Isatuximab

What is Isatuximab?[edit | edit source]

This medicine is used in combination with:

the medicines pomalidomide and dexamethasone, to treat adults who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor to treat multiple myeloma.
the medicines carfilzomib and dexamethasone, to treat adults with multiple myeloma who have already received 1 to 3 lines of treatment and they did not work or are no longer working.

A humanized IgG1 monoclonal antibody directed against the cell surface glycoprotein CD-38 with potential antineoplastic activity.
Isatuximab specifically binds to CD38 on CD38-positive tumor cells.
This may trigger antitumoral antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC) and apoptosis eventually leading to cell lysis in CD38-expressing tumor cells.
CD38, a type II transmembrane glycoprotein, is present on various immune cells and hematologic malignancies, and its expression has been correlated with poor prognosis.

This medicine cannot be used in patients with:

Patients with severe hypersensitivity to isatuximab-irfc or to any of its excipients.

Premedicate with dexamethasone, acetaminophen, H2 antagonists, and diphenhydramine.

Recommended Dosage

The recommended dose of Sarclisa is 10 mg/kg as an intravenous infusion every week for 4 weeks followed by every 2 weeks until disease progression or unacceptable toxicity.

Administration

Sarclisa will be given to you by your healthcare provider by intravenous (IV) infusion into your vein.
Sarclisa is given in treatment cycles of 28 days (4 weeks), together with either the medicines pomalidomide and dexamethasone, or carfilzomib and dexamethasone.
In cycle 1, Sarclisa is usually given weekly.
Starting in cycle 2, Sarclisa is usually given every 2 weeks.
If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
Your healthcare provider will give you medicines before each dose of Sarclisa, to help reduce the risk of infusion reactions (make them less frequent and severe).

This medicine is available in fallowing doasage form: As Injection:

This medicine is available in fallowing brand namesː

The most common side effects of Sarclisa in combination with pomalidomide and dexamethasone include:

The most common side effects of Sarclisa in combination with carfilzomib and dexamethasone include:

Sarclisa may cause serious side effects including:

This medicine may cause Infusion-Related Reactions. In case of grade ≥2, interrupt Sarclisa and manage medically. Permanently discontinue for grade 4 infusion-related reactions or anaphylactic reaction.
Monitor complete blood cell counts periodically during treatment. Monitor patients with neutropenia for signs of infection. Sarclisa dose delays and the use of colony-stimulating factor may be required to allow improvement of neutrophil count.
Monitor patients for the development of second primary malignancies.
This medicine Can cause fetal harm.

In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

Overdose related information is also available online at poisonhelp.org/help.
In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Sarclisa can cause fetal harm when administered to a pregnant woman.
There are no available data on Sarclisa use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
The combination of Sarclisa and pomalidomide is contraindicated in pregnant women because pomalidomide may cause birth defects and death of the unborn child.

Store in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.

Do not freeze. Do not shake.

Handling and Disposal

Discard unused portion of solution.
All materials that have been utilized for dilution and administration should be disposed of according to standard procedures.

Isatuximab Resources
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