Precautions of Ribociclib

1 Interstitial Lung Disease/Pneumonitis

Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis which may include hypoxia, cough, and dyspnea. In patients who have new or worsening respiratory symptoms suspected to be due to ILD or pneumonitis, interrupt  Ribociclib immediately and evaluate the patient. Permanently discontinue Ribociclib in patients with severe  ILD/pneumonitis or any recurrent symptomatic ILD/pneumonitis.

2 Severe Cutaneous Adverse Reactions

If signs or symptoms of severe cutaneous reactions occur, interrupt Ribociclib until the etiology of the reaction has been  determined. Early consultation with a dermatologist is recommended to ensure greater diagnostic accuracy and appropriate management.

If SJS, TEN, or DiHS/DRESS is confirmed, permanently discontinue Ribociclib. Do not reintroduce Ribociclib in patients who have experienced SCARs or other life-threatening cutaneous reactions during Ribociclib treatment.

3 QT Interval Prolongation

Monitor serum electrolytes (including potassium, calcium, phosphorous and magnesium) prior to the initiation of Ribociclib  at the beginning of the first 6 cycles, and as clinically indicated. Correct any abnormality before starting Ribociclib.

4 Increased QT Prolongation with Concomitant Use of Tamoxifen

higher in the tamoxifen plus placebo subgroup compared with the non-steroidal aromatase inhibitors (NSAIs) plus placebo  subgroup. In the placebo arm, an increase of > 60 ms from baseline occurred in 6/90 (7%) of patients receiving tamoxifen,  and in no patients receiving an NSAI. An increase of > 60 ms from baseline in the QTcF interval was observed in 14/87  (16%) of patients in the Ribociclib and tamoxifen combination and in 18/245 (7%) of patients receiving Ribociclib plus an NSAI.

5 Hepatotoxicity

Perform liver function tests (LFTs) in all patients before initiating Ribociclib. Monitor LFTs every 2 weeks for first 2 cycles,  at the beginning of each of the subsequent 4 cycles, and as clinically indicated. 

Based on the severity of the transaminase elevations, Ribociclib may require dose interruption, reduction, or discontinuation  as described in Table 5 (Dose Modification and Management for Hepatobiliary Toxicity).

from FDA，2024.09