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Thalix (50mg / 100mg) - Thalidomide Capsules

Thalix (50mg / 100mg) - Thalidomide Capsules

Thalix contains Thalidomide, an immunomodulatory and anti-inflammatory agent widely used in combination therapy for multiple myeloma and leprosy-related complications. It inhibits abnormal cell growth and modulates the immune response.

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Description Product Details
General Information:
Generic Name: Thalidomide
Brand Name: Thalix
Packing: Strip of 10 Capsules
Strengths Available: 50mg, 100mg
Manufacturer: Fresenius Kabi India Pvt Ltd
Form: Capsules
Category: Immunomodulatory / Antineoplastic agent
Prescription Status: Strictly prescription-only due to teratogenic risks
Product Introduction:
Thalix is an oral medication used primarily in the treatment of multiple myeloma in combination with dexamethasone. It is also approved for erythema nodosum leprosum (ENL), a severe inflammatory complication of leprosy. Manufactured by Fresenius Kabi, Thalix is known for its efficacy and safety in oncology and immunology settings.
Uses:
Thalix is used in the treatment of:
  1. Multiple Myeloma (especially newly diagnosed or relapsed/refractory)
  2. Erythema Nodosum Leprosum (ENL)
  3. Graft-vs-host disease (off-label)
  4. Certain solid tumors (off-label use in research settings)
  5. Crohn's disease and autoimmune conditions (experimental)
  6. Kaposi's sarcoma (in selected cases)
Storage Instructions:
  1. Store below 25°C, in a cool, dry place
  2. Protect from light and moisture
  3. Keep container tightly closed and away from children and pregnant women
How It Works (Mechanism of Action):
Thalix (Thalidomide) works through multiple mechanisms:
  1. Inhibits angiogenesis (formation of new blood vessels), which starves tumors
  2. Modulates the immune response by suppressing pro-inflammatory cytokines like TNF-α
  3. Affects the tumor microenvironment by altering adhesion molecules and immune cell activation
  4. Induces apoptosis (cell death) in myeloma cells
Side Effects:
Common side effects include:
  1. Drowsiness and fatigue
  2. Constipation
  3. Peripheral neuropathy (numbness or tingling in hands/feet)
  4. Rash and skin dryness
  5. Dizziness
Severe side effects may include:
  1. Severe birth defects (if taken during pregnancy)
  2. Deep vein thrombosis (DVT) or pulmonary embolism
  3. Severe neuropathy
  4. Liver function impairment
  5. Seizures (rare but reported)
Dosage (Typical Recommended Dose):
  1. Multiple Myeloma (Adults): Usually 100–200 mg daily in combination with dexamethasone
  2. ENL: 100–300 mg daily depending on severity
  3. Dose may be adjusted based on tolerance and side effects
Method of Administration:
  1. Taken orally with or without food
  2. Swallow whole with water
  3. Usually taken once daily at bedtime to reduce drowsiness during daytime
Precautions:
  1. Pregnancy Warning: Do NOT use if pregnant – causes severe birth defects
  2. Women of childbearing age must use two effective methods of contraception
  3. Men must use condoms if partner is pregnant or of childbearing potential
  4. Monitor for signs of neuropathy or blood clots
  5. Avoid alcohol or other sedatives
  6. Regular neurological exams and blood counts are essential
Drug Interactions:
  1. Increased risk of sedation with CNS depressants (e.g., alcohol, benzodiazepines)
  2. Risk of thrombosis increases when used with steroids or chemotherapy
  3. Monitor when combined with warfarin or other anticoagulants
  4. May affect digoxin levels
Allergies:
  1. Avoid in patients with known allergy to thalidomide
  2. Watch for symptoms of allergic reactions: rash, itching, swelling, breathing difficulties
Overdose Information:
  1. Symptoms: Drowsiness, hypotension, slowed heart rate, confusion
  2. No known antidote; provide supportive treatment
  3. Seek emergency medical care immediately
Missed Dose Instructions:
  1. If a dose is missed, take it as soon as remembered
  2. If it’s close to the next dose, skip the missed dose
  3. Do not take double doses
Additional Notes:
  1. Thalix is subject to a strict Risk Management Program (RMP) due to its teratogenicity
  2. Educate patients on proper contraceptive measures and regular pregnancy testing
  3. Peripheral neuropathy may be irreversible—dose should be adjusted at first sign
  4. Increased thrombotic risk—prophylactic anticoagulation may be considered in high-risk patients

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