Cibinqo

Generic Name: Abrocitinib
Dosage Form: tablets, for oral use

Medically reviewed by A Ras MD.  Last updated March 25, 2022

What is the Cibinqo?

Cibinqo can be prescribed that acts as a Janus Kinase (JAK) inhibitor. Cibinqo is prescribed for adults suffering from moderate to severe Atopic skin eczema (eczema) that does not respond to treatments and cannot be managed with prescription treatments which include biologic medicines, or in adults who can’t take these treatments.

Abrocitinib is a white to pale colored powder with the following chemical name: N-((1s,3s)-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclobutyl)propane-1-sulfonamide

The solubility of abrocitinib in water is 0.04 mg/mL at 25ºC.

Abrocitinib has a molecular weight of 323.42 g/mol and a molecular formula of C14H21N5O2S. The structural formula of abrocitinib is:

Each film-coated tablet contains 50 mg or 100 mg or 200 mg of abrocitinib and the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, lactose monohydrate, Macrogol, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, and triacetin.¶

It isn’t known whether Cibinqo is safe and effective for children.

In the initial 3 months of your treatment use Cibinqo. Do not combine Cibinqo alongside other medications that stop blood clots. Aspirin can be taken in low doses up to 81 mg daily during this time if recommended by your physician.

Mechanism of Action

It is a Janus kinase (JAK) inhibitor.

By inhibiting the adenosine triphosphate (ATP) binding site, abrocitinib inhibits JAK1 in a reversible manner. Abrocitinib was found to be more selective for JAK1 than JAK2 (28-fold), JAK3 (>340-fold), and tyrosine kinase (TYK) 2 (43-fold) in a cell-free isolated enzyme test. The impact of inhibiting individual JAK enzymes on treatment efficacy is unknown at this time. In vitro, the parent drug and active metabolites both inhibit JAK1 activity with equal selectivity.

Which is the primary information regarding Cibinqo?

This medication could result in serious side effects, such as:

Infections that are serious

This is a medication which affects the immune system. Cibinqo could reduce the capability of the immune system to fight off infections. Certain people have experienced serious infections after taking Cibinqo or similar medications such as tuberculosis (TB) as well as infections caused by fungi, bacteria or viruses which can be spread throughout the body. Certain people have died as a result of these illnesses.

• Your doctor will need to examine you for TB prior to commencing the treatment process with Cibinqo.
• Your physician should be watching closely for any signs or symptoms of TB while you are treated with Cibinqo.

You shouldn’t begin using Cibinqo if there is any type of infection unless your doctor confirms that it is safe.

There is an increased risk of getting shingles (herpes Zoster).

Following the start of Cibinqo contact your healthcare professional immediately If you experience any signs of infection. This medication may increase your risk to contract infections or make illnesses you are suffering from worse.

A higher risk of death

A higher risk of dying for people who are aged 50 and over who have at least one heart condition (cardiovascular) risk element and who are taking a medication in the class of drugs known as Janus kinase (JAK) inhibitors. Cibinqo is an inhibitor of JAK.

1. The immune system is a major cause of cancer and

This medication could increase your chances of getting certain cancers by altering the way your immune system functions.

• Lymphoma, as well as other types of cancer, such as skin cancers, may occur in patients taking Cibinqo.
• People who take medicine from the class of drugs known as Janus kinase (JAK) inhibitors are more likely to develop certain types of cancer, including lymphoma and lung cancer, particularly in the case of either a smoker or have been for a while.
• Follow the advice of your doctor regarding having your skin examined for skin cancer before treatment with Cibinqo. Limit the time you are in the sun. Avoid tanning beds and sunlamps. Wear protective clothing whenever you’re out in the sun, and apply sunscreen that has a high protection factor (SPF 30 and higher). This is particularly important when your skin is extremely fair or if you have an ancestral background for skin cancer.

Inform your doctor that you’ve had any kind of cancer.

Risk of cardiovascular events

Greater risk of major cardiovascular events like stroke, heart attack, or death for people who are 50 and older with at least one cardiovascular disease (cardiovascular) risk factor and are taking medication within the class of medications known as JAK inhibitors. This is especially true in the case of smoking or having been a smoker for a while.

Some individuals taking Cibinqo have had significant cardiovascular issues.

Contact emergency medical assistance immediately If you experience any signs of heart attack or stroke after treatment with Cibinqo. These include:

• pain in the middle of your chest that persists longer than a few minutes, or which is gone and then returns
• intense tightness, pain pressure or heaviness that is felt in your throat, chest neck, or jaw
• discomfort or pain in your back, arms or neck, jaw or stomach
• the weakness is in one area or one of the sides of your body
• Slurred speech
• breath shortness and chest pain
• exchanging an uncontrollable sweat
• nausea or vomiting  feeling lightheaded

Blood clots

The formation of blood clots in the veins in the leg (deep vein thrombosis, also known as DVT) or in your lungs (pulmonary embolism PE) may occur in certain people who take this medication. It could be life-threatening. Blood clots that form in blood vessels in the leg (deep vein thrombosis, also known as DVT) as well as in the lungs (pulmonary embolism PE) are more frequent for those who are 50 years old or older and have at least one coronary disease (cardiovascular) the risk factors include one of the classes of medications known as Janus kinase (JAK) inhibitors.

• Contact your physician that you’ve experienced blood clots within the veins of your legs, or lung previously.
• Seek medical attention immediately when you experience any indications or symptoms of blood clots following treatment with Cibinqo. These include:
  • swelling, tenderness, or pain in either or both legs
  • Unfortunate, unprovoked lower back or chest pain that isn’t explained
  • breathing difficulty or shortness of breath breathing

Variations in certain laboratory test results

Your doctor should conduct blood tests prior to you beginning taking this medication  and throughout the treatment using this medication to determine the following:

• A low number of lymphocytes. The lymphocytes contain white blood cells that aid your body fight infections.
• low neutrophil count. Neutrophils are blood-forming white cells that help the body fight off infections.
• Low red blood cell count. This could mean you are suffering from anemia. This can cause you to feel tired and weak.
• Low platelet count. Platelets aid in the formation of clots and stop bleeding or stop it.

It is not recommended to consume Cibinqo in the event that your lymphocyte count or neutrophil counts, the number of red blood cells as well as platelet counts, are low. Your doctor may decide to suspend you from taking Cibinqo therapy for a short period of time in the event of changes in the results of these blood tests. You could also experience changes in other tests, for instance, the cholesterol levels in your blood.

Your healthcare professional should perform blood tests around 4 weeks after starting taking Cibinqo and four weeks following any increase in the dosage of Cibinqo to determine the blood cell count and the frequency required for other tests at the lab.

Before you take Cibinqo

• Check out “What is the top thing I need to be aware of regarding this medication ?”
• are suffering from an infection.
• whether you are a past or current smoker
• You may have suffered a heart attack, heart issues or stroke
• are suffering from liver or kidney issues.
• suffer from low platelet counts or low white blood cells.
• are suffering from any eye problems are suffering from eye issues, including cataracts and retinal detachment.
• Have recently been given or received the vaccine (vaccine). Patients who are taking Cibinqo should not be receiving live vaccines.
• You are expecting or plan to be pregnant or plan to. It’s not clear whether this medication could affect your unborn baby.
  • Pregnancy Exposure Registry. Pfizer has an official registry for women who use Cibinqo while pregnant. The goal of the registry serves is to assess the health of both you and your child. If you are pregnant or become pregnant during treatment with Cibinqo, talk to your healthcare provider about how you can join this pregnancy registry, or you may contact the registry at 1-877-3113770 or www.cibinqopregnancyregistry.com.
• If you are nursing or planning to you plan to. It isn’t known whether Cibinqo is absorbed into breast milk. Your healthcare provider and you should determine if you wish to use Cibinqo or feed your baby. Do not combine both.

Inform your doctor about any medications you take that you are taking, including prescription and non-prescription supplements such as vitamins, herbal supplements. Cibinqo and other medications may cause side consequences.

Inform your healthcare provider whether you are taking aspirin or any other antiplatelet therapy. Check out “Do not take this medication when you.” Consult your physician in case you’re unsure.

Take note of the medicines you take. Keep a list to show your doctor and pharmacist each time you receive any new medication.

How should I take the drug?

• Take Cibinqo exactly according to the instructions of your physician that you take the.
• Take Cibinqo every day for 1 hour at the same time throughout the day.
• Take Cibinqo tablets in one swallow with water. Don’t break, crush or chew them.
• You can consume Cibinqo either with food or not.
• Cibinqo can be used in conjunction with or without prescriptions for topical medicine for Atopic allergic dermatitis. The prescribed topical medicine includes creams, lotions, or ointments that are applied to your skin.
• If you are missing a dose, you should take the dose as fast as you are able. If it’s shorter than twelve hours from your next dosage, do not take the dose. The next dose should be taken according to your regular schedule.
• If you have taken too much Cibinqo, Call the Poison Control Center at 1-800-222-1222 immediately.

What could be the possible side effects of Cibinqo?

The most frequent adverse effects of Cibinqo are:

Read “What do you think is the most significant thing I should be aware of about Cibinqo.

• common cold
• vomiting
• nausea
• Tongue and throat pain
• headache
• Flu
• herpes simplex including
• stomach sores from the cold flu
• bacterial skin infection (impetigo)
• Increased blood sugar
• Creatinine levels in high blood pressure
• an allergic skin rash that is caused by the substance you were in contact with
• dizziness
• Pain in the stomach area
• Urinary tract infection
• Shingles
• tiredness
• Low platelet count
• Acne

Cibinqo could cause fertility issues in females. This could limit your ability to become pregnant. Discuss with your physician should you have any concerns regarding fertility.

The tear or separation of the inner lining of the back of the eyes (retinal detachment) is a common occurrence in patients suffering from atopic dermatitis and which is treated by the Cibinqo. Consult your healthcare professional right now if you notice abrupt changes in your vision after treatments with Cibinqo.

These are not the only possible side effects associated with Cibinqo.

How do I store Cibinqo?

• Storage Cibinqo at room temperatures between the 68-77degF range. (20degC to 25degC).).
• Keep Cibinqo within the original container.
• The container is child-proof and has a closure.

Be sure to keep Cibinqo and all other medicines away from the reach of children.

General information on the safety of Cibinqo.

Some medicines are prescribed for reasons that are not the ones listed in the Medication Guide. Don’t use Cibinqo to treat a condition for that it is not recommended. Do not give Cibinqo to other people, even though they suffer from the same symptoms that you do. It could cause harm to them.

Label

PRINCIPAL DISPLAY PANEL – 50 MG TABLET BOTTLE LABEL

PRINCIPAL DISPLAY PANEL – 100 MG TABLET BOTTLE LABEL

 

PRINCIPAL DISPLAY PANEL – 200 MG TABLET BOTTLE LABEL