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Abrocitinib

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WARNING

Abrocitinib 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. Included in this are mild infections (like little cuts or sores), transient infections (like cold sores), and persistent, chronic infections. Additionally, inform your physician if you have ever had diabetes, HIV, AIDS, lung illness, or any other immune-compromising conditions. 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 are unsure whether certain infections are typical in your location, consult your doctor. Inform your doctor if you are taking any medications, such as the ones listed below, that reduce the immune system’s activity. azathioprine (Azasan), abatacept (Orencia), adalimumab (Humira), anakinra (Kineret), certolizumab (Cimzia); methotrexate (Otrexup, Rasuvo, Trexall), cyclosporine (Gengraf, Neoral, Sandimmune), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), methylprednisolone (Medrol), prednisolone (Orapred ODT, Prelone), and prednisone (Rayos), as well as (Actemra).

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: Frequent, painful, or scorching urination; sweating; chills; muscle aches; cough; shortness of breath; weight loss; warm, red, or painful skin; sores on the skin; diarrhoea; or excessive weariness.

Even if you don’t exhibit any symptoms of the illness, you could already have the severe lung infection tuberculosis (TB). In this situation, using abrocitinib may make your infection worse and give you symptoms. Before you start your abrocitinib medication, your doctor will do a skin test to check for the presence of an inactive TB infection. Prior to beginning abrocitinib therapy, your doctor may prescribe medicine to treat this infection. 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 have any of the following TB symptoms, or if you acquire any of these symptoms while receiving treatment for the disease: weight loss, loss of muscular tone, fever, bloody mucous coughed up, or any of the following.

The use of abrocitinib may increase your risk of developing lymphoma, a cancer that starts in the immune system cells that fight infection, as well as other cancers like skin cancer or lung cancer. If you have cancer or have ever had cancer, let your doctor know.

A serious or life-threatening heart condition, such as a heart attack or stroke, or a serious or life-threatening blood clot in the legs or lungs may result from taking abrocitinib. Inform your doctor whether you currently smoke or have ever smoked. Additionally, let your doctor know if you now have or have ever had diabetes, high cholesterol, high blood pressure, a blood clot in your arteries, a stroke, a blood clot in your legs, arms, lungs, or veins. During your therapy, call your doctor right away or seek emergency medical attention if you suffer any of the following symptoms: chest, arm, back, neck, jaw, or stomach pain; breaking out in a cold sweat, feeling faint, dizziness, numbness or weakness in the face, arm, or legs, sluggish or difficult speech, sudden shortness of breath, or trouble breathing, swelling of the leg or arm, pain in the leg, or redness, discoloration, or warmth in the leg or arm.

Keep all of your appointments with your physician and the lab. To monitor how well your body is responding to abrocitinib, your doctor may request specific lab tests prior to, during, and after your treatment.

The patient information sheet (Medication Guide) from the manufacturer will be sent to you by your doctor or pharmacist when you start abrocitinib 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 abrocitinib with your doctor.

Why is this medication prescribed?

Adults with moderate to severe eczema (atopic dermatitis; a skin condition characterised by dryness, itching, and occasionally the development of red, scaly rashes) who are unable to use topical medications for their condition or whose eczema has not responded to topical medications are treated with the drug abrocitinib. The drug abrocitinib belongs to the group of drugs known as Janus kinase (JAK) inhibitors. It functions by reducing immune system activity.

How should this medicine be used?

Abrocitinib is available as an oral tablet. It is typically taken once day, with or without food. Take abrocitinib 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 abrocitinib directions exactly. Never take it in larger or less amounts or more frequently than directed by your doctor.

Do not split, chew, or crush the tablets or capsules; instead, swallow them whole.

Abrocitinib will likely be prescribed to you at a low dose to begin with, and if you don’t react to the lower amount after 12 weeks, your doctor may increase your dose.

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 abrocitinib,

  • If you have any allergies, including those to other medicines, abrocitinib, or any of the substances in abrocitinib tablet, tell your doctor and pharmacist right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • If you take antiplatelet medications like aspirin (in doses larger than 81 mg), clopidogrel, prasugrel, or ticagrelor, let your doctor know. If you are currently on one or more of these drugs, your doctor may or is likely to advise you not to use abrocitinib.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, herbal products, vitamins, and nutritional supplements you are now taking or intend to take. Mention any of the following as well as the medications specified in the IMPORTANT WARNING section. dabigatran (Pradaxa), digoxin (Cardoxin, Digitek, Lanoxicaps, Lanoxin), probenecid (Probalan, in Colbenemid, Proben-C), rifampin, fluvoxamine (Luvox, Luvox CR), fluconazole (Diflucan), or fluvoxamine (Rifadin, Rimactane, in Rifamate, Rifater). Abrocitinib may also interact with a wide range of other drugs, so be sure to inform your doctor about all the drugs you are taking, even if they are not on this list.
  • Inform your doctor if you smoke now or have ever smoked, have anaemia (lower-than-normal levels of red blood cells), herpes zoster (shingles, a rash that can develop in people who have previously had chickenpox), cataracts, retinal detachment, or liver illness, including hepatitis B or C.
  • Inform your doctor if you are expecting, intend to get pregnant, or are nursing a baby. Call your doctor if you become pregnant while taking aborocitinib. If you get pregnant while taking arocitinib, call 1-877-311-3770 to let them know.
  • Inform your doctor or dentist that you are taking abrocitinib if you are having surgery, including dental surgery.
  • If you have just had a vaccination or have one coming up, let your doctor know. If you require any immunisations, you might have to get them and wait a little before starting your abrocitinib medication. 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. To continue with your regular dosing plan, skip the missed dose if there are less than 12 hours until the next dose. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

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

  • Sneezing, a sore throat, and a stuffy or runny nose are examples of cold symptoms.
  • Nausea
  • Headache
  • The herpes simplex virus can cause cold sores.
  • Dizziness
  • Having pain or burning when urinating, or urinating frequently
  • Tiredness
  • Acne
  • Vomiting
  • Throat and mouth pain
  • Rash
  • Abdominal pain

Some adverse effects can be very harmful. You should stop taking abrocitinib and contact your doctor right away (or seek emergency medical attention) if you have any of these symptoms or any of those mentioned in the IMPORTANT WARNING section:

  • Abrupt alterations in eyesight

Abrocitinib may make females infertile (inability to get pregnant). The dangers of using this drug should be discussed with your doctor.

Other adverse effects of abrivitinib 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 out of the reach of children and tightly closed in the original container. Keep it at normal temperature, away from sources of extreme heat and moisture (not in the bathroom).

All medications should be kept out of the sight and reach of children, as many of the containers (such as weekly pill containers and those for eye drops, lotions, patches, and inhalers) are not child-resistant and are simple for small children to open. Always lock safety caps and put the medication in a secure spot right away, up high and out of young children’s 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 monitor how your body is responding to abrocitinib, 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

  • Cibinqo®
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