BARIJAK Tablet 14's

Introduction About BARIJAK TABLET

BARIJAK TABLET contains Baricitinib which belongs to the group of medicines
called Janus kinase inhibitors. BARIJAK TABLET is used to manage adults with
moderate to severe rheumatoid arthritis (inflammatory disease of the joints),
who have responded inadequately to, or who are intolerant to previous therapies.
BARIJAK TABLET is also used to manage adults with moderate to severe atopic
dermatitis (atopic eczema).

Prior to the management, your doctor may want you to take several blood tests to
understand your existing condition like low red blood cell count (anaemia), low
white blood cell count (neutropenia or lymphopenia), high cholesterol levels  or
high levels of liver enzymes, to ensure that management with BARIJAK TABLET is
not causing problems. Along with this, your doctor may test you for TB before
starting management with BARIJAK TABLET.

BARIJAK TABLET is not recommended for use in patients having liver, kidney,
heart diseases, stroke, and active infections like Tuberculosis. You will not be
given certain live vaccines while using BARIJAK TABLET.

Inform your doctor if you have diabetes, chronic lung disease, low red blood
cells, HIV, or a weak immune system. Infections like tuberculosis,
multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute
histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus or if you often
get infections.

BARIJAK TABLET is not recommended for use in pregnant and breast feeding.
Consult your doctor before taking. BARIJAK TABLET is not recommended for use in
children and adolescents under 18 years of age and should be used with caution
in elderly patients above 75 years of age.

The most common side effects of taking BARIJAK TABLET are signs of cold sores,
shingles (painful skin rash with blisters) and infections of the throat, nose
(cold, sinus) stomach (gastroenteritis), lungs (pneumonia), urinary tract
infections, headache, nausea, stomach pain, high levels of blood cholesterol and
liver enzymes shown by blood test.

Uses Of BARIJAK TABLET

It is used to manage moderate to severe:

• rheumatoid arthritis
• atopic dermatitis or atopic eczema

How BARIJAK TABLET Works

For rheumatoid arthritis, BARIJAK TABLET works by reducing the activity of an
enzyme called Janus kinase, which is involved in inflammation. By reducing the
activity of Janus kinase enzyme, it helps to reduce pain, stiffness and swelling
in your joints, tiredness and helps to slow down the damage to the bone and
cartilage in the joints. For atopic dermatitis, BARIJAK TABLET works by reducing
the activity of Janus kinase enzyme and helps to improve the condition of skin
and reduce itching. It also helps to improve your sleep disturbance due to
itching and overall quality of life.

How to use BARIJAK TABLET

Take BARIJAK TABLET as advised by your physician. Swallow the medicine with a
glass of water. Do not crush or chew the medicine. Your doctor will decide the
correct dose and duration for you depending upon your age, body weight and
disease condition.

Side Effects Of BARIJAK TABLET

Common

• upper respiratory tract infections
• elevated  creatine
• throat and nose infections
• high levels of blood cholesterol
• cold sores (herpes simplex)
• gastroenteritis (infection of the stomach, diarrhea)
• urinary infection
• pneumonia
• increased platelets count (thrombocytosis)
• headache
• nausea
• stomach pain
• high levels of liver enzymes
• rash, acne
• high levels of creatine kinase enzymes

Uncommon

• neutropenia (low white blood cells)
• high levels of triglycerides in blood
• weight gain
• swelling of the face, urticaria
• blood clot in the veins of the legs  (deep vein thrombosis and lungs)
• diverticulitis (inflammation of small pockets in the lining of your intestine)

Rare

Stop taking BARIJAK TABLET and contact your doctor immediately if you experience
any of the following side effects:

• chest tightness, wheezing
• severe dizziness or light-headedness
• allergic reaction such as swelling of the lips, tongue and throat
• hives (itching or skin rash)
• anaphylactic reactions
• severe abdominal pain accomp
• symptoms of an infection such as fever, sweating, or chills, muscle aches, cough, shortness of breath, blood in your phlegm, weight loss, warm, red, or painful skin or diarrhea or stomach, burning when you urinate or sores on your body, pain, urinating more often than normal, feeling tired
• pneumonia and urinary tract infection
• active serious infection, including localized infections
• recurrent infections
• tuberculosis (signs include fever, night sweats, weight loss) which may present with pulmonary or extra pulmonary disease
• bacterial, invasive fungal, viral, and other opportunistic infections like multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus
• cancer (lymphoma and skin cancers)
• blood clots in leg and lungs
• diverticulitis (inflammation of  small pockets in large intestine) or ulcers in your stomach or intestines
• discomfort in the center of your chest, severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw pain or discomfort in your arms, back, neck, jaw, or stomach, shortness of breath with or without chest discomfort) and stroke  (weakness in one part or on one side of your body, slurred speech)

How To Manage Side Effects

Headache:

Rest and relax. Drink plenty of fluids such as water and electrolytes. Apply a
pain-relieving balm on the head if necessary. Do not consume alcohol. Contact
your doctor if the symptom did not improve.

Nausea and Vomiting:

Take the medicine, with or just after a meal. Stick to simple meals. Avoid
eating oily or spicy food.

Diarrhoea:

Drink lots of fluids, such as water or fruit juices to keep you hydrated. Do not
take any medicine on your own for managing diarrhea. Contact your doctor if the
symptom did not improve.

Stomach pain:

Rest and relax. Try to have smaller meals but take frequently. Keep a heat pad
on your stomach. Do not self-manage on your own and contact your doctor if the
symptom did not improve on its own.

Warning & Precautions

!### Pregnancy

BARIJAK TABLET is generally not recommended for use in pregnant women. Consult
your doctor before taking.

!### Breastfeeding

BARIJAK TABLET is generally not recommended for use in breastfeeding women as it
is not known if this medicine passes into breast milk. Consult your doctor
before taking it.

!### Driving and Using Machines

BARIJAK TABLET has no effect on the ability to drive or operate any machines.

!### Kidney

BARIJAK TABLET should be used with caution in patients with kidney disease.
Consult your doctor before taking.

!### Liver

BARIJAK TABLET should be used with caution in patients with liver disease.
Consult your doctor before taking.

!### Allergy

Do not take BARIJAK TABLET if you are allergic to Baricitinib or any of the
other ingredients of this medicine.

!### Lungs

BARIJAK TABLET should be used with caution in patients with lung diseases
(pulmonary embolism). Consult your doctor before taking.

Others

Before taking BARIJAK TABLET, inform your doctor if you have:

• infections
• herpes infection (shingles) symptoms such as painful skin rash with blisters
• hepatitis B or C
• cancer such as Lymphoma and other cancers including skin cancers
• blood clots in the veins of your legs (deep vein thrombosis)
• diverticulitis (inflammation of small pockets in large intestine) or ulcers in stomach or intestines
• low red blood cell count (anaemia), low white blood cell count (neutropenia or lymphopenia), high blood fat (cholesterol) or high levels of liver enzymes
• any stomach pain
• diabetes
• HIV, or a weak immune system
• an infection other than COVID-19

Use in pediatrics:

BARIJAK TABLET is not recommended for use in children and adolescents under 18
years of age.

Use in geriatrics:

BARIJAK TABLET should be used with caution in elderly patients (aged above 75
years). Consult your doctor before taking.

Interactions

A. Drug - Drug interactions:

Before taking BARIJAK TABLET, inform your doctor if you are taking any of the
following medicine:

• medicines used to manage gout ( Ex. probenecid)
• injectable anti-rheumatic medicines (used to manage rheumatoid arthritis) Ex. tocilizumab, etanercept, adalimumab
• injectable medicines acting on immune system (targeted biologic antibody therapies)
• medicine to control immune response (Ex. azathioprine, tacrolimus or cyclosporine)
• other medicines belonging to the group of Janus kinase inhibitors (Ex. ruxolitinib)
• medicines used to manage pain and inflammation (Ex. NSAIDs)
• medicines used to manage severe pain (Ex. opioids)
• corticosteroids (used to manage inflammatory conditions)

Overdosage:

If you or anyone else accidentally takes too much of BARIJAK TABLET, consult
your doctor immediately or visit the nearby hospital.

Synopsis

Drug	:	Baricitinib
Pharmacological Category	:	Janus kinase inhibitor
Therapeutic Indication	:	Rheumatoid arthritis, Atopic dermatitis
Dosage Forms	:	Tablet

More Information

• Keep BARIJAK TABLET out of the sight and reach of children
• Store BARIJAK TABLET below 25°C

FAQs About BARIJAK TABLET

Does BARIJAK TABLET cause cancer?

BARIJAK TABLET may increase your risk of developing certain cancers, such as
lymphoma or lung cancer. Consult your doctor before taking.

Can I use BARIJAK TABLET in pregnant?

No. BARIJAK TABLET is generally not recommended for use in pregnant women.
Consult your doctor before taking BARIJAK TABLET.

How BARIJAK TABLET works?

For rheumatoid arthritis, BARIJAK TABLET works by reducing the activity of an
enzyme called Janus kinase, which is involved in inflammation. By reducing the
activity of Janus kinase enzyme, it helps to reduce pain, stiffness and swelling
in your joints, tiredness and helps to slow down the damage to the bone and
cartilage in the joints. For atopic dermatitis, BARIJAK TABLET works by reducing
the activity of Janus kinase enzyme and helps to improve the condition of skin
and reduce itching. It also helps to improve your sleep disturbance due to
itching and overall quality of life.

What side effects can be expected while taking BARIJAK TABLET?

The most common side effects of taking BARIJAK TABLET are signs of cold sores,
shingles (painful skin rash with blisters) and infections of the throat, nose
(cold, sinus) stomach (gastroenteritis), lungs (pneumonia), urinary tract
infections, headache, nausea, stomach pain, high levels of blood cholesterol and
liver enzymes shown by blood test.

Does BARIJAK TABLET affect immunity?

Yes. BARIJAK TABLET may affect the immunity and makes you to prone to infections
like throat, nose and chest infections, cold sores, urinary tract infections and
stomach upsets. Consult your doctor before taking BARIJAK TABLET.

Can BARIJAK TABLET cause bradycardia?

BARIJAK TABLET may cause bradycardia, when used with other medicines. Consult
your doctor before taking BARIJAK TABLET.

Useful Diagnostic Tests

• Rheumatoid Factor - Agglutination
• Rheumatoid Factor - Turbidometry
• Rheumatoid Factor IgG Antibody