OmniClear
Generic Name
Clearicimab
Manufacturer
Global Pharma Inc.
Country
United States
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| omniclear 350 mg injection | ৳ 1,000.00 | N/A |
Description
Overview of the medicine
OmniClear 350 mg Injection contains Clearicimab, a novel monoclonal antibody used for the treatment of severe autoimmune conditions. It works by selectively modulating the immune response.
Uses & Indications
Dosage
Adults
350 mg administered intravenously every 4 weeks.
Elderly
No specific dose adjustment required based on age, but caution advised due to potential comorbidities.
Renal_impairment
No dose adjustment needed for mild to moderate renal impairment. Severe impairment data limited.
How to Take
For intravenous infusion only. The 350 mg dose should be diluted in 250 mL of 0.9% sodium chloride and infused over a period of at least 30 minutes.
Mechanism of Action
Clearicimab selectively targets and neutralizes a specific cytokine, Interleukin-X (IL-X), which plays a pivotal role in the inflammatory cascade of various autoimmune diseases. By inhibiting IL-X, it reduces inflammation and disease progression.
Pharmacokinetics
Onset
Clinical effects usually observed within 2-4 weeks, with pharmacodynamic effects within 24-48 hours.
Excretion
Elimination occurs via non-specific proteolytic pathways, with minimal renal or hepatic excretion of the intact molecule.
Half life
Approximately 18-22 days.
Absorption
Administered intravenously, resulting in complete systemic bioavailability.
Metabolism
Primarily catabolized through proteolytic degradation, similar to endogenous IgGs.
Side Effects
Contraindications
- Hypersensitivity to Clearicimab or any excipients
- Active severe infections
- Moderate to severe heart failure (NYHA Class III/IV)
Drug Interactions
Live vaccines
Avoid concurrent administration due to increased risk of infection.
Other immunosuppressants
Increased risk of infection and malignancy when combined with other immunosuppressive agents.
Storage
Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Do not shake.
Overdose
In case of overdose, no specific antidote is available. Management should be supportive, focusing on symptomatic treatment and monitoring for adverse reactions, particularly serious infections.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown if Clearicimab is excreted in human milk. A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Side Effects
Contraindications
- Hypersensitivity to Clearicimab or any excipients
- Active severe infections
- Moderate to severe heart failure (NYHA Class III/IV)
Drug Interactions
Live vaccines
Avoid concurrent administration due to increased risk of infection.
Other immunosuppressants
Increased risk of infection and malignancy when combined with other immunosuppressive agents.
Storage
Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Do not shake.
Overdose
In case of overdose, no specific antidote is available. Management should be supportive, focusing on symptomatic treatment and monitoring for adverse reactions, particularly serious infections.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown if Clearicimab is excreted in human milk. A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from manufacturing date when stored correctly.
Availability
Hospitals and specialized pharmacies
Approval Status
Approved by FDA and DGDA
Patent Status
Under Patent Protection
Clinical Trials
Phase III clinical trials (CLEAR-001 and CLEAR-002) demonstrated superiority over placebo and non-inferiority to active comparator in patients with severe rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Further long-term extension studies are ongoing.
Lab Monitoring
- Complete Blood Count (CBC) with differential
- Liver function tests (LFTs)
- Renal function tests
- Tuberculosis screening (prior to initiation and periodically)
Doctor Notes
- Ensure thorough screening for active and latent infections before initiating therapy.
- Monitor patients for signs of infection, allergic reactions, and malignancy throughout treatment.
- Educate patients on the importance of reporting symptoms promptly.
Patient Guidelines
- Report any signs of infection (fever, chills, persistent cough) immediately.
- Avoid live vaccines during treatment.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
- Do not stop the medication without consulting your doctor.
Missed Dose Advice
If a dose is missed, administer it as soon as possible. Then, resume the regular dosing schedule, allowing at least 4 weeks between doses.
Driving Precautions
OmniClear is not expected to affect the ability to drive or operate machinery. However, if you experience dizziness or other side effects that impair your concentration, avoid driving or operating machinery.
Lifestyle Advice
- Maintain good hygiene to reduce infection risk.
- Avoid close contact with individuals who have active infections.
- Regular exercise and a balanced diet can support overall health.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.