IMUXGEN 500mg TAB (50s)

Description

IMUXGEN 500 mg Tablet contains Mycophenolate Mofetil, an immunosuppressive medication primarily used to prevent organ rejection in transplant patients and to treat certain autoimmune diseases. Mycophenolate Mofetil is a prodrug that is rapidly converted to its active form, mycophenolic acid (MPA), which works by inhibiting inosine monophosphate dehydrogenase (IMPDH), an enzyme crucial for the synthesis of guanine nucleotides. This inhibition suppresses the proliferation of B and T lymphocytes, cells responsible for immune rejection, thereby preventing organ rejection following kidney, heart, or liver transplants. It is also used for treating autoimmune conditions such as lupus nephritis and rheumatoid arthritis.

Therapeutic Class:

Immunosuppressant

Active Ingredient:

Mycophenolate Mofetil 500 mg

Indications:

IMUXGEN 500 mg Tablet is indicated for:

• Prevention of Organ Rejection:
  • Used in combination with other immunosuppressants (e.g., corticosteroids, cyclosporine) to prevent rejection in kidney, heart, and liver transplants.
• Autoimmune Diseases:
  • Lupus Nephritis: Treatment of kidney disease associated with systemic lupus erythematosus (SLE).
  • Rheumatoid Arthritis: In cases of severe disease not adequately controlled by other medications.
• Other Immune-related Conditions:
  • It may be used for treating other autoimmune diseases at the discretion of the healthcare provider.

Mechanism of Action:

Mycophenolate Mofetil is metabolized into mycophenolic acid, which inhibits inosine monophosphate dehydrogenase (IMPDH), a key enzyme in the purine biosynthesis pathway. By limiting purine nucleotide production, it inhibits the proliferation of B and T lymphocytes, which are essential for the immune response in transplant rejection and autoimmune diseases. This immune suppression helps prevent organ rejection and control autoimmune activity.

Dosage and Administration:

• For Organ Transplantation (Kidney, Heart, Liver):
  • The usual dose for adults is 1 g twice daily (total 2 g daily), administered orally.
  • Adjustments may be necessary based on the patient’s response, renal or hepatic function, and co-administered medications.
• For Autoimmune Conditions (e.g., Lupus Nephritis, Rheumatoid Arthritis):
  • Typically, 1 g twice daily, but the dose may be adjusted based on clinical response and tolerability.
• Pediatric Use:
  • The dose for children is generally adjusted based on weight and age. Pediatric doses should be determined by a healthcare provider.
• Administration:
  • Take with or without food. Tablets should be swallowed whole with a glass of water. Avoid crushing or splitting the tablets.

Contraindications:

• Hypersensitivity to Mycophenolate Mofetil or any component of the formulation.
• Pregnancy (especially during the first trimester) due to the potential risk of fetal harm.
• Women of childbearing potential not using adequate contraception.
• Severe bone marrow suppression (low white blood cell count, low platelet count).

Warnings and Precautions:

• Infections:
  Mycophenolate Mofetil increases the risk of serious infections, including bacterial, viral, fungal, and opportunistic infections. Patients should be monitored for signs of infection.
• Teratogenicity:
  Mycophenolate Mofetil is teratogenic and can cause birth defects or pregnancy loss. Female patients should avoid pregnancy and use reliable contraception during treatment and for 6 weeks after discontinuation. Male patients are also advised to use contraception.
• Bone Marrow Suppression:
  Mycophenolate Mofetil may cause bone marrow suppression, leading to leukopenia, thrombocytopenia, and anemia. Regular monitoring of blood counts is necessary.
• Gastrointestinal Effects:
  Diarrhea, nausea, and vomiting are common side effects. Patients should be monitored for signs of dehydration or malnutrition due to persistent GI symptoms.
• Liver Dysfunction:
  Caution should be taken in patients with liver dysfunction, as Mycophenolate Mofetil is metabolized in the liver.
• Vaccination:
  Live vaccines should be avoided during treatment with Mycophenolate Mofetil due to the immunosuppressive effects.

Adverse Effects:

Common:

• Diarrhea
• Nausea and vomiting
• Abdominal pain
• Headache
• Fatigue
• Decreased appetite

Serious:

• Bone marrow suppression (e.g., leukopenia, anemia, thrombocytopenia)
• Increased risk of infection
• Liver enzyme abnormalities
• Teratogenic effects (birth defects)
• Progressive multifocal leukoencephalopathy (PML, a rare but serious viral brain infection)
• Severe gastrointestinal bleeding or ulcers

Drug Interactions:

• Immunosuppressants: When used in combination with other immunosuppressive drugs (e.g., cyclosporine, tacrolimus), dose adjustments may be necessary to avoid excessive immunosuppression.
• Antacids/Antisecretory Agents: Drugs that alter gastric pH, such as proton pump inhibitors (PPIs), may reduce the absorption of Mycophenolate Mofetil.
• ACE Inhibitors and ARBs: May increase the risk of hyperkalemia and renal dysfunction, especially in patients with pre-existing kidney disease.
• Other Drugs that Cause Bone Marrow Suppression: Caution is needed when used with drugs that also suppress bone marrow function.

Storage:

• Store in a dry place at room temperature (20°C to 25°C or 68°F to 77°F).
• Keep in the original packaging to protect from moisture and light.
• Keep out of reach of children.