tafasitamab

High Alert

Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma and patients who are not eligible for autologous stem cell transplant (in combination with lenalidomide).

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.

Availability ⬆ ⬇

Lyophilized powder for injection: 200 mg/vial

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.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Binds to CD19 antigen expressed on the surface of pre-B and mature B lymphocytes and on several B-cell malignancies, including DLBCL, which then leads to B-cell lysis via apoptosis, antibody-dependent cellular cytotoxicity, and phagocytosis.

Therapeutic effects:

Decreased progression of DLBCL.

Classifications ⬆ ⬇

Therapeutic Classification: antineoplastics

Pharmacologic Classification: monoclonal antibodies

Pharmacokinetics ⬆ ⬇

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

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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Indications ⬇