BLENREP Powder for solution for injection (2020)

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Συγγραφείς

GlaxoSmithKline LLC

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1. Indications and Usage

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, ...

2. Dosage and Administration

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 ...

3. Dosage Forms and Strengths

For injection: 100 mg of belantamab mafodotin-blmf as a white to yellow lyophilized powder in a single-dose vial for reconstitution and further dilution.

4. Contraindications

None.

5. Warnings and Precautions

5.1 Ocular Toxicity Ocular adverse reactions occurred in 77% of the 218 patients in the pooled safety population. Ocular adverse reactions included keratopathy (76%), changes in visual acuity (55%), blurred ...

6. Adverse Reactions

The following clinically significant adverse reactions are described elsewhere in the labeling: Ocular toxicity [see Warnings and Precautions (5.1)]. Thrombocytopenia [see Warnings and Precautions ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of ...

6.2. Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed ...

8.1. Pregnancy

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 ...

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 ...

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 ...

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 ...

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/1.73m² as estimated by the Modification of Diet in Renal ...

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 ...

11. Description

Belantamab mafodotin-blmf is a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate. Belantamab mafodotin-blmf is an antibody conjugate composed of 3 components: 1) afucosylated, ...

12.1. Mechanism of Action

Belantamab mafodotin-blmf is an antibody-drug conjugate (ADC). The antibody component is an afucosylated IgG1 directed against BCMA, a protein expressed on normal B lymphocytes and multiple myeloma cells. ...

12.2. Pharmacodynamics

Exposure-Response Relationships Higher belantamab mafodotin-blmf exposure was associated with higher incidence of some adverse reactions (e.g., Grade ≥2 corneal toxicity). No exposure-response relationship ...

12.3. Pharmacokinetics

Belantamab mafodotin-blmf exhibited dose-proportional pharmacokinetics, with a gradual decrease in clearance over time; the time to reach steady state was ~70 days. After a planned infusion duration of ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been conducted with belantamab mafodotin-blmf. Belantamab mafodotin-blmf was genotoxic in an in vitro micronucleus assay in human lymphocytes through an aneugenic mechanism. ...

13.2. Animal Toxicology and/or Pharmacology

Increased mitoses of corneal epithelial cells with bilateral single-cell necrosis were observed following intravenous administration of belantamab mafodotin-blmf in rats and rabbits.

14. Clinical Studies

14.1 Relapsed or Refractory Multiple Myeloma The efficacy of BLENREP was evaluated in DREAMM-2, an open-label, multicenter study (NCT 03525678). Eligible patients had relapsed or refractory multiple myeloma, ...

15. References

1 OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.

16.1. How Supplied

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 ...

16.2. Storage and Handling

Store vials refrigerated at 36ºF to 46ºF (2ºC to 8ºC). BLENREP is a hazardous drug. Follow applicable special handling and disposal procedures.1

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 ...

BOXED WARNING SECTION

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 [see Warnings and ...