Remsima
Generic Name
Infliximab (biosimilar)
Manufacturer
Celltrion Healthcare Co., Ltd.
Country
South Korea
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| remsima 100 mg injection | ৳ 34,900.00 | N/A |
Description
Overview of the medicine
Remsima is a biosimilar of infliximab, a chimeric human-murine monoclonal antibody. It is used to treat various autoimmune diseases by binding to tumor necrosis factor-alpha (TNF-alpha) and neutralizing its activity, thereby reducing inflammation and disease progression.
Uses & Indications
Dosage
Adults
Typically 5 mg/kg IV infusion at weeks 0, 2, and 6, then every 8 weeks. Dosage may vary by indication.
Elderly
No specific dose adjustment recommended; closely monitor for adverse events.
Renal_impairment
No specific dose adjustment recommended for renal impairment.
How to Take
Administered as an intravenous infusion over a period of at least 2 hours. Must be prepared and administered by healthcare professionals.
Mechanism of Action
Infliximab selectively binds with high affinity to the soluble and transmembrane forms of human tumor necrosis factor-alpha (TNF-alpha) and inhibits its activity. TNF-alpha is a pro-inflammatory cytokine involved in the pathogenesis of various autoimmune and inflammatory diseases. By neutralizing TNF-alpha, infliximab reduces inflammation and immune-mediated tissue damage.
Pharmacokinetics
Onset
Clinical response often observed within 2-6 weeks.
Excretion
Primarily cleared by degradation of the protein, not through renal or hepatic excretion in the typical sense.
Half life
Approximately 8-9.5 days.
Absorption
Administered intravenously, leading to complete bioavailability.
Metabolism
As a large protein, infliximab is catabolized into smaller peptides and amino acids via general protein degradation pathways.
Side Effects
Contraindications
- Hypersensitivity to infliximab or any excipient
- Active severe infections (e.g., sepsis, abscesses, opportunistic infections)
- Moderate to severe heart failure (NYHA Class III/IV)
- History of tuberculosis (unless treated)
Drug Interactions
Anakinra
Increased risk of serious infection; not recommended.
Abatacept
Increased risk of serious infection; not recommended.
Live vaccines
Avoid concurrent administration.
Other biologics (e.g., etanercept, adalimumab)
Increased risk of serious infection; not recommended.
Storage
Store unopened vials refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. After reconstitution, the solution should be used immediately or within 24 hours if stored at 2°C to 8°C.
Overdose
Limited experience with overdose. No specific antidote. Management involves symptomatic and supportive care. Patients should be monitored for any signs or symptoms of adverse reactions.
Pregnancy & Lactation
Pregnancy Category B. Use only if clearly needed. Infliximab crosses the placenta, and infants exposed in utero should not receive live vaccines for at least 6 months after birth. Lactation: Use with caution; consider developmental and health benefits.
Side Effects
Contraindications
- Hypersensitivity to infliximab or any excipient
- Active severe infections (e.g., sepsis, abscesses, opportunistic infections)
- Moderate to severe heart failure (NYHA Class III/IV)
- History of tuberculosis (unless treated)
Drug Interactions
Anakinra
Increased risk of serious infection; not recommended.
Abatacept
Increased risk of serious infection; not recommended.
Live vaccines
Avoid concurrent administration.
Other biologics (e.g., etanercept, adalimumab)
Increased risk of serious infection; not recommended.
Storage
Store unopened vials refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. After reconstitution, the solution should be used immediately or within 24 hours if stored at 2°C to 8°C.
Overdose
Limited experience with overdose. No specific antidote. Management involves symptomatic and supportive care. Patients should be monitored for any signs or symptoms of adverse reactions.
Pregnancy & Lactation
Pregnancy Category B. Use only if clearly needed. Infliximab crosses the placenta, and infants exposed in utero should not receive live vaccines for at least 6 months after birth. Lactation: Use with caution; consider developmental and health benefits.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 36 months when stored as recommended (unopened vial).
Availability
Hospitals, specialized clinics
Approval Status
Approved by FDA (as biosimilar), EMA, and other regulatory bodies.
Patent Status
Biosimilar; patent for reference product (Remicade) expired.
WHO Essential Medicine
YesClinical Trials
Remsima demonstrated comparable efficacy and safety to the reference product (Remicade) in extensive clinical trials across various indications (e.g., PLANETRA, PLANETAS studies).
Lab Monitoring
- Complete blood count (CBC) with differential
- Liver function tests (LFTs)
- Renal function tests
- Tuberculosis screening (latent TB test)
- Hepatitis B screening
- Monitoring for signs of infection or new malignancies
Doctor Notes
- Screen patients for latent tuberculosis and hepatitis B prior to initiating therapy.
- Monitor patients for infusion reactions during and after administration.
- Educate patients on symptoms of infection and malignancy.
- Consider potential for immunogenicity and loss of response over time.
Patient Guidelines
- Report any signs of infection (fever, cough, flu-like symptoms) to your doctor immediately.
- Do not receive live vaccines while on Remsima.
- Inform your doctor about any new or worsening symptoms, especially concerning your heart or nervous system.
- Regular follow-up appointments and lab tests are crucial.
Missed Dose Advice
Contact your doctor immediately if you miss an appointment for your Remsima infusion. Your doctor will decide if you need to reschedule or adjust your treatment plan.
Driving Precautions
Remsima may cause dizziness or visual disturbances in some patients. If these occur, avoid driving or operating machinery until you feel well.
Lifestyle Advice
- Maintain good hygiene to reduce infection risk.
- Avoid crowded places or contact with sick individuals, especially during peak flu season.
- Discuss any travel plans, especially to areas with endemic infections, with your doctor.
- Avoid smoking and excessive alcohol consumption.
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