Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Traceability

In order to improve the traceability of biological medicinal products, the name of the administered product should be clearly recorded. It is recommended to record the batch number as well.

Corneal adverse reactions

Corneal adverse reactions have been reported with the use of BLENREP. The most commonly reported adverse reactions were keratopathy or microcyst-like epithelial changes in corneal epithelium (as seen on eye examination) with or without changes in visual acuity, blurred vision, and dry eye symptoms. Patients with a history of dry eyes were more prone to develop changes in the corneal epithelium. Changes in visual acuity may be associated with difficulty in driving or operating machinery (see section 4.7).

Ophthalmic examinations, including assessment of visual acuity and slit lamp examination, should be performed at baseline, before the subsequent 3 treatment cycles and during treatment as clinically indicated. Patients should be advised to administer preservative-free artificial tears at least 4 times a day during treatment (see section 4.2). Patients should avoid using contact lenses until the end of treatment.

Patients experiencing keratopathy with or without changes in visual acuity may require a dose modification (delay and/or reduction) or treatment discontinuation based on severity of findings (see Table 1).

Cases with changes in the subbasal nerve plexus of the cornea (e.g., nerve fibre fragmentation and loss of nerve fibres) resulting in hypoesthesia of the cornea, and cases of corneal ulcer (ulcerative and infective keratitis) have been reported (see section 4.8). Corneal ulcers should be managed promptly and as clinically indicated by an eye care professional. Treatment with BLENREP should be interrupted until the corneal ulcer has healed (see Table 1).

Thrombocytopenia

Thrombocytopenic events (thrombocytopenia and platelet count decreased) were frequently reported in study 205678. Thrombocytopenia may lead to serious bleeding events, including gastrointestinal and intracranial bleeding.

Complete blood counts should be obtained at baseline and monitored during treatment, as clinically indicated. Patients experiencing Grade 3 or 4 thrombocytopenia or those on concomitant anticoagulant treatments may require more frequent monitoring and should be managed with a dose delay or dose reduction (see Table 2). Supportive therapy (e.g. platelet transfusions) should be provided according to standard medical practice.

Infusion-Related Reactions


Infusion-related reactions (IRR) have been reported with BLENREP. Most IRRs were Grade 1-2 and resolved within the same day (see section 4.8). If a grade 2 or higher infusion- related reaction occurs during administration, reduce the infusion rate or stop the infusion depending on the severity of the symptoms. Institute appropriate medical treatment and restart infusion at a slower rate, if the patient’s condition is stable. If Grade 2 or higher IRR occurs, administer premedication for subsequent infusions (see Table 2).

Pneumonitis

Cases of pneumonitis from spontaneous reports and named patient programs, including fatal events, have been observed with BLENREP. Evaluation of patients with new or worsening unexplained pulmonary symptoms (e.g. cough, dyspnea) should be performed to exclude possible pneumonitis. In case of suspected Grade 3 or higher pneumonitis, BLENREP should be withheld. If Grade 3 or higher pneumonitis is confirmed, appropriate treatment should be initiated. BLENREP should only be resumed after an evaluation of the benefit and risk.


Excipients
This medicinal product contains less than 1 mmol sodium (23 mg) per 100 mg dose, that is to say essentially “sodium-free”.

Effects on Driving

4.7    Effects on ability to drive and use machines

BLENREP has a moderate influence on the ability to drive or use machines (see sections 4.4 and 4.8).
Patients should be advised to use caution when driving or operating machines as BLENREP may affect their vision.