Deepika vegiraju at 13:03, 16 August 2022

2022-08-16T13:03:50Z

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== '''What is Isatuximab?''' ==

* Isatuximab ('''Sarclisa''') is a CD38-directed [[cytolytic]] antibody.

[[File:Isatuximab 4CMH.png|thumb]]

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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?''' ==

* {{overdose}}

== '''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.

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[[Category:Monoclonal antibodies for tumors]]
[[Category:Orphan drugs]]
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Isatuximab - Revision history

Deepika vegiraju at 13:03, 16 August 2022