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Treatment Name: Antithymocyte Globulin (ATG, ATGAM®) + Cyclosporine (Gengraf®, Neoral®) + Eltrombopag (Promacta®)

Antithymocyte Globulin (ATG, ATGAM®) + Cyclosporine (Gengraf®, Neoral®) + Eltrombopag (Promacta®) is a Treatment Regimen for Severe Aplastic Anemia (SAA)

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References

1) Townsley DM, Scheinberg P, Winkler T, et al. Eltrombopag Added to Standard Immunosuppression for Aplastic Anemia. N Engl J Med. 2017;376:1540-1550.

2) Supplement to: Townsley DM, Scheinberg P, Winkler T, et al. Eltrombopag Added to Standard Immunosuppression for Aplastic Anemia. N Engl J Med. 2017;376:1540-1550.

Created: February 14, 2019 Updated: February 14, 2019

What is Severe Aplastic Anemia (SAA)?

Severe aplastic anemia (SAA) is a rare blood disorder that can be life-threatening if left untreated. SAA is thought to result from certain cells of the immune system inappropriately attacking healthy cells within the bone marrow. This leads to:

  • A low white blood cell count, which increases the risk of infection
  • A low red blood cell count, which decreases the ability to deliver oxygen and may cause fatigue, weakness, and shortness of breath
  • A low platelet count, which increases the risk of bruising and bleeding

The treatment of aplastic anemia may include immunosuppressant agents (shown below) or a stem cell transplant if a stem cell donor can be identified. A matched sibling donor is often thought to be be the best option, if one is available. The goals of these treatments are to restore the healthy bone marrow cells, prevent infection and bleeding, and to stop the need for blood or platelet transfusions.

Common cyclosporine + ATG + eltrombopag starting doses

  • ATG 40 mg/kg intravenous (I.V.) infusion over 4 to 24 hours once daily on Days 1, 2, 3, and 4
  • Usual cyclosporine starting dose: 5 mg/kg by mouth twice daily (Important note: Ideal Body Weight is recommended for dosing cyclosporine)
  • Usual Eltrombopag starting dose: 150 mg (three 50 mg tablets) by mouth once daily starting on Day 1

Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability.

What does Cure mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium

What is a Desensitization?

Desensitization is a process that helps the body adjust to a medication to lower the risk of experiencing serious allergic reactions. Typically, the process is done slowly over several hours in a hospital setting. Very small doses of the medication are initially given and the doses are increased over time until the total amount of the medication is received.

What is Serum Sickness?

Serum sickness occurs when the body recognizes medications like ATG as “foreign” proteins and uses the immune system to attack the foreign protein to eliminate it. Symptoms typically start a few days after treatment and can include skin rash, hives, itching, joint pain, fevers, and weakness. In severe cases it can cause low blood pressure, and rarely organ damage.

Cyclosporine Trough Levels

Cyclosporine blood levels are best drawn in the morning right before you take cyclosporine. This is known as a “trough” concentration. On days when a cyclosporine level is drawn in the clinic, it is important to bring your morning dose with you to your appointment so you can take the dose immediately after the cyclosporine blood level is taken