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Baricitinib

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WARNING

Baricitinib usage may impair your resistance to infection and raise your risk of contracting a serious illness, such as a systemic fungal, bacterial, or viral infection. These infections may require medical treatment and may result in death. If you frequently experience any form of infection or believe you are experiencing one right now, let your doctor know. This includes transient infections (like cold sores), minor infections (such open cuts or sores), and persistent infections. You should also let your doctor know if you have or have ever had diabetes, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), hepatitis B virus infection (HBV; an ongoing liver infection), hepatitis C virus infection (HCV; an ongoing liver infection), herpes zoster (shingles; a rash that can happen in people who have had chickenpox in the past), a lung disease, or any other condition that affect If you are in or have ever resided in a region where severe fungal infections are more prevalent, such as the Ohio or Mississippi river valleys, you should also let your doctor know. If you take any medications that make your immune system less active, let your doctor know.

Throughout and after your treatment, your doctor will keep an eye out for any infections. Call your doctor right away if you suffer any of the following symptoms before your treatment starts, while it is being administered, or just afterward: a fever, sweating, chills, muscle aches, coughing, shortness of breath, weight loss, warm, red, or painful skin, skin sores, frequent urination that hurts or feels burning, diarrhoea, or extreme exhaustion.

Even though you may already have a deadly lung infection called tuberculosis (TB), you could not yet be showing any signs of the illness. In this instance, taking baricitinib may worsen your illness and make you feel sick. Before and during your baricitinib treatment, your doctor will do a skin test to check for an inactive TB infection. Before you begin taking baricitinib, your doctor may prescribe medicine to treat this infection if necessary. Inform your doctor if you have or ever had TB, if you’ve lived in or travelled to a country where TB is prevalent, or if you’ve come into contact with anyone who has the disease. 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: fever, weight loss, loss of muscle tone, coughing up bloody mucus, or coughing up blood.

A lymphoma, a cancer that starts in the cells that fight infection, as well as other cancers like lung cancer and skin cancer, are possible side effects of taking baricitinib. If you have cancer or have ever had cancer, let your doctor know. Additionally, let your doctor know whether you smoke or have ever smoked.

Baricitinib use has been linked to significant or fatal heart issues, including heart attacks and strokes, as well as major or fatal blood clots in the legs or lungs. If you smoke or have ever smoked, let your doctor know. Additionally, let your doctor know if you now have or have ever had diabetes, high cholesterol, high blood pressure, a stroke, a blood clot in your legs, arms, lungs, or blood vessels, or any other heart-related issues. Call your doctor right away or seek emergency medical attention if you suffer any of the following side effects while receiving treatment: Intense chest pain or heaviness; discomfort in the arms, back, neck, jaw, or stomach; cold sweats; dizziness; numbness or weakness in the face, arm, or legs; slurred speech; breathing problems; cough; or pain, warmth, redness, swelling, or tenderness in the legs.

Keep all of your appointments with your physician and the lab. To determine how your body is responding to baricitinib, your doctor may prescribe specific tests.

The patient information sheet (Medication Guide) from the manufacturer will be sent to you by your doctor or pharmacist when you start baricitinib treatment and at each time you get 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 potential risks of taking baricitinib with your doctor.

Why is this medication prescribed?

Adults with rheumatoid arthritis (condition in which the body attacks its own joints, causing pain, swelling, and loss of function) who have not responded well to one or more tumour necrosis factor (TNF) inhibitor medications are treated with baricitinib alone or in combination with other medications (s). Additionally, it is used to treat individuals hospitalised with COVID-19 infections who need extracorporeal membrane oxygenation, supplementary oxygen, or a ventilator (ECMO; a device that adds oxygen to the blood). Adults with alopecia areata, a disorder in which the body assaults hair follicles and results in hair loss, can also be treated with baricitinib. Baricitinib belongs to a group of drugs known as Janus kinase (JAK) inhibitors. In order to function, it lowers the activity of the immune system.

How should this medicine be used?

Baricitinib is available as an oral tablet. It is typically taken once day, with or without food. Take baricitinib every day at roughly the same time. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Follow the medication’s directions precisely. Never take it in larger or less amounts or more frequently than directed by your doctor.

The pills can be placed in a small glass and dissolved in about 2 teaspoonfuls (10 mL) of room temperature water if you are unable to take them. After giving the concoction a few quick swirls, consume it. After consuming the combination, top off the glass with 10 mL more water. Swallow the mixture after giving the contents a few quick swirls.

If you suffer some serious adverse effects, your doctor may need to stop your medication either temporarily or permanently. During your treatment, be careful to let your doctor know how you are feeling.

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 taking baricitinib,

  • If you have an allergy to baricitinib, any other drugs, or any of the substances in baricitinib tablets, inform your doctor 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. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Inform your doctor if you experience unexplained stomach pain, have ulcers (sores in the lining of your stomach or intestine), diverticulitis (swelling of the lining of the large intestine), have anaemia (a low level of red blood cells), have liver illness, or have ever had any of these conditions.
  • If you are pregnant or plan to become pregnant, let your doctor know. Call your doctor if you become pregnant while taking baricitinib.
  • Describe to your doctor if you are nursing a baby. While using baricitinib and for four days following your last dose, you shouldn’t breastfeed.
  • If you have just had a vaccination or have one coming up, let your doctor know. Without consulting your doctor, avoid getting any immunisations while you are receiving therapy.

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 miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

There may be negative effects from baricitinib. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Nausea
  • Headache
  • Acne
  • Around the hair follicles are red lumps or pimples

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you develop any of these signs or any of the ones detailed in the IMPORTANT WARNING section:

  • Hives; facial, eye, lip, or throat swelling; breathing or swallowing challenges
  • Especially if it is accompanied by a fever, diarrhoea, or constipation
  • Breathing difficulties, exhaustion, or pale skin

Your blood cholesterol levels may rise as a result of taking baricitinib. During the course of your baricitinib treatment, your doctor will prescribe tests to track your cholesterol levels. The dangers of using this drug should be discussed with your doctor.

Other negative effects of baricitinib 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. Store it away from excessive heat and moisture at room temperature (not in the bathroom).

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?

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

Inform the lab staff and your doctor that you are taking baricitinib prior to any laboratory test.

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

  • Olumiant®
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