products and services [1):<1) sPGA success clear (0) or almost clear (1) 168 (76) 3 (1) 481 (79) 183 (61) 12 (4) 497 (80) 179 (57) 13 (4) sPGA of clear (0) 93 (42) 1 (> <1) 274 (45) 65 (21) 2 (1) 229 (37) 58 (19) 1 (> <1) Examination of age, gender, race, use of prior systemic or phototherapy, and use of prior biologics did not identify differences in response to Siliq among these subgroups. At Week 12, compared to subjects in the placebo group, a greater proportion of subjects in Siliq 210 mg Q2W group achieved a Psoriasis Symptom Inventory (PSI) score of 0 (not at all) or 1 (mild) on every item (itch, redness, scaling, burning, stinging, cracking, flaking, pain). Maintenance of Effect In Trial 1, subjects randomized to receive Siliq and who were responders at Week 12 (i.e., sPGA of 0 or 1) were re-randomized to receive either placebo or Siliq. Among responders at Week 12, 83% (69/83) of subjects re-randomized to continued treatment with Siliq 210 mg Q2W maintained this response (sPGA of 0 or 1) at Week 52 compared to none (0/84) who were re-randomized to placebo and withdrawn from Siliq. In addition, 87% (72/83) of subjects re-randomized to continued treatment with Siliq 210 mg Q2W achieved PASI 75 response at Week 52 compared to none (0/84) who were re-randomized to placebo and withdrawn from Siliq. Trials 2 and 3 included a re-randomized phase during which subjects originally randomized to receive Siliq during the first 12 weeks were re-randomized to one of four Siliq regimens at the Week 12 visit and placebo subjects were crossed over to receive Siliq 210 mg Q2W. Subjects receiving ustekinumab continued the same treatment until crossed over at Week 52 to Siliq 210 mg Q2W. For sPGA 0 or 1 responders at Week 12, the percentage of subjects who maintained this response at Week 52 was 79% for subjects treated with Siliq 210 mg Q2W. For PASI 100 responders at Week 12, 72% of the subjects who continued on Siliq 210 mg Q2W maintained the response at Week 52. How Supplied/Storage and Handling How Supplied Siliq (brodalumab) Injection is available in a single-dose prefilled syringe containing a sterile, preservative-free clear to slightly opalescent, colorless to slightly yellow solution that may contain a few translucent to white, amorphous particles. NDC 0187-0004-02: Carton of two 210 mg/1.5 mL single-dose prefilled syringes Storage and Handling Store refrigerated at 2 C to 8 C (36 F to 46 F) in the original carton to protect from light and physical damage during storage. When necessary, prefilled syringes can be stored at room temperature up to a maximum of 77 F (25 C) in the original carton for a maximum single period of 14 days with protection from light and sources of heat. Once the prefilled syringe has reached room temperature, do not place back into the refrigerator. Discard after 14 days at room temperature. Do not freeze. Do not shake. Patient Counseling Information Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use) before the patient starts using Siliq, and each time the prescription is renewed, as there may be new information they need to know. Suicidal Thoughts and Behavior Instruct patients and their caregivers to monitor for the emergence of suicidal thoughts and behavior and promptly seek medical attention if the patient experiences suicidal thoughts, new or worsening depression, anxiety, or other mood changes [see Warnings and Precautions ( 5.1 )]. Instruct patients to carry the wallet card provided and to call the National Suicide Prevention Lifeline at 1-800-273-8255 if they experience suicidal thoughts. Siliq REMS Program Because of the observed suicidal thoughts and behavior in subjects treated with Siliq, Siliq is available only through a restricted program called the Siliq REMS Program [see Warnings and Precautions ( 5.2 )]. Inform the patient of the following: Patients must enroll in the program [see Warnings and Precautions ( 5.1 , 5.2 )]. Patients will be given a Siliq Patient Wallet Card that they should carry with them at all times. This card describes symptoms which, if experienced, should prompt the patient to immediately seek medical evaluation. Advise the patient to show the Siliq Patient Wallet Card to other treating healthcare providers. Siliq is available only from certified pharmacies participating in the program. Therefore, provide patients with the telephone number and website for information on how to obtain the product. Infections Inform patients that Siliq may lower the ability of their immune system to fight infections. Instruct patients of the importance of communicating any history of infections to their healthcare providers and to contact their healthcare providers if they develop any signs or symptoms of infection [see Warnings and Precautions ( 5.3 )]. Crohn s Disease Instruct patients to seek medical advice if they develop signs and symptoms of Crohn s disease [see Warnings and Precautions ( 5.5 )]. Instructions for Injection Instruct the patient to perform the first self-injection under the guidance and supervision of a qualified healthcare professional for proper training in subcutaneous injection technique. Instruct patients who are self-administering to inject the full dose of Siliq [see Dosage and Administration ( 2.1 ) and Instructions for Use]. Instruct patients or caregivers in the technique of proper syringe and needle disposal [see Instructions for Use]. Manufactured for: Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA Manufactured by: Valeant Pharmaceuticals Luxembourg S.à.r.l. Grand Duchy of Luxembourg, L-1931, Luxembourg U.S. License Number 2053 U.S. Patents 7,939,070; 7,786,284; 7,833,527; 7,767,206; 8,790,648; 8,545,842; 8,435,518; 9,073,999; 9,096,673 Siliq is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. Valeant Pharmaceuticals North America LLC Issued: February/2017 9586500 Medication Guide Siliq (SIL-EEK) (brodalumab) injection, for subcutaneous use What is the most important information I should know about Siliq? Siliq may cause serious side effects, including: Suicidal thoughts or behavior have happened in some people treated with Siliq. Some people have ended their own lives. Your risk of suicidal thoughts and behavior may be increased if you have a history of suicidal thoughts or depression. It is not known if Siliq causes suicidal thoughts or behavior. Get medical help right away if you or your caregiver notice any of the following symptoms: new or worsening depression or anxiety thoughts of suicide, dying, or hurting yourself changes in behavior or mood acting on dangerous impulses attempt to commit suicide Your healthcare provider will give you a Siliq Patient Wallet Card about symptoms you should get medical help for right away. Carry the card with you at all times during treatment with Siliq and show it to all of your healthcare providers. Serious infections. Siliq may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider will check you for tuberculosis (TB) before starting treatment with Siliq and may treat you for TB before you begin treatment with Siliq if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of infection and TB during and after treatment with Siliq. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: fever, sweats, or chills muscle aches cough shortness of breath sore throat or difficulty swallowing warm, red, or painful skin or sores on your body diarrhea or stomach pain burning when you urinate or urinate more often than normal See What are the possible side effects of Siliq? for more information about side effects. What is Siliq? Siliq is a prescription medicine used to treat adults with moderate to severe plaque psoriasis: who may benefit from taking injections or pills (systemic therapy) or phototherapy (ultraviolet light treatment), and who have not responded or lost response to other systemic therapy It is not known if Siliq is safe and effective in children. Do not use Siliq if you have Crohn s disease. Before you use Siliq, tell your healthcare provider about all of your medical conditions, including if you: have a history of mental problems, including suicidal thoughts, depression, anxiety, or mood problems. have an infection that does not go away or that keeps coming back. have TB or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with Siliq. are pregnant or plan to become pregnant. It is not known if Siliq can harm your unborn baby. If you are pregnant or plan on becoming pregnant, consult with your healthcare provider. are breastfeeding or plan to breastfeed. It is not known if Siliq passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use Siliq? See the detailed Instructions for Use that comes with Siliq for information on how to inject a dose of Siliq and how to properly store and throw away (dispose of) used Siliq prefilled syringes. Use Siliq exactly as your healthcare provider tells you to use it. Your healthcare provider may stop Siliq if your plaque psoriasis does not improve within 12 to 16 weeks of treatment. What are the possible side effects of Siliq? Siliq may cause serious side effects. See What is the most important information I should know about Siliq? Crohn s disease. Tell your healthcare provider if you develop diarrhea, painful diarrhea, bloody stools, stomach pain or cramping, sudden or uncontrollable bowel movements, loss of appetite, constipation, weight loss, fever, or tiredness. The most common side effects of Siliq include: joint pain, headache, tiredness, diarrhea, mouth or throat pain, nausea, muscle pain, injection site reactions, flu (influenza), low white blood count (neutropenia), and fungal infections of the skin. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. General information about safe and effective use of Siliq Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Siliq for a condition for which it was not prescribed. Do not give Siliq to other people even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Siliq that is written for health professionals. Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA Manufactured by: Valeant Pharmaceuticals Luxembourg S.à.r.l., Grand Duchy of Luxembourg, L-1931, Luxembourg U.S. License Number 2053 For more information, go to www.Siliq.com or call Valeant Pharmaceuticals at 1-800-321-4576. U.S. Patents 7,939,070; 7,786,284; 7,833,527; 7,767,206; 8,790,648; 8,545,842; 8,435,518; 9,073,999; 9,096,673 Siliq is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. Valeant Pharmaceuticals North America LLC 9586500 This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: February/2017 Instructions for Use Siliq is supplied as a single-dose prefilled syringe. Each prefilled syringe contains one 210 mg dose of Siliq. Each Siliq prefilled syringe can only be used one time. Your healthcare provider has prescribed Siliq and will tell you how often it should be injected. If your healthcare provider decides that you or a caregiver may be able to give your injections of Siliq at home, you should receive training on the right way to prepare and inject Siliq. Do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider. Read all of the instructions before using the Siliq prefilled syringe. Call your healthcare provider if you or your caregiver have any questions about the right way to inject Siliq. Instructions for Use Siliq (SIL-EEK) (brodalumab) injection, for subcutaneous use Single-Dose Prefilled Syringe Guide to parts Important: Needle is inside the gray needle cap. Important Storing your Siliq prefilled syringe Store Siliq prefilled syringe in the refrigerator at 36 F to 46 F (2 C to 8 C). If needed, Siliq prefilled syringe may be stored at room temperature up to 77 F (25 C) for up to 14 days. Do not place Siliq prefilled syringe stored at room temperature back into the refrigerator. Throw away Siliq prefilled syringe that has been stored at room temperature after 14 days. Protect Siliq prefilled syringe from heat. Do not freeze. Keep Siliq prefilled syringe in the original carton to protect from light and physical damage. Keep Siliq prefilled syringe and all medicines out of reach of children. Using your Siliq prefilled syringe It is important that you do not try to give the injection unless you or your caregiver has received training from your healthcare provider. Do not use a Siliq prefilled syringe after the expiration date on the label. Do not shake the Siliq prefilled syringe. Do not remove the gray needle cap from the Siliq prefilled syringe until you are ready to inject. Do not use a Siliq prefilled syringe if it has been dropped on a hard surface. Part of the Siliq prefilled syringe may be broken even if you cannot see the break. Use a new Siliq prefilled syringe, and call 1-800-321-4576. Step 1: Prepare A Remove one Siliq prefilled syringe from the package. Grab the syringe by the barrel to remove the prefilled syringe from the tray. Place your finger or thumb on the edge of the tray to hold it while you remove the prefilled syringe. Put the original package with any unused prefilled syringes back in the refrigerator. For safety reasons: Do not grab the plunger rod. Do not grab the gray needle cap. Do not remove the gray needle cap until you are ready to inject. Wait about 30 minutes to let the prefilled syringe warm to room temperature before you use it. Do not put the prefilled syringe back in the refrigerator after it has reached room temperature. Do not try to warm the prefilled syringe by using a heat source such as hot water or microwave. Do not leave the prefilled syringe in direct sunlight. Do not shake the prefilled syringe. Important: Always hold the prefilled syringe by the syringe barrel. B Inspect the Siliq prefilled syringe. Make sure the medicine in the prefilled syringe is clear and colorless to slightly yellow. Do not use the syringe if: The medicine is cloudy or discolored or contains flakes or particles. Any part appears cracked or broken. The gray needle cap is missing or not securely attached. The expiration date printed on the label has passed. In all cases, use a new prefilled syringe, and call 1-800-321-4576. C Gather all materials needed for your injection. Wash your hands thoroughly with soap and water. On a clean, well-lit work surface, place the: Prefilled syringe Alcohol wipes Cotton ball or gauze pad Adhesive bandage Sharps disposal container D Prepare and clean your injection site. You can use: Your thigh Stomach area (abdomen), except for a 2 -inch area right around your navel (belly button) Outer area of upper arm (only if someone else is giving you the injection) Clean your injection site with an alcohol wipe. Let your skin dry. Do not touch this area again before injecting. Choose a different site each time you give yourself an injection. If you want to use the same injection site, make sure it is not the same spot on the injection site that you used for a previous injection. Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks. Avoid injecting directly into raised, thick, red, or scaly skin patch or lesion. Step 2: Get ready E Pull the gray needle cap straight off and away from your body when you are ready to inject. It is normal to see a drop of liquid at the end of the needle. Do not twist or bend the gray needle cap. Do not put the gray needle cap back onto the prefilled syringe. Do not remove the gray needle cap from the prefilled syringe until you are ready to inject. Important: Throw the needle cap into the sharps disposal container provided. F Pinch your injection site to create a firm surface. Pinch skin firmly between your thumb and fingers, creating an area about 2 inches wide. Important: Keep skin pinched while injecting. Step 3: Inject G Hold the pinch. Insert the needle into your skin at 45 to 90 degrees. Do not place your finger on the plunger rod while inserting the needle. H Using slow and constant pressure, push the plunger rod all the way down until it reaches the bottom. I When done, release your thumb, and gently lift the syringe and pull the needle out of your skin. J Inspect the syringe. If there is still medicine in the syringe barrel, this means you have not received a full dose. Call your healthcare provider right away. Step 4: Finish K Discard (throw away) the used syringe. Put the used Siliq syringe in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the syringe in your household trash. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA s website at: http://www.fda.gov/safesharpsdisposal. Do not reuse the syringe. Do not recycle the syringe or sharps disposal container or throw them into household trash. Important: Always keep the sharps disposal container out of the reach of children. L Examine the injection site. If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. Apply an adhesive bandage if needed. Manufactured for: Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA Manufactured by: Valeant Pharmaceuticals Luxembourg S.à.r.l. Grand Duchy of Luxembourg, L-1931, Luxembourg U.S. License Number 2053 For more information, go to www.Siliq.com or call Valeant Pharmaceuticals at 1-800-321-4576. U.S. Patents 7,939,070; 7,786,284; 7,833,527; 7,767,206; 8,790,648; 8,545,842; 8,435,518; 9,073,999; 9,096,673 Siliq is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. Valeant Pharmaceuticals North America LLC This Instructions for Use has been approved by the U.S. Food and Drug Administration. 9586500 Issued: February/2017 PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0187-0004-02 Siliq (brodalumab) Injection 210 mg/1.5 mL For Subcutaneous Use Only Rx only ATTENTION: Dispense with enclosed medication guide. Siliq brodalumab injection Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0187-0004 Route of Administration SUBCUTANEOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BRODALUMAB (BRODALUMAB) BRODALUMAB 210 mg Packaging # Item Code Package Description 1 NDC:0187-0004-02 2 SYRINGE in 1 CARTON 1 NDC:0187-0004-00 1 INJECTION in 1 SYRINGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA761032 02/15/2017 Labeler - Valeant Pharmaceuticals North America LLC (042230623) Registrant - Valeant Pharmaceuticals North America LLC (042230623) Establishment Name Address ID/FEI Operations Patheon Italia S.p.A. 338336589 MANUFACTURE(0187-0004) Revised: 02/2017 Valeant Pharmaceuticals North America LLC Next Interactions Print this page Add to My Med List More about Siliq (brodalumab) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 2 Reviews Add your own review/rating Drug class: interleukin inhibitors Consumer resources Siliq Siliq (Advanced Reading) Professional resources Siliq (AHFS Monograph) Related treatment guides Plaque Psoriasis> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Valeant Pharmaceuticals International, Inc. Drug Class Interleukin inhibitors Related Drugs interleukin inhibitors Stelara , Actemra , Cosentyx , Dupixent , tocilizumab , Taltz Plaque Psoriasis Humira , dexamethasone , methylprednisolone , betamethasone topical , Enbrel , Remicade , Otezla , adalimumab , calcipotriene topical , infliximab , etanercept , Cosentyx , Taclonex , Dovonex , Calcitrene , Taltz , apremilast , Tremfya , Renflexis , Enstilar , secukinumab , Inflectra , Erelzi , ixekizumab , More... Siliq Rating 2 User Reviews 10 /10 2 User Reviews 10 Rate it!} } years to come
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