BLENREP- belantamab injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BELANTAMAB MAFODOTIN (UNII: DB1041CXDG) (BELANTAMAB MAFODOTIN - UNII:DB1041CXDG)

Available from:

GlaxoSmithKline LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

BLENREP is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. This indication is approved under accelerated approval based on response rate [see Clinical Studies (14)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). None. Risk Summary Based on its mechanism of action, BLENREP can cause fetal harm when administered to a pregnant woman, because it contains a genotoxic compound (the microtubule inhibitor, MMAF) and it targets actively dividing cells [see Clinical Pharmacology (12.1), Nonclinical Toxicology (13.1)] . Human immunoglobulin G (IgG) is known to cross the placenta; therefore, belantamab mafodotin-blmf has the potential to be transmitted from the mother to the developing fetus. There are no available data on the use of BLENREP in pregnan

Product summary:

BLENREP (belantamab mafodotin-blmf) for injection is a sterile, preservative-free, white to yellow lyophilized powder for reconstitution and further dilution prior to intravenous use. BLENREP is supplied in a carton containing one 100-mg single-dose vial with a rubber stopper (not made with natural rubber latex) and aluminum overseal with removable cap (NDC 0173-0896-01). Store vials refrigerated at 36ºF to 46ºF (2ºC to 8ºC). BLENREP is a hazardous drug. Follow applicable special handling and disposal procedures.1

Authorization status:

Biologic Licensing Application

Patient Information leaflet

GlaxoSmithKline LLC
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MEDICATION GUIDE
BLENREP (BLEN-REP)
(belantamab mafodotin-blmf)
for injection, for intravenous use
What is the most important information I should know about BLENREP?
Before you receive BLENREP, you must read and agree to all of the
instructions in the BLENREP Risk
Evaluation and Mitigation Strategy (REMS). Before prescribing BLENREP,
your healthcare provider will
explain the BLENREP REMS to you and have you sign the Patient
Enrollment Form.
BLENREP can cause serious side effects, including:
Eye problems. Eye problems are common with BLENREP. BLENREP can cause
changes to the surface of
your eye that can lead to dry eyes, blurred vision, worsening vision,
severe vision loss, and corneal ulcer.
Tell your healthcare provider if you have any vision changes or eye
problems during treatment with
BLENREP.
•
Your healthcare provider will send you to an eye specialist to check
your eyes before you start
treatment with BLENREP, prior to each dose of BLENREP, and for
worsening symptoms of eye
problems.
•
Even if your vision seems fine, it is important that you get your eyes
checked during treatment with
BLENREP because some changes can happen without symptoms and may only
be seen on an eye
exam.
•
You should use preservative-free lubricant eye drops at least 4 times
per day during treatment with
BLENREP as instructed by your healthcare provider.
•
You should use caution when driving or operating machinery as BLENREP
may affect your vision.
•
Avoid wearing contact lenses during treatment with BLENREP unless
directed by your eye specialist.
See “What are the possible side effects of BLENREP?” for more
information about serious side effects.
What is BLENREP?
BLENREP is a prescription medicine used to treat adults with multiple
myeloma who:
•
have received at least 4 prior medicines to treat multiple myeloma,
and
•
their cancer has come back or did not respond to prior treatment.
It is not known if BLENREP is safe and effective in children.
Before receiving BLENREP, tell your hea

Summary of Product characteristics

BLENREP- BELANTAMAB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
GLAXOSMITHKLINE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BLENREP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BLENREP.
BLENREP (BELANTAMAB MAFODOTIN-BLMF) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2020
WARNING: OCULAR TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
INDICATIONS AND USAGE
BLENREP is a B-cell maturation antigen (BCMA)-directed antibody and
microtubule inhibitor conjugate
indicated for the treatment of adult patients with relapsed or
refractory multiple myeloma who have
received at least 4 prior therapies including an anti-CD38 monoclonal
antibody, a proteasome inhibitor,
and an immunomodulatory agent.
This indication is approved under accelerated approval based on
response rate. Continued approval for
this indication may be contingent upon verification and description of
clinical benefit in confirmatory
trial(s). (1)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
For injection: 100 mg as a lyophilized powder in a single-dose vial
for reconstitution and further dilution. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
•
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAXOSMITHKLINE AT
1-888-825-5249 OR
BLENREP CAUSED CHANGES IN THE CORNEAL EPITHELIUM RESULTING IN CHANGES
IN VISION,
INCLUDING SEVERE VISION LOSS AND CORNEAL ULCER, AND SYMPTOMS, SUCH AS
BLURRED
VISION AND DRY EYES. (5.1)
CONDUCT OPHTHALMIC EXAMS AT BASELINE, PRIOR TO EACH DOSE, AND PROMPTLY
FOR
WORSENING SYMPTOMS. WITHHOLD BLENREP UNTIL IMPROVEMENT AND RESUME, OR
PERMANENTLY DISCONTINUE, BASED ON SEVERITY. (2.3, 5.1)
BLENREP IS AVAILABLE ONLY THROUGH A RESTRICTED PROGRAM, CALLED THE
BLENREP REMS.
(5.2)
The recommended dosage is 2.5 mg/kg as an intravenous infusion over
approximately 30 minutes
once every 3 weeks. (2.2)
See Full Prescribing Information for instructions on