in a singledose
vial.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Dermatologic Toxicity
Fatal and life-threatening skin adverse reactions, including Stevens-Johnson syndrome (SJS) andtoxic epidermal necrolysis (TEN), have occurred in recipients of POTELIGEO. Rash (drugeruption) is one of the most common adverse reactions associated with POTELIGEO. In Trial 1,25% (80/319) of patients treated with POTELIGEO had an adverse reaction of drug eruption,with 18% of these cases being severe (Grade 3) and 82% of these cases being Grade 1 or 2. Of528 patients treated with POTELIGEO in clinical trials, Grade 3 skin adverse reactions werereported in 3.6%, Grade 4 skin adverse reactions in <1%, and SJS in <1%.The onset of drug eruption is variable, and the affected areas and appearance vary. In Trial 1, themedian time to onset was 15 weeks, with 25% of cases occurring after 31 weeks.
The morecommon presentations reported included papular or maculopapular rash, lichenoid, spongiotic orgranulomatous dermatitis, and morbilliform rash. Other presentations included scaly plaques,pustular eruption, folliculitis, non-specific dermatitis, and psoriasiform dermatitis.
Monitor patients for rash throughout the treatment course. Management of dermatologic toxicityincludes topical corticosteroids and interruption or permanent cessation of POTELIGEO [seeDosage and Administration (2.2)]. Consider skin biopsy to help distinguish drug eruption fromdisease progression.
Discontinue POTELIGEO permanently for SJS or TEN or for any life-threatening (Grade 4)reaction. For possible SJS or TEN, interrupt POTELIGEO and do not restart unless SJS or TEN is ruled out and the cutaneous reaction has resolved to Grade 1 or less.
5.2 Infusion Reactions
Fatal and life-threatening infusion reactions have been reported in patients treated withPOTELIGEO.
In Trial 1, infusion reactions occurred in 35% (112/319) of patients treated withPOTELIGEO, with 8% of these reactions being severe (Grade 3). Most reactions (approximately90%) occur during or shortly after the first infusion. Infusion reactions can also occur withsubsequent infusions. The most commonly reported signs include chills, nausea, fever,tachycardia, rigors, headache, and vomiting.
Consider premedication (such as diphenhydramine and acetaminophen) for the first infusion of
POTELIGEO in all patients. Whether premedication reduces the risk or severity of thesereactions is not established. In Trial 1, infusion reactions occurred in 42% of patients withoutpremedication and 32% of patients with premedication. Monitor patients closely for signs andsymptoms of infusion reactions and interrupt the infusion for any grade reaction and treatpromptly [see Dosage and Administration (2.2)].
5.3 Infections
Fatal and life-threatening infections have occurred in patients treated with POTELIGEO,including sepsis, pneumonia, and skin infection. In Trial 1, 18% (34/184) of patients randomizedto POTELIGEO had Grade 3 or higher infection or an infection-related serious adverse reaction.
Monitor patients for signs and symptoms of infection and treat promptly.
5.4 Autoimmune Complications
Fatal and life-threatening immune-mediated complications have been reported in recipients ofPOTELIGEO. Grade 3 or higher immune-mediated or possibly immune-mediated reactions haveincluded myositis, myocarditis, polymyositis, hepatitis, pneumonitis, and a variant of GuillainBa |
