14.6 Pediatric Plaque Psoriasis
A 48-week, randomized, double-blind, placebo-controlled study enrolled 211 pediatric subjects 4 to 17 years of age, with moderate to severe plaque psoriasis (PsO) (as defined by a sPGA score ≥ 3 [moderate, marked, or severe], involving ≥ 10% of the body surface area, and a PASI score ≥ 12) who were candidates for phototherapy or systemic therapy, or were inadequately controlled on topical therapy. Subjects in all treatment groups had a median baseline PASI score of 16.4, and the percentage of subjects with baseline sPGA classifications was 65% for moderate, 31% for marked, and 3% for severe. Across all treatment groups, the percentage of subjects who previously received systemic or phototherapy for PsO was 57%.
Subjects received Enbrel 0.8 mg/kg (up to a maximum of 50 mg per dose) or placebo once weekly for the first 12 weeks. After 12 weeks, subjects entered a 24-week open-label treatment period, in which all subjects received Enbrel at the same dose. This was followed by a 12-week withdrawal-retreatment period.
Response to treatment was assessed after 12 weeks of therapy and was defined as the proportion of subjects who achieved a reduction in PASI score of at least 75% from baseline. The PASI is a composite score that takes into consideration both the fraction of body surface area affected and the nature and severity of psoriatic changes within the affected regions (induration, erythema and scaling).
Other evaluated outcomes included the proportion of subjects who achieved a score of “clear” or “almost clear” by the sPGA and the proportion of subjects with a reduction in PASI score of at least 90% from baseline. The sPGA is a 6-category scale ranging from “5 = severe” to “0 = none” indicating the physician’s overall assessment of the PsO severity focusing on induration, erythema and scaling. Treatment success of “clear” or “almost clear” consisted of none or minimal elevation in plaque, up to faint red coloration in erythema and none or minimal fine scale over < 5% of the plaque.
Efficacy results are summarized in Table 15.
Table 15. Pediatric Plaque Psoriasis Outcomes at 12 Weeks
| ||Placebo(N = 105) ||Enbrel0.8 mg/kg Once Weekly(N = 106) |
|PASI 75, n (%) ||12 (11%) ||60 (57%) |
|PASI 90, n (%) ||7 (7%) ||29 (27%) |
|sPGA “clear” or “almost clear” n (%) ||14 (13%) ||55 (52%) |
Maintenance of Response
To evaluate maintenance of response, subjects who achieved PASI 75 response at Week 36 were re-randomized to either Enbrel or placebo during a 12-week randomized withdrawal period. The maintenance of PASI 75 response was evaluated at Week 48. The proportion of subjects who maintained PASI 75 response at Week 48 was higher for subjects treated with Enbrel (65%) compared to those treated with placebo (49%).
- National Cancer Institute. Surveillance, Epidemiology, and End Results Database (SEER) Program. SEER Incidence Crude Rates, 13 Registries, 1992-2002.
- Bröms G, Granath F, Ekbom A, et al. Low Risk of Birth Defects for Infants Whose Mothers Are Treated With Anti-Tumor Necrosis Factor Agents During Pregnancy. Clin Gastroenterol Hepatol. 2016;14:234-241.e5
16 HOW SUPPLIED/STORAGE AND HANDLING
NDC: 50090-3531-0 1 mL in a KIT
17 PATIENT COUNSELING INFORMATION
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use) before the patient starts using Enbrel, and each time the prescription is renewed, as there may be new information they need to know.
Patients or their caregivers should be provided the Enbrel “Medication Guide” and provided an opportunity to read it and ask questions prior to initiation of therapy. The healthcare provider should ask the patient questions to determine any risk factors for treatment. Patients developing signs and symptoms of infection should seek medical evaluation immediately.
Patients should be advised of the potential benefits and risks of Enbrel. Physicians should instruct their patients to read the Medication Guide before starting Enbrel therapy and to reread each time the prescription is renewed.
Inform patients that Enbrel may lower the ability of their immune system to fight infections. Advise patients of the importance of contacting their doctor if they develop any symptoms of infection, tuberculosis or reactivation of hepatitis B virus infections.
Other Medical Conditions
Advise patients to report any signs of new or worsening medical conditions, such as central nervous system demyelinating disorders, heart failure or autoimmune disorders, such as lupus-like syndrome or autoimmune hepatitis. Counsel about the risk of lymphoma and other malignancies while receiving Enbrel. Advise patients to report any symptoms suggestive of a pancytopenia, such as bruising, bleeding, persistent fever or pallor.
Advise patients to seek immediate medical attention if they experience any symptoms of severe allergic reactions. Advise latex-sensitive patients that the following components contain dry natural rubber (a derivative of latex) that may cause allergic reactions in individuals sensitive to latex: the needle cover of the prefilled syringe, the needle cover within the white cap of the SureClick autoinjector, and within the purple cap of the Enbrel Mini cartridge.
Administration of Enbrel
If a patient or caregiver is to administer Enbrel, the patient or caregiver should be instructed in injection techniques and how to measure and administer the correct dose [see the Enbrel (etanercept) “Instructions for Use” insert]. For weight-based dosing, instruct caregivers and patients on the proper techniques for preparing, storing, measuring, and administering Enbrel solution in a single-dose vial or reconstituted lyophilized powder in a multiple-dose vial.
The first injection should be performed under the supervision of a qualified healthcare professional. The patient’s or caregiver’s ability to inject subcutaneously should be assessed. Patients and caregivers should be instructed in the technique, as well as proper syringe and needle disposal, and be cautioned against reuse of needles and syringes.
When using the SureClick autoinjector to administer Enbrel, the patient or caregiver should be informed that the window turns yellow when the injection is complete. After removing the autoinjector, if the window has not turned yellow, or if it looks like the medicine is still injecting, this means the patient has not received a full dose. The patient or caregiver should be advised to call their healthcare provider immediately.
When using the AutoTouch reusable autoinjector to administer Enbrel, the patient or caregiver should be informed that the status button turns green upon contact with the skin, flashes green after starting the injection, and turns off at completion of the injection. After removing the AutoTouch reusable autoinjector from the skin, if the status button has turned red, the patient or caregiver should be advised to call 1-888-4Enbrel (1-888-436-2735) immediately. If it looks like the medicine is still injecting or there is still fluid in Enbrel Mini, this means the patient has not received a full dose. The patient or caregiver should be advised to call their healthcare provider immediately.
A puncture-resistant container for disposal of needles, syringes, SureClick autoinjectors, single-dose vials, and Enbrel Mini cartridges should be used. If the product is intended for multiple use, additional syringes, needles and alcohol swabs will be required.
Patients can be advised to call 1-888-4ENBREL (1-888-436-2735) or visit www.enbrel.com for more information about Enbrel.
Thousand Oaks, CA 91320-1799
U.S. License Number 1132
© 1998-2021 Immunex Corporation. All rights reserved.1XXXXXX – v67
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|This Medication Guide has been approved by the U.S. Food and Drug Administration.||Revised: 03/2020|
|Medication Guide |
|Enbrel® (en-brel) (etanercept)injection, for subcutaneous use||Enbrel® (en-brel) (etanercept) for injection, for subcutaneous use|
|Read the Medication Guide that comes with Enbrel before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or treatment. It is important to remain under your healthcare provider’s care while using Enbrel.Enbrel is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker that affects your immune system.|
What is the most important information I should know about Enbrel? Enbrel may cause serious side effects, including:1. Risk of Infection2. Risk of Cancer1. Risk of infection Enbrel can lower the ability of your immune system to fight infections. Some people have serious infections while taking Enbrel. These infections include tuberculosis (TB), and infections caused by viruses, fungi, or bacteria that spread throughout their body. Some people have died from these infections.
You should not start taking Enbrel if you have any kind of infection unless your healthcare provider says it is okay. 2. Risk of cancer
- Your healthcare provider should test you for TB before starting Enbrel.
- Your healthcare provider should monitor you closely for symptoms of TB during treatment with Enbrel even if you tested negative for TB.
- Your healthcare provider should check you for symptoms of any type of infection before, during, and after your treatment with Enbrel.
- There have been cases of unusual cancers, some resulting in death, in children and teenage patients who started using TNF-blocking agents at less than 18 years of age.
- For children, teenagers, and adults taking TNF-blocker medicines, including Enbrel, the chances of getting lymphoma or other cancers may increase.
- People with rheumatoid arthritis, especially those with very active disease, may be more likely to get lymphoma.
Before starting Enbrel, be sure to talk to your healthcare provider:
Infections. Tell your healthcare provider if you:
Also, before starting Enbrel, tell your healthcare provider:
- have an infection. See “What is the most important information I should know about Enbrel?”
- are being treated for an infection.
- think you have an infection.
- have symptoms of an infection such as fever, sweats or chills, cough or flu-like symptoms, shortness of breath, blood in your phlegm, weight loss, muscle aches, warm, red or painful areas on your skin, sores on your body, diarrhea or stomach pain, burning when you urinate or urinating more often than normal, and feel very tired.
- have any open cuts on your body.
- get a lot of infections or have infections that keep coming back.
- have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance for infections.
- have TB, or have been in close contact with someone with TB.
- were born in, lived in, or traveled to countries where there is a risk for getting TB. Ask your healthcare provider if you are not sure.
- live, have lived in, or traveled to certain parts of the country (such as the Ohio and Mississippi River valleys, or the Southwest) where there is a greater risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, blastomycosis). These infections may happen or become more severe if you use Enbrel. Ask your healthcare provider if you do not know if you live or have lived in an area where these infections are common.
- have or have had hepatitis B.
Keep a list of all your medications with you to show your healthcare provider and pharmacist each time you get a new medicine. Ask your healthcare provider if you are not sure if your medicine is one listed above.Other important medical information you should tell your healthcare provider before starting Enbrel, includes if you:
- About all the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements including:
- Orencia (abatacept) or Kineret (anakinra). You have a higher chance for serious infections when taking Enbrel with Orencia or Kineret.
- Cyclophosphamide (Cytoxan). You may have a higher chance for getting certain cancers when taking Enbrel with cyclophosphamide.
- Anti-diabetic medicines. If you have diabetes and are taking medication to control your diabetes, your healthcare provider may decide you need less anti-diabetic medicine while taking Enbrel.
See the section “What are the possible side effects of Enbrel?” below for more information.
- have or had a nervous system problem such as multiple sclerosis or Guillain-Barré syndrome.
- have or had heart failure.
- are scheduled to have surgery.
- have recently received or are scheduled to receive a vaccine.
- All vaccines should be brought up-to-date before starting Enbrel.
- People taking Enbrel should not receive live vaccines.
- Ask your healthcare provider if you are not sure if you received a live vaccine.
- are allergic to rubber or latex.
- The needle covers on the single-dose prefilled syringes, the needle covers within the white caps on the single-dose prefilled SureClick autoinjectors, and within the purple caps of the Enbrel Mini cartridges contain dry natural rubber.
- have been around someone with varicella zoster (chicken pox).
- are pregnant or plan to become pregnant. It is not known if Enbrel will harm your unborn baby. If you took Enbrel during pregnancy, talk to your healthcare provider prior to administration of live vaccines to your infant.
- are breastfeeding or plan to breastfeed. Enbrel can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby while taking Enbrel.
|What is Enbrel? Enbrel is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker. Enbrel is used to treat: |
You may continue to use other medicines that help treat your condition while taking Enbrel, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and prescription steroids, as recommended by your healthcare provider. Enbrel can help reduce joint damage and the signs and symptoms of the above-mentioned diseases. People with these diseases have too much of a protein called tumor necrosis factor (TNF), which is made by your immune system. Enbrel can reduce the effect of TNF in the body and block the damage that too much TNF can cause, but it can also lower the ability of your immune system to fight infections. See “What is the most important information I should know about Enbrel?” and “What are the possible side effects of Enbrel?”
- moderately to severely active rheumatoid arthritis (RA). Enbrel can be used alone or with a medicine called methotrexate.
- moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in children ages 2 years and older.
- psoriatic arthritis (PsA). Enbrel can be used alone or with methotrexate.
- ankylosing spondylitis (AS).
- chronic moderate to severe plaque psoriasis (PsO) in children 4 years and older and adults who may benefit from taking injections or pills (systemic therapy) or phototherapy (ultraviolet light).
|Who should not use Enbrel?Do not use Enbrel if you: |
- have an infection that has spread through your body (sepsis).
|How should I use Enbrel? |
- Enbrel is given as an injection under the skin (subcutaneous or SC).
- If your healthcare provider decides that you or a caregiver can give the injections of Enbrel at home, you or your caregiver should receive training on the right way to prepare and inject Enbrel. Do not try to inject Enbrel until you have been shown the right way by your healthcare provider or nurse.
- Enbrel is available in the forms listed below. Your healthcare provider will prescribe the type that is best for you.
- Single-dose Prefilled Syringe
- Single-dose Prefilled SureClick Autoinjector
- Single-dose Vial
- Multiple-dose Vial
- Enbrel Mini single-dose cartridge for use with the AutoTouch reusable autoinjector
- See the detailed “Instructions for Use” with this Medication Guide for instructions about the right way to store, prepare, and give your Enbrel injections at home.
- Your healthcare provider will tell you how often you should use Enbrel. Do not miss any doses of Enbrel. If you forget to use Enbrel, inject your dose as soon as you remember. Then, take your next dose at your regular(ly) scheduled time. In case you are not sure when to inject Enbrel, call your healthcare provider or pharmacist. Do not use Enbrel more often than as directed by your healthcare provider.
- Your child’s dose of Enbrel depends on his or her weight. Your child’s healthcare provider will tell you which form of Enbrel to use and how much to give your child.
What are the possible side effects of Enbrel? Enbrel can cause serious side effects, including:
Common side effects of Enbrel include:
- See “What is the most important information I should know about Enbrel?”
- Infections. Enbrel can make you more likely to get infections or make any infection that you have worse. Call your healthcare provider right away if you have any symptoms of an infection. See “Before starting Enbrel, be sure to talk to your healthcare provider” for a list of symptoms of infection.
- Previous Hepatitis B infection. If you have been previously infected with the hepatitis B virus (a virus that affects the liver), the virus can become active while you use Enbrel. Your healthcare provider may do a blood test before you start treatment with Enbrel and while you use Enbrel.
- Nervous system problems. Rarely, people who use TNF-blocker medicines have developed nervous system problems such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes. Tell your healthcare provider right away if you get any of these symptoms: numbness or tingling in any part of your body, vision changes, weakness in your arms and legs, and dizziness.
- Blood problems. Low blood counts have been seen with other TNF-blocker medicines. Your body may not make enough of the blood cells that help fight infections or help stop bleeding. Symptoms include fever, bruising or bleeding very easily, or looking pale.
- Heart failure including new heart failure or worsening of heart failure you already have. New or worse heart failure can happen in people who use TNF-blocker medicines like Enbrel. If you have heart failure your condition should be watched closely while you take Enbrel. Call your healthcare provider right away if you get new or worsening symptoms of heart failure while taking Enbrel, such as shortness of breath or swelling of your lower legs or feet.
- Psoriasis. Some people using Enbrel developed new psoriasis or worsening of psoriasis they already had. Tell your healthcare provider if you develop red scaly patches or raised bumps that may be filled with pus. Your healthcare provider may decide to stop your treatment with Enbrel.
- Allergic reactions. Allergic reactions can happen to people who use TNF-blocker medicines. Call your healthcare provider right away if you have any symptoms of an allergic reaction. Symptoms of an allergic reaction include a severe rash, a swollen face, or trouble breathing.
- Autoimmune reactions, including:
- Lupus-like syndrome. Symptoms include a rash on your face and arms that gets worse in the sun. Tell your healthcare provider if you have this symptom. Symptoms may go away when you stop using Enbrel.
- Autoimmune hepatitis. Liver problems can happen in people who use TNF-blocker medicines, including Enbrel. These problems can lead to liver failure and death. Call your healthcare provider right away if you have any of these symptoms: feel very tired, skin or eyes look yellow, poor appetite or vomiting, pain on the right side of your stomach (abdomen).
These are not all the side effects with Enbrel. Tell your healthcare provider about any side effect that bothers you or does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
- Injection site reactions such as redness, itching, pain, swelling, bleeding or bruising. These symptoms usually go away within 3 to 5 days. If you have pain, redness, or swelling around the injection site that does not go away or gets worse, call your healthcare provider.
- Upper respiratory infections (sinus infections).
|How should I store Enbrel? |
- Store Enbrel in the refrigerator between 36°F to 46°F (2°C to 8°C).
- Store Enbrel in the original carton to protect from light or damage.
- If needed, you may store the Enbrel prefilled syringe, SureClick autoinjector, single-dose vial, Enbrel Mini cartridge, or the dose tray for the multiple-dose vial at room temperature between 68°F to 77°F (20°C to 25°C) for up to 14 days.
- When Enbrel has reached room temperature, do not put it back in the refrigerator.
- Throw away Enbrel that has been stored at room temperature after 14 days.
- Mixed Enbrel multiple-dose vials should be used right away or kept in the refrigerator between 36°F to 46°F (2°C to 8°C) for up to 14 days.
- Do not store Enbrel in extreme heat or cold such as in your vehicle’s glove box or trunk.
- Do not shake.
- Do not freeze.
- Keep Enbrel and all medicines out of the reach of children.
|General information about the safe and effective use of Enbrel. Medicines are sometimes prescribed for purposes not mentioned in a Medication Guide. Do not use Enbrel for a condition for which it was not prescribed. Do not give Enbrel to other people, even if they have the same condition. It may harm them.This Medication Guide summarizes the most important information about Enbrel. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Enbrel that was written for healthcare professionals.|
|What are the ingredients in Enbrel? Single-dose Prefilled Syringe, Single-dose Prefilled SureClick Autoinjector, Single-dose Vial and Enbrel Mini single-dose cartridge: Active Ingredient: etanerceptInactive Ingredients: L-arginine hydrochloride, sodium chloride, and sucroseMultiple-dose Vial: Active Ingredient: etanerceptInactive Ingredients: mannitol, sucrose, tromethamine AMGEN ® Manufactured by: Immunex Corporation, Thousand Oaks, CA 91320-1799, U.S. License Number 1132Immunex Corporation. All rights reserved.1XXXXXX – v19For more information, call 1 888 4ENBREL (1 888 436 2735) or www.enbrel.com. |
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