Possible Side effects of Ipilimumab
Colitis, diarrhea and cytomegalovirus (CMV) infection/activation
Hepatitis
Dermatologic reactions including:
Rash
Bullous dermatitis
Exfoliative dermatitis
Stevens-Johnson syndrome
Toxic epidermal necrolysis
Drug rash with eosinophilia and systemic symptoms (DRESS)
Endocrinopathies including:
Hypophysitis
Hypopituitarism
Adrenal insufficiency
Hypogonadism
Thyroiditis
Hypothyroidism
Hyperthyroidism
Type I diabetes mellitus
Cushing’s syndrome
Pneumonitis
Nephritis and renal dysfunction
Neuropathies including meningitis, myelitis, demyelination, encephalitis, myasthenia gravis/myasthenic syndrome, nerve paresis, motor dysfunction and Guillain-Barre syndrome
Cardiovascular reactions including myocarditis, pericarditis, angiopathy, temporal arteritis and vasculitis
Eye conditions including blepharitis, scleritis, episcleritis, conjunctivitis, orbital myositis, iritis, and uveitis
Neurosensory hearing loss (hypoacusis)
Gastritis, duodenitis and pancreatitis
Arthritis, myositis, polymyositis, polymyalgia rheumatica and rhabdomyolysis
Erythema multiforme and psoriasis
Sarcoidosis
Blood disorders including aplastic anemia, cytopenias and eosinophilia
Histiocytic necrotizing lymphadenitis
Solid organ transplant rejection
Systemic inflammatory response syndrome
Ipilimumab may cause severe infusion reactions. Interrupt or slow the rate of infusion in patients with mild or moderate infusion reactions and discontinue for severe and life-threatening infusion reactions.
In patients who receive donor (allogeneic) hematopoietic stem cell transplantation (HSCT) before or after ipilimumab therapy, serious and fatal graft-versus-host disease (GVHD) can occur, despite intervening therapy between HSCT and ipilimumab therapy.
Consider benefit and risks before initiating ipilimumab after HSCT.
Monitor patients closely for evidence of GVHD and intervene promptly.
Ipilimumab can cause fetal harm. Apprise pregnant women of potential risk to the fetus and advise women of reproductive potential to use effective contraception during therapy and for 3 months following the last dose.
When used in combination with nivolumab, refer to prescribing information for additional risk information that applies to the combination use treatment.
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