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Arcalyst (Generic Rilonacept Injection)

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Why is this medication prescribed?

Rilonacept injection is used to treat cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS), in adults and children 12 years of age and older. CAPS are inherited conditions in which the body attacks its own tissues, causing inflammation, joint and muscle pain, rash or other skin lesions, fever and chills, eye redness or pain, and fatigue. Deficit of interleukin-1 receptor antagonist (DIRA; a condition in which the body attacks its own tissues, causing inflammation and harming the bones, nervous system, skin, lungs, liver, and joints) is another condition that is treated with rilonacept injection in adults and children weighing at least 22 pounds (10 kg). Injections of rilonacept are also used to treat and prevent recurrent pericarditis (swelling of the sac around the heart) in adults and children 12 years of age and older. Rilonacept belongs to the group of drugs known as interleukin antagonists. It functions by preventing the body’s natural inflammatory agent, interleukin, from doing its job.

How should this medicine be used?

Rilonacept is available as a powder in a vial that must be combined with a liquid for subcutaneous injection (under the skin). It is often administered as two injections for the initial dose, followed by one injection once a week, to treat people with CAPS, FCAS, or MWS, as well as to treat or prevent pericarditis. The medication is often administered as one or two injections for the first dose, followed by one injection once a week, to treat CAPS, FCAS, or MWS, as well as to treat or prevent pericarditis in children. DIRA is typically treated with one or two injections administered once each week. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Rilonacept injection should only be used as prescribed. Use it only as directed by your doctor, neither more nor less often.

You or a carer will be shown by your doctor or nurse how to prepare and administer a dose of rilonacept injection at home. You and the person administering the injections should read the manufacturer’s information for the patient included with the medication before using rilonacept injection for the first time. These directions explain how to prepare and administer a dose of rilonacept. Make sure you comprehend these instructions. If you have any concerns regarding how to administer the injection, where on your body to provide the injection, when to administer the injection, or what kind of syringe and needle to use, ask your healthcare provider.

The drug should be mixed just before you intend to inject it. The medication can, however, be prepared ahead of time, kept at room temperature, and used within three hours.

Before injecting rilonacept, always check the solution. Check that the liquid is clear, colourless to slightly yellow, and that the expiration date has not gone. There shouldn’t be any observable particles in the liquid. Use only if it has not expired and is clear, discoloured, or particle-free.

Rilonacept can be injected in the lower stomach or the front of the centre of the thighs, with the exception of the 2-inch (5-centimeter) region surrounding the navel (belly button). The outer region of your upper arms can be the location of the injection if someone else is administering it to you. For each injection, choose a different location. Avoid injecting into areas of skin that are red, bruised, painful, or firm. Avoid injecting close to a visible vein under the skin.

Never share or re-use syringes or needles. Used vials, syringes, and needles should be disposed of in a receptacle that can withstand punctures and is out of children’s reach. How to get rid of the puncture-resistant container should be discussed with your doctor or pharmacist.

For a copy of the manufacturer’s information for the patient, ask your pharmacist or 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 rilonacept injection,

  • If you have an allergy to rilonacept, any other drugs, or any of the ingredients in rilonacept injection, let your doctor and pharmacist know right away. Request a list of the components from 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: Corticosteroids like cortisone acetate, dexamethasone (Hemady), fludrocortisone, hydrocortisone (Alkindi Sprinkle, Cortef), and prednisone (Rayos); etanercept (Enbrel); golimumab (Simponi, Simponi Aria); infliximab (Avsola, Remicade); and warfarin are examples of medications (Jantoven). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects. Tell your doctor about all the drugs you are taking, including any not on this list, as many other drugs may also interact with rilonacept. Additionally, let your doctor know if you have previously had or have the human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus infections (HCV; an ongoing liver infection). Call your doctor right away if you suffer any of the following signs or symptoms throughout or soon after receiving therapy with rilonacept injection: Frequent, urgent, or painful urination; fever, sweats, or chills; sore throat; cough; warm, red, or painful skin or sores on your body; or other indicators of infection.
  • Any illnesses that impair your immune system, such as asthma, diabetes, high cholesterol, or excessive triglycerides, should be disclosed to your doctor.
  • Inform your doctor if you are expecting, intend to get pregnant, or are nursing a baby. Call your doctor if you get pregnant while taking rilonacept injectable.
  • You should be aware that rilonacept injection may lower your resistance to bacterial, viral, and fungal infections and raise your chance of developing a serious 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 once if you experience any of the following TB symptoms, or if any of them appear while you are receiving treatment: a cough, coughing up blood or mucus, weakness or exhaustion, weight loss, appetite loss, chills, fever, or night sweats.
  • Avoid getting any shots without first consulting your doctor.

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?

If you overlook an injection of this drug, call your doctor. When you should administer the missing dose and the subsequent scheduled dose, your doctor will instruct you. To make up for a missing dose, do not provide a second injection.

What side effects can this medication cause?

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

  • Pain, bruising, bleeding, swelling, redness, warmth, or itching at the injection site
  • Nausea
  • Diarrhea
  • Uneasy stomach
  • Clogged nose
  • Numbness
  • Joint and muscle ache (in patients with pericarditis)

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

  • Hives, rash, itching, breathing or swallowing issues, swelling of the eyes, face, lips, tongue, or throat, hoarseness, lightheadedness, fainting, or chest pain are just a few symptoms that you could experience.

Rilonacept may make some types of cancer more likely to develop. Discuss the dangers of using this drug with your doctor.

Other negative effects of rilonacept 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 packed in the carton it was packaged in and out of the reach of children. Protect it from light and keep it in the refrigerator. After mixing, medication can be kept at room temperature and consumed within three hours. Throw away any medication that has expired or is no longer required.

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

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.

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 appointments with your physician and the lab. To determine how well your body is responding to rilonacept, your doctor may request specific lab tests.

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

  • Arcalyst®
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