ULO
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ULO (ULO).
ULO is a brand name for the drug ublituximab, a monoclonal antibody that targets CD20 on B-cells, leading to B-cell lysis via antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity.
| Metabolism | Catabolized via reticuloendothelial system; not metabolized by CYP450 enzymes. |
| Excretion | Primarily renal (60-80% as unchanged drug) via glomerular filtration and active tubular secretion; remainder as inactive metabolites. Biliary/fecal excretion accounts for <10%. |
| Half-life | Terminal elimination half-life is 1.5-3 hours (mean 2.2 hours) in adults with normal renal function; prolonged to 20-30 hours in severe renal impairment (CrCl <15 mL/min), necessitating dose adjustment. |
| Protein binding | 85-95% bound primarily to albumin (and to a lesser extent alpha-1-acid glycoprotein). |
| Volume of Distribution | 0.3-0.5 L/kg (mean 0.4 L/kg), indicating distribution mainly in extracellular fluid and well-perfused tissues. |
| Bioavailability | Oral: 70-85%; Intramuscular: 90-100%. |
| Onset of Action | Oral: 30-60 minutes; Intravenous: 5-15 minutes; Intramuscular: 10-30 minutes. |
| Duration of Action | Oral/IV/IM: 4-8 hours, depending on dose and renal function; hepatic impairment does not significantly prolong duration. |
100 mg orally twice daily for 7 days
| Dosage form | SYRUP |
| Renal impairment | No adjustment required for GFR >=30 mL/min; not recommended for GFR <30 mL/min |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B or C: not recommended |
| Pediatric use | Not approved for pediatric use; safety and efficacy not established |
| Geriatric use | No specific dose adjustment; use with caution due to age-related renal decline |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ULO (ULO).
| Breastfeeding | It is unknown if urofollitropin is excreted in human milk. Due to potential for serious adverse reactions, breastfeeding is not recommended during treatment and for at least 1 month after last dose. M/P ratio: not available. |
| Teratogenic Risk | ULo (urofollitropin) is not indicated for use in pregnant women. No adequate studies exist. Animal studies show no evidence of teratogenicity, but risk cannot be ruled out. Use only if clearly needed. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
["Active hepatitis B virus infection","History of life-threatening infusion reaction to ublituximab"]
| Precautions | ["Infusion reactions","Infections","Hepatitis B virus reactivation","Progressive multifocal leukoencephalopathy (PML)","Vaccinations should be given at least 4 weeks prior to initiation"] |
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| Monitor for ovarian hyperstimulation syndrome (OHSS). Monitor serum estradiol levels and follicular development via ultrasound. In case of pregnancy, monitor for multiple gestation and ectopic pregnancy. |
| Fertility Effects | ULo is used for ovulation induction; it can cause multiple follicular development. No known negative impact on fertility. However, it is used to treat infertility. |