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LITFULO is a brand name for Ritlecitinib, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: LITFULO (ritlecitinib) is indicated for: • the treatment of adults and adolescents 12 years and older with severe alopecia areata. Limitations of Use: Not recommended for use in combination with JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. 1.1 Pediatrics 12-17 years of…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Treatment should be initiated and supervised by a healthcare professional experienced in the diagnosis and treatment of alopecia areata. The benefit-risk of treatment should be re-assessed at regular intervals on an individual basis.
Consideration should be given to discontinuing patients who show no evidence of therapeutic benefit after 36 weeks of treatment. Recommended Evaluations and Immunizations Prior to Treatment Initiation Perform the following evaluations prior to LITFULO initiation: • Patients should be screened for tuberculosis (TB) before starting therapy.
LITFULO should not be given to patients with active TB. Anti-TB therapy should be started prior to initiating therapy with LITFULO in patients with a new diagnosis of latent TB or previously untreated latent TB. In patients with a negative latent TB test, consider anti-TB therapy before initiating treatment with LITFULO in those at high risk [see 7 WARNINGS AND PRECAUTIONS].
• Viral hepatitis screening in accordance with clinical guidelines: LITFULO initiation is not recommended in patients with hepatitis B or hepatitis C [see 7 WARNINGS AND PRECAUTIONS]. • Treatment with LITFULO should not be initiated in patients with an absolute lymphocyte count (ALC) <500/mm3 or a platelet count <100,000/mm3 [see 7 WARNINGS AND PRECAUTIONS].
• Blood work for liver enzymes should be drawn at baseline and thereafter according to routine patient management. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury.
If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt LITFULO [see 8 ADVERSE REACTIONS]. • Update immunizations according to current immunization guidelines [see 7 WARNINGS AND PRECAUTIONS]. • Skin examination for malignancy is recommended before treatment initiation and periodically thereafter, especially for patients who are at increased risk for skin cancer [see 7 WARNINGS AND PRECAUTIONS].
2 Recommended Dose and Dosage Adjustment • The recommended dosage of LITFULO is 50 mg orally once daily. 3 Pharmacokinetics, Special Populations and Conditions]. 3 Pharmacokinetics, Special Populations and Conditions].
Under 12 years of age:
]. Reported infections from Janus kinase (JAK) inhibitors used to treat inflammatory conditions: • Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test for latent TB before and during therapy; start treatment of latent TB prior to use.
Monitor all patients for active TB during treatment, even patients with initial negative latent TB test. • Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
• Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens. LITFULO (ritlecitinib) Page 5 of 31 Treatment with LITFULO should be avoided in patients with an active, serious infection. If a serious or opportunistic infection develops during treatment, interrupt LITFULO until the infection is controlled.
The risks and benefits of treatment with LITFULO should be carefully considered prior to initiating therapy in patients with chronic or recurrent infections. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with LITFULO [see 7 WARNINGS AND PRECAUTIONS].
Malignancies Malignancies were reported in patients treated with LITFULO [see 7 WARNINGS AND PRECAUTIONS]. 1 Dosing Considerations Treatment should be initiated and supervised by a healthcare professional experienced in the diagnosis and treatment of alopecia areata.
The benefit-risk of treatment should be re-assessed at regular intervals on an individual basis. Consideration should be given to discontinuing patients who show no evidence of therapeutic benefit after 36 weeks of treatment. Recommended Evaluations and Immunizations Prior to Treatment Initiation Perform the following evaluations prior to LITFULO initiation: • Patients should be screened for tuberculosis (TB) before starting therapy.
• LITFULO is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
2 Breast-feeding]. 3 Pharmacokinetics, Special Populations and Conditions].
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 3 Pharmacokinetics, Special Populations and Conditions]. LITFULO is contraindicated in patients with severe hepatic impairment (Child Pugh C) [see 2 CONTRAINDICATIONS].
3 Pharmacokinetics, Special Populations and Conditions]. LITFULO has not been studied in patients with end-stage renal disease (ESRD) or in patients with renal transplants and is therefore not recommended for use in these patients. Treatment Interruption or Discontinuation There is variability in time to response to treatment.
Consideration should be given to discontinuing patients who show no evidence of therapeutic benefit after 36 weeks of treatment. The benefit-risk of treatment should be re-assessed at regular intervals on an individual basis. If treatment interruption is indicated, a temporary treatment interruption for less than 6 weeks is not expected to result in significant loss of regrown scalp hair.
Infections If a patient develops serious infection or an opportunistic infection, LITFULO should be interrupted until the infection is controlled [see 7 WARNINGS AND PRECAUTIONS]. Hematologic abnormalities Recommendations for LITFULO treatment interruption or discontinuation for hematologic abnormalities are summarized in Table 1.
Monitoring during Treatment Consider screening patients at high risk for TB during treatment with LITFULO.
LITFULO (ritlecitinib) Page 7 of 31 Table 1:
Laboratory Measures and Monitoring Guidance Laboratory Measure Monitoring guidance Recommendation Platelet Count Before treatment initiation and 4 weeks after initiation, and thereafter according to routine patient management. [see 7 WARNINGS AND PRECAUTIONS] Treatment should be discontinued if platelet count is <50,000/mm3 Lymphocytes Treatment should be interrupted if ALC is <500/mm3 and may be restarted once ALC returns above this value.
3 Pharmacokinetics]. 3 Pharmacokinetics]. 3 Pharmacokinetics]. Capsules should be swallowed whole and should not be crushed, split, or chewed. 5 Missed Dose If a dose is missed, patients should be advised to take the dose as soon as possible unless it is less than 8 hours before the next dose, in which case the patient should not take the missed dose.
Thereafter, dosing should be resumed at the regular scheduled time.
LITFULO should not be given to patients with active TB. Anti-TB therapy should be started prior to initiating therapy with LITFULO in patients with a new diagnosis of latent TB or previously untreated latent TB. In patients with a negative latent TB test, consider anti-TB therapy before initiating treatment with LITFULO in those at high risk [see 7 WARNINGS AND PRECAUTIONS].
• Viral hepatitis screening in accordance with clinical guidelines: LITFULO initiation is not recommended in patients with hepatitis B or hepatitis C [see 7 WARNINGS AND PRECAUTIONS]. • Treatment with LITFULO should not be initiated in patients with an absolute lymphocyte count (ALC) <500/mm3 or a platelet count <100,000/mm3 [see 7 WARNINGS AND PRECAUTIONS].
• Blood work for liver enzymes should be drawn at baseline and thereafter according to routine patient management. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury.
If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt LITFULO [see 8 ADVERSE REACTIONS]. • Update immunizations according to current immunization guidelines [see 7 WARNINGS AND PRECAUTIONS]. • Skin examination for malignancy is recommended before treatment initiation and periodically thereafter, especially for patients who are at increased risk for skin cancer [see 7 WARNINGS AND PRECAUTIONS].
2 Recommended Dose and Dosage Adjustment • The recommended dosage of LITFULO is 50 mg orally once daily. 3 Pharmacokinetics, Special Populations and Conditions]. 3 Pharmacokinetics, Special Populations and Conditions].
Under 12 years of age:
No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 3 Pharmacokinetics, Special Populations and Conditions]. LITFULO is contraindicated in patients with severe hepatic impairment (Child Pugh C) [see 2 CONTRAINDICATIONS].
3 Pharmacokinetics, Special Populations and Conditions]. LITFULO has not been studied in patients with end-stage renal disease (ESRD) or in patients with renal transplants and is therefore not recommended for use in these patients. Treatment Interruption or Discontinuation There is variability in time to response to treatment.
Consideration should be given to discontinuing patients who show no evidence of therapeutic benefit after 36 weeks of treatment. The benefit-risk of treatment should be re-assessed at regular intervals on an individual basis. If treatment interruption is indicated, a temporary treatment interruption for less than 6 weeks is not expected to result in significant loss of regrown scalp hair.
Infections If a patient develops serious infection or an opportunistic infection, LITFULO should be interrupted until the infection is controlled [see 7 WARNINGS AND PRECAUTIONS]. Hematologic abnormalities Recommendations for LITFULO treatment interruption or discontinuation for hematologic abnormalities are summarized in Table 1.
Monitoring during Treatment Consider screening patients at high risk for TB during treatment with LITFULO.
LITFULO (ritlecitinib) Page 7 of 31 Table 1:
Laboratory Measures and Monitoring Guidance Laboratory Measure Monitoring guidance Recommendation Platelet Count Before treatment initiation and 4 weeks after initiation, and thereafter according to routine patient management. [see 7 WARNINGS AND PRECAUTIONS] Treatment should be discontinued if platelet count is <50,000/mm3 Lymphocytes Treatment should be interrupted if ALC is <500/mm3 and may be […]