Pronunciation:

a-broe-SYE-ti-nib

Brand Names:

• Cibinqo

Dosage Forms:

• Tablet

Warnings:

Serious InfectionsPatients treated with abrocitinib may be at increased risk for developing serious infections that may lead to hospitalization or death. The most frequent serious infection reported with abrocitinib were herpes simplex, herpes zoster, and pneumonia.If a serious or opportunistic infection develops, discontinue abrocitinib and control the infection.Reported infections from Janus kinase (JAK) inhibitors used to treat inflammatory conditions:Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized disease.Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.Avoid use of abrocitinib in patients with an active, serious infection including localized infections. The risks and benefits of treatment with abrocitinib should be carefully considered prior to initiating therapy in patients with chronic or recurrent infections.Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with abrocitinib, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.MortalityIn a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing another JAK inhibitor to TNF blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor. Abrocitinib is not approved for use in RA patients.MalignanciesMalignancies were reported in patients treated with abrocitinib. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer [NMSC]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risks.Major Adverse Cardiovascular EventsMajor adverse cardiovascular events were reported in patients treated with abrocitinib. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue abrocitinib in patients that have experience a myocardial infarction or stroke.ThrombosisDeep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients treated with abrocitinib. Thrombosis, including PE, DVT, and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid abrocitinib in patients at risk. If symptoms of thrombosis occur, discontinue abrocitinib and treat appropriately .

Classifications:

Therapeutic—

Dermatological Agent

Uses of This Medicine:

Abrocitinib is used to treat moderate to severe atopic dermatitis (eczema) in patients who have taken other medicines that did not work well and whose condition is not well controlled with other treatments or in patients who cannot tolerate these treatments.

Abrocitinib is a Janus kinase (JAK) inhibitor that works on the immune system.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of abrocitinib in children younger than 12 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of abrocitinib in the elderly. However, elderly patients are more likely to have serious infections (eg, herpes zoster), which may require caution in patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Abciximab
• Anagrelide
• Aspirin
• Cangrelor
• Cilostazol
• Clopidogrel
• Dipyridamole
• Epoprostenol
• Eptifibatide
• Iloprost
• Prasugrel
• Selexipag
• Sulfinpyrazone
• Ticagrelor
• Ticlopidine
• Tirofiban
• Treprostinil
• Vorapaxar

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Apalutamide
• Digoxin
• Fluconazole
• Fluvoxamine
• Mavacamten
• Phenobarbital
• Primidone
• Rifampin
• Sparsentan

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia (low number of red blood cells) or
• Hyperlipidemia (high cholesterol in the blood) or
• Infection, history of or
• Neutropenia (blood disease) or
• Thrombocytopenia (low number of platelets)—Use with caution. May make these conditions worse.

• Diabetes or
• Heart or blood vessel disease or
• Hepatitis B, history of or
• Hepatitis C, history of or
• Herpes zoster infection or
• HIV infection or
• Lung disease, chronic or
• Skin cancer, history of or
• Tuberculosis, active or history of or
• Weakened immune system—May cause side effects to become worse.

• Infection, active or
• Kidney disease, severe or
• Liver disease, severe—Use is not recommended in patients with these conditions.

• Kidney disease, mild or moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Smoker, current or past—May increase risk for serious side effects.

Proper Use of This Medicine:

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Take this medicine at the same time each day. You may take it with or without food.

Swallow the tablet whole with water. Do not crush, split, or chew it.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For atopic dermatitis:
    • Adults and children 12 years of age and older—100 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose, take it as soon as possible, and then go back to your regular schedule. If you miss a dose and it is less than 12 hours before the next dose, skip the missed dose and take your next dose at the regular time.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

This medicine should not be used together with medicine that prevents blood clots during the first 3 months of treatment.

Some women who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Your body's ability to fight infections may be reduced while you are using abrocitinib. It is very important that you call your doctor at the first sign of an infection. Check with your doctor right away if you have a fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections (eg, herpes, tuberculosis, hepatitis B, hepatitis C, fungal infection) more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may increase your risk of cancer (eg, lymphoma, lung cancer, non-melanoma skin cancer). Tell your doctor right away if you have black, tarry stools, general feeling of illness, swollen glands, weight loss, yellow skin and eyes, persistent non-healing sore, reddish patch or irritated area, shiny bump, pink growth, or white, yellow or waxy scar-like area on the skin.

This medicine may increase your risk of developing blood clots (eg, arterial thrombosis, deep vein thrombosis, pulmonary embolism), especially in patients with rheumatoid arthritis who are 50 years of age and older and with a heart or blood vessel disease. Check with your doctor right away if you have anxiety, chest pain, cough, dizziness, lightheadedness, or fainting, fast heartbeat, pain, redness, or swelling in the arm or leg, pains in the chest, groin, or legs, especially calves of the legs, severe headaches, sudden loss of coordination, sudden onset of slurred speech, sudden vision changes, or trouble breathing.

This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

This medicine may increase your risk of serious heart or blood vessel problems (eg, heart attack, stroke), especially in patients with rheumatoid arthritis who are 50 years of age and older and with a heart or blood vessel disease. Call your doctor right away if you have chest pain or discomfort, confusion, difficulty in speaking, double vision, headache, inability to move arms, legs, or facial muscles, nausea, pain or discomfort in the arms, jaw, back, or neck, sweating, trouble breathing, or vomiting

While you are being treated with abrocitinib, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Abrocitinib may lower your body's resistance and there is a chance you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

This medicine may increase the level of cholesterol and fat in your blood. Talk to your doctor if you have concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Black, tarry stools

bleeding gums

blood in the urine or stools

burning or stinging of skin

chills

cough

diarrhea

fever

general feeling of discomfort or illness

headache

joint pain

loss of appetite

muscle aches and pains

nausea

painful blisters on the trunk of the body

painful cold sores or blisters on the lips, nose, eyes, or genitals

pinpoint red spots on the skin

runny nose

shivering

sore throat

stomach pain

sweating

trouble sleeping

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

Rare

Blistering, burning, crusting, dryness, or flaking of the skin

blurred vision

dizziness

itching, scaling, severe redness, soreness, or swelling of the skin

nervousness

pounding in the ears

red rash with watery, yellow-colored, or pus filled blisters

slow or fast heartbeat

thick yellow to honey-colored crusts

Incidence not known

Chest pain or tightness

persistent non-healing sore

pink growth

reddish patch or irritated area

seeing flashes or sparks of light

seeing floating spots before the eyes, or a veil or curtain appearing across part of vision

white, yellow or waxy scar-like area

shiny bump

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Stuffy nose

Less common

Bladder pain

blemishes on the skin

difficult, burning, or painful urination

frequent urge to urinate

lower back or side pain

pimple

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.