Isatuximab

What is Isatuximab?

• Isatuximab (Sarclisa) is a CD38-directed cytolytic antibody.

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What are the uses of this medicine?

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.

How does this medicine work?

• 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

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

Is this medicine FDA approved?

• It was approved for use in the United States in 2020.

How should this medicine be used?

• 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).

What are the dosage forms and brand names of this medicine?

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

• 100 mg/5 mL (20 mg/mL) solution in single-dose vial
• 500 mg/25 mL (20 mg/mL) solution in single-dose vial

This medicine is available in fallowing brand namesː

• Sarclisa

What side effects can this medication cause?

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

• lung infection (pneumonia)
• decreased red blood cell counts (anemia)
• upper respiratory tract infection
• decreased platelet counts (thrombocytopenia)
• diarrhea

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

• upper respiratory tract infection
• tiredness and weakness
• high blood pressure
• diarrhea
• lung infection (pneumonia)
• trouble breathing
• trouble sleeping
• bronchitis
• cough
• back pain
• decreased red blood cells (anemia)
• decrease platelet count (thrombocytopenia)

Sarclisa may cause serious side effects including:

• Infusion reactions
• Decreased white blood cell counts
• Risk of new cancers
• Changes in blood tests
• Heart failure

What special precautions should I follow?

• 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.

What to do in case of emergency/overdose?

• 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.

Can this medicine be used in pregnancy?

• 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.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What should I know about storage and disposal of this medication?

• 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.

• Dailymed label info on Isatuximab
• FDA Isatuximab

Isatuximab Resources
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