This post was developed in collaboration with Novartis
During a Sunday phone call 15 years ago, Mitch learned he had leukemia from a doctor who talked so fast, Mitch couldn’t make out his name. His own doctor had told him the day before that his white blood cell count was off on his recent blood tests, and she wanted him to see a specialist right away. She never mentioned leukemia. Being a “broad brushstroke kind of guy,” Mitch didn’t ask questions. He’d learn what was up from the specialist, he thought.
When the fast‐talking doctor called, he asked Mitch a litany of questions about his health. “‘Did you ever have this? Did you ever feel that?’” Mitch remembered him asking. When Mitch responded no to all the questions, the doctor said, “That’s great, because with leukemia we tend to think of these things.” He then told Mitch to have a good day and hung up!
“My wife was out with a girlfriend and I was alone,” said Mitch, a small business owner in Biddeford, ME, who was 45 years old at the time. “I was in a mild state of shock. When you hear the word ‘leukemia’, it doesn’t exactly conjure up the idea that this will be fine.” He tried not to dwell on it for the rest of the day. “I’ll know what I’ll be facing when I see the specialist tomorrow,” Mitch remembered thinking. He never learned the identity of fast talker. He just knows that was probably the worst phone call of his life.
“It’s the classic signature of Ph+ CML, and we’ve got to get your white blood cell count down,” the specialist matter-of-factly told Mitch. “You’d be in the hospital if the count was any higher. After that, we’re going to introduce you to a drug that’s been very successful in treating this type of leukemia,” the doctor explained to Mitch.
Ph+ CML are the initials for Philadelphia chromosome–positive chronic myeloid leukemia – a type of blood and bone marrow cancer which is associated with a mutation in the genes called the Philadelphia (Ph) chromosome. This triggers the bone marrow to grow abnormal white blood cells uncontrollably. This form of leukemia is most often diagnosed in people over 60, but can occur in younger adults, as it did with Mitch.
The specialist made it clear that Mitch had a serious illness known as Ph+ CML in chronic phase and needed treatment. Other than feeling “a little tired and out of sorts,” Mitch said he had no other symptoms. “I was working 60 or 70 hours a week. Being tired and feeling out of sorts at times is part and parcel of the whole thing, so I didn’t think anything of it,” Mitch noted.
THE TREATMENT JOURNEY: BUMPY, THEN SMOOTH SAILING
Over the next five years, Mitch’s leukemia was treated with two drugs, and while they kept his white blood cell count in check, he faced unfortunate side effects. Fortunately, another drug – Tasigna® (nilotinib) capsules – had received FDA approval by this time, and patients like Mitch, who endured side effects with other drugs, were having some success with this one. Tasigna can cause side effects, however, such as headache, nausea and potentially other serious outcomes.
Mitch has been taking Tasigna twice a day for the last 10 years, and his white blood cell count is under control. While the experience with Tasigna is different for every patient, Mitch has not reported experiencing side effects “worth mentioning.” After his doctors cautioned him about a potential side effect called QTc prolongation, a serious and possibly life‐threatening heart problem that causes an irregular heartbeat, Mitch is careful to note if he becomes lightheaded, faint or senses an irregular heartbeat.
Mitch is proud of his role in his treatment process for Ph+ CML: Going for blood work every single week, at first, to determine his white blood count and giving bone marrow samples once a month. “It’s like ice core drilling in the Arctic,” Mitch jested. “They use a small core drill to take marrow from my hip.” He takes Tasigna twice a day, 12 hours apart. What’s more, he also can’t eat for two hours before and one hour after his dose.
“It’s my responsibility to honor the process,” Mitch advised. “You really need to be engaged in your treatment. How can I expect the most out of my doctor if I’m not giving it my best? I’m part of a club and I have an obligation to follow the rules. It’s not just about me; it’s about my family. And, it’s about the thousands of people who worked incredibly hard to bring this drug to market, which makes an impact on the lives of thousands every year.”
Mitch hopes his own experience will help others who have been diagnosed with Ph+ CML, which is why he’s excited to be part of an important Tasigna campaign called Your Blood Demands to Be Heard. “If you own your treatment journey every step of the way, as I’ve owned mine, you can have a better chance for success,” he stressed.
This 15‐year veteran of Ph+ CML also offered seven specific strategies on how he successfully incorporated his treatment into his life:
➠ JUGGLING ON AND OFF DAYS: “You will learn how to predict good days and bad days and operate accordingly. When I became tired, I’d have to be mindful that it wasn’t safe to climb ladders in my job or walk as far and as long as I once did. I knew my clients wanted to see me being engaged and energetic, so I’d reserve those activities for the good days.”
➠ USING KNOWLEDGE AS POWER: “I made sure to completely understand early on what I needed to do, when I needed to do it, and what was supposed to be happening with my body. Be mindful of side effects. I was probably a little more ignorant than I should have been.”
➠ SHOWING UP: “Monitoring your blood count is a key part of the process, so when the doctor told me to show up for blood work or other testing, I knew I had to show up.”
➠ MINDING THE MEDS: “You might feel so good, you decide to stop taking the meds. But you shouldn’t change your routine without discussing it with your doctor.”
➠ LOOKING AT THE BIG PICTURE: “You have to play an active part in your treatment. I’m not engaged in the minutiae, in all the numbers and information the doctors must review, but I always discuss my test results with the doctor or a nurse. I want to know whether everything looks good or whether I had a blip that month. I’m more thumbs up or thumbs down. How am I doing this week and this month? Other patients want to know every number and what it means, but that’s not me.”
➠ SETTING THE TIMES FOR TASIGNA: “It might take a while to establish a comfortable routine for taking the medication, since you need it two hours before a meal, and you can’t eat for an hour after the dose. Mornings are super easy for me, since I usually wake up at 6 am and I don’t typically eat breakfast until 8 am. I put the pill on the table next to the bed, pop it in at 6 am and go back to sleep. The timing is more difficult for me in the evening if I’m having dinner with a client or a friend than when I’m home with my wife. It’s not mind‐bending advice, but you have to figure it out on your own.”
➠ TRUSTING YOUR DOCS: “It’s more important that I trust the competence and the capability of my doctors and key members of their staff. If that breaks down, I’d look for someone else I can trust. It’s great if you like them, too, but not essential.”
Mitch says his disease is under control, but he’ll likely be on Tasigna for the rest of his life. His blood is tested every six months, and he doesn’t need bone marrow checks at this point, unless something unusual were to show up in his blood. Does he worry? “Heck yeah, every six months it’s like the biggest job interview of my life or waiting to get the biggest contract. I know that Ph+ CML will forever be part of my life, but it doesn’t have to sit at the head of the table. It can sit off to the side just as long as I recognize that it’s there,” he said.
Know your blood count, what the numbers mean, and get a treatment that can help.
TASIGNA® (nilotinib) capsules is a prescription medicine used to treat:
• Adults with newly diagnosed Philadelphia chromosome–positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
• Adults with Ph+ CML in chronic phase and accelerated phase who no longer benefit from, or did not tolerate, other treatment, including GLEEVEC® (imatinib)
IMPORTANT SAFETY INFORMATION ABOUT TASIGNA® (nilotinib) Capsules
TASIGNA can cause serious side effects that can even lead to death. During treatment with TASIGNA your doctor will do tests to check for side effects. These tests will check your heart, blood cells (white blood cells, red blood cells, and platelets), electrolytes (potassium, magnesium), cholesterol, blood sugar, and pancreas and liver function. Your doctor may have you stop TASIGNA for some time or lower your dose if you have side effects. You should follow your doctor’s instructions. Serious side effects include:
• Low Blood Counts: Low blood counts are common with TASIGNA but can also be severe. Your doctor will check your blood counts regularly during treatment with TASIGNA. Call your doctor right away if you have symptoms of low blood counts including:
° Fever, chills, or other signs of infection
° Unexplained bleeding or bruising
° Shortness of breath
° Unexplained weakness
• Decreased Blood Flow to the Legs, Heart, or Brain: People who have recently been diagnosed with Ph+ CML and take TASIGNA may develop decreased blood flow to the legs, heart, or brain. Get medical help right away if you suddenly develop any of the following symptoms:
° Chest pain or discomfort
° Numbness or weakness
° Problems walking or speaking
° Leg pain or your leg feels cold
° Change in the skin color of your leg
• Pancreas Inflammation (Pancreatitis): Call your doctor if you have symptoms including sudden stomach area pain with nausea and vomiting
• Liver Problems: TASIGNA can increase your risk of liver problems. People who have had liver problems in the past may be at risk for getting liver problems with TASIGNA. Call your doctor, or get medical help right away if you develop any symptoms of liver problems including stomach area (abdominal) pain, yellow skin/eyes, and dark‐colored urine
• Tumor Lysis Syndrome (TLS): TLS is caused by a fast breakdown of cancer cells. Your doctor may do blood tests to check you for TLS. TLS can cause you to have kidney failure (with the need for dialysis treatment) and/or an abnormal heartbeat
• Bleeding Problems: Serious bleeding problems and death have happened during treatment with TASIGNA. Call your doctor right away if you develop signs and symptoms of bleeding such as uncontrolled bleeding, changes in eyesight, unconsciousness, sudden headache, or sudden confusion about your surroundings
• Total Gastrectomy: Tell your doctor if you have had a surgical procedure involving the removal of the entire stomach (total gastrectomy). Your doctor may need to change your dose
• Lactose: Tell your doctor if you have a severe problem with lactose (milk sugar) or other sugars. TASIGNA capsules contain lactose. Most people who have mild or moderate lactose intolerance can take TASIGNA
• Fluid Retention: Your body may hold too much fluid (fluid retention). Symptoms of fluid retention include shortness of breath, rapid weight gain, and swelling
• Abnormal Growth or Development in Children: Effects on growth and development have happened in children with chronic phase Ph+ CML during treatment with TASIGNA. Some children and adolescents who take TASIGNA may have slower than normal growth
• Pregnancy and Breastfeeding: TASIGNA should not be used during pregnancy since it may harm an unborn baby. If you become pregnant, think you may be pregnant, or are planning to become pregnant, tell your doctor right away. If you are able to become pregnant, your doctor should perform a pregnancy test before you start TASIGNA. Effective birth control should be used during treatment and for at least 14 days after your last TASIGNA dose. Do not breastfeed during treatment with TASIGNA and for at least 14 days after the final dose
• Treatment‐Free Remission in Adults: Your doctor will monitor your CML during treatment with TASIGNA to see if you are in remission. After at least 3 years of treatment with TASIGNA, your doctor may do certain tests to determine if you continue to be in remission. Based on your test results, your doctor will decide if you are eligible to try stopping treatment with TASIGNA. This is called treatment‐free remission (TFR)
° Your doctor will carefully monitor your CML during and after you stop taking TASIGNA. If your test results show your CML is no longer in remission, your doctor will restart TASIGNA treatment
° It is important that your doctor does frequent monitoring to find out if you need to restart your TASIGNA treatment. Follow your doctor’s instructions about restarting TASIGNA if you are no longer in TFR
• Drug Interactions: TASIGNA can interact with many medicines and supplements. This may increase your chances for serious and life‐threatening side effects. Tell your doctor about all the medicines you take including prescription and over‐the‐counter medicines, vitamins, and herbal supplements
If you need to take antacids (medicines to treat heartburn) do not take them at the same time that you take TASIGNA. If you take:
° A medicine to block the amount of acid produced in the stomach (H2 blocker): Take these medicines about 10 hours before you take TASIGNA or about 2 hours after you take TASIGNA
° An antacid that contains aluminum hydroxide, magnesium hydroxide,and simethicone to reduce the amount of acid in the stomach: Take these medicines about 2 hours before or about 2 hours after you take TASIGNA
• Common Side Effects in Adults and Children Include:
• Nausea • Diarrhea • Rash • Cough
• Headache • Constipation • Tiredness • Muscle and joint pain
• Itching • Vomiting • Fever • Night sweats
• Runny or stuffy nose, sneezing, sore throat
• Side Effects in Adults Attempting TFR: If you and your doctor decide that you can stop taking TASIGNA and try TFR, you may have more muscle and bone (musculoskeletal) symptoms than before you stopped treatment. Symptoms may include muscle pain, bone pain, arm and leg pain, spinal pain, and joint pain
Tell your doctor if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of TASIGNA. For more information, ask your doctor or pharmacist.
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.
Please see the full Prescribing Information, including the Boxed WARNING, and the TASIGNA Medication Guide.
1. American Cancer Society. Chronic Myeloid Leukemia (CML), About Chronic Myeloid Leukemia. 22 February 2016. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8684.00.pdf. Accessed November 2019
2. Tasigna [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2019