Thymoglobulin

Name: Thymoglobulin

US Brand Name

  1. Thymoglobulin

Descriptions

Anti-thymocyte globulin (rabbit) is used to reduce the body's natural immunity in patients who receive kidney transplants.

This medicine is an immunosuppressant. When a patient receives an organ transplant, the body's white blood cells will try to get rid of (reject) the transplanted organ. Anti-thymocyte globulin (rabbit) works by preventing the white blood cells from doing this.

The effect of anti-thymocyte globulin (rabbit) on the white blood cells may also reduce the body's ability to fight infections. Before you begin treatment, you and your doctor should talk about the benefits of this medicine as well as the risks of using it.

This medicine is to be given only by or under the immediate supervision of your doctor.

This product is available in the following dosage forms:

  • Powder for Solution

Adverse Effects

>10%

Abdominal pain (38%)

Asthenia (27%)

Chills (57%)

Diarrhea (37%)

Dyspnea (28%)

Fever (63%),

Headache (40%)

HTN (37%)

Hyperkalemia (27%)

Infection (37%)

Leukopenia (57%)

Malaise (13%)

Nausea (37%)

Pain (46%)

Peripheral edema (34%)

Tachycardia (27%)

Thrombocytopenia (37%)

1-10%

Dizziness

Digestive

Gastritis

Oral moniliasis

Herpes simplex infection

Uses

This medication is used to prevent and treat rejection of a kidney transplant. This medication belongs to a class of drugs known as immunosuppressants. It works by decreasing your body's natural defense (immune system). This helps prevent your body from rejecting the kidney transplant so it can work normally.OTHER This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.This medication may also be used for the treatment of certain blood disorders (aplastic anemia, myelodysplastic syndrome).

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of anti-thymocyte globulin (rabbit) in the elderly with use in other age groups.

Uses for Thymoglobulin

Renal Allotransplantation

Treatment of acute rejection of renal allografts in conjunction with other immunosuppressive agents.2 8 a b e g

ATG (rabbit) found to be more effective than ATG (equine) in reversing acute rejection episodes (88% compared with 76%) and preventing recurrent rejection episodes in renal transplant recipients.2 b

Has also been used successfully as induction therapy in conjunction with maintenance immunosuppressive therapy for the prevention of renal allograft rejection†.4 5 a d g m n o p q r s u w x

Hepatic Allotransplantation

Induction therapy to prevent hepatic allograft rejection and minimize maintenance immunosuppression† in pediatric patients (designated an orphan drug by FDA for this use)j t and in adults.v

Myelodysplastic Syndrome and Aplastic Anemia

Has been used for the treatment of myelodysplastic syndrome† (designated an orphan drug by FDA for this use).j k

Has been used for the treatment of aplastic anemia†, usually in conjunction with cyclosporine.7 9 a l

Thymoglobulin Pharmacokinetics

Absorption

Onset

T-cell depletion usually observed within 1 day after initiating therapy.b g

Plasma Concentrations

Average 21.5 and 87 mcg/mL 4–8 hours post-infusion after first and last IV doses, respectively, when given for 7–11 days.b

Duration

Lymphopenia may persist ≥1–2 years after ATG (rabbit) administration.5 g r

Distribution

Extent

Not known whether ATG (rabbit) distributes into human milk; however, other immunoglobulins are distributed into human milk.a b

Elimination

Half-life

2–3 days after first dose;b may increase after multiple-dose administration.2 y

What are some other side effects of Thymoglobulin?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Upset stomach or throwing up.
  • Belly pain.
  • Loose stools (diarrhea).
  • Feeling tired or weak.
  • Muscle or joint pain.
  • Not able to sleep.
  • Sweating a lot.
  • Pimples (acne).
  • Hard stools (constipation).
  • Back pain.
  • Not hungry.
  • Redness or swelling where the shot is given.
  • Pain where the shot was given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Thymoglobulin Dosage and Administration

Thymoglobulin is intended for intravenous use only.

Dosing Information

Prophylaxis of Acute Rejection

The recommended dosage of Thymoglobulin for prophylaxis of acute rejection in patients receiving a kidney transplant is 1.5 mg/kg of body weight administered daily with the first dose initiated prior to reperfusion of the donor kidney. The usual duration of administration is 4 to 7 days.

Treatment of Acute Rejection

The recommended dosage of Thymoglobulin for treatment of acute rejection in patients receiving a kidney transplant is 1.5 mg/kg of body weight administered daily for 7 to 14 days.

Recommended Dosing Regimen

Administer the first dose of Thymoglobulin over a minimum of 6 hours; administer doses on subsequent days over at least 4 hours [see Warnings and Precautions (5.3)].

Premedication with corticosteroids, acetaminophen, and/or an antihistamine 1 hour prior to each infusion of Thymoglobulin is recommended and may reduce the incidence and intensity of infusion-associated reactions [see Warnings and Precautions (5.2, 5.3); Adverse Reactions (6.1)].

Dose Modifications

Monitor patients for adverse reactions during and after infusion. Monitor total white blood cell and platelet counts during and after Thymoglobulin therapy.

Reduce the Thymoglobulin dose by one-half if the white blood cell (WBC) count is between 2,000 and 3,000 cells/mm3 or if the platelet count is between 50,000 and 75,000 cells/mm3. Consider stopping Thymoglobulin treatment if the WBC count falls below 2,000 cells/mm3 or if the platelet count falls below 50,000 cells/mm3.

Recommended Concomitant Medication

Thymoglobulin is used with concomitant immunosuppressants.

Administer prophylactic antifungal and antibacterial therapy if clinically indicated [see Warnings and Precautions (5.5)].

Antiviral prophylactic therapy is recommended for patients who are seropositive for cytomegalovirus (CMV) at the time of transplant and for CMV-seronegative patients scheduled to receive a kidney from a CMV-seropositive donor [see Warnings and Precautions (5.5)].

Instructions for Dilution and Administration

Reconstitution

After calculating the number of vials needed, using aseptic technique, reconstitute each vial of Thymoglobulin with 5 mL of Sterile Water for Injection, USP (SWFI).

  1. Allow Thymoglobulin vials to reach room temperature before reconstituting the lyophilized product.
  2. Aseptically remove caps to expose rubber stoppers.
  3. Clean stoppers with germicidal or alcohol swab.
  4. Aseptically reconstitute each vial of Thymoglobulin lyophilized powder with the 5 mL of SWFI.
  5. Rotate vial gently until powder is completely dissolved. Each reconstituted vial contains 25 mg or 5 mg/mL of Thymoglobulin.
  6. Inspect solution for particulate matter after reconstitution. Should some particulate matter remain, continue to gently rotate the vial until no particulate matter is visible. If particulate matter persists, discard this vial.

Dilution

  1. Transfer the contents of the calculated number of Thymoglobulin vials into the bag of infusion solution (saline or dextrose). Recommended volume: per one vial of Thymoglobulin use 50 mL of infusion solution (total volume usually between 50 to 500 mL).
  2. Mix the solution by inverting the bag gently only once or twice.

Infusion

Administer Thymoglobulin under strict medical supervision in a hospital setting, and carefully monitor patients during the infusion.

Thymoglobulin is less likely to produce side effects when administered at the recommended flow rate [see Warnings and Precautions (5.3)].

  1. Follow the manufacturer's instructions for the infusion administration set. Infuse through a 0.22 micrometer filter into a high-flow vein.
  2. Set the flow rate to deliver the dose over a minimum of 6 hours for the first dose and over at least 4 hours for subsequent doses.
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