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Relistor

Last reviewed on RxList: 3/23/2018
Relistor Side Effects Center

Last reviewed on RxList 3/23/2018

Relistor (methylnaltrexone bromide) is a mu-opioid receptor antagonist, a type of special narcotic drug that blocks certain effects of other narcotic medicines, used to reduce constipation caused by narcotic medications that are often used to treat pain in people with terminal illness. Relistor is usually given after laxatives have been tried without successful treatment of constipation. Common side effects of Relistor include:

  • stomach/abdominal pain,
  • gas,
  • nausea,
  • diarrhea,
  • dizziness,
  • increased sweating,
  • hot flashes,
  • flushing,
  • tremor, or
  • chills.

Tell your doctor if you have serious side effects of Relistor including:

  • severe or ongoing diarrhea,
  • stomach pain that will not go away,
  • black or bloody stools,
  • coughing up blood, or
  • nausea or vomiting that are new or worsening symptoms.

Relistor is administered as a subcutaneous (under the skin) injection. The usual schedule is one dose every other day, but no more than one dose in a 24-hour period Dosage is based on the patient's weight. Relistor may interact with buprenorphine, butorphanol, codeine, hydrocodone, hydromorphone, levorphanol, meperidine, methadone, morphine, nalbuphine, naloxone, oxycodone, oxymorphone or propoxyphene. Tell your doctor all medications you use. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Relistor. It is unknown if this medication passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Relistor (methylnaltrexone bromide) 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.

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Relistor Consumer Information

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

Stop using methylnaltrexone and call your doctor at once if you have:

  • severe stomach pain that gets worse or will not go away;
  • severe or ongoing diarrhea;
  • extreme dizziness, or feeling like you might pass out;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • nausea or vomiting that are new or worsening symptoms; or
  • symptoms of narcotic medicine withdrawal--anxiety, sweating, chills, yawning, stomach pain, diarrhea.

Common side effects may include:

  • stomach pain, gas, bloating;
  • mild nausea or diarrhea;
  • headache, muscle spasms;
  • dizziness, tremors, feeling anxious;
  • runny nose; or
  • chills, sweating, or hot flashes.

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 Relistor (Methylnaltrexone Bromide Injection)

QUESTION

Medically speaking, the term "myalgia" refers to what type of pain? See Answer
Relistor Professional Information

SIDE EFFECTS

Serious and important adverse reactions described elsewhere in the labeling include:

  • Gastrointestinal perforation [see WARNINGS AND PRECAUTIONS]
  • Severe or persistent diarrhea [see WARNINGS AND PRECAUTIONS]
  • Opioid withdrawal [see WARNINGS AND PRECAUTIONS]

Clinical Trials 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 clinical practice.

Opioid-Induced Constipation In Adult Patients With Chronic Non-Cancer Pain

The safety of RELISTOR tablets was evaluated in a double-blind, placebo-controlled trial in adult patients with OIC and chronic non-cancer pain receiving opioid analgesia. This study (Study 1) included a 12-week, double-blind, placebo-controlled period in which adult patients were randomized to receive RELISTOR tablets 450 mg orally (200 patients) or placebo (201 patients) [see Clinical Studies]. After 4 weeks of double-blind treatment administered once daily, patients continued 8 weeks of double-blind treatment on an as needed basis (but not more than once daily).

The most common adverse reactions in adult patients with OIC and chronic non-cancer pain receiving RELISTOR tablets are shown in Table 4. Adverse reactions of abdominal pain, diarrhea, hyperhidrosis, anxiety, rhinorrhea, and chills may reflect symptoms of opioid withdrawal.

Table 4: Adverse Reactions* in 4,-Week Double-Blind, Placebo-Controlled Period of Clinical Study of RELISTOR Tablets in Adult Patients with OIC and Chronic Non-Cancer Pain (Study 1)

Adverse Reaction RELISTOR Tablets
n = 200
Placebo
n = 201
Abdominal Pain ** 14% 10%
Diarrhea 5% 2%
Headache 4% 3%
Abdominal Distention 4% 2%
Vomiting 3% 2%
Hyperhidrosis 3% 1%
Anxiety 2% 1%
Muscle Spasms 2% 1%
Rhinorrhea 2% 1%
Chills 2% 0%
* Adverse reactions occurring in at least 2% of patients receiving RELISTOR tablets 450 mg once daily and at an incidence greater than placebo.
** Includes: abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort and abdominal tenderness

The safety of RELISTOR injection was evaluated in a double-blind, placebo-controlled trial in adult patients with OIC and chronic non-cancer pain receiving opioid analgesia. This study (Study 2) included a 4-week, double-blind, placebo-controlled period in which adult patients were randomized to receive RELISTOR injection 12 mg subcutaneously once daily (150 patients) or placebo (162 patients) [see Clinical Studies]. After 4 weeks of double-blind treatment, patients began an 8-week open-label treatment period during which RELISTOR injection 12 mg subcutaneously was administered less frequently than the recommended dosage regimen of 12 mg once daily.

The most common adverse reactions in adult patients with OIC and chronic non-cancer pain receiving RELISTOR injection are shown in Table 5. The adverse reactions in the table below may reflect symptoms of opioid withdrawal.

Table 5: Adverse Reactions* in 4-Week Double-Blind, Placebo-Controlled Period of Clinical Study of RELISTOR Injection in Adult Patients with OIC and Chronic Non-Cancer Pain (Study 2)

Adverse Reaction RELISTOR Injection
n = 150
Placebo
n = 162
Abdominal Pain** 21% 7%
Nausea 9% 6%
Diarrhea 6% 4%
Hyperhidrosis 6% 1%
Hot Flush 3% 2%
Tremor 1% <1%
Chills 1% 0%
* Adverse reactions occurring in at least 1% of patients receiving RELISTOR injection 12 mg subcutaneously once daily and at an incidence greater than placebo.
** Includes: abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort and abdominal tenderness

During the 4-week double-blind period, in patients with OIC and chronic non-cancer pain that received RELISTOR every other day, there was a higher incidence of adverse reactions, including nausea (12%), diarrhea (12%), vomiting (7%), tremor (3%), feeling of body temperature change (3%), piloerection (3%), and chills (2%) as compared to daily RELISTOR dosing. Use of RELISTOR injection 12 mg subcutaneously every other day is not recommended in patients with OIC and chronic non-cancer pain [see DOSAGE AND ADMINISTRATION]. The rates of discontinuation due to adverse reactions during the double-blind period (Study 2) were higher in the RELISTOR once daily (7%) than the placebo group (3%). Abdominal pain was the most common adverse reaction resulting in discontinuation from the double-blind period in the RELISTOR once daily group (2%).

The safety of RELISTOR injection was also evaluated in a 48-week, open-label, uncontrolled trial in 1034 adult patients with OIC and chronic non-cancer pain (Study 3). Patients were allowed to administer RELISTOR injection 12 mg subcutaneously less frequently than the recommended dosage regimen of 12 mg once daily, and took a median of 6 doses per week. A total of 624 patients (60%) completed at least 24 weeks of treatment and 477 (46%) completed the 48-week study. The adverse reactions seen in this study were similar to those observed during the 4-week double-blind period of Study 2. Additionally, in Study 3, investigators reported 4 myocardial infarctions (1 fatal), 1 stroke (fatal), 1 fatal cardiac arrest and 1 sudden death. It is not possible to establish a relationship between these events and RELISTOR.

Opioid-Induced Constipation In Adult Patients With Advanced Illness

The safety of RELISTOR injection was evaluated in two, double-blind, placebo-controlled trials in adult patients with OIC and advanced illness receiving palliative care: Study 4 included a single-dose, double-blind, placebo-controlled period, whereas Study 5 included a 14-day multiple dose, double-blind, placebo-controlled period [see Clinical Studies].

The most common adverse reactions in adult patients with OIC and advanced illness receiving RELISTOR injection are shown in Table 6 below.

Table 6: Adverse Reactions from All Doses in Double-Blind, Placebo-Controlled Clinical Studies of RELISTOR Injection in Adult Patients with OIC and Advanced Illness* (Studies 4 and 5)

Adverse Reaction RELISTOR Injection
n = 165
Placebo
n = 123
Abdominal Pain ** 29% 10%
Flatulence 13% 6%
Nausea 12% 5%
Dizziness 7% 2%
Diarrhea 6% 2%
* Adverse reactions occurring in at least 5% of patients receiving all doses of RELISTOR injection (0.075, 0.15, and 0.3 mg/kg) and at an incidence greater than placebo
** Includes: abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort and abdominal tenderness

The rates of discontinuation due to adverse reactions during the double-blind, placebo-controlled clinical trials (Study 4 and Study 5) were comparable between RELISTOR (1%) and placebo (2%).

Postmarketing Experience

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

Gastrointestinal

Perforation, cramping, vomiting

General Disorders And Administration Site Disorders

Diaphoresis, flushing, malaise, pain. Cases of opioid withdrawal have been reported [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Relistor (Methylnaltrexone Bromide Injection)

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© Relistor Patient Information is supplied by Cerner Multum, Inc. and Relistor Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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