General Information
Manufacturer: TG Therapeutics
Medical Name: ublituximab-xiiy
Purpose: Briumvi is a 1-hour, twice-per-year* infusion therapy for people with RMS
Common Side Effects
| Side Effect | Percentage Affected |
|---|---|
| Infusion reactions. Common symptoms include fever, chills, headache, and flu-like illness. | 48% (highest with the first infusion at 43%, decreasing to 10% for the second, and 8% for the third infusion) |
| Upper respiratory tract infections (e.g., common cold, sinusitis, tonsillitis) | 45% |
| Nausea | 10.6% |
| Lower respiratory tract infections (e.g., bronchitis, pneumonia) | 9% |
| Herpes virus-associated infections (e.g., cold sores, shingles) | 6% |
| Pain in extremity (arms/hands, legs/feet) | 6% |
| Insomnia (trouble sleeping) | 6% |
| Fatigue | 5% |
Serious Side Effects and Warnings
| Side Effect | Description |
|---|---|
| Serious infections | Occurred in 5% of Briumvi-treated patients in clinical trials. Three infection-related deaths occurred during trials. |
| Serious infusion reactions | While most are mild, 0.6% of patients experienced serious infusion reactions that required hospitalization. |
| Progressive multifocal leukoencephalopathy (PML) | No cases have been reported in Briumvi trials, but this life-threatening brain infection has occurred with other anti-CD20 therapies. |
| Liver Injury | Clinically significant liver injury has been reported in patients treated with anti-CD20 therapies. |
| Fetal Risk | Briumvi may cause fetal harm when administered during pregnancy. Females of reproductive potential are advised to use effective contraception during treatment and for at least 6 months after the last dose. |
Preconditions
| Precondition | Description |
|---|---|
| Active Hepatitis B Virus (HBV) Infection | Briumvi is contraindicated in patients with active HBV infection, confirmed by positive HBsAg and anti-HBV tests. Patients who are carriers of HBV or have a history of infection require expert consultation with a liver specialist before and during treatment. |
| Previous Life-Threatening Infusion Reactions | The medication is contraindicated in patients who have had a severe, life-threatening allergic or hypersensitivity reaction to Briumvi or any of its ingredients. A history of life-threatening reactions to other anti-CD20 antibodies may also be a contraindication. |
| Active Infections | Administration of Briumvi should be delayed in patients with an active infection until the infection has resolved. |
| Pregnancy and Breastfeeding | Briumvi may cause fetal harm based on animal data. Females of reproductive potential must use effective contraception during treatment and for at least 6 months after the last dose. It is unknown if Briumvi passes into breast milk. |
| Recent or Planned Vaccinations | Live-attenuated or live vaccines are not recommended during treatment and until B-cell repletion after discontinuation. All required immunizations should be administered at least 4 weeks before starting Briumvi for live vaccines and, whenever possible, at least 2 weeks prior for non-live vaccines. |
| Low Serum Immunoglobulins | B-cell depleting therapies can reduce immunoglobulin levels. Patients with low baseline serum immunoglobulins should be evaluated by an immunologist before starting treatment, and levels should be monitored during therapy. |
| Concurrent Use with Other MS Disease-Modifying Therapies (DMTs) | Briumvi should not be used concurrently with other MS DMTs unless the previous agent is being discontinued as part of a transition plan. |