Siliq

Name: Siliq

What Is Siliq?

Brodalumab is a monoclonal antibody that blocks certain proteins in the body that can affect inflammation and other immune responses.

Brodalumab is used to treat moderate to severe plaque psoriasis in adults.

Brodalumab is usually given after other psoriasis medicines have been tried without success.

Brodalumab is available only from a certified pharmacy under a special program called Siliq REMS. You must be registered in the program and understand the risks and benefits of taking this medicine.

Brodalumab may also be used for purposes not listed in this medication guide.

Some people have thoughts about suicide while taking this medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor, such as mood changes, anxiety, or depression.

Brodalumab is available only from a certified pharmacy under a special program.

You should not use brodalumab if you are allergic to it, or if you have:

  • Crohn's disease.

To make sure brodalumab is safe for you, tell your doctor if you have:

  • an active or chronic infection;
  • a history of tuberculosis; or
  • a history of anxiety, depression, mental illness, or a mood disorder.

Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common. Your doctor may perform tests to make sure you do not have tuberculosis or other infections.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether brodalumab passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Brodalumab is not approved for use by anyone younger than 18 years old.

Siliq Dosage

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Brodalumab is injected under the skin. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.

Brodalumab is usually given once a week for 3 weeks, and then once every 2 weeks thereafter. Follow your doctor's dosing instructions very carefully.

Read all instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Do not shake the medicine. Prepare your dose only when you are ready to give an injection. Do not use the medicine if it looks cloudy or has large particles in it. Call your pharmacist for new medicine.

Store prefilled syringes in their original container in the refrigerator. Protect from light and do not freeze.

Take the medicine out of the refrigerator and allow it to reach room temperature for 30 minutes before injecting your dose. Do heat the medicine in a microwave oven or place it into hot water. Leave the needle cap in place while the medicine warms to room temperature.

You may store a syringe for up to 14 days at room temperature. Keep the syringe in its original container and protect it from heat and light.

Any syringe warmed to room temperature should not be placed back into a refrigerator.

Each single-use prefilled syringe is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Brodalumab can lower blood cells that help your body fight infections. You may get an infection more easily. Call your doctor if you have signs of infection such as fever, chills, flu symptoms, diarrhea, painful urination, and skin warmth or redness.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 12 weeks of using brodalumab.

Brodalumab comes with a Medication Guide and a Patient Wallet Card that lists the symptoms of a serious side effect. Read this information carefully and carry the Wallet Card with you at all times so you will know what symptoms to watch for.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Uses for Siliq

Brodalumab has the following uses:

Brodalumab is a human interleukin-17 receptor A (IL-17RA) antagonist indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.1

Additional Information

AHFS First Release. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Proper Use of Siliq

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot under your skin, usually on the upper arms, abdomen (stomach), or thighs.

This medicine comes with a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Brodalumab may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.

You might not use all of the medicine in each prefilled syringe. Use each prefilled syringe only one time. Do not save an open syringe. If the medicine in the syringe has changed color, or if you see particles in it, do not use it. Do not shake.

Do not inject the medicine into areas where the skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For injection dosage form (solution):
    • For plaque psoriasis:
      • Adults—210 milligrams (mg) injected under your skin as a single dose at Weeks 0, 1, and 2. This is followed by 210 mg every 2 weeks.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Keep the medicine in the original carton until you are ready to use it. You may store the prefilled syringe at room temperature, for up to 14 days. Do not put it back in the refrigerator once it has reached room temperature. Throw away any unused medicine that has been stored at room temperature after 14 days. Do not freeze.

Do not reuse syringes and needles. Put used syringes and needles in a puncture-resistant disposable container, or dispose of them as directed by your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of Crohn's disease like bloody stools, constipation or diarrhea, fever, not able to control bowels, not hungry, painful diarrhea, stomach pain or cramps, sudden need to have a bowel movement, tiredness, or weight loss.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Warm, red, or painful skin or sores on the body.
  • Sweating a lot.
  • Muscle pain or weakness.
  • Shortness of breath.
  • Passing urine more often.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Siliq?

  • Store in a refrigerator. Do not freeze.
  • Store in the carton to protect from light.
  • If needed, you may store at room temperature for up to 14 days. Write down the date you take this medicine out of the refrigerator. If stored at room temperature and not used within 14 days, throw Siliq away.
  • Do not put this medicine back in the refrigerator after it has been stored at room temperature.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Siliq is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Siliq or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Siliq. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Contraindications

Siliq is contraindicated in patients with Crohn’s disease because Siliq may cause worsening of disease [see Warnings and Precautions (5.5)].

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

What should I avoid while taking Siliq?

Avoid injecting Siliq into skin that is bruised or tender, or skin that is affected by psoriatic plaques (red, thick, or scaly).

Do not receive a "live" vaccine while using Siliq. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

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