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 (incidence in at least 10% of patients) reported following administration of RETHYMIC were hypertension (high blood pressure), cytokine release syndrome, rash, hypomagnesemia (low magnesium), renal impairment / failure (decrease of kidney function), thrombocytopenia (low platelets), and graft versus host disease.
The most common (>10%) adverse events related to RETHYMIC included: hypertension (high blood pressure, 19%), cytokine release syndrome (18%), rash (15%), hypomagnesemia (low magnesium, 16%), renal impairment / failure (decrease of kidney function, 12%), thrombocytopenia (low platelets, 12%), and graft versus host disease, (10%).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sumitomo Pharma America at 833-369-9868 or FDA at 1-800-FDA-1088 or https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.
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 safety data described in this section are derived from 10 prospective, single-center, open-label studies, and include 105 patients who were treated with RETHYMIC in these studies and who had at least one year of follow-up.
Table 1 lists the adverse reactions occurring in 105 patients who were treated with RETHYMIC in these studies.
Table 1: Adverse Reactions Occurring in at least 5% of Patients Treated with RETHYMIC During Clinical Studies System Organ Class Preferred Term RETHYMIC (N=105) n (%) Number of Patients with Adverse Reactions Reactions which occurred in the 2 years after treatment.
80 (76) Hypertension (high blood pressure) 20 (19) Cytokine release syndrome All events (19/19) of cytokine release syndrome occurred in association with ATG-R treatment.
19 (18) Hypomagnesemia (low magnesium) 17 (16) Rash Rash includes rash, granuloma skin, rash papular, urticaria.
16 (15) Renal impairment / failure Renal impairment / failure includes renal failure and acute kidney injury, proteinuria and blood creatinine increased.
5 WARNINGS AND PRECAUTIONS Immune reconstitution sufficient to protect from infection is unlikely to develop prior to 6 to 12 months after treatment with RETHYMIC.
Given the immunocompromised condition of athymic patients, infection control measures should be followed until the development of thymic function can be established.
( 5.1 ) Monitor and treat patients at risk for the development of graft versus host disease (GVHD).
( 5.2 ) Monitor for the development of autoimmune disorders, including complete blood counts with differential, liver enzymes, serum creatinine, urinalysis, and thyroid function.
( 5.3 ) Pre-existing renal impairment is a risk factor for death.
Like all medications, Rethymic 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: