Unit Price:
৳ 100.00
(3 x 10: ৳ 3,000.00)
Strip Price:
৳ 1,000.00
Indications
Rinva is a Janus kinase (JAK) inhibitor indicated for the treatment of-
- Adults with moderate to severe active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers.
- Adults and pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.
- Adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable.
- Adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers.
- Adults with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to one or more TNF blockers.
- Adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers.
- Adults with active nonradiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy.
- Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.
Pharmacology
Upadacitinib is a Janus kinase (JAK) inhibitor. JAKs are intracellular enzymes that transmit signals arising from cytokine or growth factor- receptor interactions on the cellular membrane to influence cellular processes of hematopoiesis and immune cell function. Within the signaling pathway, JAKs phosphorylate and activate signal. Transducers and Activators of Transcription(STATs) which modulate intracellular activity including gene expression. Upadacitinib modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs.
Dosage & Administration
Rheumatoid Arthritis: 15 mg once daily.
Psoriatic Arthritis:
Non-radiographic Axial Spondyloarthritis: 15 mg once daily.
Polyarticular Juvenile Idiopathic Arthritis: (30 kg and greater): 15 mg once daily.
Psoriatic Arthritis:
- Adults 18 Years of Age and Older: 15 mg once daily.
- 12 kg-65 kg (Weighing at least 40 kg): Initiate with 15 mg once daily. If an adequate response is not achieved, consider increasing the dosage to 30 mg once daily. Discontinue if an adequate response is not achieved with the 30 mg dose.
- Adults 65 Years of Age and Older: 15 mg once daily.
- Induction: 45 mg once daily for 8 weeks.
- Maintenance: 15 mg once daily. A dosage of 30 mg once daily may be considered for patients with refractory, severe or extensive disease. Discontinue if an adequate therapeutic response is not achieved with the 30 mg dosage.
- Induction: 45 mg once daily for 12 weeks.
- Maintenance: 15 mg once daily. A dosage of 30 mg once daily may be considered for patients with refractory, severe or extensive disease. Discontinue if an adequate therapeutic response is not achieved with the 30 mg dosage.
Non-radiographic Axial Spondyloarthritis: 15 mg once daily.
Polyarticular Juvenile Idiopathic Arthritis: (30 kg and greater): 15 mg once daily.
Interaction
Strong CYP3A4 Inhibitors: Rinva exposure is increased when co-administered with strong CYP3A4 inhibitors (such as ketoconazole). Rinva should be used with caution in patients receiving chronic treatment with strong CYP3A4 inhibitors.
Strong CYP3A4 Inducers: Rinva exposure is decreased when co-administered with strong CYP3A4 inducers (such as rifampin), which may lead to reduced therapeutic effect of Rinva. Coadministration of Rinva with strong CYP3A4 inducers is not recommended.
Strong CYP3A4 Inducers: Rinva exposure is decreased when co-administered with strong CYP3A4 inducers (such as rifampin), which may lead to reduced therapeutic effect of Rinva. Coadministration of Rinva with strong CYP3A4 inducers is not recommended.
Side Effects
Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and nonradiographic axial spondyloarthritis: Adverse reactions (≥ 1%) were: upper respiratory tract infections, herpes zoster, herpes simplex, bronchitis, nausea, cough, pyrexia, acne, and headache.
Atopic Dermatitis: Adverse reactions ( ≥1%) are: upper respiratory tract infections, acne, herpes simplex, headache, blood creatine phosphokinase increased, cough, hypersensitivity, folliculitis, nausea, abdominal pain, pyrexia, increased weight, herpes zoster, influenza, fatigue, neutropenia, myalgia, and influenza like illness.
Ulcerative Colitis: Adverse reactions (≥ 5%) reported during induction or maintenance are: upper respiratory tract infections, increased blood creatine phosphokinase, acne, neutropenia, elevated liver enzymes, and rash.
Crohn's Disease: Adverse reactions ( ≥5%) reported during induction or maintenance are: upper respiratory tract infections, anemia, pyrexia, acne, herpes zoster, and headache.
Atopic Dermatitis: Adverse reactions ( ≥1%) are: upper respiratory tract infections, acne, herpes simplex, headache, blood creatine phosphokinase increased, cough, hypersensitivity, folliculitis, nausea, abdominal pain, pyrexia, increased weight, herpes zoster, influenza, fatigue, neutropenia, myalgia, and influenza like illness.
Ulcerative Colitis: Adverse reactions (≥ 5%) reported during induction or maintenance are: upper respiratory tract infections, increased blood creatine phosphokinase, acne, neutropenia, elevated liver enzymes, and rash.
Crohn's Disease: Adverse reactions ( ≥5%) reported during induction or maintenance are: upper respiratory tract infections, anemia, pyrexia, acne, herpes zoster, and headache.
Pregnancy & Lactation
The limited human data on the use of Upadacitinib in pregnant women are not sufficient to evaluate a drug-associated risk for major birth defects or miscarriage. Based on animal studies, upadacitinib has the potential to adversely affect a developing fetus. Advise not to breastfeed.
Precautions & Warnings
Serious Infections: Avoid use of Rinva in patients with active, serious infection, including localized infections.
Malignancy: Consider the risks and benefits of Rinva treatment prior to initiating therapy in patients with a known malignancy.
Thrombosis: Consider the risks and benefits prior to treating patients who may be at increased risk of thrombosis. Promptly evaluate patients with symptoms of thrombosis and treat appropriately.
Gastrointestinal Perforations: Use with caution in patients who may be at increased risk.
Laboratory Monitoring: Recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes and lipids.
Embryo-Fetal Toxicity: Rinva may cause fetal harm based on animal studies. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
Vaccinations: Avoid use of Rinva with live vaccines.
Malignancy: Consider the risks and benefits of Rinva treatment prior to initiating therapy in patients with a known malignancy.
Thrombosis: Consider the risks and benefits prior to treating patients who may be at increased risk of thrombosis. Promptly evaluate patients with symptoms of thrombosis and treat appropriately.
Gastrointestinal Perforations: Use with caution in patients who may be at increased risk.
Laboratory Monitoring: Recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes and lipids.
Embryo-Fetal Toxicity: Rinva may cause fetal harm based on animal studies. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
Vaccinations: Avoid use of Rinva with live vaccines.
Use in Special Populations
Pediatric Use: No data available for pediatric patients under 2 years.
Hepatic Impairment: Rinva is not recommended in patients with severe hepatic impairment.
Renal Impairment: For Rinva, no dosage adjustment is needed for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or polyarticular juvenile idiopathic arthritis patients with mild to severe renal impairment. For atopic dermatitis, the maximum dose is 15 mg once daily with severe renal impairment. For ulcerative colitis or Crohn's disease with severe renal impairment, the recommended dose is 30 mg once daily for induction and 15 mg once daily for maintenance. Rinva is not recommended in end-stage renal disease for atopic dermatitis, ulcerative colitis, or Crohn's disease.
Hepatic Impairment: Rinva is not recommended in patients with severe hepatic impairment.
Renal Impairment: For Rinva, no dosage adjustment is needed for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or polyarticular juvenile idiopathic arthritis patients with mild to severe renal impairment. For atopic dermatitis, the maximum dose is 15 mg once daily with severe renal impairment. For ulcerative colitis or Crohn's disease with severe renal impairment, the recommended dose is 30 mg once daily for induction and 15 mg once daily for maintenance. Rinva is not recommended in end-stage renal disease for atopic dermatitis, ulcerative colitis, or Crohn's disease.
Overdose Effects
Rinva was administered in clinical trials up to doses equivalent in daily AUC to 60 mg extended-release once daily. Adverse events were comparable to those seen at lower doses and no specific toxicities were identified. Approximately 90% of Rinva in the systemic circulation is eliminated within 24 hours of dosing (within the range of doses evaluated in clinical studies). In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions. Patients who develop adverse reactions should receive appropriate treatment.
Therapeutic Class
Drugs used for Rheumatoid Arthritis
Storage Conditions
Do not store above 25°C. Protect from light. Keep out of reach of children.
Pack Image: Rinva 15 mg Tablet