Isatuximab

Isatuximab is a prescription medication used in combination with pomalidomide and dexamethasone, for multiple myeloma in adults who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor.

• Isatuximab is available under the following different brand names: Sarclisa, isatuximab-irfc

Common side effects of Isatuximab include:

• low white blood cell count (neutropenia)
• infusion-related reactions (shortness of breath, high blood pressure, and bronchospasm)
• pneumonia
• upper respiratory tract infection
• diarrhea
• anemia
• low lymphocytes (lymphopenia)
• low platelets (thrombocytopenia)

Serious side effects of Isatuximab include:

• pneumonia
• upper respiratory tract infections
• febrile neutropenia 

Rare side effects of Isatuximab include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution

• 20 mg/mL (5-mL, 25-mL single-dose via

Multiple myeloma

Adult dosage

• Combination with pomalidomide and dexamethasone
• Each cycle consists of 28 days
• Cycle 1
  • 10 mg/kg (actual body weight) IV every week (Days 1, 8, 15, 22)
• Cycle 2 and beyond
  • 10 mg/kg IV every 2 weeks (Days 1, 15)
  • Continue until disease progression or unacceptable toxicity
  • Combination with carfilzomib and dexamethasone
• Each cycle is of 28 days.
• Cycle 1
  • 10 mg/kg (actual body weight) IV every week (Days 1, 8, 15, 22)
• Cycle 2 and beyond
  • 10 mg/kg IV every 2 weeks (Days 1, 15)
  • Continue until disease progression or unacceptable toxicity

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Isatuximab has no noted severe interactions with any other drugs.
• Isatuximab has no noted serious interactions with any other drugs.
• Isatuximab has no noted moderate interactions with any other drugs.
• Isatuximab has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions, or concerns.

Contraindications

• Severe hypersensitivity to isatuximab or any of its excipients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Isatuximab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Isatuximab?”

Cautions

• Neutropenia reported; monitor complete blood cell counts periodically; consider antibiotics and antiviral prophylaxis during treatment; if grade 4 neutropenia occurs, delay the dose until neutrophil count recovers to at least 1 x 109/L, and provide supportive care with growth factors, according to institutional guidelines
• Second primary malignancies (SPMs) reported; monitor for the development of SPM, as per International Myeloma Working Group guidelines
• Can cause fetal harm
• Infusion-related reactions
  • Serious infusion-related reactions, including life-threatening anaphylactic reactions, have been reported; severe signs and symptoms have included cardiac arrest, hypertension, hypotension, bronchospasm, dyspnea, angioedema, and swelling
  • All infusion-related reactions started during the first infusion and resolved within the same day
  • Premedicate before the infusion to decrease the risk and severity of the reactions; monitor vital signs frequently during the entire infusion
  • For Grade 1 or 2 reactions, interrupt the infusion and provide appropriate medical support
  • If symptoms improve, restart infusion and reduce the rate by half, with supportive care as needed, and closely monitor
  • If symptoms do not recur after 30 minutes, then increase the infusion rate to the initial rate, and then increase it incrementally
  • In case symptoms do not improve or recur after the interruption, permanently discontinue the treatment and institute appropriate management
  • Permanently discontinue therapy if a grade 3 or higher infusion-related reaction occurs and institute appropriate medical management
• Drug interaction overview
  • Serological testing (indirect antiglobulin test)
  • Isatuximab binds to CD38 on red blood cells (RBCs) and may result in a false-positive indirect antiglobulin test (indirect Coombs test)
  • Type and screen patients before starting treatment
  • Inform the blood bank that the patient is receiving Isatuximab
  • If an emergency transfusion is required, non-cross-matched ABO/RhD-compatible RBCs can be given as per local blood bank practices
  • Serum protein electrophoresis and immunofixation tests
  • Isatuximab is an IgG kappa monoclonal antibody that can be incidentally detected on both serum protein electrophoresis and immunofixation assays used for clinical monitoring of endogenous M-protein
  • This interference may affect the accuracy of the determination of complete response in some patients with IgG kappa myeloma protein

Pregnancy and Lactation

• Based on its mechanism of action, fetal harm may occur when isatuximab is administered to a pregnant woman
• No data available on the drug’s use in pregnant women to evaluate drug-associated risks
• Animal reproduction toxicity studies have not been conducted
• Clinical considerations
  • IgG1 monoclonal antibodies are known to cross the placenta
  • Based on its mechanism of action, Isatuximab may cause depletion of fetal CD38-positive immune cells and decrease bone density
• Contraception
  • Advise women of reproductive potential to use effective contraception during treatment and for at least 5 months after the last dose
• Lactation
  • Data not available on the presence of Isatuximab in human milk, its effects on milk production or breastfed children
  • Maternal IgF is known to be present in human milk; effects of local gastrointestinal exposure in breastfed infants are unknown
  • Advise lactating women not to breastfeed during treatment
  • Refer to the prescribing information of pomalidomide and dexamethasone for further recommendations