HIGHLIGHT
Blenrep

Blenrep Dosage/Direction for Use

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
The information highlighted (if any) are the most recent updates for this brand.
Full Prescribing Info
Dosage/Direction for Use
Treatment with BLENREP should be initiated and supervised by physicians experienced in the treatment of multiple myeloma.
Recommended supportive care: Patients should have an ophthalmic examination (including visual acuity and slit lamp examination) performed by an eye care professional at baseline, before the subsequent 3 treatment cycles, and as clinically indicated whilst on treatment (see Precautions).
Physicians should advise patients to administer preservative-free artificial tears at least 4 times a day beginning on the first day of infusion and continuing until completion of treatment as this may reduce corneal symptoms (see Precautions).
For patients with dry eye symptoms, additional therapies may be considered as recommended by their eye care professional.
Posology: The recommended dose is 2.5 mg/kg of BLENREP administered as an intravenous infusion once every 3 weeks.
It is recommended that treatment should be continued until disease progression or unacceptable toxicity (see Precautions).
Dose modifications: Recommended dose modifications for corneal adverse reactions are provided in Table 3. Table 4 provides dose modifications recommended for other adverse reactions.
Management of corneal adverse reactions: Corneal adverse reactions may include findings upon eye examination and/or changes in visual acuity (see Precautions and Adverse Reactions). The treating physician should review the patient's ophthalmic examination report before dosing and should determine the dose of BLENREP based on the highest category from the report in the most severely affected eye as both eyes may not be affected to the same degree (Table 3).
During the ophthalmic examination, the eye care professional should assess the following: The corneal examination finding(s) and the decline in best corrected visual acuity (BCVA).
If there is a decline in BCVA, the relationship of corneal examination findings to BLENREP should be determined.
The highest category grading for these examination findings and BCVA should be reported to the treating physician.
See Tables 3 and 4.

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Special populations: Elderly: No dose adjustment is required for elderly patients (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment is required in patients with mild or moderate renal impairment (eGFR ≥30 mL/min). There are insufficient data in patients with severe renal impairment to support a dose recommendation (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment is required in patients with mild hepatic impairment (bilirubin greater than ULN to less than or equal to 1.5 × ULN or aspartate transaminase [AST] greater than ULN). There are insufficient data in patients with moderate hepatic impairment and no data in patients with severe hepatic impairment to support a dose recommendation (see Pharmacology: Pharmacokinetics under Actions).
Body weight: BLENREP has not been studied in patients with body weight <40 kg or >130 kg (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of BLENREP in children and adolescents below 18 years of age have not been established. No data are available.
Method of administration: BLENREP is for intravenous use.
BLENREP must be reconstituted and diluted by a healthcare professional prior to administration as an intravenous infusion. BLENREP should be infused over a minimum of 30 minutes (see Special precautions for disposal and other handling under Cautions for Usage).
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