Drug Safety-related Labeling Changes (SrLC)

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SINUVA (NDA-209310)

(MOMETASONE FUROATE)

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

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01/20/2023 (SUPPL-6)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Local Nasal Adverse Reactions

Subsection title revised

5.2 Glaucoma and Cataracts

Subsection title revised

Newly added information:

Nasal steroids may result in development of glaucoma and/or cataracts.

5.4 Immunosuppression and Risk of Infections

Subsection title revised

Additions and revisions underlined:

Persons who are using drugs that suppress the immune system, such as corticosteroids, including SINUVA Sinus Implant are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In such children or adults who have not had these diseases or who are not properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The safety and effectiveness of SINUVA Sinus Implant have not been established in pediatric patients less than 18 years of age and SINVA is not indicated for use in this population.

. . .

6 Adverse Reactions

Additions and revisions underlined:

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

• Local Nasal Adverse Reactions [see Warnings and Precautions (5.1)]

• Glaucoma and Cataracts [see Warnings and Precautions (5.2)]

• Hypersensitivity Reactions [see Warnings and Precautions (5.3)]

• Immunosuppression and Risk of Infections [see Warnings and Precautions (5.4)]

• Hypercorticism and Adrenal Suppression [see Warnings and Precautions (5.5)]

6.1 Clinical Trials Experience

Additions and revisions underlined:

Hypersensitivity (4% (n=2) vs. 0), chronic rhinosinusitis (11% (n=6) vs. 9% (n=4)), and upper respiratory tract infections (8% (n=4) vs. 2% (n=1)) were reported in more than 2 subjects in the treatment group, and more commonly than the control group during this time period.

8 Use in Specific Populations

8.4 Pediatric Use

Additions and revisions underlined:

The safety and effectiveness of the SINUVA Sinus Implant have not been established in pediatric patients less than 18 years of age.

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

PATIENT COUNSELING INFORMATION

Additions and revisions underlined:

. . .

Local Nasal Adverse Reactions

Patients should be informed that treatment with the SINUVA Sinus Implant may be associated with local adverse reactions such as nose-bleed (epistaxis), injury to nerves or blood vessels of the middle turbinate or septum, bacterial or candida infection.

. . .

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.

04/28/2020 (SUPPL-3)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

(additions underlined)

…

The safety of repeat administration of the SINUVA Sinus Implant was evaluated in Study 3 that was an open-label, single-arm, multicenter study in 50 patients. All patients underwent an in- office bilateral placement of the SINUVA Sinus Implant in each ethmoid sinus (totaling 2 implants) and were followed for 365 days. Patients were required to use mometasone furoate nasal spray once daily (200 mcg of mometasone furoate) through 365 days. At 90 days, the remaining implants were removed. To maximize the size of the safety population, patients with ethmoid sinus polyps grade greater than or equal to 1 on any side were considered for repeat implant placement.

Repeat placement was not performed if polyp grade was < 1, or if the patient declined it. Of the 50 patients, 41 received repeat implant placement (33 bilaterally and 8 unilaterally). Acute sinusitis (29%, n=12), upper respiratory infection (17%, n=7) epistaxis (12%, n=5), nasal discomfort or rhinalgia (12%, n=5), headache (7%, n=3), were the common adverse reactions that occurred in at least 3 subjects who underwent repeat placement during the study period.

6.2 Postmarketing Experience

(additions underlined)

The following adverse reactions have been identified during postapproval use of the SINUVA sinus implant. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to SINUVA, or a combination of these factors, include: implant migration, lack of efficacy, nasal pain, headache, epistaxis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug experience.

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

PATIENT COUNSELING INFORMATION

(additions underlined)

…

• Advise the patient to call a health care professional immediately if they experience any of the following:

• Excessive nasal bleeding or symptoms of infection, such as excessive pain or discomfort, persistent headache, increased sinus discharge.

• Symptoms suggesting the Implant has migrated posteriorly, such as irritation or choking sensation in the back of the throat or swallowing the Implant.

   

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