This medicinal product has been authorised under a 'conditional approval' scheme. This means that further evidence on this medicinal product is awaited.

Special warnings and precautions for use¹

A. Effusion and oedema

Patients should be monitored for new or worsening oedema or effusions. ZYNLONTA should be withheld for Grade 2 or greater oedema or effusion until the toxicity resolves. Diagnostic imaging should be considered in patients who develop symptoms of pleural effusion or pericardial effusion, such as new or worsened dyspnoea, chest pain, and/or ascites such as swelling in the abdomen and bloating. Appropriate medical management for oedema or effusions should be instituted (see section SmPC 4.2).
 

B. Photosensitivity and cutaneous reactions

Serious cutaneous reactions have been reported in patients treated with ZYNLONTA. In clinical studies with ZYNLONTA oral and topical corticosteroids and anti-pruritic therapy were used to treat cutaneous reactions (see section SmPC 4.8).

Patients should be monitored for new or worsening cutaneous reactions, including photosensitivity reactions. ZYNLONTA should be withheld for severe (Grade 3) cutaneous reactions until resolution (see section SmPC 4.2). Patients should be advised to minimise or avoid exposure to direct natural or artificial sunlight including exposure through glass windows. Patients should be instructed to protect skin from exposure to sunlight by wearing sun-protective clothing and/or the use of sunscreen products. If a skin reaction or rash develops, dermatologic consultation should be considered (see section SmPC 5.3).

C. Infections

Fatal and serious infections, including opportunistic infections, have been reported in patients treated with ZYNLONTA (see SmPC section 4.8).

Patients should be monitored for any new or worsening signs or symptoms consistent with infection. For Grade 3 or 4 infection, ZYNLONTA should be withheld until infection has resolved (see SmPC section 4.2).
 

D. Embryo-foetal toxicity

ZYNLONTA may cause embryo-foetal harm when administered to a pregnant woman because it contains a genotoxic compound (SG3199), which affects actively dividing cells.

Pregnant women should be advised of the potential risk to the foetus.

Women of childbearing potential should be advised to use effective contraception during treatment with ZYNLONTA and for 10 months after the last dose. Men with partners of childbearing potential should be advised to use effective contraception during treatment with ZYNLONTA, and for 7 months after the last dose (see SmPC section 4.6).
 

E. Fertility

In non-clinical studies, loncastuximab tesirine was associated with testicular toxicity so may impair male reproductive function and fertility (see SmPC section 5.3).
 

F. Fertility, pregnancy and lactation

Women of childbearing potential/Contraception in men and women.

Women

Women of childbearing potential should be advised to use effective contraception during treatment with ZYNLONTA and for at least 10 months after the last dose.

Men

Because of the potential for genotoxicity, men with partners of childbearing potential should be advised to use effective contraception during treatment with ZYNLONTA and for at least 7 months after the last dose.

Pregnancy

There are no data on the use of ZYNLONTA in pregnant women.

No animal reproduction studies were conducted with ZYNLONTA. ZYNLONTA may cause embryo-foetal toxicity when administered to a pregnant woman, because it contains a genotoxic compound (SG3199) and affects actively dividing cells. ZYNLONTA is not recommended during pregnancy unless the potential benefit for the woman outweighs the potential risk to the foetus. ZYNLONTA is not recommended in women of childbearing potential not using contraception.

Pregnancy testing is advised prior to initiating ZYNLONTA.