Dosing & Uses
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 200mg/vial
Diffuse Large B-Cell Lymphoma
Indicated in combination with lenalidomide for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) , in adults who are not eligible for autologous stem cell transplantation
Each cycle is 28 days
Cycle 1
- Days 1-21: Lenalidomide 25 mg PO qDay
- Days 1, 4, 8, 15, and 22: Tafasitamab 12 mg/kg IV
Cycles 2 and 3
- Days 1-21: Lenalidomide 25 mg PO qDay
- Days 1, 8, 15, and 22: Tafasitamab 12 mg/kg IV
Cycle 4 and thereafter
- Days 1-21: Lenalidomide 25 mg PO qDay
- Days 1 and 15: Tafasitamab 12 mg/kg IV
- Administer tafasitamab in combination with lenalidomide for up to 12 cycles, then continue tafasitamab as monotherapy until disease progression or unacceptable toxicity
Dosage Modifications
Refer to lenalidomide prescribing information for dosage modifications
Infusion-related reactions
-
Grade 2
- Interrupt infusion immediately and manage signs and symptoms
- Once signs and symptoms resolve to Grade ≤1, resume at ≤50% of rate at which reaction occurred
- If no further reaction occurs within 1 hr and vital signs are stable, may increase infusion rate every 30 min as tolerated to rate at which the reaction occurred
-
Grade 3
- Interrupt infusion immediately and manage signs and symptoms
- Once signs and symptoms resolve to Grade ≤1, resume infusion at ≤25% of rate at which reaction occurred
- If no further reaction occurs within 1 hr and vital signs are stable, may increase infusion rate every 30 min as tolerated to up to 50% of the rate at which reaction occurred
- Stop infusion immediately if reaction returns after rechallenge
-
Grade 4
- Stop infusion immediately and permanently discontinue
Thrombocytopenia
-
Platelet count ≤50,000/mcL
- Withhold tafasitamab and lenalidomide and monitor CBC count weekly until platelet count ≥50,000/mcL
- Resume tafasitamab at same dose and lenalidomide at reduced dose
Neutropenia
- Defined as a neutrophil count ≤500/mcL, or neutrophil count ≤1,000/mcL for ≥7 days, or with an increase of body temperature ≥100.4ºF (38ºC)
- Withhold tafasitamab and lenalidomide and monitor CBC count weekly until neutrophil count ≥1,000/mcL
- Resume tafasitamab at same dose and lenalidomide at reduced dose
Renal impairment
- Mild-to-moderate (CrCl 30-89 mL/min): No dosage adjustment necessary
- Severe (CrCl <30 mL/min): Pharmacokinetics are unknown
Hepatic impairment
- Mild-to-moderate (total bilirubin ≤1.5x ULN and any AST): No dosage adjustment necessary
- Severe (total bilirubin >1.5x ULN and any AST): Pharmacokinetics are unknown
Safety and efficacy not established
Adverse Effects
>10%
All grades
- Neutropenia (51%)
- Glucose increased (49%)
- Calcium decreased (47%)
- Activated partial thromboplastin time (aPTT) increased (46%)
- Fatigue (38%)
- Anemia (36%)
- Diarrhea (36%)
- Gamma glutamyl transferase (GGT) increased (34%)
- Thrombocytopenia (31%)
- Albumin decreased (26%)
- Cough (26%)
- Respiratory tract infection (24%)
- Pyrexia (24%)
- Peripheral edema (24%)
- Decreased appetite (22%)
- Magnesium decreased (22%)
- Urate increased (20%)
- Phosphate decreased (20%)
- Creatinine increased (20%)
- AST increased (20%)
- Back pain (19%)
- Hypokalemia (19%)
- Constipation (17%)
- Urinary tract infection (17%)
- Bronchitis (16%)
- Nausea (15%)
- Vomiting (15%)
- Muscle spasms (15%)
- Febrile neutropenia (12%)
- Dyspnea (12%)
Grade 3 or 4
- Neutropenia (49%)
- Thrombocytopenia (17%)
- Febrile neutropenia (12%)
1-10%
All grades
- Arthralgia (9%)
- Pain in extremity (9%)
- Headache (9%)
- Paresthesia (7%)
- Dysgeusia (6%)
- Lymphopenia (6%)
- Infusion-related reaction (6%)
- Sepsis (4.9%)
- Nasal congestion (4.9%)
- Weight decreased (4.9%)
- Erythema (4.9%)
- Alopecia (2.5%)
- Hyperhidrosis (2.5%)
- Musculoskeletal pain (2.5%)
- Basal cell carcinoma (1.2%)
- Exacerbation of chronic obstructive pulmonary disease (1.2%)
Grade 3 or 4
- Anemia (7%)
- Urate increased (7%)
- Hypokalemia (6%)
- Glucose increased (5%)
- Phosphate decreased (5%)
- GGT increased (5%)
- Respiratory tract infection (4.9%)
- Urinary tract infection (4.9%)
- aPTT increased (4.1%)
- Fatigue (3.7%)
- Back pain (2.5%)
- Calcium decreased (1.4%)
- Creatinine increased (1.4%)
- Bronchitis (1.2%)
- Cough (1.2%)
- Dyspnea (1.2%)
- Pyrexia (1.2%)
- Diarrhea (1.2%)
Warnings
Contraindications
None
Cautions
May cause infusion-related reactions; signs and symptoms included chills, flushing, dyspnea, and hypertension
Serious or severe myelosuppression, including neutropenia, thrombocytopenia, and anemia, have been reported; monitor CBC count and monitor patients with neutropenia for signs of infection; consider granulocyte colony-stimulating factor administration
Fatal and serious infections, including opportunistic infections, occurred; monitor for signs and symptoms of infection and manage infections appropriately
May cause fetal B-cell depletion when administered to pregnant females; concomitant use of tafasitamab with lenalidomide is contraindicated in pregnant females
Pregnancy & Lactation
Pregnancy
Based on its mechanism of action, tafasitamab may cause fetal B-cell depletion when administered to pregnant females
No available data on use in pregnant females to evaluate for a drug-associated risk
Animal reproductive toxicity studies have not been conducted
Lenalidomide
- Contraindicated during pregnancy
- Tafasitamab is used in combination with lenalidomide for up to 12 cycles
- Refer to lenalidomide prescribing information for additional information (eg, contraception, pregnancy testing)
- Lenalidomide is only available through a Risk Evaluation and Mitigation Strategy program
Contraception
- Females of reproductive potential: Use effective contraception during treatment and for at least 3 months after final dose
Fetal/neonatal adverse reactions
- IgG monoclonal antibodies are transferred across the placenta
- May cause depletion of fetal CD19-positive immune cells
- Defer administering live vaccines to neonates and infants exposed to tafasitamab in utero until completing a hematology evaluation
Lactation
There are no data on presence of tafasitamab in human milk or effects on the breastfed child or milk production
Maternal immunoglobulin G is known to be present in human milk
Effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant are unknown
Advise women not to breastfeed during treatment and for at least 3 months after final dose
Refer to lenalidomide prescribing information for additional information
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Humanized Fc-modified cytolytic CD19-directed monoclonal antibody that binds to CD19 antigen expressed on the surface of pre-B and mature B lymphocytes and on several B-cell malignancies
Upon binding to CD19, tafasitamab-cxix mediates B-cell lysis through apoptosis and immune effector mechanisms, including antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis
Absorption
Mean trough concentration: 179 mcg/mL (Cycle 1-3 and Cycle 4 day 1); 153 mcg/mL (Cycle 4 and onwards)
Peak plasma concentration: 483 mcg/mL
Distribution
Vd: 9.3 L
Elimination
Clearance: 0.41 L/day
Half-life: 17 days
Administration
IV Compatibilities
0.9% NaCl
IV Preparation
Reconstitution
- Calculate dose (mg) and determine the number of vials needed
- Reconstitute each 200-mg vial with 5 mL sterile water for injection; directing stream toward the vial wall to obtain a final concentration of 40 mg/mL
- Gently swirl vial(s) until completely dissolved, which may take up to 5 min; do not shake or swirl vigorously
- Visually inspect reconstituted solution for particulate matter or discoloration; should appear as a colorless to slightly yellow solution; discard if solution is cloudy, discolored, or contains visible particles
Dilution
- Remove volume equal to the calculated drug volume from a 250-mL infusion bag of 0.9% NaCl and discard it
- Withdraw calculated volume from reconstituted vial(s) and slowly inject into prepared 0.9% NaCl 250-mL infusion bag for a final concentration of 2-8 mg/mL; discard any unused portion remaining in vial
- Gently mix by slowly inverting bag; do not shake
- Visually inspect infusion bag for particulate matter and discoloration before administration
Premedication
Administer 30 min to 2 hr before starting infusion
Premedications may include acetaminophen, histamine H1-receptor antagonists, histamine H2-receptor antagonists, and/or glucocorticosteroids
No infusion-related reactions during first 3 infusions: Premedication is optional for subsequent infusions
If an infusion-related reaction occurs, administer premedications before each subsequent infusion
IV Administration
Administer IV infusion only
First infusion: Start at 70 mL/hr for the first 30 min, then increase rate so that infusion is administered within 1.5-2.5 hr
All subsequent infusions: Infuse within 1.5-2 hr
Do not coadminister other drugs through same infusion line
No incompatibilities have been observed with infusion containers made of polypropylene, polyvinylchloride (PVC), polyethylene, polyethylenterephthalate, or glass and infusion sets made of polyurethane (PUR) or PVC
Storage
Unopened vials
- Refrigerate at 36-46ºF (2-8ºC) in original carton to protect from light
- Do not shake; do not freeze
Reconstituted vials or diluted solution
Protect from light
Do not shake or freeze
-
Reconstituted vials
- Refrigerate at 36-46ºF (2-8ºC) or store at room temperature for up to 12 hr at 68-77ºF (20-25ºC)
-
Diluted solution
- Refrigerate for up to 18 hr at 36-46ºF (2-8ºC) and/or at room temperature for up to 12 hr at 68-77ºF (20-25ºC); storage includes time for infusion
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Formulary
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