tafasitamab

Absorption: IV administration results in complete bioavailability.

Distribution: Distributed to extravascular tissues.

Metabolism/Excretion: Unknown.

Half-Life: 17 days.

Time/Action Profile ⬆ ⬇

(↓ in peripheral B-cell counts)

ROUTE	ONSET	PEAK	DURATION
IV	8 days	16 wk	21 mo

Contraind./Precautions ⬆ ⬇

Contraindicated in:

OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

Rep: Women of reproductive potential;
Pedi: Safety and effectiveness not established in children;
Geri: ↑risk of adverse reactions in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

CV: peripheral edema

Derm: ↑sweating, alopecia, basal cell carcinoma, erythema

EENT: nasal congestion

Endo: hyperglycemia

F and E: hypocalcemia, hypokalemia, hypomagnesemia, hypophosphatemia

GI: ↑liver enzymes, constipation, diarrhea, hypoalbuminemia, nausea, vomiting

GU: ↑serum creatinine

Hemat: ↑activated partial thromboplastin time (aPTT), anemia, neutropenia, thrombocytopenia, lymphopenia

Metab: ↓appetite, hyperuricemia, weight loss

MS: muscle spasm, arthralgia, pain

Neuro: fatigue, dysgeusia, headache, paresthesia, PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY, STROKE

Resp: cough, dyspnea, respiratory failure

Misc: fever, infection, infusion reactions

Interactions ⬆ ⬇

Drug-drug:

None reported.

Route/Dosage ⬆ ⬇

IV (Adults ): Cycle 1: 12 mg/kg (actual body weight) on Days 1, 4, 8, 15, and 22; Cycles 2 and 3: 12 mg/kg (actual body weight) on Days 1, 8, 15, and 22; Cycles 4 and beyond: 12 mg/kg (actual body weight) on Days 1 and 15. Administer with lenalidomide for a maximum of 12 cycles; then continue as monotherapy until disease progression or unacceptable toxicity.

Availability ⬆ ⬇

Lyophilized powder for injection: 200 mg/vial

Assessment ⬆ ⬇

Monitor for infusion-related reactions frequently during infusion. If Grade 2 infusion-related reactions occur, discontinue infusion immediately and treat clinically. Once resolved to Grade ≤1, resume infusion at ≤50% original rate; if symptoms do not recur and vital signs stable for 1 hr, may ↑ rate every 30 min to original rate as tolerated. If Grade 3 infusion-related reactions occur, discontinue infusion immediately and treat clinically. Once resolved to Grade ≤1, resume infusion at ≤25% original rate; if symptoms do not recur and vital signs stable for 1 hr, may ↑ rate every 30 min to ≤50% original rate as tolerated. Stop immediately if reaction recurs. If Grade 4 infusion-related reactions occur, permanently discontinue tafasitamab and treat clinically.
Monitor for infection, including opportunistic (nasopharyngeal, upper and lower respiratory tract, urinary); manage as clinically indicated.

Lab Test Considerations:

Verify negative pregnancy test prior to initiating the combination of tafasitamab and lenalidomide.
Monitor CBC with differential prior to each treatment cycle and throughout therapy. For platelets ≤50,000/mcL, hold tafasitamab and lenalidomide; monitor weekly CBC until platelets >50,000/mcL. Resume tafasitamab at same dose and lenalidomide at ↓ dose; see prescribing information. For neutrophils ≤1000/mcL for ≥7 days; ≤1000/mcL with fever ≥100.4°F (38°C); or neutrophils <500/mcL, hold tafasitamab and lenalidomide; monitor weekly CBC until neutrophils ≥1000/mcL. Resume tafasitamab at same dose and lenalidomide at ↓ dose; see prescribing information. Consider granulocyte stimulating factor administration as clinically indicated.
May ↑ glucose, uric acid, GGT, serum creatinine, and AST.
May ↓ calcium magnesium, phosphate, and albumin.

Implementation ⬆ ⬇

Keep emergency equipment and appropriate medical support nearby during infusion.
Premedicate 30 min–2 hr prior to infusion; may include acetaminophen, histamine receptor antagonist, and/or glucocorticoid. If no infusion-reaction occurs during first 3 infusions, premedication is then optional; otherwise, premedicate prior to each subsequent infusion.

IV Administration:

Intermittent Infusion: Reconstitution: Inject 5 mL sterile water for injection toward the wall of each vial. Gently swirl until dissolved; may take 5 min. Do not shake. Solution is colorless to slightly yellow. Discard if solution is discolored, cloudy, or contains particulates. Use immediately, or store <12 hr at room temperature or refrigerated. Do not freeze. Protect from light. 40 mg/mL. Diluent: Remove volume from 250 mL 0.9% NaCl infusion bag equal to the volume needed for required dose of the reconstituted solution and discard it. Withdraw required amount of reconstituted solution and inject into infusion bag. Gently mix by slowly inverting the bag. Use immediately or refrigerate 18 hr; may leave at room temperature, including infusion time, 12 hr. Protect from light. Do not shake or freeze. Concentration: 2–8 mg/mL. Rate: 1st infusion: 70 mL/hr for 30 min; then to infuse remaining solution in 1.5–2.5 hr. Subsequent infusions: Infuse over 1.5–2 hr.
Y-Site Compatibility:
- Do not administer other drugs through same IV line

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
Advise patient to notify health care professional immediately if infusion reaction symptoms (fever, chills, rash, flushing, headache, difficulty breathing) or signs of infection (fever ≥100.4°F) occur during therapy.
Advise patient to notify health care professional if fatigue, diarrhea, cough, swelling of lower legs or arms, respiratory infection, or ↓ appetite occur during therapy.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Rep: May cause fetal harm. Advise women of reproductive potential to use effective contraception, not to breastfeed during and for ≥3 mo after last dose, and to notify health care professional if pregnancy is planned or suspected.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇