Bonspri Patient Counseling Information

Advise the patient to read patient labeling (Patient Information Leaflet).
Infections: Advise patients to contact their healthcare provider for any signs of infection during treatment or after the last dose. Signs include fever, chills, constant cough, or dysuria [see Infections under Precautions].
Advise patients that BONSPRI may cause reactivation of hepatitis B infection and that monitoring will be required if they are at risk [see Infections under Precautions].
Advise patients that PML has happened with an intravenous form of ofatumumab administered at a higher intravenous dosage in patients with CLL, as well as with drugs that are similar to BONSPRI, and may happen with BONSPRI. Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months. Instruct the patient of the importance of contacting their healthcare provider if they develop any symptoms suggestive of PML. Inform the patient that typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes [see Infections under Precautions].
Vaccinations: Advise patients to complete any required live or live-attenuated vaccinations at least 4 weeks and, whenever possible at least 2 weeks prior to initiation of BONSPRI for inactivated vaccines.
Administration of live-attenuated or live vaccines is not recommended during BONSPRI treatment and until B-cell recovery [see Infections under Precautions].
Injection-Related Reactions: Inform patients about the signs and symptoms of injection-related reactions, and that these reactions generally occur within 24 hours and predominantly following the first injection. Advise patients to contact their healthcare provider if they experience signs or symptoms of injection-related reactions [see Injection-Related Reactions under Precautions].
Contraception: Advise females of childbearing potential to use effective contraception while receiving BONSPRI and for 6 months after the last treatment of BONSPRI [see Fetal Risk under Precautions and Females and Males of Reproductive Potential under Use in Pregnancy & Lactation].
Instruction on Injection Technique: Patients or caregivers should be instructed by a healthcare professional on how to administer BONSPRI [see Instructions for Use and Handling under Cautions for Usage].
Instruct patients or caregivers in the technique of proper syringe and needle disposal, and advise them not to reuse these items. Instruct patients to inject the full amount of BONSPRI according to the directions provided in the Instructions for Use and Handling under Cautions for Usage. Dispose of syringes in a puncture-resistant container.