tion and Management for Other Toxicities (Excluding Hyperglycemia, Rash, andDiarrhea)
Grade1 Recommendation
Grade 1 or 2 No PIQRAY dose adjustment is required. Initiate appropriate medical therapy and monitor as clinically
indicated2,3.
Grade 3 Interrupt PIQRAY dose until recovery to Grade ≤ 1, then resume PIQRAY at the next lower dose level.
Grade 4 Permanently discontinue PIQRAY.
1Grading according to CTCAE Version 5.0
2For Grade 2 and 3 pancreatitis, interrupt PIQRAY dose until recovery to Grade < 2 and resume at next lower dose level. Only one dosereduction is permitted. If toxicity reoccurs, permanently discontinue PIQRAY treatment.
3For Grade 2 total bilirubin elevation, interrupt PIQRAY dose until recovery to Grade ≤ 1 and resume at the same dose if resolved in ≤ 14 daysor resume at the next lower dose level if resolved in > 14 days.
Refer to the Full Prescribing Information of fulvestrant for dose modification guidelines in the event of toxicityand for other relevant safety information.
3 DOSAGE FORMS AND STRENGTHS
Tablets: 50 mg, 150 mg, and 200 mg alpelisib50 mg: Light pink, unscored, round and curved with beveled edges film-coated tablet, imprinted with “L7” on
one side and “NVR” on the other side.
150 mg: Pale red, unscored, ovaloid and curved with beveled edges film-coated tablet, imprinted with “UL7” onone side and “NVR” on the other side.
200 mg: Light red, unscored, ovaloid and curved with beveled edges film-coated tablet, imprinted with “YL7”on one side and “NVR” on the other side.
4 CONTRAINDICATIONS
PIQRAY is contraindicated in patients with severe hypersensitivity to it or any of its components [see Warningsand Precautions (5.1)].
5 WARNINGS AND PRECAUTIONS
5.1 Severe Hypersensitivity
Severe hypersensitivity reactions, including anaphylaxis and anaphylactic shock, were reported in patientstreated with PIQRAY. Severe hypersensitivity reactions were manifested by symptoms including, but notlimited to, dyspnea, flushing, rash, fever, or tachycardia.
The incidence of Grade 3 and 4 hypersensitivity reactions was 0.7% [see Adverse Reactions (6)].
Advise patients of the signs and symptoms of severe hypersensitivity reactions. Permanently discontinuePIQRAY in the event of severe hypersensitivity.
5.2 Severe Cutaneous Reactions
Severe cutaneous reactions, including Stevens-Johnson Syndrome (SJS) and Erythema Multiforme (EM) were
reported in patients treated with PIQRAY [see Adverse Reactions (6)].
SJS and EM were reported in 0.4% and 1.1% of patients, respectively. Do not initiate PIQRAY treatment inpatients with a history of SJS, EM, or Toxic Epidermal Necrolysis (TEN).
If signs or symptoms of severe cutaneous reactions occur, interrupt PIQRAY until the etiology of the reactionhas been determined. Consultation with a dermatologist is recommended.
If SJS, TEN, or EM is confirmed, permanently discontinue PIQRAY. Do not reintroduce PIQRAY in patientswho have experienced previous severe cutaneous reactions during PIQRAY treatment.
If SJS, TEN, or EM is not confirmed, PIQRAY may require dose modifications, topical corticosteroids, or oralantihistamine treatment as described in Table 3 [see Dosage and Administration (2.3)].
Advise patients of the signs and symptoms of severe cutaneous reactions (e.g., a prodrome of fever, flu-likesymptoms, mucosal |
