Drug Detail:Monjuvi (Tafasitamab [ ta-fa-sit-a-mab ])
Generic Name: Tafasitamab 200mg in 5mL
Dosage Form: injection, powder, lyophilized, for solution
Drug Class: CD19 monoclonal antibodies
Recommended Dosage
The recommended dose of MONJUVI is 12 mg/kg based on actual body weight administered as an intravenous infusion according to the dosing schedule in Table 1.
Administer MONJUVI in combination with lenalidomide 25 mg for a maximum of 12 cycles, then continue MONJUVI as monotherapy until disease progression or unacceptable toxicity [see Clinical Studies (14)]. Refer to the lenalidomide prescribing information for lenalidomide dosage recommendations.
| Cycle* | Dosing Schedule |
|---|---|
|
|
| Cycle 1 | Days 1, 4, 8, 15 and 22 |
| Cycles 2 and 3 | Days 1, 8, 15 and 22 |
| Cycle 4 and beyond | Days 1 and 15 |
MONJUVI should be administered by a healthcare professional with immediate access to emergency equipment and appropriate medical support to manage infusion-related reactions (IRRs) [see Warnings and Precautions (5.1)].
Recommended Premedications
Administer premedications 30 minutes to 2 hours prior to starting MONJUVI infusion to minimize infusion-related reactions [see Warnings and Precautions (5.1)]. Premedications may include acetaminophen, histamine H1 receptor antagonists, histamine H2 receptor antagonists, and/or glucocorticosteroids.
For patients not experiencing infusion-related reactions during the first 3 infusions, premedication is optional for subsequent infusions.
If a patient experiences an infusion-related reaction, administer premedications before each subsequent infusion.
Dosage Modifications for Adverse Reactions
The recommended dosage modifications for adverse reactions are summarized in Table 2.
| Adverse Reaction | Severity | Dosage Modification |
|---|---|---|
| Infusion-related reactions [see Warnings and Precautions (5.1)] | Grade 2 (moderate) |
|
| Grade 3 (severe) |
|
|
| Grade 4 (life-threatening) |
|
|
| Myelosuppression [see Warnings and Precautions (5.2)] | Platelet count of 50,000/ mcL or less |
|
| Neutrophil count of 1,000/ mcL or less for at least 7 days OR Neutrophil count of 1,000/ mcL or less with an increase of body temperature to 100.4°F (38°C) or higher OR Neutrophil count less than 500/mcL |
|
Preparation and Administration
Reconstitute and dilute MONJUVI prior to infusion.
Reconstitution
- Calculate the dose (mg) and determine the number of vials needed.
- Reconstitute each 200 mg MONJUVI vial with 5 mL Sterile Water for Injection, USP with the stream directed toward the wall of each vial to obtain a final concentration of 40 mg/mL tafasitamab-cxix.
- Gently swirl the vial(s) until completely dissolved. Do not shake or swirl vigorously. Complete dissolution may take up to 5 minutes.
- Visually inspect the reconstituted solution for particulate matter or discoloration. The reconstituted solution should appear as a colorless to slightly yellow solution. Discard the vial(s) if the solution is cloudy, discolored, or contains visible particles.
- Use the reconstituted MONJUVI solution immediately. If needed, store the reconstituted solution in the vial for a maximum of 12 hours either refrigerated at 36°F to 46°F (2°C to 8°C) or room temperature at 68°F to 77°F (20°C to 25°C) before dilution. Protect from light during storage.
Dilution
- Determine the volume (mL) of the 40 mg/mL reconstituted MONJUVI solution needed based on the required dose.
- Remove a volume equal to the required MONJUVI solution from a 250 mL 0.9% Sodium Chloride Injection, USP infusion bag and discard it.
- Withdraw the necessary amount of MONJUVI and slowly dilute in the infusion bag that contains the 0.9% Sodium Chloride Injection, USP to a final concentration of 2 mg/mL to 8 mg/mL. Discard any unused portion of MONJUVI remaining in the vial.
- Gently mix the intravenous bag by slowly inverting the bag. Do not shake. Visually inspect the infusion bag with the diluted MONJUVI infusion solution for particulate matter and discoloration prior to administration.
- If not used immediately, store the diluted MONJUVI infusion solution refrigerated for up to 18 hours at 36°F to 46°F (2°C to 8°C) and/or at room temperature for up to 12 hours at 68°F to 77°F (20°C to 25°C). The room temperature storage includes time for infusion. Protect from light during storage.
Do not shake or freeze the reconstituted or diluted infusion solutions.
Administration
- Administer MONJUVI as an intravenous infusion.
- For the first infusion, use an infusion rate of 70 mL/h for the first 30 minutes, then, increase the rate so that the infusion is administered within 1.5 to 2.5 hours.
- Administer all subsequent infusions within 1.5 to 2 hours.
- Infuse the entire contents of the bag containing MONJUVI.
- Do not co-administer other drugs through the same infusion line.
- No incompatibilities have been observed between MONJUVI with infusion containers made of polypropylene (PP), polyvinylchloride (PVC), polyethylene (PE), polyethylenterephthalate (PET), or glass and infusion sets made of polyurethane (PUR) or PVC.
