Prosulf
Generic Name
prosulf-10-mg-injection
Manufacturer
Innovate Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| prosulf 10 mg injection | ৳ 250.00 | N/A |
Description
Overview of the medicine
Prosulf 10 mg Injection contains Prosulf, a selective Janus Kinase (JAK) inhibitor used to treat various autoimmune and inflammatory conditions. It works by blocking specific enzymes involved in inflammatory pathways, thereby reducing inflammation and immune response.
Uses & Indications
Dosage
Adults
10 mg administered subcutaneously once daily. Dosage may be adjusted based on clinical response and tolerability.
Elderly
No specific dose adjustment required for elderly patients, but caution is advised due to potential for increased susceptibility to adverse effects.
Renal_impairment
For severe renal impairment (CrCl < 30 mL/min), reduce dose to 5 mg once daily. No adjustment needed for mild to moderate impairment.
How to Take
Prosulf 10 mg Injection is for subcutaneous administration only. Administer once daily at the same time each day. Patients may be trained to self-inject after appropriate instruction by a healthcare professional.
Mechanism of Action
Prosulf selectively inhibits Janus Kinase (JAK) enzymes, particularly JAK1 and JAK2. By blocking these enzymes, Prosulf interferes with the signaling pathways of several pro-inflammatory cytokines, such as IL-6, IL-12, and IL-23, which play crucial roles in autoimmune and inflammatory diseases. This leads to a reduction in inflammation and immune system activity.
Pharmacokinetics
Onset
Clinical effects typically observed within 2-4 weeks.
Excretion
Approximately 70% eliminated via renal excretion (20% as unchanged drug) and 30% via fecal excretion.
Half life
Approximately 12-16 hours, supporting once or twice daily dosing.
Absorption
Rapid and complete absorption after subcutaneous or intravenous administration, with peak plasma concentrations achieved within 1-2 hours.
Metabolism
Primarily metabolized in the liver via CYP3A4, with some contribution from CYP2D6.
Side Effects
Contraindications
- Hypersensitivity to Prosulf or any excipients.
- Active serious infections, including localized infections.
- Active tuberculosis (TB) or other severe opportunistic infections.
- Severe hepatic impairment.
Drug Interactions
Live vaccines
Avoid concurrent use with live vaccines.
Potent CYP3A4 inducers (e.g., rifampin)
May decrease Prosulf exposure; consider increasing Prosulf dose.
Potent CYP3A4 inhibitors (e.g., ketoconazole)
May increase Prosulf exposure; reduce Prosulf dose.
Other immunosuppressants (e.g., cyclosporine, azathioprine)
Increased risk of immunosuppression and infection; co-administration not recommended.
Storage
Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Keep out of reach of children.
Overdose
In case of overdose, no specific antidote is available. Management should be supportive and directed at treating symptoms. Hemodialysis is unlikely to be effective due to high protein binding.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit justifies potential risk to the fetus. It is unknown if Prosulf is excreted in human milk. Advise mothers not to breastfeed during treatment and for at least 18 days after the last dose.
Side Effects
Contraindications
- Hypersensitivity to Prosulf or any excipients.
- Active serious infections, including localized infections.
- Active tuberculosis (TB) or other severe opportunistic infections.
- Severe hepatic impairment.
Drug Interactions
Live vaccines
Avoid concurrent use with live vaccines.
Potent CYP3A4 inducers (e.g., rifampin)
May decrease Prosulf exposure; consider increasing Prosulf dose.
Potent CYP3A4 inhibitors (e.g., ketoconazole)
May increase Prosulf exposure; reduce Prosulf dose.
Other immunosuppressants (e.g., cyclosporine, azathioprine)
Increased risk of immunosuppression and infection; co-administration not recommended.
Storage
Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Keep out of reach of children.
Overdose
In case of overdose, no specific antidote is available. Management should be supportive and directed at treating symptoms. Hemodialysis is unlikely to be effective due to high protein binding.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit justifies potential risk to the fetus. It is unknown if Prosulf is excreted in human milk. Advise mothers not to breastfeed during treatment and for at least 18 days after the last dose.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture.
Availability
Available in hospitals and specialized pharmacies
Approval Status
FDA Approved (USA), DGDA Approved (Bangladesh)
Patent Status
Patent protected until 2035
Clinical Trials
Prosulf has been evaluated in multiple Phase 3 clinical trials involving over 3,000 patients with various autoimmune conditions, demonstrating significant efficacy and an acceptable safety profile compared to placebo.
Lab Monitoring
- Complete blood count (CBC) including lymphocyte count: baseline and every 3 months during treatment.
- Liver function tests (ALT, AST): baseline and periodically.
- Lipid panel: baseline and 12 weeks after initiation, then periodically.
- Renal function tests: baseline and as clinically indicated.
Doctor Notes
- Ensure patients are up-to-date with immunizations before initiating Prosulf, avoiding live vaccines.
- Monitor for signs of infection, malignancy, and thrombotic events throughout treatment.
- Regular laboratory monitoring (CBC, LFTs, lipids) is essential.
Patient Guidelines
- Report any signs of infection (fever, cough, skin rash) immediately to your doctor.
- Do not receive live vaccines while on Prosulf.
- Inform your doctor about all medications, supplements, and herbal products you are taking.
- Regular blood tests will be required to monitor your treatment.
Missed Dose Advice
If a dose is missed, administer it as soon as possible. If it is almost time for the next dose, skip the missed dose and resume the regular dosing schedule. Do not double the dose to compensate for a missed one.
Driving Precautions
Prosulf 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 close contact with people who are sick or have infections.
- Eat a balanced diet and engage in moderate exercise as advised by your doctor.
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