Tafasitamab
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Recommended Premedications Administer premedications 30 minutes to 2 hours prior to starting MONJUVI infusion to minimize infusion-related reactions [see Warnings and Precautions ]. Premedications may include acetaminophen, histamine H 1 receptor antagonists, histamine H 2 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.
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.
| Adverse Reaction | Severity | Dosage Modification |
|---|---|---|
| Infusion-related reactions [see Warnings and Precautions (5.1)] | Grade 2 (moderate) | Interrupt infusion immediately and manage signs and symptoms.Once signs and symptoms resolve or reduce to Grade 1, resume infusion at no more than 50% of the rate at which the reaction occurred. If the patient does not experience further reaction within 1 hour and vital signs are stable, the infusion rate may be increased every 30 minutes as tolerated to the rate at which the reaction occurred. |
| Grade 3 (severe) | Interrupt infusion immediately and manage signs and symptoms.Once signs and symptoms resolve or reduce to Grade 1, resume infusion at no more than 25% of the rate at which the reaction occurred. If the patient does not experience further reaction within 1 hour and vital signs are stable, the infusion rate may be increased every 30 minutes as tolerated to a maximum of 50% of the rate at which the reaction occurred.If after rechallenge the reaction returns, stop the infusion immediately. | |
| Grade 4 (life-threatening) | Stop the infusion immediately and permanently discontinue MONJUVI. | |
| Myelosuppression [see Warnings and Precautions (5.2)] | Platelet count of 50,000/ mcL or less | Withhold MONJUVI and lenalidomide and monitor complete blood count (CBC) weekly until platelet count is 50,000/mcL or higher.Resume MONJUVI at the same dose and lenalidomide at a reduced dose. Refer to lenalidomide prescribing information for dosage modifications. |
| 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 | Withhold MONJUVI and lenalidomide and monitor CBC weekly until neutrophil count is 1,000/ mcL or higher.Resume MONJUVI at the same dose and lenalidomide at a reduced dose. Refer to lenalidomide prescribing information for dosage modifications. |
Contraindications
None. None.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on its mechanism of action, MONJUVI may cause fetal B-cell depletion when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on MONJUVI use in pregnant women to evaluate for a drug-associated risk. Animal reproductive toxicity studies have not been conducted with tafasitamab-cxix. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. MONJUVI is administered in combination with lenalidomide for up to 12 cycles.
Lenalidomide can cause embryo-fetal harm and is contraindicated for use in pregnancy. Refer to the lenalidomide prescribing information for additional information. Lenalidomide is only available through a REMS program. Clinical Considerations Fetal/Neonatal Adverse Reactions Immunoglobulin G (IgG) monoclonal antibodies are transferred across the placenta. Based on its mechanism of action, MONJUVI may cause depletion of fetal CD19 positive immune cells. Defer administering live vaccines to neonates and infants exposed to tafasitamab-cxix in utero until a hematology evaluation is completed. Data Animal Data Animal reproductive studies have not been conducted with tafasitamab-cxix.
Tafasitamab-cxix is an IgG antibody and thus has the potential to cross the placental barrier permitting direct fetal exposure and depleting fetal B lymphocytes.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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