BLENREP Powder for solution for injection Ref.[9941] Active ingredients: Belantamab mafodotin

2.1 Important Safety Information

Perform an ophthalmic exam prior to initiation of BLENREP and during treatment [see Warnings and Precautions (5.1)].

Advise patients to use preservative-free lubricant eye drops and avoid contact lenses unless directed by an ophthalmologist [see Warnings and Precautions (5.1)].

2.2 Recommended Dosage

The recommended dosage of BLENREP is 2.5 mg/kg of actual body weight given as an intravenous infusion over approximately 30 minutes once every 3 weeks until disease progression or unacceptable toxicity.

2.3 Dosage Modifications for Adverse Reactions

The recommended dose reduction for adverse reactions is: BLENREP 1.9 mg/kg intravenously once every 3 weeks.

Discontinue BLENREP in patients who are unable to tolerate a dose of 1.9 mg/kg (see Tables 1 and 2).

Corneal Adverse Reactions

The recommended dosage modifications for corneal adverse reactions, based on both corneal examination findings and changes in best-corrected visual acuity (BCVA), are provided in Table 1 [see Warnings and Precautions (5.1)]. Determine the recommended dosage modification of BLENREP based on the worst finding in the worst affected eye. Worst finding should be based on either a corneal examination finding or a change in visual acuity per the Keratopathy and Visual Acuity (KVA) scale.

Table 1. Dosage Modifications for Corneal Adverse Reactions per the KVA Scale:

^a Mild superficial keratopathy (documented worsening from baseline), with or without symptoms.
^b Changes in visual acuity due to treatment-related corneal findings.
^c Moderate superficial keratopathy with or without patchy microcyst-like deposits, sub-epithelial haze (peripheral), or a new peripheral stromal opacity.
^d Severe superficial keratopathy with or without diffuse microcyst-like deposits, sub-epithelial haze (central), or a new central stromal opacity.
^e Corneal epithelial defect such as corneal ulcers. |

Other Adverse Reactions

The recommended dosage modifications for other adverse reactions are provided in Table 2.

Table 2. Dosage Modifications for Other Adverse Reactions:

2.4 Preparation and Administration

BLENREP is a hazardous drug. Follow applicable special handling and disposal procedures.¹

Calculate the dose (mg), total volume (mL) of solution required, and the number of vials of BLENREP needed based on the 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 the vial(s) of BLENREP from the refrigerator and allow to stand for approximately 10 minutes to reach room temperature (68°F to 77°F [20°C to 25°C]).
• Reconstitute each 100-mg vial of BLENREP with 2 mL of Sterile Water for Injection, USP, to obtain a final concentration of 50 mg/mL. Gently swirl the vial to aid dissolution. Do not shake.
• If the reconstituted solution is not used immediately, store refrigerated at 36ºF to 46ºF (2ºC to 8ºC) or at room temperature (68°F to 77°F [20°C to 25°C]) for up to 4 hours in the original container. Discard if not diluted within 4 hours. Do not freeze.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The reconstituted solution should be clear to opalescent, colorless to yellow to brown liquid. Discard if extraneous particulate matter is observed.

Dilution:

• Withdraw the calculated volume of BLENREP from the appropriate number of vials and dilute in a 250-mL infusion bag of 0.9% Sodium Chloride Injection, USP, to a final concentration of 0.2 mg/mL to 2 mg/mL. The infusion bags must be made of polyvinylchloride (PVC) or polyolefin (PO).
• Mix the diluted solution by gentle inversion. Do not shake.
• Discard any unused reconstituted solution of BLENREP left in the vial(s).
• If the diluted infusion solution is not used immediately, store refrigerated at 36ºF to 46ºF (2ºC to 8ºC) for up to 24 hours. Do not freeze. Once removed from refrigeration, administer the diluted infusion solution of BLENREP within 6 hours (including infusion time).
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The diluted infusion solution should be clear and colorless. Discard if particulate matter is observed.

Administration:

• If refrigerated, allow the diluted infusion solution to equilibrate to room temperature (68ºF to 77ºF [20ºC to 25ºC]) prior to administration. Diluted infusion solution may be kept at room temperature for no more than 6 hours (including infusion time).
• Administer by intravenous infusion over approximately 30 minutes using an infusion set made of polyvinyl chloride (PVC) or polyolefin (PO).
• Filtration of the diluted solution is not required; however, if the diluted solution is filtered, use a polyethersulfone (PES)-based filter (0.2 micron).

Do not mix or administer BLENREP as an infusion with other products. The product does not contain a preservative.

Store vials refrigerated at 36ºF to 46ºF (2ºC to 8ºC).

BLENREP is a hazardous drug. Follow applicable special handling and disposal procedures.¹