Ublituximab

Ublituximab is a prescription medicine used for the treatment of multiple sclerosis. 

• Ublituximab is available under the following different brand names: Briumvi, ublituximab-xiiy

Common side effects of Ublituximab include:

• fever,
• chills,
• headache,
• flu-like symptoms,
• upper or lower respiratory tract infections,
• Herpes virus-associated infections,
• pain in your arms or legs,
• difficulty sleeping (insomnia), and
• fatigue

Serious side effects of Ublituximab include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• fever,
• chills,
• headache,
• flu-like symptoms,
• sore throat, and
• abnormal blood values (reduction in Immunoglobins, Neutrophils)

Rare side effects of Ublituximab include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution

• 25 mg/mL (150 mg/6 mL single-dose vial)

Multiple Sclerosis

Adult dosage

• First infusion: 150 mg IV
• Second infusion: 450 mg IV 2 weeks after the first infusion
• Subsequent infusions: 450 mg IV 24 weeks after the first infusion and then every 24 weeks after that

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ublituximab has severe interactions with no other drugs.
• Ublituximab has serious interactions with the following drugs:
  • axicabtagene ciloleucel
  • brexucabtagene autoleucel
  • ciltacabtagene autoleucel
  • idecabtagene vicleucel
  • lisocabtagene maraleucel
  • tisagenlecleucel
• Ublituximab has moderate interactions with the following drug:
  • efgartigimod alfa
• Ublituximab has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Active hepatitis B virus infection
• History of life-threatening infusion reaction to ublituximab

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ublituximab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ublituximab?”

Cautions

• Based on animal studies, fetal harm may occur when administered to pregnant females
• Decreased immunoglobulin levels
• Decreased immunoglobulin levels observed; monitor levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation until B-cell repletion
• Consider discontinuing therapy if:
  • Patients with low immunoglobulins develop serious opportunistic or recurrent infections
  • Prolonged hypogammaglobulinemia occurs requiring treatment with IV immunoglobulins
• Infections
  • Serious bacterial and viral infections reported
  • An increased risk of infections, including serious and fatal bacterial, fungal, and new or reactivated viral infections, observed during and after the completion of other anti-CD20 B-cell–depleting treatments
  • Delay administration in patients with an active infection until the infection is resolved
• When initiating after an immunosuppressive therapy or initiating an immunosuppressive therapy, consider the potential for increased immunosuppressive effects
• Not studied in combination with other MS therapies
• Progressive multifocal leukoencephalopathy (PML)
  • PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised
  • JCV infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies
  • Symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes
  • At the first sign or symptom suggestive of PML, withhold therapy and perform an appropriate diagnostic evaluation
  • If PML is suspected, monitor with MRI for signs that may be consistent with PML and further investigate
  • If confirmed, discontinue treatment
• HBV reactivation
  • HBV reactivation may occur
  • Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation were reported in patients treated with anti-CD20 antibodies
  • Screen for HBV in all patients before initiating
  • Do not initiate with active HBV confirmed by positive results for HBsAg and anti-HB tests
  • For patients who are negative for HBsAg and HBcAb+ or who are HBsAg+, consult a liver disease expert before starting and during treatment
• Infusion-related reactions
  • Infusion-related reactions (eg, pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, anaphylactic reactions) reported
  • Administer premedications (eg, methylprednisolone or an equivalent corticosteroid, and an antihistamine) to reduce the frequency and severity of infusion reactions; consider adding an antipyretic (eg, acetaminophen)
  • Manage infusion reactions based on the severity
• Drug interaction overview
• Vaccinations
  • Administer all immunizations according to immunization guidelines at least 4 weeks before initiating live or live-attenuated vaccines and, whenever possible, at least 2 weeks before initiating non-live vaccines
  • Ublituximab may interfere with non-live vaccine efficacy
  • Safety of immunization with live or live-attenuated vaccines during or following treatment not studied
  • Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion
  • Vaccination of Infants born to mothers treated during pregnancy
  • Do not administer live or live-attenuated vaccines to infants of mothers exposed to ublituximab during pregnancy, before confirming recovery of B-cell counts as measured by CD19+ B cells
  • Depletion of B cells in these infants may increase the risks from live or live-attenuated vaccines
  • Inactivated or non-live vaccines may be administered as indicated, before recovering from B-cell depletion; consider assessing vaccine immune responses, such as through consultation with a qualified specialist, to determine whether a protective immune response has mounted
• Immunosuppressive or immune-modulating therapies
  • Ublituximab may potentiate the risk of additive immune system effects when coadministered with immunosuppressive or immune-modulating therapies
  • Owing to potential additive immunosuppressive effects, consider the duration of effect and mechanism of action of these therapies when switching from therapies with immune effects to ublituximab

Pregnancy and Lactation

• There are no data on the developmental risk associated with use in pregnant females
• Data are insufficient to identify drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• However, monoclonal antibodies can be actively transported across the placenta and may cause immunosuppression to in-utero exposed infant
• Verify pregnancy status in females of reproductive potential
• Fetal/neonatal adverse reactions
  • Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses and peaks during the third trimester
  • No data are available on B-cell levels in human neonates following maternal exposure to ublituximab
  • However, transient peripheral B-cell depletion and lymphocytopenia were reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy
  • Avoid administering live vaccines to neonates and infants exposed to ublituximab in utero until B-cell recovery occurs
• Contraception
  • Females of reproductive potential: Use effective contraception during treatment and for 6 months after the final dose
• Lactation
  • There are no data on drug presence in human milk, effects on breastfed infants, or effects on milk production
  • Human IgG is excreted in human milk; the potential for drug absorption leading to B-cell depletion in infants is unknown