Thymoglobulin Side Effects

Please note - some side effects for Thymoglobulin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Thymoglobulin - for the Consumer

Thymoglobulin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Thymoglobulin:

Chills; diarrhea; dizziness; fever; general body discomfort; headache; nausea; swelling of the hands and feet; urinary tract infection; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Thymoglobulin:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); diarrhea; dizziness; easy bleeding or bruising; fast or irregular heartbeat; fever; infection; joint or muscle pain; persistent sore throat; stomach pain; unusual fatigue.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Thymoglobulin Side Effects - for the Professional

Thymoglobulin

Clinical Trials

US Phase 3 Study

Thymoglobulin adverse events are generally manageable or reversible. In the US Phase 3 controlled clinical trial (n=163) comparing the efficacy and safety of Thymoglobulin and Atgam, there were no significant differences in clinically significant adverse events between the two treatment groups (Table 2). Malignancies were reported in 3 patients who received Thymoglobulin and in 3 patients who received Atgam during the one-year follow-up period. These included two post-transplant lymphoproliferative diseases (PTLDs) in the Thymoglobulin group and two PTLDs in the Atgam group.

Table 2. Frequently Reported and Significant Adverse Events*  

Preferred Term	Thymoglobulin n=82		Atgam n=81		p Value†
	No. of     Patients	(%)	No. of     Patients	(%)
* Treatment Emergent Adverse Events (TEAE) are summarized. Frequently reported adverse events are those reported by more than 25% of patients in a treatment group; significant adverse events are those where the incidence rate differed between treatment groups by a significance level of ≤0.05. † p Value comparing treatment groups using Fisher's exact test. ‡ statistically significant differences in the AEs.
Frequently Reported Events
Fever	52	(63.4)	51	(63.0)	1.0
Chills	47	(57.3)	35	(43.2)	0.086
Leukopenia	47	(57.3)	24	(29.6)	<0.001
Pain	38	(46.3)	35	(43.2)	0.753
Headache	33	(40.2)	28	(34.6)	0.518
Abdominal pain	31	(37.8)	22	(27.2)	0.181
Diarrhea	30	(36.6)	26	(32.1)	0.622
Hypertension	30	(36.6)	23	(28.4)	0.316
Nausea	30	(36.6)	23	(28.4)	0.316
Thrombocytopenia	30	(36.6)	36	(44.4)	0.341
Peripheral edema	28	(34.1)	28	(34.6)	1.0
Dyspnea	23	(28.0)	16	(19.8)	0.271
Asthenia	22	(26.8)	26	(32.1)	0.495
Hyperkalemia	22	(26.8)	15	(18.5)	0.262
Tachycardia	22	(26.8)	19	(23.5)	0.719
Significant Events‡
Leukopenia	47	(57.3)	24	(29.6)	<0.001
Malaise	11	(13.4)	3	(3.7)	0.047
Dizziness	7	(8.5)	20	(24.7)	0.006

Infections occurring in both treatment groups during the 3-month follow-up are summarized in Table 3. No significant differences were seen between the Thymoglobulin and Atgam groups for all types of infections, and the incidence of cytomegalovirus (CMV) infection was equivalent in both groups. (Viral prophylaxis was by the center’s discretion during antibody treatment, but all centers used gancyclovir infusion during treatment.)

Table 3. Infections

BODY SYSTEM Preferred Term	Thymoglobulin n=82			Atgam n=81			p Value*
	No. of      Patients	(%)	Total     Reports	No. of     Patients	(%)	Total     Reports
* p Value comparing treatment groups using Fisher’s exact test.
BODY AS A WHOLE	30	(36.6)	36	22	(27.2)	29	0.240
Infection	25	(30.5)	26	19	(23.5)	21	0.378
Other	14	(17.1)	15	11	(13.6)	12	0.665
CMV	11	(13.4)	11	9	(11.1)	9	0.812
Sepsis	10	(12.2)	10	7	(9.6)	7	0.610
Moniliasis	0	(0.0)	0	1	(1.2)	1	0.497
DIGESTIVE	5	(6.1)	5	3	(3.7)	3	0.720
Gastrointestinal moniliasis	4	(4.9)	4	1	(1.2)	1	0.367
Oral moniliasis	3	(3.7)	0	2	(2.5)	1	0.497
Gastritis	1	(1.2)	1	0	(0.0)	0	1.000
RESPIRATORY	0	(0.0)	0	1	(1.2)	1	0.497
Pneumonia	0	(0.0)	0	1	(1.2)	1	0.497
SKIN	4	(4.9)	4	0	(0.0)	0	0.120
Herpes simplex	4	(4.9)	4	0	(0.0)	0	0.120
UROGENITAL	15	(18.3)	15	22	(29.2)	22	0.195
Urinary tract infection	15	(18.3)	15	21	(25.9)	21	0.262
Vaginitis	0	(0.0)	0	1	(1.2)	1	0.497
NOT SPECIFIED	0	(0.0)	0	2	(2.5)	2	0.245

Post-marketing Experience

The following adverse reactions have been identified during post approval use of Thymoglobulin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Infusion-Associated Reactions and Immune System Disorders

IARs may occur following the administration of Thymoglobulin and may occur as soon as the first or second infusion during a single course of Thymoglobulin treatment. Clinical manifestations of infusion-associated reactions IARs have included some of the following signs and symptoms: fever, chills/rigors, dyspnea, nausea/vomiting, diarrhea, hypotension or hypertension, malaise, rash, and/or headache. IARs with Thymoglobulin are generally manageable with a reduction in infusion rates and/or with medications. Serious and fatal anaphylactic reactions have been reported. The fatalities occurred in patients who did not receive epinephrine during the event.

IARs consistent with cytokine release syndrome (CRS) have been reported. Severe and potentially life-threatening CRS have also been reported. Post-marketing reports of severe CRS have included cardiorespiratory dysfunction (including hypotension, acute respiratory distress syndrome, pulmonary edema, myocardial infarction, tachycardia, and/or death).

During post-marketing surveillance, reactions such as fever, rash, arthralgia, and/or myalgia, indicating possible serum sickness, have been reported. Serum sickness tends to occur 5 to 15 days after onset of Thymoglobulin therapy. Symptoms are manageable with corticosteroid treatment. 

Adverse Events Due to Immunosuppression

Infections, reactivation of infection, and sepsis have been reported after Thymoglobulin administration in combination with multiple immunosuppressive agents. Malignancies including, but not limited to post-transplant lymphoproliferative disorder (PTLD) and other lymphomas as well as solid tumors have been reported. These adverse events were reported with use of a combination of multiple immunosuppressive agents.

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Side Effects by Body System - for Healthcare Professionals

General

General side effects have included chills, fever, infections and pain.

Cardiovascular

Cardiovascular side effects have included hypertension, peripheral edema, tachycardia, pulmonary edema and myocardial infarction.

Other

Other side effects have included infections (bacterial, fungal, viral and protozoal), reactivation of infections (particularly cytomegalovirus [CMV]) and sepsis.

Nervous system

Nervous system side effects have included headache, malaise, asthenia and dizziness.

Hematologic

Hematologic side effects have included leukopenia and thrombocytopenia.

Gastrointestinal

Gastrointestinal side effects have included gastrointestinal and oral moniliasis, abdominal pain, nausea, diarrhea and vomiting.

Genitourinary

Genitourinary side effects have included urinary tract infection and vaginitis.

Dermatologic

Dermatologic side effects have included herpes simplex infections and rash.

Respiratory

Respiratory side effects have included pneumonia, acute respiratory distress syndrome, pulmonary edema and dyspnea.

Metabolic

Metabolic side effects have included hyperkalemia.

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