Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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, 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.
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.
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.
Prophylaxis of Acute Rejection The 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;
Table 1: Adverse Reactions Adverse reactions are treatment emergent adverse events (TEAE) reported as related to the study agent in at least 1 patient.
and Laboratory Abnormalities Reported More Frequently (incidence Number (percentage) is shown regardless of causal relationship.
>5%) Following THYMOGLOBULIN versus Active Comparator basiliximab Adverse Reaction [n (%) ] THYMOGLOBULIN (N=141) Active Comparator (N=137) Urinary tract infection 55 (39%) 36 (26%) Pyrexia 39 (28%) 25 (18%) Headache 26 (18%) 17 (12%) Hyperlipidemia 21 (15%) 9 (7%) Anxiety 20 (14%) 12 (9%) Chills 13 (9%) 5 (4%) Laboratory Abnormalities Hyperkalemia: blood potassium ≥5.5 mmol/L;
Leukopenia: WBC <3000 cells/mm 3 .
Thrombocytopenia: platelet count <75,000 cells/mm 3 .
5 WARNINGS AND PRECAUTIONS THYMOGLOBULIN should only be used by physicians experienced in immunosuppressant therapy in transplantation.
( 5.1 ) Hypersensitivity and infusion-related reactions: THYMOGLOBULIN infusion could result in an anaphylactic reaction.
Close compliance with the recommended infusion time may reduce the incidence and severity of infusion-related reactions.
( 5.2 ) Cytopenias including anemia, neutropenia, and thrombocytopenia have occurred with THYMOGLOBULIN administration ( 6 ) and require monitoring of blood counts.
Adjust dose accordingly to reverse cytopenias.
Like all medications, Thymoglobulin can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: