Shop

Description

What is Tofakey Tablet?

Tofakey Tablet is a prescription medication called a Janus Kinase (JAK) inhibitor. It is a Disease-Modifying Anti-Rheumatic Drug (DMARD), which works by suppressing the immune system.

Tofacitinib is an inhibitor of Janus kinases, a group of intracellular enzymes involved in signalling pathways that affect hematopoiesis and immune cell function. By targeting these specific enzymes, Tofakey works from inside your cells to interrupt the overactive immune signals that drive chronic inflammation, joint destruction, and bowel disease — without the need for injections.

When Tofacitinib was approved by the FDA in 2012, it was the first approved JAK inhibitor for the treatment of rheumatoid arthritis and also the first new oral DMARD to be approved for the condition in more than a decade. Tofakey is an affordable generic version of this globally trusted active ingredient, available in 5mg (twice daily) and 10mg (twice daily for induction) strengths.

Uses & Indications

Tofakey Tablet is medically prescribed for the following conditions:

1. Rheumatoid Arthritis (RA) Tofacitinib in combination with Methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.

2. Psoriatic Arthritis (PsA) Tofacitinib tablets are used to treat adults with active psoriatic arthritis when 1 or more TNF blocker medicines have been used and did not work well or cannot be tolerated.

3. Ankylosing Spondylitis (AS) Tofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.

4. Ulcerative Colitis (UC) Tofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

5. Polyarticular Juvenile Idiopathic Arthritis (pcJIA) Tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have responded inadequately to previous therapy with DMARDs.

Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Tofacitinib is indicated.

Dosage & How to Take

Available Strengths:

• 5mg Tablet — Standard maintenance dose (twice daily)
• 10mg Tablet — Induction dose for Ulcerative Colitis (twice daily for 8 weeks)

Recommended Dosage by Condition:

How to Take:

1. Take Tofakey tablets 2 times a day with or without food.
2. Swallow the tablets whole — do not split, chew, or crush them.
3. Take at the same times each day (e.g. morning and evening) to maintain consistent drug levels.
4. Your doctor may need to decrease your dose or stop your treatment if you experience certain severe side effects. Be sure to tell your doctor how you are feeling during your treatment.
5. It may take 3 to 6 months to have remarkable therapeutic effects, so this medication should be continued for as long as it is prescribed by the attending physician.

Never adjust your dose, skip doses, or stop taking Tofakey without consulting your specialist doctor.

How Does Tofakey Work?

Tofakey is a JAK inhibitor that works from inside your cells to stop the pathways that cause inflammation.

In autoimmune diseases like rheumatoid arthritis and ulcerative colitis, the immune system mistakenly attacks the body’s own tissues, triggering chronic inflammation. Tofacitinib is an inhibitor of Janus kinases — a group of intracellular enzymes involved in signalling pathways that affect hematopoiesis and immune cell function.

By blocking JAK1 and JAK3 enzymes, Tofakey interrupts the chain of inflammatory signals (cytokines) that cause swollen, painful joints, bowel inflammation, and progressive tissue damage — helping to:

• Reduce joint inflammation, pain, and swelling
• Slow the progression of joint damage and deformity
• Improve physical functioning and quality of life
• Reduce bowel inflammation in ulcerative colitis
• Achieve measurable improvement — in clinical trials, higher ACR20 responses were observed within 2 weeks in some patients, with improvements in physical functioning greater than placebo also noted

Key Benefits of Tofakey Tablet

• FDA-approved JAK inhibitor — first oral DMARD approved for RA in over a decade
• Oral tablet — convenient twice-daily tablet, no injections required
• Fast-acting — measurable improvement in joint pain and function noted within 2 weeks in some patients
• Broad-spectrum anti-inflammatory — treats RA, PsA, AS, UC, and JIA
• Works when TNF blockers fail — effective in patients who have not responded to biologics
• Slows disease progression — reduces inflammation and slows disease progression, alleviating symptoms like pain, swelling, and stiffness
• Improves quality of life — restores physical function and daily independence
• Available in 5mg and 10mg — flexible dosing for different conditions and stages
• Affordable generic — same trusted active ingredient as Xeljanz at a fraction of the cost

Precautions & Important Warnings

BOXED WARNING: Tofacitinib is required by the FDA to have a boxed warning on its label about possible injury and death due to problems such as infections, lymphoma, and other malignancies, which can arise from use of this drug.

Before taking Tofakey, inform your doctor if you:

• Have any active infection — including TB, fungal, bacterial, or viral infections
• Have liver disease, hepatitis B or C
• Have kidney disease or are on dialysis
• Have a history of cancer
• Have heart disease or cardiovascular risk factors
• Are pregnant or planning to become pregnant
• Are currently breastfeeding
• Have a history of blood clots (deep vein thrombosis, pulmonary embolism)
• Have low blood cell counts (lymphocytes, neutrophils, hemoglobin)

Critical Safety Warnings:

• Serious Infections — Tofacitinib can lower the ability of your immune system to fight infections. Some people can have serious infections while taking Tofacitinib, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should test you for TB before starting Tofacitinib and during treatment.
• Cancer Risk — Taking Tofacitinib may increase the risk that you will develop a lymphoma or other types of cancers, including lung cancer and skin cancer.
• Blood Clots — According to post-marketing research, Tofacitinib may increase the risk for pulmonary embolism. Prescribers should consider risk factors including age, obesity, smoking, and immobilization.
• Laboratory Monitoring — Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body’s response to Tofacitinib.
• Live Vaccines — Immunizations with live vaccines should be avoided by Tofacitinib users.
• Patients 50 years of age or older can be at greater risk for some side effects from Tofakey. Talk to your healthcare provider about your risks if you are in this age group.
• Not for use during pregnancy — Tofacitinib may harm the developing baby. Use effective contraception during treatment.

Drug Interactions

Inform your doctor if you are currently taking:

• Ketoconazole or Fluconazole — antifungal medicines that may significantly increase Tofacitinib blood levels
• Rifampin — commonly used to treat tuberculosis; may significantly reduce Tofacitinib effectiveness
• Immunosuppressants — azathioprine, tacrolimus, or cyclosporine — not recommended to use with Tofakey
• Other biologic DMARDs — tocilizumab, etanercept, adalimumab, infliximab, rituximab, abatacept — do not use in combination with Tofakey
• Methotrexate (MTX) — commonly prescribed together with Tofakey for RA; safe under medical supervision
• NSAIDs — aspirin, ibuprofen, naproxen — inform your doctor before starting Tofacitinib
• St. John’s Wort — herbal supplement that may reduce Tofacitinib effectiveness
• CYP3A4 inhibitors or inducers — various antibiotics, antifungals, and anticonvulsants — dose adjustment may be required

Side Effects

Common Side Effects (mild & usually temporary): The most commonly reported adverse reactions during the first three months in controlled clinical trials were upper respiratory tract infections, headache, diarrhea, and nasopharyngitis (the “common cold”).

• Upper respiratory tract infection (cold, sore throat)
• Headache or dizziness
• Diarrhea or nausea
• Runny or stuffy nose (nasopharyngitis)
• High blood pressure
• Elevated cholesterol levels (lipid abnormalities)
• Stomach pain or discomfort

Serious Side Effects — Seek Immediate Medical Attention:

• Signs of serious infection — high fever, chills, sweating, cough, painful urination, skin sores
• Signs of TB — persistent cough, night sweats, weight loss, fatigue
• Signs of blood clots — sudden chest pain, difficulty breathing, leg pain or swelling
• Signs of liver problems — dark urine, jaundice (yellowing of skin or eyes)
• Signs of low blood cell counts — unusual bruising, bleeding, extreme fatigue, pale skin
• Signs of allergic reaction — rash, hives, swelling of face, lips, throat, difficulty breathing
• Sudden or unusual skin changes (possible skin cancer)

If you notice any serious or unusual symptoms, stop taking Tofakey and seek emergency medical help immediately.

Missed Dose

For a missed dose, take it as soon as possible. If it is already nearing the next dose, skip the missed dose and resume to the regular schedule. Never double the dose to catch up — it may cause an overdose.

Storage Instructions

• Store at room temperature (15°C–30°C / 59°F–86°F), away from direct heat, light, and moisture.
• Keep in a cool, dry place, away from bathroom storage due to humidity.
• Store out of reach of children and pets.
• Keep in the original blister pack or bottle until use.
• Do not freeze.
• Check the expiry date before use. Dispose of expired or unused tablets safely through a medicine take-back programme.
• Keep a written list of all the prescription and non-prescription medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or are admitted to hospital. Frequently Asked Questions (FAQ)

Q: What is Tofakey Tablet used for?

A: Tofakey Tablet is used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, polyarticular-course juvenile idiopathic arthritis, and ulcerative colitis.

Q: How quickly does Tofakey start working?

A: In placebo-controlled trials, higher ACR20 responses were observed within 2 weeks in some patients, with improvements in physical functioning greater than placebo also noted. However, full therapeutic benefits may take 3–6 months of consistent use.

Q: Can Tofakey be taken without Methotrexate?

A: Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. Your doctor will determine the best treatment approach for your condition.

Q: Is Tofakey the same as Xeljanz?

A: Tofacitinib IR oral tablets are a generic drug, which means they are an exact copy of the active drug in the brand-name medication Xeljanz. Generic drugs are thought to be as safe and effective as the brand-name drug they’re based on.

Q: Do I need to avoid vaccines while taking Tofakey?

A: Immunizations with live vaccines should be avoided by Tofacitinib users. Consult your doctor about which vaccines are safe during treatment.

Q: Can I see something unusual in my stool while taking Tofakey?

A: If you are taking an extended-release version, you may see something that looks like a tablet in your stool. This is the empty shell from the tablet after the medicine has been absorbed by your body.

Q: Is a prescription required to buy Tofakey?

A: Yes. Tofakey is a Schedule H1 prescription medicine. Please upload a valid specialist doctor’s prescription at checkout.