Getting started on Otezla Your guide to starting and staying on treatment Otezla (apremilast) is a prescription medicine approved for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. Otezla is a prescription medicine approved for the treatment of adult patients with active psoriatic arthritis. Please see Important Safety Information on back cover.
What is psoriasis? Psoriasis is an autoimmune disease that causes scaly, red patches covered with a silvery white buildup to appear on the skin. The patches most commonly occur on the knees, elbows, lower back, and scalp. Approved use Otezla (apremilast) is a prescription medicine approved for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. Proven in clinical studies Otezla isn t a cream. It s not an injection. It s a daily pill that can help treat moderate to severe plaque psoriasis in a different way. Some people who took Otezla saw clearer skin after 4 months. Otezla reduced: u Redness u Scaliness u Skin thickness Selected Safety Information You must not take Otezla if you are allergic to apremilast or to any of the ingredients in Otezla. Otezla is associated with an increase in adverse reactions of depression. In clinical studies, some patients reported depression and suicidal behavior while taking Otezla (apremilast). Some patients stopped taking Otezla due to depression. Before starting Otezla, tell your doctor if you have had feelings of depression, suicidal thoughts, or suicidal behavior. Be sure to tell your doctor if any of these symptoms or other mood changes develop or worsen during treatment with Otezla. Some patients taking Otezla lost body weight. Your doctor should monitor your weight regularly. If unexplained or significant weight loss occurs, your doctor will decide if you should continue taking Otezla. Please see additional Important Safety Information on back cover. Plaque Psoriasis Want more info? Visit otezla.com. 2 3
What is psoriatic arthritis? Psoriatic arthritis is an autoimmune disease that causes tender and swollen joints. Symptoms of psoriatic arthritis include: u Tenderness, pain, and swelling of tendons u Swollen fingers and toes u Stiffness, pain, throbbing, swelling, and tenderness in one or more joints Approved use Otezla (apremilast) is a prescription medicine approved for the treatment of adult patients with active psoriatic arthritis. Proven in clinical studies Selected Safety Information Side effects of Otezla were diarrhea, headache, nausea, nasal congestion, sore throat, upper respiratory tract infection, vomiting, and stomach pain. These are not all the possible side effects with Otezla (apremilast). Tell your doctor about any side effect that bothers you or does not go away. Please see additional Important Safety Information on back cover. Want more info? Visit otezla.com. Psoriatic Arthritis Otezla isn t an injection. It s a daily pill that treats active psoriatic arthritis in a different way. Some people who took Otezla for 4 months had improvements in their joint swelling and joint tenderness. Some people in these studies also experienced significant improvement in: u Physical activities of daily living u Joint pain u Swelling of joints affected by psoriatic arthritis (fingers, toes, knees, and heels) 4 5
Why Otezla (apremilast)? Otezla (apremilast) is different. It s a daily pill that can help treat people with moderate to severe plaque psoriasis or active psoriatic arthritis. Otezla is different u Otezla is not an injection u Otezla is not a cream u Otezla works from inside the body to help reduce inflammation u Otezla is taken twice daily as directed by your doctor u Otezla is taken once in the morning and once at night, every day u For people with severe kidney disease, Otezla is one pill a day Take Otezla exactly as directed by your doctor. Selected Safety Information Some medicines may make Otezla less effective, and should not be taken with Otezla. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines. Tell your doctor if you are pregnant, planning to become pregnant or planning to breastfeed. Otezla (apremilast) has not been studied in pregnant women or in women who are breastfeeding. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-332-1088. Please see additional Important Safety Information on back cover. Want more info? Visit otezla.com. Why Otezla? 6 7
Getting started Begin taking the Otezla (apremilast) pills in your Starter Pack exactly as directed by your doctor. Expect a phone call Within the next few days, you will receive a call from your specialty pharmacy, which may show up as an unfamiliar or an unknown number on your caller ID. Expect a package Your prescription of Otezla will be delivered directly to you from the specialty pharmacy. Get in touch Need a little help? Have questions about what to expect? Give us a ring at 1-844-4OTEZLA (1-844-468-3952), and our SupportPlus advocates will get things sorted out. We re available 8 am 8 pm ET, Monday Friday. What is a specialty pharmacy? Specialty pharmacies provide medication for chronic health care conditions, such as psoriasis and psoriatic arthritis. Your specialty pharmacy will coordinate delivery of your Otezla prescription, and offer support, including access to pharmacists, refill reminders when you re running low on medication, and more. Getting your prescription is easy u Your doctor will send your Otezla (apremilast) prescription directly to a specialty pharmacy u The speciality pharmacy will give you a call, and will work with you to make sure you get your Otezla u That means you don t have to worry about going to your local pharmacy to pick up Otezla. It ll come to you! Ask about savings Want to make sure you re taking advantage of all the benefits available to you? Ask your specialty pharmacy about financial assistance and how you may be able to pay $0 for Otezla each month.* * Certain restrictions apply. This offer is not valid for persons eligible for reimbursement of this product, in whole or in part, under Medicaid, Medicare, or similar state or federal programs. Offer void where prohibited by law. Please see Important Safety Information on back cover. Taking Otezla 8 9
Your first 2 weeks Take Otezla (apremilast) only as directed by your doctor. You should have received a Starter Pack, which contains your first 2 weeks of Otezla. The first 5 days of treatment is called the titration period, which means you ll gradually increase your dose over 5 days until you reach the recommended dose of 30 mg twice a day. Day 1: Take only one 10-mg pill in the morning Day 2: Take one 10-mg pill in the morning and one 10-mg pill at night Day 3: Take one 10-mg pill in the morning and one 20-mg pill at night Day 4: Take one 20-mg pill in the morning and one 20-mg pill at night Day 5: Take one 20-mg pill in the morning and one 30-mg pill at night Days 6-14: Take one 30-mg pill in the morning and one 30-mg pill at night Taking Otezla Once you complete your Starter Pack, you should take one pill in the morning, and one at night. If you have severe kidney disease, be sure to talk to your doctor about how to take Otezla. Please see additional dosing information on page 12 and Important Safety Information on back cover. 10 11
Taking Otezla twice a day, every day A few things to know about taking Otezla (apremilast) each day: u Otezla is one pill in the morning, and one at night u Otezla can be taken with or without food u Do not crush, split, or chew the pill Once you ve completed your Starter Pack as directed by your doctor, you ll receive your Otezla in the mail via a specialty pharmacy. For people with severe kidney disease, Otezla is one pill a day. Selected Safety Information Taking Otezla Some medicines may make Otezla less effective, and should not be taken with Otezla. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines. Please see additional Important Safety Information on back cover. 12 13
Proven results For plaque psoriasis In clinical studies, Otezla (apremilast) reduced the redness, thickness, and scaliness of plaque psoriasis. For psoriatic arthritis Some people who took Otezla for 4 months had improvements in their joint swelling and joint tenderness. Some people in these studies also experienced significant improvement in physical activities of daily living, joint pain, and swelling of joints affected by psoriatic arthritis (fingers, toes, knees, and heels). Side effects Side effects of Otezla in psoriasis clinical studies were diarrhea, nausea, upper respiratory tract infection, tension headache, and headache. Side effects of Otezla in psoriatic arthritis clinical studies were diarrhea, nausea, and headache. The majority of patients reporting nausea and diarrhea did so within the first 2 weeks of treatment, and these events tended to resolve over time with continued dosing. Effectiveness and Side Effects Please see Important Safety Information on back cover. 14 15
Staying on treatment Otezla (apremilast) is taken daily as directed by your doctor. Do not stop taking Otezla unless directed by your doctor. After you complete your 5-day titration period, keep in mind: Take one pill in the morning and one pill at night Keep your Otezla bottle where you can see it Store tablets below 30 C (86 F) Connect taking your medication to something you do each day, such as after you brush your teeth If you have severe kidney disease, speak to your doctor about how to take Otezla. Please see Important Safety Information on back cover. Staying on Otezla 16 Actual Otezla patient. 17
Take advantage of Otezla SupportPlus Introducing SupportPlus : a support program here to help you with every step of your treatment Co-pay You could get Otezla for $0 per month.* Call 1-844-4OTEZLA (1-844-468-3952) for eligibility information and insurance support from a reimbursement advocate (8 AM 8 PM ET, Monday Friday). * Certain restrictions apply. This offer is not valid for persons eligible for reimbursement of this product, in whole or in part, under Medicaid, Medicare, or similar state or federal programs. Offer void where prohibited by law. Join the program and you ll receive information about: u $0 co-pay* and other offers. Eligibility restrictions apply. Please call for details u Comprehensive insurance support from a reimbursement advocate (8 AM 8 PM ET, Monday Friday) u Information about what to expect when taking Otezla (apremilast) u 24/7 access to specially trained nurses Connect to the Otezla SupportPlus program Visit otezla.com or call 1-844-4OTEZLA (1-844-468-3952). Please see Important Safety Information on back cover. 18 19 SupportPlus
APPROVED USES Otezla (apremilast) is a prescription medicine approved for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. Otezla is a prescription medicine approved for the treatment of adult patients with active psoriatic arthritis. IMPORTANT SAFETY INFORMATION You must not take Otezla if you are allergic to apremilast or to any of the ingredients in Otezla. Otezla is associated with an increase in adverse reactions of depression. In clinical studies, some patients reported depression and suicidal behavior while taking Otezla. Some patients stopped taking Otezla due to depression. Before starting Otezla, tell your doctor if you have had feelings of depression, suicidal thoughts, or suicidal behavior. Be sure to tell your doctor if any of these symptoms or other mood changes develop or worsen during treatment with Otezla. Some patients taking Otezla lost body weight. Your doctor should monitor your weight regularly. If unexplained or significant weight loss occurs, your doctor will decide if you should continue taking Otezla. Some medicines may make Otezla less effective, and should not be taken with Otezla. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines. Side effects of Otezla were diarrhea, nausea, upper respiratory tract infection, tension headache, and headache. These are not all the possible side effects with Otezla. Ask your doctor about other potential side effects. Tell your doctor about any side effect that bothers you or does not go away. Tell your doctor if you are pregnant, planning to become pregnant or planning to breastfeed. Otezla has not been studied in pregnant women or in women who are breastfeeding. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-332-1088. Please click here for full Prescribing Information. Otezla is a registered trademark of Celgene Corporation. 2014 Celgene Corporation 09/14 USII-APR140112a