TOFASHINE 5mg Tablet 15's

Introduction About TOFASHINE 5MG TABLET

What is TOFASHINE 5MG TABLET?

TOFASHINE 5MG 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.

TOFASHINE 5MG 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 TOFASHINE 5MG 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 TOFASHINE 5MG 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 TOFASHINE 5MG 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 TOFASHINE 5MG TABLET

How effective is TOFASHINE 5MG TABLET for arthritis?

• Clinical trials demonstrate TOFASHINE 5MG 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 TOFASHINE 5MG TABLET Works

TOFASHINE 5MG 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 TOFASHINE 5MG TABLET Modulates the Immune System to Reduce Symptoms

• TOFASHINE 5MG 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, TOFASHINE 5MG TABLET manages phosphorylation and activation of STAT proteins inside immune cells. This disruption reduces the transcription of genes involved in inflammatory responses, leading to decreased production of pro-inflammatory cytokines such as interleukins (IL-2, IL-4, IL-6, IL-7, IL-9, IL-15, IL-21) and interferons (IFN-alpha and IFN-gamma)
• Through this targeted inhibition, TOFASHINE 5MG TABLET limits both innate and adaptive immune reactions, lowering joint inflammation, swelling, pain, and tissue damage in autoimmune diseases like rheumatoid arthritis and psoriatic arthritis. It also modulates immune cell populations, reducing T-cell and natural killer cell activity involved in disease progression

How to use TOFASHINE 5MG TABLET

1. Recommended Dosage and How to Take TOFASHINE 5MG TABLET

• Take TOFASHINE 5MG 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 TOFASHINE 5MG TABLET Be Taken with Food?

TOFASHINE 5MG 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 optimize treatment effectiveness. Taking it with food may help reduce potential stomach upset, but it is not mandatory.

3. Is it safe to crush or chew TOFASHINE 5MG TABLET?

It is not safe to crush, chew, break, or split TOFASHINE 5MG TABLET. The tablet should be swallowed whole with water to ensure proper absorption and effectiveness.

What if I forgot to take TOFASHINE 5MG 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 TOFASHINE 5MG TABLET, consult your doctor immediately or visit the nearby hospital.

Side Effects Of TOFASHINE 5MG TABLET

Common

• 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

Contraindicated

TOFASHINE 5MG 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

Contraindicated

TOFASHINE 5MG TABLET is not recommended for use in breastfeeding women.

Driving and Using Machines

Safe

TOFASHINE 5MG TABLET does not affect your ability to drive or use machines.

Kidney

Use with Caution

TOFASHINE 5MG TABLET should be taken with caution in patients with kidney disease. The dose will be adjusted by your doctor.

Liver

Consult your doctor

TOFASHINE 5MG 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

Contraindicated

Do not take TOFASHINE 5MG TABLET if you are allergic to Tofacitinib or any other ingredients of this medicine.

Lungs

Consult your doctor

TOFASHINE 5MG 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 Caution

TOFASHINE 5MG TABLET should be taken with caution in patients with heart diseases such as heart attack and high blood pressure.

Use In Pediatrics

Consult your doctor

The safety and effectiveness of TOFASHINE 5MG TABLET in children below 2 years of age have not been established yet.  

Use In Geriatrics

Use with Caution

TOFASHINE 5MG 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 TOFASHINE 5MG TABLET

Before taking TOFASHINE 5MG 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 TOFASHINE 5MG TABLET

TOFASHINE 5MG 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 TOFASHINE 5MG 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 TOFASHINE 5MG TABLET with other medicines and foods including tuberculosis or hepatitis history

• TOFASHINE 5MG 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 TOFASHINE 5MG TABLET. The drug suppresses immune response, increasing susceptibility to infections, so vigilance is essential.

Hepatitis

Use caution in patients with a history of hepatitis B or C. Liver function should be monitored regularly, as TOFASHINE 5MG 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

More Information

Use Comparative Insights to Differentiate TOFASHINE 5MG TABLET:

Briefly contrast TOFASHINE 5MG TABLET with older DMARDs or biologics regarding efficacy, side effects, administration ease, or monitoring needs.

TOFASHINE 5MG 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, TOFASHINE 5MG 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:
  TOFASHINE 5MG 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 options for convenience, or a better tolerability profile minimizing GI side effects. Clarify how these factors can improve adherence and overall wellness.

• TOFASHINE 5MG 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 options, which enhance convenience for patients managing complex medication schedules or multiple health conditions. This reduced dosing frequency helps improve compliance by fitting more easily into daily routines, thus maintaining consistent drug levels essential for effective symptom control.
• TOFASHINE 5MG 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 TOFASHINE 5MG TABLET

Q: Can TOFASHINE 5MG TABLET cure rheumatoid arthritis?

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

Q: How long does TOFASHINE 5MG TABLET take to work?

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

Q: Is TOFASHINE 5MG TABLET safe for long-term use?

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

Q: What is TOFASHINE 5MG TABLET and why is it prescribed?

A: TOFASHINE 5MG 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 TOFASHINE 5MG TABLET?

A: TOFASHINE 5MG 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 TOFASHINE 5MG TABLET be taken by pregnant or breastfeeding women?

A: TOFASHINE 5MG 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 TOFASHINE 5MG TABLET used by children?

A: TOFASHINE 5MG 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 TOFASHINE 5MG 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 TOFASHINE 5MG TABLET.

Q: How do I manage if I forget to take a dose of TOFASHINE 5MG TABLET?

A: If you forgot to take a dose of TOFASHINE 5MG 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 TOFASHINE 5MG 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.  

References

1. R.S Satoskar, Nirmala N. Rege, S.D. Bhandarkar. Pharmacotherapy of Rheumatoid Arthritis. Pharmacology and Pharmacotherapeutics. Twenty-Fourth Edition. 2015. Page – 1637.

2. Kucharz EJ, Stajszczyk M, Kotulska-Kucharz A, Batko B, Brzosko M, Jeka S, Leszczynski P, Majdan M, Olesinska M, Samborski W, Wiland P.Tofacitinib in the treatment of patients with rheumatoid arthritis: position statement of experts of the Polish Society for Rheumatology. Reumatologia. NIH National Library of Medicine, National center for biotechnology information. Pubmed. 2018. [Accessed on 20th November 2025]

3. Sohita Dhillon. Tofacitinib: A Review in Rheumatoid Arthritis. NIH National Library of Medicine, National center for biotechnology information. Pubmed. 2017. [Accessed on 20th November 2025]

4. NIH National Library of Medicine, National center for biotechnology information. Pubchem. Tofacitinib. [Revised on September 2022] [Accessed on 20th November 2025]

Useful Diagnostic Tests

• X-ray
• MRI
• Complete Blood Count
• Skin test
• Liver/kidney function test

Author Details

Written By Dr. Karthikeyan Rajagopal - M.Pharm (Pharmacology)

Reviewed For Accuracy By Dr. Srikar Modepu - MBBS, MD (Diabetology)

Last updated on 22 Nov 2025 | 04:57 PM(IST)