Perform the following evaluations prior to LITFULO initiation:
The recommended dosage of LITFULO is 50 mg orally once daily with or without food [see Clinical Pharmacology (12.3)].
Swallow capsules whole. Do not crush, split, or chew LITFULO capsules.
If a dose is missed, administer the dose as soon as possible unless it is less than 8 hours before the next dose, in which case, skip the missed dose. Thereafter, resume dosing at the regular scheduled time.
LITFULO is not recommended in patients with severe (Child Pugh C) hepatic impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
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.
Hematologic Abnormalities
Recommendations for LITFULO treatment interruption or discontinuation for hematologic abnormalities are summarized in Table 1.
| Laboratory Measure | Recommendation |
|---|---|
| ALC = absolute lymphocyte count. | |
Platelet Count | 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 return above this value. |
ALC and platelet counts are recommended before treatment initiation and at 4 weeks after treatment initiation, and thereafter according to routine patient management [see Warnings and Precautions (5.7)].
Perform the following evaluations prior to LITFULO initiation:
The recommended dosage of LITFULO is 50 mg orally once daily with or without food [see Clinical Pharmacology (12.3)].
Swallow capsules whole. Do not crush, split, or chew LITFULO capsules.
If a dose is missed, administer the dose as soon as possible unless it is less than 8 hours before the next dose, in which case, skip the missed dose. Thereafter, resume dosing at the regular scheduled time.
LITFULO is not recommended in patients with severe (Child Pugh C) hepatic impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
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.
Hematologic Abnormalities
Recommendations for LITFULO treatment interruption or discontinuation for hematologic abnormalities are summarized in Table 1.
| Laboratory Measure | Recommendation |
|---|---|
| ALC = absolute lymphocyte count. | |
Platelet Count | 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 return above this value. |
ALC and platelet counts are recommended before treatment initiation and at 4 weeks after treatment initiation, and thereafter according to routine patient management [see Warnings and Precautions (5.7)].
{{section_body_html_patient}}
Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.
*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5PM ET Monday to Friday; excluding holidays.
Submit a medical question for Pfizer prescription products.
Pfizer Safety
To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, 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 this product, adverse events should be reported to your coordinating study site.
If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety 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/medwatch or call (800) 822-7967.