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.

ASMANEX TWISTHALER (NDA-021067)

(MOMETASONE FUROATE)

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

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02/16/2021 (SUPPL-32)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Oropharyngeal Candidiasis

Additions underlined

…After administration, advise patients to rinse the mouth with water and spit out contents without swallowing.

5.2 Acute Asthma Episodes

Additions underlined

ASMANEX TWISTHALER is not a bronchodilator and is not indicated for rapid relief of bronchospasm or other acute episodes of asthma. A short acting beta2-agonist, such as albuterol, should be available at all times to treat acute asthma symptoms. Instruct patients to contact their physician immediately if episodes of asthma that are not responsive to bronchodilators occur during the course of treatment with ASMANEX TWISTHALER. During such episodes, patients may require therapy with oral corticosteroids.

5.4 Immunosuppression and Risk of Infections

Addition of the following to the title of subsection

Risk of Infections

5.5 Transferring Patients from Systemic Corticosteroid Therapy

Additions underlined

HPA Suppression/Adrenal Insufficiency

…

Unmasking of Allergic Conditions Previously Suppressed by Systemic Corticosteroids

…

Corticosteroid Withdrawal Symptoms

…

6 Adverse Reactions

Additions underlined

The following clinically significant adverse reactions are described elsewhere in the labeling:

Oropharyngeal Candidiasis [see Warnings and Precautions (5.1)]
Immunosuppression and Risk of Infections [see Warnings and Precautions (5.4)]
Hypercorticism and Adrenal Suppression [see Warnings and Precautions (5.6)]
Reduction in Bone Mineral Density [see Warnings and Precautions (5.7)]
Growth Effects [see Warnings and Precautions (5.8) and Use in Specific Populations (8.4)]
Glaucoma and Cataracts [see Warnings and Precautions (5.9)]

8 Use in Specific Populations

8.4 Pediatric Use

Additions underlined

The safety and effectiveness of ASMANEX TWISTHALER for maintenance treatment of asthma as prophylactic therapy have been established in children 4 years of age and older. Use of ASMANEX TWISTHALER in pediatric patients 12 years of age and older is supported by evidence from adequate and well-controlled clinical trials in this patient population [see Clinical Studies (14.1) and Adverse Reactions (6.1)].

…

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

PATIENT COUNSELING INFORMATION

Additions underlined

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Oropharyngeal Candidiasis

Patients should be advised that localized infections with Candida albicans occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing with ASMANEX TWISTHALER therapy, but at times therapy with ASMANEX TWISTHALER may need to be temporarily interrupted under close medical supervision. Rinsing the mouth after inhalation is advised [see Warnings and Precautions (5.1)].

…

Immunosuppression and Risk of Infections

Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to consult their physician without delay. Patients should be informed of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex [see Warnings and Precautions (5.4)].

…

Instructions for Use

…After administration, the patient should rinse their mouth with water and spit out contents without swallowing.

…

PATIENT INFORMATION

Additions underlined

…

How should I use ASMANEX TWISTHALER?

…

Rinse your mouth with water after each dose of ASMANEX TWISTHALER. Spit out the water. Do not swallow it. This will help lessen the chance of getting a yeast infection (thrush) in your mouth and throat.
…
What are the possible side effects of ASMANEX TWISTHALER?
ASMANEX TWISTHALER can cause serious side effects, including:

Thrush in your mouth and throat. This is a serious but common side effect. You may develop thrush, a yeast (Candida albicans), in your mouth or throat. After each dose of ASMANEX TWISTHALER, rinse your mouth with water. Spit out the water. Do not swallow it. This will help to prevent thrush in your mouth or throat.
Increased wheezing right after taking ASMANEX TWISTHALER. Always have a rescue inhaler with you to treat sudden wheezing.
…
Immune system effects and a higher chance for infections. You are more likely to get infections if you take medicines that weaken your immune system. Avoid contact with people who have contagious diseases such as chicken pox or measles while using ASMANEX TWISTHALER.
Tell your healthcare provider about any signs of infection such as:
- fever o feeling tired o body aches o vomiting o pain
- nausea o chills
  …
Slowed growth in children. A child’s growth should be checked often.

…

12/19/2019 (SUPPL-29)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

(Pregnancy and Lactation Labeling Rule (PLLR) conversion; please refer to label)

8.2 Lactation

(Pregnancy and Lactation Labeling Rule (PLLR) conversion; additions and/or revisions underlined)

Risk Summary

There are no available data on the presence of ASMANEX TWISTHALER in human milk, the effects on the breastfed child, or the effects on milk production. Other inhaled corticosteroids, similar to mometasone furoate, are present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ASMANEX TWISTHALER and any potential adverse effects on the breastfed infant from ASMANEX TWISTHALER or from the underlying maternal condition.

03/26/2018 (SUPPL-26)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.11 Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors

(Newly Added Subsection)

Caution should be exercised when considering the coadministration of ASMANEX TWISTHALER with ketoconazole, and other known strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat-containing products, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) because adverse effects related to increased systemic exposure to mometasone furoate may occur.

7 Drug Interactions

7.1 Inhibitors of Cytochrome P450 3A4

(Additions and/or revisions are underlined)

Concomitant administration of CYP3A4 inhibitors may inhibit the metabolism of, and increase the systemic exposure to, mometasone furoate and potentially increase the risk for systemic corticosteroid side effects. Caution should be exercised when considering the coadministration of ASMANEX TWISTHALER with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat-containing products, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin). Consider the benefit of coadministration versus the potential risk of systemic corticosteroid effects, in which case patients should be monitored for systemic corticosteroid side effects.

03/26/2018 (SUPPL-28)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.9 Glaucoma and Cataracts

(Additions and/or revisions are underlined)

In clinical trials, glaucoma, increased intraocular pressure, and cataracts have been reported in 8 of 3007 patients following the administration of ASMANEX TWISTHALER. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use ASMANEX TWISTHALER long term.

6 Adverse Reactions

6.2 Postmarketing Experience

(Additions and/or revisions are underlined)

Eye disorders: Vision blurred

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

Patient Information

(Newly added subsection)

BEFORE AND DURING TREATMENT WITH ASMANEX TWISTHALER

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

ASMANEX TWISTHALER may affect the way other medicines work, and other medicines may affect how ASMANEX TWISTHALER works.

Especially, tell your healthcare provider if you take antifungal medicines, antibiotic medicines, or anti-HIV medicines such as: ritonavir, ketoconazole, nefazodone, nelfinavir, indinavir, atazanavir, clarithromycin, saquinavir, telithromycin, itraconazole, and cobicistat-containing products.

For some medicines (including medicines for HIV such as ritonavir, cobicistat-containing products, and certain antifungals and antibiotics) your doctor may wish to monitor you carefully.

Ask your healthcare provider if you are not sure if any of your medicines are the kinds listed above.

Know the medicines you take. Keep a list and show it to your healthcare provider and pharmacist each time you get a new medicine.