USE IN SPECIFIC POPULATIONS Sample Clauses

USE IN SPECIFIC POPULATIONS. ∙Lactation: Advise women not to breastfeed. Please see Full Prescribing Information<hxxxx://xxxxxxx.xxx/xxx/full-prescribing-information.pdf> for additional safety information. Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses the global development and commercialization rights to three drug candidates — PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. NERLYNX was granted marketing authorization by the European Commission in September 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc. Further information about Puma Biotechnology can be found at wxx.xxxxxxxxxxxxxxxxx.xxx.
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USE IN SPECIFIC POPULATIONS. Pregnancy Breast-feeding Fertility Please see the full Prescribing Information for additional Important Safety Information. Forward-Looking Statements
USE IN SPECIFIC POPULATIONS. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. ​ Treatment with IMCIVREE is not recommended for use while breastfeeding. ​ To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at +0 (000) 000-0000 or FDA at 1-800-FDA-1088 or xxx.xxx.xxx/xxxxxxxx. ​ See U.S. Full Prescribing Information, EU SmPC and MHRA SmPC for IMCIVREE. ​ ​ ​ ​
USE IN SPECIFIC POPULATIONS. Lactation: Advise women not to breastfeed.
USE IN SPECIFIC POPULATIONS. Advise females of reproductive potential to use effective contraception during Adstiladrin treatment and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during Adstiladrin treatment and for 3 months after the last dose. ADVERSE REACTIONS: The most common (>10%) adverse reactions, including laboratory abnormalities (>15%), were glucose increased, instillation site discharge, triglycerides increased, fatigue, bladder spasm, micturition (urination urgency), creatinine increased, hematuria (blood in urine), phosphate decreased, chills, pyrexia (fever), and dysuria (painful urination). You are encouraged to report negative side effects of prescription drugs to FDA. About Royalty Pharma plc About Ferring Pharmaceuticals
USE IN SPECIFIC POPULATIONS. 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use
USE IN SPECIFIC POPULATIONS. Pregnancy: May cause fetal harm (8.1).
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