Tofenver
Generic Name
Tofenver
Manufacturer
Medigen Pharma Inc.
Country
USA
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| tofenver 1 mg tablet | ৳ 2.50 | ৳ 25.00 |
Description
Overview of the medicine
Tofenver 1 mg tablet is an oral Janus Kinase (JAK) inhibitor used to treat certain chronic inflammatory conditions such as rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.
Uses & Indications
Dosage
Adults
Typical starting dose is 1 mg once daily. May be adjusted based on clinical response and tolerability, up to a maximum of 2 mg once daily.
Elderly
No specific dose adjustment is required based on age alone; however, monitor for renal impairment and co-morbidities.
Renal_impairment
For moderate renal impairment (CrCl 30-60 mL/min), reduce dose to 1 mg every other day. Not recommended for severe renal impairment (CrCl <30 mL/min).
How to Take
Oral administration. Can be taken with or without food. Swallow whole, do not crush or chew.
Mechanism of Action
Tofenver selectively inhibits Janus Kinase (JAK) enzymes, particularly JAK1 and JAK2, involved in the signaling pathways of various cytokines. By inhibiting JAK activity, it interferes with the production and function of inflammatory mediators, thereby reducing inflammation and immune responses.
Pharmacokinetics
Onset
Clinical effects may be observed within 2-4 weeks, with maximal effect seen after 3-6 months of continuous therapy.
Excretion
Excreted predominantly via urine (approximately 70%) and feces (approximately 30%).
Half life
Approximately 6-8 hours.
Absorption
Rapidly absorbed after oral administration, peak plasma concentrations reached within 1-2 hours.
Metabolism
Primarily metabolized in the liver, mainly by CYP3A4 and to a lesser extent by CYP2C19.
Side Effects
Contraindications
- Hypersensitivity to Tofenver or any excipients
- Active serious infections (e.g., tuberculosis, herpes zoster)
- Severe hepatic impairment
Drug Interactions
Live vaccines
Avoid concurrent use due to immunosuppression.
Strong CYP3A4 inducers (e.g., Rifampin)
May decrease Tofenver exposure; avoid co-administration.
Strong CYP3A4 inhibitors (e.g., Ketoconazole)
May increase Tofenver exposure; reduce Tofenver dose.
Storage
Store below 30°C in a dry place, protected from light. Keep out of reach of children.
Overdose
No specific antidote. Management involves symptomatic and supportive care. Hemodialysis is unlikely to be effective.
Pregnancy & Lactation
Not recommended during pregnancy due to potential fetal harm. Women of childbearing potential should use effective contraception. Avoid breastfeeding as Tofenver may be excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months
Availability
Available in pharmacies, hospitals
Approval Status
Approved by regulatory authorities (e.g., FDA/DGDA)
Patent Status
Under patent protection
Clinical Trials
Extensive Phase I, II, and III clinical trials demonstrated efficacy and safety in rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis patients. Studies are ongoing for additional indications and long-term safety.
Lab Monitoring
- Complete Blood Count (CBC) including lymphocyte count (baseline and periodically)
- Lipid panel (baseline and periodically)
- Liver function tests (LFTs) (baseline and periodically)
- Renal function tests (baseline and periodically)
Doctor Notes
- Assess patients for latent tuberculosis before initiating therapy.
- Monitor CBC, LFTs, and lipid panel periodically during treatment.
- Educate patients about signs of infection and malignancy.
Patient Guidelines
- Take Tofenver exactly as prescribed by your doctor.
- Report any signs of infection (fever, chills) immediately.
- Do not stop taking the medicine suddenly without consulting your doctor.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Tofenver is not expected to affect the ability to drive or operate machinery. However, if you experience dizziness or visual disturbances, avoid such activities.
Lifestyle Advice
- Maintain good hygiene to reduce infection risk.
- Avoid live vaccines while on therapy.
- Discuss any planned surgeries with your doctor.
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Global Brand Names
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