Cablivi · 4.4 Special warnings and precautions for use · 1

HOS-098239 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The most frequent adverse reactions in the TITAN and HERCULES clinical studies were epistaxis, headache and gingival bleeding. The most common serious adverse reaction was epistaxis. Tabulated list of adverse reactions Adverse reactions are listed below by MedDRA system organ class and by frequency. Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000), not known (cannot be estimated from the available data). 5 Table 1 . List of adverse reactions in TITAN and HERCULES studies MedDRA System organ class Very common Common Nervous system disorders Headache Cerebral infarction Eye disorders Eye Haemorrhage* Vascular disorders Haematoma* Respiratory, thoracic and mediastinal disorders Epistaxis* Dyspnoea, Haemoptysis* Gastrointestinal disorders Gingival Haematemesis*, bleeding* haematochezia*, melaena*, upper gastrointestinal haemorrhage*, haemorrhoidal haemorrhage*, rectal haemorrhage *, abdominal wall haematoma* Skin and subcutaneous tissue disorders Urticaria Musculoskeletal and connective tissue disorders Myalgia Renal and urinary disorders Haematuria* Reproductive system and breast disorders Menorrhagia*, vaginal haemorrhage* General disorders and administration site Pyrexia, Fatigue Injection site haemorrhage*, conditions injection site pruritus,

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HOS-098235 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-098234 · has-indication-information · PDF-Seite 2

Cablivi is indicated for the treatment of adults and adolescents of 12 years of age and older weighing at least 40 kg experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression.

HOS-098237 · has-interaction-information · PDF-Seite 4

No interaction studies evaluating use of caplacizumab with oral anticoagulants (e.g. vitamin K antagonists, direct oral anticoagulants [DOAC] such as thrombin inhibitors or factor Xa inhibitors), antiplatelet agents, thrombolytic agents such as urokinase, tPA (e.g. alteplase) or heparin have been performed (see section 4.4 In the setting of concomitant use of oral anticoagulants, anti-platelet agents, thrombolytic agents or heparin). 4

HOS-098238 · has-pregnancy-information · PDF-Seite 5

Pregnancy There are no data on the use of caplacizumab in pregnant women. Studies in guinea pigs showed no effect of caplacizumab on the dams or foetuses (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Cablivi during pregnancy. Breastfeeding There are no data on the use of caplacizumab in breastfeeding women. It is unknown whether caplacizumab is excreted in human milk. A risk to the child cannot be excluded. A decision must be made whether to discontinue breastfeeding or to abstain/discontinue from therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman. Fertility The effects of caplacizumab on fertility in humans are unknown. In animal toxicology studies, no impact of caplacizumab on male and female fertility parameters was observed (see section 5.3).

HOS-098236 · has-warning-information · PDF-Seite 3

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 3 Bleeding Cablivi increases the risk of bleeding. Cases of major bleeding, including life-threatening and fatal bleeding have been reported in patients receiving caplacizumab, mainly in those using concomitant anti-platelet agents or anticoagulants. Caplacizumab should be used with caution in patients with underlying conditions that may predispose them to a higher risk of bleeding. In case of clinically significant bleeding, treatment with Cablivi should be interrupted. If needed, the use of von Willebrand Factor concentrate could be considered to correct haemostasis. Cablivi should only be restarted upon the advice of a physician experienced in the management of thrombotic microangiopathies. If Cablivi is restarted, monitor closely for signs of bleeding. In the setting of concomitant use of oral anticoagulants, anti-platelet agents, thrombolytic agents or heparin The risk of bleeding is increased with concomitant use of Cablivi with other medicinal products affecting haemostasis and coagulation. Initiation or continuation of treatment with oral anticoagulants (e.g., vitamin K antagonists or direct oral anticoagulants [DOAC] such as thrombin inhibitors or factor Xa inhibitors), anti-platelet agents, thrombolytic agents such as urokinase, tissue plasminogen activator (t-PA) (e.g. alteplase) or heparin requires careful consideration and close clinical monitoring. In patients with coagulopathies Due to a potential increased risk of bleeding, use of Cablivi in patients with underlying coagulopathies (e.g. haemophilia, other coagulation factor deficiencies) must be accompanied by close clinical monitoring. In patients undergoing surgery If a patient is to undergo elective surgery, an invasive dental procedure or other invasive interventions, the patient must be advised to inform the physician or dentist that they are using caplacizumab and it is recommended to withhold treatment for at least 7 days before the planned intervention. The patient must also notify the physician who supervises the treatment with caplacizumab about the planned procedure. After the risk of surgical bleeding has resolved, and caplacizumab is resumed, the patient should be monitored closely for signs of bleeding. If emergency surgery is needed, the use of von

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