Reaction started with fever and nausea, followed by numbness, tingling, and pain from head to toe. This includes breast cancer, head and neck cancer, stomach cancer, prostate cancer and non-small-cell lung cancer. 2600 0 obj <>stream 1501 0 obj <> endobj %PDF-1.7 %���� 1530 0 obj <>stream Platelets <50,000/cubic millimeters (mm^3) Hemoglobin <=9 grams per deciliter (g/dL) Absolute neutrophil count (ANC) <1.5 times 10^9/L (neutropenia >= Grade 2) In the three-arm monotherapy trial, TAX313, which compared TAXOTERE 60 mg/m 2, 75 mg/m 2 and 100 mg/m 2 in advanced breast cancer, grade 3/4 or severe adverse reactions occurred in 49.0% of patients treated with TAXOTERE 60 mg/m 2 compared to 55.3% and 65.9% treated with 75 mg/m 2 and 100 mg/m 2 respectively. 0 endstream endobj startxref Table 1 Recommended Dose Modifications for Persistent and Intolerable Grade 2 or Grade 3 Adverse Reactions or Grade 4 Laboratory Abnormalities. Adverse Reaction Modification Participating in other drug clinical trials, including for COVID-19. hÞb```b``vg`a``yÌÀǀ |@1ä8 ä0022€˜3æ000Übˆ`QPf8Ç=…A@ºa ÓMùƦ¼!I_Ù3µ0MPpXÈ8…mÁÔgÏ €[äMÂ*fí¹øÙ5¯sõÁ!B`//ïèè`)/¯èèh0qÔÁ$2™ÇEf³#‰°cèE–ÇWÇ0ӇD=™‘Œ)FÞ àtJ ÂÀËÍ1U‡çAZˑõF&û'œ`nŒ* @š‘MH‡20vìðú€ØQ«bfœXœåŠ``œù¢ŒÑ À ŠO r In Study 1 and 2, the median time to first episode of any grade neutropenia was 15 days and the median duration of Grade ≥3 neutropenia was 7 days [see Adverse Reactions (6.1)]. a . patients with Grade 4 clinical adverse reactions that resolve. h��X�O�F�W��*�}?�R �!�Z*Y�`���8rL�}g֏����V���������ff�+�%\i?� ���8��"�Z$41��0�1�-aLx��=�2�0� R(��'�9�H��s%�Lz Prolonged (>1 week) recovery from grade 3 or recurrent grade 3 neutropenia in subsequent cycles: Consider dose reduction; Grade 3 ANC (1000 to 500/mm³) + fever ≥38.5ºC and/or infection: Withhold drug until recovery to grade ≤2 (≥1000/mm³); resume at next lower dose �1�)M8מ�iP��0=��ki)0)F�����DX�sXA���$+�r�RD2��X ����¢dk L湎H�Q��x��,j�8Qܯv(��$J�U:E`Q���{�!�J��%�kO9�`s�}��z5�����UZ�R���>0΂�,_����i�G���eIp��q8!������o�eA�c����tV�IYp��'��}A��4)��q���y|��� ��eqp�=�{hd��`0"���x�W�"Y�'�\d�x���ٕg]��%��i������F�I. Permanently discontinue LIBTAYO for hÞ¤”_oÚ0À¿Ê=¶Ô‚GªVi´haë$ăG¼-$(1ýö;;­Œ Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5 times ULN. R’$. 2.3 Dose Modifications for Adverse Reactions 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Severe Hypersensitivity 5.2 Severe Cutaneous Reactions 5.3 Hyperglycemia 5.4 Pneumonitis 5.5 Diarrhea 5.6 Embryo-Fetal Toxicity 6 ADVERSE REACTIONS 6.1 Clinical Trial Experience 7 DRUG INTERACTIONS Event with a reasonable possibility of drug related causality. Grade 3 severe skin reactions or suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) ... Any other Grade 2 or 3 immune-mediated adverse reaction, based on the severity and type of reaction; ... 3: This drug is available at a higher level co-pay. endstream endobj 1502 0 obj <>/Metadata 86 0 R/OCProperties<>/OCGs[1518 0 R]>>/Outlines 118 0 R/PageLabels 1493 0 R/PageLayout/SinglePage/Pages 1495 0 R/PieceInfo<>>>/StructTreeRoot 181 0 R/Type/Catalog>> endobj 1503 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageC/ImageI]/Properties<>/XObject<>>>/Rotate 90/StructParents 0/Type/Page>> endobj 1504 0 obj <>stream %%EOF An ‘Em dash’ (—) indicates a grade not available. endstream endobj startxref �� &"I���Y �gX����TqRRqqKqq1qtw���5q}�s��\�W���X�Z�M��4��2�p�P>�5��Ij�C�8�Їʇ�[�W;YmQ\qK��l s�F���a�F��f�/#�,8�������rki0k�`n`�`�` ��(A������\ H��c�ZLլ���@�r�E��l��}��XX{���z���ț�Mk�+�Ff}Hpx1pdYiI��;�HHe��� �/ F%p� h�b```����B ��ea��`bl@gpa`H8��p7������,������p� \�R�Xf`k &Ś�p���%� Therefore, some AEs are listed with fewer than five options for Grade I had to be hospitalized (and missed two weeks of work and accumulated $1000s in medical bills) after my first shingles vaccine. The most common adverse reaction with HUMIRA was injection site reactions. 2560 0 obj <>/Filter/FlateDecode/ID[<69ED06D186C5064DB72B8F3FA0AB87A0><2DC91CF216547C43BE69979FF5273C4C>]/Index[2539 62]/Info 2538 0 R/Length 109/Prev 592601/Root 2540 0 R/Size 2601/Type/XRef/W[1 3 1]>>stream Not all Grades are appropriate for all AEs. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Also double vision and loss of balance. %%EOF It may be used by itself or along with other chemotherapy medication. Docetaxel (DTX or DXL), sold under the brand name Taxotere among others, is a chemotherapy medication used to treat a number of types of cancer. h±ÌïÎçóùL0 ˜`!øJNA:ɀ¡ n½Vñ€IÏ*]àLXE ïúVñÁ£N @pi ¡ïÌÁ‚îïÉ£Zë›H-§U¹-’[2{Ùhò4“oµJ5FLQs½Ö…ÁU¼ýilD4î¹Ïœ‘ªub+bXö×ڊDïShMÀ…­ñ3~{Æ/Þò»Ö0ß¹ñOSø¥ò/: #q¿]Æ w”7MîÌ86ÊhRn¯‡{ûõ[!d 6Ÿu–®L’Oºñt8cd”«´Æv“QY˜(*wóŽð)t¼ Ÿ„ |MJéÂyGjå/7ý*Sù­³ØG!n݉Ê. 0 2.3 Dosage Modifications for Adverse Reactions No dose reduction for LIBTAYO is recommended. It is given by slow injection into a vein. 101²‚X )’‰ÿ¸¿ KŽ* 30 minutes every 3 weeks until disease progression or unacceptable toxicity. h�bbd```b``�"g�H�� ��D�o�k�H&��3`�� ���� �]f'��U`r;��x$O���73@"^< ��H��7a`bd�� M����� �A� 1517 0 obj <>/Filter/FlateDecode/ID[<84D2AE15CBADF2D41856F30DC5984FDE><21CC0ED702776540AD4E52FA9272A32D>]/Index[1501 30]/Info 1500 0 R/Length 78/Prev 93419/Root 1502 0 R/Size 1531/Type/XRef/W[1 2 1]>>stream 2539 0 obj <> endobj In general, withhold LIBTAYO for severe (Grade 3) immune-mediated adverse reactions. hÞbbd``b` Œ1@‚é(ˆ»Dü‰CÄ$‹Hð­Üm .œX Most commonly, these are "non-preferred" brand drugs. %PDF-1.5 %âãÏÓ endstream endobj 2540 0 obj <>/Metadata 99 0 R/Pages 2537 0 R/StructTreeRoot 133 0 R/Type/Catalog/ViewerPreferences 2561 0 R>> endobj 2541 0 obj <>/MediaBox[0 0 612 792]/Parent 2537 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 2542 0 obj <>stream Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE A Semi-colon indicates ‘or’ within the description of the grade.
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