Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

MOVANTIK (NDA-204760)

(NALOXEGOL OXALATE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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04/13/2020 (SUPPL-9)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3 Gastrointestinal Perforation

(Additions and/or revisions underlined)

Cases of gastrointestinal (GI) perforation have been reported with use of peripherally acting opioid antagonists, including MOVANTIK. Postmarketing cases of GI perforation, including fatal cases, were reported when MOVANTIK was used in patients at risk of GI perforation (e.g., infiltrative gastrointestinal tract malignancy, recent gastrointestinal tract surgery, diverticular disease including diverticulitis, ischemic colitis, or concomitantly treated with bevacizumab). MOVANTIK is contraindicated in patients with known or suspected gastrointestinal obstruction or in patients at risk of recurrent obstruction. Take into account the overall risk-benefit profile when using MOVANTIK in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn’s disease). Monitor for the development of severe, persistent or worsening abdominal pain; discontinue MOVANTIK in patients who develop this symptom.

6 Adverse Reactions

6.2 Postmarketing Experience

(Additions and/or revisions underlined)

The following adverse reactions have been identified during post-approval use of MOVANTIK. 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.

Hypersensitivity reactions: angioedema, rash, and urticaria.

Gastrointestinal disorders: Gastrointestinal perforation

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

(Additions and/or revisions underlined)

…

What should I tell my healthcare provider before taking MOVANTIK?

Before you take MOVANTIK, tell your healthcare provider about all of your medical conditions, including if you:

have any stomach or bowel (intestines) problems, including inflammation in parts of the large intestine (diverticulitis), inflammation and injury of the intestines caused by reduced blood flow (ischemic colitis), or cancer of the stomach or bowel.
have had recent surgery on the stomach or intestines.
have kidney problems.
have liver problems.
are pregnant or plan to become pregnant. Taking MOVANTIK during pregnancy may cause opioid withdrawal symptoms in you or your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with MOVANTIK.
are breastfeeding or plan to breastfeed. It is not known if MOVANTIK passes into your breast milk.

taking MOVANTIK while you are breastfeeding may cause opioid withdrawal in your baby. You and your healthcare provider should decide if you will take MOVANTIK or breastfeed. You should not breastfeed if you take MOVANTIK.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect the way MOVANTIK works.

Especially tell your healthcare provider if you take a medicine called bevacizumab.

…

05/29/2019 (SUPPL-8)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

(new subsection added)

Hypersensitivity reactions: angioedema, rash and urticaria.

02/28/2018 (SUPPL-7)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

(Additions and/or revisions are underlined)

Table 1. Adverse Reactions* in Patients with OIC and Non-Cancer Pain (Studies 1 and 2)

†Includes: abdominal pain, abdominal pain upper, abdominal pain lower, and gastrointestinal pain.

8 Use in Specific Populations

8.1 Pregnancy

(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; Additions and/or revisions are underlined)

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…

The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically-recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations

Maternal and Fetal/Neonatal adverse reactions

The use of MOVANTIK may be associated with opioid withdrawal in the pregnant woman and the fetus.

8.2 Lactation

(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; Additions and/or revisions are underlined)

There are no data on the presence of naloxegol in human milk, the effects in nursing infants, or the effects on milk production. Naloxegol is present in rat milk (see Data). Because of the potential for adverse reactions, including opioid withdrawal in breastfed infants, advise women that breastfeeding is not recommended during treatment with MOVANTIK.

Data

Following oral administration of naloxegol in lactating rats, concentrations of naloxegol in milk were approximately 3 to 4 fold higher than concentrations of naloxegol in maternal plasma. Naloxegol was detected in plasma from pups.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Pregnancy

Advise females of reproductive potential, who become pregnant or are planning to become pregnant that the use of MOVANTIK during pregnancy may precipitate opioid withdrawal in the pregnant women and the fetus.

Lactation

Advise females that breastfeeding is not recommended during treatment with MOVANTIK.

08/22/2016 (SUPPL-2)

Approved Drug Label (PDF)

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MG - How should I take MOVANTIK?

If you cannot swallow MOVANTIK tablets whole, MOVANTIK can be mixed with water and taken by mouth or given through a nasogastric (NG) tube. To take MOVANTIK by mouth:
- crush the tablet to a powder
- place your dose of MOVANTIK in a glass that contains 4 ounces (120 mL) of water and stir
- swallow MOVANTIK and water mixture right away
- add 4 more ounces (120 mL) of water to the glass and drink right away, to make sure that you take your full dose of MOVANTIK.
If you cannot swallow MOVANTIK tablets and have a nasogastric (NG) tube, MOVANTIK may be given as follows:
- draw up 1 ounce (30 mL) of water into a 60 mL syringe and flush the NG tube
- crush the tablet to a powder
- place your dose of MOVANTIK in a container and mix with approximately 2 ounces (60 mL) of water draw up the MOVANTIK and water into the 60 mL syringe and give the mixture through the NG tube add approximately 2 ounces (60 mL) of water to the same container you used to prepare your dose of MOVANTIK
- draw up the water using the same 60 mL syringe and use all the water to flush the NG tube and any remaining medicine from the NG tube into the stomach.

PCI - Administration

Advise patients to:

If patients are unable to swallow the MOVANTIK tablet whole, the tablet can be crushed to a powder, mixed with water and administered orally or via a nasogastric (NG) tube, as described in the Medication Guide. (addition)

08/22/2016 (SUPPL-3)

Approved Drug Label (PDF)

5 Warnings and Precautions

Severe Abdominal Pain and/or Diarrhea

Reports of severe abdominal pain and/or diarrhea have been reported, some of which resulted in hospitalization. Most of the cases of severe abdominal pain were reported in patients taking the 25 mg dosage. Symptoms generally occurred within a few days of initiation of MOVANTIK. Monitor patients for the development of abdominal pain and/or diarrhea with MOVANTIK discontinue therapy if severe symptoms occur. Consider restarting MOVANTIK at 12.5 mg once daily, if appropriate.

6 Adverse Reactions

Serious and important adverse reactions described elsewhere in labeling include:

Severe abdominal pain and/or diarrhea (addition)

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MG - What is the most important information I should know about MOVANTIK?

MOVANTIK may cause serious side effects, including:

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. (addition)

PCI - Severe Abdominal Pain and/or Diarrhea (addition)

Advise patients that symptoms may occur after starting treatment. The patient should discontinue MOVANTIK and contact their healthcare provider if they develop severe abdominal pain and/or diarrhea.