Inebilizumab

Inebilizumab is a prescription medication used to treat neuromyelitis optica spectrum disorder in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

• Inebilizumab is available under the following different brand names: Uplizna, inebilizumab-cdon

Common side effects of Inebilizumab include:

• urinary tract infection
• joint pain
• headache
• back pain

Serious side effects of Inebilizumab include:

• headache
• nausea
• sleepiness
• shortness of breath
• fever
• muscle aches
• rash
• infection symptoms, such as painful and frequent urination, nasal congestion, runny nose, sore throat, fever, chills, cough, body aches
• tuberculosis (TB)

Rare side effects of Inebilizumab 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, coordination loss, 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

Injection, solution

• 100 mg/10 mL (10 mg/mL) single-dose vials

Neuromyelitis optica spectrum disorder

Adult dosage

• Initial doses: 300 mg IV × 1 dose; follow 2 weeks later by a second 300-mg IV infusion
• Subsequent doses (starting 6 months from the first infusion): 300 mg IV every 6 months

Premedication before each infusion

• 30 minutes before
  • IV corticosteroids (eg, methylprednisolone 80-125 mg or equivalent)
• 30-60 minutes before
  • Oral antihistamine (eg, diphenhydramine 25-50 mg or equivalent)
  • Oral antipyretic (eg, acetaminophen 500-650 mg)

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, healthcare provider, or pharmacist first.

Inebilizumab has severe interactions with no other drugs.

Inebilizumab has serious interactions with the following drugs:

• axicabtagene ciloleucel
• brexucabtagene autoleucel
• ciltacabtagene autoleucel
• idecabtagene vicleucel
• lisocabtagene maraleucel
• tisagenlecleucel
• upadacitinib

Inebilizumab has moderate interactions with the following drugs:

• efgartigimod alfa
• efgartigimod/hyaluronidase SC
• isavuconazonium sulfate
• rozanolixizumab
• ublituximab

Inebilizumab 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 the products you use. 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, health questions, or concerns.

Contraindications

• History of life-threatening infusion reaction to Inebilizumab
• Active HBV infection
• Active or untreated latent TB

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Progressive and prolonged hypogammaglobulinemia may occur; monitor levels of quantitative serum immunoglobulins during treatment and until B-cell repletion after discontinuation of therapy, especially in patients with opportunistic or recurrent infections; consider discontinuation in case of low levels of IgG/IgM or if a serious infection develops
• Based on animal data, inebilizumab can cause fetal harm owing to B-cell lymphopenia
• Infusion reactions
  • Can cause infusion reactions, which may include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other signs or symptoms
  • Reactions are most common with initial infusion but can also be observed during subsequent infusions
  • Premedication with IV corticosteroid, antihistamine, and antipyretic required before every infusion
  • For life-threatening infusion reactions, discontinue inebilizumab immediately and permanently and administer appropriate supportive treatment
  • For less severe infusion reactions, management may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment
• Infections
  • Increased risk for infections observed with other B-cell-depleting therapies
  • Risks include additive effects if coadministered with other immunosuppressants; HBV reactivation; progressive multifocal leukoencephalopathy; TB reactivation; or risk from live virus administration
• Drug interaction overview
  • Immunosuppressive drugs
    • Coadministration with immunosuppressant drugs, including systemic corticosteroids, may increase the risk for infection
  • Vaccines
  • Administer all the required vaccines at least 4 weeks before initiating inebilizumab
  • Vaccination with live-attenuated or live vaccines is not recommended during treatment and until B-cell repletion
  • Vaccination of infants born to mothers treated with inebilizumab during pregnancy
  • Do not administer live or live-attenuated vaccines before confirming recovery of B-cell count in the infant
  • Depletion of B cells in these exposed infants may increase the risks from live or live-attenuated vaccines
  • Nonlive vaccines, as indicated, may be administered before recovery from B-cell and immunoglobulin level depletion; consider consulting with a qualified specialist to assess whether a protective immune response was mounted

Pregnancy and Lactation

• Humanized IgG1 monoclonal antibodies and immunoglobulins are known to cross the placental barrier
• Data are not available on the developmental risk associated with the drug’s use in pregnant women; however, transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other B-cell depleting antibodies during pregnancy
• The potential duration of B-cell depletion in such infants and the impact of B-cell depletion on vaccine safety and effectiveness are unknown
• Contraception
  • Females of childbearing potential should use contraception during therapy and for 6 months after the last infusion
• Lactation
  • Data are not available on the presence of inebilizumab in human milk or its effects on breastfed infants and milk production
  • Human IgG is excreted in human milk, and the potential for absorption of inebilizumab to cause B-cell depletion in breastfed infants is unknown