Presentation and Status in Health Basket
Presentation | Basket | Yarpa | Pharmasoft |
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Hard Capsules 28 x 50 mg |
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24875 | 12661 |
Related information
Dosage
The recommended dose is 50 mg once daily.
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.
This medical product is to be taken once daily with or without food.
See prescribing information for full details.
Indications
Treatment of severe alopecia areata in adults and adolescents 12 years and older.
Limitations of Use: It is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants.
Contra-Indications
* Hypersensitivity to the active substance(s) or to any of the excipients
* Active serious infections, including tuberculosis (TB).
* Severe hepatic impairment.
* Pregnancy and breast-feeding
Special Precautions
Serious infections
Serious infections have been reported in patients receiving ritlecitinib. The most frequent serious infections have been appendicitis, COVID-19 infection (including pneumonia), and sepsis. Treatment with ritlecitinib must not be initiated in patients with an active, serious infection.
The risks and benefits of treatment should be considered in patients who are:
* With chronic or recurrent infection
* Exposed to tuberculosis (TB)
* Having a history of serious or opportunistic infection
* Resided or traveled in areas of endemic TB or mycoses, or with underlying conditions that may predispose them to infection.
Patients receiving ritlecitinib should be closely monitored for signs and symptoms of infection during and after treatment. If a serious or opportunistic infection develops, treatment must be interrupted. Patients with new infections should receive prompt diagnostic testing and appropriate antimicrobial therapy, along with close monitoring. Ritlecitinib may be resumed once the infection is controlled.
Due to the higher incidence of infections in the elderly and diabetic populations, caution should be exercised when treating them, with particular attention to infection occurrence.
Tuberculosis
Patients should be screened for TB before starting therapy with ritlecitinib. Ritlecitinib must not be given to patients with active TB. Anti TB therapy should be started prior to initiating therapy with ritlecitinib in patients with a new diagnosis of latent TB or previously untreated latent TB. In patients with a negative latent TB test, anti TB therapy should still be considered before initiating treatment with ritlecitinib in those at high risk and screening for patients at high risk for TB during treatment with ritlecitinib should be considered.
Viral reactivation
Viral reactivations, including cases of herpes virus reactivation (e.g., herpes zoster), have been reported. If a patient develops herpes zoster, temporary interruption of treatment may be considered until the episode resolves.
Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy with ritlecitinib. Patients with evidence of hepatitis B or C infection were excluded from studies with ritlecitinib. Monitoring for reactivation of viral hepatitis according to clinical guidelines is recommended during ritlecitinib treatment. If there is evidence of reactivation, a liver specialist should be consulted.
Malignancy (including non melanoma skin cancer)
Malignancies, including non melanoma skin cancer (NMSC) have been reported in patients receiving ritlecitinib.
The risks and benefits of ritlecitinib treatment should be considered prior to initiating or continuing therapy in patients with a known malignancy other than a successfully treated NMSC or cervical cancer.
Periodic skin examination is recommended for patients who are at increased risk of skin cancer
Major adverse cardiovascular events (MACE), deep venous thrombosis (DVT) and pulmonary embolism (PE)
Events of venous and arterial thromboembolism, including MACE, have been reported in patients receiving ritlecitinib.
Ritlecitinib should be used with caution in patients with known risk factors for thromboembolism. In patients with a suspected thromboembolic event, discontinuation of ritlecitinib and prompt re evaluation is recommended. The risks and benefits of ritlecitinib treatment should be considered prior to initiating therapy in patients.
Neurological events
Ritlecitinib-related axonal dystrophy has been observed in chronic Beagle dog toxicity studies. Treatment with ritlecitinib should be discontinued in case unexplained neurological symptoms occur.
Haematologic abnormalities
Treatment with ritlecitinib was associated with decreases in lymphocytes and platelets. Prior to initiating treatment with ritlecitinib, ALC and platelet counts should be performed. Treatment with ritlecitinib should not be initiated in patients with an ALC < 0.5 × 103/mm3 or a platelet count < 100 × 103/mm3. After initiating treatment with ritlecitinib, treatment interruption or discontinuation are recommended based on ALC and platelet count abnormalities. ALC and platelet counts are recommended at 4 weeks after initiation of therapy with ritlecitinib, and thereafter according to routine patient management.
Vaccinations
No data are available on the response to vaccination in patients receiving ritlecitinib. Use of live attenuated vaccines should be avoided during or immediately prior to ritlecitinib treatment. Prior to initiating ritlecitinib, it is recommended that patients are brought up to date with all immunisations, including prophylactic herpes zoster vaccinations, in agreement with current immunisation guidelines.
See prescribing information for full details.
Side Effects
Common: Herpes zoster, Folliculitis, Upper respiratory tract infections, Dizziness, Diarrhoea, Acne, Urticaria, Rash, Blood creatine phosphokinase increased.
See prescribing information for full details.
Drug interactions
Potential for other medicinal products to affect the pharmacokinetics of ritlecitinib
* Itraconazole– increased the area under curve (AUC)inf of ritlecitinib, This is not considered clinically significant and, therefore dose adjustment is not required when ritlecitinib is coadministered with CYP3A inhibitors.
* Rifampicin– decreased the AUCinf of ritlecitinib, this is not considered clinically significant and, therefore dose adjustment is not required when ritlecitinib is coadministered with inducers of CYP enzymes.
Potential for ritlecitinib to affect the pharmacokinetics of other medicinal products
* Ritlecitinib is a moderate inhibitor of CYP3A; caution should be exercised with concomitant use of ritlecitinib with CYP3A substrates (e.g., quinidine, cyclosporine, dihydroergotamine, ergotamine, pimozide) where moderate concentration changes may lead to serious adverse reactions. Dose adjustment recommendations for the CYP3A substrate (e.g., colchicine, everolimus, tacrolimus, sirolimus) should be considered.
* Ritlecitinib is a moderate inhibitor of CYP1A2; caution should be exercised with concomitant use of ritlecitinib with other CYP1A2 substrates (e.g., tizanidine) where moderate concentration changes may lead to serious adverse reactions. Dose adjustment recommendations for the CYP1A2 substrate (e.g., theophylline, pirfenidone) should be considered.
* Caution should be exercised with concomitant use of ritlecitinib with OCT1 substrates where small concentration changes may lead to serious adverse reactions.
Ritlecitinib did not produce clinically significant changes in the exposures of oral contraceptives (e.g., ethinyl oestradiol or levonorgestrel), CYP2B6 substrates (e.g., efavirenz), CYP2C substrates (e.g., tolbutamide), or substrates of organic anion transporter (OAT)P1B1, breast cancer resistant protein (BCRP), and OAT3 (e.g., rosuvastatin).
See prescribing information for full details.
Pregnancy and Lactation
Women of childbearing potential: Women of childbearing potential have to use effective contraception during treatment and for 1 month following the final dose of this medical product.
Pregnancy: There are no or limited data from the use of ritlecitinib in pregnant women. ritlecitinib is contraindicated during pregnancy.
Lactation: Ritlecitinib is contraindicated during breast feeding.
Overdose
Ritlecitinib was administered in placebo controlled studies up to a single oral dose of 800 mg and multiple oral doses of 400 mg daily for 14 days. No specific toxicities were identified. In case of overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions. There is no specific antidote for overdose with ritlecitinib. Treatment should be symptomatic and supportive.
Pharmacokinetics (PK) data up to and including a single oral dose of 800 mg in healthy adult volunteers indicate that more than 90% of the administered dose is expected to be eliminated within 48 hours