LITFULO™ How Supplied/Storage and Handling (ritlecitinib) | Pfizer Medical Information - US

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16 HOW SUPPLIED/STORAGE AND HANDLING

LITFULO capsules are packaged in child-resistant, white, high-density polyethylene (HDPE) bottles with polypropylene (PP) cap with a foil heat induction seal liner. The bottles contain 1g of desiccant in a high-density polyethylene (HDPE) canister. Do not eat the desiccant.

Dosage Form

Strength

Description

Bottle Size

(number of capsules)

NDC Number

Capsules

50 mg of ritlecitinib

Size 3, opaque capsules with yellow body and blue cap. The body is printed with “RCB 50” and the cap is printed with “Pfizer” in black.

28 count bottle

0069-0334-28

Store LITFULO at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Keep in original package.

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

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Resources

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...

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WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS

•: Increased risk of serious bacterial,...

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1 INDICATIONS AND USAGE

LITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older.

Limitations of Use: Not...

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2 DOSAGE AND ADMINISTRATION

2.1 Recommended Evaluations and Immunizations Prior to Treatment Initiation

Perform the following evaluations prior to LITFULO initiation...

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3 DOSAGE FORMS AND STRENGTHS

Capsules: 50 mg of ritlecitinib, size 3, opaque capsules with yellow body and blue cap. The body is printed with “RCB 50” and the cap is printed with “Pfizer” in black.

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4 CONTRAINDICATIONS

LITFULO is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients [see Warnings and Precautions (5.6)].

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5 WARNINGS AND PRECAUTIONS

5.1 Serious Infections

Serious infections have been reported in patients receiving LITFULO. The most frequent serious infections have been...

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6 ADVERSE REACTIONS

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

•: Serious Infections [see Warnings and Precautions...

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7 DRUG INTERACTIONS

7.1 Effects of LITFULO on Other Drugs

Table 3 includes clinically significant drug interactions affecting other drugs....

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Exposure Registry...

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10 OVERDOSAGE

LITFULO was administered in clinical trials up to a single oral dose of 800 mg. Adverse reactions were comparable to those seen at lower doses and no specific toxicities were identified. Pharmacokinetics (PK)...

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11 DESCRIPTION

LITFULO (ritlecitinib) capsules are formulated with ritlecitinib tosylate, a kinase inhibitor.

Ritlecitinib tosylate is a white to off white to pale pink solid which is freely soluble in water. The...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

LITFULO is a kinase inhibitor.

Ritlecitinib irreversibly inhibits Janus kinase 3 (JAK3) and the tyrosine...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 2-year rat carcinogenicity study, ritlecitinib increased the incidence of...

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14 CLINICAL STUDIES

The efficacy and safety of LITFULO were evaluated in one randomized, double-blind, placebo-controlled trial (Trial AA-I) in subjects 12 years of age and older with alopecia areata with ≥50% scalp hair...

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16 HOW SUPPLIED/STORAGE AND HANDLING

LITFULO capsules are packaged in child-resistant, white, high-density polyethylene (HDPE) bottles with polypropylene (PP) cap with a foil heat induction seal liner. The bottles contain 1g...

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This Medication Guide...

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For Medical Information about LITFULO, please visit www.pfizermedinfo.com or call 1-800-438-1985.

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Pfizer Safety

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.