agnesium and serum calcium should be kept within normal range to reduce the risk of electrocardiogram QT prolongation.
Avoid using CAPRELSA with drugs known to prolong the electrocardiogram QT interval [see Warnings and Precautions (5.11) and Drug Interactions (7.3)]. If such drugs are given to patients already receiving CAPRELSA and no alternative therapy exists, ECG monitoring of the QT interval should be performed more frequently.
Patients who develop a QTcF greater than 500 ms should stop taking CAPRELSA until QTcF returns to less than 450 ms. Dosing of CAPRELSA can be resumed at a reduced dose [see Dosage and Administration (2.1)].
5.2 Skin Reactions and Stevens-Johnson Syndrome
Severe skin reactions (including Stevens-Johnson syndrome), some leading to death, have been reported with CAPRELSA. Treatment of severe skin reactions has included systemic corticosteroids and permanent discontinuation of CAPRELSA. Mild to moderate skin reactions may manifest as rash, acne, dry skin, dermatitis, pruritis and other skin reactions (including photosensitivity reactions and palmar-plantar erythrodysesthesia syndrome). Mild to moderate skin reactions have been treated with topical and systemic corticosteroids, oral antihistamines, and topical and systemic antibiotics. If CTCAE grade 3 or greater skin reactions occur, CAPRELSA treatment should be stopped until improved. Upon improvement, consideration should be given to continuing treatment at a reduced dose or permanent discontinuation of CAPRELSA. [see Dosage and Administration (2.1)]
Photosensitivity reactions are increased with CAPRELSA. Patients should be advised to wear sunscreen and protective clothing when exposed to the sun. Due to the long half-life of CAPRELSA, protective clothing and sunscreen should continue for 4 months after discontinuation of treatment.
5.3 Interstitial Lung Disease
Interstitial Lung Disease (ILD) or pneumonitis has been observed with CAPRELSA and deaths have been reported. Consider a diagnosis of ILD in patients presenting with non-specific respiratory signs and symptoms such as hypoxia, pleural effusion, cough, or dyspnea, and in whom infectious, neoplastic, and other causes have been excluded by means of appropriate investigations. Advise patients to report promptly any new or worsening respiratory symptoms.
Patients who develop radiological changes suggestive of ILD and have few or no symptoms may continue CAPRELSA therapy with close monitoring at the discretion of the treating physician.
If symptoms are moderate, consider interrupting therapy until symptoms improve. The use of corticosteroids and antibiotics may be indicated.
For cases where symptoms of ILD are severe, discontinue CAPRELSA therapy and the use of corticosteroids and antibiotics may be indicated until clinical symptoms resolve. Even upon resolution of severe ILD, permanent discontinuation of CAPRELSA should be considered.
5.4 Ischemic Cerebrovascular Events
Ischemic cerebrovascular events have been observed with CAPRELSA and some cases have been fatal. In the randomized medullary thyroid cancer (MTC) study, ischemic cerebrovascular events were observed more frequently with CAPRELSA compared to placebo (1.3% compared to 0%) and no deaths were reported. The safety of resumption of CAPRELSA therapy after resolution of an ischemic cerebrovascular event has not been studied. Discontinue CAPRELSA in patients who experience a severe ischemic cerebrovascu |
