isatuximab

High Alert

Multiple myeloma in patients who have received ≥2 prior therapies including lenalidomide and a proteasome inhibitor (in combination with pomalidomide and dexamethasone).
Relapsed or refractory multiple myeloma in patients who have received 1–3 prior lines of therapy (in combination with carfilzomib and dexamethasone).
Newly diagnosed multiple myeloma in patients who are not eligible for autologous stem cell transplantation (in combination with bortezomib, lenalidomide, and dexamethasone).

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Severe hypersensitivity;
OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

Rep: Women of reproductive potential;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

GI: diarrhea, nausea, vomiting

Hemat: anemia, lymphopenia, neutropenia, thrombocytopenia

Resp: dyspnea, pneumonia, upper respiratory tract infection

Misc: infection, infusion-related reactions (including anaphylaxis and angioedema), SECOND PRIMARY MALIGNANCY (PRIMARILY SKIN CANCERS)

Interactions ⬆ ⬇

Drug-drug:

None reported.

Availability ⬆ ⬇

Solution for injection: 20 mg/mL

Route/Dosage ⬆ ⬇

In Combination with Pomalidomide + Dexamethasone or Carfilzomib + Dexamethasone

IV (Adults ): Cycle 1: 10 mg/kg on Days 1, 8, 15, and 22 of the 28-day cycle. Cycle 2 and beyond: 10 mg/kg on Days 1 and 15 of each 28-day cycle; continue until disease progression or unacceptable toxicity.

In Combination with Bortezomib + Lenalidomide + Dexamethasone

IV (Adults ): Cycle 1: 10 mg/kg on Days 1, 8, 15, 22, and 29 of the 42-day cycle. Cycles 2–4: 10 mg/kg on Days 1, 15, and 29 of each 42-day cycle. Cycles 5–17: 10 mg/kg on Days 1 and 15 of each 28-day cycle. Cycle 18 and beyond: 10 mg/kg on Day 1 of each 28-day cycle; continue until disease progression or unacceptable toxicity.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Binds to CD38 on tumor cells causing apoptosis, thereby inhibiting growth of CD38-expressing tumor cells.

Therapeutic effects:

Improved progression-free survival.

Classifications ⬆ ⬇

Therapeutic Classification: antineoplastics

Pharmacologic Classification: monoclonal antibodies

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Minimally distributed to extravascular tissues.

Metabolism/Excretion: Metabolized into small peptides by catabolic pathways.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	end of infusion	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of isatuximab to patient. Do not stop receiving drug without consulting health care professional. If an appointment is missed, contact health care professional as soon as possible to reschedule. Advise patient to read Patient Information before starting and periodically during therapy in case of changes.
Advise patient to notify health care professional if signs and symptoms of infusion-related reactions (shortness of breath, cough, chills, nausea) occur within 24 hr of start of infusion.
Instruct patient to notify health care professional promptly signs and symptoms of infection (fever, sore throat, lower back or side pain, difficult or painful urination) occur. Caution patient to avoid crowds and persons with known infections.
Advise patient to stay hydrated; side effects can include diarrhea, nausea, and vomiting.
Inform patient of potential for development of second primary malignancies. Advise patients to maintain regular exams for skin cancer.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Instruct patient to notify health care professional of therapy in case RBC transfusion is planned.
Rep: May cause fetal harm. Advise women of reproductive potential to use effective contraception for ≥5 mo after last dose and to avoid breastfeeding during therapy. Advise patient to notify health care professional immediately if pregnancy is planned or suspected or if breastfeeding. Hold the administration of live vaccines to neonates and infants exposed to isatuximab in utero until a hematology evaluation is completed.

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Indications ⬇