Description
Brodalumab injection is used to treat moderate to severe plaque psoriasis, which is a skin disease with red patches and white scales that do not go away. It is given to patients who did not respond well to other types of treatment (eg, phototherapy, pills, injections).
This medicine is available only under a restricted distribution program called Siliq™ REMS (Risk Evaluation and Mitigation Strategy) Program.
This product is available in the following dosage forms:
- Solution
Before Using
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.
Pediatric
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.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of brodalumab injection in the elderly.
Breastfeeding
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.
Drug Interactions
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.
- Abatacept
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Anifrolumab-fnia
- Bacillus of Calmette and Guerin Vaccine, Live
- Cholera Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Haloperidol
- Infliximab
- Influenza Virus Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Poliovirus Vaccine, Live
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox 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.
- Tuberculosis, inactive—Should be treated first before receiving this medicine.
Proper Use
This medicine is given as a shot under the skin of your thigh, stomach, or upper arm. It may 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 this medicine.
It is very important that you understand the requirements of the Siliq™ REMS program, and become familiar with the Siliq™ Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the medication guide if you do not have one.
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. Do not inject into skin areas that are bruised, red, hard, tender, thick, scaly, or areas with psoriasis.
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.
To use the prefilled syringe:
- Wash your hands with soap and water before and after using this medicine.
- Allow 30 minutes for the prefilled syringe to warm up to room temperature. Do not warm using heat sources (eg, hot water, microwave, or sunlight).
- Check the liquid in the prefilled syringe. It should be clear and colorless to slightly yellow. Do not use it if it is cloudy, discolored, or has flakes or particles in it. Do not shake.
- Pull the gray needle cap straight off and away from your body. Do not twist or bend the gray needle cap. Do not recap the needle.
- Pinch skin firmly between your thumb and fingers. Insert the needle into your skin.
- Push the plunger rod all the way down until it reaches the bottom. Gently lift the syringe and pull the needle our of your skin.
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 (prefilled syringe):
- 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.
- For plaque psoriasis:
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.
Throw away used syringes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Precautions
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.
If your condition does not improve within 12 to 16 weeks, or if it become worse, check with your doctor.
This medicine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, a cough, difficulty swallowing, a fast heartbeat, hives, itching, a rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.
Your body's ability to fight infection may be reduced while you are being treated with brodalumab. It is very important that you call your doctor at the first signs of any infection. Check with your doctor right away if you have any of the following symptoms while using this medicine: fever, chills, cough or hoarseness, flu-like symptoms, lower back or side pain, painful or difficult urination, or unusual tiredness or weakness.
This medicine may cause serious skin reactions that look like eczema. Check with your doctor right away if you have blistering, crusting, irritation, itching, or reddening of the skin, cracked, dry, scaly skin, small bumps or patches, or swelling.
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
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
- Blistering, crusting, irritation, itching, or reddening of the skin
- changes in behavior
- chest tightness
- cracked, dry, scaly skin
- difficulty swallowing
- dizziness
- discouragement
- feeling sad or empty
- hives, itching, skin rash
- irritability
- lack of appetite
- loss of interest or pleasure
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- swelling
- thoughts of killing oneself
- trouble breathing
- 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
- joint pain
- muscle pain or stiffness
- 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.
CON-XXXXXXXX
