CIBINQO (abrocitinib) Tablets for Eczema

CIBINQO is a once-daily prescription medicine to treat adults with moderate-to-severe eczema or atopic dermatitis that did not respond to other treatment and is not well controlled with prescription medicines, including biologics, or when they cannot be tolerated.

It is not known if CIBINQO is safe to use in children and hence CIBINQO is not approved for use in pediatric patients.

CIBINQO is a Janus kinase (JAK) inhibitor that works inside the body and helps disrupt how cells respond to some cytokines. Cytokines allow cells to communicate with each other, and too many of these cytokines may cause inflammation.

Limitations of Use: CIBINQO shouldn’t be used in combination with other biologic immunomodulators, JAK inhibitors, or with other immunosuppressants.

CIBINQO is 100% steroid-free and proven to help provide clearer skin and itch relief.

Clearer skin:

More people saw 75% skin improvement with CIBINQO after just 3 months. Some people also saw clear or almost clear skin with CIBINQO alone after just 3 months.

Fast itch reduction:

More people felt itch reduction taking CIBINQO after just 2 weeks.

Before taking CIBINQO, tell your healthcare provider about all of your medical conditions, including if you:

• are being treated for an infection, have an infection that keeps coming back, that won’t go away, or think if you have symptoms of an infection.
• are a current or past smoker
• have had other heart problems, heart attack, stroke
• have kidney problems or liver problems.
• have white blood cell counts and low platelet counts.
• have any eye problems, including cataracts or retinal detachment.
• have received or are planning to receive a vaccine. You shouldn’t receive live vaccines when taking CIBINQO.
• are pregnant or planning to become pregnant. It is not known if CIBINQO will harm your unborn baby.
• are breastfeeding or planning to breastfeed. It is not known if CIBINQO can pass into your breast milk.
• Tell your doctor about all the medicines you take, including prescriptions, vitamins, over-the-counter medicines, and herbal supplements.
• Especially tell your doctor if you take aspirin or any antiplatelet therapies.

• Take CIBINQO exactly as your doctor tells you to take it.
• You take CIBINQO 1 time each day (at the same time).
• Swallow CIBINQO tablets with water. Do not crush, split, or chew the tablets.
• You can take CIBINQO with or without food.
• CIBINQO can be used with other prescribed topical medicines for atopic dermatitis.
• If you miss a dose, take that dose as soon as possible. If it is less than 12 hours before the next dose, skip the dose. Take the next dose at your usual scheduled time.
• If you take too much CIBINQO, call your doctor.
• During the first 3 months of treatment, do not take CIBINQO with other medicines that prevent blood clots. You can take aspirin up to a dose of 81 mg each day during this time if prescribed by your doctor.

The recommended dosage of CIBINQO is 100 mg orally once daily.

If you do not see any improvement with CIBINQO 100 mg after 3 months, your doctor may increase it to CIBINQO 200 mg. If no improvement is seen with CIBINQO 200 mg, stop taking CIBINQO 200 mg.

CIBINQO can be used with or without topical corticosteroids.

If a dose is missed, take the dose as soon as possible unless it is less than 12 hours before the next dose, in which case skip the missed dose. Thereafter, resume dosing at the regular scheduled time.

Renal Impairment

In patients with mild and moderate renal impairment, if an improvement is not seen after 12 weeks, the dose of CIBINQO can be doubled.

Hepatic Impairment

CIBINQO is not recommended for use in patients with severe hepatic impairment.

In patients who are known (suspected) to be CYP2C19 poor metabolizers, the recommended dosage of CIBINQO is 50 mg once daily. If there is no improvement with CIBINQO 50 mg orally daily after 12 weeks, your doctor will increase the dosage to 100 mg orally once daily. You can discontinue therapy if no improvement is seen after a dosage increase to 100 mg once daily.

If you’re taking strong inhibitors of cytochrome P450 (CYP) 2C19 your doctor will reduce the dosage to 50 mg once daily. If no improvement is seen with CIBINQO 50 mg orally daily after 12 weeks, the dosage will be increased to 100 mg orally once daily. Discontinue therapy if no improvement is seen after dosage increase to 100 mg once daily.

Opportunistic or Serious Infections: If a patient develops an opportunistic or serious infection, your doctor will discontinue treatment with CIBINQO and control the infection.

Hematologic Abnormalities: consult a doctor.

• 50 mg tablet
• 100 mg tablet
• 200 mg tablet

• common cold
• nausea
• headache
• herpes simplex including cold sores
• an increased blood level of creatinine phosphokinase
• dizziness
• urinary tract infection
• tiredness
• acne
• vomiting
• mouth and throat pain
• flu
• stomach flu
• impetigo (bacterial skin infection)
• high blood pressure
• allergic skin rash to something you came into contact with
• stomach-area pain
• shingles
• low platelet count

• Serious infections: CIBINQO can affect your immune system and lower the ability of your immune system to fight infections. Infections including shingles, tuberculosis (TB), and infections caused by bacteria, fungi, or viruses can occur when taking CIBINQO. Some people have also died from these infections. It can also make you more prone to get infections or may make any infections that you have worse Your doctor should test you for TB before starting CIBINQO and watch for any TB symptoms during treatment. You should not start CIBINQO unless your doctor tells you it is okay. Call your doctor right away if you show symptoms of an infection, such as:
  • fever, sweating, or chills
  • muscle aches
  • cough
  • blood in phlegm
  • shortness of breath
  • diarrhea or stomach pain
  • weight loss
  • red, warm, painful skin or sores on your body
  • urinating more often than normal or burning sensation when urinating
  • feeling tired

• Cancer and immune system problems: CIBINQO may increase your risk of skin cancers and lymphoma. People taking medicine, especially in the class of medicines called JAK inhibitors have a higher risk of certain cancers, including lung cancer and lymphoma, especially if you are a current or past smoker. Follow your doctor’s advice about having your skin checked for skin cancer during treatment with CIBINQO.

• There will be a increased risk of heart attack, stroke, or death in people who are 50 years of age and above who have at least 1 heart disease risk factor and taking medicine, especially in the class of medicines called JAK inhibitors, especially if you are a current or past smoker. Call your doctor right away if you show symptoms of a heart attack or stroke while taking CIBINQO, including:
  • discomfort in the center of your chest
  • severe pain, pressure, tightness, or heaviness in your throat, neck, chest, or jaw
  • pain or discomfort in your back, neck, arms, jaw, or stomach
  • nausea or vomiting
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • feeling lightheaded
  • weakness on one side of your body or in one part
  • slurred speech

• Blood clots: in the veins of your lungs or legs, and arteries. This may even be life-threatening and can cause death. Blood clots in the veins of legs or lungs, and arteries have happened more often in people who are 50 years of age or older and with at least 1 heart disease risk factor taking a medicine in the class of medicines called JAK inhibitors. Stop taking and call your doctor right away if you have any signs and symptoms of blood clots including:
  • pain, swelling, or tenderness in one or both legs
  • sudden, unexplained chest or upper back pain
  • shortness of breath or difficulty breathing

• Allergic reactions: While taking CIBINQO, if you have symptoms, such as swelling of your lips, tongue, or throat, rash, trouble breathing, feeling faint or dizzy stop taking CIBINQO and get emergency help right away.

• Changes in laboratory test results. Your doctor should also do blood tests before and while taking CIBINQO. You should not take CIBINQO if your red blood cell or white count is too low or your liver tests are too high. Your doctor may pause your treatment with CIBINQO because of changes in these test results. Your doctor will also check your cholesterol levels approximately 12 weeks after you start CIBINQO and when needed.

• Vaccinations: make sure to avoid the use of live vaccines with CIBINQO.

Strong CYP2C19 Inhibitors, Moderate to Strong Inhibitors of both CYP2C19 and CYP2C9, and Strong CYP2C19 or CYP2C9 Inducers can interact with CIBINQO.

• Store CIBINQO at room temperature between 68°F to 77°F (20°C to 25°C).
• Store CIBINQO in the original package.
• The container has a child-resistant closure.

Active ingredient: abrocitinib
Inactive ingredients: microcrystalline cellulose, sodium starch glycolate, dibasic calcium phosphate anhydrous, hypromellose, Macrogol, magnesium stearate, iron oxide red, lactose monohydrate, titanium dioxide, and triacetin.