Ipilimumab

Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr) Hypertension The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2025 to include information about the risk of hypertension. Example: Ajovy labeling Apriso (mesalamine) Asacol (mesalamine) Asacol HD (mesalamine) Azulfidine (sulfasalazine) Azulfidine EN-Tabs (sulfasalazine) Canasa (mesalamine) Colazal (balsalazide disodium) Delzicol (mesalamine) Dipentum (osalazine sodium) Giazo (balsalazide disodium) Lialda (mesalamine) Rowasa (mesalamine) Pentasa (mesalamine) Severe cutaneous adverse reactions The Warnings and Precautions section of the labeling was updated November 2021 to include severe cutaneous adverse reactions. Example: Delzicol labeling Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Pancreatitis FDA determined that no action is necessary at the time based on available information. Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Anaphylactic shock The "Warnings and Precautions" section of the labeling was updated between September 2022 and February 2023 to include anaphylactoid/anaphylactic reactions. Example: Avastin labeling Ayvakit (avapritinib) Photosensitivity reaction The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2023 to include information about photosensitivity. Ayvakit labeling Azacitidine Onureg (azacitidine) Vidaza (azacitidine) Generic products containing azacitidine Pericarditis The "Adverse Reactions" section of the labeling was updated between September 2022 and June 2023 to include pericarditis. Example: Vidaza labeling FDA determined that no action is necessary at the time based on available information for Onureg. Bavencio (avelumab) Imfinzi (durvalumab) Libtayo (cemiplimab-rwlc) Keytruda (pembrolizumab) Opdivo (nivolumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) Tumour lysis syndrome FDA determined that no action is necessary at the time based on available information. Cymbalta (duloxetine hydrochloride) Drizalma Sprinkle (duloxetine hydrochloride) Generic products containing duloxetine hydrochloride Anosmia, Hyposmia This issue is posted as two individual newly identified safety signal (NISS) entries in the January-March 2022 quarter, to reflect the focus on the potential signals of anosmia and hyposmia, separately. Darzalex (daratumumab) Darzalex Faspro (daratumumab and hyaluronidase-fihj) Blood stem cell transplant failure FDA determined that no action is necessary at the time based on available information. Dipeptidyl peptidase-4 (DPP-4) inhibitors Glyxambi (empagliflozin and linagliptin) Janumet (metformin hydrochloride and sitagliptin phosphate) Janumet XR (metformin hydrochloride and sitagliptin phosphate) Jentadueto (linagliptin and metformin hydrochloride) Jentadueto XR (linagliptin and metformin hydrochloride) Kazano (alogliptin and metformin hydrochloride) Kombiglyze XR (metformin hydrochloride and saxagliptin) Nesina (alogliptin) Onglyza (saxagliptin) Oseni (alogliptin and pioglitazone) Steglujan (ertugliflozin and sitagliptin) Tradjenta (linagliptin) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Qtern (saxagliptin and dapagliflozin) Generic products containing dipeptidyl peptidase-4 inhibitors Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated between March 2022 and June 2022 for products containing alogliptin and sitagliptin to include tubulointerstitial nephritis. Example: Janumet labeling FDA determined that no action is necessary for products containing linagliptin and saxagliptin at the time based on available information. *An administrative error resulted in the omission of Januvia from the list of product names after the initial quarterly report was posted. Dupixent (dupilumab) Angioedema The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include angioedema. Dupixent labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua 100/33 (insulin glargine and lixisenatide injection) Trulicity (dulaglutide) Victoza (liraglutide) Wegovy (semaglutide) Xultophy 100/3.6 (insulin degludec and liraglutide injection) Generic products containing glucagon-like peptide-1 analogues Gallbladder related disorders The "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the GLP-1 analogues labeling were updated between March 2022 and June 2022 to include information about acute gallbladder disease. Example: Adlyxin labeling FDA has determined that the last approved labeling for Saxenda and Wegovy is adequately labeled for acute gallbladder disease, and that no further regulatory action is needed at this time. Gonadotropin releasing hormone (GnRH) analogues Fensolvi (leuprolide acetate) Lupron Depot-PED (leuprolide acetate) Supprelin LA (histrelin acetate) Synarel (nafarelin acetate) Triptodur (triptorelin) Idiopathic intracranial hypertension The "Warnings", "Precautions", and "Adverse Reactions" sections of the labeling were updated in April 2022 to include idiopathic intracranial hypertension. Example: Fensolvi labeling Jakafi (ruxolitinib phosphate) Herpes simplex virus (HSV) reactivation and/or disseminated HSV The "Dosage and Administration", "Warnings and Precautions", and "Adverse Reactions" sections of the labeling were updated in January 2023 to include information about herpes simplex and herpes zoster infections. Jakafi labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Embolic and thrombotic events, venous The "Adverse Reactions" section of the Ibrance labeling was updated in December 2024 to include venous thromboembolism. Ibrance labeling FDA determined that no action is necessary at the time for Kisqali and Kisqali Femara Co-Pack based on available information. Ocrevus (ocrelizumab) Myocardial infarction FDA determined that no action is necessary at the time based on available information. Potassium Chloride Product preparation error The “Warnings” section of the labeling was updated in December 2022 to include information about fatal cardiac adverse reactions with intravenous administration of undiluted potassium chloride. Praxbind (idarucizumab) Wrong dose errors The carton labeling and "Dosage and Administration" sections of the labeling were revised in February 2022 to clarify the number of vials included in each carton and the recommended dosing. Praxbind labeling Qbrexza (glycopyrronium tosylate) Accidental exposure to product The container label, carton labeling, "Dosage and Administration", "Warnings and Precautions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in October 2022 to include information about accidental exposure. Qbrexza labeling Qbrexza (glycopyrronium tosylate) Urinary retention The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in October 2022 to include information about new or worsening urinary retention. Qbrexza labeling Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Farxiga (dapagliflozin) Glyxambi (empagliflozin and linagliptin) Invokamet (canagliflozin and metformin hydrochloride) Invokamet XR (canagliflozin and metformin hydrochloride) Invokana (canagliflozin) Jardiance (empagliflozin) Qtern (saxagliptin and dapagliflozin) Steglatro (ertugliflozin) Steglujan (ertugliflozin and sitagliptin) Segluromet (ertugliflozin and metformin hydrochloride) Synjardy (empagliflozin and metformin hydrochloride) Synjardy XR (empagliflozin and metformin hydrochloride) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Xigduo XR (dapagliflozin and metformin) Generic products containing sodium-glucose cotransporter-2 (SGLT-2) inhibitors Tubulointerstitial nephritis FDA determined that no action is necessary at the time based on available information. Somatostatin Receptor Imaging Agents Detectnet (copper Cu-64 dotatate injection) Gallium Dotatoc (GA 68) Octreoscan (Indium In 111 Pentetreotide) Netspot (Gallium GA 68 Dotatate) Hypersensitivity The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include hypersensitivity reactions. Example: Netspot labeling Stromectol (ivermectin) Generic products containing ivermectin Off label use FDA determined that no action is necessary at the time based on available information. Stromectol (ivermectin) Generic products containing ivermectin Neurotoxicity The "Warnings", "Adverse Reactions", and "Overdosage" sections of the labeling were updated in March 2022 to include neurotoxicity. Example: Stromectol labeling Sunosi (solriamfetol hydrochloride) Hypersensitivity FDA determined that no action is necessary at the time based on available information. Vivitrol (naltrexone) Incorrect route of product administration The container label (vial), carton labeling, "Dosage and Administration", "Warnings and Precautions", and "Description", sections of the labeling were revised in September 2022 to emphasize the appropriate route and site of administration. Vivitrol labeling Xcopri (cenobamate) Psychiatric disorders The "Adverse Reactions" section of the labeling was updated in June 2022 to include psychiatric disorders. Xcopri labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Adcetris (brentuximab vedotin) Guillain-Barre syndrome FDA determined that no action is necessary at the time based on available information. Arzerra (ofatumumab) Gazyva (obinutuzumab) Riabni (rituximab-arrx) Rituxan (rituximab) Rituxan Hycela (rituximab and hyaluronidase human) Ruxience (rituximab-pvvr) Truxima (rituximab-abbs) Colitis FDA determined that no action is necessary at the time based on available information. Balversa (erdafitinib) Calciphylaxis The "Warnings and Precautions", "Patient Counseling Information", and the "Patient Information" sections of the labeling were updated in April 2022 to include information about soft tissue mineralization, including calciphylaxis. Balversa labeling Bavencio (avelumab) Keytruda (pembrolizumab) Opdivo (nivolumab) Yervoy (ipilimumab) Imfinzi (durvalumab) * Necrotizing fasciitis FDA determined that no action is necessary at this time based on available information. *An administrative error resulted in the omission of Imfinzi (durvalumab) from the list of product names. Imfinzi was added after the initial quarterly report was posted. Beta-blockers Betapace (sotalol hydrochloride) Brevibloc (esmolol hydrochloride) Bystolic (nebivolol) Byvalson (nebivolol and valsartan) Coreg (carvedilol) Coreg CR (carvedilol) Corgard (nadolol) Corzide (nadolol and bendroflumethiazide) Dutoprol (metoprolol succinate and hydrochlorothiazide) Kapspargo Sprinkle (metoprolol succinate) Lopressor HCT (metoprolol tartrate and hydrochlorothiazide) Sectral (acebutolol hydrochloride) Sotylize (sotalol hydrochloride) Tenoretic (atenolol and chlorthalidone) Toprol XL (metoprolol succinate) Trandate (labetalol hydrochloride) Ziac (bisoprolol fumarate and hydrochlorothiazide) Generic products containing beta-blockers Hemangeol (Propranolol Hydrochloride)* Inderal LA (Propranolol Hydrochloride)* Innopran XL (Propranolol hydrochloride)* Lopressor (metoprolol tartrate)* Tenormin (Atenolol)* Hypoglycemia in pediatric patients The "Warnings and Precautions" and "Patient Counseling Information" sections of the labeling were updated between March 2023 and June 2024 to add additional information regarding hypoglycemia. Example: Coreg labeling An administrative error resulted in the inclusion of Betapace AF, Levatol, and Zebeta in the list of product names at the time of the initial quarterly posting. *An administrative error resulted in the omission of Hemangeol, Inderal LA, Innopran XL, Lopressor, and Tenormin from the list of product names and was added after the initial quarterly report was posted. Bosulif (bosutinib monohydrate) Gleevec (imatinib mesylate) Iclusig (ponatinib) Sprycel (dasatinib) Tasigna (nilotinib) Osteonecrosis The "Adverse Reactions" section of the Tasigna labeling was updated in February 2024 to include information about osteonecrosis. Tasigna labeling FDA determined that Gleevec and Sprycel are adequately labeled for osteonecrosis, and that no further regulatory action is needed at this time. FDA determined no action is necessary at this time for Iclusig and Bosulif based on available information. Cablivi (caplacizumab-yhdp) Hemorrhage The "Warnings and Precautions", "Drug Interactions", and "Patient Counseling Information" sections of the labeling were updated in February 2022 to include information about life-threatening and fatal bleeding. Cablivi labeling Cyramza (ramucirumab) Cardiac failure The "Adverse Reactions" section of the labeling was updated in March 2022 to include information about heart failure. Cyramza labeling Doxil (doxorubicin hydrochloride) Acute interstitial pneumonitis FDA determined that no action is necessary at the time based on available information. Gleevec (imatinib mesylate) Tasigna (nilotinib) Myasthenia gravis FDA determined that no action is necessary at the time based on available information. Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (ribociclib; letrozole) Verzenio (abemaciclib) Radiation recall phenomenon FDA determined that no action is necessary at the time based on available information. Lokelma (sodium zirconium cyclosilicate) Gastrointestinal disorders FDA determined that no action is necessary at the time based on available information. Padcev (enfortumab vedotin-ejfv) Pancreatitis FDA determined that no action is necessary at the time based on available information. Padcev (enfortumab vedotin-ejfv) Pneumonitis The "Adverse Reactions", "Warnings and Precautions", and "Patient Counseling Information" sections of the labeling were updated in July 2021 to include information about pneumonitis. Padcev labeling Poteligeo (mogamulizumab-kpkc) Cytomegalovirus viraemia The "Adverse Reactions" section of the labeling was updated in March 2022 to include cytomegalovirus infection. Poteligeo labeling Procysbi (cysteamine bitartrate) Generic products containing cysteamine bitartrate Fibrosing colonopathy The "Warnings and Precautions", "Adverse Reactions", "Patient Information", and "Patient Counseling Information" sections of the labeling were updated in February 2022 to include information about fibrosing colonopathy. Example: Procysbi labeling Sarclisa (isatuximab-irfc) Herpes zoster The "Dosage and Administration", "Adverse Reactions", and "Patient Information" sections of the labeling were updated in July 2022 to include information about herpes zoster. Sarclisa labeling Sprycel (dasatinib) Drug-induced liver injury The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information” and “Patient Information” sections of the labeling were updated in February 2023 to include information about hepatotoxicity. Sprycel labeling Taxotere (docetaxel) Rhabdomyolysis FDA determined that no action is necessary at the time based on available information. Veklury (remdesivir) Bradycardia FDA determined that no action is necessary at the time based on available information. Zepzelca (lurbinectedin) Extravasation The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in April 2022 to include information about extravasation. Zepzelca labeling Zepzelca (lurbinectedin) Tumor lysis syndrome The “Adverse Reactions” section of the labeling was updated in April 2022 to include tumor lysis syndrome. Zepzelca labeling Zepzelca (lurbinectedin) Rhabdomyolysis The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Patient Information” sections of the labeling were updated in April 2022 to include rhabdomyolysis. Zepzelca labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.