THYMOGLOBULIN (anti-thymocyte globulin- rabbit injection, powder, lyophilized, for solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN (UNII: D7RD81HE4W) (LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN - UNII:D7RD81HE4W)
Available from:
Genzyme Corporation
INN (International Name):
LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN
Composition:
LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN 5 mg in 1 mL
Administration route:
INTRAVENOUS
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
THYMOGLOBULIN is indicated for the prophylaxis and treatment of acute rejection in patients receiving a kidney transplant. THYMOGLOBULIN is to be used in conjunction with concomitant immunosuppression. THYMOGLOBULIN is contraindicated in patients with history of allergy or anaphylactic reaction to rabbit proteins or to any product excipients, or who have active acute or chronic infections that contraindicate any additional immunosuppression [see Warnings and Precautions (5.2, 5.5) and Adverse Reactions (6.2)] . Risk Summary Animal reproduction studies have not been conducted with THYMOGLOBULIN. It is also not known whether THYMOGLOBULIN can cause fetal harm. THYMOGLOBULIN should be given to a pregnant woman only if the benefit outweighs the risk. Risk Summary THYMOGLOBULIN has not been studied in nursing women. It is not known whether this drug is excreted in human milk. Because other immunoglobulins are excreted in human milk, breastfeeding should be discontinued during THYMOGLOBULIN therapy. Contracepti
Product summary:
THYMOGLOBULIN is supplied as a single-dose clear glass 10 mL vial containing 25 mg of lyophilized (solid) THYMOGLOBULIN. Each carton contains one THYMOGLOBULIN vial (NDC 58468-0080-1).
Authorization status:
Biologic Licensing Application
Authorization number:
58468-0080-1

THYMOGLOBULIN- anti-thymocyte globulin (rabbit) injection, powder, lyophilized, for

solution

Genzyme Corporation

----------

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use THYMOGLOBULIN safely and effectively.

See full prescribing information for THYMOGLOBULIN.

THYMOGLOBULIN (anti-thymocyte globulin [rabbit]) for injection, for intravenous use

Initial U.S. Approval: 1998

WARNING: IMMUNOSUPPRESSION

THYMOGLOBULIN should only be used by physicians experienced in immunosuppressive therapy in

transplantation. (5.1)

INDICATIONS AND USAGE

THYMOGLOBULIN is an immunoglobulin G indicated for the prophylaxis and treatment of acute rejection in patients

receiving a kidney transplant. (1)

Use in conjunction with concomitant immunosuppression. (1)

DOSAGE AND ADMINISTRATION

The first dose should be infused over at least 6 hours; doses on subsequent days should be infused over at least 4

hours. (2.2)

Premedication with corticosteroids, acetaminophen, and/or an antihistamine prior to each infusion is recommended.

(2.2)

The THYMOGLOBULIN dose should be reduced by one-half if the white blood cell (WBC) count is between 2,000 and

3,000 cells/mm or if the platelet count is between 50,000 and 75,000 cells/mm . Stopping THYMOGLOBULIN

treatment should be considered if the WBC count falls below 2,000 cells/mm or if the platelet count falls below 50,000

cells/mm . (2.3)

Indic atio n

Do se

Prophylaxis of acute rejection

1.5 mg/kg of body weight administered daily for 4 to 7 days

Treatment of acute rejection

1.5 mg/kg of body weight administered daily for 7 to 14 days

For complete dosing instructions, see full prescribing information. (2)

DOSAGE FORMS AND STRENGTHS

Single-dose 10 mL vial containing 25 mg of anti-thymocyte globulin (rabbit) lyophilized, sterile powder. (3)

CONTRAINDICATIONS

Allergy or anaphylactic reaction to rabbit proteins or to any product excipients, or active acute or chronic infections which

contraindicate any additional immunosuppression (4)

WARNINGS AND PRECAUTIONS

THYMOGLOBULIN should only be used by physicians experienced in immunosuppressant therapy in transplantation.

(5.1)

Immune-mediated reactions: THYMOGLOBULIN infusion could result in an anaphylactic reaction. (5.2)

Infusion-associated reactions: Close compliance with the recommended infusion time may reduce the incidence and

severity of infusion-associated reactions. (5.3)

Hematologic effects: low counts of platelets and white blood cells have been identified and are reversible following dose

adjustments. Monitor total white blood cell and platelet counts. (5.4)

Infection: Infections and reactivation of infections have been reported. Monitor patients and administer anti-infective

prophylaxis. (5.5)

Malignancy: Incidence of malignancies may increase. (5.6)

Immunization with attenuated live vaccines is not recommended for patients who have recently received

THYMOGLOBULIN. (5.7)

THYMOGLOBULIN may interfere with rabbit antibody–based immunoassays and with cross-match or panel-reactive

antibody cytotoxicity assays. (5.8)

®

ADVERSE REACTIONS

The most common adverse reactions and laboratory abnormalities (incidence >5% higher than comparator) are urinary

tract infection, abdominal pain, hypertension, nausea, shortness of breath, fever, headache, anxiety, chills, increased

potassium levels in the blood, low counts of platelets and white blood cells. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 1-800-633-1610 or FDA at 1-

800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 4/2020

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: IMMUNOSUPPRESSION

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Information

2.2 Recommended Dosing Regimen

2.3 Dose Modifications

2.4 Recommended Concomitant Medication

2.5 Instructions for Dilution and Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Management of Immunosuppression

5.2 Immune-Mediated Reactions

5.3 Infusion-Associated Reactions

5.4 Hematologic Effects

5.5 Infection

5.6 Malignancy

5.7 Immunizations

5.8 Laboratory Tests

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

8.4 Pediatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

14 CLINICAL STUDIES

14.1 Prophylaxis of Acute Rejection in Patients Receiving a Kidney Transplant

14.2 Treatment of Acute Rejection in Patients Receiving a Kidney Transplant

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

16.2 Storage and Handling

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

WARNING: IMMUNOSUPPRESSION

THYMOGLOBULIN should only be used by physicians experienced in

immunosuppressive therapy in transplantation [see Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

THYMOGLOBULIN is indicated for the prophylaxis and treatment of acute rejection in patients

receiving a kidney transplant. THYMOGLOBULIN is to be used in conjunction with concomitant

immunosuppression.

2 DOSAGE AND ADMINISTRATION

THYMOGLOBULIN is intended for intravenous use only.

2.1 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.

2.2 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) and Adverse Reactions (6.1)].

2.3 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/mm or if the platelet count is between 50,000 and 75,000 cells/mm . Consider

stopping THYMOGLOBULIN treatment if the WBC count falls below 2,000 cells/mm or if the

platelet count falls below 50,000 cells/mm .

2.4 Recommended Concomitant Medication

THYMOGLOBULIN is used with concomitant immunosuppressants.

Administer prophylactic antifungal and antibacterial therapy if clinically indicated [see Warnings and

Sections or subsections omitted from the full prescribing information are not listed.

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)].

2.5 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). Discard unused

portion.

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.

3 DOSAGE FORMS AND STRENGTHS

THYMOGLOBULIN for injection: 25 mg anti-thymocyte globulin (rabbit) as a sterile lyophilized

powder, in single-dose 10 mL vials for reconstitution.

4 CONTRAINDICATIONS

THYMOGLOBULIN is contraindicated in patients with history of allergy or anaphylactic reaction to

rabbit proteins or to any product excipients, or who have active acute or chronic infections that

contraindicate any additional immunosuppression [see Warnings and Precautions (5.2, 5.5) and Adverse

Reactions (6.2)].

5 WARNINGS AND PRECAUTIONS

5.1 Management of Immunosuppression

To prevent over-immunosuppression, physicians may wish to decrease the dose of the maintenance

immunosuppression regimen during the period of THYMOGLOBULIN use.

Dosing for THYMOGLOBULIN is different from dosing for other anti-thymocyte globulin (ATG)

products, because protein composition and concentrations vary depending on the source of ATG. The

prescribing physician must ensure that the dose prescribed is appropriate for the ATG product being

administered.

5.2 Immune-Mediated Reactions

Serious immune-mediated reactions, including anaphylaxis or severe cytokine release syndrome (CRS),

have been reported with the use of THYMOGLOBULIN [see Warnings and Precautions (5.3)].

Fatal anaphylaxis has been reported. If an anaphylactic reaction occurs, terminate the infusion

immediately. Provide emergency treatment, such as 0.3 mL to 0.5 mL aqueous epinephrine (1:1000

dilution) subcutaneously and other resuscitative measures including oxygen, intravenous fluids,

antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated.

5.3 Infusion-Associated Reactions

Cases consistent with cytokine release syndrome (CRS) have been reported with rapid infusion rates.

CRS is attributed to the release of cytokines by activated monocytes and lymphocytes. Severe acute

CRS can cause serious cardiorespiratory events and/or death [see Adverse Reactions (6.2)]. Close

compliance with the recommended dosage and infusion time may reduce the incidence and severity of

infusion-associated reactions (IARs). Slowing the infusion rate may minimize many of these IARs.

Reactions at the infusion site may include pain, swelling, and redness of the skin.

5.4 Hematologic Effects

Low counts of platelets and white blood cells (including low counts of lymphocytes and neutrophils)

have been identified and are reversible following dose adjustments. Total white blood cell and platelet

counts should be monitored [see Dosage and Administration (2.3)].

5.5 Infection

THYMOGLOBULIN is routinely used in combination with other immunosuppressive agents. Infections

(bacterial, fungal, viral and protozoal), reactivation of infection (particularly cytomegalovirus [CMV])

and sepsis have been reported after THYMOGLOBULIN administration in combination with multiple

immunosuppressive agents. These infections can be fatal.

Monitor patients carefully and administer appropriate anti-infective treatment when indicated [see

Dosage and Administration (2.4)].

5.6 Malignancy

Use of immunosuppressive agents, including THYMOGLOBULIN, may increase the incidence of

malignancies, including lymphoma or lymphoproliferative disorders. These events have been

associated with fatal outcome [see Adverse Reactions (6.2)].

5.7 Immunizations

The safety of immunization with attenuated live vaccines following THYMOGLOBULIN therapy has

not been studied; therefore, immunization with attenuated live vaccines is not recommended for patients

who have recently received THYMOGLOBULIN.

5.8 Laboratory Tests

THYMOGLOBULIN may interfere with rabbit antibody–based immunoassays and with cross-match or

panel-reactive antibody cytotoxicity assays. THYMOGLOBULIN has not been shown to interfere with

any routine clinical laboratory tests that do not use immunoglobulins.

6 ADVERSE REACTIONS

The most common adverse reactions and laboratory abnormalities (incidence >5% higher than

comparator) are urinary tract infection, abdominal pain, hypertension, nausea, shortness of breath, fever,

headache, anxiety, chills, increased potassium levels in the blood, and low counts of platelets and white

blood cells.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed

in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug

and may not reflect the rates observed in practice.

Prophylaxis of Acute Rejection

The efficacy and safety of THYMOGLOBULIN compared to Active Comparator for the prophylaxis

of acute rejection in patients receiving a kidney transplant were evaluated in a randomized, open-label,

international, multicenter trial in patients receiving solitary kidneys from deceased donors (n=278).

There were more Adverse Reactions (incidence >5%) occurring within 12 months of transplantation in

the THYMOGLOBULIN group than in the Active Comparator group (Table 1).

Table 1: Adverse Reactions

and Laboratory Abnormalities Reported More

Frequently (incidence >5%) Following THYMOGLOBULIN versus Active

Comparator

Adverse Reaction

[n (%)

]

THYMOGLOBULIN

(N=141)

Active Comparator

(N=137)

Urinary tract infection

55 (39%)

36 (26%)

Pyrexia

(fever)

39 (28%)

25 (18%)

Headache

26 (18%)

17 (12%)

Hyperlipidemia

(high lipids in blood)

21 (15%)

9 (7%)

Anxiety

20 (14%)

12 (9%)

Chills

13 (9%)

5 (4%)

Laboratory Abnormalities

Hyperkalemia

(high potassium)

81 (57%)

70 (51%)

Leukopenia

(low white blood cell

count)

89 (63%)

20 (15%)

Thrombocytopenia

(low platelet count)

23 (16%)

7 (5%)

*

Adverse reactions are treatment emergent adverse events (TEAE) reported as related to the

study agent in at least 1 patient.

Number (percentage) is shown regardless of causal relationship.

basiliximab

Hyperkalemia: blood potassium ≥5.5 mmol/L; Leukopenia: WBC <3000 cells/mm .

§

Hematologic Abnormalities

The incidence of laboratory abnormalities of leukopenia with WBC<3000 cells/mm was 63% in

THYMOGLOBULIN patients and 15% in Active Comparator patients. The incidence of

thrombocytopenia laboratory abnormalities with platelets <75,000 cells/ mm within 1 month following

transplantation was 16% in THYMOGLOBULIN patients and 5% in Active Comparator patients.

Malignancies

Six patients in the THYMOGLOBULIN group developed malignancies (Epstein-Barr virus-induced

lymphoma of the cavum, Epstein-Barr virus-positive large B-cell lung lymphoma, Epstein-Barr virus-

induced lymphoma of the brain, squamous cell carcinoma, renal cancer, and recurrent basal cell

carcinoma). In the Active Comparator group, 1 patient developed renal cancer.

Infections

Infections occurred in 76% of THYMOGLOBULIN-treated patients (severe in 23%), and in 63% of

Active Comparator-treated patients (severe in 15%).

Infections occurring in ≥5% of the patients in either treatment group during the 12-month follow-up are

summarized in Table 2. Urinary tract infection was the most frequent type of infection, and was reported

as severe in 9% of THYMOGLOBULIN-treated patients and in 2% of Active Comparator-treated

patients. CMV infections were reported more frequently in the Active Comparator group, with an

incidence of 6% (severe in 1%) in THYMOGLOBULIN-treated patients and of 18% (severe in 7%) in

Active Comparator-treated patients. Patients who were CMV-positive at the time of transplant, as well

as CMV-negative recipients of transplants from CMV-positive donors, were required to receive

antiviral prophylaxis for 3 months after transplant.

Table 2: Infections Reported in ≥5% of Study Patients

Infection

THYMOGLOBULIN

(N=141)

Active Comparator

(N=137)

All

Severe/Unknown

All

Severe/Unknown

Urinary tract infections

59 (42%)

12 (9%)

39 (29%)

3 (2%)

Sepsis

9 (6%)

5 (4%)

1 (1%)

1 (1%)

Lower respiratory tract

and lung infections

18 (13%)

2 (1%)

16 (12%)

4 (3%)

Upper respiratory tract

infection

15 (11%)

15 (11%)

1 (1%)

Nasopharyngitis

7 (5%)

9 (7%)

Cytomegaloviral

infections

8 (6%)

2 (1%)

21 (18%)

7 (7%)

Herpes zoster

7 (5%)

2 (2%)

1 (1%)

Oral candidiasis

8 (6%)

11 (8%)

Thrombocytopenia: platelet count <75,000 cells/mm .

*

basiliximab

Urinary tract infection group includes: Urinary tract infections, Urinary tract infection

fungal, Urinary tract infection bacterial, Bacterial pyelonephritis, Urosepsis.

Sepsis group includes: Sepsis, Escherichia sepsis, Staphylococcal bacteremia.

Lower respiratory tract and lung infections group includes: Lower respiratory tract and

lung infections, and Pneumonia pseudomonal.

The collective term "cytomegaloviral infections" includes CMV duodenitis, CMV gastritis,

CMV hepatitis, CMV infection, and CMV viremia.

Adverse Drug Reactions Occurring within 24 Hours and Infusion-Associated Reactions

Adverse reactions occurring during or within 24 hours of infusion in >5% of patients in the

THYMOGLOBULIN group are summarized in Table 3.

Table 3: Adverse Drug Reactions

Occurring within 24 Hours of Infusion and with

>5% Incidence in Patients who Received THYMOGLOBULIN

Primary System Organ Class

n (%)

THYMOGLOBULIN

(N=141)

Active Comparator

(N=137)

Constipation

47 (33%)

23 (17%)

Anemia

(low red blood cell count)

35 (25%)

19 (14%)

Hyperkalemia

(high potassium)

33 (23%)

18 (13%)

Hypertension

(elevated blood pressure)

25 (18%)

19 (14%)

Leukopenia and White blood cell

count decreased

29 (21%)

Pyrexia

(fever)

18 (13%)

3 (2%)

Vomiting

17 (12%)

14 (10%)

Thrombocytopenia

(low platelet count)

13 (9%)

1 (1%)

Abdominal pain

11 (8%)

6 (4%)

Anxiety

10 (7%)

2 (2%)

Hyperphosphatemia

(high phosphate)

10 (7%)

2 (2%)

Tachycardia

(fast heart rate)

10 (7%)

5 (4%)

Acidosis

(accumulation of acid in the body)

9 (6%)

8 (6%)

Diarrhea

9 (6%)

1 (1%)

Hypokalemia

(low potassium)

9 (6%)

4 (3%)

Infusion-associated reactions

Adverse reactions that occurred within 24 hours after the completion of the THYMOGLOBULIN

administration and are considered as possible infusion associated reactions (IARs) include the

following: anxiety, confusional state, agitation, restlessness, headache, lethargy, dizziness, decreased

sensitivity, fast heart rate, myocardial infarction, elevated blood pressure, decreased blood pressure,

cough, throat irritation, reduced oxygen supply to tissues, shortness of breath, pulmonary edema, pain in

mouth and throat, diarrhea, upper abdominal pain, abdominal tenderness, abdominal discomfort, nausea,

pruritus, rash, joint pain, fever, chills, lack of energy, localized edema, malaise, and chest pain.

Serum sickness was reported in 6 of 405 patients enrolled across completed studies where patients had

been treated with THYMOGLOBULIN for the prophylaxis of acute rejection in patients receiving a

kidney transplant. Anaphylactic shock was reported in 2 of 405 patients enrolled across completed

studies.

*

Adverse reactions that occurred during or within 24 hours of an infusion, and where the

incidence was higher in the THYMOGLOBULIN group.

basiliximab

Treatment of acute rejection

In the US Phase 3 randomized controlled clinical trial (n=163) comparing the efficacy and safety of

THYMOGLOBULIN and Active Comparator in the treatment of acute rejection in kidney transplant

patients, adverse reactions occurring at least 5% more frequently in the THYMOGLOBULIN group

than in the Active Comparator group are shown in Table 4. Malignancies were reported in 3 patients

who received THYMOGLOBULIN and in 3 patients who received Active Comparator during the one-

year follow-up period. These included two cases of post-transplant lymphoproliferative disease

(PTLD) in the THYMOGLOBULIN group and two cases of PTLD in the Active Comparator group.

Table 4: Adverse Reactions

Reported More Frequently (incidence ≥5%)

Following THYMOGLOBULIN versus Active Comparator

Frequently Reported

Events

THYMOGLOBULIN

n=82

Active Comparator

n=81

Chills

47 (57%)

35 (43%)

Leukopenia

(low white blood cell count)

47 (57%)

24 (30%)

Headache

33 (40%)

28 (35%)

Abdominal pain

31 (38%)

22 (27%)

Hypertension

(elevated blood pressure)

30 (37%)

23 (28%)

Nausea

30 (37%)

23 (28%)

Dyspnea

23 (28%)

16 (20%)

Hyperkalemia

(high potassium)

22 (27%)

15 (19%)

Myalgia

16 (20%)

10 (12%)

Insomnia

16 (20%)

10 (12%)

Hypotension

(decreased blood pressure)

13 (16%)

6 (7%)

Rash

11 (13%)

6 (7%)

Sweating

11 (13%)

4 (5%)

Malaise

11 (13%)

3 (4%)

Acne

10 (12%)

4 (5%)

Overdose

5 (6%)

Treatment-emergent thrombocytopenia was reported in 30 (37%) of patients following

THYMOGLOBULIN infusion and in 36 (44%) of patients following Active Comparator infusion.

Infections occurring more frequently in the THYMOGLOBULIN group during the 3-month follow-up

are summarized in Table 5. No significant differences were seen between the THYMOGLOBULIN and

Active Comparator groups for all types of infections. The incidence of CMV infection was the same in

both groups. Viral prophylaxis was by the center's discretion during antibody treatment, but all centers

used ganciclovir infusion during treatment.

Table 5: Infections

THYMOGLOBULIN

n=82

Active Comparator

n=81

No. of

Total

No. of

Total

*

Treatment-emergent adverse events/reactions (TEAE) are summarized.

Anti-thymocyte globulin equine (ATG-E)

*

Body System

No. of

Patients

(%)

Total

Reports

No. of

Patients

(%)

Total

Reports

Body as a Whole

(37)

(27)

Infection

(31)

(24)

Other

(17)

(14)

(13)

(11)

Sepsis

(12)

(10)

Diges tive

Gastrointestinal

moniliasis

Gastritis

Skin

Herpes simplex

Adverse reactions occurring during or shortly following THYMOGLOBULIN infusion (infusion-

associated adverse reactions) are generally manageable or reversible. Adverse reactions occurring

during or within 24 hours of infusion in at least 5% of patients in the THYMOGLOBULIN group are

listed in Table 6.

Table 6: Adverse Reactions* Occurring within 24 Hours of Infusion and with >5%

Incidence in THYMOGLOBULIN Patients

Adverse Reaction

THYMOGLOBULIN

(N=82)

Active Comparator

(N=81)

Chills

45 (55%)

28 (35%)

Leukopenia

(low white blood cell count)

40 (49%)

10 (12%)

Fever

38 (46%)

39 (48%)

Nausea

24 (29%)

17 (21%)

Thrombocytopenia

(low platelet count)

24 (29%)

30 (37%)

Headache

22 (27%)

22 (27%)

Hypertension

22 (27%)

16 (20%)

Pain

21 (26%)

19 (24%)

Tachycardia

(fast heart rate)

19 (23%)

16 (20%)

Diarrhea

16 (20%)

15 (19%)

Peripheral edema

(swelling)

16 (20%)

13 (16%)

Vomiting

16 (20%)

12 (15%)

Abdominal pain

14 (17%)

13 (16%)

Hyperkalemia

(increased potassium level)

14 (17%)

12 (15%)

Arthralgia

(joint pain)

12 (15%)

11 (14%)

Constipation

12 (15%)

16 (20%)

Dyspnea

(shortness of breath)

12 (15%)

11 (14%)

Asthenia

11 (13%)

11 (14%)

ATG-E

*

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