Brodalumab Injection : Uses, Side Effects, Interactions & More
Some people who used Brodalumab Injection had suicidal thoughts and behaviors (thinking about harming or killing themselves or planning or trying to do so). It is not known whether brodalumab injection causes suicidal thoughts and behaviors. Tell your doctor and pharmacist if you have a history of depression or suicidal thoughts. If you experience any of the following symptoms, call your doctor immediately: new or worsening depression or anxiety; thoughts of suicide, dying or hurting yourself, or planning or trying to do so; changes in your behavior or mood; or acting on dangerous impulses. Your healthcare provider will give you a patient wallet card with a list of symptoms. If any of these symptoms occur, you should seek medical help immediately. Carry the card with you at all times during your treatment with Brodalumab Injection and show it to all your healthcare providers.
Due to the risk of suicidal thoughts and behaviors with this drug, brodalumab injection is only available through a special program called Siliq REMS®. You, your doctor, and your pharmacist must be enrolled in this program before you can receive your brodalumab injection. All individuals prescribed brodalumab injection must have a prescription from a physician who is registered with Siliq REMS® and obtain the prescription from a Siliq REMS® registered pharmacy in order to receive this medication. Ask your doctor for more information about this program and how you will receive your medicine.
Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you start treatment with brodalumab injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.
Talk to your doctor about the risks of using brodalumab injection.
Why is this medication prescribed?
Brodalumab injection is used to treat moderate to severe plaque psoriasis (a skin condition in which red, scaly patches form on some areas of the body) in people whose psoriasis is too severe to be treated with topical medications alone. and that they have not been treated satisfactorily with other medications. Brodalumab injection is in a class of medications called monoclonal antibodies. It works by blocking the action of a certain natural substance in the body that causes psoriasis symptoms.
How should this medicine be used?
Brodalumab injection comes as a liquid in a pre-filled syringe to inject subcutaneously (under the skin). It is usually injected once a week for the first 3 doses and then once every 2 weeks. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any parts you do not understand. Use brodalumab injection exactly as directed. Do not inject more or less or more often than prescribed by your doctor.
You can inject brodalumab yourself or ask a friend or family member to give you the injections. Before using brodalumab injection for the first time, read the manufacturer’s instructions carefully. Ask your doctor or pharmacist to show you or the person who will inject the medicine how to do it.
Use each pre-filled syringe only once and inject all of the solution into the syringe. Dispose of used syringes and pens in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture resistant container.
If you are using a pre-filled syringe that has been refrigerated, place the syringe on a flat surface without removing the needle cap and allow it to warm to room temperature for approximately 30 minutes before using. Do not try to warm the medicine by heating it in a microwave, placing it in hot water, or by any other method. Do not put the pre-filled syringe back in the refrigerator after it has reached room temperature.
Do not shake the medicine.
Always look at the brodalumab solution before you inject. The medicine should be clear and colorless to slightly yellow. Do not use the syringe if the medicine is cloudy, discolored, or contains flakes or particles.
Do not use a syringe if it has been dropped on a hard surface. Part of the syringe may break even if you cannot see it.
Brodalumab can be injected into any part of the thighs (upper leg), upper outer arms, or stomach, except for the navel and the 2-inch (5-centimeter) area around it. To reduce the chances of pain or redness, use a different site for each injection. Do not inject into an area where the skin is tender, bruised, red, hard, thick, scaly, affected by psoriasis, or where there are scars or stretch marks.
Your healthcare provider may tell you to stop using brodalumab injection if your psoriasis does not improve within 12 to 16 weeks of treatment. Talk to your doctor about how you feel during your treatment.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before using brodalumab injection,
- Tell your doctor and pharmacist if you are allergic to brodalumab, any other medications, or any of the ingredients in brodalumab injection. Ask your pharmacist or see the Medication Guide for a list of the ingredients.
- Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: cyclosporine (Gengraf, Neoral, Sandimmune) and warfarin (Coumadin, Jantoven). Your doctor may need to change the doses of your medications or monitor you closely for side effects. Many other medications can also interact with brodalumab injection, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
- Tell your doctor if you have Crohn’s disease (condition in which the immune system attacks the lining of the digestive tract causing pain, diarrhea, weight loss, and fever). Your doctor will probably tell you not to use Brodalumab Injection.
- Tell your doctor if you have or have ever had any medical conditions.
- Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using brodalumab injection, call your doctor.
- If you are having surgery, including dental surgery, tell the doctor or dentist that you are using brodalumab injection.
- Check with your doctor to see if you need any vaccinations. It is important to have all the appropriate vaccinations for your age before starting your treatment with Brodalumab Injection. Do not get vaccinated during your treatment without consulting your doctor.
- You should know that brodalumab injection may decrease your ability to fight bacterial, viral, and fungal infections and increase the risk of a serious or life-threatening infection. Tell your doctor if you frequently have any type of infection or if you have or think you may have any type of infection now. This includes minor infections (such as open wounds or sores), infections that come and go (such as herpes or cold sores), and chronic infections that do not go away. If you experience any of the following symptoms during or shortly after your treatment with brodalumab injection, call your doctor immediately: fever, sweats, or chills; muscle pains; cough; difficulty breathing; sore throat or trouble swallowing; hot, red, or painful skin or sores on your body; Diarrhea; stomach ache; frequent, urgent, or painful urination; or other signs of infection.
- You should know that the use of Brodalumab Injection increases the risk of developing tuberculosis (TB; a serious lung infection), especially if you are already infected with TB but do not have any symptoms of the disease. Tell your doctor if you have or have ever had TB, if you have lived in a country where TB is common, or if you have been around someone who has TB. Your doctor will screen you for TB before starting treatment with brodalumab injection and may treat you for TB if you have a history of TB or active TB. If you have any of the following symptoms of tuberculosis or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, coughing up blood or mucus, weakness or tiredness, weight loss, loss of appetite, chills, fever , or night sweats.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
Use the missed dose as soon as you remember it and then continue your regular dosing schedule. Do not use a double dose to make up for a missed one.
What side effects can this medication cause?
Brodalumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- joint or muscle pain
- pain, redness, bruising, bleeding, or itching in the area where the medication was injected
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section or SPECIAL PRECAUTIONS section, call your doctor immediately:
- painful diarrhea
- bloody stools
- sudden or uncontrollable bowel movements
- stomach pain or cramping
- weight loss
Brodalumab injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medicine.
If you experience a serious side effect, you or your doctor can submit a report online to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I know about storage and disposal of this medication?
Keep this medicine in the container it came in, tightly closed, and out of the reach of children. Store brodalumab pre-filled syringes in the refrigerator, but do not freeze them. Keep syringes in their original cartons to protect from light. When necessary, pre-filled syringes can be stored at room temperature for up to 14 days. Discard the syringes after 14 days at room temperature. Do not put pre-filled syringes stored at room temperature back in the refrigerator.
Unnecessary medications must be disposed of in special ways to ensure that pets, children, and others cannot consume them. However, you should not flush this medicine down the toilet. Instead, the best way to dispose of your medications is through a drug take-back program. Talk to your pharmacist or contact your local garbage / recycling department to find out about take-back programs in your community. See the FDA Safe Drug Disposal website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
It is important to keep all medicines out of the sight and reach of children, since many containers (such as those containing weekly pills and those for eye drops, creams, patches and inhalers) are not resistant to children and small children can easily open them. To protect young children from poisoning, always close the safety caps and immediately place the medicine in a safe place, one that is upright and out of their sight and reach. http://www.upandaway.org
In case of emergency/overdose
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim collapsed, had a seizure, is having trouble breathing, or is unable to wake up, immediately call 911 for emergency services.
What other information should I know?
Keep all your appointments with your doctor.
Do not let anyone else take your medicine. Ask your pharmacist any questions you have about refilling your prescription.
It is important that you keep a written list of all prescription and over-the-counter (over-the-counter) medications you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should take this list with you each time you visit a doctor or if you go into hospital. It is also important information to take with you in case of emergencies.
Disclaimer: DrLinex has made every effort to ensure that all information is factually accurate, comprehensive and up-to-date. However, this article should not be used as a licensed health care professional’s choice of knowledge and expertise. You should always consult your doctor or other health care professional before taking any medication. The information given here is subject to change and it has not been used to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions or adverse effects. The lack of warning or other information for any drug does not indicate that the combination of medicine or medication is safe, effective or appropriate for all patients or all specific uses.