Belantamab mafodotin interacts in the following cases:
Based on findings in animals and the mechanism of action, belantamab mafodotin may impair fertility in females and males of reproductive potential.
Therefore, women of childbearing potential who may desire children in the future should be counselled prior to therapy regarding the option of having eggs frozen before treatment. Men being treated with this medicine are advised to have sperm samples frozen and stored before treatment.
There are no data from the use of belantamab mafodotin in pregnant women.
Based on the mechanism of action of the cytotoxic component monomethyl auristatin F (MMAF), belantamab mafodotin can cause embryo-foetal harm when administered to a pregnant woman. Human immunoglobulin G (IgG) is known to cross the placenta; therefore, belantamab mafodotin has the potential to be transmitted from the mother to the developing foetus.
Belantamab mafodotin should not be used during pregnancy unless the benefit to the mother outweighs the potential risks to the foetus. If a pregnant woman needs to be treated she should be clearly advised on the potential risk to the foetus.
It is not known whether belantamab mafodotin is excreted into human milk. Immunoglobulin G (IgG) is present in human milk in small amounts. Since belantamab mafodotin is a humanised IgG monoclonal antibody, and based on the mechanism of action, it may cause serious adverse reactions in breast-fed children. Women should be advised to discontinue breast-feeding prior to initiating treatment with belantamab mafodotin and for 3 months after the last dose.
The pregnancy status of child-bearing women should be verified prior to initiating therapy with belantamab mafodotin.
Women of child-bearing potential should use effective contraception during treatment with belantamab mafodotin and for 4 months after the last dose.
Men with female partners of child-bearing potential should use effective contraception during treatment with belantamab mafodotin and for 6 months after the last dose.
Based on findings in animals and the mechanism of action, belantamab mafodotin may impair fertility in females and males of reproductive potential.
Therefore, women of childbearing potential who may desire children in the future should be counselled prior to therapy regarding the option of having eggs frozen before treatment. Men being treated with this medicine are advised to have sperm samples frozen and stored before treatment.
Belantamab mafodotin has a moderate influence on the ability to drive or use machines. Patients should be advised to use caution when driving or operating machines as belantamab mafodotin may affect their vision.
The safety of belantamab mafodotin was evaluated in 95 patients who received belantamab mafodotin 2.5 mg/kg in study 205678. The most frequent adverse reactions (≥30%) were keratopathy (71%) and thrombocytopenia (38%). The most commonly reported serious adverse reactions were pneumonia (7%), pyrexia (7%) and IRRs (3%). Permanent discontinuation due to an adverse reaction occurred in 9% of patients who received belantamab mafodotin with 3% related to ocular adverse reactions.
The table below summarises adverse drug reactions that occurred in patients receiving the recommended dose of belantamab mafodotin 2.5 mg/kg once every 3 weeks.
Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, where relevant, adverse reactions are presented in order of decreasing seriousness.
Adverse reactions reported in multiple myeloma patients treated with belantamab mafodotin:
| System Organ Class | Adverse reactionsa | Frequency | Incidence (%) | |
|---|---|---|---|---|
| Any Grade | Grade 3-4 | |||
| Infections and infestations | Pneumoniab | Very common | 11 | 7 |
| Upper respiratory tract infection | Common | 9 | 0 | |
| Blood and lymphatic system disorders | Thrombocytopeniac | Very common | 38 | 22 |
| Anaemia | 27 | 21 | ||
| Lymphopeniad | 20 | 17 | ||
| Leukopeniae | 17 | 6 | ||
| Neutropeniaf | 15 | 11 | ||
| Eye disorders | Keratopathyg | Very common | 71 | 31 |
| Blurred vision eventsh | 25 | 4 | ||
| Dry eye eventsi | 15 | 1 | ||
| Photophobia | Common | 4 | 0 | |
| Eye irritation | 3 | 0 | ||
| Ulcerative keratitis | Uncommon | 1 | 1 | |
| Infective keratitis | 1 | 1 | ||
| Respiratory, thoracic and mediastinal disorders | Pneumonitis | Not known | NA | NA |
| Gastrointestinal disorders | Nausea | Very common | 25 | 0 |
| Diarrhoea | 13 | 1 | ||
| Vomiting | Common | 7 | 2 | |
| Renal and urinary Disorders | Albuminuriak | Common | 2 | 1 |
| General disorders and administration site conditions | Pyrexia | Very common | 23 | 4 |
| Fatigue | 16 | 2 | ||
| Investigations | Increased aspartate aminotransferase | Very common | 21 | 2 |
| Increased gamma glutamyltransferase | 11 | 3 | ||
| Increased creatine phosphokinase | Common | 5 | 2 | |
| Injury, poisoning and procedural complications | Infusion-related reactionsj | Very common | 21 | 3 |
NA = not applicable
a Adverse reactions coded using MedDRA and graded for severity based CTCAE v4.03.
b Includes pneumonia and herpes simplex pneumonia
c Includes thrombocytopenia and decreased platelet count.
d Includes lymphopenia and decreased lymphocyte count.
e Includes leukopenia and decreased leukocyte count.
f Includes neutropenia and decreased neutrophil count.
g Based on eye examination, characterised as corneal epithelium changes with or without symptoms.
h Includes diplopia, vision blurred, visual acuity reduced, and visual impairment.
i Includes dry eye, ocular discomfort, and eye pruritus.
j Includes events determined by investigators to be related to infusion. Infusion reactions may include, but are not limited to, pyrexia, chills, diarrhea, nausea, asthenia, hypertension, lethargy, tachycardia.
k Identified from patients across the belantamab mafodotin clinical program including study 205678. The frequency is based on the program-wide exposure.
Corneal adverse reactions were assessed in Study 205678 from the safety population (n=218) which included patients treated with 2.5 mg/kg (n=95). Eye disorder events occurred in 74% patients and the most common adverse reactions were keratopathy or microcyst-like epithelial changes in corneal epithelium [identified on eye exam, with or without symptoms] (71%), blurred vision (25%), and dry eye symptoms (15%). Decreased vision (Snellen Visual Acuity worse than 20/50) in the better eye was reported in 18% and severe vision loss (20/200 or worse) in the better seeing eye was reported in 1% of patients treated with belantamab mafodotin.
The median time to onset of Grade 2 or above corneal findings (best corrected visual acuity or keratopathy on eye examination) was 36 days (range: 19 to 143 days). The median time to resolution of these corneal findings was 91 days (range: 21 to 201 days).
Corneal findings (keratopathy) led to dose delays in 47% of patients, and dose reductions in 27% of patients. Three percent of patients discontinued treatment due to ocular events.
In clinical studies, the incidence of infusion-related reactions (IRR) with belantamab mafodotin 2.5 mg/kg was 21%, and most (90%) occurred during the first infusion. Most IRRs were reported as Grade 1 (6%) and Grade 2 (12%) while 3% experienced Grade 3 IRRs. Serious IRRs were reported by 4% of patients and included symptoms of pyrexia and lethargy. Median time to onset and the median duration of the first occurrence of an IRR was 1 day. One patient (1%) discontinued treatment due to IRRs, experiencing Grade 3 IRRs at first and second infusion. No Grade 4 or 5 IRRs were reported.
Thrombocytopenic events, (thrombocytopenia and platelet count decreased) occurred in 38% of patients treated with belantamab mafodotin 2.5 mg/kg. Grade 2 thrombocytopenic events occurred in 3% of patients, Grade 3 in 9%, and Grade 4 in 13%. Grade 3 bleeding events occurred in 2% of patients and no Grade 4 or 5 events were reported.
Upper respiratory tract infections were commonly reported across the belantamab mafodotin clinical programme and were mostly mild to moderate (Grade 1 to 3), occurring in 9% of patients treated with belantamab mafodotin 2.5 mg/kg. There were no SAEs of upper respiratory tract infections reported. Pneumonia was the most frequent infection reported in 11% of patients treated with belantamab mafodotin 2.5 mg/kg. Pneumonia was also the most frequent SAE, reported in 7% of patients. Infections with a fatal outcome were primarily due to pneumonia (1%).
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