MONJUVI
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MONJUVI (MONJUVI).
MONJUVI (tafasitamab-cxix) is a humanized Fc-engineered CD19-directed cytolytic monoclonal antibody. It binds to CD19 antigen on the surface of pre-B and mature B lymphocytes, and upon binding, facilitates antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).
| Metabolism | Tafasitamab is a monoclonal antibody; it is catabolized via general protein degradation processes. No specific metabolic pathways or enzymes involved. |
| Excretion | Monjuvi (tafasitamab-cxix) is a monoclonal antibody primarily catabolized into small peptides and amino acids. No specific data on renal or biliary excretion; minimal intact drug excreted in urine or feces. Expected to undergo general protein degradation. |
| Half-life | Terminal half-life: approximately 17 days (range 11-27 days). This supports a dosing interval of every 2 weeks, as steady state is reached by approximately 70 days. |
| Protein binding | No specific binding studies; as a humanized IgG1 monoclonal antibody, expected to have minimal nonspecific binding. Not bound to albumin or alpha-1-acid glycoprotein in a clinically meaningful manner. |
| Volume of Distribution | Vd: approximately 4.5 L (typical for an IgG antibody), suggesting distribution primarily in the vascular and interstitial spaces. In a 70 kg individual, this corresponds to ~0.064 L/kg. |
| Bioavailability | Administered intravenously; bioavailability is 100% by the IV route. No oral or other route available. |
| Onset of Action | Time to clinical effect not precisely defined; based on clinical trials, initial responses observed as early as the first tumor assessment at 8 weeks (after 4 doses) when given in combination with lenalidomide. |
| Duration of Action | Duration of action corresponds to drug exposure; after discontinuation, therapeutic concentrations persist for several weeks (approx. 5 half-lives ~85 days). Clinical responses are maintained as long as treatment continues; no specific duration data beyond treatment period. |
3 mg/kg intravenously over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment (CrCl ≥30 mL/min). Insufficient data for severe renal impairment (CrCl <30 mL/min) or dialysis. |
| Liver impairment | No dose adjustment recommended for Child-Pugh class A or B. For Child-Pugh class C, use only if benefit outweighs risk; no specific dose recommendation available. |
| Pediatric use | Safety and efficacy not established in pediatric patients; no recommended dose. |
| Geriatric use | No dose adjustment required based on age; monitor closely for adverse events, particularly infections. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MONJUVI (MONJUVI).
| Breastfeeding | There are no data on the presence of tafasitamab-cxix in human milk, effects on the breastfed child, or milk production. Since human immunoglobulin G is excreted into breast milk, and the potential for absorption and harm to the infant is unknown, advise women not to breastfeed during treatment with MONJUVI and for at least 3 months after the last dose. |
| Teratogenic Risk | Based on its mechanism of action as an anti-CD19 monoclonal antibody, MONJUVI (tafasitamab-cxix) is expected to cause fetal harm when administered to pregnant women. Immunoglobulin G antibodies cross the placenta, and fetal exposure increases as pregnancy progresses, with the largest amounts transferred during the third trimester. There are no available human data on use in pregnant women; however, animal studies have not been conducted. Advise women of reproductive potential of the potential risk to the fetus. |
■ FDA Black Box Warning
None
| Common Effects | Nausea Slow heart rate Abdominal pain Dizziness Fatigue Sleepiness Ankle swelling Constipation Edema swelling Flushing sense of warmth in the face ears neck and trunk Palpitations Headache Vomiting Visual disturbance Orthostatic hypotension sudden lowering of blood pressure on standing Breathlessness Muscle cramp |
| Serious Effects |
["None known."]
| Precautions | ["Infusion-related reactions: Monitor during infusion; interrupt or discontinue if severe reactions occur.","Myelosuppression: Neutropenia, thrombocytopenia, and anemia may occur; monitor blood counts regularly.","Infections: Serious, including fatal infections; monitor for signs and symptoms.","Embryo-fetal toxicity: Can cause fetal harm; advise females of reproductive potential to use effective contraception.","Immunization: Do not administer live vaccines during treatment."] |
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| Fetal Monitoring | Fetal monitoring: No specific fetal monitoring is recommended; however, pregnancy testing should be performed prior to initiation in women of reproductive potential. Advise these patients to use effective contraception during treatment and for at least 3 months after the last dose. |
| Fertility Effects | Based on animal studies, MONJUVI may impair female fertility. In a 6-month repeat-dose toxicology study in cynomolgus monkeys, increased incidences of ovarian follicular degeneration and atrophy were observed at doses approximately 6 times the human exposure. The effects on male fertility are unknown; no dedicated fertility studies have been conducted. |