Litfulo 50 mg/1
ritlecitinib · CAPSULE · Pfizer Laboratories Div Pfizer Inc
Litfulo is a capsule containing ritlecitinib at 50 mg/1, taken oral. Manufactured by Pfizer Laboratories Div Pfizer Inc.
Key Facts
- Brand Name
- Litfulo
- Generic Name
- ritlecitinib
- NDC Code (Product)
0069-0334- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Strength
- 50 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- NDA215830
- Marketing Start
- 07/06/2023
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
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 recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. LITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older. ( 1 ) Limitations of Use : Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants ( 1 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • For recommended testing, evaluations and immunizations prior to LITFULO initiation, see Full Prescribing Information. ( 2.1 ) • Recommended dosage is 50 mg orally once daily. ( 2.2 ) • For dosage interruption for certain adverse reactions, see Full Prescribing Information. ( 2.4 ) 2.1 Recommended Evaluations and Immunizations Prior to Treatment Initiation Perform the following evaluations prior to LITFULO initiation: • Tuberculosis (TB) infection evaluation: LITFULO initiation is not recommended in patients with active TB. For patients with latent TB or those with a negative latent TB test who are at high risk for TB, start preventive therapy for latent TB prior to initiation of LITFULO [see Warnings and Precautions (5.1) ] . • Viral hepatitis screening in accordance with clinical guidelines: LITFULO initiation is not recommended in patients with hepatitis B or hepatitis C [see Warnings and Precautions (5.1) ] . • Treatment with LITFULO should not be initiated in patients with an absolute lymphocyte count (ALC) <500/mm 3 or a platelet count <100,000/mm 3 [see Warnings and Precautions (5.8) ] . • Update immunizations according to current immunization gu…
Contraindications
4 CONTRAINDICATIONS LITFULO is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients [see Warnings and Precautions (5.6) ] . LITFULO is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS • Certain CYP3A substrates : Additional monitoring and dose adjustment of CYP3A substrate should be considered. ( 7.1 ) • Certain CYP1A2 substrates : Additional monitoring and dose adjustment of CYP1A2 substrate should be considered. ( 7.1 ) • Certain CYP3A inducers: Coadministration with strong inducers of CYP3A is not recommended. ( 7.2 ) 7.1 Effects of LITFULO on Other Drugs Table 3 includes clinically significant drug interactions affecting other drugs. Table 3. Clinically Significant Interactions Affecting Other Drugs CYP3A Substrates Where Small Concentration Changes May Lead to Serious Adverse Reactions Clinical Impact Ritlecitinib is a CYP3A inhibitor. Concomitant use of ritlecitinib increases AUC and C max of CYP3A substrates [see Clinical Pharmacology (12.3 )] , which may increase the risk of adverse reactions of these substrates. Intervention Consider additional monitoring and dosage adjustment in accordance with approved product labeling of CYP3A substrates where small concentration changes may lead to serious adverse reactions when used with LITFULO. CYP1A2 Substrates Where Small Concentration Changes May Lead to Serious Adverse Reactions Clinical I…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Serious Infections [see Warnings and Precautions (5.1) ] • Malignancy and Lymphoproliferative Disorders [see Warnings and Precautions (5.3) ] • Thromboembolic Events [see Warnings and Precautions (5.5) ] • Hypersensitivity [see Warnings and Precautions (5.6) ] • Laboratory Abnormalities [see Warnings and Precautions (5.8) ] Most common adverse reactions (incidence ≥1%) are headache, diarrhea, acne, rash, urticaria, folliculitis, pyrexia, atopic dermatitis, dizziness, blood creatine phosphokinase increased, herpes zoster, red blood cell count decreased, and stomatitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of LITFULO was evaluated in three randomized, placebo-controlled …
Frequently Asked Questions
What is Litfulo used for?
Litfulo contains ritlecitinib. It is a capsule taken oral. Consult your doctor for specific uses.
Is Litfulo a controlled substance?
Litfulo is not classified as a controlled substance by the DEA.
What is the generic name for Litfulo?
The generic name for Litfulo is ritlecitinib. There are no other listed brand versions of ritlecitinib.
What is the NDC code for Litfulo 50 mg/1?
The NDC (National Drug Code) for Litfulo 50 mg/1 is 0069-0334, listed by Pfizer Laboratories Div Pfizer Inc.
Other Litfulo Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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