etri in patients with a chronic infection or a history of recurrent or recent serious infection.
Patients should be instructed to seek medical advice if signs or symptoms suggestive of a clinically relevant chronic or acute infection occur. If a patient develops a serious infection, the patient should be closely monitored and Ilumetri should not be administered until the infection resolves.
Pre-treatment eva luation for tuberculosis
Prior to initiating treatment with Ilumetri, patients should be eva luated for tuberculosis (TB) infection. Patients receiving Ilumetri should be closely monitored for signs and symptoms of active TB during and after treatment. Anti-TB therapy should be considered prior to initiating Ilumetri in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Hypersensitivity
If a serious hypersensivity reaction occurs, administration of Ilumetri should be discontinued immediately and appropriate therapy initiated.
Vaccinations
Prior to initiating treatment with tildrakizumab, consider completion of all appropriate immunisations according to current immunisation guidelines. If a patient has received live viral or bacterial vaccination it is recommended to wait at least 4 weeks prior to starting treatment with tildrakizumab. Patients treated with Ilumetri should not receive live vaccines during treatment and for at least 17 weeks after treatment (see section 4.5).
4.5 Interaction with other medicinal products and other forms of interaction
Vaccines
No data are available on the response to live or inactivated vaccines. Live vaccines should not be given concurrently with Ilumetri (see section 4.4).
Interactions with cytochrome p450
Concomitant medicines affecting Ilumetri pharmacokinetics are not expected since it is cleared from the body by general protein catabolism processes with no contribution of cytochrome P450 (CYP450) enzymes, and it is not eliminated by renal or hepatic pathways. Furthermore, Ilumetri does not impact the pharmacokinetics of concomitant medicines metabolized by CYP450 enzymes either through direct or indirect mechanisms (see section 5.2).
Interactions with other immunosuppressive agents or phototherapy
The safety and efficacy of Ilumetri in combination with other immunosupressive agents, including biologics, or phototherapy has not been eva luated.
4.6 Fertility, pregnancy and lactation
Women of childbearing potential
Women of childbearing potential should use an effective method of contraception during treatment and for at least 17 weeks after treatment.
Pregnancy
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of tildrakizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effect with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Ilumetri during pregnancy.
Breast-feeding
It is unknown whether tildrakizumab is excreted in human milk. Available toxicological data in cynomolgus monkey have shown negligible levels of Ilumetri in milk on postnatal day 28 (see section 5.3). In humans, during the first few days after birth antibodies may be transferred to the newborns through milk. In this short period, a risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Ilumetri therapy taking i |
