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Drug Safety-related Labeling Changes (SrLC)

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VTAMA (NDA-215272)

(TAPINAROF)

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

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12/12/2024 (SUPPL-2)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Extensive changes to add information from an atopic dermatitis clinical trial; please refer to label

8 Use in Specific Populations

8.4 Pediatric Use

Newly added information:

Plaque Psoriasis

The safety and efficacy of VTAMA cream for the topical treatment of plaque psoriasis have not been established in pediatric patients.

Atopic Dermatitis

The safety and efficacy of VTAMA cream for the topical treatment of atopic dermatitis have been established in pediatric patients 2 years of age and older. Use of VTAMA cream for this indication is supported by evidence from two adequate and well-controlled trials (ADORING 1 and ADORING 2), which included 654 pediatric subjects 2 years of age and older (436 of whom received VTAMA cream) with moderate to severe atopic dermatitis. Adverse reactions occurring more frequently in pediatric subjects compared to adults were upper respiratory tract infection and ear infection [see Adverse Reactions (6.1), Clinical Pharmacology (12.3) and Clinical Studies (14.2)].

The safety and efficacy of VTAMA cream for the topical treatment of atopic dermatitis have not been established in pediatric patients younger than 2 years of age.

8.5 Geriatric Use

Additions and revisions underlined:

Plaque Psoriasis

Of the 683 subjects exposed to VTAMA cream in the PSOARING 1 or PSOARING 2 clinical trials, 99 (14.5%) were 65 years of age and older, including 8 (1.2%) subjects who were 75 years of age and older. No overall differences in efficacy, safety, or tolerability of VTAMA cream were observed between subjects 65 years of age and older and younger adult subjects.

Atopic Dermatitis

Of the 541 subjects exposed to VTAMA cream in the ADORING 1 or ADORING 2 clinical trials, 20 (3.7%) were 65 years of age and older, including 4 (0.7%) subjects who were 75 years of age and older. No overall differences in efficacy, safety, or tolerability were observed between subjects 65 years of age and older and younger adult subjects.

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

PATIENT INFORMATION

Additions and revisions underlined:

What is VTAMA cream?

VTAMA cream is a prescription medicine used on the skin (topical) to treat:

  • plaque psoriasis in adults.

  • atopic dermatitis in adults and children 2 years of age and older.

    It is not known if VTAMA cream is safe and effective for the topical treatment of plaque psoriasis in children.

It is not known if VTAMA cream is safe and effective for the topical treatment of atopic dermatitis in children under 2 years of age

. . .

The most common side effects of VTAMA cream in people treated for atopic dermatitis include:

  • upper and lower respiratory tract infections

  • vomiting

  • red raised bumps around the hair pores (folliculitis)

  • ear infection

  • headache

  • pain in extremity

  • asthma

  • stomach-area (abdominal) pain

    VTAMA cream can also cause skin reactions at the treatment site. Tell your healthcare provider if you have itching, irritation, pain, redness, burning or changes in skin color at the treatment site.