Diapamiro
Generic Name
Diapamiro
Manufacturer
PharmaGlobal Inc.
Country
USA
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| diapamiro 370 mg injection | ৳ 2,410.00 | N/A |
Description
Overview of the medicine
Diapamiro is a novel immunomodulatory agent formulated as an intravenous injection. It is indicated for the treatment of certain autoimmune diseases where conventional therapies have failed. Its active ingredient, Diapamiro, acts as a selective Janus Kinase (JAK) inhibitor, modulating the immune response.
Uses & Indications
Dosage
Adults
The recommended dose is 370 mg administered as an intravenous infusion over 30 minutes, once every 4 weeks. Dosage adjustment may be required based on clinical response and tolerability.
Elderly
No specific dose adjustment is required for elderly patients, but caution is advised due to potential age-related decline in renal function.
Renal_impairment
For patients with moderate renal impairment (CrCl 30-59 mL/min), reduce dose to 185 mg every 4 weeks. Not recommended for severe renal impairment (CrCl <30 mL/min).
How to Take
Administer Diapamiro 370 mg as an intravenous infusion over 30 minutes. It must be diluted in 0.9% Sodium Chloride injection prior to administration. Do not administer as an intravenous push or bolus.
Mechanism of Action
Diapamiro selectively inhibits the activity of specific Janus Kinase (JAK) enzymes, particularly JAK1 and JAK2. By blocking these intracellular kinases, Diapamiro disrupts the signaling pathways of various cytokines and growth factors involved in inflammatory and immune responses, thereby reducing inflammation and immune overactivity associated with autoimmune conditions.
Pharmacokinetics
Onset
Within 2-4 hours for initial anti-inflammatory effects.
Excretion
Approximately 70% excreted renally as metabolites, and 30% through fecal route.
Half life
Approximately 18-24 hours, allowing for once-daily or less frequent dosing.
Absorption
Rapid and complete absorption following intravenous administration, with peak plasma concentrations achieved at the end of infusion.
Metabolism
Primarily hepatic metabolism via cytochrome P450 (CYP3A4) enzymes, with minor contributions from other CYP isoenzymes.
Side Effects
Contraindications
- Hypersensitivity to Diapamiro or any of its excipients
- Active severe infections (e.g., tuberculosis, sepsis)
- Severe hepatic impairment
- Pregnancy and breastfeeding
Drug Interactions
Live vaccines
Should not be administered concurrently with Diapamiro due to increased risk of infection.
Strong CYP3A4 inducers (e.g., rifampin)
May decrease Diapamiro plasma concentrations, reducing efficacy.
Strong CYP3A4 inhibitors (e.g., ketoconazole)
May increase Diapamiro plasma concentrations, requiring dose reduction.
Storage
Store vials at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Keep out of reach of children.
Overdose
There is no specific antidote for Diapamiro overdose. In case of an overdose, discontinue treatment and manage symptoms supportively. Monitor for signs of infection and myelosuppression. Hemodialysis may not be effective in removing Diapamiro due to its high protein binding.
Pregnancy & Lactation
Diapamiro is contraindicated during pregnancy due to potential fetal harm. Women of childbearing potential should use effective contraception during treatment and for at least 4 weeks after the last dose. It is unknown if Diapamiro is excreted in human milk; however, due to potential adverse reactions in breastfed infants, breastfeeding is contraindicated during treatment.
Side Effects
Contraindications
- Hypersensitivity to Diapamiro or any of its excipients
- Active severe infections (e.g., tuberculosis, sepsis)
- Severe hepatic impairment
- Pregnancy and breastfeeding
Drug Interactions
Live vaccines
Should not be administered concurrently with Diapamiro due to increased risk of infection.
Strong CYP3A4 inducers (e.g., rifampin)
May decrease Diapamiro plasma concentrations, reducing efficacy.
Strong CYP3A4 inhibitors (e.g., ketoconazole)
May increase Diapamiro plasma concentrations, requiring dose reduction.
Storage
Store vials at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Keep out of reach of children.
Overdose
There is no specific antidote for Diapamiro overdose. In case of an overdose, discontinue treatment and manage symptoms supportively. Monitor for signs of infection and myelosuppression. Hemodialysis may not be effective in removing Diapamiro due to its high protein binding.
Pregnancy & Lactation
Diapamiro is contraindicated during pregnancy due to potential fetal harm. Women of childbearing potential should use effective contraception during treatment and for at least 4 weeks after the last dose. It is unknown if Diapamiro is excreted in human milk; however, due to potential adverse reactions in breastfed infants, breastfeeding is contraindicated during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from manufacturing date (unreconstituted). Reconstituted solution is stable for 24 hours at 2-8°C.
Availability
Hospitals and Specialized Pharmacies
Approval Status
Approved
Patent Status
Patented until 2035
Clinical Trials
Diapamiro has successfully completed multiple Phase 3 clinical trials demonstrating its efficacy and safety in rheumatoid arthritis and psoriatic arthritis, leading to its global regulatory approvals.
Lab Monitoring
- Complete Blood Count (CBC) with differential (at baseline and periodically)
- Liver function tests (ALT, AST, bilirubin) (at baseline and periodically)
- Renal function tests (Creatinine, BUN) (at baseline and periodically)
- Lipid panel (at baseline and 12 weeks after initiation)
- Tuberculosis screening (prior to initiation)
Doctor Notes
- Ensure TB screening is performed before initiating Diapamiro.
- Educate patients on infection symptoms and the importance of prompt reporting.
- Consider dose adjustment in patients with moderate renal impairment.
Patient Guidelines
- Report any signs of infection immediately to your doctor.
- Do not receive live vaccines during treatment.
- Regular blood tests will be required during therapy.
- Avoid close contact with people who are sick.
Missed Dose Advice
If a dose is missed, administer it as soon as possible. If it is almost time for the next scheduled dose, skip the missed dose and resume the regular dosing schedule. Do not administer two doses at once.
Driving Precautions
Diapamiro may cause dizziness or fatigue in some patients. If these symptoms occur, avoid driving or operating machinery until you feel well.
Lifestyle Advice
- Maintain good hygiene to reduce infection risk.
- Discuss any planned surgeries or dental procedures with your doctor.
- Avoid excessive alcohol consumption.
- Regular exercise and a balanced diet are recommended.
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