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Brodalumab Injection

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WARNING

Some users of brodalumab injection displayed suicidal thoughts and actions (thinking about harming or killing oneself or planning or trying to do so). It is unknown if brodalumab injection results in suicidal ideas and actions. If you have a history of depression or suicidal thoughts, let your doctor and pharmacist know. Call your doctor right away if you have any of the following symptoms: Changes in your behaviour or mood; new or worsening depression or anxiety; thoughts of suicide, death, or self-harm; planning or trying to commit any of these acts; acting on risky impulses. You will receive a Patient Wallet Card from your doctor that includes a list of symptoms. If any of these symptoms appear, you should seek immediate medical attention. Show the card to all of your healthcare providers while you are receiving therapy with brodalumab injection.

Brodalumab injection is only offered through a unique programme known as Siliq REMS® because of the possibility of suicidal thoughts and actions when taking this medication. Before receiving a brodalumab injection, you must enrol in this programme along with your physician and pharmacist. All patients who are prescribed brodalumab injectable must have a prescription filled at a pharmacy that is registered with Siliq REMS® and written by a physician who is registered with Siliq REMS®. For additional information about this programme and how you will receive your medication, speak with your doctor.

The manufacturer’s patient information sheet (Medication Guide) will be sent to you by your doctor or pharmacist when you start receiving treatment with brodalumab injection and at each time you need a prescription refill. If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

Discuss the dangers of using brodalumab injection with your doctor.

Why is this medication prescribed?

Brodalumab injection is used to treat moderate to severe plaque psoriasis in patients whose psoriasis is too severe to be treated by topical medications alone and who have not found success with other medications. Plaque psoriasis is a skin condition in which red, scaly patches develop on some areas of the body. The drug brodalumab injection belongs to the group of drugs known as monoclonal antibodies. It functions by preventing the body’s natural substance from acting in a way that results in the psoriasis symptoms.

How should this medicine be used?

To be administered subcutaneously, brodalumab injection is provided as a liquid in a prefilled syringe (under the skin). For the first three doses, it is typically injected once a week, and then once every two weeks after that. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Administer the brodalumab injection as prescribed. Never inject more, less, or more frequently than your doctor has instructed.

You can administer the brodalumab injection yourself, or you can ask a friend or family member to do it for you. Read the manufacturer’s instructions thoroughly before to administering brodalumab injection for the first time. To learn how to inject a medicine, ask your doctor or pharmacist to demonstrate it to you or the person doing the injecting.

Each prefilled syringe should only be used once to inject the entire solution within. Put used pens and syringes in a container that won’t puncture. How to get rid of the puncture-resistant container should be discussed with your doctor or pharmacist.

If you’re using a prefilled syringe that has been chilled, set it down on a flat surface, leaving the needle cap on, and give it about 30 minutes to get to room temperature before using. Never attempt to reheat the drug by putting it in a hot water bath, microwave, or any other device. Once the prefilled syringe has warmed up, do not place it back in the freezer.

The medicine should not be shaken.

Before injecting brodalumab solution, always check it out. The drug should be colourless to faintly yellow, clear, and transparent. If the medication is murky, discoloured, or contains flakes or particles, do not use the syringe.

If a syringe has been spilled on a hard surface, do not use it. Even if you cannot see the break, the syringe may be partially fractured.

Brodalumab injections can be injected anywhere on the stomach, upper outside arms, or thighs (upper leg), with the exception of the navel and the region 2 inches (5 cm) around it. Use a different place for each injection to lessen the possibility of discomfort or redness. Injecting into skin that is painful, bruised, red, hard, thick, scaly, psoriasis-affected, or that has scars or stretch marks is not advised.

If your psoriasis does not get better within 12 to 16 weeks of treatment, your doctor may advise you to stop using brodalumab injection. Discuss your feelings regarding your treatment with your doctor.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before using brodalumab injection,

  • If you have an allergy to brodalumab, any other drugs, or any of the ingredients in brodalumab injection, let your doctor and pharmacist know right once. For a list of the ingredients, consult the Medication Guide or speak to your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Incorporate any of the following: Warfarin with cyclosporine (Gengraf, Neoral, Sandimmune) (Coumadin, Jantoven). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects. Brodalumab injection may interact with a variety of other drugs, so be sure to inform your doctor about all the drugs you are taking, even those not on this list.
  • In case you have Crohn’s disease, tell your doctor (condition in which the immune system attacks the lining of the digestive tract causing pain, diarrhea, weight loss, and fever). Most likely, your doctor will advise against using brodalumab injection.
  • If you have or have previously had any medical conditions, let your doctor know.
  • If you are breastfeeding a child or intend to become pregnant, let your doctor know. Call your doctor if you become pregnant while receiving the injection of brodalumab.
  • Inform the doctor or dentist that you are using brodalumab injection if you are having surgery, including dental surgery.
  • To find out if you require any immunisations, consult your doctor. Before starting your brodalumab injectable medication, it’s crucial to have had all the vaccinations recommended for your age. Avoid getting any shots while you are receiving therapy without first consulting your doctor.
  • You should be aware that receiving a brodalumab injection may reduce your resistance to bacterial, viral, and fungal infections and raise your chance of developing a serious or lethal infection. Inform your doctor if you frequently contract any kind of infection, currently possess one, or suspect one. This includes transient infections (like herpes or cold sores), chronic illnesses that persist over time, and mild infections (like open cuts or sores). Call your doctor right away if you have any of the following signs or symptoms during or soon after receiving a brodalumab injection for your condition: a cough, shortness of breath, muscle aches, fever, sweats, or chills; diarrhoea, stomach pain, frequent, urgent, or painful urination, or other indications of infection. sore throat or difficulty swallowing. warm, red, or painful skin or sores on your body.
  • You should be aware that receiving brodalumab injection increases your risk of contracting tuberculosis (TB; a dangerous lung infection), particularly if you have the disease but are asymptomatic. If you have TB now or formerly had it, have lived in a nation where TB is widespread, or have been near someone with TB, let your doctor know. Before beginning therapy with a brodalumab injection, your doctor will test you for TB. If you have a history of TB or have active TB, you might also receive treatment for TB. Contact your doctor right away if you get any of the following TB symptoms, including coughing up blood or mucus, weakness or exhaustion, weight loss or loss of appetite, chills, fever, or night sweats.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

Once you remember to take the missed dosage, proceed with your regular dosing regimen. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

The injection of brodalumab may have negative effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  1. Headache
  2. Muscular or joint ache
  3. Nausea
  4. The area where the drug was injected may experience discomfort, redness, bruising, bleeding, or itching

Some adverse effects can be very harmful. Call your doctor right away if you have any of the following symptoms or any of those detailed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections:

  • Unpleasant diarrhoea
  • Soiled stools
  • Uncontrollable or sudden bowel motions
  • Stomach cramps or discomfort
  • Constipation
  • Loss of weight

Other negative effects from brodalumab injection are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Prefilled syringes of brodalumab should be kept in the refrigerator rather than the freezer. To protect them from light, keep the syringes in their original boxes. Prefilled syringes can be kept at room temperature for up to 14 days if required. After 14 days at room temperature, throw away the syringes. Prefilled syringes left out at room temperature shouldn’t be put back in the fridge.

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

Keep all of your doctor’s appointments.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Siliq®
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