Ilumya

/ Taro International Ltd

The recommended dose is 100 mg by subcutaneous injection at weeks 0, and 4 and every 12 weeks thereafter.
See prescribing information for full details.

For the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Hypersensitivity to the active substance or to any of the excipients. Clinically important active infection, e.g. active tuberculosis.

Tildrakizumab has the potential to increase the risk of infection. Caution should be exercised when considering the use in patients with a chronic infection or a history of recurrent or recent serious infection.
Prior to initiating treatment, patients should be evaluated for tuberculosis (TB) infection.
If a serious hypersensivity reaction occurs, administration of the drug should be discontinued immediately and appropriate therapy initiated.
Prior to initiating treatment, consider completion of all appropriate immunisations according to current immunisation guidelines. Patients treated with tildrakizumab should not receive live vaccines during treatment and for at least 17 weeks after treatment.

The most common adverse reactions are upper respiratory tract infections, headache, gastroenteritis, nausea, diarrhea, injection site pain and back pain.
See prescribing information for full details.

Vaccines
Live vaccines should not be given concurrently with Tildrakizumab.
Cytochrome p450
Concomitant medicines affecting tildrakizumab 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.
Other immunosuppressive agents or phototherapy
The safety and efficacy in combination with other immunosupressive agents, including biologics, or phototherapy has not been evaluated.

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
Animal studies do not indicate direct or indirect harmful effect with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use during pregnancy.
Breast-feeding
It is unknown whether tildrakizumab is excreted in human milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility
The effect on human fertility has not been evaluated. Animal studies do not indicate direct or indirect harmful effects with respect to fertility.
Fertility
The effect on human fertility has not been evaluated. Animal studies do not indicate direct or indirect harmful effects with respect to fertility.

Doses up to 10 mg/kg intravenously have been safely administered in clinical trials.
In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and that appropriate symptomatic treatment be instituted immediately.