The State Drug Administration revised the instructions for gifeitinib tablets

On January 25th, the State Drug Administration issued a notice on the revision of the instructions for gifeitinib tablets (No. 17 of 2021), which amended the instructions for gifeitinib tablets, "Adverse Reactions" and "Precautions".
specifically as follows: First, "Adverse Reactions" added the following: Post-market experience: Gifeitinib tablets after the market observed the following adverse reactions.
these adverse reactions come from spontaneous reports that do not determine the sample size, and it is difficult to estimate exactly how often they occur.
skin and subsc skin tissue abnormalities: skin adverse reactions are one of the most common adverse reactions of gifactinib tablets, can occur in any part of the body, mostly manifested as mild to moderate rash, dryness, itching and so on.
After listing, adverse reaction monitoring has received reports of palm erythema syndrome (hand-foot syndrome, hand-foot skin reaction), which is manifested in abnormal palm and foot sensations, erythema, chippy, blisters, bleeding, cleft palate, edema or excessive ablation.
II, Note: Add the following: Skin toxicity: Severe skin adverse reactions (NCI CTCAE level 3 or above) need to be suspended (see Usage Dosage), early intervention of skin reactions is conducive to the continuous treatment of gifetinib.
patients with abnormal skin sensations, erythema, chippy, blisters, bleeding, cleft palate, edema or excessive ablation should seek medical attention in a timely manner.
after the listing of adverse reaction monitoring has received palm redness syndrome (hand-foot syndrome, hand-foot skin reaction) report, patients should pay attention to reduce skin compression and friction during medication, especially to prevent the compression of the opponent's palm and foot.
(Note: If the other contents of the manual are inconsistent with the above-mentioned amendment requirements, they shall be revised in une.)
) The State Drug Administration requires all production enterprises of gifeitinib tablets to file a supplementary application for revision of the instructions in accordance with the relevant provisions of the Measures for the Administration of Drug Registration and other relevant provisions, and to report the revised instructions to the Drug Approval Center of the State Administration or the provincial drug regulatory department for the record by April 20, 2021.
the contents of the drug shall be revised together, and the instructions and other contents of the label shall be consistent with the original approval contents.
to replace all factory-issued drug instructions and labels within 9 months of filing the supplementary application.