Ublituximab-xiiy (Intravenous)

Ublituximab-xiiy injection is used to treat the relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. This medicine will not cure MS, but it may help slow some of the disabling effects and reduce the number of relapses.

This medicine should only be given by your doctor or under their direct supervision.

It is very important for your doctor to check your progress at regular visits to ensure this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

Taking this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to confirm that you are not pregnant before you receive this medicine. Use an effective form of birth control to prevent pregnancy during treatment with this medicine and for 6 months after the last dose. If you think you might be pregnant while receiving this medicine, inform your doctor immediately.

This medicine may cause an infusion reaction, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you experience chest tightness, chills, cough, difficulty swallowing, dizziness, fever, headache, nausea, fast, pounding, or irregular heartbeat or pulse, lightheadedness or faintness, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, sore throat, swelling in your face or hands, skin itching, redness, rash, or hives, trouble breathing, or unusual tiredness or weakness while receiving this medicine.

This medicine may increase your risk of developing infections. Avoid being around people who are sick or have infections while using this medicine. Wash your hands frequently. Also, inform your doctor if you have ever had an infection that would not go away or one that kept coming back.

This medicine may cause hepatitis B virus reactivation. Inform your doctor right away if you have yellow skin or eyes, dark brown urine, right-sided stomach pain, fever, or severe tiredness.

This medicine may increase your risk of developing infections, including a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML). This is more likely if you have a JCV infection. Check with your doctor if you experience weakness on one side of your body, clumsiness, blurred vision, changes in thinking, memory problems, confusion, or personality changes.

While you are being treated with ublituximab-xiiy, and after you stop treatment, do not get any immunizations (vaccinations) without your doctor's approval. Complete any required live or live-attenuated vaccines at least 4 weeks, or non-live vaccines at least 2 weeks, before starting this medicine. This medicine may lower your body's resistance, increasing the chance of getting the infection the immunization is meant to prevent. Additionally, others in your household should not take the oral polio vaccine, as they could potentially pass the polio virus to you. Also, avoid people who have taken the oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for long. If you cannot take these precautions, consider wearing a protective face mask that covers your nose and mouth.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a drug, the chances of taking the drug must be weighed against the beneficial it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your clinician if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Additionally tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ublituximab-xiiy injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ublituximab-xiiy injection in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this drug during breastfeeding. Weigh the potential benefits against the potential chances prior to taking this medication while breastfeeding.

Interactions with Medications

Although certain medicines should not be used together at all, in other cases two different medications may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially essential that your healthcare professional know if you are using any of the drugs listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medication with any of the following medicines is normally not advised, but may be required in some cases. If both drugs are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine, Live
• Anthrax Vaccine Adsorbed
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Diphtheria Toxoid, Adsorbed
• Ebola Zaire Vaccine, Live
• Haemophilus B Vaccine
• Hepatitis A Vaccine, Inactivated
• Hepatitis B Vaccine
• Human Papillomavirus Vaccine
• Influenza Virus Vaccine
• Influenza Virus Vaccine, Live
• Japanese Encephalitis Virus Vaccine
• Measles Virus Vaccine, Live
• Meningococcal Polysaccharide Vaccine
• Meningococcal Vaccine
• Mumps Virus Vaccine, Live
• Pertussis Vaccine
• Pneumococcal Vaccine
• Pneumococcal Vaccine, Diphtheria Conjugate
• Pneumococcal Vaccine Polyvalent
• Poliovirus Vaccine, Inactivated
• Poliovirus Vaccine, Live
• Rabies Vaccine
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• SARS-COV-2 (COVID-19) Vaccine, Adenovirus 26 Vector (Janssen)
• SARS-COV-2 (COVID-19) Vaccine, mRNA (Moderna)
• SARS-COV-2 (COVID-19) Vaccine, mRNA (Pfizer)
• SARS-COV-2 (COVID-19) Vaccine, Protein Subunit, Adjuvanted (Novavax)
• SARS-COV-2 (COVID-19) Vaccine, Protein Subunit, Adjuvanted (Sanofi)
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Tetanus Toxoid
• Tick-Borne Encephalitis Vaccine
• Typhoid Vaccine
• Typhoid Vaccine, Live
• Typhoid Vi Polysaccharide Vaccine
• Varicella Virus Vaccine
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Interactions with Food/Tobacco/Alcohol

Certain drugs should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medications may also cause interactions to occur. Discuss with your healthcare professional the use of your medication with food, alcohol, or tobacco.

Other Medical Issues

The presence of other medical issues may affect the use of this medicine. Make sure you inform your doctor if you have any other medical issues, especially:

• Hepatitis B infection, active or
• Infusion reaction, history of—Should not be used in patients with these conditions.

• Hepatitis B infection, history of—Use with caution. May make this condition worse.

• Infection, active—Should be treated first prior to receiving this drug.

• Weak immune system—Use with caution. May increase risk for more severe side effects.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Body aches or pain
• chest pain or tightness
• chills
• cough
• cough producing mucus
• diarrhea
• dizziness
• dryness or soreness of the throat
• ear congestion
• facial swelling
• fever or chills
• general feeling of discomfort or illness
• headache
• hoarseness
• joint pain
• loss of voice
• muscle aches and pains
• nausea or vomiting
• pain or tenderness around the eyes and cheekbones
• skin rash
• sneezing
• stuffy or runny nose
• sweating
• tender, swollen glands in the neck
• trouble breathing
• trouble in swallowing
• trouble sleeping
• unusual tiredness or weakness
• voice changes
• vomiting

Incidence not known

• Back pain
• blurred vision
• confusion
• dark urine
• drowsiness
• light-colored stools
• seizures
• upper right abdominal or stomach pain
• yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Pain in the arms or legs

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Available Dosage Forms:

• Solution

Therapeutic Class: Immune Modulator

Pharmacologic Class: Ublituximab

Find detailed information on biosimilars for this medication.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins.

You will receive the first dose of this medicine that will last for at least 4 hours. Your second dose will be given 2 weeks after your first dose for at least 1 hour. You will receive your next doses as 1 infusion every 24 weeks that will last for at least 1 hour.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Your doctor may give you other medicines (eg, allergy medicine, fever medicine, steroid) 30 to 60 minutes before receiving this medicine to prevent unwanted effects (eg, infusion reactions). Your doctor may also want you to stay for at least 1 hour after the first 2 infusions to check for unwanted effects.

Missed Dose

Call your doctor or pharmacist for instructions.

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