Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Gefitinib | Iressa | 4.6 Fertility, pregnancy and lactation | In animal reproductive studies IRESSA can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment for at least two weeks following completion of therapy. | Mar,2023 |
| Trastuzumab | Kanjinti | 4.6 Fertility, pregnancy and lactation | In the post‑marketing setting, cases of skeletal abnormalities, and neonatal death have been reported in pregnant women receiving trastuzumab. | Mar,2023 |
| Denosumab | Proolia | 4.6 Fertility, pregnancy and lactation | Prolia is contraindicated in pregnancy because it may cause harm to a fetus. Fetal loss, stillbirths, and postnatal mortality, absent lymph nodes, abnormal bone growth, and decreased neonatal growth was reported in animal studies. | Mar,2023 |
| Rifampicin | Rifadin | 4.5. Interactions with other medicinal products | Interactions with clopidogrel, caspofungin, strong Cytochrome (CYP3A4) inducers and Vandetanib therapy. | Mar,2023 |
| Amphotericin B Lipid Complex | Abelcet | 4.5. Interactions with other medicinal products | Interactions with Antineoplastic agents, Corticosteroids , Corticotropin, Cyclosporin, Digitalis glycosides, Flucytosine, Imidazoles and Other nephrotoxic medications. | Mar,2023 |
| Zanubrutinib | Brukinsa | 2.3 Dosage Modifications for Drug Interactions | Avoid coadministration of Zanubrutinib with moderate Cytochrome (CYP3A4) inducers. Narrow therapeutic index medicines that are metabolized by Cytochrome (CYP3A) and Cytochrome (CYP2C19) should be used with caution with Zanubrutinib | Mar,2023 |