belantamab mafodotin (Rx)

Brand and Other Names:Blenrep, belantamab mafodotin-blmf
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 100mg/single-dose vial

Multiple Myeloma

Indicated for relapsed or refractory multiple myeloma in adults who have received at least 4 prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent

2.5 mg/kg (actual body weight) IV q3Weeks  

Continue until disease progression or unacceptable toxicity

Dosage Modifications

Recommended dose reduction for adverse reactions

  • First dose reduction: 1.9 mg/kg IV q3Weeks
  • Unable to tolerate first dose reduction: Discontinue

Corneal adverse reactions

  • Grade 1
    • Corneal examination finding: Mild superficial keratopathy
    • Change in best-corrected visual acuity (BCVA): Decline from baseline of 1 line on Snellen visual acuity
    • Continue treatment at current dose
  • Grade 2
    • Corneal examination finding: Moderate superficial keratopathy
    • Change in BCVA: Decline from baseline of 2 or 3 lines on Snellen visual acuity and not worse than 20/200
    • Withhold until improvement in both corneal examination findings and change in BCVA to Grade ≤1 and resume at same dose
  • Grade 3
    • Corneal examination finding: Severe superficial keratopathy
    • Change in BCVA: Decline from baseline by >3 lines on Snellen visual acuity and not worse than 20/200
    • Withhold until improvement in both corneal examination findings and change in BCVA to Grade ≤1 and resume at reduced dose
  • Grade 4
    • Corneal examination finding: Corneal epithelial defect
    • Change in BCVA: Snellen visual acuity worse than 20/200
    • Consider permanent discontinuation; if continuing treatment, withhold until improvement in both corneal examination findings and change in BCVA to Grade ≤1 and resume at reduced dose

Thrombocytopenia

  • Platelet count 25,000 to <50,000/mcL
    • Consider withholding and/or reducing dose
  • Platelet count <25,000
    • Withhold until platelet count improves to Grade ≤3; consider resuming at a reduced dose

Infusion-related reactions

  • Grade 2 or 3
    • Interrupt infusion and provide supportive care
    • Once symptoms resolve, resume at lower infusion rate; reduce infusion rate by at least 50%
  • Grade 4
    • Permanently discontinue and provide emergency care

Other adverse reactions

  • Grade 3
    • Withhold until improvement to Grade ≤1
    • Consider resuming at a reduced dose
  • Grade 4
    • Consider permanent discontinuation
    • If continuing treatment, withhold until improvement to Grade ≤1 and resume at reduced dose

Renal impairment

  • Mild-to-moderate (eGFR 30-89 mL/min/1.73m2): No dosage adjustment necessary
  • Severe or end-stage renal disease not on dialysis (eGFR <29 mL/min/1.73m2): Recommended dosage has not been established

Hepatic impairment

  • Mild (total bilirubin ≤1.5x ULN and any AST): No dosage adjustment necessary
  • Moderate-to-severe (total bilirubin >1.5x ULN and any AST): Recommended dosage has not been established

Dosing Considerations

Perform an ophthalmic examination before initiation and during treatment

Advise patients to use preservative-free lubricant eye drops and avoid contact lenses unless directed by an ophthalmologist

Safety and efficacy not established

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Adverse Effects

>10%

All grades

  • Keratopathy (71%)
  • Platelets decreased (62%)
  • AST increased (57%)
  • Decreased visual acuity (53%)
  • Lymphocytes decreased (49%)
  • Albumin decreased (43%)
  • Glucose increased (38%)
  • Hemoglobin decreased (32%)
  • Creatinine increased (28%)
  • Neutrophils decreased (28%)
  • Alkaline phosphatase increased (26%)
  • Gamma-glutamyl transferase increased (25%)
  • Nausea (24%)
  • Blurred vision (22%)
  • Pyrexia (22%)
  • Creatinine phosphokinase increased (22%)
  • Sodium decreased (21%)
  • Infusion-related reactions (21%)
  • Fatigue (20%)
  • Potassium decreased (20%)
  • Dry eyes (14%)
  • Constipation (13%)
  • Diarrhea (13%)
  • Arthralgia (12%)
  • Decreased appetite (12%)
  • Back pain (11%)
  • Upper respiratory tract infection (11%)

Grade 3-4

  • Keratopathy (44%)
  • Decreased visual acuity (28%)
  • Lymphocytes decreased (22%)
  • Platelets decreased (21%)
  • Hemoglobin decreased (18%)

1-10%

All grades

  • Photophobia (<10%)
  • Eye irritation (<10%)
  • Infective keratitis (<10%)
  • Ulcerative keratitis (<10%)
  • Vomiting (<10%)
  • Pneumonia (<10%)
  • Albuminuria (<10%)

Grade 3-4

  • Neutrophils decreased (9%)
  • Creatinine increased (5%)
  • Gamma-glutamyl transferase increased (5%)
  • Blurred vision (4%)
  • Albumin decreased (4%)
  • Infusion-related reactions (3%)
  • Pyrexia (3%)
  • Glucose increased (3%)
  • AST increased (2%)
  • Sodium decreased (2%)
  • Potassium decreased (2%)
  • Fatigue (2%)
  • Back pain (2%)
  • Alkaline phosphatase increased (1%)
  • Creatinine phosphokinase increased (1%)
  • Dry eyes (1%)
  • Diarrhea (1%)
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Warnings

Black Box Warnings

Ocular toxicity

  • May cause corneal epithelium changes resulting in vision changes, including severe vision loss, corneal ulcer, and visual symptoms (eg, blurred vision, dry eyes)
  • Conduct ophthalmic examinations at baseline, before each dose, and promptly for worsening symptoms
  • Withhold until improvement and resume, or permanently discontinue, based on severity
  • Owing to ocular toxicity, available only through a restricted program under a REMS program called the BLENREP REMS

Blenrep REMS

  • Notable requirements include the following:
    • Prescribers must be certified with the program by enrolling and completing training
    • Prescribers must counsel patients about risk of ocular toxicity and need for ophthalmic examinations before each dose
    • Patients must be enrolled and comply with monitoring
    • Healthcare facilities must be certified with the program and verify patients are authorized to receive belantamab mafodotin
    • Wholesalers and distributors must only distribute to certified healthcare facilities
    • Further information is available, at www.BLENREPREMS.com and 1-855-209-9188

Contraindications

None

Cautions

Severe ocular adverse reactions occurred in clinical trials; changes in visual acuity may be associated with difficulty driving and reading; advise patients to use caution when driving or operating machinery; only available through restricted REMS program

Thrombocytopenia reported; perform CBC counts at baseline and during treatment as clinically indicated

Infusion-related reactions reported; monitor for infusion-related reactions; if reactions occurs, administer premedication for all subsequent infusion

May cause fetal harm when administered to pregnant females

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Pregnancy & Lactation

Pregnancy

Based on its mechanism of action, fetal harm may occur when administered to pregnant females; contains genotoxic compound (the microtubule inhibitor, monomethyl auristatin phenylalanine [MMAF]) that targets actively dividing cells

Human IgG is known to cross the placenta; therefore, belantamab mafodotin has the potential to be transmitted from mother to developing fetus

No data available on use in pregnant females to evaluate for drug-associated risks

No animal reproduction studies were conducted

Advise pregnant females of potential risks

Recommend pregnancy testing for females of reproductive potential before initiating treatment

Contraception

  • Females of reproductive potential: Use effective contraception during treatment and for 4 months after last dose
  • Males with female partners of reproductive potential: Use effective contraception during treatment and for 6 months after last dose

Infertility

  • Based on findings in animal studies, may impair fertility in females and males
  • Effects were not reversible in male rats, but were reversible in female rats

Lactation

There is no data on presence in human milk or effects on breastfed children or milk production

Advise women not to breastfeed during treatment and for 3 months after last dose

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

An ADC consisting of an afucosylated, humanized monoclonal antibody, directed against the B-cell maturation antigen (BCMA), conjugated to the auristatin analogue and microtubule inhibitor MMAF, with potential antineoplastic activity

The anti-BCMA antibody moiety selectively binds to the BCMA on tumor cell surfaces; upon internalization, the MMAF moiety binds to tubulin and inhibits its polymerization, which results in G2/M phase arrest and induces tumor cell apoptosis

Absorption

Peak plasma concentration: 42 mcg/mL

Peak plasma time: 0.78 hr

Plasma trough concentration: 2.4 mcg/mL

AUC: 4,666 mcg⋅hr/mL

Distribution

Vd: 11 L

Metabolism

Monoclonal antibody portion is expected to be metabolized into small peptides and individual amino acids by catabolic pathway

cysmcMMAF is mainly hydrolyzed and dehydrated to a cyclized isomeric form of cys-mcMMAF

Elimination

Half-life: 12 days (first dose); 14 days (steady-state)

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Administration

IV Incompatibilities

Do not mix or administer as an infusion with other products

IV Compatibilities

0.9% NaCl

IV Preparation

Hazardous drug; follow applicable special handling and disposal procedures

Calculate dose (mg), total volume (mL) of solution required, and number of vials needed based on patient’s actual body weight

More than 1 vial may be needed for a full dose; do not round down for partial vials

Reconstitution

  • Remove vial(s) from refrigerator and allow to stand for ~10 minutes to reach room temperature (68-77ºF [20-25ºC])
  • Reconstitute each 100-mg vial with 2 mL of sterile water for injection to obtain a final concentration of 50 mg/mL
  • Gently swirl vial to aid dissolution; do not shake
  • Visually inspect for particulate matter and discoloration before administration, whenever solution and container permit; reconstituted solution should be clear to opalescent, colorless to yellow to brown liquid
  • Discard if extraneous particulate matter is observed

Dilution

  • Withdraw calculated drug volume and dilute in a 250-mL infusion bag of 0.9% NaCl, to a final concentration of 0.2-2 mg/mL
  • Infusion bags must be made of polyvinylchloride (PVC) or polyolefin (PO)
  • Mix diluted solution by gentle inversion; do not shake
  • Discard any unused reconstituted solution left in vial(s)
  • Visual inspect for particulate matter and discoloration before administration, whenever solution and container permit; diluted infusion solution should be clear and colorless; discard if particulate matter is observed

IV Administration

If refrigerated, allow diluted infusion solution to equilibrate to room temperature (68-77ºF [20-25ºC]) before administration

Diluted infusion solution may be kept at room temperature for no more than 6 hr (including infusion time)

Administer by IV infusion over ~30 minutes using an infusion set made of PVC or PO

Filtration of the diluted solution is not required; however, if filtered, use a polyethersulfone-based filter (0.2 micron)

Do not mix or administer as an infusion with other products

Product does not contain a preservative

Storage

Hazardous drug; follow applicable special handling and disposal procedures

Unused vials

  • Refrigerate at 36-46ºF (2-8ºC)

Reconstituted vials

  • Refrigerate at 36-46ºF (2-8ºC) or at room temperature (68-77°F [20-25°C]) for up to 4 hr in original container; do not freeze
  • Discard if not diluted within 4 hr

Diluted solutions

  • Refrigerate at 36-46ºF (2-8ºC) for up to 24 hr; do not freeze
  • Once removed from refrigeration, administer diluted infusion solution within 6 hr (including infusion time)
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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.