Risk information

Clinical use

Geriatrics (>65 years of age): No overall differences in safety or efficacy were observed.

Most serious warnings and precautions

Eye-related side effects: BLENREP can cause changes in the corneal epithelium, leading to eye-related symptoms, such as vision changes and dry eyes. Severe visual impairment and/or infected corneal ulcers may occur. Ophthalmic exams (visual acuity testing and slit lamp exams) should be conducted before each dose of BLENREP or more frequently as clinically indicated. If changes in vision or corneal signs are not observed at or before the sixth dose exam, the ophthalmic examination frequency may be reduced to approximately every 3 months and whenever clinically indicated. If ocular adverse reactions are noted, withhold BLENREP until improvement and resume, or permanently discontinue, based on severity. Eye-related side effects can recur after resuming BLENREP at a reduced dose.

Other warnings and precautions

• Driving and operating machinery: Patients experiencing vision changes should not drive or operate machinery until evaluated by an eye care professional and thereafter, adhere to the eye care professional's recommendations
• Thrombocytopenia: Monitor patients with Grade 3 or 4 thrombocytopenia or those on concomitant anticoagulant treatments
• Infections: Monitor patients; consider prophylactic antimicrobials as per the current guidelines
• Infusion-related reactions: For a ≥Grade 2 IRR during administration, reduce the infusion rate or stop the infusion; administer premedication for subsequent infusions
• Pneumonitis: Monitor patients; for suspected ≥Grade 3 pneumonitis withhold BLENREP; initiate appropriate treatment for confirmed ≥Grade 3 pneumonitis
• Fertility: Females and males of reproductive potential should use effective contraception during and after treatment for 4 and 6 months after the last dose, respectively; pregnancy testing is recommended for females of reproductive potential before initiating BLENREP
• Breast-feeding: Women should be advised to discontinue breast-feeding before treatment and for 3 months after the last dose
• Pregnancy: BLENREP should not be used during pregnancy unless the benefit to the mother outweighs the potential risk to the fetus

For more information

Consult the Product Monograph at gsk.ca/BLENREP/PM for important information relating to adverse reactions, drug interactions and dosing information, which has not been discussed in this piece.

To request a Product Monograph or report an adverse event, please call 1-800-387-7374.