8.2 Lactation Risk Summary
There is no data on the presence of belantamab mafodotin-blmf in human milk or the effects on the breastfed child or milk production . Because of the potential for serious adverse reactions in the breastfed child , advise women not to breastfeed during treatment with BLENREP and for 3 months after the last dose .
8.3 Females and Males of Reproductive Potential
BLENREP can cause fetal harm when administered to pregnant women [ see Use in Specific Populations ( 8.1 )].
Pregnancy Testing
Pregnancy testing is recommended for females of reproductive potential prior to initiating BLENREP .
Contraception
Females : Advise women of reproductive potential to use effective contraception during treatment and for 4 months after the last dose .
Males : Because of the potential for genotoxicity , advise males with female partners of reproductive potential to use effective contraception during treatment with BLENREP and for 6 months after the last dose [ see Nonclinical Toxicology ( 13.1 ) of full Prescribing Information ].
Infertility
Based on findings in animal studies , BLENREP may impair fertility in females and males . The effects were not reversible in male rats , but were reversible in female rats [ see Nonclinical Toxicology ( 13.1 ) of full Prescribing Information ].
8.4 Pediatric Use
The safety and effectiveness of BLENREP in pediatric patients have not been established .
8.5 Geriatric Use
Of the 218 patients who received BLENREP in DREAMM-2 , 43 % were aged 65 to less than 75 years and 17 % were aged 75 years and older . Clinical studies of BLENREP did not include sufficient numbers of patients aged 65 and older to determine whether the effectiveness differs compared with that of younger patients . Keratopathy occurred in 80 % of patients aged less than 65 years and 73 % of patients aged 65 years and older . Among the patients who received BLENREP at the 2.5-mg / kg dose in DREAMM-2 ( n = 95 ), keratopathy occurred in 67 % of patients aged less than 65 years and 73 % of patients aged 65 years and older . Clinical studies did not include sufficient numbers of patients 75 years and older to determine whether they respond differently compared with younger patients .
8.6 Renal Impairment
No dose adjustment is recommended for patients with mild or moderate renal impairment ( estimated glomerular filtration rate [ eGFR ] 30 to 89 mL / min / 1.73m 2 as estimated by the Modification of Diet in Renal Disease [ MDRD ] equation ) [ see Clinical Pharmacology ( 12.3 ) of full Prescribing Information ]. The recommended dosage has not been established in patients with severe renal impairment ( eGFR 15 to 29 mL / min / 1.73 m 2 ) or end-stage renal disease ( ESRD ) with eGFR < 15 mL / min / 1.73 m 2 not on dialysis or requiring dialysis [ see Clinical Pharmacology ( 12.3 ) of full Prescribing Information ].
8.7 Hepatic Impairment
No dose adjustment is recommended for patients with mild hepatic impairment ( total bilirubin ≤upper limit of normal [ ULN ] and aspartate aminotransferase ( AST ) > ULN or total bilirubin 1 to ≤1.5 × ULN and any AST ).
The recommended dosage of BLENREP has not been established in patients with moderate or severe hepatic impairment ( total bilirubin > 1.5 × ULN and any AST ) [ see Clinical Pharmacology ( 12.3 ) of full Prescribing Information ].
15 REFERENCES
1 . “ OSHA Hazardous Drugs .” OSHA . http :// www . osha . gov / SLTC / hazardousdrugs / index . html .
BLENREP REMS
BLENREP is available only through a restricted program called BLENREP REMS [ see Warnings and Precautions ( 5.2 )]. Inform the patient of the following notable requirements :
• Patients must complete the enrollment form with their provider .
• Patients must comply with ongoing monitoring for eye exams [ see Warnings and Precautions ( 5.1 )].
Thrombocytopenia
• Advise patients to inform their healthcare provider if they develop signs or symptoms of bleeding [ see Warnings and Precautions ( 5.3 )].
Infusion-Related Reactions
• Advise patients to immediately report any signs and symptoms of infusion-related reactions to their healthcare provider [ see Warnings and Precautions ( 5.4 )].
Embryo-Fetal Toxicity
• Advise pregnant women of the potential risk to a fetus . Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [ see Warnings and Precautions ( 5.5 ), Use in Specific Populations ( 8.1 , 8.3 )].
• Advise women of reproductive potential to use highly effective contraception during treatment and for 4 months after the last dose [ see Warnings and Precautions ( 5.5 ), Use in Specific Populations ( 8.3 )].
• Advise males with female partners of reproductive potential to use effective contraception during treatment with BLENREP and for 6 months after the last dose [ see Use in Specific Populations ( 8.3 ), Nonclinical Toxicology ( 13.1 ) of full Prescribing Information ].
Lactation
• Advise women not to breastfeed during treatment with BLENREP and for 3 months after the last dose [ see Use in Specific Populations ( 8.2 )].
Infertility
• Advise males and females of reproductive potential that BLENREP may impair fertility [ see Use in Specific Populations ( 8.3 )].
Trademarks are owned by or licensed to the GSK group of companies . Manufactured by :
GlaxoSmithKline Intellectual Property Development Ltd . England Brentford , Middlesex , UK TW8 9GS U . S . License No . 2148
including by use of Potelligent technology licensed from BioWa , Inc .
For :
GlaxoSmithKline Research Triangle Park , NC 27709 © 2020 GSK group of companies or its licensor .
August 2020 BRP : 1BRS
© 2020 GSK or licensor . BLMJRNA200002 August 2020 Produced in USA .
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Ocular Toxicity
• Advise patients that ocular toxicity may occur during treatment with BLENREP [ see Warnings and Precautions ( 5.1 )].
• Advise patients to administer preservative-free lubricant eye drops as recommended during treatment and to avoid wearing contact lenses during treatment unless directed by a healthcare professional [ see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.1 )].
• Advise patients to use caution when driving or operating machinery as BLENREP may adversely affect their vision [ see Warnings and Precautions ( 5.1 )].