Pronunciation:

broe-DAL-ue-mab

Brand Names:

• Siliq

Dosage Forms:

• Solution

Warnings:

Suicidal ideation and behavior, including completed suicides, have occurred with brodalumab. Weigh potential risks and benefits in each patient prior to initiation, and advise patients and caregivers to seek medical attention for new or worsening depression, anxiety, or other mood changes. Refer patients with new or worsening suicidal ideation and behavior to a mental health professional. Brodalumab is only available through a restricted program called the Siliq REMS Program .

Classifications:

Therapeutic—

Antipsoriatic

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Brodalumab injection is used to treat moderate to severe plaque psoriasis in patients who may benefit from receiving phototherapy (ultraviolet light treatment) or other treatments. Plaque psoriasis is a skin disease with red patches and white scales that don't go away.

This medicine is only available through a restricted access program. Doctors who are enrolled in the restricted program can write a prescription for this medicine.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of brodalumab injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of brodalumab injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine
• Anifrolumab-fnia
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Infliximab
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Crohn's disease—Should not be used in patients with this condition.

• Depression, or history of or
• Mental health problems, history of—Use with caution. May make these conditions worse.

• Infection (bacteria, fungus, virus)—Brodalumab is not recommended for patients with an active infection. Caution should be used if you have a chronic infection or history of a recurring infection.

• Tuberculosis infection, inactive—Should be treated first before starting therapy with this medicine.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors, such as feeling sad or hopeless, getting upset easily, or feeling nervous or hostile. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

It is important to check with your doctor if you have any symptoms of an infection such as fever or chills, cough or hoarseness, lower back or side pain, painful or difficult urination.

Do not have any live vaccines (immunizations) while you are being treated with brodalumab. Be sure to ask your doctor if you have any questions about this.

Tell your doctor if you have bloody diarrhea, a fever, or severe stomach pain after receiving this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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:

Less common

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

Incidence not known

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 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:

Less common

Difficulty with moving

muscle pain or stiffness

pain in the joints

pain, redness, burning, or itching at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.