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Isatuximab

Brand name: Saclisa
Intravenous solution (20 mg/ml).
Drug class: CD38 monoclonal antibodies

What is the Isatuximab?

Isatuximab can be used to treat multiple myeloma in adults. Isatuximab can be given with carfilzomib, pomalidomide, and a steroid.

Isatuximab can be given when other cancer treatments have failed or stopped working. This medication guide does not list all possible uses of isatuximab.

Side effects of Isatuximab

If you experience any of the following signs and symptoms of an allergic reaction: hives, difficulty breathing, facial, lip or throat swelling and redness then seek medical help immediately: hives; difficulty in swallowing or breathing and reddening on the skin or lips or throat swelling (anaphylaxis).

During the injection, some side effects can occur. You should tell your carer if any of the following symptoms occur: nausea, cold, itchy skin, feeling like you may pass out, cough, or  or headache symptoms include a stuffy or runny nose, a headache, or a throat irritation.

Isatuximab can cause serious side effects. If you experience:

  • Easy bruising, unusual bleeding, or purple or red patches under the skin
  • Low white blood cells: fever; mouth sores or skin sores; sore neck; coughing; difficulty breathing.
  • Low red blood cells (anemia)--pale or pale-coloured skin, feeling of being light-headed, shortness of breath or feeling, or cold hands or feet;
  • Symptoms of pneumonia include a cough with mucus and chest pain.

If you experience certain side effects, your cancer treatment may be stopped or delayed.

Side effects of isatuximab include:

  • Low blood cell count
  • Pneumonia;
  • Diarrhea;
  • Cold symptoms, such as runny noses, sneezing fits and sore throats;

There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.

Similar/related drugs

Blenrep, Tecvayli, Carvykti, Xpovio, Kyprolis, Elrexfio, and Talvey

Warnings

Tell your doctor if you have any medical conditions, allergies, or medicines that you take. Also, tell him if you're pregnant or nursing.

Before you take this drug

If you have an allergy to isatuximab, it should be avoided. Before starting the treatment, you may need to take a pregnancy test. Use effective contraception during and after treatment with isatuximab to avoid pregnancy. Exposure to isatuximab during pregnancy could impact your baby's vaccine schedule in the first few months after birth.

If you plan to get pregnant or are already pregnant, do not take isatuximab with pomalidomide. Pomalidomide is capable of causing severe birth defects that can be life-threatening with only one dose. Men and women who use pomalidomide must both use birth control to avoid pregnancy. If you become pregnant while using pomalidomide and isatuximab, tell your doctor immediately.

Breastfeeding is not recommended while taking isatuximab. Isatuximab can increase your risk of developing other cancers. Discuss this matter with your physician.

How to take Isatuximab?

Isatuximab can be infused into a vein. This injection will be given by a healthcare provider. After your first two infusions, you will be closely monitored for at least 30 minutes to ensure that you don't have an allergic response. Isatuximab can be given on a 28-day cycle. It is possible that you will only need to take the medication on certain days during each cycle. Your doctor will decide how long you should take this medication.

Other medications may be prescribed to prevent allergic reactions or serious side effects. Continue to use these medications as prescribed by your doctor. You should read all the medication guides that you receive for other medications used with isatuximab.

Isatuximab may lower your blood count. You will have to test your blood frequently. The results may delay your cancer treatment. It can interfere with certain medical tests. Inform any doctor that you see about your use of isatuximab. Tell the staff if you need a transfusion of blood or plasma and that you're being treated with isatuximab.

Details on dosage

Adult dose for multiple myeloma:

When used in conjunction with POMALIDOMIDE and DEXAMETHASONE
Cycle 1, 10 mg/kg IV, Days 1, 8, 15, and 22 (weekly)
Cycle 2 and Beyond: 10 mg/kg intravenous on Day 1 and 15 every 2 weeks
Each treatment cycle is 28 days long.
The treatment is repeated as long as the disease progresses or there are unacceptable side effects.
Premedications are recommended (administered 15–60 minutes before the infusion).
-Dexamethasone, 40 mg orally (or 20 mg orally for patients over 75 years old).
Acetaminophen orally, 650 mg to 1,000 mg (or equivalent).
-H2 antagonists.
Diphenhydramine, orally or IV (or an equivalent dose). For at least the initial four infusions, it is best to use the IV route.
Use: In combination with pomalidomide dexamethasone in the treatment of adults with multiple myeloma after at least two prior treatments, including Lenalidomide, and a proteasome inhibitor

Usual geriatric dose for multiple myeloma:

When used in conjunction with POMALIDOMIDE and DEXAMETHASONE
Cycle 1, 10 mg/kg IV, Days 1, 8, 15, and 22 (weekly)
Cycle 2 and Beyond: 10 mg/kg intravenous on Day 1 and 15 every 2 weeks
Each treatment cycle is 28 days long.
The treatment is repeated as long as the disease progresses or there are unacceptable side effects.
Premedication (to be administered 15–60 minutes before the infusion)
-Dexamethasone, 40 mg orally (or 20 mg orally for patients over 75 years old).
-Acetaminophen, 650 mg to 1,000 mg orally
-H2 antagonists.
Diphenhydramine, 25–50 mg IV or orally (or equivalent). For at least the initial four infusions, it is preferable to use an IV.
Use: As a combination with dexamethasone and pomalidomide for adult patients with myeloma multiplex who have had at least two prior treatments, including lenalidomide, a proteasome inhibitor, and/or a proteasome inhibitor.

What happens if I miss the dose?

If you missed your appointment for the isatuximab shot, call your doctor to get instructions.

What happens if I overdose?

Overdoses are unlikely because isatuximab will be administered by a healthcare provider in a medical environment.

What should be avoided?

If your doctor prescribes any restrictions regarding food, beverage, or activity, follow their instructions.

Interaction with other drug

Other drugs, such as prescription and over-the-counter medicines, vitamins, and herbal products, may also affect isatuximab. Inform your doctor of all the medicines you are taking and those that you stop or start using.