Tofe
✅ Vermindert gewrichtsontsteking
✅ Improves physical function
✅ Relieves rheumatoid pain
✅ Slows disease progression
✅ Enhances daily mobility
Tofe bevat Tofacitinib 5 mg.
✓ Medisch beoordeeld door Morgan Ellis — Apotheekonderzoeker · 8 jaar ervaring · Laatst beoordeeld: mei 2026
⚡ Quick Answer — What is Tofe?
Tofe is an oral tablet from Intas Pharmaceuticals containing tofacitinib — an oral Janus kinase (JAK) inhibitor that blocks intracellular cytokine signalling through JAK1 and JAK3 (with some JAK2 activity). Available at 5 mg. Standard dose: 5 mg twice daily (or 11 mg once daily extended-release). Used for moderate-to-severe rheumatoid arthritis and several other autoimmune conditions after conventional DMARDs have failed. Carries an FDA black-box warning for serious infections, major adverse cardiovascular events (MACE), thrombosis, and malignancy — particularly in patients over 50 with at least one cardiovascular risk factor. Mandatory pre-treatment screening: latent TB, hepatitis B, hepatitis C, CBC with differential, LFTs, lipid panel, and varicella-zoster status. Not a first-line drug — reserve for patients who have failed methotrexate or biologic DMARDs.
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What Is Tofe?
Tofe is an oral tablet manufactured by Intas Pharmaceuticals containing tofacitinib, a small-molecule Janus kinase (JAK) inhibitor. JAK inhibitors are a newer class of targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs) that block the intracellular signalling cascade triggered when inflammatory cytokines bind to their receptors on immune cells.
Tofe is Intas’ generic tofacitinib — the first-approved oral JAK inhibitor (Xeljanz, Pfizer) with the broadest regulatory indications in the class: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis and polyarticular juvenile idiopathic arthritis. Unlike the older injectable biologics (TNF inhibitors, IL-6 inhibitors), tofacitinib is taken as a tablet, has rapid onset (clinical improvement within 2–4 weeks), and works on a different molecular pathway — making it a useful option for patients who have failed conventional DMARDs or one or more biologics. Pivotal evidence: ORAL Standard, ORAL Scan, ORAL Start (rheumatoid arthritis), OCTAVE Induction/Sustain (ulcerative colitis), and OPAL Broaden/Beyond (psoriatic arthritis).
How Does Tofe Work?
Many inflammatory cytokines (IL-6, IFN-γ, GM-CSF, IL-2, IL-4, IL-15, IL-21, and others) signal inside cells by activating the JAK-STAT pathway. When cytokine binds its receptor, JAK enzymes phosphorylate STAT proteins, which then translocate to the nucleus and switch on genes that drive inflammation, T-cell activation and synovial proliferation.
- Tofacitinib blocks JAK1 and JAK3 (with some JAK2 activity) inside the cell, cutting off signalling for multiple inflammatory cytokines simultaneously.
- Broad effect on cytokine signalling — because multiple cytokine receptors use JAK1/JAK2/JAK3/TYK2 in different combinations, a single JAK inhibitor dampens many inflammatory pathways at once. This gives rapid clinical benefit but also explains the infection and malignancy signals.
- Reversible inhibition — effects wear off within 1–2 days of stopping the drug. Useful before surgery or during infection.
Onset of symptomatic benefit: joint-pain improvement at 2–4 weeks; peak clinical response at 3–6 months. Radiographic slowing of joint damage takes 12 months of consistent dosing to demonstrate.
Toepassingen en Indicaties
- Moderate-to-severe rheumatoid arthritis — after inadequate response to methotrexate or other DMARDs
- Moderate-to-severe ulcerative colitis — after failure of conventional and biologic therapy
- Psoriatic arthritis — after inadequate response to DMARDs
- Ankylosing spondylitis — after inadequate response to TNF inhibitors
- Polyarticular juvenile idiopathic arthritis (age 2+)
Tofe is niet first-line therapy for any of these conditions. It is reserved for patients who have failed (or cannot tolerate) methotrexate and, per current FDA guidance, ideally also a TNF inhibitor before JAK inhibitor initiation — particularly in patients aged 50+ with one or more cardiovascular risk factors, where the ORAL Surveillance trial demonstrated higher rates of MACE and malignancy vs TNFi.
Before Starting Tofe — Mandatory Screening
Every patient must complete these checks before the first dose. Skipping them is the single most common cause of serious adverse events on JAK inhibitors.
- Latent tuberculosis screening — QuantiFERON-TB Gold or T-SPOT (preferred) or tuberculin skin test. JAK inhibition reactivates dormant TB in ~1% of patients. If positive, complete at least 1 month of isoniazid (or equivalent) before starting the drug.
- Hepatitis B — HBsAg, anti-HBc, anti-HBs. Positive chronic HBV needs hepatologist input and antiviral cover (entecavir or tenofovir) for the duration of JAK therapy.
- Hepatitis C — anti-HCV, confirm with HCV RNA if positive. Treat HCV first if present.
- HIV status — not an absolute contraindication but needs specialist input.
- Complete blood count with differential — do not start if ANC < 1.0 × 10&sup9;/L, ALC < 0.5 × 10&sup9;/L, or haemoglobin < 9 g/dL.
- Liver function — do not start if ALT/AST > 3× upper limit of normal.
- Renal function — eGFR dictates dose.
- Lipid panel — baseline total cholesterol, LDL, HDL, triglycerides. JAK inhibitors raise lipids; repeat at 8 weeks and annually.
- Pregnancy test in women of childbearing potential. Effective contraception required during treatment and for ~1 week after last dose.
- Varicella-zoster status — history of chickenpox or VZV serology. If seronegative, vaccinate with varicella vaccine at least 4 weeks before starting JAK therapy.
- Vaccination review — update all inactivated vaccines (influenza, pneumococcal, COVID-19, HPV, shingles recombinant Shingrix). Live vaccines are contraindicated during treatment — give at least 4 weeks before starting.
Tofe Dosage and How to Take
Tofe is supplied at 5 mg. Dose depends on indication, renal function, and concomitant medications.
- Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis: 5 mg twice daily OR 11 mg extended-release once daily
- Ulcerative colitis induction (8 weeks): 10 mg twice daily; step down to 5 mg BID maintenance once in remission
- Polyarticular juvenile idiopathic arthritis (weight ≥ 40 kg): 5 mg twice daily
- Renal adjustment: moderate-severe (eGFR < 60 mL/min) → 5 mg ONCE daily; not recommended in eGFR < 15
- Hepatic adjustment: moderate (Child-Pugh B) → 5 mg ONCE daily; avoid in severe
- With food or fasting: may be taken either way; take at the same times each day
How to Take Tofe Properly
- Do not start without the pre-treatment screens listed above. Every missed check raises the risk of a serious event.
- Swallow tablet whole with water — do not crush, split, or chew. Tofacitinib immediate-release can be split if scored; extended-release 11 mg must be swallowed whole.
- Same time each day. Consistency matters more than timing relative to meals.
- If a dose is missed, take it as soon as remembered on the same day. If the next scheduled dose is due, skip the missed one — do not double-dose.
- Pause during infections — stop Tofe at the first sign of serious infection (high fever, productive cough, pyelonephritis, cellulitis, shingles). Resume only after the infection has resolved and the prescriber has reviewed.
- Pause before elective surgery. Stop 3–7 days (5 half-lives) before major surgery; restart 1–2 weeks after, once wound healing is underway and infection-free.
- Ongoing laboratory monitoring — CBC + LFT at weeks 4, 8, 12, then every 3 months. Lipid panel at week 8, then annually. Do not miss these tests.
- Report any new cough, fever, night sweats, unexplained weight loss, chest pain, leg swelling, calf tenderness, or shortness of breath immediately — these may signal serious infection, MACE, or thrombosis.
- Avoid live vaccines. Inactivated vaccines are fine and recommended (flu, pneumococcal, Shingrix).
- Daily SPF 50 sun protection — JAK inhibitors increase non-melanoma skin cancer risk. Annual dermatology skin check is advisable for patients with fair skin, previous skin cancer, or > 12 months of therapy.
Side Effects of Tofe
- Serious infections — bacterial, fungal, viral, mycobacterial (including TB reactivation), opportunistic
- Major adverse cardiovascular events (MACE) — MI, stroke, cardiovascular death, at higher rate than TNFi in the high-risk population
- Thrombosis — deep vein thrombosis, pulmonary embolism, arterial thrombosis
- Malignancy — lymphoma, lung cancer (especially in current/former smokers), non-melanoma skin cancer
- Mortality — all-cause mortality was numerically higher with tofacitinib vs TNFi in the high-risk cohort
Per current FDA labelling, reserve JAK inhibitors for patients with inadequate response or intolerance to one or more TNF inhibitors, unless alternatives are unsuitable.
Common side effects:
- Upper respiratory tract infections, nasopharyngitis, sinusitis
- Nausea, diarrhoea
- Hoofdpijn
- Rash, acne
- Herpes simplex and herpes zoster (shingles) reactivation — significantly higher incidence than background, particularly in Asian populations
- Raised LDL, HDL and total cholesterol
- Raised ALT/AST and creatine kinase
- Lymphopenia, neutropenia, anaemia
Minder vaak maar belangrijk:
- Pneumonia (bacterial and opportunistic including Pneumocystis)
- Cellulitis, urinary tract infection, diverticulitis (higher risk of perforation with tofacitinib in elderly)
- Reactivation of hepatitis B
- Interstitial lung disease
- Gastrointestinal perforation (especially with concomitant NSAIDs or corticosteroids)
Rare but serious — seek medical attention immediately:
- Active TB or disseminated fungal infection (fever, night sweats, productive cough, weight loss)
- Myocardial infarction, stroke (chest pain, arm or jaw pain, sudden one-sided weakness, face droop)
- Deep vein thrombosis / pulmonary embolism (unilateral leg swelling with calf tenderness, sudden shortness of breath, pleuritic chest pain)
- Disseminated herpes zoster, encephalitis
- New lymphadenopathy or unexplained weight loss (possible lymphoma)
- Severe skin reaction (SJS, TEN, DRESS)
Waarschuwingen en voorzorgsmaatregelen
- Age 65+ and/or current/former smokers — at significantly higher risk of MACE, malignancy and mortality. Use only when alternatives (TNF inhibitors, IL-6 inhibitors) are unsuitable; prefer the lowest effective dose.
- History of MI, stroke, VTE, active malignancy, or lymphoproliferative disease — relative or absolute contraindication; specialist decision.
- Active serious infection — do not start. Withhold during febrile illness.
- Herpes zoster reactivation — particularly common. Vaccinate with recombinant zoster vaccine (Shingrix) at least 4 weeks before starting, if age ≥ 50 or otherwise eligible.
- Chronic/recurrent infections, indwelling catheters, recent intracranial/intra-abdominal surgery — individualised risk-benefit; specialist review.
- Lymphopenia, neutropenia, anaemia — interrupt if ALC < 0.5, ANC < 1.0, or Hb < 8 g/dL. Restart at lower dose after recovery.
- Lipid elevation — treat per cardiovascular risk; statins do not interact meaningfully with tofacitinib.
- Diverticular disease — higher risk of bowel perforation, particularly in elderly on tofacitinib with concomitant NSAIDs or corticosteroids.
- Pregnancy and lactation — avoid. Effective contraception required during treatment and for at least 1 week after last dose. Not recommended during breastfeeding.
- Pediatric use — tofacitinib is approved for polyarticular JIA from age 2.
- Live vaccines — contraindicated during treatment. If a live vaccine is needed (yellow fever, MMR booster, varicella, live shingles Zostavax, live nasal flu), give at least 4 weeks before starting and wait 1–2 weeks off drug before restarting.
Contraindications — Who Should NOT Take Tofe
- Known hypersensitivity to tofacitinib or any tablet excipient
- Active serious infection (bacterial, viral, fungal, mycobacterial — including active TB)
- Untreated chronic hepatitis B
- Ernstige leverfunctiestoornis (Child-Pugh C)
- Severe renal impairment (eGFR < 15 mL/min)
- Severe lymphopenia (ALC < 0.5), neutropenia (ANC < 1.0), or anaemia (Hb < 8 g/dL)
- Zwangerschap
- Recent major MACE (MI, stroke) within the last 6 months
- Active malignancy (other than treated non-melanoma skin cancer)
Geneesmiddelinteracties
| Combineren met | Effect | Wat te doen |
|---|---|---|
| Strong CYP3A4 inhibitors (ketoconazole, ritonavir, clarithromycin) | Raise tofacitinib levels ~2× | Reduce dose by half (5 mg once daily for RA; 5 mg BID for UC induction). |
| Moderate CYP3A4 + strong CYP2C19 combined (fluconazole) | Raise tofacitinib levels | Reduce tofacitinib dose as for strong 3A4 inhibitors. |
| Strong CYP3A4 inducers (rifampicin, carbamazepine, phenytoin, St John's wort) | Lower tofacitinib levels — possible loss of efficacy | Avoid combination if possible; consider alternative tsDMARD. |
| Other biologic DMARDs (adalimumab, etanercept, infliximab, tocilizumab, rituximab, abatacept) | Additive immunosuppression — severe infection risk | Niet combineren. Allow appropriate washout before switching. |
| Other JAK inhibitors (upadacitinib, filgotinib) | Additive toxicity with no added benefit | Use only one JAK inhibitor at a time. |
| Potent immunosuppressants (azathioprine, ciclosporin, tacrolimus, mycophenolate) outside transplant | Additive infection and lymphoma risk | Avoid in non-transplant settings. Transplant patients: specialist decision. |
| Live vaccines (MMR, varicella, live zoster, live nasal flu, yellow fever, BCG) | Disseminated vaccine-strain infection risk | Contraindicated during treatment. Give 4+ weeks before starting or wait 1–2 weeks after stopping. |
| NSAIDs and concomitant corticosteroids | Increased GI perforation risk (especially tofacitinib + elderly + diverticular disease) | Use lowest effective dose of both; avoid long-term combination. |
| Methotrexate (low-dose, weekly) | Standard combination in RA — no pharmacokinetic interaction | Continue methotrexate as background DMARD; monitor CBC and LFT jointly. |
Bewaaradvies
- Bewaren bij kamertemperatuur, below 30°C, in the original blister pack.
- Protect from light and moisture. Do not store in the bathroom.
- Keep out of reach of children — accidental ingestion can cause severe immunosuppression.
- Do not use after the expiry date on the pack.
- Return unused tablets to a pharmacy for disposal — do not flush or put in household rubbish.
Gerelateerde alternatieven op MedsBase
Other medications used in anti-inflammatory and autoimmune care stocked alongside this product:
- Barinat (baricitinib 2 / 4 mg) — JAK1/2 inhibitor for RA
- Azoran (azathioprine 50 mg) — classic immunosuppressant DMARD
- Lefuheal (leflunomide) — oral DMARD for rheumatoid arthritis
- Conimune ME (cyclosporine) — calcineurin inhibitor
- Wysolone (prednisolone 5 / 10 / 20 mg) — oral corticosteroid
- Medrol (methylprednisolone 4 / 8 / 16 mg) — oral corticosteroid
- Predniheal (prednisolone) — oral corticosteroid
- Hisone (hydrocortisone) — physiologic replacement steroid
- Budez CR (budesonide) — gut-targeted corticosteroid for Crohn's
- Kenacort (triamcinolone) — systemic corticosteroid
Explore the full Anti-Inflammatory & Autoimmune Care category.
Veelgestelde vragen
When will I feel Tofe working?
Joint pain and morning stiffness usually improve within 2–4 weeks. Peak clinical response at 3–6 months. If there is no meaningful improvement by 12–16 weeks on an adequate dose, most rheumatologists would consider switching to an alternative targeted therapy rather than continuing indefinitely.
Why do I need TB and hepatitis B testing before starting Tofe?
JAK inhibitors reactivate dormant infections. Latent TB reactivates in ~1% of patients, and chronic hepatitis B can reactivate explosively. The only way to prevent these is to screen before the first dose and treat (or cover with antiviral prophylaxis) anyone who tests positive. Skipping these tests is the single most common avoidable cause of serious harm on JAK therapy.
Why is there a black-box warning on Tofe?
The FDA added the class-wide black-box warning in September 2021 after the ORAL Surveillance trial showed that tofacitinib, at doses approved for rheumatoid arthritis, produced more major adverse cardiovascular events (MI, stroke, CV death), more malignancies (especially lung cancer in smokers), more blood clots, and higher all-cause mortality than TNF inhibitors — specifically in RA patients aged 50+ with at least one cardiovascular risk factor. The warning was extended to the entire JAK-inhibitor class. Current FDA guidance: reserve JAK inhibitors for patients who have failed or cannot use a TNF inhibitor first.
Is Tofe safe long-term?
Long-term data (up to 9.5 years on tofacitinib) show that cardiovascular and malignancy rates in standard-risk patients remain close to background population rates. The signal from ORAL Surveillance is concentrated in older patients with pre-existing cardiovascular risk factors. In otherwise healthy younger patients with RA, long-term tofacitinib is a reasonable option — but annual skin checks, lipid monitoring, CBC, and vaccination review remain essential.
Can I get shingles from Tofe?
Reactivation of dormant varicella-zoster (shingles) is significantly more common on JAK inhibitors than on TNFi or background population — rates 2–5× higher, with Asian patients at highest risk. If you are age 50+ or immunocompromised, get the recombinant zoster vaccine (Shingrix, two doses) at least 4 weeks before starting Tofe. The live-attenuated shingles vaccine (Zostavax) is contraindicated on JAK therapy.
Can Tofe be combined with methotrexate?
Yes — methotrexate is the standard background DMARD used alongside tofacitinib in rheumatoid arthritis, and combination therapy produces better outcomes than tofacitinib alone in most trials. There is no pharmacokinetic interaction. Monitor CBC and LFT regularly on both drugs. JAK inhibitors must niet be combined with biologic DMARDs (TNFi, IL-6i, rituximab, abatacept) — the infection risk is unacceptable.
What about pregnancy and breastfeeding?
Tofacitinib is not recommended in pregnancy — animal data show skeletal and visceral teratogenicity, and human data are insufficient. Use effective contraception during treatment and for at least 1 week after the last dose. Do not use while breastfeeding — tofacitinib is expected to pass into breast milk and could affect the infant. Plan pregnancy in discussion with your rheumatologist — switch to a pregnancy-compatible DMARD (hydroxychloroquine, certolizumab, sulfasalazine) before conception.
Should I stop Tofe if I catch a cold or flu?
For mild upper respiratory infection with no fever, continue the drug and monitor. For anything more serious — fever ≥ 38°C, productive cough, pyelonephritis symptoms, cellulitis, shingles outbreak, suspected pneumonia, or COVID-19 requiring treatment — stop Tofe immediately and contact your prescriber. Resume only once the infection has fully resolved. This “pause-during-infection” rule is the single most important self-management skill on JAK therapy.
What laboratory tests do I need, and how often?
Standard monitoring after starting Tofe: CBC with differential and LFTs at weeks 4, 8, 12, then every 3 months. Lipid panel at week 8, then annually. Renal function every 3–6 months. Annual dermatology review is advisable in fair-skinned patients, prior skin cancer, or after 12 months of therapy. A drop in lymphocytes below 0.5 × 10&sup9;/L, neutrophils below 1.0, or a rise in ALT above 3× upper limit of normal all trigger treatment interruption until recovery.
Waarom bestellen bij MedsBase
Tofe is supplied through a WHO-GMP certified manufacturer with full COA documentation. We ship worldwide in plain, discreet packaging, and every order is covered by our Reshipment Assurance Policy. Your statement descriptor when paying by card shows the regulated payment processor (a regulated card-payment processor), never “MedsBase” or any medication name.
Other Anti-Inflammatory & Autoimmune Medications
If Tofe does not suit your situation, the following options are available in this category:
- Barinat (Baricitinib 2/4 mg, Cipla) — selective JAK1/JAK2 inhibitor
- Wysolone (Prednisolone 5/10/20 mg, Wyeth) — bridging corticosteroid for flares
- Kenacort (Triamcinolone 4 mg, Abbott) — oral corticosteroid
- Azoran (Azathioprine 50 mg, RPG) — purine antimetabolite
- Conimune ME (Cyclosporine 25/50/100 mg) — calcineurin inhibitor
More options in Anti Inflammatory & Autoimmune Care
Gerangschikt op recente bestelvolumes van MedsBase — wat andere klanten in deze categorie kiezen.
| Sterkte | 5 mg |
|---|---|
| Hoeveelheid | 30 Tablets, 60 Tablets, 90 Tablets, 200 Tablets, 400 Tablets |
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