Brodalumab

1-10%

Headache (3.5%)

Arthralgia (3.3%)

Fungal infections (2.4%)

Injection site reaction (1.3%)

Fatigue (1.1%)

Diarrhea (1.1%)

Oropharyngeal pain (1.1%)

Nausea (1.1%)

<1%

Serious infections (0.5%)

Influenza (0.5%)

Neutropenia (0.5%)

Tinea infections (0.2%)

Conjunctivitis

Candida infections

Black Box Warnings

Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with brodalumab

Prior to prescribing, weigh the potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior

Patients with new or worsening suicidal ideation and behavior should be referred to a mental health professional, as appropriate

Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new-onset or worsening depression, anxiety, or other mood changes

Because of the observed suicidal behavior, brodalumab is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the SILIQ REMS Program

Patient wallet card

• Give patients the Patient Wallet Card and instruct them to carry it with them at all times
• Patients should seek medical evaluation and show the card, to the treating healthcare provider, if they experience symptoms of suicide or depression described on the card
• They should also call the National Suicide Prevention Lifeline at 1-800-273-8255 if they experience suicidal thoughts

Contraindications

Crohn disease

Cautions

Suicidal ideation and behavior, including 4 completed suicides, occurred in subjects treated in the psoriasis clinical trials; there were no completed suicides in the 12-week placebo-controlled portion of the trials; brodalumab users with a history of suicidality or depression had an increased incidence of suicidal ideation and behavior as compared with users without such a history (see Black Box Warnings)

Available only through a restricted access program (see Black Box Warnings)

May increase risk of infections; in patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing; if a patient develops a serious infection or is not responding to standard therapy for the infection, monitor the patient closely and discontinue the drug until the infection resolves

Evaluate patients for TB before initiating; do not administer to patients with active TB; initiate treatment for latent TB prior to administering brodalumab; closely monitor patients for signs and symptoms of active TB during and after treatment

In psoriasis trials, which excluded subjects with active Crohn disease, Crohn disease occurred in 1 subject during treatment and led to brodalumab discontinuation; in other trials, exacerbation of Crohn disease was observed with brodalumab (see Contraindications)

Drug interaction overview

• Avoid use of live vaccines; no data are available on the ability of live or inactive vaccines to elicit an immune response in patients being treated with brodalumab
• CYP450 substrates
  • The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (eg, IL-1, IL-6, IL-10, TNF-alpha, IFN) during chronic inflammation
  • Brodalumab may modulate serum levels of some cytokines
  • Therefore, upon initiating or discontinuing brodalumab in patients who are receiving concomitant drugs that are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (eg, for warfarin) or drug concentration (eg, for cyclosporine) and consider dosage modification of the CYP450 substrate

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.

Usual Adult Dose for Plaque Psoriasis:

210 mg subcutaneously at Weeks 0, 1, and 2 followed by 210 mg subcutaneously every 2 weeks

Comments:
-Continued therapy beyond 16 weeks in patients who have not achieved an adequate response is not likely to result in greater success.
-Evaluate patients for tuberculosis (TB) infection prior to initiating therapy.

Use: 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

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

General

Brodalumab is available in the following dosage form(s) and strength(s):

• Injection: 210 mg/1.5 mL solution in a single-dose prefilled syringe.1

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

• Administer 210 mg of brodalumab by subcutaneous injection at weeks 0, 1, and 2 followed by 210 mg every 2 weeks.1

Advise the patient to read the FDA-approved patient labeling (medication guide and instructions for use) for brodalumab before the patient starts using the drug, and each time the prescription is renewed, as there may be new information they need to know.1

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,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.1

REMS Program

Because of the observed suicidal thoughts and behavior in subjects treated with brodalumab, the drug is available only through a restricted program called the Siliq REMS Program. Inform the patient of the following: patients must enroll in the program and 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 patient wallet card to other treating healthcare providers.1

Brodalumab 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.1

Infections

Inform patients that brodalumab 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.1

Crohn’s Disease

Instruct patients to seek medical advice if they develop signs and symptoms of Crohn’s disease.1

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.1

Instruct patients who are self-administering to inject the full dose of brodalumab.1

Instruct patients or caregivers in the technique of proper syringe and needle disposal.1

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Have patient safety card with you at all times.
• You will need a TB (tuberculosis) test before starting brodalumab.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• Talk with your doctor before getting any vaccines. Use with this medicine may either raise the chance of an infection or make the vaccine not work as well.
• This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking brodalumab with your other drugs.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• 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 brodalumab 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 brodalumab 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 brodalumab. 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

Refer to adult dosing.

Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with brodalumab. Prior to prescribing brodalumab, weigh the potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. Patients with new or worsening suicidal ideation and behavior should be referred to a mental health professional, as appropriate. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes.

Because of the observed suicidal behavior in subjects treated with brodalumab, brodalumab is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the SILIQ REMS Program.

Applies to brodalumab: subcutaneous solution

Along with its needed effects, brodalumab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking brodalumab:

• Black, tarry stools
• chills
• cough
• diarrhea
• fever
• general feeling of discomfort or illness
• headache
• joint pain
• loss of appetite
• lower back or side pain
• muscle aches and pains
• nausea
• painful or difficult urination
• pale skin
• runny nose
• shivering
• sore throat
• sweating
• trouble sleeping
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

• Changes in behavior
• discouragement
• feeling sad or empty
• irritability
• lack of appetite
• loss of interest or pleasure
• thoughts of killing oneself
• trouble concentrating
• trouble sleeping

Some side effects of brodalumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Difficulty with moving
• muscle pain or stiffness
• pain in the joints
• pain, redness, burning, or itching at the injection site

Data not available