Pronunciation:

rit-le-SYE-ti-nib

Brand Names:

• Litfulo

Dosage Forms:

• Capsule

Warnings:

Warning: Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events (MACE) and ThrombosisIncreased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment if serious infection occurs until the infection is controlled. Ritlecitinib should not be given to patients with active tuberculosis. 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.Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. Ritlecitinib is not approved for use in RA patients.Malignancies have occurred in patients treated with ritlecitinib. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients.Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another JAK inhibitor vs. TNF blockers in RA patients.Thrombosis has occurred in patients treated with ritlecitinib. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers .

Classifications:

Therapeutic—

Alopecia Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

Ritlecitinib is used to treat severe alopecia areata (autoimmune disorder that causes patchy hair loss). This medicine is a Janus kinase 3 (JAK3) and tyrosine kinase 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 ritlecitinib 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 ritlecitinib in the elderly. However, elderly patients are more likely to have unwanted effects (eg, infection), which may require caution and adjustment in the dose for patients receiving ritlecitinib.

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 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.

• Abemaciclib
• Acalabrutinib
• Adenovirus Vaccine, Live
• Alfentanil
• Alosetron
• Apalutamide
• Aprepitant
• Atazanavir
• Atorvastatin
• Avanafil
• Avapritinib
• Bacillus of Calmette and Guerin Vaccine, Live
• Bosutinib
• Brotizolam
• Budesonide
• Buspirone
• Caffeine
• Capivasertib
• Carbamazepine
• Cholera Vaccine, Live
• Cobimetinib
• Conivaptan
• Crizotinib
• Cyclosporine
• Daridorexant
• Darifenacin
• Darunavir
• Dasatinib
• Dengue Tetravalent Vaccine, Live
• Dihydroergotamine
• Dofetilide
• Dronedarone
• Duloxetine
• Ebastine
• Ebola Zaire Vaccine, Live
• Eletriptan
• Elvitegravir
• Entrectinib
• Enzalutamide
• Eplerenone
• Ergotamine
• Everolimus
• Felodipine
• Fentanyl
• Finerenone
• Flibanserin
• Fluticasone
• Fosaprepitant
• Fosphenytoin
• Ibrexafungerp
• Ibrutinib
• Indinavir
• Influenza Virus Vaccine, Live
• Isavuconazole
• Ivabradine
• Ivacaftor
• Ivosidenib
• Levomethadyl
• Lomitapide
• Lopinavir
• Lovastatin
• Lumacaftor
• Lurasidone
• Maraviroc
• Measles Virus Vaccine, Live
• Melatonin
• Midazolam
• Midostaurin
• Mitotane
• Mobocertinib
• Mumps Virus Vaccine, Live
• Naloxegol
• Nirogacestat
• Nisoldipine
• Oliceridine
• Oxycodone
• Paritaprevir
• Phenytoin
• Pimavanserin
• Pimozide
• Poliovirus Vaccine, Live
• Quetiapine
• Quinidine
• Ramelteon
• Repotrectinib
• Rifampin
• Rifapentine
• Roflumilast
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Sildenafil
• Simvastatin
• Sirolimus
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• St John's Wort
• Sufentanil
• Tacrine
• Tacrolimus
• Tasimelteon
• Temsirolimus
• Terfenadine
• Theophylline
• Ticagrelor
• Tilidine
• Tipranavir
• Tizanidine
• Tolvaptan
• Tramadol
• Triazolam
• Typhoid Vaccine, Live
• Ubrogepant
• Ulipristal
• Vardenafil
• Varicella Virus Vaccine, Live
• Venetoclax
• Voclosporin
• Yellow Fever Vaccine
• Zoster Vaccine, Live

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:

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

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

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

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more or less of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

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

You may take this medicine with or without food.

Swallow the capsule whole. Do not chew, crush, or split 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 (capsule):
  • For alopecia areata:
    • Adults and children 12 years of age and older—50 milligrams (mg) once a day.
    • 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 it is less than 8 hours before your next dose, skip the missed dose and go back to your regular dosing schedule.

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. This will allow your doctor to see if this medicine is working properly and to decide whether you should continue to use it. Blood tests are 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.

Your body's ability to fight infections may be reduced while you are using ritlecitinib. 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 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.

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.

While you are being treated with ritlecitinib, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Ritlecitinib 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 can cause serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, or unusual tiredness or weakness.

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

Burning, itching, and pain in hairy areas, pus at the root of hair

painful blisters on the trunk of the body

Incidence not known

Anxiety

black, tarry stools

chest pain, discomfort, or tightness

confusion

cough or hoarseness

coughing or spitting up blood

difficulty breathing

difficulty in speaking

dizziness or lightheadedness

double vision

fainting

fast heartbeat

fever or chills

general feeling of illness

headache

hives, itching, skin rash

inability to move the arms, legs, or facial muscles

inability to speak

lower back or side pain

muscle aches

nausea

night sweats

pain, redness, or swelling in the arm or leg

pain or discomfort in the arms, jaw, back, or neck

painful or difficult urination

persistent non-healing sore

pink growth

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

reddish patch or irritated area

shiny bump

slow speech

sore throat

sudden high fever or low grade fever for months

sweating

swollen glands

tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area

unusual tiredness or weakness

vomiting

weight loss

white, yellow, or waxy scar-like area

yellow skin and eyes

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

Diarrhea

Less common

Blemishes on the skin

pimples

swelling or inflammation of the mouth

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.