Baxter Healthcare Corporation DOCETAXEL- …

1 DOCETAXEL- docetaxel injection , solution Baxter Healthcare Corporation ----------HIGHLIGHTS OF PRESCRIBING INFORMATIONT hese highlights do not include all the information needed to use DOCETAXEL injection safely andeffectively. See full prescribing information for DOCETAXEL injection , Solution for Intravenous Infusion (IV)Initial Approval: 1996 WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS,and FLUID RETENTIONSee full prescribing information for complete boxed warning INDICATIONS AND USAGEDoce taxe l Inje ction is a microtubule inhibitor indicate d for: DOSAGE AND ADMINISTRATIONA dminis te r in a facility e quippe d to manage pos s ible complications (e .g., anaphylaxis ). Adminis te r intrave nous ly (IV) ove r1 hr e ve ry 3 we e ks . PVC e quipme nt is not re comme nde d. Treatment-related mortality increases with abnormal liver function, at higher doses, and in patientswith NSCLC and prior platinum-based therapy receiving docetaxel at 100 mg/m ( )2 Should not be given if bilirubin > ULN, or if AST and/or ALT > ULN concomitant with alkalinephosphatase > ULN.

2 LFT elevations increase risk of severe or life-threatening LFTs before each treatment cycle ( )Should not be given if neutrophil counts are <1500 cells/mm. Obtain frequent blood counts tomonitor for neutropenia (4)3 Severe hypersensitivity, including very rare fatal anaphylaxis, has been reported in patients whoreceived dexamethasone premedication. Severe reactions require immediate discontinuation ofDocetaxel injection and administration of appropriate therapy ( )Contraindicated if history of severe hypersensitivity reactions to docetaxel or to drugs formulatedwith polysorbate 80 (4)Severe fluid retention may occur despite dexamethasone ( )Breast Cancer (BC): s ingle age nt for locally advance d or me tas tatic BC afte r che mothe rapy failure ; and withdoxorubicin and cyclophos phamide as adjuvant tre atme nt of ope rable node -pos itive BC ( )Non-Small Cell Lung Cancer (NSCLC): s ingle age nt for locally advance d or me tas tatic NSCLC afte r platinumthe rapy failure.

3 And with cis platin for unre s e ctable , locally advance d or me tas tatic untre ate d NSCLC ( )Hormone Refractory Prostate Cancer (HRPC): with pre dnis one in androge n inde pe nde nt (hormone re fractory)me tas tatic pros tate cance r ( )Gastric Adenocarcinoma (GC): with cis platin and fluorouracil for untre ate d, advance d GC, including thegas troe s ophage al junction ( )Squamous Cell Carcinoma of the Head and Neck Cancer (SCCHN): with cis platin and fluorouracil for inductiontre atme nt of locally advance d SCCHN ( )BC locally advance d or me tas tatic: 60 mg/m to 100 mg/m s ingle age nt ( )22BC adjuvant: 75 mg/m adminis te re d 1 hour afte r doxorubicin 50 mg/m and cyclophos phamide 500 mg/m e ve ry 3we e ks for 6 cycle s ( )222 NSCLC: afte r platinum the rapy failure : 75 mg/m s ingle age nt ( )2 NSCLC: che mothe rapy-naive : 75 mg/m followe d by cis platin 75 mg/m ( )22 HRPC: 75 mg/m with 5 mg pre dnis one twice a day continuous ly ( )2GC: 75 mg/m followe d by cis platin 75 mg/m (both on day 1 only) followe d by fluorouracil 750 mg/m pe r day as a24-hr intrave nous infus ion (days 1-5), s tarting at e nd of cis platin infus ion ( )222 SCCHN: 75 mg/m followe d by cis platin 75 mg/m intrave nous ly (day 1), followe d by fluorouracil 750 mg/m pe r dayas a 24-hr intrave nous infus ion (days 1-5), s tarting at e nd of cis platin infus ion.

4 For 4 cycle s ( )222 For all patients: DOSAGE FORMS AND STRENGTHSM ultiple dos e vial 20 mg/2 mL, 80 mg/8 mL and 160 mg/16 mL (3)CONTRAINDICATIONS WARNINGS AND PRECAUTIONS ADVERSE REACTIONSMos t common adve rs e re actions acros s all doce taxe l indications are infe ctions , ne utrope nia, ane mia, fe brile ne utrope nia,hype rs e ns itivity, thrombocytope nia, ne uropathy, dys ge us ia, dys pne a, cons tipation, anore xia, nail dis orde rs , fluid re te ntion,as the nia, pain, naus e a, diarrhe a, vomiting, mucos itis , alope cia, s kin re actions , myalgia (6)To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or INTERACTIONS See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient : 12/2017 FULL PRESCRIBING INFORMATION: CONTENTS*1. INDICATIONS AND Breast Non-Small Cell Lung Prostate Gastric Head and Neck Cancer2.

5 DOSAGE AND Breast Non-Small Cell Lung Prostate Gastric Head and Neck CancerSCCHN: 75 mg/m followe d by cis platin 100 mg/m IV (day 1), followe d by fluorouracil 1000 mg/m pe r day as a 24-hr IV (days 1-4); for 3 cycle s ( )222 Pre me dicate with oral corticos te roids ( )Adjus t dos e as ne e de d ( )Hype rs e ns itivity to doce taxe l or polys orbate 80 (4)Ne utrophil counts of < 1500 ce lls /mm (4)3 Acute mye loid le uke mia: In patie nts who re ce ive d doce taxe l, doxorubicin and cyclophos phamide , monitor forde laye d mye lodys plas ia or mye loid le uke mia ( )Cutane ous re actions : Re actions including e rythe ma of the e xtre mitie s with e de ma followe d by de s quamation mayoccur. Se ve re s kin toxicity may re quire dos e adjus tme nt ( )Ne urologic re actions : Re actions including pare s the s ia, dys e s the s ia, and pain may occur. Se ve re ne uros e ns orys ymptoms re quire dos e adjus tme nt or dis continuation if pe rs is te nt.

6 ( )As the nia: Se ve re as the nia may occur and may re quire tre atme nt dis continuation. ( )Alcohol conte nt: T he alcohol conte nt in a dos e of Doce taxe l Inje ction may affe ct the ce ntral ne rvous s ys te m. T hismay include impairme nt of a patie nt s ability to drive or us e machine s imme diate ly afte r infus ion. ( )Pre gnancy: Fe tal harm can occur whe n adminis te re d to a pre gnant woman. Wome n of childbe aring pote ntial s houldbe advis e d not to be come pre gnant whe n re ce iving Doce taxe l Inje ction ( , )Cytochrome P450 3A4 induce rs , inhibitors , or s ubs trate s : May alte r doce taxe l me tabolis m. (7) Premedication Dosage Adjustments During T Administration Preparation and Stability3. DOSAGE FORMS AND STRENGTHS4. CONTRAINDICATIONS5. WARNINGS AND T oxic Hepatic Hematologic Hypersensitivity Fluid Acute Myeloid Cutaneous Neurologic Eye Alcohol Use in Pregnancy6.

7 ADVERSE Clinical T rial Post-Marketing Experiences7. DRUG INTERACTIONS8. USE IN SPECIFIC Nursing Pediatric Geriatric Hepatic Impairment10. OVERDOSAGE11. DESCRIPTION12. CLINICAL Mechanism of Human Pharmacokinetics13. NONCLINICAL Carcinogenesis, Mutagenesis, Impairment of Fertility14. CLINICAL Locally Advanced or Metastatic Breast Adjuvant T reatment of Breast Non-Small Cell Lung Cancer (NSCLC) Hormone Refractory Prostate Gastric Head and Neck Cancer15. REFERENCES16. HOW SUPPLIED/STORAGE AND How Handling and Disposal17. PATIENT COUNSELING INFORMATION*Sectio ns o r subsectio ns o mitted fro m the full prescribing info rmatio n are no t PRESCRIBING INFORMATIONWARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA,HYPERSENSITIVITY REACTIONS, and FLUID RETENTIONThe incidence of treatment-related mortality associated with docetaxel therapy is increasedin patients with abnormal liver function, in patients receiving higher doses, and in patientswith non-small cell lung carcinoma and a history of prior treatment with platinum-basedchemotherapy who receive docetaxel as a single agent at a dose of 100 mg/m[see Warningand Precautions ( )].

8 Docetaxel injection should not be given to patients with bilirubin > upper limit of normal(ULN), or to patients with AST and/or ALT > x ULN concomitant with alkalinephosphatase > x ULN. Patients with elevations of bilirubin or abnormalities oftransaminase concurrent with alkaline phosphatase are at increased risk for thedevelopment of grade 4 neutropenia, febrile neutropenia, infections, severethrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Patients withisolated elevations of transaminase > x ULN also had a higher rate of febrile neutropeniagrade 4 but did not have an increased incidence of toxic death. Bilirubin, AST or ALT, andalkaline phosphatase values should be obtained prior to each cycle of Docetaxel Injectiontherapy [see Warning and Precautions ( )]. Docetaxel injection therapy should not be givento patients with neutrophil counts of <1500 cells/mm. In order to monitor the occurrenceof neutropenia, which may be severe and result in infection, frequent blood cell countsshould be performed on all patients receiving Docetaxel injection [see Warning andPrecautions ( )].

9 Severe hypersensitivity reactions characterized by generalized rash/erythema, hypotensionand/or bronchospasm, or very rarely fatal anaphylaxis, have been reported in patients whoreceived a 3-day dexamethasone premedication. Hypersensitivity reactions requireimmediate discontinuation of the Docetaxel injection infusion and administration ofappropriate therapy [see Warning and Precautions ( )]. Docetaxel injection must not begiven to patients who have a history of severe hypersensitivity reactions to docetaxel or toother drugs formulated with polysorbate 80 [see Contraindications (4)].Severe fluid retention occurred in (6/92) of patients despite use of a 3-daydexamethasone premedication regimen. It was characterized by one or more of thefollowing events: poorly tolerated peripheral edema, generalized edema, pleural effusionrequiring urgent drainage, dyspnea at rest, cardiac tamponade, or pronounced abdominaldistention (due to ascites) [see Warning and Precautions ( )].

10 1. INDICATIONS AND Breast CancerDocetaxel injection is indicated for the treatment of patients with locally advanced or metastatic breastcancer after failure of prior injection in combination with doxorubicin and cyclophosphamide is indicated for the adjuvanttreatment of patients with operable node-positive breast Non-Small Cell Lung CancerDocetaxel injection as a single agent is indicated for the treatment of patients with locally advanced or23metastatic non-small cell lung cancer after failure of prior platinum-based injection in combination with cisplatin is indicated for the treatment of patients withunresectable, locally advanced or metastatic non-small cell lung cancer who have not previouslyreceived chemotherapy for this Prostate CancerDocetaxel injection in combination with prednisone is indicated for the treatment of patients withandrogen independent (hormone refractory) metastatic prostate Gastric AdenocarcinomaDocetaxel injection in combination with cisplatin and fluorouracil is indicated for the treatment ofpatients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophagealjunction, who have not received prior chemotherapy for advanced Head and Neck CancerDocetaxel injection in combination with cisplatin and fluorouracil is indicated for the inductiontreatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).