YOUR LIFE. First-line nd Mintennce Tretment with ALIMTA therpy for dvnced nonsqumous non-smll cell lung cncer (NSCLC) ALIMTA is pproved by the FDA in combintion with cispltin (nother chemotherpy drug) for the initil tretment of dvnced nonsqumous non-smll cell lung cncer (NSCLC), specific type of NSCLC. ALIMTA is pproved by the FDA for the tretment of ptients with dvnced nonsqumous non-smll cell lung cncer (NSCLC), specific type of NSCLC, to mintin the effect of initil tretment with chemotherpy nd whose disese hs not worsened. ALIMTA is not indicted for ptients who hve different type of NSCLC clled squmous cell. ALIMTA cn suppress bone mrrow function, which my cuse low blood cell counts. For more informtion bout the sfety profile of ALIMTA, plese see the Importnt Sfety Informtion on pges 4-44, the ccompnying Ptient Prescribing Informtion nd Prescribing Informtion, visit www.alimta.com, or cll -8-545-5979. You re encourged to report negtive side effects of prescription drugs to the FDA. Visit www.fd.gov/medwtch, or cll -8-FDA-88.
Tble of Contents Introduction 2 Wht is ALIMTA (pemetrexed for injection)? 3 Histology (cncer cell types) 4 Your tretment pln 5 First-line therpy 9 How is your tretment given? Side effects 3 Mintennce therpy 23 How is your tretment given? 25 Side effects 28 Frequently sked questions 38 Your helthcre tem 39 Importnt Sfety Informtion for ALIMTA 4 ALIMTA (pemetrexed for injection) cn suppress bone mrrow function, which my cuse low blood cell counts. Resources 46 For more informtion bout the sfety profile of ALIMTA, plese see the Importnt Sfety Informtion on pges 4-44, the ccompnying Ptient Prescribing Informtion nd Prescribing Informtion, visit www.alimta.com, or cll -8-545-5979. You re encourged to report negtive side effects of prescription drugs to the FDA. Visit www.fd.gov/medwtch, or cll -8-FDA-88. www.alimta.com -8-545-5979
Introduction Like mny people living with cncer, you re probbly deling with issues tht you hve never fced before. And it is norml if you re worried bout the new chllenges tht lie hed. Your doctor hs chosen ALIMTA (pemetrexed for injection) becuse it is tretment specificlly prescribed for your type of cncer. If you hve just lerned tht you hve dvnced nonsqumous non-smll cell lung cncer (NSCLC), you my receive ALIMTA nd cispltin (nother chemotherpy drug) s first-line therpy. If you hve lredy received first-line chemotherpy for your lung cncer, your doctor my prescribe mintennce therpy with ALIMTA. Mintennce therpy is the continued tretment with cncer mediction for ptients whose cncer hs not spred or grown fter first-line tretment. Whether you re receiving first-line or mintennce tretment, know tht your helthcre tem is there for you, nd you should feel comfortble tlking with them. By working together with them sking questions, tlking bout side effects you might be experiencing, nd understnding your options you cn help your tem understnd how your tretment is going. This guide includes specific sections bout ALIMTA tretment. See pges 9-2 (blue section) to lern bout first-line therpy with ALIMTA nd possible side effects. For informtion on mintennce therpy with ALIMTA nd side effects, see pges 23-35 (green section). The rest of the guide hs informtion for ll ptients on ALIMTA therpy (pges 3-7, 37-44), including resources for ptients nd cregivers on pges 46-47. 2 www.alimta.com Wht is ALIMTA (pemetrexed for injection)? ALIMTA (lso known s pemetrexed) is n injectble chemotherpy or nticncer drug. Chemotherpy is tretment with one or more nticncer drugs tht re intended to kill cncer cells. ALIMTA is used to tret certin kind of lung cncer clled dvnced nonsqumous NSCLC. We ll explin wht tht mens in the next section. ALIMTA ppers to work by interfering with very importnt process tht llows cncer cells to reproduce nd spred. For more informtion bout the sfety profile of ALIMTA, plese see the Importnt Sfety Informtion on pges 4-44, the ccompnying Ptient Prescribing Informtion nd Prescribing Informtion, visit www.alimta.com, or cll -8-545-5979. -8-545-5979 3
Histology (cncer cell types) Why does it mtter to you? Tumors re groups of cells tht divide more thn they should or do not die when they should. Tumors differ in the wy they look, the types of cells they hve, nd how they grow. These differences cn llow helthcre professionls to identify specific types of lung cncer. Decisions bout your tretment cn be mde bsed on tht informtion. The specific types of cells tht mke up your tumor re known s your tumor s histology. Within non-smll cell lung cncer (NSCLC), the two mjor groups re nonsqumous (which includes the subtypes denocrcinom, lrge cell crcinom, nd other cell types) nd squmous cell crcinom. Reserch hs shown tht there is connection between histology nd the effectiveness of ALIMTA (pemetrexed for injection) in NSCLC. Knowing the histology of your tumor hs llowed your helthcre tem to offer therpy specificlly prescribed for your type of cncer. They my hve lredy discussed this informtion with you. If not, feel free to spek with your oncologist bout your specific type of histology. Reference. Scgliotti GV, et l. J Clin Oncol. 28;26(2):3543-355. Your tretment pln Wht do you need to know? You re receiving ALIMTA for the tretment of your specific type of lung cncer. Before you begin therpy, it is importnt for you to do some things to help you get redy for your tretment. If you re unsure bout ny of the following sfety informtion, be sure to sk your helthcre tem. Working with your tem is very importnt during your course of therpy. If you know you re llergic to ALIMTA, tell your doctor becuse you should not receive it. If you think you re pregnnt, re plnning to become pregnnt, or re nursing, plese tell your helthcre tem. ALIMTA my hrm your unborn or nursing bby. Your physicin my tell you to use contrception (birth control) to prevent pregnncy while you re being treted with ALIMTA. Beginning 7 dys before you strt tking ALIMTA, you will need to tke folic cid pill ( type of B vitmin) once per dy to lower your risk of certin hrmful side effects. Your helthcre tem will tell you exctly wht to tke; the recommended mount is between 4 nd mcg ech dy. You will continue to tke folic cid pill every dy until 2 dys fter your lst dose of ALIMTA. (continues on next pge) For more informtion bout the sfety profile of ALIMTA, plese see the Importnt Sfety Informtion on pges 4-44, the ccompnying Ptient Prescribing Informtion nd Prescribing Informtion, visit www.alimta.com, or cll -8-545-5979. 4 www.alimta.com -8-545-5979 5
Your tretment pln Wht do you need to know? (continued) Your helthcre tem will give you shot (into muscle) of vitmin B 2 one week before you strt ALIMTA (pemetrexed for injection) to lower your risk of certin hrmful side effects. Your helthcre tem will then give you shot pproximtely every 9 weeks, most likely on the sme dy tht you receive your ALIMTA chemotherpy, for the rest of your tretment cycles. To help your helthcre tem effectively oversee your tretment, mke sure you tell them bout ll of your medicl conditions. If you hve liver or kidney problems, be sure to tell this to your helthcre tem. Your dose of ALIMTA my hve to be chnged, or ALIMTA my not be right for you. Tell your helthcre tem if you re tking other medicines, including prescription nd nonprescription medicines, vitmins, nd herbl supplements. ALIMTA nd other medictions my ffect ech other, cusing serious side effects (like rsh). If you re tking nonsteroidl nti-inflmmtory drug (n NSAID, like ibuprofen, or other drugs used to tret pin nd rthritis conditions), you should mke sure to tell your helthcre tem. Depending on your sitution, you my be sked to stop tking these for period of time. You will be given n orl steroid mediction clled corticosteroid to lower the risk of skin-relted side effects (like rsh). Be sure to tke this drug twice dily on the dy before, the dy of, nd the dy fter tretment, unless your helthcre tem gives you different instructions. This booklet contins dditionl importnt informtion on the sfety profile nd side effects of ALIMTA therpy tht you must be wre of. Plese see the Importnt Sfety Informtion for ALIMTA nd Side effects sections in this booklet. For more informtion bout the sfety profile of ALIMTA, plese see the Importnt Sfety Informtion on pges 4-44, the ccompnying Ptient Prescribing Informtion nd Prescribing Informtion, visit www.alimta.com, or cll -8-545-5979. 6 www.alimta.com -8-545-5979 7
First-line therpy for dvnced nonsqumous non-smll cell lung cncer ALIMTA (pemetrexed for injection) is pproved by the FDA in combintion with cispltin (nother chemotherpy drug) for the initil tretment of dvnced nonsqumous non-smll cell lung cncer (NSCLC), specific type of NSCLC. ALIMTA is pproved by the FDA for the tretment of ptients with dvnced nonsqumous non-smll cell lung cncer (NSCLC), specific type of NSCLC, to mintin the effect of initil tretment with chemotherpy nd whose disese hs not worsened. ALIMTA is not indicted for ptients who hve different type of NSCLC clled squmous cell. ALIMTA cn suppress bone mrrow function, which my cuse low blood cell counts. For more informtion bout the sfety profile of ALIMTA, plese see the Importnt Sfety Informtion on pges 4-44, the ccompnying Ptient Prescribing Informtion nd Prescribing Informtion, visit www.alimta.com, or cll -8-545-5979. -8-545-5979 9
First-line therpy If you hve just lerned tht you hve dvnced nonsqumous non-smll cell lung cncer (NSCLC), your doctor my prescribe ALIMTA (pemetrexed for injection) in combintion with cispltin ( pltinumcontining chemotherpy drug) s first-line therpy to tret your cncer. First-line therpy is the first tretment you will receive for cncer fter you hve been dignosed. During your first-line tretment, your helthcre tem my discuss further tretment options, including continuing tretment with ALIMTA lone (continution mintennce) if you re eligible. st-line nd Mintennce Therpy With ALIMTA For Advnced Nonsqumous NSCLC How is your tretment given? ALIMTA should be given to you only by qulified helthcre professionl. Your helthcre tem will prepre ALIMTA by mixing it into solution nd giving it to you through needle into vein this is clled n intrvenous (IV) infusion. Cispltin will lso be given to you through n IV. Your first-line tretment with ALIMTA plus cispltin will be given usully once every 2 dys (3 weeks equl tretment cycle). ALIMTA Plus Cispltin Tretment Administrtion 3 minute brek Strt Initil Tretment ALIMTA Pltinum Agent Cispltin Mintennce Eligibility* ALIMTA ALIMTA will be given to you s -minute IV infusion. Cispltin will be given to you s 2-hour IV infusion. After these two infusions, you will not be given ny more chemotherpy for the next 2 dys. These rest dys re norml prt of your tretment with ALIMTA. (continues on next pge) Mintennce Discussion * Tlk to your doctor bout whether you re eligible for mintennce tretment fter receiving ALIMTA plus cispltin. The following sections will give you informtion on how first-line therpy with ALIMTA plus cispltin is given nd the possible side effects you my experience. For more informtion bout the sfety profile of ALIMTA, plese see the Importnt Sfety Informtion on pges 4-44, the ccompnying Ptient Prescribing Informtion nd Prescribing Informtion, visit www.alimta.com, or cll -8-545-5979. www.alimta.com -8-545-5979
First-line therpy How is your tretment given? (continued) As prt of your tretment, you will lso receive dditionl medictions (including vitmin B 2, folic cid, nd corticosteroids) to help reduce hrmful side effects. You will hve regulr blood tests before nd during your tretment with ALIMTA (pemetrexed for injection). Your doctor my djust your dose of ALIMTA or dely tretment bsed on the results of your blood tests nd on your generl condition, including ny side effects tht you my hve hd. Your helthcre tem my sk you to come bck for follow-up visits fter you receive ALIMTA therpy so they cn check on how you re doing. It s importnt to tlk bout how you re feeling nd bout ny side effects you might be experiencing. Your helthcre tem needs this informtion from you so tht they cn monitor how your tretment is going. If you hve questions bout how ALIMTA is given, plese be sure to discuss them with your helthcre tem. For more informtion bout the sfety profile of ALIMTA, plese see the Importnt Sfety Informtion on pges 4-44, the ccompnying Ptient Prescribing Informtion nd Prescribing Informtion, visit www.alimta.com, or cll -8-545-5979. First-line therpy Side effects Wht should you expect? Chemotherpy Side effects from chemotherpy re different depending on the type of cncer you hve nd the combintion of drugs you re given. Side effects my lso be different from ptient to ptient nd from tretment to tretment. This section discusses the most frequent nd/or most serious side effects tht ptients experienced in the clinicl tril tht studied ALIMTA plus cispltin for dvnced non-smll cell lung cncer (NSCLC). Side effects from chemotherpy should be wtched crefully both by you nd your helthcre tem. Ftigue (tiredness), nuse, nd vomiting re few exmples. Another group of side effects, such s those tht chnge your blood cell counts, re monitored through regulr blood tests, but they cn lso be identified through signs nd symptoms you might notice. We will discuss some of these in the following pges. Side effects cn be serious, but most cn be treted. Though few side effects cn be permnent, mny lst only for short time nd go wy fter the tretment dose is lowered or stopped. You re encourged to report negtive side effects of prescription drugs to the FDA. Visit www.fd.gov/ medwtch, or cll -8-FDA-88. (continues on next pge) 2 www.alimta.com -8-545-5979 3
First-line therpy Side effects Wht should you expect? (continued) ALIMTA (pemetrexed for injection) in combintion with cispltin Most ptients tking ALIMTA plus cispltin will hve side effects. For the purpose of this booklet, we will discuss some of the most common nd/or most serious side effects tht my hppen if you tke ALIMTA plus cispltin for the first-line tretment of dvnced nonsqumous non-smll cell lung cncer (NSCLC). It is not lwys possible to tell whether ALIMTA, cispltin, nother mediction, or the cncer itself is cusing these side effects. You should lwys tell your helthcre tem if you re experiencing nything new. Cll your helthcre tem right wy if you hve fever, chills, dirrhe, or mouth sores. These symptoms could men you hve n infection, which my be severe nd could led to deth. For more informtion bout ll of the side effects noted in the clinicl tril of ALIMTA plus cispltin for dvnced NSCLC, plese tlk with your helthcre tem, see the Ptient Prescribing Informtion nd Prescribing Informtion ccompnying this booklet, visit www.alimta.com, or cll -8-545-5979. You re encourged to report negtive side effects of prescription drugs to the FDA. Visit www.fd.gov/ medwtch, or cll -8-FDA-88. 4 www.alimta.com Side effects tht you nd your helthcre tem should wtch for Before nd during your tretment with ALIMTA plus cispltin, you will hve regulr blood tests to llow your helthcre tem to wtch for low blood cell counts. You my lso hve dditionl symptoms tht you must tell your helthcre tem bout. Some of these side effects nd symptoms re described in the next sections. The side effects of ALIMTA plus cispltin for first-line therpy were studied in clinicl tril. Frequent nd/or serious side effects from this tril re presented in the sections below. Low white blood cell count (neutropeni/leukopeni) White blood cells (leukocytes) help you fight infection. A low white blood cell count is clled leukopeni. Neutrophils re type of white blood cell, nd when your count is low, you hve neutropeni. During this time, you re more likely to develop n infection, nd you should void crowds nd those with colds. You should cll your helthcre tem right wy if you hve ny signs of infection, such s chills or temperture over.4 F. In the first-line clinicl tril, 29 percent of ptients on ALIMTA plus cispltin hd neutropeni, nd 8 percent hd leukopeni. (continues on next pge) For more informtion bout the sfety profile of ALIMTA, plese see the Importnt Sfety Informtion on pges 4-44, the ccompnying Ptient Prescribing Informtion nd Prescribing Informtion, visit www.alimta.com, or cll -8-545-5979. -8-545-5979 5
First-line therpy Side effects tht you nd your helthcre tem should wtch for (continued) Low red blood cell count (nemi) Red blood cells help crry oxygen from your lungs to the other prts of your body. A low red blood cell count is clled nemi. If your red blood cell count is low, you my feel tired, get tired esily, pper ple, nd become short of breth. In the first-line clinicl tril, 33 percent of ptients on ALIMTA (pemetrexed for injection) plus cispltin hd nemi. Low pltelet count (thrombocytopeni) Pltelets help your blood to clot. A low pltelet count puts you t more risk for bleeding. If your helthcre tem tells you tht you hve low pltelet count, you my be sked to tke some precutions, including voiding injury, voiding constiption, using soft-bristle toothbrush, etc. It is importnt tht you cll your helthcre tem if you see ny signs of bleeding, such s unexplined bruising or blood in your stool (blck, trry stools). In the first-line clinicl tril, percent of ptients on ALIMTA plus cispltin hd low pltelet count. Additionl side effects you ll wnt to wtch for Fever Fever my be the first symptom of infection. There re medictions tht my reduce fever tht cn be given long with chemotherpy. If you hve fever of.4 F or higher, you should cll your helthcre tem right wy. Tiredness (ftigue) If you experience tiredness or ftigue, some ides to counterct it include blncing your periods of ctivity with rest, incresing your fluid intke, nd following well-blnced diet. In the first-line clinicl tril, 43 percent of ptients on ALIMTA plus cispltin hd some degree of ftigue. Gstrointestinl (GI) upset Be sure to tlk with your helthcre tem if you notice ny of the following side effects or nything different bout the wy you feel: Nuse nd/or vomiting It is importnt to tell your helthcre tem if you hve nuse or vomiting. There re medictions tht cn help prevent nd tret nuse nd vomiting. (continues on next pge) You re encourged to report negtive side effects of prescription drugs to the FDA. Visit www.fd.gov/ medwtch, or cll -8-FDA-88. 6 www.alimta.com For more informtion bout the sfety profile of ALIMTA, plese see the Importnt Sfety Informtion on pges 4-44, the ccompnying Ptient Prescribing Informtion nd Prescribing Informtion, visit www.alimta.com, or cll -8-545-5979. -8-545-5979 7
First-line therpy Additionl side effects you ll wnt to wtch for (continued) In the first-line clinicl tril, 56 percent of ptients on ALIMTA (pemetrexed for injection) plus cispltin hd some degree of nuse, nd 4 percent hd vomiting. Loss of ppetite (norexi) If you experience loss of ppetite, plese be sure to tell your helthcre tem. Also, the Ntionl Cncer Institute hs helpful booklet titled Eting Hints, which you cn get by clling -8-4-CANCER (-8-422-6237) or visiting the NCI website t www.cncer.gov. In the first-line clinicl tril, 27 percent of ptients on ALIMTA plus cispltin hd loss of ppetite. Constiption Your helthcre tem cn help you tret your constiption. It is importnt tht you tlk with them before you tke ny over-the-counter lxtives or stool softeners. In the first-line clinicl tril, 2 percent of ptients on ALIMTA plus cispltin hd constiption. Dirrhe Tell your helthcre tem if you hve dirrhe. It is very importnt tht you tlk with them before you tke ny over-the-counter dirrhe medicines. In the first-line clinicl tril, 2 percent of ptients on ALIMTA plus cispltin hd dirrhe. 8 www.alimta.com Mouth, throt, lip, or food pipe sores (stomtitis, phryngitis, esophgitis) Redness or sores in your mouth, throt, or on your lips my hppen few dys fter you get tretment. You my lso feel pin or hve difficulty when drinking or swllowing food. Tlk with your helthcre tem bout proper mouth, lip, nd throt cre if you hve ny of these symptoms. In the first-line clinicl tril, 4 percent of ptients on ALIMTA plus cispltin hd redness or sores in their mouth, throt, or on their lips. Hir loss (lopeci) Hir loss is rrely permnent. Tlk with your helthcre tem bout ny hir loss tht my hppen. In the first-line clinicl tril, 2 percent of ptients on ALIMTA plus cispltin hd some degree of lopeci. Nerve dmge (neuropthy) Symptoms of neuropthy my include wekness, pin, tingling senstion, nd/or numbness, especilly in the toes nd fingertips. In the first-line clinicl tril, 9 percent of ptients on ALIMTA plus cispltin hd some form of nerve dmge. You re encourged to report negtive side effects of prescription drugs to the FDA. Visit www.fd.gov/ medwtch, or cll -8-FDA-88. (continues on next pge) For more informtion bout the sfety profile of ALIMTA, plese see the Importnt Sfety Informtion on pges 4-44, the ccompnying Ptient Prescribing Informtion nd Prescribing Informtion, visit www.alimta.com, or cll -8-545-5979. -8-545-5979 9
First-line therpy Additionl side effects you ll wnt to wtch for (continued) Rsh You my get rsh or itching during tretment. These rections usully pper between tretments with ALIMTA (pemetrexed for injection) nd usully go wy before the next tretment. Skin rections or rshes tht include blistering or peeling my be severe nd could led to deth. Cll your doctor if you hve ny of these symptoms. Before strting ALIMTA, your helthcre tem will give you mediction ( steroid) to help reduce this side effect. In the first-line clinicl tril, 7 percent of ptients on ALIMTA plus cispltin hd rsh. Side effects my or my not be cused by the drug tretment itself; some effects my be due to the disese or to other resons. Contct your helthcre tem right wy if you hve fever, chills, dirrhe, or mouth sores. These symptoms could men you hve n infection, which my be severe nd could led to deth. Tlk with your helthcre tem if you hve ny side effects tht bother you or don t go wy. For more informtion bout ll of the side effects noted in the clinicl tril of ALIMTA plus cispltin for dvnced non-smll cell lung cncer (NSCLC), plese tlk with your helthcre tem, see the Ptient Prescribing Informtion nd Prescribing Informtion ccompnying this booklet, visit www.alimta.com, or cll -8-545-5979. You re encourged to report negtive side effects of prescription drugs to the FDA. Visit www.fd.gov/ medwtch, or cll -8-FDA-88. Drug delys nd discontinution You will hve regulr blood tests before nd during your tretment with ALIMTA plus cispltin. Your helthcre tem my chnge your dose of ALIMTA or stop tretment for period of time bsed on the results of your blood tests or your generl condition. For more informtion bout the sfety profile of ALIMTA, plese see the Importnt Sfety Informtion on pges 4-44, the ccompnying Ptient Prescribing Informtion nd Prescribing Informtion, visit www.alimta.com, or cll -8-545-5979. 2 www.alimta.com -8-545-5979 2
Mintennce therpy for dvnced nonsqumous non-smll cell lung cncer ALIMTA (pemetrexed for injection) is pproved by the FDA for the tretment of ptients with dvnced nonsqumous non-smll cell lung cncer (NSCLC), specific type of NSCLC, to mintin the effect of initil tretment with chemotherpy nd whose disese hs not worsened. ALIMTA is not indicted for ptients who hve different type of NSCLC clled squmous cell. ALIMTA cn suppress bone mrrow function, which my cuse low blood cell counts. For more informtion bout the sfety profile of ALIMTA, plese see the Importnt Sfety Informtion on pges 4-44, the ccompnying Ptient Prescribing Informtion nd Prescribing Informtion, visit www.alimta.com, or cll -8-545-5979. -8-545-5979 23
Mintennce therpy After first-line therpy, whether you received ALIMTA (pemetrexed for injection) plus cispltin or nother type of chemotherpy, your doctor my prescribe ALIMTA lone s mintennce therpy. Mintennce therpy is the continued use of cncer mediction beyond first-line tretment if your cncer hs not spred or grown. In lrge clinicl tril, people with the type of cncer you hve (dvnced nonsqumous non-smll cell lung cncer [NSCLC]) who strted tretment with ALIMTA plus cispltin nd continued with ALIMTA by itself slowed the growth of their cncer nd lived longer compred to people who didn t continue with mintennce chemotherpy. Tlk to your doctor bout whether you re eligible for mintennce tretment fter receiving ALIMTA plus cispltin. The following sections will give you informtion on how mintennce therpy with ALIMTA is given nd the possible side effects you my experience. How is your tretment given? ALIMTA should be given to you only by qulified helthcre professionl. Your helthcre tem will prepre ALIMTA by mixing it into solution nd giving it to you through needle into vein this is clled n intrvenous (IV) infusion. After first-line therpy, your mintennce tretment with ALIMTA by itself will be given usully once every 2 dys (3 weeks equls tretment cycle). ALIMTA Tretment Administrtion st-line nd Mintennce Therpy With ALIMTA For Advnced Nonsqumous NSCLC Strt Initil Tretment ALIMTA Pltinum Agent Cispltin Mintennce Discussion Mintennce Eligibility* ALIMTA * Tlk to your doctor bout whether you re eligible for mintennce tretment fter receiving ALIMTA plus cispltin. For more informtion bout the sfety profile of ALIMTA, plese see the Importnt Sfety Informtion on pges 4-44, the ccompnying Ptient Prescribing Informtion nd Prescribing Informtion, visit www.alimta.com, or cll -8-545-5979. ALIMTA will be given to you s -minute IV infusion. After this infusion, you won t be given ny more chemotherpy for the next 2 dys. These rest dys re norml prt of your tretment with ALIMTA. Select Importnt Sfety Informtion If you know you re llergic to ALIMTA (pemetrexed for injection), tell your doctor immeditely becuse you should not receive it. (continues on next pge) References. ALIMTA (pemetrexed for injection) [pckge insert]. Indinpolis, IN: Eli Lilly nd Compny; 23. 2. Pz-Ares LG, et l. J Clin Oncol. 23;3(23):2895-292. 24 www.alimta.com -8-545-5979 25
Mintennce therpy How is your tretment given? (continued) As prt of your tretment, you will lso receive dditionl medictions (including vitmin B 2, folic cid, nd corticosteroids) to help reduce hrmful side effects. You will hve regulr blood tests before nd during your tretment with ALIMTA (pemetrexed for injection). Your doctor my djust your dose of ALIMTA or dely tretment bsed on the results of your blood tests nd on your generl condition, including ny side effects tht you my hve hd. Your helthcre tem my sk you to come bck for follow-up visits fter you receive ALIMTA therpy so they cn check on how you re doing. It s importnt to tlk bout how you re feeling nd bout ny side effects you might be experiencing. Your helthcre tem needs this informtion from you so tht they cn monitor how your tretment is going. If you hve questions bout how ALIMTA is given, plese be sure to discuss them with your helthcre tem. For more informtion bout the sfety profile of ALIMTA, plese see the Importnt Sfety Informtion on pges 4-44, the ccompnying Ptient Prescribing Informtion nd Prescribing Informtion, visit www.alimta.com, or cll -8-545-5979. 26 www.alimta.com
Mintennce therpy Side effects Wht should you expect? Chemotherpy Side effects from chemotherpy re different depending on the type of cncer you hve nd the combintion of drugs you re given. Side effects my lso be different from ptient to ptient nd from tretment to tretment. This section discusses the most common nd/or most serious side effects tht ptients experienced in clinicl trils tht studied ALIMTA (pemetrexed for injection) for dvnced non-smll cell lung cncer (NSCLC). Side effects from chemotherpy should be wtched crefully both by you nd your helthcre tem. Ftigue (tiredness), nuse, nd vomiting re few exmples. Another group of side effects, such s those tht chnge your blood cell counts, re monitored through regulr blood tests, but they cn lso be identified through signs nd symptoms you might notice. We will discuss some of these in the following pges. Side effects cn be serious, but most cn be treted. Though few side effects cn be permnent, mny lst only for short time nd go wy fter the tretment dose is lowered or stopped. ALIMTA (pemetrexed for injection) s single gent (by itself) Most ptients tking ALIMTA will hve side effects. For the purpose of this booklet, we will discuss some of the most common nd/or most serious side effects tht my hppen if you tke ALIMTA by itself for the tretment of dvnced nonsqumous NSCLC to mintin initil tretment effect. It is not lwys possible to tell whether ALIMTA, nother mediction, or the cncer itself is cusing these side effects. You should lwys tell your helthcre tem if you re experiencing nything new. Cll your helthcre tem right wy if you hve fever, chills, dirrhe, or mouth sores. These symptoms could men you hve n infection, which my be severe nd could led to deth. For more informtion bout ll of the side effects noted in the clinicl trils of ALIMTA s single gent for dvnced NSCLC, plese tlk with your helthcre tem, see the Ptient Prescribing Informtion nd Prescribing Informtion ccompnying this booklet, visit www.alimta.com, or cll -8-545-5979. You re encourged to report negtive side effects of prescription drugs to the FDA. Visit www.fd.gov/ medwtch, or cll -8-FDA-88. For more informtion bout the sfety profile of ALIMTA, plese see the Importnt Sfety Informtion on pges 4-44, the ccompnying Ptient Prescribing Informtion nd Prescribing Informtion, visit www.alimta.com, or cll -8-545-5979. 28 www.alimta.com -8-545-5979 29
Mintennce therpy Side effects tht you nd your helthcre tem should wtch for Before nd during your tretment with ALIMTA (pemetrexed for injection), you will hve regulr blood tests to llow your helthcre tem to wtch for low blood cell counts. You my lso hve dditionl symptoms tht you must tell your helthcre tem bout. Some of these side effects nd symptoms re described in the next sections. Mintennce therpy with ALIMTA ws studied in two clinicl trils. Frequent nd/or serious side effects from both of these trils re presented in the sections below. Low white blood cell count (neutropeni/leukopeni) White blood cells (leukocytes) help you fight infection. A low white blood cell count is clled leukopeni. Neutrophils re type of white blood cell, nd when your count is low you hve neutropeni. During this time, you re more likely to develop n infection, nd you should void crowds nd those with colds. You should cll your helthcre tem right wy if you hve ny signs of infection, such s chills or temperture over.4 F. In the first mintennce tril, 6 percent of ptients on ALIMTA hd neutropeni, nd 6 percent hd leukopeni. In the second mintennce tril, 9 percent of ptients on ALIMTA hd neutropeni. Low red blood cell count (nemi) Red blood cells help crry oxygen from your lungs to the other prts of your body. A low red blood cell count is clled nemi. If your red blood cell count is low, you my feel tired, get tired esily, pper ple, nd become short of breth. In the first mintennce tril, 5 percent of ptients on ALIMTA hd nemi. In the second mintennce tril, 5 percent of ptients on ALIMTA hd nemi. You re encourged to report negtive side effects of prescription drugs to the FDA. Visit www.fd.gov/ medwtch, or cll -8-FDA-88. (continues on next pge) For more informtion bout the sfety profile of ALIMTA, plese see the Importnt Sfety Informtion on pges 4-44, the ccompnying Ptient Prescribing Informtion nd Prescribing Informtion, visit www.alimta.com, or cll -8-545-5979. 3 www.alimta.com
Mintennce therpy Side effects tht you nd your helthcre tem should wtch for (continued) Low pltelet count (thrombocytopeni) Pltelets help your blood to clot. A low pltelet count puts you t more risk for bleeding. If your helthcre tem tells you tht you hve low pltelet count, you my be sked to tke some precutions, including voiding injury, voiding constiption, using soft-bristle toothbrush, etc. It is importnt tht you cll your helthcre tem if you see ny signs of bleeding, such s unexplined bruising or blood in your stool (blck, trry stools). In both mintennce trils, less thn 5 percent of ptients on ALIMTA (pemetrexed for injection) hd low pltelet count. You re encourged to report negtive side effects of prescription drugs to the FDA. Visit www.fd.gov/ medwtch, or cll -8-FDA-88. For more informtion bout the sfety profile of ALIMTA, plese see the Importnt Sfety Informtion on pges 4-44, the ccompnying Ptient Prescribing Informtion nd Prescribing Informtion, visit www.alimta.com, or cll -8-545-5979. 32 www.alimta.com Additionl side effects you ll wnt to wtch for Tiredness (ftigue) If you experience tiredness or ftigue, some ides to counterct it include blncing your periods of ctivity with rest, incresing your fluid intke, nd following well-blnced diet. In the first mintennce tril, 25 percent of ptients on ALIMTA hd ftigue. In the second mintennce tril, 8 percent of ptients on ALIMTA hd ftigue. Gstrointestinl (GI) upset Be sure to tlk with your helthcre tem if you notice ny of the following side effects or nything different bout the wy you feel: Nuse nd/or vomiting It is importnt to tell your helthcre tem if you hve nuse or vomiting. There re medictions tht cn help prevent nd tret nuse nd vomiting. In the first mintennce tril, 9 percent of ptients on ALIMTA hd some degree of nuse, nd 9 percent hd vomiting. In the second mintennce tril, 2 percent of ptients on ALIMTA hd some degree of nuse, nd 6 percent hd vomiting. (continues on next pge) -8-545-5979 33
Mintennce therpy Additionl side effects you ll wnt to wtch for (continued) Loss of ppetite (norexi) If you experience loss of ppetite, plese be sure to tell your helthcre tem. Also, the Ntionl Cncer Institute hs helpful booklet titled Eting Hints, which you cn get by clling -8-4-CANCER (-8-422-6237) or visiting the NCI website t www.cncer.gov. In the first mintennce tril, 9 percent of ptients on ALIMTA (pemetrexed for injection) hd loss of ppetite. In the second mintennce tril, less thn 5 percent of ptients on ALIMTA hd loss of ppetite. Dirrhe Tell your helthcre tem if you hve dirrhe. It is very importnt tht you tlk with them before you tke ny over-the-counter dirrhe medicines. In the first mintennce tril, 5 percent of ptients on ALIMTA hd dirrhe. In the second mintennce tril, less thn 5 percent of ptients on ALIMTA hd dirrhe. Rsh You my get rsh or itching during tretment. These rections usully pper between tretments with ALIMTA nd usully go wy before the next tretment. Skin rections or rshes tht include blistering or peeling my For more informtion bout the sfety profile of ALIMTA, plese see the Importnt Sfety Informtion on pges 4-44, the ccompnying Ptient Prescribing Informtion nd Prescribing Informtion, visit www.alimta.com, or cll -8-545-5979. 34 www.alimta.com be severe nd could led to deth. Cll your doctor if you hve ny of these symptoms. Before strting ALIMTA, your helthcre tem will give you mediction ( steroid) to help reduce this side effect. In the first mintennce tril, percent of ptients on ALIMTA hd rsh. In the second mintennce tril, less thn 5 percent of ptients on ALIMTA hd rsh. Drug delys nd discontinution You will hve regulr blood tests before nd during your tretment with ALIMTA. Your helthcre tem my chnge your dose of ALIMTA or stop tretment for period of time bsed on the results of your blood tests or your generl condition. Side effects my or my not be cused by the drug tretment itself; some effects my be due to the disese or to other resons. Contct your helthcre tem right wy if you hve fever, chills, dirrhe, or mouth sores. These symptoms could men you hve n infection, which my be severe nd could led to deth. Tlk with your helthcre tem if you hve ny side effects tht bother you or don t go wy. For more informtion bout ll of the side effects noted in the clinicl trils of ALIMTA s single gent for dvnced non-smll cell lung cncer (NSCLC), plese tlk with your helthcre tem, see the Ptient Prescribing Informtion nd Prescribing Informtion ccompnying this booklet, visit www.alimta.com, or cll -8-545-5979. You re encourged to report negtive side effects of prescription drugs to the FDA. Visit www.fd.gov/ medwtch, or cll -8-FDA-88. -8-545-5979 35
Frequently sked questions Your helthcre tem Importnt Sfety Informtion for ALIMTA (pemetrexed for injection) Resources For more informtion bout the sfety profile of ALIMTA, plese see the Importnt Sfety Informtion on pges 4-44, the ccompnying Ptient Prescribing Informtion nd Prescribing Informtion, visit www.alimta.com, or cll -8-545-5979. -8-545-5979 37
Your helthcre tem When should you cll them? Frequently sked questions Why re folic cid nd vitmin B 2 so importnt? It is very importnt to tke folic cid nd vitmin B 2 s prescribed by your helthcre tem to lower your chnces of hrmful side effects. How do I get more informtion bout side effects? For more informtion bout ll of the side effects noted in the clinicl trils of ALIMTA (pemetrexed for injection) s single gent or in combintion with cispltin, plese tlk with your helthcre tem, see the Ptient Prescribing Informtion nd Prescribing Informtion ccompnying this booklet, visit www.alimta.com, or cll -8-545-5979. You re probbly in tune with chnges in your body now more thn ever. You must never tke these chnges for grnted. As person living with cncer, you my feel well enough to continue tking on the chllenges in your dily life, but you must lwys be wre of infection. If you suspect n infection of ny kind, cll your helthcre tem immeditely. You should lso cll your helthcre tem right wy if you notice ny other chnges in your body or experience ny of the symptoms shown below during your chemotherpy tretment. They will let you know wht to do or decide if you need to go to the emergency room. A one-time temperture bove F or temperture bove.4 F for more thn hour Confusion or chnge in mentl sttus, including hllucintions Difficulty brething A new rsh Trouble swllowing, drooling, or fcil, neck, or tongue swelling Incresed pin Hedche Abdominl pin Constiption or uncontrollble dirrhe Uncontrollble nuse nd/or vomiting Bleeding Swelling in legs or rms For more informtion bout the sfety profile of ALIMTA, plese see the Importnt Sfety Informtion on pges 4-44, the ccompnying Ptient Prescribing Informtion nd Prescribing Informtion, visit www.alimta.com, or cll -8-545-5979. Reference. Ntionl Comprehensive Cncer Network. When to go to the emergency room. http://www.nccn.org/ptients/resources/life_with_cncer/mnging_symptoms/ emergency_room.spx. Accessed Februry 4, 25. 38 www.alimta.com -8-545-5979 39
Importnt Sfety Informtion for ALIMTA (pemetrexed for injection) Wht is the most importnt informtion tht I should know bout ALIMTA? ALIMTA cn suppress bone mrrow function, which my cuse low blood cell counts. ALIMTA my not be pproprite for some ptients. If you re llergic to ALIMTA, tell your doctor becuse you should not receive it. If you hve liver or kidney problems, be sure to tell your doctor. Your dose of ALIMTA my hve to be chnged, or ALIMTA my not be right for you. It is very importnt to tke the following medictions prior to nd during your tretment with ALIMTA to lower your chnces of hrmful side effects: You must tke folic cid every dy by mouth beginning 7 dys before your first dose of ALIMTA. You must keep tking folic cid every dy during the time you re being treted with ALIMTA, nd every dy for 2 dys fter you receive your lst dose of ALIMTA. Your doctor will give you vitmin B 2 injections while you re getting tretment with ALIMTA. You will get your first vitmin B 2 injection one week before your first dose of ALIMTA, nd then bout every 9 weeks during tretment. Your doctor will prescribe medicine clled corticosteroid tht you must tke the dy before, the dy of, nd the dy fter ech tretment with ALIMTA to reduce rsh. You will hve regulr blood tests before nd during your tretment with ALIMTA. Your doctor my djust your dose of ALIMTA or dely your tretment bsed on the results of your blood test nd on your generl condition. Wht should I tell my doctor before receiving ALIMTA? If you think you re pregnnt, re plnning to become pregnnt, or re nursing, plese tell your helthcre tem. ALIMTA my hrm your unborn or nursing bby. Your physicin my dvise you to use effective contrception (birth control) to prevent pregnncy while you re being treted with ALIMTA. Tell your doctor if you re tking other medicines, including prescription nd nonprescription medicines, vitmins, nd herbl supplements. ALIMTA nd other medicines my ffect ech other, cusing serious side effects. Especilly, tell your doctor if you re tking medicines clled nonsteroidl nti-inflmmtory drugs (NSAIDs) for pin or swelling. (continues on next pge) For more informtion bout the sfety profile of ALIMTA, plese see the ccompnying Ptient Prescribing Informtion nd Prescribing Informtion, visit www.alimta.com, or cll -8-545-5979. 4 www.alimta.com -8-545-5979 4
Importnt Sfety Informtion for ALIMTA (pemetrexed for injection) (continued) Wht re the possible side effects of ALIMTA? Most ptients tking ALIMTA will hve side effects. Sometimes it is not lwys possible to tell whether ALIMTA, nother medicine, or the cncer itself is cusing these side effects. Cll your doctor right wy if you hve fever, chills, dirrhe, or mouth sores. These symptoms could men you hve n infection, which my be severe nd could led to deth. The most common side effects of ALIMTA when given lone or in combintion with cispltin re: Stomch upset, including nuse, vomiting, dirrhe, or constiption. You cn obtin medicines to help control some of these symptoms. Cll your doctor if you get ny of these symptoms. Low blood cell counts: Low red blood cells. Low red blood cells my mke you feel tired, get tired esily, pper ple, nd become short of breth. Low white blood cells. Low white blood cells my give you greter chnce for infection. If you hve fever (temperture bove.4 F) or other signs of infection, cll your doctor right wy. Low pltelets. Low pltelets give you greter chnce for bleeding. Your doctor will do blood tests to check your blood counts before nd during tretment with ALIMTA. Tiredness. You my feel tired or wek for few dys fter your ALIMTA tretments. If you hve severe wekness or tiredness, cll your doctor. Redness or sores in your mouth, throt, on your lips, or in the tube tht connects your throt nd stomch (esophgus). You my get redness or sores in your mouth, throt, on your lips, or in your esophgus (stomtitis, phryngitis, esophgitis) or you my feel pin or hve difficulty when drinking or swllowing food. These symptoms my hppen few dys fter ALIMTA tretment. Tlk with your doctor if you get ny of these symptoms. Loss of ppetite. You my lose your ppetite nd lose weight during your tretment. Tlk to your doctor if this is problem for you. Rsh. You my get rsh or itching during tretment. These rections usully pper between tretments with ALIMTA nd usully go wy before the next tretment. Skin rections or rshes tht include blistering or peeling my be severe nd could led to deth. Cll your doctor if you hve ny of these symptoms. (continues on next pge) For more informtion bout the sfety profile of ALIMTA, plese see the ccompnying Ptient Prescribing Informtion nd Prescribing Informtion, visit www.alimta.com, or cll -8-545-5979. 42 www.alimta.com -8-545-5979 43
Importnt Sfety Informtion for ALIMTA (pemetrexed for injection) (continued) Tlk with your doctor, nurse, or phrmcist bout ny side effect tht bothers you or tht doesn t go wy. These re not ll the side effects of ALIMTA. For more informtion, sk your doctor, nurse, or phrmcist. How is ALIMTA given? ALIMTA is slowly infused (injected) into vein. The injection or infusion will lst bout minutes. You will usully receive ALIMTA once every 2 dys (3 weeks). For more informtion bout ll of the side effects of ALIMTA, plese tlk with your helthcre tem, see the Ptient Prescribing Informtion nd Prescribing Informtion ccompnying this booklet, visit www.alimta.com, or cll -8-545-5979. You re encourged to report negtive side effects of prescription drugs to the FDA. Visit www.fd.gov/ medwtch, or cll -8-FDA-88. PM_CON_ISI_All_7OCT22 For more informtion bout the sfety profile of ALIMTA, plese see the ccompnying Ptient Prescribing Informtion nd Prescribing Informtion, visit www.alimta.com, or cll -8-545-5979. 44 www.alimta.com -8-545-5979 45
Resources For more informtion bout lung cncer, living with cncer, nd ptient nd fmily support groups, visit the websites below. These resources re independent from Lilly Oncology; Lilly does not control the content. Lung Cncer-Specific Resources Americn Lung Assocition www.lung.org The Americn Lung Assocition hs been fighting for over yers to sve lives by improving lung helth nd preventing lung disese through eduction, dvoccy, nd reserch. This orgniztion offers severl support groups, including the Lung Connection Community. This free online community is for people who re living with lung diseses nd their cregivers. Lung Cncer Allince www.lungcncerllince.org Lung Cncer Allince is nonprofit orgniztion solely dedicted to sving lives nd dvncing reserch by empowering those living with nd t risk for lung cncer. They offer personlized, professionl support, dvocte for incresed lung cncer reserch funding, nd conduct ntionwide eduction cmpigns. LUNGevity www.lungevity.org LUNGevity is focused on chnging outcomes for people living with lung cncer through reserch, eduction, nd support. LUNGevity strtegiclly funds robust portfolio of trnsltionl reserch to find lung cncer erly nd tret it more effectively. The orgniztion lso provides community of empowerment, support, nd hope for everyone ffected by lung cncer through their extensive eductionl resources, online peer-to-peer support, nd in-person survivorship progrms. Bonnie J. Addrio Lung Cncer Foundtion www.lungcncerfoundtion.org The Bonnie J. Addrio Lung Cncer Foundtion (ALCF) is nonprofit orgniztion tht ctively works with physicins, orgniztions, nd people ffected by lung cncer. Their gol is to identify solutions nd mke progress towrd turning lung cncer into chroniclly mnged disese. To dte, this philnthropy (ptient-founded, ptient-focused, nd ptient-driven) hs rised lmost $25 million for lung cncer reserch nd progrms. Generl Cncer Resources Americn Cncer Society www.cncer.org/tretment Cncer Support Community www.cncersupportcommunity.org The LIVESTRONG Foundtion www.livestrong.org CncerCre www.cncercre.org/counseling For more informtion bout the sfety profile of ALIMTA (pemetrexed for injection), plese see the Importnt Sfety Informtion on pges 4-44, the ccompnying Ptient Prescribing Informtion nd Prescribing Informtion, visit www.alimta.com, or cll -8-545-5979. Ptient Advocte Foundtion www.ptientdvocte.org 46 www.alimta.com -8-545-5979 47
Notes Notes 48-8-545-5979 49
Notes For more informtion bout the sfety profile of ALIMTA, plese see the Importnt Sfety Informtion on pges 4-44, the ccompnying Ptient Prescribing Informtion nd Prescribing Informtion, visit www.alimta.com, or cll -8-545-5979. You re encourged to report negtive side effects of prescription drugs to the FDA. Visit www.fd.gov/medwtch, or cll -8-FDA-88. 5 www.alimta.com -8-545-5979 5
YOUR LIFE. Your Guide to ALIMTA Therpy. Advnced nonsqumous non-smll cell lung cncer (NSCLC) Know wht to expect during therpy Find nswers to your tretment questions Locte resources for informtion nd support ALIMTA cn suppress bone mrrow function, which my cuse low blood cell counts. www.alimta.com -8-545-5979 PM9558 4/25 Lilly USA, LLC 25. All rights reserved. ALIMTA is registered trdemrk of Eli Lilly nd Compny nd is vilble by prescription only.
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include ll the informtion needed to use ALIMTA sfely nd effectively. See full prescribing informtion for ALIMTA. ALIMTA (pemetrexed for injection), for Intrvenous Use Initil U.S. Approvl: 24 RECENT MAJOR CHANGES Dosge nd Administrtion, Premediction Regimen nd Concurrent Medictions (2.3) /22 Wrnings nd Precutions, Requirement for Premediction nd Concomitnt Mediction to Reduce Toxicity (5.) /22 Wrnings nd Precutions, Required Lbortory Monitoring (5.5) /22 INDICATIONS AND USAGE ALIMTA is folte nlog metbolic inhibitor indicted for: Loclly Advnced or Metsttic Nonsqumous Non-Smll Cell Lung Cncer: Initil tretment in combintion with cispltin. (.) Mintennce tretment of ptients whose disese hs not progressed fter four cycles of pltinum-bsed first-line chemotherpy. (.2) After prior chemotherpy s single-gent. (.3) Mesotheliom: in combintion with cispltin. (.4) Limittions of Use: ALIMTA is not indicted for the tretment of ptients with squmous cell non-smll cell lung cncer. (.5) DOSAGE AND ADMINISTRATION Combintion use in Non-Smll Cell Lung Cncer nd Mesotheliom: Recommended dose of ALIMTA is 5 mg/m 2 i.v. on Dy of ech 2-dy cycle in combintion with cispltin 75 mg/m 2 i.v. beginning 3 minutes fter ALIMTA dministrtion. (2.) Single-Agent use in Non-Smll Cell Lung Cncer: Recommended dose of ALIMTA is 5 mg/m 2 i.v. on Dy of ech 2-dy cycle. (2.2) Prior to inititing ALIMTA, initite supplementtion with orl folic cid nd intrmusculr vitmin B 2. Continue folic cid nd vitmin B 2 supplementtion throughout tretment. Administer corticosteroids the dy before, the dy of, nd the dy fter ALIMTA dministrtion. (2.3) Dose Reductions: Dose reductions or discontinution my be needed bsed on toxicities from the preceding cycle of therpy. (2.4) DOSAGE FORMS AND STRENGTHS mg vil for injection (3) 5 mg vil for injection (3) CONTRAINDICATIONS History of severe hypersensitivity rection to pemetrexed. (4) WARNINGS AND PRECAUTIONS Premediction regimen: Prior to tretment with ALIMTA, initite supplementtion with orl folic cid nd intrmusculr vitmin B 2 to reduce the severity of hemtologic nd gstrointestinl toxicity of ALIMTA. (5.) Bone mrrow suppression: Reduce doses for subsequent cycles bsed on hemtologic nd nonhemtologic toxicities. (5.2) Renl function: Do not dminister when CrCl <45 ml/min. (2.4, 5.3) NSAIDs with renl insufficiency: Use cution in ptients with mild to moderte renl insufficiency (CrCl 45-79 ml/min). (5.4) Lb monitoring: Do not initite cycle unless ANC 5 cells/mm 3, pltelets, cells/mm 3, nd CrCl 45 ml/min. (5.5) Pregnncy: Fetl hrm cn occur when dministered to pregnnt womn. Women should be dvised to use effective contrception mesures to prevent pregnncy during tretment with ALIMTA. (5.6) ADVERSE REACTIONS The most common dverse rections (incidence 2%) with single-gent use re ftigue, nuse, nd norexi. Additionl common dverse rections when used in combintion with cispltin include vomiting, neutropeni, leukopeni, nemi, stomtitis/phryngitis, thrombocytopeni, nd constiption. (6.) To report SUSPECTED ADVERSE REACTIONS, contct Eli Lilly nd Compny t -8-LillyRx (-8-545-5979) or FDA t -8-FDA-88 or www.fd.gov/medwtch. DRUG INTERACTIONS NSAIDs: Use cution with NSAIDs. (7.) Nephrotoxic drugs: Concomitnt use of these drugs nd/or substnces which re tubulrly secreted my result in delyed clernce. (7.2) See 7 for PATIENT COUNSELING INFORMATION nd FDA-pproved ptient lbeling. Revised: 9/23 FULL PRESCRIBING INFORMATION: CONTENTS* INDICATIONS AND USAGE. Nonsqumous Non-Smll Cell Lung Cncer Combintion with Cispltin.2 Nonsqumous Non-Smll Cell Lung Cncer Mintennce.3 Nonsqumous Non-Smll Cell Lung Cncer After Prior Chemotherpy.4 Mesotheliom.5 Limittions of Use 2 DOSAGE AND ADMINISTRATION 2. Combintion Use with Cispltin for Nonsqumous Non-Smll Cell Lung Cncer or Mlignnt Pleurl Mesotheliom 2.2 Single-Agent Use s Mintennce Following First-Line Therpy, or s Second- Line Therpy 2.3 Premediction Regimen nd Concurrent Medictions 2.4 Lbortory Monitoring nd Dose Reduction/Discontinution Recommendtions 2.5 Preprtion nd Administrtion Precutions 2.6 Preprtion for Intrvenous Infusion Administrtion 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5. Requirement for Premediction nd Concomitnt Mediction to Reduce Toxicity 5.2 Bone Mrrow Suppression 5.3 Decresed Renl Function 5.4 Use with Non-Steroidl Anti-Inflmmtory Drugs (NSAIDs) with Mild to Moderte Renl Insufficiency 5.5 Required Lbortory Monitoring 5.6 Pregnncy Ctegory D 6 ADVERSE REACTIONS 6. Clinicl Trils Experience 6.2 Postmrketing Experience 7 DRUG INTERACTIONS 7. Non-Steroidl Anti-Inflmmtory Drugs (NSAIDs) 7.2 Nephrotoxic Drugs 8 USE IN SPECIFIC POPULATIONS 8. Pregnncy 8.3 Nursing Mothers 8.4 Peditric Use 8.5 Geritric Use 8.6 Ptients with Heptic Impirment 8.7 Ptients with Renl Impirment 8.8 Gender 8.9 Rce OVERDOSAGE DESCRIPTION 2 CLINICAL PHARMACOLOGY 2. Mechnism of Action 2.2 Phrmcodynmics 2.3 Phrmcokinetics 3 NONCLINICAL TOXICOLOGY 3. Crcinogenesis, Mutgenesis, Impirment of Fertility 4 CLINICAL STUDIES 4. Non-Smll Cell Lung Cncer (NSCLC) Combintion with Cispltin 4.2 Non-Smll Cell Lung Cncer Mintennce 4.3 Non-Smll Cell Lung Cncer After Prior Chemotherpy 4.4 Mlignnt Pleurl Mesotheliom 5 REFERENCES 6 HOW SUPPLIED/STORAGE AND HANDLING 6. How Supplied 6.2 Storge nd Hndling 7 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing informtion re not listed. ALIMTA (pemetrexed for injection), for Intrvenous Use PV 8927 AMP ALIMTA (pemetrexed for injection), for Intrvenous Use PV 8927 AMP ALIMTA PI PV8927AMP W/ PPI PX4AMP PRINTER VERSION OF