TNIB ER Tablet 10's

Introduction About TNIB ER TABLET

TNIB ER TABLET contains Tofacitinib, a disease-modifying anti-rheumatic drug
(DMARD) belonging to the Janus kinase (JAK) inhibitors class. It is used to
manage moderate to severe inflammatory conditions including rheumatoid
arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.

TNIB ER TABLET inhibits Janus kinase enzymes (JAK 1 and JAK 3), blocking the
signaling pathways that lead to inflammation and immune system overactivation.
This results in reduced pain, swelling, and tissue damage in autoimmune
conditions.

Take TNIB ER TABLET exactly as prescribed by your doctor, usually once or twice
daily. Swallow the tablet whole with water, with or without food. Do not crush
or chew the tablet. Consistent dosing at the same time each day helps maintain
symptom control.

Inform your doctor if you have infections, liver or kidney disease, or a history
of tuberculosis before starting TNIB ER TABLET. Pregnant or breastfeeding women
should consult their healthcare provider before use.

Avoid live vaccines without medical approval while taking this medication.
Regular monitoring of blood counts and liver function is necessary during
treatment. The common side effects are headache, dizziness, respiratory
infections, increased cholesterol levels, nausea, diarrhea, abdominal pain and
increased risk of serious infections.

Uses Of TNIB ER TABLET

• Management of rheumatoid arthritis and reduction of joint pain and swelling
• Management of psoriatic arthritis and improving skin and joint symptoms
• Relief of inflammation and pain in ankylosing spondylitis
• Control of ulcerative colitis symptoms including inflammation in the digestive tract
• Also used in juvenile idiopathic arthritis in appropriate patients

Benefits of TNIB ER TABLET

How effective is TNIB ER TABLET for arthritis?

• Clinical trials demonstrate TNIB ER TABLET significantly reduces joint pain, swelling, and stiffness, improving physical function and quality of life for patients, including those not responding to prior treatments.
• Tofacitinib monotherapy or combination therapy with methotrexate achieves low disease activity or remission in a substantial proportion of patients (30-70%) within 3 to 12 months, with maintained efficacy long-term up to several years
• It also inhibits radiographic progression, slowing joint damage compared to placebo or methotrexate alone, supporting its role in preserving joint integrity
• Real-world data confirm consistent effectiveness across different doses, treatment lines, and regimens, demonstrating broad applicability and treatment persistence similar to biologics
• Rapid onset of symptom relief is observed often within the first few weeks, and once-daily or twice-daily oral dosing enhances patient convenience and adherence.

How TNIB ER TABLET Works

TNIB ER TABLET inhibits Janus kinase enzymes (JAK 1 and JAK 3), blocking the
signaling pathways that lead to inflammation and immune system overactivation.
This results in reduced pain, swelling, and tissue damage in autoimmune
conditions.

How TNIB ER TABLET Modulates the Immune System to Reduce Symptoms

• TNIB ER TABLET (Tofacitinib) modulates the immune system to reduce symptoms primarily through inhibition of Janus kinase (JAK) enzymes, specifically JAK1 and JAK3. These enzymes play a key role in the JAK-STAT signaling pathway, which is responsible for transmitting signals from cytokines and growth factors involved in immune cell activation and inflammation
• By blocking JAK1 and JAK3, TNIB ER TABLET manages phosphorylation and activation of STAT proteins inside immune cells. This disru
• Through this targeted inhibition, TNIB ER TABLET limits both innate and ada

How to use TNIB ER TABLET

1. Recommended Dosage and How to Take TNIB ER TABLET

• Take TNIB ER TABLET Exactly as prescribed by your doctor, usually once or twice daily
• Swallow the tablet whole with water, with or without food
• Do not crush or chew the tablet. Consistent dosing at the same time each day helps maintain symptom control

2. Should TNIB ER TABLET Be Taken with Food?

TNIB ER TABLET can be taken with or without food according to medical sources.
It is recommended to take the tablet at the same time each day to maintain
consistent drug levels and o
may help reduce potential stomach upset, but it is not mandatory.

3. Is it safe to crush or chew TNIB ER TABLET?

It is not safe to crush, chew, break, or split TNIB ER TABLET. The tablet should
be swallowed whole with water to ensure proper absor

What if I forgot to take TNIB ER TABLET

If you miss a dose, take it as soon as you remember unless it is almost time for
your next scheduled dose. In that case, skip the missed dose and continue with
your regular dosing schedule. Do not take a double dose to make up for the
missed one, as this could increase the risk of side effects.

Overdose

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

Side Effects Of TNIB ER TABLET

Common side effects of TNIB ER TABLET:

• headache
• dizziness
• respiratory infections
• increased cholesterol levels
• nausea
• diarrhea
• abdominal pain
• increased risk of serious infections

Serious Risks and When to Seek Help

• signs of serious infections such as fever and chills, cough, skin blisters, stomach pain, persistent headaches
• fever, stomach or abdominal pain, blood in the stool, unexplained changes in bowel habits
• chest tightness, wheezing, severe dizziness or light-headedness, swelling of the lips, tongue or throat, hives
• signs of blood clots in lungs or veins
• signs of a heart attack such as severe chest pain or tightness (that may spread to arms, back, jaw, neck), shortness of breath, cold sweat, light-headedness or sudden dizziness

Warning & Precautions

!### Pregnancy

ContraindicatedTNIB ER TABLET is not recommended for use in pregnant women or women planning to
have a baby. If you are a woman of childbearing age, you should use effective
birth control during management and for at least 4 weeks after the last dose.

!### Breastfeeding

ContraindicatedTNIB ER TABLET is not recommended for use in breastfeeding women.

!### Driving and Using Machines

Use with CautionTNIB ER TABLET does not affect your ability to drive or use machines.

!### Kidney

Use with CautionTNIB ER TABLET should be taken with caution in patients with kidney disease. The
dose will be adjusted by your doctor.

!### Liver

Consult your doctorTNIB ER TABLET is not recommended in patients with severe liver problems such as
cirrhosis (scarring of the liver). It should be used with caution in patients
having other liver diseases such as hepatitis B or hepatitis C. Dose will be
adjusted by your doctor.

!### Allergy

ContraindicatedDo not take TNIB ER TABLET if you are allergic to Tofacitinib or any other
ingredients of this medicine.

!### Lungs

Consult your doctorTNIB ER TABLET is not recommended for use in active tuberculosis. It should be
taken with caution in patients with chronic lung disease or a history of
tuberculosis.

!### Heart Disease

Use with CautionTNIB ER TABLET should be taken with caution in patients with heart diseases such
as heart attack and high blood pressure.

!### Use In Pediatrics

Consult your doctorThe safety and effectiveness of TNIB ER TABLET in children below 2 years of age
have not been established yet.

!### Use In Geriatrics

Use with CautionTNIB ER TABLET should be used with caution in patients above the age of 65 years
of age as they may be at increased risk of infections, heart attack and some
types of cancer.

Other Warnings for TNIB ER TABLET

Before taking TNIB ER TABLET, inform your doctor if you have,

• conditions that increase the chances of infections
• tendency of having infections/ recurrent infections
• cancer or at risk of developing cancer, especially skin cancer
• habit of smoking
• lactose intolerance
• inflammation of the large intestine (diverticulitis)
• stomach or intestine ulcers
• high cholesterol
• risk of developing blood clots
• plans for getting vaccinated
• have undergone a major surgery

Who should not take TNIB ER TABLET

TNIB ER TABLET is not recommended for use if you have:

• severe bloodstream infection

Diet and Lifestyle Advice

1. Balanced Diet and Hydration:

Maintain a nutritious, well-balanced diet rich in fruits, vegetables, lean
proteins, and whole grains to support overall health and immune function. Stay
well-hydrated to assist medication metabolism and reduce potential
gastrointestinal side effects.

2. Regular Physical Activity:

Engage in low-impact exercises such as walking, swimming, or yoga to improve
joint flexibility, muscle strength, and cardiovascular health without
overstressing inflamed joints.

3. Infection Management

Because TNIB ER TABLET suppresses the immune system, practice good hygiene,
avoid close contact with sick individuals, get recommended vaccinations, and
promptly report signs of infection to your healthcare provider.

4. Avoid Smoking and Limit Alcohol:

Smoking may worsen inflammatory conditions and impair healing, while excessive
alcohol can increase liver stress and gastrointestinal risks. Aim to quit
smoking and limit alcohol intake under medical guidance.

5. Stress Management:

Incorporate relaxation techniques like meditation, deep breathing exercises, or
counselling to reduce stress, which can exacerbate autoimmune symptoms.

6. Routine Monitoring and Doctor Visits

Adhere strictly to scheduled blood tests and healthcare appointments to monitor
treatment efficacy and side effects, enabling timely adjustments.

Drug - Drug interaction

Interaction of TNIB ER TABLET with other medicines including tuberculosis or hepatitis history

• TNIB ER TABLET should not be combined with other biologic DMARDs or potent immunosuppressants such as azathioprine, cyclosporine, or tacrolimus due to increased risk of adverse effects. It can increase or decrease blood levels when taken with antifungals (ketoconazole, fluconazole), antibiotics like rifampicin, and certain antivirals.

Tuberculosis and Infections:

Patients with active tuberculosis or a history of latent TB should be screened
and managed appropriately before starting TNIB ER TABLET. The drug suppresses
immune response, increasing susce
essential.

Hepatitis

Use caution in patients with a history of hepatitis B or C. Liver function
should be monitored regularly, as TNIB ER TABLET may affect liver enzymes and
exacerbate underlying liver conditions.

Drug - Food interaction

Grapefruit products and St. John’s Wort can affect metabolism and should be
avoided.

Synopsis

Drug	Tofacitinib
Pharmacological Category	Janus Kinase Inhibitors
Therapeutic Indication	Inflammatory diseases
Dosage Forms	Tablet

More Information

Use Comparative Insights to Differentiate TNIB ER TABLET:

Briefly contrast TNIB ER TABLET with older DMARDs or biologics regarding
efficacy, side effects, administration ease, or monitoring needs.

TNIB ER TABLET differs from older traditional DMARDs and biologic therapies in
several important ways that contribute to its unique value:

• Efficacy:

Tofacitinib has demonstrated comparable or superior efficacy in improving arthritis symptoms, physical function, and remission rates compared to classic DMARDs like methotrexate and some biologics such as adalimumab and etanercept. Clinical trials and meta-analyses have shown tofacitinib monotherapy or in combination can lead to higher ACR20/50/70 response rates and better patient-reported outcomes.

• Administration Ease:

Unlike biologics, which require subcutaneous injections or intravenous infusions, TNIB ER TABLET is an oral medication, increasing convenience and potentially improving patient adherence. Oral dosing avoids needle-related anxiety and the need for healthcare facility visits for administration.

• Side Effect Profile:

While sharing some immunosuppressive risks, tofacitinib shows a tolerability profile that can be more favorable for certain patients, with less injection site reactions and comparable rates of serious adverse events to biologics. GI side effects may be less frequent compared to traditional DMARDs like methotrexate.

• Monitoring Needs:

TNIB ER TABLET requires regular blood monitoring for blood counts, liver, kidney function, and lipid levels, similar to biologics, but potentially less frequent than complex combination therapies with older DMARDs. This allows targeted safety surveillance while maintaining efficacy.

• Cost and Access:

Tofacitinib’s oral administration can reduce associated healthcare costs like administration fees or facility visits, improving total cost-effectiveness for some patients despite the drug's retail price.

Mention features such as a sugar-free formulation reducing metabolic risks, once-daily dosing o

• TNIB ER TABLET offers several patient-friendly features designed to improve adherence and overall wellness during treatment. Its sugar-free formulation reduces the metabolic risks often associated with sugar-containing medications, making it a safer choice for patients with diabetes or those concerned about blood sugar levels. This formulation helps avoid additional metabolic burden, supporting better health management alongside arthritis treatment.
• The tablet also provides once-daily dosing o
• TNIB ER TABLET has a better tolerability profile that minimizes gastrointestinal (GI) side effects common with many arthritis medications, such as nausea, indigestion, or stomach pain. This improved GI safety profile helps patients continue therapy without discomfort, reducing the risk of discontinuation due to adverse effects

FAQs About TNIB ER TABLET

Q: Can TNIB ER TABLET cure rheumatoid arthritis?

A: No, it helps control symptoms and slow disease progression but is not a cure.

Q: How long does TNIB ER TABLET take to work?

A: It may take several weeks to observe full therapeutic effects.

Q: Is TNIB ER TABLET safe for long-term use?

A: Long-term use requires regular medical supervision due to potential risks.

Q: What is TNIB ER TABLET and why is it prescribed?

A: TNIB ER TABLET contains tofacitinib, which belongs to the group of medicines
called immunosuppressants. It is used to manage inflammatory diseases such as
rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and ankylosing
spondylitis. It is used together with medicines such as methotrexate when
previous rheumatoid arthritis management was not sufficient or was not well
tolerated.

Q: What should I know before starting to take TNIB ER TABLET?

A: TNIB ER TABLET can lower the ability of your immune system to fight
infections. Do not start stating this medicine if you have any kind of
infection, a history of infection or are at risk of developing one.

Q: Can TNIB ER TABLET be taken by pregnant or breastfeeding women?

A: TNIB ER TABLET is not recommended for use by pregnant or breastfeeding women.
If you are a woman of childbearing age, effective birth control methods must be
used during management with this medicine and for at least 4 weeks after the
last dose. Tell your doctor immediately if you become pregnant while taking the
medicine.

Q: Is TNIB ER TABLET used by children?

A: TNIB ER TABLET is used to manage polyarticular juvenile idiopathic arthritis
and juvenile psoriatic arthritis, which cause pain and inflammation of joints in
children over 2 years of age. Ask for your doctor?s advice before giving it to
your child.

Q: Do I need to undergo routine diagnostic tests while taking TNIB ER TABLET?

A: Your doctor might check you regularly for the levels of white blood cells and
red blood cells in your blood while you take TNIB ER TABLET.

Q: How do I manage if I forget to take a dose of TNIB ER TABLET?

A: If you forgot to take a dose of TNIB ER TABLET, then do not take the missed
dose between meals. Continue taking your medication as usual until your next
scheduled dose and meal. Do not take a double dose to make up for a forgotten
dose.

Q: Can TNIB ER TABLET be used safely on elderly patients?

A: Patients aged 65 years and older may be at increased risk of infections,
heart attacks and some types of cancer; therefore, it should be used with
caution in patients above the age of 65 years.

Useful Diagnostic Tests

• Complete Blood Count
• Liver Function Test (LFT)
• Kidney Function Test (KFT)