Betrecep 5mg Tablet (Tofacitinib)
Manufactured By
Pfizer
Pack Of
14
Salt Composition
Tofacitinib
Storage
Store at room temperature; verify exact pack.
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Overview
Betrecep 5mg Tablet contains tofacitinib 5 mg, an oral Janus kinase (JAK) inhibitor used for several immune-mediated inflammatory diseases. It primarily inhibits JAK1 and JAK3 signalling, reducing cytokine pathways involved in rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and other approved conditions. Because systemic JAK inhibition can increase serious infections, malignancy, major adverse cardiovascular events (MACE) and thrombosis, tofacitinib 50mg tablet requires careful patient selection—particularly in older patients, smokers and people with cardiovascular or cancer risk factors.
Quick Product Facts
| Field | Publication wording |
|---|---|
| Brand | Betrecep 5mg Tablet |
| Molecule / Combination | Tofacitinib |
| Strength / Composition | 5 mg |
| Dosage form | Tablet |
| Manufacturer / Marketer | Pfizer Ltd |
| Pack / Presentation | 14 tablets |
| Storage | Store at room temperature; verify exact pack. |
| Prescription | Required |
| Publication status | Medical-review sign-off required |
Uses and Indications
Major current indications include moderate-to-severe rheumatoid arthritis after inadequate response/intolerance to TNF blockers or other DMARD strategies depending on label, active psoriatic arthritis, active ankylosing spondylitis and moderate-to-severe ulcerative colitis. Exact line-of-therapy restrictions differ by jurisdiction and have tightened following safety trials. Tofacitinib 5mg tablet should not be combined with biologic DMARDs or potent immunosuppressants such as azathioprine/ciclosporin because of excessive immunosuppression.
How Betrecep 5mg Tablet Works
Tofacitinib 5mg tablet inhibits JAK-mediated phosphorylation and activation of STAT proteins, reducing signalling from multiple pro-inflammatory cytokines that drive autoimmune disease.
Clinical Evidence for Betrecep 5mg Tablet
ORAL Strategy/RA development programme: Tofacitinib 5mg tablet demonstrated clinical efficacy in RA as monotherapy and with methotrexate.
OCTAVE trials: Tofacitinib induced and maintained remission in moderate-to-severe ulcerative colitis.
ORAL Surveillance: In RA patients aged ≥50 with cardiovascular risk factors, tofacitinib 5mg tablet was associated with higher MACE and malignancy risk versus TNF inhibitors, driving boxed-warning restrictions.
Side Effects of Betrecep 5mg Tablet
Default side effects information
Common or Clinically Frequent Side Effects
- ● Upper respiratory infection
- ● Headache
- ● Diarrhoea
- ● Nausea
- ● Increased cholesterol
- ● Shingles
Serious Side Effects
- ● Serious/opportunistic infection including TB
- ● MACE
- ● Malignancy
- ● Venous/arterial thrombosis
- ● GI perforation
- ● Cytopenias
- ● Liver injury
Critical Safety Warning
BOXED SAFETY THEMES: serious infections, mortality, malignancy, major cardiovascular events and thrombosis are key risks. Use the lowest effective dose and prefer alternatives in high-risk patients when clinically appropriate under the current label.
Betrecep 5mg Tablet Dosage and How To Take It
Clinical context | Typical labelled / protocol guidance |
RA/PsA/AS common regimen | 5 mg orally twice daily; indication and line-of-therapy restrictions apply. |
Ulcerative colitis induction | 10 mg twice daily for a limited induction period under the reference label, followed by the lowest effective maintenance dose. |
Renal/hepatic impairment | Dose reduction or avoidance may be required. |
Strong CYP3A4 inhibitors | Dose modification may be required. |
Important: Dose and regimen must be prescribed by the treating specialist. Tablet/vial strength is not necessarily the patient dose. Do not start, stop, split, combine or substitute treatment based on website information.
Betrecep 5mg Tablet Missed Dose
Take a missed dose when remembered unless close to the next dose; do not double.
Safety Advice for Betrecep 5mg Tablet
| Category | Status | Guidance |
|---|---|---|
| Infection/TB | Screen/monitor | Test for TB and assess hepatitis risk before therapy. |
| Vaccines | Avoid live vaccines | Update appropriate vaccines before treatment. |
| Heart/clot risk | High caution | Review age, smoking, CVD and VTE history. |
| Pregnancy | Specialist guided | Avoid unless benefits justify risk under local guidance. |
| Driving | Usually minimal | Avoid if dizziness occurs. |
Monitoring During Betrecep 5mg Tablet Treatment
● CBC/lymphocytes/neutrophils/haemoglobin
● Liver function
● Lipids after initiation
● TB/hepatitis screening
● Infection signs
● Cardiovascular and thrombotic risk
Betrecep 5mg Tablet Fact Box
| Parameter | Verified / publication wording |
|---|---|
| Brand | Betrecep 5mg Tablet |
| Generic / Combination | Tofacitinib |
| Strength | 5 mg |
| Form | Tablet |
| Manufacturer / Marketer | Pfizer Ltd |
| Pack | 14 tablets |
| Storage | Store at room temperature; verify exact pack. |
| Major safety theme | BOXED SAFETY THEMES |
| Prescription | Yes |
Betrecep 5mg Tablet Drug Interactions
| Drug / Class | Risk | What To Do |
|---|---|---|
| Strong CYP3A4 inhibitors | Increase tofacitinib 5mg exposure | Use label-directed dose adjustment. |
| Strong CYP inducers | Reduce exposure | Avoid when possible. |
| Biologic DMARDs/azathioprine/ciclosporin | Excess immunosuppression | Do not combine. |
| Live vaccines | Infection risk | Avoid during therapy. |
FAQs About Betrecep 5mg Tablet
Why does Betrecep have strong warnings?
JAK inhibition can increase serious infection, cancer, cardiovascular and clotting risks in susceptible patients.
What is the usual RA dose?
A common dose is 5 mg twice daily when indicated.
Why is TB testing required when undergoing betrecep treatment?
Tofacitinib 5mg tablet can reactivate latent tuberculosis thats why one should get tested for TB
Why are cholesterol tests done when undergoing treatment with betrecep?
One should get tested for cholesterol because JAK inhibitors can raise lipid levels.
Can betrecep used with biologic arthritis drugs?
Generally no; combining potent immunosuppressants can be unsafe.
Is the ulcerative-colitis dose the same?
Induction may use a higher dose for a limited period; maintenance should use the lowest effective dose.
What symptoms need urgent review?
Fever, chest pain, sudden breathlessness, leg swelling, neurological symptoms or shingles-like rash.
Who markets Betrecep 5mg Tablet?
It is possible to verify the availability of betrecep tablet by contacting any licensed pharmacy or reputable online pharmacy. Current stock and prescription fulfillment can be confirmed by visiting their website. Availability may vary by location, so it is advised to first check the stock before placing order.
References
1. Current tofacitinib 5mg tablet prescribing information (Xeljanz/reference). https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s018lbl.Pdf
2. Ytterberg SR, et al. ORAL Surveillance. New England Journal of Medicine.https://www.nejm.org/doi/full/10.1056/NEJMoa2109927
3. Sandborn WJ, et al. OCTAVE trials. New England Journal of Medicine.https://www.nejm.org/doi/full/10.1056/NEJMoa1606910
4. Current rheumatology/gastroenterology guidelines. Https://rheumatology.org/clinical-practice-guidelines.
5. National library of health. Efficacy of tofacitinib tablet.https://pmc.ncbi.nlm.nih.gov/articles/PMC6451219
Marketer Details
Pfizer
Author Details
Written By:
Nonish Sharma
I am a medical content writer with a strong academic background in life sciences, holding an M.Sc. in Biotechnology... Read More
Reviewed By:
Vaibhav Shakya
Dr. Vaibhav Shakya, MD, is a Medical reviewer and medicine expert at Globans Pharma, with more than 9 years of experienc... Read More
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