Overview:

Adults with multiple myeloma (a kind of bone marrow cancer) who have taken at least four different treatments and the disease has reappeared or have not improved, are treated with Belantamab mafodotin. The drug Belantamab mafodotin belongs to the category of drugs known as antibody-drug conjugates. It eliminates cancer cells from working. Belantamab mafodotin is also known by the brand name Blenrep.

Keratopathy (change in the corneal epithelium on eye examination), decreased visual acuity, nausea, blurred vision, pyrexia, infusion-related responses, and exhaustion are among the most frequent side effects. Humanized IgG1 monoclonal antibody against B-cell maturation antigen (BCMA) linked with the cytotoxic compound maleimidocaproyl monomethyl auristatin F is known as belantamab mafodotin. The antibody-drug combination binds to B-cell maturation antigen on the surface of myeloma cells, causing cell cycle arrest and cytotoxicity that is antibody-dependent.

In August 2020, the European Union and the United States both granted medicinal use approval for Belantamab mafodotin. The Food and Drug Administration (FDA) in the United States regards it as a first-in-class drug.

Participating in the BLENREP REMS or risk evaluation and mitigation strategy, which was created to ensure proper use of the medication, makes Belantamab mafodotin accessible. The program mandates education on the risks to the eyes associated with treatment and monitoring for all doctors who prescribe the drug, as well as their patients. Belantamab mafodotin works by various mechanisms and targets BCMA, a plasma cell survival factor found on multiple myeloma cells and is a cell-surface protein.

The vital DREAMM-2 study, enrolling patients with refractory or relapsed multiple myeloma with actively advancing disease that had gotten worse despite receiving the current standard of care, provided the primary results after six months that were used to support the approval of Belantamab mafodotin. The anti-BCMA (B-cell maturation antigen) medication Belantamab mafodotin is the first of its kind to receive worldwide approval. Based on the response by patients, the drug is approved. The clinical efficacy of Belantamab mafodotin for this application is still being studied.

How Does Belantamab Mafodotin Work?

Multiple myeloma is a type of blood cancer that Belantamab mafodotin is approved to treat. Plasma cells, a subset of white blood cells that aid in the immune system's defense against infection, are impacted by this illness.

The body produces a lot of abnormal plasma cells, sometimes referred to as multiple myeloma cells, when one has multiple myeloma. The bone marrow may become overcrowded with these aberrant plasma cells. Lower amounts of other cells, including platelets, red blood cells, and white blood cells, may result from this. The chance of contracting an infection can also rise if someone has multiple myeloma.

The active component in the drug is Belantamab mafodotin-blmf. It is a kind of medication known as an antibody-drug conjugate. This indicates that it includes an active medication linked to an antibody (a type of protein used by the body's immune system). Myeloma cells in the patient's blood target the drug's action. It accomplishes this by clinging to cells and killing them. One component of the drug binds to a protein in myeloma cells. The B cell maturation antigen is the name of the protein. After that, a separate portion of the drug penetrates and kills the myeloma cell. Immediately following the first dose, the drug begins to work. But patients would not likely recognize the drug's effects on their bodies. Their doctor will probably order blood tests to determine whether the drug is successfully treating their multiple myeloma.

Indications for the Usage of the Drug:

Adults with multiple myeloma (a kind of bone marrow cancer) who have taken at least four different treatments, such as an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulating drug, and the disease has reappeared or has not improved are treated with Belantamab mafodotin-blmf injection. The drug Belantamab mafodotin-blmf belongs to the category of drugs known as antibody-drug conjugates. It eliminates cancer cells from working.

Dosage of the Drug:

An intravenous (IV) infusion of Belantamab Mafodotin-blmf is administered into a vein. The dosage of Belantamab Mafodotin-blmf that the patient will receive is determined by a number of variables, including weight, general health, and any underlying medical conditions. The physician will choose their precise dosage and timetable.

A doctor or nurse will administer Belantamab mafodotin-blmf intravenously over the course of 30 minutes after mixing the powder with fluids. Typically, it is given once every three weeks. One can repeat the cycle if their doctor advises it. The body's response to the medication, as well as any adverse effects the patient may have, will determine how long the therapy will continue.

While the patient is receiving the drug, a doctor or nurse will keep a close eye on them to ensure they are not having a dangerous response to the medication. Chills, flushing, itching, rash, shortness of breath, cough, wheezing, fatigue, fever, dizziness or lightheadedness, or swelling of your lips, tongue, neck, or face should all be reported to the doctor or nurse right away. The doctor may lower the dosage or stop the medication temporarily or permanently.

Drug Form and Strength:

In order to create a liquid solution, sterile water must be combined with the powder form of the drug. A healthcare provider gives the drug as an intravenous (IV) infusion. This involves a series of injections into a vein. Typically, infusions last for 30 minutes. There is only one strength of the drug, which is 100 milligrams (mg).

Warnings and Precautions:

Ocular Toxicity: Ocular adverse events occurred in 77% of the combined safety population patients. Among the ocular side effects were Keratopathy, changes in visual acuity, impaired vision, and dry eye. Around half of the keratopathy patients presented with ocular symptoms, and 34% of patients presented with both ocular symptoms and visual acuity changes, thus showing clinically significant alterations in visual acuity.
Keratopathy: According to the KVA scale, Keratopathy was recorded in various patient grades. There have been infected and ulcerative keratitis, sometimes known as corneal ulcers. In the first two treatment cycles conducted during the clinical study, most keratopathy episodes developed in the patients.
Changes in Visual Acuity: Of the 218 patients, 19% experienced a clinically significant decline in their better-seeing eye's visual acuity. The median duration to resolution for patients with impaired visual acuity of worse than 20/40 was 22 days, and 88 percent of these patients experienced this resolution. The median length was 22 days, and all patients with impaired visual acuity of 20/200 or worse resolved at this time.
Monitoring and Patient Education: Perform visual acuity and slit lamp exams of the eyes at baseline, before each dose, and right away for symptoms that are getting worse. Three weeks before the first dose, conduct baseline exams. Each follow-up examination should be carried out at least a week after the previous dose and no later than two weeks before the next dose. Withhold the drug until one feels better, then restart it at the same or a lower dose, or, depending on your condition, think about completely stopping it. Until the completion of the course of treatment, advise patients to use preservative-free lubricating eye drops at least four times per day, beginning with the first infusion. The use of contact lenses should only be done under a doctor's supervision. Driving and reading difficulties may be linked to changes in visual acuity. Remind patients to drive carefully and operate machines safely. Only restricted software run under a REMS offers Belantamab mafodotin.
Embryo-Fetal Toxicity: Belantamab mafodotin, when given to a pregnant woman, has the potential to harm the fetus due to its mode of action. Inform expectant mothers of the potential fetal risk. Encourage females who are sexually active to utilize reliable contraception during their drug treatment and for four months following their final dosage. Men should be advised to use effective contraception while taking the drug and for six months following the last dose if they have female partners who can become pregnant. Pregnancy testing is advised for females with the potential to become pregnant before beginning the medication.
Infusion-Related Responses: Of the 218 people in the pooled safety group, 18% experienced infusion-related reactions, with Grade 3 reactions occurring in 1.8% of those cases. Infusion-related responses should be watched in patients. Interrupt the infusion and administer supportive care for Grade 2 or 3 responses. Restart at a slower infusion rate after the symptoms have subsided. Prescriptions should be given before each consecutive infusion. In the event of life-threatening infusion-related reactions, discontinue the drug and administer the necessary emergency care.
Thrombocytopenia: In the pooled safety cohort, 218 individuals experienced thrombocytopenia in 69 % of cases, with Grade 2 cases accounting for 13 %, Grade 3 cases for 10 %, and Grade 4 cases for 17 %. It took 26.5 days on average until the first thrombocytopenic episode manifested itself. 9 % of patients experienced dose decrease, 2.8 % experienced dose interruption, and 0.5 % experienced dose cessation due to thrombocytopenia. 6% of patients experienced bleeding events with a grade of 3 to 4, with one patient experiencing a grade 4 incident. Cerebral bleeding occurred in 2 patients who died as a result of adverse events. Complete blood counts should be done as clinically recommended at baseline and throughout treatment. Depending on the severity, take into account holding back or lowering the dose.

Adverse Reactions:

The pooled safety population mentioned in Warnings and Precautions refers to 218 patients who participated in the DREAMM-2 study and who were exposed to Belantamab mafodotin, administered intravenously once every three weeks. One hundred ninety-four of these patients received a liquid formulation, which was not the dose form that had been approved. Eight percent of patients who received Belantamab mafodotin experienced permanent cessation due to an adverse reaction.

Keratopathy was the most common adverse reaction leading to permanent discontinuation
Blurred vision.
Dry eyes.
Pneumonia.
Thrombocytopenia.
Pyrexia.
Infusion-related responses.
Fatigue.
Lymphocytes drop.
Platelet reduction.
Hemoglobin decreases.
Neutrophils decrease.
Creatinine rise.
Gamma-glutamyl transferase increases.
Sepsis.
Lung infection.
Cardiac arrest.

For Patients

What Is Multiple Myeloma?

A malignancy known as multiple myeloma develops in a white blood cell known as a plasma cell. Healthy plasma cells produce antibodies that bind to and destroy bacteria, assisting our bodies in fighting illnesses. Cancerous plasma cells build up in the bone marrow and drive out healthy blood cells in multiple myeloma. Cancer cells create aberrant proteins that can lead to difficulties rather than beneficial antibodies.

What Is the Cause of Multiple Myeloma?

It is unknown what causes myeloma. In the middle of the majority of our bones, a soft, blood-producing tissue known as bone marrow, myeloma is known to start with one aberrant plasma cell. The aberrant cell rapidly divides. Cancer cells build up over time, eventually outnumbering the generation of healthy cells since they do not mature and subsequently die, as do the normal cells. Myeloma cells compress out healthy blood cells in the bone marrow, causing exhaustion and a lack of ability to fight infections.

As healthy plasma cells do, myeloma cells keep trying to create antibodies, but they produce aberrant antibodies that the body cannot utilize. Instead, the aberrant antibodies (also known as monoclonal proteins, or M proteins) accumulate in the body and lead to issues, including kidney damage. Bone damage brought on by cancer cells raises the possibility of fractured bones. Typically, monoclonal gammopathy of undetermined significance, a seemingly benign illness, is the initial presentation of multiple myeloma.

M proteins, which are produced by aberrant plasma cells and are present in the blood, are indicative of both MGUS (monoclonal gammopathy of undetermined significance) and multiple myeloma. However, there is no bodily harm in MGUS since the amounts of M proteins are lower.

Multiple myeloma risk factors include the following:

Aging - As one age, the risk of developing multiple myeloma rises; most cases are discovered in persons in their mid-sixties.
Sex - Men are more prone to getting the illness than women.
Race - Compared to people of other races, black people are more prone to acquiring multiple myeloma.
Family History - You are more likely to get multiple myeloma if a sibling, parent, or parent has the condition.
Personal Experience with MGUS - You are more likely to develop multiple myeloma if you have MGUS since it almost usually precedes the disease.

What Are the Symptoms?

Multiple myeloma symptoms can vary, and there may be almost nothing in the early stages of the disease. However, when symptoms do emerge, they may include:

Bone pain.
Nausea.
Constipation.
Reduced appetite.
Perplexity or haziness of the mind.
Fatigue.
Infections.
Loss of weight.
Leg trembling or numbness.
Extreme thirst.

Complications:

The body's capacity to fight infections is hampered by myeloma cells.
The bones can be impacted by multiple myeloma, which can cause pain, thinning, and fractured bones.
Kidney failure and other issues with kidney function may be brought on by multiple myeloma.
Multiple myeloma can also result in anemia and other blood issues because myeloma cells force out healthy blood cells.

How to Diagnose Multiple Myeloma?

Occasionally, the doctor will diagnose multiple myeloma after unintentionally finding it during a blood test for another illness. Additionally, it can be identified if your doctor believes you might have multiple myeloma based on the signs and symptoms.

The following tests and methods are used to identify multiple myeloma:

Blood Test - Beta-2-microglobulin is a different aberrant protein made by myeloma cells that may be found in the blood and provide the doctor with information about how aggressive the myeloma is.

Urine Test - The urine analysis may reveal M proteins, also known as Bence Jones proteins. When found in urine, the doctor might take a sample of the bone marrow for analysis in the lab. A lengthy needle is used to gather the sample inside a bone (bone marrow aspiration and biopsy).

To find gene alterations in myeloma cells, specialized procedures like fluorescence in situ hybridization (FISH) can examine the cells.

Imaging studies such as X-rays, MRIs (magnetic resonance imaging), CT (computerized tomography) scans, and positron emission tomography, could be suggested.

How Is Multiple Myeloma Managed?

Targeted medication therapies concentrate on particular flaws in cancer cells. Targeted medicational therapies can kill cancer cells by preventing these aberrations.

Immunotherapy uses the immune system to combat cancer. Due to the cancer cell's ability to create proteins that aid in their concealment from immune system cells, the body's illness-fighting immune system may not attack cancer. Immunotherapy affects that process in order to work.

Chemotherapy uses drugs to kill cancer cells. Myeloma cells are among the fast-growing cells that the medications kill. Before a bone marrow transplant, a high dosage of chemotherapy medication is administered.

In order to manage inflammation in the body, corticosteroid drugs influence the immune system. They work on myeloma cells as well.

In a bone marrow transplant, commonly referred to as a stem cell transplant, healthy bone marrow is substituted for the damaged bone marrow in the body. Blood is drawn to gather blood-forming stem cells prior to a bone marrow transplant. The damaged bone marrow in the body is then destroyed with large doses of chemotherapy. Then, after being put into the body, the stem cells travel to the bones and start regenerating the bone marrow.

High-powered radiation beams from sources like X-rays and protons are used in radiation treatment to kill cancer cells.

More About the Drug:

Dosage of the Drug for Multiple Myeloma:

Adult patients with multiple myeloma may use Belantamab mafodotin when appropriate. Adults with multiple myeloma who have used at least four previous treatments in the past but whose condition has recurred or has not improved are prescribed the drug. The multiple myeloma must either have relapsed or be refractory for treatment to work. Relapsing signifies that cancer has returned. Refractory cancers did not improve despite receiving specific therapy in the past.

Belantamab mafodotin is typically administered every three weeks at a dosage of 2.5 milligrams per kilogram (mg/kg) of body weight. A male weighing 175 pounds (lb) would be roughly 80 kilograms (kg). This implies that the 200 mg per infusion dosage would be appropriate. Depending on the patient's side effects while taking the drug, their doctor can prescribe them a different dosage. Patients should consult their doctor if they have any concerns about the dosage that is best for them.

What if the Patient Misses a Dose?

Call your doctor's office as soon as possible to rearrange a missed Belantamab mafodotin appointment. Try setting a medication reminder to help ensure that you do not miss an infusion appointment.

What Is the Duration for a Patient to Consume This Medication?

As long as the medication is efficient and there are no bothersome side effects, the drug may be used as a long-term treatment. Patients will probably continue taking Belantamab mafodotin for a long time if they and their doctor decide it is safe and beneficial.

Belantamab Mafodotin Interactions:

There are no documented interactions between Belantamab mafodotin and other drugs, foods, herbs, or supplements. Drug interactions with Belantamab mafodotin were not investigated by the manufacturers. However, this does not rule out the possibility of drug interactions with Belantamab mafodotin.

Patients should consult with their doctor and pharmacist prior to taking Belantamab mafodotin. Any prescription, over-the-counter, and other medications they use should be disclosed to them. Tell them if you are under supplements, herbs, or vitamins. Patients can avoid potential interactions by disclosing this information.

Herbs, Vitamins, and Belantamab Mafodotin - There have not been any particular reports of herbs or supplements interfering with the drug. However, before using any of these items while taking the drug, one should still speak to their doctor or pharmacist.

Belantamb Mafodotin and Food - No specific foods have been found to interact negatively with the drug. Consult a doctor about any concerns about consuming particular foods while taking the drug.

Vaccinations and Belantamb Mafodotin - No known interactions exist between vaccinations and the drug. However, it is advised against obtaining some vaccines while receiving Belantmab mafodotin. This is so vaccinations can be successful, typically requiring a strong immune system. Getting vaccines while receiving cancer treatment can reduce the effectiveness of the vaccines because cancer can impair the immune system. Take advice from a doctor if you have any concerns about receiving a particular vaccine while taking the drug.

Alcohol and Belanamab Mafodotin - Alcohol and Belantamab mafodotin do not seem to interact. However, more research is needed pertaining to this to fully understand the dangers of drinking alcohol while receiving cancer treatments like Belantamab mafodotin. If someone consumes alcohol, it is crucial to discuss how much is safe for them to consume while taking the drug with their doctor.

Belantamab Mafodotin With Other Drugs - Taking Blenrep can result in serious eye issues, including corneal ulcers and eyesight loss. One should thus use lubricating eye drops when taking Belantamab mafodotin. The eyes may stay less dry and irritated if they use lubricating eye drops. The eye drops should not contain any preservatives. Preservative-free eye drops are crucial if patients want to lessen eye irritation. Consult the doctor if you are concerned about using eye drops while taking Belantamab mafodotin.

For Medical Professionals

Pharmacodynamics:

Through G2/M cell cycle arrest and antibody-dependent cell-mediated cytotoxicity, Belantamab mafodotin treats multiple myeloma. Due to the likelihood of side effects, it has a limited therapeutic index and a lengthy half-life because it is administered every three weeks. Patients should receive advice on how to reduce their risk of keratopathy.

Pharmacokinetics:

The pharmacokinetics of Belantamab mafodotin-blmf were dose-proportional, with a gradual decline in clearance over time; the period to achieve a steady state was about 70 days. Maximum plasma concentrations of Belantamab mafodotin-blmf occurred at or shortly after the infusion's 0.5-hour scheduled length. When given every three weeks, Belantamab mafodotin-blmf accumulation was at 70%.

Mechanism of Action:

Afucosylated monoclonal antibody Belantamab mafodotin, also known as GSK2857916, is used to treat B cell maturation antigen (BCMA), which is linked to the microtubule disruptor monomethyl auristatin-F (MMAF). Monoclonal antibodies' Fc regions are afucosylated to increase their binding to the Fc region, which increases the antibody-dependent cell-mediated cytotoxicity. Myeloma cells that are CD138-positive exclusively express BCMA. Belantamab mafodotin can deliver MMAF to multiple myeloma cells extremely specifically by targeting BCMA. One releases MMAF when Belantamab mafodotin attaches to BCMA and enters cells. Apoptosis is caused when the DNA damage checkpoint between the G2 and M stages of the cell cycle is reached by the MMAF payload binding to tubulin.

Metabolism:

It is anticipated that monoclonal antibodies will break down into smaller peptides and amino acids. It is anticipated that oxidation and demethylation will be used to break down MMAF, although more information is not yet publicly available.

Elimination and Clearance:

After being phagocytosed and disassembled into smaller peptides and amino acids, monoclonal antibodies are removed similarly to other proteins. However, only a small portion of monoclonal antibodies is excreted in bile, and they are typically not removed in the urine. Belantamab mafodotin's terminal half-life was 12 days after the initial dose and 14 days at a steady state.

After the initial dose, the clearance of Belantamab mafodotin was 0.9 L/day, and at a steady state, it was 0.7 L/day.

Chemical Taxonomy:

Kingdom - Organic Compounds

Super Class - Organic Acids

Class - Carboxylic Acids and Derivatives

Subclass - Amino Acids, Peptides, and Analogues

Direct Parent - Peptides

Non-Clinical Toxicology- Carcinogenesis, Mutagenesis, Impairment of Fertility

There has been no research on the carcinogenicity of Belantamab mafodotin-blmf. In an in vitro micronucleus assay using human lymphocytes, Belantamab mafodotin-blmf caused genotoxicity via an aneugenic mechanism. These findings are in line with MMAF binding to tubulin's pharmacological action of causing microtubule depolymerization, which results in spindle disarray during cell division.

There have not been any Belantamab mafodotin-blmf fertility studies. Results of repeat dose toxicity tests in rats with Belantamab mafodotin-blmf suggest that male and female fertility and reproductive function may be affected. The seminiferous tubules in the testes and luteinized non ovulatory follicles in the ovaries in rats underwent degeneration and atrophy after receiving weekly doses of Belantamab mafodotin-blmf for three weeks.

Cys-mcMMAF was not mutagenic in the L5178Y mouse lymphoma forward mutation assay.

Clinical Trial Results:

An open-label, multicenter research called DREAMM-2 assessed the effectiveness of Belantemab mafodotin. Patients needed to have relapsed or refractory multiple myeloma, failed at least three prior treatments, including an anti-CD38 monoclonal antibody, and failed immunomodulatory and proteasome inhibitor therapy. Patients having the corneal epithelial disease at baseline were not included in the trial, with the exception of moderate punctate keratopathy.

Patients with baseline eGFRs between 30 and 89 mL/min/1.73m2 and mild or severe renal impairment were also eligible for the research. Until the disease progressed or the side effects became intolerable, patients received either Belantemab mafodotin at 2.5 mg/kg or 3.4 mg/kg intravenously once every three weeks. Belantamab mafodotin was given to 97 individuals in total. The majority of patients (77%) were in stages II or III of the International Staging System (ISS), 87%) had had autologous stem cell transplantation (ASCT), and 16%) had an ECOG performance score of 2.

The first response took an average of 1.4 months. A response period of less than six months was reported by 73% of respondents. The overall response rate was 31%, with 1% of responses being complete and 15% of responses being very good.

Because adverse reaction rates in clinical trials are determined under a variety of different circumstances, they cannot be directly compared to adverse reaction rates in clinical trials of other drugs and may not accurately represent rates seen in actual clinical practice.

In DREAMM-2, the safety of Belantamab mafodotin was assessed as a single drug. The drug was given to patients at the indicated dose of 2.5 mg/kg intravenously once every three weeks. Twenty-two percent of these patients had exposure for at least six months. 40% of patients who got the drug experienced serious adverse effects such as pneumonia, pyrexia, renal impairment, sepsis, and infusion-related responses. The most typical adverse event leading to permanent cessation was keratopathy. Blurred vision, dry eye, and pneumonia were among the adverse events that required a dosage stoppage in more than 3 percent of patients. 29 percent of patients saw dose reductions as a result of a negative reaction. The most prevalent Grade 3 or Grade 4 laboratory abnormalities were reduced lymphocytes, platelets, hemoglobin, and nephrotic syndrome.

Immunogenicity:

Immunogenicity is a possibility. The sensitivity and specificity of the assay play a key role in detecting antibody production. Additionally, a number of elements, such as the assay's technique, sample handling, the timing of sample collection, concurrent drugs, and underlying diseases, may impact the recorded incidence of antibody positives in an assay. After four weeks of treatment, one of the two patients had a positive test for neutralizing anti-Belantamab mafodotin antibodies. There are not enough patients with Belantamab mafodotin-blmf antibodies to draw any conclusions about how immunogenicity would affect pharmacokinetics, effectiveness, or safety.

Usage of the Drug in a Specific Population:

Patients With Renal Dysfunction

No dose change is advised for individuals with mild or moderate renal impairment (eGFR 30 to 89 mL/min/1.73m2 as calculated by the modification of diet in renal disease [MDRD] equation). Patients with end-stage renal disease and severe renal impairment have not yet had the required dosage determined.
Pregnant Patients

Due to the fact that it targets actively dividing cells and contains a genotoxic substance (the microtubule inhibitor, MMAF), Belantamab mafodotin has the potential to harm an unborn child when given to a pregnant woman. Because it is known for human immunoglobulin G (IgG) to penetrate the placenta, Belantamab mafodotin-blmf may be passed from the mother to the growing fetus.

No data are currently available to assess the risk associated with the use of the drug during pregnancy. With Belentemab mafodotin, no investigations on animal reproduction were carried out. Inform expectant mothers of the potential fetal risk. For the indicated group, it is uncertain what the background risk is for serious birth abnormalities and miscarriages. Every pregnancy has a background risk of birth deformity, miscarriage, or another unfavorable outcome.
Potentially Reproductive Males and Females

When given to pregnant women, Belentemab mafodotin has the potential to harm the fetus. For females with the potential to become pregnant, pregnancy testing is advised before beginning Belentemab mafodotin.

Females are recommended to use effective contraception during therapy and for four months following the last dose for women who are sexually active. In males, due to the risk of genotoxicity and who have female partners who are capable of becoming pregnant to use reliable contraception throughout their Belentemab mafodotin therapy and for six months following the last dosage. According to results from tests done on animals, Belentemab mafodotin may harm both male and female fertility.
Patients With Liver Impairment

For individuals with mild hepatic impairment, no dose change is advised.

In patients suffering from a moderate or severe hepatic impairment, the recommended dosage of Belentemab mafodotin has not been established.
Lactating Patients

There is no information on Belantamab mafodotin-presence in human milk, its effects on nursing infants, or its ability to be present in breast milk. Therefore, women are advised to cease breastfeeding during treatment with the drug and for three months following the final dosage due to the possibility of significant adverse effects in the breastfed child.
Pediatric Patients

Belentemab mafodotin has not been proven safe or beneficial in pediatric patients.
Geriatrics Patients

43 percent of the 218 patients who got Belentemab mafodotin in DREAMM-2 were 65 to under 75 years old, and 17 percent were 75 years of age or more. However, there were insufficient elderly participants in the drug’s clinical investigations to assess whether their effectiveness varied from that of younger ones.