Transcription
Not an actual patientTreatmentStopped Fighting MyAdvanced Breast Cancer.But I Didn’t.AFINITOR (everolimus) Tabletsis a prescription medicine usedto treat advanced hormonereceptor-positive, HER2-negativebreast cancer, along with themedicine exemestane, inpostmenopausal women who havealready received certain othermedicines for their cancer.Please see Important Safety Informationthroughout, and click here for full PrescribingInformation, including Patient Information.
What Is AFINITOR?Keep FIGHTINGImportant Safety InformationAFINITOR can cause serious side effects, including the following:Your doctor prescribed AFINITOR along with the hormone therapyAromasin (also called exemestane) for your advanced HR , HER2breast cancer. HR , also called estrogen receptor-positive (ER ) orprogesterone receptor-positive (PR ), breast cancer simply meansthat your breast cancer grows with the help of the hormone estrogenor progesterone. HER2- means that you have normal amounts ofHER2 protein in your tumors. It’s important to know your specific typeof breast cancer so you can work closely with your doctor to makeinformed decisions about your treatment goals.How DoesAFINITOR Work?You may develop lung or breathing problems: In some people, lung or breathingproblems may be severe and can lead to death. Tell your health care providerright away if you have any of these symptoms: new or worsening cough,shortness of breath, chest pain, difficulty breathing, or wheezing.What Are theSide Effects?Do not take AFINITOR (everolimus) Tablets if you have had a severe allergicreaction to everolimus. Talk to your health care provider before taking thismedicine if you are allergic to sirolimus (Rapamune ) or temsirolimus (Torisel ).Ask your health care provider if you do not know.Every woman with advanced hormone receptor-positive,HER2-negative (HR , HER2-) breast cancer is unique, and not alltreatments work the same for everyone. So if your hormone therapy(anastrozole or letrozole) stopped working, it’s important to know thatyou haven’t done anything wrong. And you are not alone. There aremany women, just like you, who are determined to stay focused onwhat’s next by taking an active role in their treatment.How Do I TakeAFINITOR?You are the center of your care, so stay involved and continue to be yourown best advocate. You’re in charge of your health and deserve the bestpossible care.Where Can I FindSavings & Support?It’s important to remember that you are not alone in the fight.Sincerely,The AFINITOR TeamThe brands listed are the trademarks or registered trademarks of their respective ownersand are not trademarks or registered trademarks of Novartis.What Else Do INeed to Know?Aromasin is a registered trademark of Pfizer Inc.Please see Important Safety Information throughout, and click here for fullPrescribing Information, including Patient Information.23
What Is AFINITOR?What Are theSide Effects?Please seeImportant SafetyInformationthroughout, andclick here forfull PrescribingInformation, includingPatient Information.Not an actual patientHow DoesAFINITOR Work?How Do I TakeAFINITOR?Where Can I FindSavings & Support?What Else Do INeed to Know?What isAFINITOR?45
7.8exemestanemonthsDOUBLES THETIMEAFINITORplus VS HORMONE THERAPY ALONE48How DoesAFINITOR Work?Data have not shown an increase in overall survival.SLOWS THE GROWTH AND SPREAD OF TUMORSNearly 2 times as many people taking AFINITOR with exemestane had tumorsthat shrank, disappeared, or were stable vs people taking exemestane alone.25People taking AFINITORwith exemestanePeople takingexemestane alone03 patients (0.6%) had a complete response (tumor disappeared) with AFINITOR exemestane58 patients (12.0%) had a partial response (tumor shrank) with AFINITOR exemestaneNo patients (0%) had a complete response with exemestane alone4 patients (1.7%) had a partial response with exemestane aloneWhat Else Do INeed to Know? Where Can I FindSavings & Support?0More than 50%of patientsMORETHANexperienced tumorshrinkage or disappearance,or were stable at 24 weeksPercentage ofpatients for whomtumors shrank ordisappeared, orwere stable forat least 24 weeks51.3%50Important Safety Information (cont)51.3%2526.4%MORE THANHow Do I TakeAFINITOR?50 Proven to help delay the growth and spread of tumors66239 patients received placebo exemestane S hown to more than double the time that patients live without the diseasegetting worse (the median progression-free survival period), comparedwith exemestane aloneAromasin is a registered trademark of Pfizer Inc.8485 patients received AFINITOR exemestaneAFINITOR, in combination with exemestane, gives postmenopausal womenwith advanced HR , HER2- breast cancer a treatment option other thanhormone therapy alone and/or chemotherapy.You may be more likely to develop an infection, such as pneumonia, or abacterial, fungal, or viral infection. Viral infections may include active hepatitisB in people who have had hepatitis B in the past (reactivation). In some people(including adults and children), these infections may be severe and can leadto death. You may need to be treated as soon as possible. Tell your healthcare provider right away if you have a temperature of 100.5 F or above, havechills, or do not feel well. Symptoms of hepatitis B or infection may includethe following: fever, chills, skin rash, joint pain and swelling, tiredness, lossof appetite, nausea, pale stools or dark urine, yellowing of the skin, or pain inthe upper right side of the stomach.7.86What Are theSide Effects?3.2Proven results matterAFINITOR works in combination with the hormone therapy Aromasin (alsocalled exemestane) to help delay the growth of advanced HR , HER2- breastcancer. It is:4monthsMedianMONTHSM2AFINITOR plusprogression-freeexemestanesurvival period (how long aExemestanealonepatient liveswithout the disease gettingMONTHSM2 worse)monthsAFINITOR (everolimus) Tablets is a once-daily oral prescription medicineused to treat advanced HR , HER2- breast cancer, along with the medicineAromasin (also called exemestane), in women who have gone throughmenopause and have already received certain other medicines for theircancer. 3.226.4%AFINITOR?alonemonthsWhen added to the hormone therapy exemestane, AFINITOR doubled theamount of timeExemestanepatients lived without their tumors growing.Please see Important Safety Information throughout, and click here for fullPrescribing Information, including Patient Information.7
Not an actual patientWhat Are theSide Effects?Please seeImportant SafetyInformationthroughout, andclick here forfull PrescribingInformation, includingPatient Information.How DoesAFINITOR Work?How Do I TakeAFINITOR?Where Can I FindSavings & Support?What are the8What Else Do INeed to Know?SIDEEFFECTS?9
Mouth ulcers and sores: Mouth ulcers and sores are common during treatmentwith AFINITOR and can be severe. It can appear as early as within the first 2weeks of treatment, or it can occur at any time. Stay on the lookout for:What are the SIDE EFFECTS?It’s common to be concerned about side effects before starting a newtreatment. AFINITOR (everolimus) Tablets may cause some side effectsyou are not familiar with. That’s why it’s important to learn everything youcan, so you’re prepared to work closely with your doctor or nurse as soonas a side effect occurs.You may develop lung or breathing problems: In some people, lung orbreathing problems may be severe and can lead to death. Tell your health careprovider right away if you have any of these symptoms: new or worsening cough,shortness of breath, chest pain, difficulty breathing, or wheezing.Changesin tasteIf you develop any of these symptoms in your mouth, tell your health care provider. When youstart treatment with AFINITOR, you may be prescribed alcohol‑free dexamethasone‑basedmouthwash to reduce the likelihood of getting mouth ulcers or sores and to reduce their severity.Follow your health care provider’s instructions on how to use this prescription mouthwash.If you develop pain, discomfort, or open sores in your mouth, tell your health careprovider. Your health care provider may tell you to re-start this mouthwash or touse a special mouthwash or gel that does not contain alcohol, hydrogen peroxide,iodine, or thyme.It’s good to know you can take a proactive role in managing this side effect.See the next page for some oral care tips your doctor may recommend.You may develop kidney failure: In some people, this may be severe and can leadto death.Yourhealthcare providershoulddo testschecktoyourThemTORpathwayis one paththat canallowtocancergrowkidney functionbefore and during your treatment with AFINITOR.Risk of woundUP healingTO problems: Wounds may not heal properly during treatmentwith AFINITOR. Tell your health care provider if you plan to have any surgery beforestarting or during treatment with AFINITOR. You should stop taking AFINITOR atleast 1 week before planned surgery. Your health care provider should tell you whenyou may start taking AFINITOR again after surgery.If you have any of these serious side effects, you may need to stop taking AFINITORfor a while or use a lower dose. Follow your health care provider’s instructions.Please see Important Safety Information throughout, and click here for fullPrescribing Information, including Patient Information.XmTORXmTOR10 Difficulty eating, drinking,or swallowingWhat Else Do INeed to Know?Possible increased risk for an allergic reaction called angioedema in peoplewho take an angiotensin-converting enzyme (ACE) inhibitor medicine duringtreatment with AFINITOR. Talk with your health care provider before takingAFINITOR if you are not sure if you take an ACE inhibitor medicine. Get medicalhelp right away if you have trouble breathing or develop swelling of your tongue,mouth, or throat during treatment with AFINITOR. Difficulty eating spicy foodsWhere Can I FindSavings & Support?Severe allergic reactions: Call your health care provider or get medical helpright away if you get signs and symptoms of a severe allergic reaction includingrash, itching, hives, flushing, trouble breathing or swallowing, chest pain,or dizziness. Feelings of tenderness,swelling, tingling, pain,or burningHow Do I TakeAFINITOR?You may be more likely to develop an infection, such as pneumonia, or abacterial, fungal, or viral infection. Viral infections may include active hepatitisB in people who have had hepatitis B in the past (reactivation). In some people(including adults and children), these infections may be severe and can leadto death. You may need to be treated as soon as possible. Tell your health careprovider right away if you have a temperature of 100.5 F or above, have chills,or do not feel well. Symptoms of hepatitis B or infection may include thefollowing: fever, chills, skin rash, joint pain and swelling, tiredness, loss ofappetite, nausea, pale stools or dark urine, yellowing of the skin, or pain inthe upper right side of the stomach.Sores orrednessHow DoesAFINITOR Work?What are the most serious side effects of AFINITOR?MOUTH SORES11
What are some oral-care tips mydoctor might recommend?Before starting on AFINITOR (everolimus) Tablets, and duringtreatment, your doctor may offer suggestions about proper oral care.Things to Do: B rush twice a day. Try to brush after every meal with a soft-bristledtoothbrush and mild toothpaste F oods and drinks that can irritate your mouth (such as citrus fruitsand juices, tomatoes, spicy or salty foods, raw ginger, onions, andcrunchy chips) Drinking hot liquids or beveragesTalk to your doctor if you have any questions or concerns.How Do I TakeAFINITOR? I f you’re flossing with dental floss, continue with your daily flossingroutine. If you have not been flossing daily, do not start, because yourmouth may become more sensitiveHow DoesAFINITOR Work? Take good care of your mouth and visit your dentist regularlyThings to Avoid: A lways follow your doctor’s instructions when using dexamethasoneoral solution E at soft foods (such as milkshakes, smoothies, pudding, yogurt,mashed potatoes, or bananas)Biotene is a registered trademark of GlaxoSmithKline group of companies.CloSYS is a registered trademark of Rowpar Pharmaceuticals.12Increased blood sugar and fat (cholesterol and triglyceride) levels in blood:Your health care provider should do blood tests to check your fasting blood sugar,cholesterol, and triglyceride levels in your blood before you start and duringtreatment with AFINITOR.Decreased blood cell counts: AFINITOR can cause you to have decreased redblood cells, white blood cells, and platelets. Your health care provider should doblood tests to check your blood cell counts before you start and during treatmentwith AFINITOR.What Else Do INeed to Know?Please see Important Safety Information throughout, and click here for fullPrescribing Information, including Patient Information.Important Safety Information (cont)Where Can I FindSavings & Support? I f you are using an over-the-counter mouthwash, please use it beforetaking your dexamethasone rinse. Make sure to use over-the-countermouthwash that does not contain alcohol, hydrogen peroxide, iodine,or thyme, because these ingredients may irritate your mouth. Biotene and CloSYS mouthwashes do not contain these ingredientsWorsening side effects from radiation treatment can sometimes be severe.Tell your health care provider if you have had or are planning to receive radiationtherapy.13
Share any side effectsyou’re experiencingWhat are common side effectsof AFINITOR?Common side effects of AFINITOR (everolimus) Tablets include: Infections Diarrhea Your doctor may change your dose of AFINITOR or tell you to temporarily stoptreatment, if needed Flexible dosing can be a normal part of treatment, and it helps your doctorfind the dose of AFINITOR that’s right for you You should not change or adjust your dose by yourself Always follow your doctor’s instructions, and contact your doctor or nurse ifyou are having any problemsHow DoesAFINITOR Work? Swelling of arms, hands, feet, ankles, face,or other parts of the body It is important that you report any side effects you’re experiencing as soon aspossible to your doctor or nurse Feeling weak or tired Rash Cough Nausea Decreased appetite Stomach-area (abdominal) pain HeadacheBefore taking AFINITOR, tell your health care provider about all your medicalconditions, including if you: Have or have had kidney problems Have or have had liver problems Have diabetes or high blood sugar Have high blood cholesterol levels Have any infections Absence of menstrual periods (menstruation). You may miss 1 or moremenstrual periods. Tell your health care provider if this happens Previously had hepatitis BWhere Can I FindSavings & Support?Other side effects that may occur with AFINITOR: AFINITOR may affect fertility in females and males, and may affect your abilityto become pregnant if you are female or your ability to father a child if you aremale. Talk to your health care provider if this is a concern for youHow Do I TakeAFINITOR? FeverImportant Safety Information (cont) A re scheduled to receive any vaccinations. You should not receive a live vaccineor be around people who have recently received a live vaccine during yourtreatment with AFINITOR. If you are not sure about the type of vaccine, askyour health care providerWhat Else Do INeed to Know?Please see Important Safety Information throughout, and click here for fullPrescribing Information, including Patient Information.1415
Please seeImportant SafetyInformationthroughout, andclick here forfull PrescribingInformation, includingPatient Information.Not an actual patientHow DoesAFINITOR Work?How Do I TakeAFINITOR?Where Can I FindSavings & Support?How doesAFINITOR16What Else Do INeed to Know?WORK?17
HR , HER2-negative metastatic breast cancer growthHow does AFINITOR plus exemestane work?Estrogen flows throughthe ER pathway, fuelingthe growth and spreadof cancerThe mTOR pathwayalso sends signals thatfuel cancer growthHR , HER2-negative breast cancer can grow in multiple ways—2 of which are the estrogen receptor (ER) pathway andthe mammalian target of rapamycin (mTOR) pathway.UP TOof breast cancer cases havechanges, or mutations, on themTOR pathway.*The bathtub—at risk of overflowing—representsthe growth and spread of cancer*PI3K/AKT/mTOR pathway.BLOCKING THE mTOR PATHWAY CAN HELP SLOWTHE GROWTH AND SPREAD OF CANCER CELLSExemestane limitsestrogen production tohelp block tumor growthAFINITOR blocks the mTORpathway, helping stop cancercells from growingHow Do I TakeAFINITOR?AFINITOR (everolimus) Tablets also affects noncancerous cells.Although AFINITOR has been studied in patients with advancedHR , HER2- breast cancer, how AFINITOR works has only beendemonstrated in laboratory settings.Treatment with AFINITOR plus exemestaneImportant Safety Information (cont) Are breastfeeding or plan to breastfeed. Do not breastfeed during treatmentand for 2 weeks after your last doseWhere Can I FindSavings & Support? Are pregnant, could become pregnant, or have a partner who could becomepregnant. AFINITOR can cause harm to your unborn baby. For femaleswho are able to become pregnant, your health care provider will give you apregnancy test before you start treatment with AFINITOR. You should useeffective birth control during treatment and for 8 weeks after your last doseof AFINITOR. Males with a female partner should use effective birth controlduring treatment and for 4 weeks after your last dose of AFINITORTogether, AFINITOR plus exemestane fight in 2 ways instead of 1Watch how AFINITOR exemestane work in ouranimated bathtub video at www.AFINITOR.com Have received radiation therapy or are planning to receive radiation therapyin the future18What Else Do INeed to Know? Are planning to have surgery or if you have had a recent surgery. You shouldstop taking AFINITOR at least 1 week before planned surgeryPlease see Important Safety Information throughout, and click here for fullPrescribing Information, including Patient Information.19
Please seeImportant SafetyInformationthroughout, andclick here forfull PrescribingInformation, includingPatient Information.Not an actual patientHow Do I TakeAFINITOR?Where Can I FindSavings & Support?How do20What Else Do INeed to Know?I TAKEAFINITOR?21
LLERC A NCC A NCERCECELYYLHow do I take AFINITOR?AFINITOR (everolimus) Tablets is a prescription medicine that is aonce-daily oral tablet. Your health care provider will prescribe the doseof AFINITOR that is right for you. Take AFINITOR exactly as prescribed.Your health care provider may change your dose, or temporarily interruptdosing, if needed.Take AFINITOR Tablets:Whole—not crushed,chewed, or brokenAt the same time eachday with a glass of waterAlways with food oralways without foodImportant Safety Information (cont) I f you take too much AFINITOR, contact your health care provider or goto the nearest hospital emergency room right away. Take the pack ofAFINITOR with you I f a dose is missed, it can be taken within 6 hours; if more than 6 hours havepassed, skip that dose and take AFINITOR as usual the next day Do not take 2 doses to replace a missed dose If you’re not sure what to do, call your health care providerWhat other important things should I know? D o not drink grapefruit juice or eat grapefruit during your treatmentwith AFINITOR. It may make the amount of AFINITOR in your bloodincrease to a harmful level S hare lists of all your prescription medicines, over-the-countermedicines, herbal supplements (St John’s wort), and vitamins with yourhealth care provider and your pharmacist. Talk with your health careprovider before starting any new medicine Y ou should have blood tests before you start AFINITOR and as neededduring your treatment. These will include tests to check your blood cellcount, kidney and liver function, cholesterol, and blood sugar levelsWhere Can I FindSavings & Support?Tell your health care provider about all of the medicines you take, includingprescription and nonprescription medicines, vitamins, and herbal supplements.Using AFINITOR with certain other medicines can cause serious side effects.Keep a list of medicines you take, and show it to your health care provider whenyou get a new medicine. Especially tell your health care provider if you takethe following:What if I take too much or miss a dose of AFINITOR? St John’s wort (Hypericum perforatum) Medicine for:º Seizuresº HIV-AIDSº Heart conditions or high blood pressure Medicines that weaken the immune system (your body’s ability to fightinfections and other diseases)22What Else Do INeed to Know?º Fungal infectionsº Bacterial infectionsº TuberculosisPlease see Important Safety Information throughout, and click here for fullPrescribing Information, including Patient Information.23
Not an actual patientPlease seeImportant SafetyInformationthroughout, andclick here forfull PrescribingInformation, includingPatient Information.Where Can I FindSavings & Support?Where can I find24What Else Do INeed to Know?SAVINGS &SUPPORT?25
Where can I find savings & support?The AFINITOR (everolimus) Tablets 0 Co-pay CardNovartis Oncology offers access to financial assistance for almost allNovartis Oncology products.Patient Support at AFINITOR.comHaving advanced HR , HER2- breast cancer isn’t easy, but it’s importantto know you’re not alone. There are many resources available atwww.AFINITOR.com to give you the support you need throughoutyour treatment.You may be eligible for immediate co-pay savings on your next prescription: Eligible patients with private insurance may pay 0 per month N ovartis will pay the remaining co-pay, up to 15,000 percalendar year, per product** Limitations apply. This offer is only available to patients with private insurance. The program isnot available for patients who are enrolled in Medicare, Medicaid, or any other federal or statehealth care program. Novartis reserves the right to rescind, revoke, or amend this programwithout notice. For full Terms and Conditions, visit Copay.NovartisOncology.com or call1-877-577-7756.{To find out if you are eligible for the UniversalCo-pay Program, call 1‑877‑577‑7756 or visitCopay.NovartisOncology.com.Issues with Insurance?We’ve Got It Covered: This program provides support forpatients taking AFINITOR throughout the insurance coverageand financial assistance process. If you’re not eligible for theAFINITOR Co-pay Card, our experts can help you get informationabout alternate sources of funding.Patient Support Program: Register for ongoing support designedespecially for you, including informative emails.Support Groups & Organizations: Find local and nationalcommunities that offer support for patients and caregivers copingwith advanced breast cancer.Patient Education Materials: Download helpful materialsthat can help you learn more about treatment with AFINITOR.If you don’t currently have insurance or are unsure of your coverage, weare still here to help. Please call 1-888-4-AFINITOR (1-888-423-4648)for more information.What Else Do INeed to Know?Please see Important Safety Information throughout, and click here for fullPrescribing Information, including Patient Information.2627
Not an actual patientPlease seeImportant SafetyInformationthroughout, andclick here forfull PrescribingInformation, includingPatient Information.What else do I28What Else Do INeed to Know?NEED TOKNOW?29
Important Safety Information (cont)What else do I NEED TO KNOW?Being an active participant is key to coping with your condition,working with your doctor, and learning what to expect from treatmentwith AFINITOR (everolimus) Tablets. Here are some tips, provided byother women with advanced breast cancer, that you may find helpful:Ask your health care provider or pharmacist if you are not sure if your medicineis one of those taken for the conditions listed above. If you are taking any medicinesfor the conditions listed above, your health care provider might need to prescribea different medicine or your dose of AFINITOR may need to be changed. Tell yourhealth care provider before you start taking any new medicine.You should not drink grapefruit juice or eat grapefruit during your treatmentwith AFINITOR. It may make the amount of AFINITOR in your blood increaseto a harmful level.Common side effects include the following: Don’t blame yourself—this is not your fault Be kind to yourself—let yourself feel your emotionsced Knowledge is power—learn everything you can about advanHR , HER2- breast cancerin your care, Take the lead and be assertive—the more involved you arethe better Don’t be afraid to ask questions that are important to you Bring a friend or caregiver with you to your appointmentsit and When you start experiencing a side effect, acknowledgecall your doctor right awayng record Keep a journal of your side effects so you have an ongoiof your experienceto support you Ask for help when you need it—the people in your life want Live your life as fully as possible Infections S tomach-area (abdominal) pain Rash Nausea Feeling weak or tired Fever Diarrhea Cough S welling of arms, hands, feet, ankles,face, or other parts of the body Headache Decreased appetiteOther side effects that may occur with AFINITOR: A bsence of menstrual periods (menstruation). You may miss 1 or moremenstrual periods. Tell your health care provider if this happens A FINITOR may affect fertility in females and males, and may affect your ability tobecome pregnant if you are female or your ability to father a child if you are male.Talk to your health care provider if this is a concern for youTell your health care provider if you have any side effect that bothers you or doesnot go away.These are not all the possible side effects of AFINITOR. For more information, askyour health care provider or pharmacist. Call your doctor for medical advice aboutside effects.You are encouraged to report negative side effects of prescription drugs to the FDA.Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.The brands listed are the trademarks or registered trademarks of their respectiveowners.Please see Important Safety Information throughout, and click here for full PrescribingInformation, including Patient Information.3031
Like ourAFINITOR (everolimus) TabletsConnections Facebook pageto get informational andinspirational updates.Visit www.AFINITOR.com to learn more—and explore resources that can support youduring your treatment.Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936-1080 2021 Novartis5/21122624
Severe allergic reactions: Call your health care provider or get medical help right away if you get signs and symptoms of a severe allergic reaction including rash, itching, hives, flushing, trouble breathing or swallowing, chest pain, or dizziness. Possible increased risk for an allergic reaction called angioedema in people
