MOVANTIK- naloxegol oxalate tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NALOXEGOL OXALATE (UNII: 65I14TNM33) (NALOXEGOL - UNII:44T7335BKE)

Available from:

AstraZeneca Pharmaceuticals LP

INN (International Name):

NALOXEGOL OXALATE

Composition:

NALOXEGOL 12.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

MOVANTIK® is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. MOVANTIK is contraindicated in: Risk Summary Limited available data with MOVANTIK use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. MOVANTIK may precipitate opioid withdrawal in the pregnant women and the fetus (see Clinical Considerations) . In animal development studies, no effects on embryo-fetal development were observed following administration of naloxegol in pregnant rats during the period of organogenesis at doses up to 1452 times the human AUC (area under the plasma concentration-time curve) at the maximum recommended human dose. No effects on embryo-fetal development were observed following administration of naloxegol in pregnant rabbits during the period of organogenesis at

Product summary:

MOVANTIK (naloxegol) tablets are supplied as: Storage Store MOVANTIK at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Patient Information leaflet

AstraZeneca Pharmaceuticals LP
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MEDICATION GUIDE
MOVANTIK® (mo-van-tic)
(naloxegol) tablets, for oral use
Read this Medication Guide before you start taking MOVANTIK and each
time you get a refill. There
may be new information. This information does not take the place of
talking with your healthcare
provider about your medical condition or your treatment.
What is the most important information I should know about MOVANTIK?
MOVANTIK may cause serious side effects, including:
•
Opioid withdrawal. You may have symptoms of opioid withdrawal during
treatment with
MOVANTIK including sweating, chills, diarrhea, stomach pain, anxiety,
irritability, and yawning.
If you take methadone to treat your pain, you may be more likely to
have stomach pain and
diarrhea than people who do not take methadone. Tell your health care
provider if you have any of
these symptoms.
•
Severe stomach pain or diarrhea, or both severe stomach pain and
diarrhea. Severe stomach pain
and diarrhea can happen when you take MOVANTIK. These problems can
happen within a few
days after you start taking MOVANTIK and can lead to hospitalization.
Stop taking MOVANTIK
and call your healthcare provider right away if you have severe
stomach pain or diarrhea, or both
severe stomach pain and diarrhea.
•
Tear in your stomach or intestinal wall (perforation). Stomach pain
that is severe can be a sign of a
serious medical condition. If you have stomach pain that gets worse or
does not go away, stop
taking MOVANTIK and get emergency medical help right away.
What is MOVANTIK?
MOVANTIK is a prescription medicine used to treat constipation that is
caused by prescription pain
medicines called opioids, in adults with long-lasting (chronic) pain
that is not caused by active cancer.
It is not known if MOVANTIK is safe and effective in children.
Who should not take MOVANTIK?
Do not take MOVANTIK if you:
•
have a bowel blockage (intestinal obstruction) or have a history of
bowel blockage.
•
are allergic to MOVANTIK or any of the ingredients in MOVANTIK.

Summary of Product characteristics

MOVANTIK- NALOXEGOL OXALATE TABLET, FILM COATED
ASTRAZENECA PHARMACEUTICALS LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MOVANTIK SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MOVANTIK.
MOVANTIK (NALOXEGOL) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2014
RECENT MAJOR CHANGES
Warnings and Precautions (5.3) 04/2020
INDICATIONS AND USAGE
MOVANTIK is an opioid antagonist indicated for the treatment of
opioid-induced constipation (OIC) in adult
patients with chronic non-cancer pain, including patients with chronic
pain related to prior cancer or its
treatment who do not require frequent (e.g., weekly) opioid dosage
escalation. (1)
DOSAGE AND ADMINISTRATION
Administration:
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Recommended dosage:
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions in clinical trials (≥3%) are:
abdominal pain, diarrhea, nausea,
flatulence, vomiting, and headache. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at
1-800-236-9933 or FDA at 1-800-
®
Discontinue maintenance laxative therapy before starting MOVANTIK; may
resume laxatives if
patients have OIC symptoms after taking MOVANTIK for 3 days. (2.1)
Alteration in analgesic dosing regimen prior to starting MOVANTIK is
not required. (2.1)
Patients receiving opioids for less than 4 weeks may be less
responsive to MOVANTIK. (2.1)
Take on an empty stomach at least 1 hour prior to the first meal of
the day or 2 hours after the meal.
(2.1)
For patients who are unable to swallow the MOVANTIK tablet whole, the
tablet can be crushed and
given orally or administered via nasogastric tube, see full
prescribing information. (2.1)
Avoid consumption of grapefruit or grapefruit juice. (2.1, 7.1)
Discontinue if treatment with the opioid pain medication is also
discontinued. (2.1)
25 mg once daily; if not tolerated, reduce to 12.5 mg once daily.
(2.2)
Renal Impairment