abdominal distension

2

3

Vomiting

2

3

Abdominal discomfort

1

1

Nervous system disorders

Headache

1

2

General disorders and site administration conditions

Peripheral edema

< 1

1

The most common adverse reactions (incidence > 4%) in OIC were nausea and diarrhea.

Approximately 11% of patients who received Amitiza 24 mcg twice daily experienced nausea; 1% of patients had severe nausea and 2% of patients discontinued treatment due to nausea. Nausea:

Approximately 8% of patients who received Amitiza 24 mcg twice daily experienced diarrhea; 2% of patients had severe diarrhea and 1% of patients discontinued treatment due to diarrhea. Diarrhea:

The following adverse reactions (assessed by investigator as probably or definitely related to treatment) occurred in less than 1% of patients receiving Amitiza 24 mcg twice daily in clinical studies, occurred in at least two patients, and occurred more frequently in patients receiving study drug than those receiving placebo: fecal incontinence, blood potassium decreased. Less common adverse reactions:

Irritable Bowel Syndrome with Constipation

The data described below reflect exposure to Amitiza 8 mcg twice daily in 1011 patients with IBS-C for up to 12 months and from 435 patients receiving placebo twice daily for up to 16 weeks. The total population (N = 1267) had a mean age of 46.5 (range 18–85) years; was 91.6% female; 77.5% Caucasian, 12.9% African American, 8.6% Hispanic, 0.4% Asian; and 8.0% elderly (≥ 65 years of age). Table 3 presents data for the adverse reactions that occurred in at least 1% of patients who received Amitiza 8 mcg twice daily and that occurred more frequently with study drug than placebo. Adverse reactions in dose-finding, efficacy, and long-term clinical studies:

*
Includes only those events associated with treatment (possibly or probably related, as assessed by the investigator).

Table 3: Percent of Patients with Adverse Reactions (IBS-C Studies)

System/Adverse Reaction *

Placebo N = 435 %

Amitiza 8 mcg Twice Daily N = 1011 %

Gastrointestinal disorders

Nausea

4

8

Diarrhea

4

7

Abdominal pain

5

5

Abdominal distension

2

3

The most common adverse reactions (incidence > 4%) in IBS-C were nausea, diarrhea, and abdominal pain.

Approximately 8% of patients who received Amitiza 8 mcg twice daily experienced nausea; 1% of patients had severe nausea and 1% of patients discontinued treatment due to nausea. Nausea:

Approximately 7% of patients who received Amitiza 8 mcg twice daily experienced diarrhea; <1% of patients had severe diarrhea and <1% of patients discontinued treatment due to diarrhea. Diarrhea:

The following adverse reactions (assessed by investigator as probably related to treatment) occurred in less than 1% of patients receiving Amitiza 8 mcg twice daily in clinical studies, occurred in at least two patients, and occurred more frequently in patients receiving study drug than those receiving placebo: dyspepsia, loose stools, vomiting, fatigue, dry mouth, edema, increased alanine aminotransferase, increased aspartate aminotransferase, constipation, eructation, gastroesophageal reflux disease, dyspnea, erythema, gastritis, increased weight, palpitations, urinary tract infection, anorexia, anxiety, depression, fecal incontinence, fibromyalgia, hard feces, lethargy, rectal hemorrhage, pollakiuria. Less common adverse reactions:

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