AMITIZA (lubiprostone) 24 mcg capsules twice daily are indicated for the treatment of Opioid-Induced Constipation (OIC) in adults with chronic, non-cancer pain, including chronic pain related to prior cancer or its treatment who do not require frequent (e.g. weekly) opioid dose escalation. The effectiveness in patients with OIC taking diphenylheptane opioids (e.g., methadone) has not been established.
Data 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.1
*Data for adverse reactions that occurred in ≥ 1% of patients who received AMITIZA 24 mcg twice daily and that occurred more frequently with study drug than with placebo.
†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."
Based upon the results of in vitro human microsome studies, there is low likelihood of pharmacokinetic drug-drug interactions with AMITIZA.1
Non-clinical studies have shown opioids of the diphenylheptane chemical class (e.g., methadone) to dose-dependently reduce the activation of ClC-2 by lubiprostone in the gastrointestinal tract.1 There is a possibility of a dose-dependent decrease in the efficacy of AMITIZA in patients using diphenylheptane opioids.
AMITIZA has demonstrated efficacy in OIC in adult patients with non-cancer pain.
Learn about dosing for you and your patients.
AMITIZA is covered for 89% of Medicare Part D lives.
Fingertip Formulary, September 2018.
AMITIZA (lubiprostone) is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated by the treating healthcare provider (HCP) to confirm the absence of such an obstruction prior to initiating AMITIZA treatment.
Patients taking AMITIZA may experience nausea. Concomitant administration of food with AMITIZA may reduce symptoms of nausea.
Avoid use of AMITIZA in patients with severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment. Instruct patients to discontinue AMITIZA and contact their HCP if severe diarrhea occurs.
Syncope and hypotension have been reported with AMITIZA in the postmarketing setting and a few of these adverse reactions resulted in hospitalization. Most reports occurred in patients taking 24 mcg twice daily. Patients should be aware that the risk of syncope and hypotension may be increased with concomitant diarrhea, vomiting, or use of medications known to lower blood pressure. Inform patients that syncope and hypotension may occur within an hour of the first dose or subsequent doses of AMITIZA and generally resolve prior to the next dose, but may recur with repeat dosing. Instruct patients to discontinue AMITIZA and contact their HCP if these reactions occur.
Dyspnea may occur within an hour of first dose. This symptom generally resolves within three hours, but may recur with repeat dosing. Instruct patients to contact their HCP if dyspnea occurs. Some patients have discontinued therapy because of dyspnea.
In clinical trials of AMITIZA (24 mcg twice daily vs placebo; N=1113 vs N=316, respectively) in patients with CIC, the most common adverse reactions (incidence > 4%) were nausea (29% vs 3%), diarrhea (12% vs 1%), headache (11% vs 5%), abdominal pain (8% vs 3%), abdominal distension (6% vs 2%), and flatulence (6% vs 2%).
In clinical trials of AMITIZA (24 mcg twice daily vs placebo; N=860 vs N=632, respectively) in patients with OIC, the most common adverse reactions (incidence > 4%) were nausea (11% vs 5%) and diarrhea (8% vs 2%).
In clinical trials of AMITIZA (8 mcg twice daily vs placebo; N=1011 vs N=435, respectively) in patients with IBS-C, the most common adverse reactions (incidence > 4%) were nausea (8% vs 4%), diarrhea (7% vs 4%), and abdominal pain (5% vs 5%).
Concomitant use of diphenylheptane opioids (e.g., methadone) may interfere with the efficacy of AMITIZA.
The safety of AMITIZA in pregnancy has not been evaluated in humans. Based on animal data, AMITIZA may cause fetal harm. AMITIZA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when AMITIZA is administered to a nursing woman. Advise nursing women to monitor infants for diarrhea.
Reduce the dosage in CIC and OIC patients with moderate and severe hepatic impairment. Reduce the dosage in IBS-C patients with severe hepatic impairment.
AMITIZA (lubiprostone) 24 mcg capsules twice daily are indicated for the treatment of Chronic Idiopathic Constipation (CIC) in adults and Opioid-Induced Constipation (OIC) in adults with chronic, non-cancer pain, including chronic pain related to prior cancer or its treatment who do not require frequent (e.g. weekly) opioid dose escalation. The effectiveness in patients with OIC taking diphenylheptane opioids (e.g., methadone) has not been established. AMITIZA 8 mcg capsules twice daily are also indicated for Irritable Bowel Syndrome with Constipation (IBS-C) in women ≥ 18 years old.
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You must meet Eligibility Requirements. You agree to report your use of this offer to any Third Party that reimburses you or pays for any part of the prescription price. Use of this offer is confirmation that you are permitted, under the terms and conditions of the health benefit plan(s) covering your prescriptions, to take advantage of co-pay coverage programs. You additionally agree that you will not submit the cost of any portion of the product dispensed pursuant to this offer to a federal or state healthcare program for purposes of counting it toward your out-of-pocket expenses. This savings card covers out-of-pocket expenses up to a maximum benefit of $75 for a 30-day prescription or up to $225 for a 90-day prescription. For mail order prescriptions, a mail-in rebate form is available at www.patientrebateonline.com or by calling 1-866-279-8995. This coupon is not valid with any other program, discount, or incentive involving AMITIZA (lubiprostone). This offer may be rescinded, revoked, or amended without notice. No reproductions. This offer is void where prohibited by law, taxed, or restricted. Limit one offer per purchase. Cash value of 1/100 of 1¢. For questions about this offer, call the Customer Service Center at
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