- Approval Id
- 02eccb5ef0f54957
- Drug Name
- LITFULO CAPSULE 50MG
- Product Name
- LITFULO CAPSULE 50MG
- Approval Number
- SIN17041P
- Approval Date
- 2024-07-05
- Registrant
- PFIZER PRIVATE LIMITED
- Licence Holder
- PFIZER PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- CAPSULE
- Dosage
- <p><strong>4.2. Posology and method of administration</strong></p>
<p>Treatment should be initiated and supervised by a healthcare professional experienced in the diagnosis and treatment of alopecia areata.</p>
<p><u>Posology</u></p>
<p>The recommended dose is 50 mg once daily.</p>
<p>The benefit-risk of treatment should be re-assessed at regular intervals on an individual basis.</p>
<p>Consideration should be given to discontinuing patients who show no evidence of therapeutic benefit after 36 weeks.</p>
<p><em>Laboratory monitoring</em></p>
<img src="/TGIF/Litfulo-Table1.png" alt="Litfulo Dosage Table 1" /><br><br>
<p><em>Treatment initiation</em><br>
Treatment with ritlecitinib should not be initiated in patients with an absolute lymphocyte count (ALC) <0.5 × 10<sup>3</sup>/mm<sup>3</sup> or a platelet count <100 × 10<sup>3</sup>/mm<sup>3</sup> (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Treatment interruption or discontinuation</em><br>
If a patient develops a serious infection or opportunistic infection, ritlecitinib should be interrupted until the infection is controlled (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Interruption or discontinuation of treatment may be needed for management of haematologic abnormalities as described in Table 1.</p>
<p>If treatment interruption is needed, the risk of significant loss of regrown scalp hair after a temporary treatment interruption for less than 6 weeks is low.</p>
<p><em>Missed doses</em><br>
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.</p>
<p><u>Special populations</u></p>
<p><em>Renal impairment</em><br>
No dose adjustment is required in patients with mild, moderate, or severe renal impairment (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Ritlecitinib 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.</p>
<p><em>Hepatic impairment</em><br>
No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment (see section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). Ritlecitinib is contraindicated in patients with severe (Child Pugh C) hepatic impairment (see section 4.3).</p>
<p><em>Elderly</em><br>
No dose adjustment is required for patients ≥65 years of age. There are limited data in patients ≥65 years of age.</p>
<p><em>Paediatric population</em><br>
No dose adjustment is required for adolescents 12 to <18 years of age.</p>
<p>The safety and efficacy of LITFULO in children under 12 years of age have not yet been established. No data are available.</p>
<p><u>Method of administration</u></p>
<p>Oral use.</p>
<p>LITFULO is to be taken once daily with or without food.</p>
<p>Capsules should be swallowed whole and should not be crushed, split or chewed, because these methods of administration have not been studied in clinical trials.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1. Therapeutic indications</strong></p>
<p>LITFULO is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older (see section 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Contraindications
- <p><strong>4.3. Contraindications</strong></p>
<ul>
<li>Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</li>
<li>Active serious infections, including tuberculosis (TB) (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>Severe hepatic impairment (see section 4.2).</li>
<li>Pregnancy and breast-feeding (see section 4.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
</ul>
- Atc Code
- L04AF08
- Pharma Manufacturer Name
- PFIZER PRIVATE LIMITED
